A Study to Evaluate the Safety of HIN1 Monovalent Vaccine (MEDI3414) in Children 2 to 17 Years of Age - MI-CP217

Study identifier:MI-CP217

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety of MEDI3414 in Children

Medical condition

Influenza

Phase

Phase 4

Healthy volunteers

Yes

Study drug

Sex

All

Actual Enrollment

326

Study type

Interventional

Age

2 Years - 17 Years

Date

Study Start Date: 01 Aug 2009

Primary Completion Date: 01 Sept 2009

Study Completion Date: 01 Mar 2010

Study design

Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Prevention

Verification:

Verified 01 Jul 2011 by MedImmune, LLC

Collaborators

Department of Health and Human Services

Inclusion and exclusion criteria

Inclusion Criteria

- Male or female, 2 to 17 years of age (not yet reached their 18th birthday) at the time of randomization
- Healthy by medical history and physical exam
- Written informed consent and any locally required authorization (eg, Health Insurance Portability and Accountability Act [HIPAA] in the United States of America [USA], European Union [EU] Data Privacy Directive in the EU and written informed assent) obtained from the subject/legal representative prior to performing any protocol-related procedures, including screening evaluations
- Females of child-bearing potential, (ie, unless premenarchal, surgically sterile [eg, bilateral tubal ligation, bilateral oophorectomy, or hysterectomy], has sterile male partner, or practices abstinence) must use an effective method of avoiding pregnancy (including oral, transdermal, or implanted contraceptives, intrauterine device, female condom with spermicide, diaphragm with spermicide, cervical cap, or use of a condom with spermicide by the sexual partner) for 30 days prior to the first dose of investigational product, and must agree to continue using such precautions for 60 days after the second dose of investigational product. In addition, the subject must also have a negative urine or blood pregnancy test at screening and, if screening and Day 1 do not occur on the same day, on the day of vaccination prior to randomization. Investigator judgment is required to assess the childbearing potential of a pre-adolescent or adolescent girl.
- Males, unless not sexually active, must use an effective method of birth control with a female partner and must agree to continue using such contraceptive precautions for at least 30 days after the second dose of investigational product (from Day 1 through Day 59 of the study)
- Subject's legal representative available by telephone
- Subject/subject's legal representative is able to understand and comply with the requirements of the protocol, as judged by the investigator
- Ability to complete follow-up period of 180 days after Dose 2 as required by the protocol

Exclusion Criteria

- History of hypersensitivity to any component of the investigational product including egg or egg protein, gelatin or arginine, or serious, life-threatening, or severe reactions to previous influenza vaccinations
- History of hypersensitivity to gentamicin
- Any condition for which the inactivated influenza vaccine is indicated, including chronic disorders of the pulmonary or cardiovascular systems (eg, asthma), chronic metabolic diseases (eg, diabetes mellitus), renal dysfunction, or hemoglobinopathies that required regular medical follow-up or hospitalization during the preceding year
- Acute febrile (> 100.0°F oral or equivalent) and/or clinically significant respiratory illness (eg, cough or sore throat) within 14 days prior to randomization
- History of asthma, or in children < 5 years of age, history of recurrent wheezing
- Any known immunosuppressive condition or immune deficiency disease, including human immunodeficiency virus infection, or ongoing immunosuppressive therapy
- History of Guillain-Barré syndrome
- A household contact who is severely immunocompromised (eg, hematopoietic stem cell transplant recipient, during those periods in which the immunocompromised individual requires care in a protective environment); subject should additionally avoid close contact with severely immunocompromised individuals for at least 21 days after receipt of investigational product
- Receipt of any investigational agent within 30 days prior to randomization, or expected receipt through 30 days after the second dose of investigational product (use of licensed agents for indications not listed in the package insert is permitted)
- Use of aspirin or salicylate-containing products within 30 days prior to randomization or expected receipt through 30 days after final vaccination
- Expected receipt of antipyretic or analgesic medication (non-salicylate-containing) on a daily or every other day basis from randomization through 14 days after receipt of each dose of investigational product
- Administration of intranasal medications within 14 days prior to randomization, or expected receipt through 14 days after administration of each dose of investigational product
- Receipt of any nonstudy vaccine within 30 days before or after Dose 1 or expected receipt of any nonstudy vaccine within 30 days before or after Dose 2
- Known or suspected mitochondrial encephalomyopathy
- Adolescent subject is pregnant or a nursing mother
- Any condition (eg, chronic cough, allergic rhinitis) that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study results
- Subject, legal representative, or immediate family member of subject is an employee of the clinical study site or is otherwise in involved with the conduct of the study

Location

Kentucky Pediatric Research Center

Bardstown, KY, United States, 40004

Location

Central Kentucky Research Associates, Inc.

Lexington, KY, United States, 40509

Location

California Research Foundation

San Diego, CA, United States, 92103-6204

Location

Spartanburg Medical Research

Spartanburg, SC, United States, 29303

Location

Benchmark Research

Austin, TX, United States, 78705

Location

Rochester Clinical Research Inc.

Rochester, NY, United States, 14069

Location

Meridian Clinical Research

Omaha, NE, United States, 68134

Location

Omega Medical Research

Warwick, RI, United States, 02886

Arms	Assigned Interventions
Active Comparator: MEDI3414 [Influenza A (H1N1) vaccine] MEDI3414- Monovalent vaccine was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 FFU (fluorescent focus units) of influenza virus type A/California/07/2009.	Biological/Vaccine: MEDI3414 [Influenza A(H1N1) live attenuated, intranasal] 0.5 mL: (intranasal sprayer)
Placebo Comparator: Placebo Placebo - Placebo was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer	Biological/Vaccine: Placebo Placebo was supplied in intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Study participation began once written informed consent was obtained. The first and last dates of informed consent were 03 Aug 2009 and 19 Aug 2009. Once informed consent was obtained, a subject identification number was assigned using an interactive voice response system, and screening evaluations began to assess study eligibility.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Eligible subjects were randomly assigned in a 4:1 ratio to receive 2 doses of study monovalent vaccine or placebo by intranasal spray; the doses were administered approximately 28 days apart, on Days 1 and 29.

Reporting Groups

	Description
H1N1 monovalent influenza vaccine	MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
Placebo	Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.

Participant Flow: Overall Study

	H1N1 monovalent influenza vaccine	Placebo
STARTED	261^[1]	65
Day 15 Post Dose 1	260	64
Day 15 Post Dose 2	254	63
COMPLETED	257	63
NOT COMPLETED	4	2
Lost to Follow-up	2	1
Withdrawal of consent	2	0
Physician Decision	0	1

[1]	Intent to Treat population, enrolled and randomized

Baseline Characteristics

Analysis Population Description -- Explanation of how the number of participants for analysis was determined.

Reporting Groups

	Description
H1N1 monovalent influenza vaccine	MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
Placebo	Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.

Baseline Measures

	H1N1 monovalent influenza vaccine	Placebo	Total
Number of Participants [units: Participants]	261	65	326
Age Continuous [units: years] Mean ± Standard Deviation	8.9 ± 4.3	9.2 ± 4.3	9.0 ± 4.3
Gender, Male/Female [units: participants]
Female	130	36	166
Male	131	29	160
Ethnicity (NIH/OMB) [units: participants]
Hispanic or Latino	50	17	67
Not Hispanic or Latino	211	48	259
Unknown or Not Reported	0	0	0
Race (NIH/OMB) [units: participants]
American Indian or Alaska Native	4	0	4
Asian	2	4	6
Native Hawaiian or Other Pacific Islander	2	0	2
Black or African American	43	12	55
White	198	43	241
More than one race	8	1	9
Other	4	5	9
Unknown or Not Reported	0	0	0

Outcome Measures

1. Primary Outcome Measure: Number of participants with fever post Dose 1 (Days 1-8), defined as an axillary temperature ≥ 101°F (38.3°C). [ Time Frame: Days 1- 8 ]

Measure Type	Primary
Measure Name	Number of participants with fever post Dose 1 (Days 1-8), defined as an axillary temperature ≥ 101°F (38.3°C).
Measure Description	The number of participants with fever between the two treatment groups was compared based on the upper limit of the two-sided 95% exact confidence intervals for the rate difference (Vaccine minus Placebo). The upper limit of the two-sided 95% confidence intervals was evaluated against the prespecified equivalence criterion of 10% which corresponded to the following hypotheses: H0 (null): rate difference ≥ 10%, HA (alternative): rate difference < 10%.
Time Frame	Days 1- 8
Safety Issue?	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The safety population included all participants who received at least one dose of investigational product and experienced any follow-up for safety (H1N1=259; Placebo=65).

Reporting Groups

	Description
H1N1 monovalent influenza vaccine	MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
Placebo	Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.

Measured Values

	H1N1 monovalent influenza vaccine	Placebo
Number of Participants Analyzed [units:participants]	259	65
Number of participants with fever post Dose 1 (Days 1-8), defined as an axillary temperature ≥ 101°F (38.3°C). [units: participants]	4	1

Statistical Analysis 1 for Number of participants with fever post Dose 1 (Days 1-8), defined as an axillary temperature ≥ 101°F (38.3°C).

Groups^[1]	All groups
Non-Inferiority/Equivalence Test^[2]	Yes
Method^[3]	Other [score]
Other^[5]	0.0
95% Confidence Interval	( -6.4 to 3.1 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	The rate of subjects with fever between the two treatment groups was compared based on the upper limit of the two-sided 95% exact confidence intervals for the rate difference (Vaccine minus Placebo). The upper limit of the two-sided 95% confidence intervals was evaluated against the pre-specified equivalence criterion of 10% which corresponds to the following hypotheses: H0 (null): rate difference ≥ 10%, HA (alternative): rate difference < 10%
[2]	Additional details about a non-inferiority or equivalence analysis:
	For the calculation of the power to rule out a 10% increase of fever rate in vaccine recipients with 300 evaluable subjects (240 vaccine and 60 placebo recipients), it is assumed that the true fever rate in the monovalent vaccine group is 3.0% to 8.0%,and the true fever rate in placebo group is 0% to 3% lower than the fever rate in the vaccine group.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[5]	Other relevant estimation information:
	No text entered.

2. Primary Outcome Measure: Number of participants who experience a post Dose 1 (Day 15) seroresponse against the H1N1 strain in all participants regardless of baseline serostatus [ Time Frame: Day 1, Day 15 ]

Measure Type	Primary
Measure Name	Number of participants who experience a post Dose 1 (Day 15) seroresponse against the H1N1 strain in all participants regardless of baseline serostatus
Measure Description	Seroresponse is described as greater than or equal to a 4-fold rise in hemagglutination inhibition (HAI) titer from baseline. All immunogenicity analyses was based on the immunogenicity population.
Time Frame	Day 1, Day 15
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants who received Dose 1 of study vaccine (H1N1=259; Placebo=65), had valid HAI measurements from blood samples obtained at baseline and post Dose 1 were included in the analysis (H1N1=129; Placebo=32).

Reporting Groups

	Description
H1N1 monovalent influenza vaccine	MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
Placebo	Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.

Measured Values

	H1N1 monovalent influenza vaccine	Placebo
Number of Participants Analyzed [units:participants]	129	32
Number of participants who experience a post Dose 1 (Day 15) seroresponse against the H1N1 strain in all participants regardless of baseline serostatus [units: participants]	10	2

Statistical Analysis 1 for Number of participants who experience a post Dose 1 (Day 15) seroresponse against the H1N1 strain in all participants regardless of baseline serostatus

Groups^[1]	All groups
Non-Inferiority/Equivalence Test^[2]	No
Method^[3]	Other [score]
Other^[5]	1.5
95% Confidence Interval	( -12.8 to 9.8 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	The number of subjects who experienced a post-dose seroresponse was compared based on the upper limit of the two-sided 95% exact confidence intervals for the rate difference (Vaccine minus Placebo).
[2]	Additional details about a non-inferiority or equivalence analysis:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[5]	Other relevant estimation information:
	No text entered.

3. Primary Outcome Measure: Number of participants who experience a post Dose 1 (Day 29) seroresponse against the H1N1 strain in all participants regardless of baseline serostatus [ Time Frame: Day 1, Day 29 ]

Measure Type	Primary
Measure Name	Number of participants who experience a post Dose 1 (Day 29) seroresponse against the H1N1 strain in all participants regardless of baseline serostatus
Measure Description	Seroresponse is described as greater than or equal to a 4-fold rise in HAI titer from baseline. All immunogenicity analyses are based on the immunogenicity population.
Time Frame	Day 1, Day 29
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants who received Dose 1 of study vaccine (H1N1=259; Placebo=65) and had valid HAI measurements from blood samples obtained at baseline and post Dose 1 (H1N1=126; Placebo=32).

Reporting Groups

	Description
H1N1 monovalent influenza vaccine	MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
Placebo	Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.

Measured Values

	H1N1 monovalent influenza vaccine	Placebo
Number of Participants Analyzed [units:participants]	126	32
Number of participants who experience a post Dose 1 (Day 29) seroresponse against the H1N1 strain in all participants regardless of baseline serostatus [units: participants]	14	2

Statistical Analysis 1 for Number of participants who experience a post Dose 1 (Day 29) seroresponse against the H1N1 strain in all participants regardless of baseline serostatus

Groups^[1]	All groups
Non-Inferiority/Equivalence Test^[2]	No
Method^[3]	Other [score]
Other^[5]	4.9
95% Confidence Interval	( -9.6 to 13.8 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	The number of subjects who experienced a post-dose seroresponse was compared based on the upper limit of the two-sided 95% exact confidence intervals for the rate difference (Vaccine minus Placebo).
[2]	Additional details about a non-inferiority or equivalence analysis:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[5]	Other relevant estimation information:
	No text entered.

4. Primary Outcome Measure: Number of participants who experience a post Dose 2 (Day 57) seroresponse against the H1N1 strain in all participants regardless of baseline serostatus [ Time Frame: Day 1, Day 57 ]

Measure Type	Primary
Measure Name	Number of participants who experience a post Dose 2 (Day 57) seroresponse against the H1N1 strain in all participants regardless of baseline serostatus
Measure Description	Seroresponse is described as greater than or equal to a 4-fold rise in HAI titer from baseline. All immunogenicity analyses are based on the immunogenicity population.
Time Frame	Day 1, Day 57
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants who received 2 doses of the same study vaccine (H1N1=258; Placebo=65) and had valid HAI measurements from blood samples obtained at baseline and post Dose 2 were included in the analysis (H1N1=250; Placebo=62).

Reporting Groups

	Description
H1N1 monovalent influenza vaccine	MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
Placebo	Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.

Measured Values

	H1N1 monovalent influenza vaccine	Placebo
Number of Participants Analyzed [units:participants]	250	62
Number of participants who experience a post Dose 2 (Day 57) seroresponse against the H1N1 strain in all participants regardless of baseline serostatus [units: participants]	80	9

Statistical Analysis 1 for Number of participants who experience a post Dose 2 (Day 57) seroresponse against the H1N1 strain in all participants regardless of baseline serostatus

Groups^[1]	All groups
Non-Inferiority/Equivalence Test^[2]	No
Method^[3]	Other [score]
Other^[5]	17.5
95% Confidence Interval	( 5.5 to 27.1 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	The number of subjects who experienced a post-dose seroresponse was compared based on the upper limit of the two-sided 95% exact confidence intervals for the rate difference (Vaccine minus Placebo).
[2]	Additional details about a non-inferiority or equivalence analysis:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[5]	Other relevant estimation information:
	No text entered.

5. Secondary Outcome Measure: Number of participants with any solicited symptoms within 7 days after vaccination with investigational product, Dose 1 [ Time Frame: Days 1-8 ]

Measure Type	Secondary
Measure Name	Number of participants with any solicited symptoms within 7 days after vaccination with investigational product, Dose 1
Measure Description	Other solicited symptoms include fever (> 100°F [37.8°C] axillary), runny/stuffy nose, sore throat, cough, headache, generalized muscle aches, decreased activity level (lethargy) or tiredness/weakness, decreased appetite.
Time Frame	Days 1-8
Safety Issue?	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The safety population included all participants who received at least one dose of investigational product (H1N1=259; Placebo=65), experienced any follow-up for safety and had solicited symptoms data available during the reporting period (H1N1=259; Placebo=65).

Reporting Groups

	Description
H1N1 monovalent influenza vaccine	MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
Placebo	Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.

Measured Values

	H1N1 monovalent influenza vaccine	Placebo
Number of Participants Analyzed [units:participants]	259	65
Number of participants with any solicited symptoms within 7 days after vaccination with investigational product, Dose 1 [units: participants]	97	21

Statistical Analysis 1 for Number of participants with any solicited symptoms within 7 days after vaccination with investigational product, Dose 1

Groups^[1]	All groups
Non-Inferiority/Equivalence Test^[2]	No
Method^[3]	Other [score]
Other^[5]	5.1
95% Confidence Interval	( -8.4 to 17.6 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Rates of solicited symptoms following each dose (Days 1 to 8 and Days 1 to 15) between the two treatment groups were compated following each dose. Exact two-sided 95% confidence intervals (Chan and Zhang, 1999) on the rate difference (Vaccine minus Placebo) were constructed. There were no prespecified equivalence criteria for the secondary analyses.
[2]	Additional details about a non-inferiority or equivalence analysis:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[5]	Other relevant estimation information:
	No text entered.

6. Secondary Outcome Measure: Number of participants reporting adverse events (AEs) within 7 days after vaccination with investigational product, Dose 1 [ Time Frame: Days 1-8 ]

Measure Type	Secondary
Measure Name	Number of participants reporting adverse events (AEs) within 7 days after vaccination with investigational product, Dose 1
Measure Description
Time Frame	Days 1-8
Safety Issue?	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The safety population included all participants who received at least one dose of investigational product (H1N1=259; Placebo=65) and experienced any follow-up for safety (H1N1=259; Placebo=65).

Reporting Groups

	Description
H1N1 monovalent influenza vaccine	MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
Placebo	Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.

Measured Values

	H1N1 monovalent influenza vaccine	Placebo
Number of Participants Analyzed [units:participants]	259	65
Number of participants reporting adverse events (AEs) within 7 days after vaccination with investigational product, Dose 1 [units: participants]	28	7

No statistical analysis provided for Number of participants reporting adverse events (AEs) within 7 days after vaccination with investigational product, Dose 1

7. Secondary Outcome Measure: Number of participants using anti-pyretic and analgesic agents within 7 days after vaccination with investigational product, Dose 1 [ Time Frame: Days 1-8 ]

Measure Type	Secondary
Measure Name	Number of participants using anti-pyretic and analgesic agents within 7 days after vaccination with investigational product, Dose 1
Measure Description
Time Frame	Days 1-8
Safety Issue?	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The safety population included all participants who received at least one dose of investigational product (H1N1=259; Placebo=65) and experienced any follow-up for safety (H1N1=259; Placebo=65).

Reporting Groups

	Description
H1N1 monovalent influenza vaccine	MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
Placebo	Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.

Measured Values

	H1N1 monovalent influenza vaccine	Placebo
Number of Participants Analyzed [units:participants]	259	65
Number of participants using anti-pyretic and analgesic agents within 7 days after vaccination with investigational product, Dose 1 [units: participants]	18	1

No statistical analysis provided for Number of participants using anti-pyretic and analgesic agents within 7 days after vaccination with investigational product, Dose 1

8. Secondary Outcome Measure: Number of participants with any solicited symptoms within 14 days after vaccination with investigational product, Dose 1 [ Time Frame: Days 1-15 ]

Measure Type	Secondary
Measure Name	Number of participants with any solicited symptoms within 14 days after vaccination with investigational product, Dose 1
Measure Description
Time Frame	Days 1-15
Safety Issue?	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The safety population included all participants who received at least one dose of investigational product (H1N1=259; Placebo=65), experienced any follow-up for safety, and had solicited symptoms data available during the reporting period (H1N1=259; Placebo=65).

Reporting Groups

	Description
H1N1 monovalent influenza vaccine	MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
Placebo	Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.

Measured Values

	H1N1 monovalent influenza vaccine	Placebo
Number of Participants Analyzed [units:participants]	259	65
Number of participants with any solicited symptoms within 14 days after vaccination with investigational product, Dose 1 [units: participants]	122	22

Statistical Analysis 1 for Number of participants with any solicited symptoms within 14 days after vaccination with investigational product, Dose 1

Groups^[1]	All groups
Non-Inferiority/Equivalence Test^[2]	No
Method^[3]	Other [score]
Other^[5]	13.3
95% Confidence Interval	( -0.4 to 25.7 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Rates of solicited symptoms following each dose (Days 1 to 8 and Days 1 to 15) between the two treatment groups were compared following each dose. Exact two-sided 95% confidence intervals (Chan and Zhang, 1999) on the rate difference (Vaccine minus Placebo) were constructed. There were no prespecified equivalence criteria for the secondary analyses.
[2]	Additional details about a non-inferiority or equivalence analysis:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[5]	Other relevant estimation information:
	No text entered.

9. Secondary Outcome Measure: Number of participants reporting AEs within 14 days after vaccination with investigational product, Dose 1 [ Time Frame: Days 1-15 ]

Measure Type	Secondary
Measure Name	Number of participants reporting AEs within 14 days after vaccination with investigational product, Dose 1
Measure Description
Time Frame	Days 1-15
Safety Issue?	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The safety population included all participants who received at least one dose of investigational product (H1N1=259; Placebo=65) and experienced any follow-up for safety (H1N1=259; Placebo=65).

Reporting Groups

	Description
H1N1 monovalent influenza vaccine	MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
Placebo	Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.

Measured Values

	H1N1 monovalent influenza vaccine	Placebo
Number of Participants Analyzed [units:participants]	259	65
Number of participants reporting AEs within 14 days after vaccination with investigational product, Dose 1 [units: participants]	47	11

No statistical analysis provided for Number of participants reporting AEs within 14 days after vaccination with investigational product, Dose 1

10. Secondary Outcome Measure: Number of participants using anti-pyretic and analgesic agents within 14 days after vaccination with investigational product, Dose 1 [ Time Frame: Days 1-15 ]

Measure Type	Secondary
Measure Name	Number of participants using anti-pyretic and analgesic agents within 14 days after vaccination with investigational product, Dose 1
Measure Description
Time Frame	Days 1-15
Safety Issue?	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The safety population included all participants who received at least one dose of investigational product (H1N1=259; Placebo=65) and experienced any follow-up for safety (H1N1=259; Placebo=65).

Reporting Groups

	Description
H1N1 monovalent influenza vaccine	MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
Placebo	Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.

Measured Values

	H1N1 monovalent influenza vaccine	Placebo
Number of Participants Analyzed [units:participants]	259	65
Number of participants using anti-pyretic and analgesic agents within 14 days after vaccination with investigational product, Dose 1 [units: participants]	27	2

No statistical analysis provided for Number of participants using anti-pyretic and analgesic agents within 14 days after vaccination with investigational product, Dose 1

11. Secondary Outcome Measure: Number of participants with any solicited symptoms within 7 days after vaccination with investigational product, Dose 2 [ Time Frame: Days 29-36 ]

Measure Type	Secondary
Measure Name	Number of participants with any solicited symptoms within 7 days after vaccination with investigational product, Dose 2
Measure Description
Time Frame	Days 29-36
Safety Issue?	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The safety population for solicited symptoms Dose 2 included all participants who received Dose 2 (H1N1=258; Placebo=65), experienced any follow-up for safety and had solicited symptom data available during the reporting period (H1N1=255; Placebo=63).

Reporting Groups

	Description
H1N1 monovalent influenza vaccine	MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
Placebo	Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.

Measured Values

	H1N1 monovalent influenza vaccine	Placebo
Number of Participants Analyzed [units:participants]	255	63
Number of participants with any solicited symptoms within 7 days after vaccination with investigational product, Dose 2 [units: participants]	65	20

Statistical Analysis 1 for Number of participants with any solicited symptoms within 7 days after vaccination with investigational product, Dose 2

Groups^[1]	All groups
Non-Inferiority/Equivalence Test^[2]	No
Method^[3]	Other [score]
Other^[5]	-6.3
95% Confidence Interval	( -19.7 to 6.1 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Rates of solicited symptoms following each dose (Days 1 to 8 and Days 1 to 15) between the two treatment groups were compared following each dose. Exact two-sided 95% confidence intervals (Chan and Zhang, 1999) on the rate difference (Vaccine minus Placebo) were constructed. There were no prespecified equivalence criteria for the secondary analyses.
[2]	Additional details about a non-inferiority or equivalence analysis:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[5]	Other relevant estimation information:
	No text entered.

12. Secondary Outcome Measure: Number of participants reporting AEs within 7 days after vaccination with investigational product, Dose 2 [ Time Frame: Days 29-36 ]

Measure Type	Secondary
Measure Name	Number of participants reporting AEs within 7 days after vaccination with investigational product, Dose 2
Measure Description
Time Frame	Days 29-36
Safety Issue?	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The safety population included all participants who received Dose 2 (H1N1=258; Placebo) and experienced any follow-up for safety (H1N1=255; Placebo=63).

Reporting Groups

	Description
H1N1 monovalent influenza vaccine	MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
Placebo	Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.

Measured Values

	H1N1 monovalent influenza vaccine	Placebo
Number of Participants Analyzed [units:participants]	255	63
Number of participants reporting AEs within 7 days after vaccination with investigational product, Dose 2 [units: participants]	20	2

No statistical analysis provided for Number of participants reporting AEs within 7 days after vaccination with investigational product, Dose 2

13. Secondary Outcome Measure: Number of participants using anti-pyretic and analgesic agents within 7 days after vaccination with investigational product, Dose 2 [ Time Frame: Days 29-36 ]

Measure Type	Secondary
Measure Name	Number of participants using anti-pyretic and analgesic agents within 7 days after vaccination with investigational product, Dose 2
Measure Description
Time Frame	Days 29-36
Safety Issue?	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The safety population included all participants who received Dose 2 (H1N1=258; Placebo=65) and experienced any follow-up for safety (H1N1=255; Placebo=63).

Reporting Groups

	Description
H1N1 monovalent influenza vaccine	MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
Placebo	Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.

Measured Values

	H1N1 monovalent influenza vaccine	Placebo
Number of Participants Analyzed [units:participants]	255	63
Number of participants using anti-pyretic and analgesic agents within 7 days after vaccination with investigational product, Dose 2 [units: participants]	10	5

No statistical analysis provided for Number of participants using anti-pyretic and analgesic agents within 7 days after vaccination with investigational product, Dose 2

14. Secondary Outcome Measure: Number of participants with any solicited symptoms within 14 days after vaccination with investigational product, Dose 2 [ Time Frame: Days 29-43 ]

Measure Type	Secondary
Measure Name	Number of participants with any solicited symptoms within 14 days after vaccination with investigational product, Dose 2
Measure Description
Time Frame	Days 29-43
Safety Issue?	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The safety population for solicited symptoms Dose 2 included all participants who received Dose 2 (H1N1=258; Placebo=65), experienced any follow-up for safety and had solicited symptom data available during the reporting period (H1N1=255; Placebo=63).

Reporting Groups

	Description
H1N1 monovalent influenza vaccine	MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
Placebo	Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.

Measured Values

	H1N1 monovalent influenza vaccine	Placebo
Number of Participants Analyzed [units:participants]	255	63
Number of participants with any solicited symptoms within 14 days after vaccination with investigational product, Dose 2 [units: participants]	93	27

Statistical Analysis 1 for Number of participants with any solicited symptoms within 14 days after vaccination with investigational product, Dose 2

Groups^[1]	H1N1 monovalent influenza vaccine
Non-Inferiority/Equivalence Test^[2]	No
Method^[3]	Other [score]
Other^[5]	-6.4
95% Confidence Interval	( -20.3 to 7.1 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Rates of solicited symptoms following each dose (Days 1 to 8 and Days 1 to 15) between the two treatment groups were compared following each dose. Exact two-sided 95% confidence intervals (Chan and Zhang, 1999) on the rate difference (Vaccine minus Placebo) were constructed. There were no prespecified equivalence criteria for the secondary analyses.
[2]	Additional details about a non-inferiority or equivalence analysis:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[5]	Other relevant estimation information:
	No text entered.

15. Secondary Outcome Measure: Number of participants reporting AEs within 14 days after vaccination with investigational product, Dose 2 [ Time Frame: Days 29-43 ]

Measure Type	Secondary
Measure Name	Number of participants reporting AEs within 14 days after vaccination with investigational product, Dose 2
Measure Description
Time Frame	Days 29-43
Safety Issue?	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The safety population included all participants who received Dose 2 (H1N1=258; Placebo=65), experienced any follow-up for safety (H1N1=255; Placebo=63).

Reporting Groups

	Description
H1N1 monovalent influenza vaccine	MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
Placebo	Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.

Measured Values

	H1N1 monovalent influenza vaccine	Placebo
Number of Participants Analyzed [units:participants]	255	63
Number of participants reporting AEs within 14 days after vaccination with investigational product, Dose 2 [units: participants]	35	9

No statistical analysis provided for Number of participants reporting AEs within 14 days after vaccination with investigational product, Dose 2

16. Secondary Outcome Measure: Number of participants using anti-pyretic and analgesic agents within 14 days after vaccination with investigational product, Dose 2 [ Time Frame: Days 29-43 ]

Measure Type	Secondary
Measure Name	Number of participants using anti-pyretic and analgesic agents within 14 days after vaccination with investigational product, Dose 2
Measure Description
Time Frame	Days 29-43
Safety Issue?	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The safety population included all participants who received Dose 2 (H1N1=258; Placebo=65), experienced any follow-up for safety (H1N1=255; Placebo=63).

Reporting Groups

	Description
H1N1 monovalent influenza vaccine	MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
Placebo	Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.

Measured Values

	H1N1 monovalent influenza vaccine	Placebo
Number of Participants Analyzed [units:participants]	255	63
Number of participants using anti-pyretic and analgesic agents within 14 days after vaccination with investigational product, Dose 2 [units: participants]	22	11

No statistical analysis provided for Number of participants using anti-pyretic and analgesic agents within 14 days after vaccination with investigational product, Dose 2

17. Secondary Outcome Measure: Number of participants with new onset chronic diseases (NOCDs) within 28 days after vaccination with investigational product, Dose 1. [ Time Frame: Days 1-29 ]

Measure Type	Secondary
Measure Name	Number of participants with new onset chronic diseases (NOCDs) within 28 days after vaccination with investigational product, Dose 1.
Measure Description	An NOCD was a newly diagnosed medical condition that was of a chronic, ongoing nature and was assessed by the investigator as medically significant. Examples of NOCDs included, but were not limited to, diabetes, asthma, autoimmune disease (eg, lupus, rheumatoid arthritis), and neurological disease (eg, epilepsy, autism). Examples of events not considered NOCDs were mild eczema, diagnosis of a congenital anomaly present at study entry, or acute illness (eg, otitis media, bronchitis).
Time Frame	Days 1-29
Safety Issue?	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The safety population included all participants who received at least one dose of investigational product (H1N1=259; Placebo=65) and experienced any follow-up for safety (H1N1=259; Placebo=65).

Reporting Groups

	Description
H1N1 monovalent influenza vaccine	MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
Placebo	Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.

Measured Values

	H1N1 monovalent influenza vaccine	Placebo
Number of Participants Analyzed [units:participants]	259	65
Number of participants with new onset chronic diseases (NOCDs) within 28 days after vaccination with investigational product, Dose 1. [units: participants]	0	0

No statistical analysis provided for Number of participants with new onset chronic diseases (NOCDs) within 28 days after vaccination with investigational product, Dose 1.

18. Secondary Outcome Measure: Number of participants with serious adverse events (SAEs) within 28 days after vaccination with investigational product, Dose 1 [ Time Frame: Days 1-29 ]

Measure Type	Secondary
Measure Name	Number of participants with serious adverse events (SAEs) within 28 days after vaccination with investigational product, Dose 1
Measure Description	SAEs were those AEs that resulted in death; were immediately life threatening; resulted in inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability or incapacity; were a congenital anomaly in the offspring of a participant; or were an important medical event that may not have resulted in death, threatened life, or required hospitalization and that, based on appropriate medical judgment, may have jeopardized the participant and may have required medical or surgical intervention to prevent one of the outcomes listed above.
Time Frame	Days 1-29
Safety Issue?	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The safety population included all participants who received at least one dose of investigational product (H1N1=259; Placebo=65) and experienced any follow-up for safety (H1N1=259; Placebo=65).

Reporting Groups

	Description
H1N1 monovalent influenza vaccine	MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
Placebo	Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.

Measured Values

	H1N1 monovalent influenza vaccine	Placebo
Number of Participants Analyzed [units:participants]	259	65
Number of participants with serious adverse events (SAEs) within 28 days after vaccination with investigational product, Dose 1 [units: participants]	1	0

No statistical analysis provided for Number of participants with serious adverse events (SAEs) within 28 days after vaccination with investigational product, Dose 1

19. Secondary Outcome Measure: Number of participants with NOCDs within 28 days after vaccination with investigational product, Dose 2. [ Time Frame: Days 29-57 ]

Measure Type	Secondary
Measure Name	Number of participants with NOCDs within 28 days after vaccination with investigational product, Dose 2.
Measure Description	An NOCD was a newly diagnosed medical condition that was of a chronic, ongoing nature and was assessed by the investigator as medically significant. Examples of NOCDs included, but were not limited to, diabetes, asthma, autoimmune disease (eg, lupus, rheumatoid arthritis), and neurological disease (eg, epilepsy, autism). Examples of events not considered NOCDs were mild eczema, diagnosis of a congenital anomaly present at study entry, or acute illness (eg, otitis media, bronchitis).
Time Frame	Days 29-57
Safety Issue?	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The safety population included all participants who received Dose 2 (H1N1=258; Placebo=65) and experienced any follow-up for safety (H1N1=255; Placebo=63).

Reporting Groups

	Description
H1N1 monovalent influenza vaccine	MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
Placebo	Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.

Measured Values

	H1N1 monovalent influenza vaccine	Placebo
Number of Participants Analyzed [units:participants]	255	63
Number of participants with NOCDs within 28 days after vaccination with investigational product, Dose 2. [units: participants]	0	1

No statistical analysis provided for Number of participants with NOCDs within 28 days after vaccination with investigational product, Dose 2.

20. Secondary Outcome Measure: Number of participants with SAEs within 28 days after vaccination with investigational product, Dose 2 [ Time Frame: Days 29-57 ]

Measure Type	Secondary
Measure Name	Number of participants with SAEs within 28 days after vaccination with investigational product, Dose 2
Measure Description	SAEs were those AEs that resulted in death; were immediately life threatening; resulted in inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability or incapacity; were a congenital anomaly in the offspring of a participant; or were an important medical event that may not have resulted in death, threatened life, or required hospitalization and that, based on appropriate medical judgment, may have jeopardized the participant and may have required medical or surgical intervention to prevent one of the outcomes listed above.
Time Frame	Days 29-57
Safety Issue?	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The safety population included all participants who received Dose 2 (H1N1=258; Placebo=65) and experienced any follow-up for safety (H1N1=255; Placebo=63).

Reporting Groups

	Description
H1N1 monovalent influenza vaccine	MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
Placebo	Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.

Measured Values

	H1N1 monovalent influenza vaccine	Placebo
Number of Participants Analyzed [units:participants]	255	63
Number of participants with SAEs within 28 days after vaccination with investigational product, Dose 2 [units: participants]	0	0

No statistical analysis provided for Number of participants with SAEs within 28 days after vaccination with investigational product, Dose 2

21. Secondary Outcome Measure: Number of participants with NOCDs within 180 days post final dose of investigational product. [ Time Frame: Days 1-209 ]

Measure Type	Secondary
Measure Name	Number of participants with NOCDs within 180 days post final dose of investigational product.
Measure Description	An NOCD was a newly diagnosed medical condition that was of a chronic, ongoing nature and was assessed by the investigator as medically significant. Examples of NOCDs included, but were not limited to, diabetes, asthma, autoimmune disease (eg, lupus, rheumatoid arthritis), and neurological disease (eg, epilepsy, autism). Examples of events not considered NOCDs were mild eczema, diagnosis of a congenital anomaly present at study entry, or acute illness (eg, otitis media, bronchitis).
Time Frame	Days 1-209
Safety Issue?	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The safety population included all participants who received at least one dose of investigational product (H1N1=259; Placebo=65) and experienced any follow-up for safety (H1N1=259; Placebo=65).

Reporting Groups

	Description
H1N1 monovalent influenza vaccine	MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
Placebo	Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.

Measured Values

	H1N1 monovalent influenza vaccine	Placebo
Number of Participants Analyzed [units:participants]	259	65
Number of participants with NOCDs within 180 days post final dose of investigational product. [units: Participants]	0	1

No statistical analysis provided for Number of participants with NOCDs within 180 days post final dose of investigational product.

22. Secondary Outcome Measure: Number of participants with SAEs within 180 days post final dose of investigational product. [ Time Frame: Days 1-209 ]

Measure Type	Secondary
Measure Name	Number of participants with SAEs within 180 days post final dose of investigational product.
Measure Description	SAEs were those AEs that resulted in death; were immediately life threatening; resulted in inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability or incapacity; were a congenital anomaly in the offspring of a participant; or were an important medical event that may not have resulted in death, threatened life, or required hospitalization and that, based on appropriate medical judgment, may have jeopardized the participant and may have required medical or surgical intervention to prevent one of the outcomes listed above.
Time Frame	Days 1-209
Safety Issue?	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The safety population included all participants who received at least one dose of investigational product (H1N1=259; Placebo=65) and experienced any follow-up for safety (H1N1=259; Placebo=65).

Reporting Groups

	Description
H1N1 monovalent influenza vaccine	MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
Placebo	Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.

Measured Values

	H1N1 monovalent influenza vaccine	Placebo
Number of Participants Analyzed [units:participants]	259	65
Number of participants with SAEs within 180 days post final dose of investigational product. [units: participants]	2	1

No statistical analysis provided for Number of participants with SAEs within 180 days post final dose of investigational product.

23. Secondary Outcome Measure: Number of participants who achieve a post Dose 1 (Day 15) HAI titer greater than or equal to 32 against the H1N1 strain in all participants, regardless of baseline serostatus. [ Time Frame: Day 1, Day 15 ]

Measure Type	Secondary
Measure Name	Number of participants who achieve a post Dose 1 (Day 15) HAI titer greater than or equal to 32 against the H1N1 strain in all participants, regardless of baseline serostatus.
Measure Description	All immunogenicity analyses are based on the immunogenicity population.
Time Frame	Day 1, Day 15
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants who received Dose 1 of study vaccine (H1N1=259; Placebo=65), had valid HAI measurements from blood samples obtained at baseline and post Dose 1 were included in the analysis (H1N1=129; Placebo=32).

Reporting Groups

	Description
H1N1 monovalent influenza vaccine	MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
Placebo	Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.

Measured Values

	H1N1 monovalent influenza vaccine	Placebo
Number of Participants Analyzed [units:participants]	129	32
Number of participants who achieve a post Dose 1 (Day 15) HAI titer greater than or equal to 32 against the H1N1 strain in all participants, regardless of baseline serostatus. [units: participants]	13	1

Statistical Analysis 1 for Number of participants who achieve a post Dose 1 (Day 15) HAI titer greater than or equal to 32 against the H1N1 strain in all participants, regardless of baseline serostatus.

Groups^[1]	H1N1 monovalent influenza vaccine
Non-Inferiority/Equivalence Test^[2]	No
Method^[3]	Other [score]
Other^[5]	7.0
95% Confidence Interval	( -6.1 to 14.7 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	The number of subjects who achieved a post Dose 1 HAI titer greater than or equal to 32 against the H1N1 strain was compared based on the upper limit of the two-sided 95% exact confidence intervals for the rate difference (Vaccine minus Placebo).
[2]	Additional details about a non-inferiority or equivalence analysis:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[5]	Other relevant estimation information:
	No text entered.

24. Secondary Outcome Measure: Number of participants who achieve a post Dose 1 (Day 29) HAI titer greater than or equal to 32 against the H1N1 strain in all participants, regardless of baseline serostatus. [ Time Frame: Day 1, Day 29 ]

Measure Type	Secondary
Measure Name	Number of participants who achieve a post Dose 1 (Day 29) HAI titer greater than or equal to 32 against the H1N1 strain in all participants, regardless of baseline serostatus.
Measure Description	All immunogenicity analyses are based on the immunogenicity population.
Time Frame	Day 1, Day 29
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants who received Dose 1 of study vaccine (H1N1=259; Placebo=65), had valid HAI measurements from blood samples obtained at baseline and post Dose 1 were included in the analysis (H1N1=126; Placebo=32).

Reporting Groups

	Description
H1N1 monovalent influenza vaccine	MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
Placebo	Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.

Measured Values

	H1N1 monovalent influenza vaccine	Placebo
Number of Participants Analyzed [units:participants]	126	32
Number of participants who achieve a post Dose 1 (Day 29) HAI titer greater than or equal to 32 against the H1N1 strain in all participants, regardless of baseline serostatus. [units: participants]	13	1

Statistical Analysis 1 for Number of participants who achieve a post Dose 1 (Day 29) HAI titer greater than or equal to 32 against the H1N1 strain in all participants, regardless of baseline serostatus.

Groups^[1]	All groups
Non-Inferiority/Equivalence Test^[2]	No
Method^[3]	Other [score]
Other^[5]	7.2
95% Confidence Interval	( -5.8 to 15.1 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	The number of subjects who achieved a post Dose 1 HAI titer greater than or equal to 32 against the H1N1 strain was compared based on the upper limit of the two-sided 95% exact confidence intervals for the rate difference (Vaccine minus Placebo).
[2]	Additional details about a non-inferiority or equivalence analysis:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[5]	Other relevant estimation information:
	No text entered.

25. Secondary Outcome Measure: Number of participants who achieve a post Dose 2 (Day 57) HAI titer greater than or equal to 32 against the H1N1 strain in all participants, regardless of baseline serostatus. [ Time Frame: Day 1, Day 57 ]

Measure Type	Secondary
Measure Name	Number of participants who achieve a post Dose 2 (Day 57) HAI titer greater than or equal to 32 against the H1N1 strain in all participants, regardless of baseline serostatus.
Measure Description	All immunogenicity analyses are based on the immunogenicity population.
Time Frame	Day 1, Day 57
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants who received 2 doses of the same study vaccine (H1N1=258; Placebo=65), had valid HAI measurements from blood samples obtained at baseline and post Dose 2 were included in the analysis (H1N1=250; Placebo=62).

Reporting Groups

	Description
H1N1 monovalent influenza vaccine	MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
Placebo	Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.

Measured Values

	H1N1 monovalent influenza vaccine	Placebo
Number of Participants Analyzed [units:participants]	250	62
Number of participants who achieve a post Dose 2 (Day 57) HAI titer greater than or equal to 32 against the H1N1 strain in all participants, regardless of baseline serostatus. [units: participants]	66	6

Statistical Analysis 1 for Number of participants who achieve a post Dose 2 (Day 57) HAI titer greater than or equal to 32 against the H1N1 strain in all participants, regardless of baseline serostatus.

Groups^[1]	All groups
Non-Inferiority/Equivalence Test^[2]	No
Method^[3]	Other [score]
Other^[5]	16.7
95% Confidence Interval	( 5.9 to 25.2 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	The number of subjects who achieved a post Dose 2 HAI titer greater than or equal to 32 against the H1N1 strain was compared based on the upper limit of the two-sided 95% exact confidence intervals for the rate difference (Vaccine minus Placebo).
[2]	Additional details about a non-inferiority or equivalence analysis:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[5]	Other relevant estimation information:
	No text entered.

26. Secondary Outcome Measure: Serum HAI geometric mean titers (GMTs) in all participants, regardless of baseline serostatus, Dose 1 (Day 15) [ Time Frame: Day 1, Day 15 ]

Measure Type	Secondary
Measure Name	Serum HAI geometric mean titers (GMTs) in all participants, regardless of baseline serostatus, Dose 1 (Day 15)
Measure Description	All immunogenicity analyses are based on the immunogenicity population.
Time Frame	Day 1, Day 15
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants who received Dose 1 of study vaccine (H1N1=259; Placebo=65), had valid HAI measurements from blood samples obtained at baseline and post Dose 1 were included in the analysis (H1N1=129; Placebo=32).

Reporting Groups

	Description
H1N1 monovalent influenza vaccine	MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
Placebo	Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.

Measured Values

	H1N1 monovalent influenza vaccine	Placebo
Number of Participants Analyzed [units:participants]	129	32
Serum HAI geometric mean titers (GMTs) in all participants, regardless of baseline serostatus, Dose 1 (Day 15) [units: titer] Geometric Mean (Full Range)	3.55 (2 to 128)	2.89 (2 to 32)

No statistical analysis provided for Serum HAI geometric mean titers (GMTs) in all participants, regardless of baseline serostatus, Dose 1 (Day 15)

27. Secondary Outcome Measure: Serum HAI GMTs in all participants, regardless of baseline serostatus, Dose 1 (Day 29) [ Time Frame: Day 1, Day 29 ]

Measure Type	Secondary
Measure Name	Serum HAI GMTs in all participants, regardless of baseline serostatus, Dose 1 (Day 29)
Measure Description	All immunogenicity analyses are based on the immunogenicity population.
Time Frame	Day 1, Day 29
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants who received Dose 1 of study vaccine (H1N1=259; Placebo=65), had valid HAI measurements from blood samples obtained at baseline and post Dose 1 were included in the analysis (H1N1=126; Placebo=32).

Reporting Groups

	Description
H1N1 monovalent influenza vaccine	MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
Placebo	Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.

Measured Values

	H1N1 monovalent influenza vaccine	Placebo
Number of Participants Analyzed [units:participants]	126	32
Serum HAI GMTs in all participants, regardless of baseline serostatus, Dose 1 (Day 29) [units: titer] Geometric Mean (Full Range)	3.53 (2 to 512)	2.71 (2 to 64)

No statistical analysis provided for Serum HAI GMTs in all participants, regardless of baseline serostatus, Dose 1 (Day 29)

28. Secondary Outcome Measure: Serum HAI GMTs in all participants, regardless of baseline serostatus, Dose 2 (Day 57) [ Time Frame: Day 1, Day 57 ]

Measure Type	Secondary
Measure Name	Serum HAI GMTs in all participants, regardless of baseline serostatus, Dose 2 (Day 57)
Measure Description	All immunogenicity analyses are based on the immunogenicity population.
Time Frame	Day 1, Day 57
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants who received 2 doses of the same study vaccine (H1N1=258; Placebo=65), had valid HAI measurements from blood samples obtained at baseline and post Dose 2 were included in the analysis (H1N1=250; Placebo=62).

Reporting Groups

	Description
H1N1 monovalent influenza vaccine	MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
Placebo	Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.

Measured Values

	H1N1 monovalent influenza vaccine	Placebo
Number of Participants Analyzed [units:participants]	250	62
Serum HAI GMTs in all participants, regardless of baseline serostatus, Dose 2 (Day 57) [units: titer] Geometric Mean (Full Range)	7.61 (2 to 4096)	3.70 (2 to 128)

No statistical analysis provided for Serum HAI GMTs in all participants, regardless of baseline serostatus, Dose 2 (Day 57)

Serious Adverse Events

Time Frame	Adverse event data were collected through 14 days after each vaccination, ie, Days 1-15 and Days 29-43. Serious adverse events (SAEs) were collected through 28 days after each vaccination, ie, Days 1-28 and Days 29-57 and through 180 days post last dose.
Additional Description	Telephone contacts were made by site personnel to the participant/participant's parent or legal guardian at various times during the study to assess safety.

Reporting Groups

	Description
H1N1 monovalent vaccine Days 1-28	MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009.
Placebo Days 1-28	Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers
H1N1 monvalent vaccine Days 29-57	MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009.
Placebo Days 29-57	Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers.
H1N1 monovalent vaccine Days 58-209	MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009.
Placebo Days 58-209	Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers.

Serious Adverse Events

H1N1 monovalent vaccine Days 1-28

Placebo Days 1-28

H1N1 monvalent vaccine Days 29-57

Placebo Days 29-57

H1N1 monovalent vaccine Days 58-209

Placebo Days 58-209

Total, serious adverse events

# participants affected / at risk

1/259 (0.39%)

0/65 (0.00%)

0/255 (0.00%)

0/63 (0.00%)

1/259 (0.39%)

1/65 (1.54%)

Psychiatric disorders

Depression¹,^†

# participants affected / at risk

1/259 (0.39%)

0/65 (0.00%)

0/255 (0.00%)

0/63 (0.00%)

0/259 (0.00%)

0/65 (0.00%)

# events

Infections and infestations

Cellulitis staphylococcal²,^†

# participants affected / at risk

0/259 (0.00%)

0/65 (0.00%)

0/255 (0.00%)

0/63 (0.00%)

0/259 (0.00%)

1/65 (1.54%)

# events

Infections and infestations

Osteomyelitis²,^†

# participants affected / at risk

0/259 (0.00%)

0/65 (0.00%)

0/255 (0.00%)

0/63 (0.00%)

1/259 (0.39%)

0/65 (0.00%)

# events

†	Events were collected by systematic assessment
1	Term from vocabulary, MedDRA 12.0
2	Term from vocabulary, MedDRA (12.0)

Other Adverse Events

Time Frame	Adverse event data were collected through 14 days after each vaccination, ie, Days 1-15 and Days 29-43. Serious adverse events (SAEs) were collected through 28 days after each vaccination, ie, Days 1-28 and Days 29-57 and through 180 days post last dose.
Additional Description	Telephone contacts were made by site personnel to the participant/participant's parent or legal guardian at various times during the study to assess safety.

Frequency Threshold

Threshold above which other adverse events are reported	2%

Reporting Groups

	Description
H1N1 monovalent vaccine Days 1-28	MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009.
Placebo Days 1-28	Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers
H1N1 monvalent vaccine Days 29-57	MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009.
Placebo Days 29-57	Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers.
H1N1 monovalent vaccine Days 58-209	MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009.
Placebo Days 58-209	Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers.

Other Adverse Events

H1N1 monovalent vaccine Days 1-28

Placebo Days 1-28

H1N1 monvalent vaccine Days 29-57

Placebo Days 29-57

H1N1 monovalent vaccine Days 58-209

Placebo Days 58-209

Total, other (not including serious) adverse events

# participants affected / at risk

13/259 (5.02%)

2/65 (3.08%)

11/255 (4.31%)

3/63 (4.76%)

0/255 (0.00%)

0/63 (0.00%)

Gastrointestinal disorders

nausea¹,^†

# participants affected / at risk

5/259 (1.93%)

2/65 (3.08%)

2/255 (0.78%)

1/63 (1.59%)

0/255 (0.00%)

0/63 (0.00%)

# events

Gastrointestinal disorders

vomiting¹,^†

# participants affected / at risk

7/259 (2.70%)

1/65 (1.54%)

6/255 (2.35%)

2/63 (3.17%)

0/255 (0.00%)

0/63 (0.00%)

# events

Gastrointestinal disorders

diarrhea¹,^†

# participants affected / at risk

4/259 (1.54%)

1/65 (1.54%)

5/255 (1.96%)

0/63 (0.00%)

0/255 (0.00%)

0/63 (0.00%)

# events

†	Events were collected by systematic assessment
1	Term from vocabulary, MedDRA (12.0)

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days . The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: MedImmune has 60 days to review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome. The PIs also agree for data to be presented first as a joint, multi-center publication.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact

Name/Title:	Elissa Malkin, D.O.
Organization:	MedImmune, LLC an affiliate of AstraZeneca AB
Phone	301-398-0000
E-mail:	[email protected]

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Trial Results Summaries
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Contacts

Contact

Terramika Bellamy

301-398-0000

bellamyt@medimmune.com

Contact Backup

Jessie Alsina

301-398-0000

alsinaj@medimmune.com

Investigators

Principal Investigator

Elissa Malkin

MedImmune, LLC

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Kentucky Pediatric Research Center

Central Kentucky Research Associates, Inc.

California Research Foundation

Spartanburg Medical Research

Benchmark Research

Rochester Clinical Research Inc.

Meridian Clinical Research

Omega Medical Research