A Study to Evaluate the Safety of H1N1 Monovalent Vaccine (MEDI3414) in Healthy Adults - MI-CP215

Study identifier:MI-CP215

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 Adults

Medical condition

Healthy

Phase

Phase 4

Healthy volunteers

Yes

Study drug

Sex

All

Actual Enrollment

300

Study type

Interventional

Age

18 Years - 49 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 Sept 2011 by MedImmune, LLC

Collaborators

Department of Health and Human Services

Inclusion and exclusion criteria

Inclusion Criteria

- Male or female, 18 to 49 years of age (not yet reached their 50th birthday) at the time of randomization
- Healthy by medical history and physical examination
- 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) obtained from the subject/legal representative prior to performing any protocol-related procedures, including screening evaluations
- Females of childbearing potential, (ie, unless surgically sterile [eg, bilateral tubal ligation, bilateral oophorectomy, or hysterectomy], has sterile male partner, is at least 1 year post menopause, 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.
- 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 is available by telephone
- Subject is able to understand and comply with the requirements of the protocol, as judged by the investigator
- Subject is able 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
- 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)
- Expected receipt of antipyretic or analgesic medication 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
- 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 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

Covance Daytona Beach

Daytona Beach, FL, United States, 30060

Location

Pharmax Research Clinic

Miami, FL, United States, 33126

Location

Miami Research Associates

South Miami, FL, United States, 33143

Location

Center for Pharmaceutical Research

Kansas City, MO, United States, 64114

Location

Clinical Research Associates, Inc.

Nashville, TN, United States, 37203

Arms	Assigned Interventions
Experimental: MEDI3414 [Influenza A (H1N1) vaccine] MEDI3414 - Monovalent vaccine was supplied in intranasal sprayers containing a total volume of 0.5mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of live, attenuated influenza virus reassortant A/California/7/2009 strain that was propagated in chicken eggs. H1N1 monovalent influenza vaccine (MEDI3414) contained no preservatives and no adjuvants.	Biological/Vaccine: MEDI3414 [Influenza A/H1N1 live attenuated, intranasal] 0.5 mL; (intranasal sprayer) Other Name: MEDI3414
Placebo Comparator: Placebo Placebo -Placebo was supplied in intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer.	Other: Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer)

Arms

Assigned Interventions

Experimental: MEDI3414 [Influenza A (H1N1) vaccine]
MEDI3414 - Monovalent vaccine was supplied in intranasal sprayers containing a total volume of 0.5mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of live, attenuated influenza virus reassortant A/California/7/2009 strain that was propagated in chicken eggs. H1N1 monovalent influenza vaccine (MEDI3414) contained no preservatives and no adjuvants.

Biological/Vaccine: MEDI3414 [Influenza A/H1N1 live attenuated, intranasal]
0.5 mL; (intranasal sprayer)

Other Name: MEDI3414

Placebo Comparator: Placebo
Placebo -Placebo was supplied in intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer.

Other: Placebo
(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
Subjects were screened for the study within 14 days prior to randomization. The first and last dates of informed consent were 03 Aug 2009 and 18 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 monovalent vaccine or placebo by intranasal spray; the doses were administered approximately 28 days apart, on Days 1 and 29.

Reporting Groups

	Description
Placebo	Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray administered approximately 28 days apart on Days 1 and 29.
MEDI3414 [Influenza A (H1N1) vaccine]	MEDI3414 - Monovalent vaccine was supplied in intranasal sprayers containing a total volume of 0.5mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 FFU (fluorescent focus units) of live, attenuated influenza virus reassortant A/California/7/2009 strain that was propagated in chicken eggs. H1N1 monovalent influenza vaccine (MEDI3414) contained no preservatives and no adjuvants.

Description

Placebo

Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray administered approximately 28 days apart on Days 1 and 29.

MEDI3414 [Influenza A (H1N1) vaccine]

MEDI3414 - Monovalent vaccine was supplied in intranasal sprayers containing a total volume of 0.5mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 FFU (fluorescent focus units) of live, attenuated influenza virus reassortant A/California/7/2009 strain that was propagated in chicken eggs. H1N1 monovalent influenza vaccine (MEDI3414) contained no preservatives and no adjuvants.

Participant Flow: Overall Study

	Placebo	MEDI3414 [Influenza A (H1N1) vaccine]
STARTED	60	240
Day 15 post Dose 1	60	238
Day 15 post Dose 2	54	226
COMPLETED	57	230
NOT COMPLETED	3	10
Lost to Follow-up	2	8
Withdrawal of consent	1	2

Baseline Characteristics

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

Reporting Groups

	Description
Placebo	Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
MEDI3414 [Influenza A (H1N1) vaccine]	MEDI3414 - Monovalent vaccine was supplied in intranasal sprayers containing a total volume of 0.5mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 FFU (fluorescent focus units) of live, attenuated influenza virus reassortant A/California/7/2009 strain that was propagated in chicken eggs. H1N1 monovalent influenza vaccine (MEDI3414) contained no preservatives and no adjuvants.

Description

Placebo

Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.

MEDI3414 [Influenza A (H1N1) vaccine]

Baseline Measures

	Placebo	MEDI3414 [Influenza A (H1N1) vaccine]	Total
Number of Participants [units: Participants]	60	240	300
Age Continuous [units: years] Mean ± Standard Deviation	34.1 ± 8.9	33.3 ± 9.2	33.5 ± 9.2
Gender, Male/Female [units: participants]
Female	33	138	171
Male	27	102	129
Ethnicity (NIH/OMB) [units: participants]
Hispanic or Latino	18	95	113
Not Hispanic or Latino	42	145	187
Unknown or Not Reported	0	0	0
Race (NIH/OMB) [units: participants]
American Indian or Alaska Native	0	1	1
Asian	0	0	0
Native Hawaiian or Other Pacific Islander	0	1	1
Black or African American	13	37	50
White	47	199	246
More than one race	0	1	1
Other	0	1	1
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 Oral 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 Oral 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 (CIs) for the rate difference (Vaccine minus Placebo). The upper limit of the two-sided 95% CI 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.
Safety Population was defined as all participants who received at least one dose of investigational product and had any follow-up for safety.

Reporting Groups

	Description
Placebo	Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
MEDI3414 [Influenza A (H1N1) vaccine]	MEDI3414 - Monovalent vaccine was supplied in intranasal sprayers containing a total volume of 0.5mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 FFU (fluorescent focus units) of live, attenuated influenza virus reassortant A/California/7/2009 strain that was propagated in chicken eggs. H1N1 monovalent influenza vaccine (MEDI3414) contained no preservatives and no adjuvants.

Description

Placebo

Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.

MEDI3414 [Influenza A (H1N1) vaccine]

Measured Values

	Placebo	MEDI3414 [Influenza A (H1N1) vaccine]
Number of Participants Analyzed [units:participants]	60	240
Number of Participants with Fever Post Dose 1 (Days 1-8), Defined as an Oral Temperature ≥ 101°F (38.3°C). [units: Participants]	0	0

Statistical Analysis 1 for Number of Participants with Fever Post Dose 1 (Days 1-8), Defined as an Oral 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	( -6.0 to 1.9 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	The upper limit of the two-sided 95% CI 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%
[2]	Additional details about a non-inferiority or equivalence analysis:
	The currently proposed study provided at least 99.9% power to rule out a rate increase of 10 percentage points assuming the true difference between the treatment groups is zero and the true fever rate is ≤ 3%. Power is also high if the true difference is slightly greater than zero and the true fever rate is ≤ 3%.
[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 Experienced 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 Experienced a Post Dose 1 (Day 15) Seroresponse Against the H1N1 Strain in All Participants Regardless of Baseline Serostatus
Measure Description	Seroresponse was defined as a ≥ 4-fold rise in hemagglutination inhibition (HAI) titer from baseline. All immunogenicity analyses were 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.
For each treatment group, participants were randomized at a 1:1 ratio to have their post Dose 1 immunogenicity blood draw occur on either Day 15 or Day 29. Participants who received Dose 1 of the investigational product and had valid HAI measurements from blood samples obtained at baseline and post Dose 1 were included in the analysis.

Reporting Groups

	Description
Placebo	Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
MEDI3414 [Influenza A (H1N1) vaccine]	MEDI3414 - Monovalent vaccine was supplied in intranasal sprayers containing a total volume of 0.5mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 FFU (fluorescent focus units) of live, attenuated influenza virus reassortant A/California/7/2009 strain that was propagated in chicken eggs. H1N1 monovalent influenza vaccine (MEDI3414) contained no preservatives and no adjuvants.

Description

Placebo

Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.

MEDI3414 [Influenza A (H1N1) vaccine]

Measured Values

	Placebo	MEDI3414 [Influenza A (H1N1) vaccine]
Number of Participants Analyzed [units:participants]	30	120
Number of Participants Who Experienced a Post Dose 1 (Day 15) Seroresponse Against the H1N1 Strain in All Participants Regardless of Baseline Serostatus [units: Participants]	0	3

Statistical Analysis 1 for Number of Participants Who Experienced 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]	2.5
95% Confidence Interval	( -8.8 to 7.7 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	The number of participants who experienced a post-dose seroresponse was compared based on the upper limit of the limit of the two-sided 95% exact CI 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 Experienced 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 Experienced a Post Dose 1 (Day 29) Seroresponse Against the H1N1 Strain in All Participants Regardless of Baseline Serostatus
Measure Description	Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline. All immunogenicity analyses were 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.
For each treatment group, participants were randomized at a 1:1 ratio to have their post Dose 1 immunogenicity blood draw occur on either Day 15 or Day 29. Participants who received Dose 1 of the investigational product and had valid HAI measurements from blood samples obtained at baseline and post Dose 1 were included in the analysis.

Reporting Groups

	Description
Placebo	Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
MEDI3414 [Influenza A (H1N1) vaccine]	MEDI3414 - Monovalent vaccine was supplied in intranasal sprayers containing a total volume of 0.5mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 FFU (fluorescent focus units) of live, attenuated influenza virus reassortant A/California/7/2009 strain that was propagated in chicken eggs. H1N1 monovalent influenza vaccine (MEDI3414) contained no preservatives and no adjuvants.

Description

Placebo

Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.

MEDI3414 [Influenza A (H1N1) vaccine]

Measured Values

	Placebo	MEDI3414 [Influenza A (H1N1) vaccine]
Number of Participants Analyzed [units:participants]	29	115
Number of Participants Who Experienced a Post Dose 1 (Day 29) Seroresponse Against the H1N1 Strain in All Participants Regardless of Baseline Serostatus [units: Participants]	0	7

Statistical Analysis 1 for Number of Participants Who Experienced 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]	6.1
95% Confidence Interval	( -5.6 to 12.6 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	The number of participants who experienced a post-dose seroresponse was compared based on the upper limit of the two-sided 95% exact CIs 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 Experienced 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 Experienced a Post Dose 2 (Day 57) Seroresponse Against the H1N1 Strain in All Participants Regardless of Baseline Serostatus
Measure Description	Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline. All immunogenicity analyses were 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 investigational product and had valid HAI measurements from blood samples obtained at baseline and post Dose 2 were included in the analysis.

Reporting Groups

	Description
Placebo	Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
MEDI3414 [Influenza A (H1N1) vaccine]	MEDI3414 - Monovalent vaccine was supplied in intranasal sprayers containing a total volume of 0.5mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 FFU (fluorescent focus units) of live, attenuated influenza virus reassortant A/California/7/2009 strain that was propagated in chicken eggs. H1N1 monovalent influenza vaccine (MEDI3414) contained no preservatives and no adjuvants.

Description

Placebo

Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.

MEDI3414 [Influenza A (H1N1) vaccine]

Measured Values

	Placebo	MEDI3414 [Influenza A (H1N1) vaccine]
Number of Participants Analyzed [units:participants]	54	222
Number of Participants Who Experienced a Post Dose 2 (Day 57) Seroresponse Against the H1N1 Strain in All Participants Regardless of Baseline Serostatus [units: Participants]	3	33

Statistical Analysis 1 for Number of Participants Who Experienced 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]	9.3
95% Confidence Interval	( -0.8 to 16.3 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	The number of participants who experienced a post-dose seroresponse was compared based on the upper limit of the limit of the two-sided 95% exact CI 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 Symptom Within 7 Days Post Vaccination, Dose 1 [ Time Frame: Days 1-8 ]

Measure Type	Secondary
Measure Name	Number of Participants With Any Solicited Symptom Within 7 Days Post Vaccination, Dose 1
Measure Description	Solicited symptoms were events considered likely to occur post dosing. For this study, other solicited symptoms included: Fever (> 100°F [37.8°C] oral), Runny nose, Sore throat, Cough, Vomiting, Muscle aches, Chills, Decreased activity (tiredness), and Headache.
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 for solicited symptoms was defined as all participants who received at least one dose of investigational product, had any follow-up for safety and had solicited symptom data available during the reporting period.

Reporting Groups

	Description
Placebo	Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
MEDI3414 [Influenza A (H1N1) vaccine]	MEDI3414 - Monovalent vaccine was supplied in intranasal sprayers containing a total volume of 0.5mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 FFU (fluorescent focus units) of live, attenuated influenza virus reassortant A/California/7/2009 strain that was propagated in chicken eggs. H1N1 monovalent influenza vaccine (MEDI3414) contained no preservatives and no adjuvants.

Description

Placebo

Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.

MEDI3414 [Influenza A (H1N1) vaccine]

Measured Values

	Placebo	MEDI3414 [Influenza A (H1N1) vaccine]
Number of Participants Analyzed [units:participants]	60	240
Number of Participants With Any Solicited Symptom Within 7 Days Post Vaccination, Dose 1 [units: Participants]	19	100

Statistical Analysis 1 for Number of Participants With Any Solicited Symptom Within 7 Days Post Vaccination, Dose 1

Groups^[1]	All groups
Non-Inferiority/Equivalence Test^[2]	Yes
Method^[3]	Other [Score]
Other^[5]	10.0
95% Confidence Interval	( -4.1 to 22.8 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Additional details about a non-inferiority or equivalence analysis:
	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% CIs (Chan and Zhang, 1999) on the rate difference (monovalent vaccine minus placebo) were constructed. There were no prespecified equivalence criteria for the secondary analyses.
[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 Post Vaccination, Dose 1 [ Time Frame: Days 1-8 ]

Measure Type	Secondary
Measure Name	Number of Participants Reporting Adverse Events (AEs) Within 7 Days Post Vaccination, 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 was defined as all participants who received at least one dose of investigational product and had any follow-up for safety.

Reporting Groups

	Description
Placebo	Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
MEDI3414 [Influenza A (H1N1) vaccine]	MEDI3414 - Monovalent vaccine was supplied in intranasal sprayers containing a total volume of 0.5mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 FFU (fluorescent focus units) of live, attenuated influenza virus reassortant A/California/7/2009 strain that was propagated in chicken eggs. H1N1 monovalent influenza vaccine (MEDI3414) contained no preservatives and no adjuvants.

Description

Placebo

Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.

MEDI3414 [Influenza A (H1N1) vaccine]

Measured Values

	Placebo	MEDI3414 [Influenza A (H1N1) vaccine]
Number of Participants Analyzed [units:participants]	60	240
Number of Participants Reporting Adverse Events (AEs) Within 7 Days Post Vaccination, Dose 1 [units: Participants]	7	26

No statistical analysis provided for Number of Participants Reporting Adverse Events (AEs) Within 7 Days Post Vaccination, Dose 1

7. Secondary Outcome Measure: Number of Participants Using Anti-pyretic and Analgesic Agents within 7 Days Post Vaccination, Dose 1. [ Time Frame: Days 1-8 ]

Measure Type	Secondary
Measure Name	Number of Participants Using Anti-pyretic and Analgesic Agents within 7 Days Post Vaccination, 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 was defined as all participants who received at least one dose of investigational product and had any follow-up for safety.

Reporting Groups

	Description
Placebo	Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
MEDI3414 [Influenza A (H1N1) vaccine]	MEDI3414 - Monovalent vaccine was supplied in intranasal sprayers containing a total volume of 0.5mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 FFU (fluorescent focus units) of live, attenuated influenza virus reassortant A/California/7/2009 strain that was propagated in chicken eggs. H1N1 monovalent influenza vaccine (MEDI3414) contained no preservatives and no adjuvants.

Description

Placebo

Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.

MEDI3414 [Influenza A (H1N1) vaccine]

Measured Values

	Placebo	MEDI3414 [Influenza A (H1N1) vaccine]
Number of Participants Analyzed [units:participants]	60	240
Number of Participants Using Anti-pyretic and Analgesic Agents within 7 Days Post Vaccination, Dose 1. [units: Participants]	3	20

No statistical analysis provided for Number of Participants Using Anti-pyretic and Analgesic Agents within 7 Days Post Vaccination, Dose 1.

8. Secondary Outcome Measure: Number of Participants With Any Solicited Symptom Within 14 Days Post Vaccination, Dose 1 [ Time Frame: Days 1-15 ]

Measure Type	Secondary
Measure Name	Number of Participants With Any Solicited Symptom Within 14 Days Post Vaccination, 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 for solicited symptoms was defined as all participants who received at least one dose of investigational product, had any follow-up for safety and had solicited symptom data available during the reporting period.

Reporting Groups

	Description
Placebo	Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
MEDI3414 [Influenza A (H1N1) vaccine]	MEDI3414 - Monovalent vaccine was supplied in intranasal sprayers containing a total volume of 0.5mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 FFU (fluorescent focus units) of live, attenuated influenza virus reassortant A/California/7/2009 strain that was propagated in chicken eggs. H1N1 monovalent influenza vaccine (MEDI3414) contained no preservatives and no adjuvants.

Description

Placebo

Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.

MEDI3414 [Influenza A (H1N1) vaccine]

Measured Values

	Placebo	MEDI3414 [Influenza A (H1N1) vaccine]
Number of Participants Analyzed [units:participants]	60	240
Number of Participants With Any Solicited Symptom Within 14 Days Post Vaccination, Dose 1 [units: Participants]	28	113

Statistical Analysis 1 for Number of Participants With Any Solicited Symptom Within 14 Days Post Vaccination, Dose 1

Groups^[1]	All groups
Non-Inferiority/Equivalence Test^[2]	Yes
Method^[3]	Other [Score]
Other^[5]	0.4
95% Confidence Interval	( -13.9 to 14.5 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Additional details about a non-inferiority or equivalence analysis:
	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% CIs (Chan and Zhang, 1999) on the rate difference (monovalent vaccine minus placebo) were constructed. There were no prespecified equivalence criteria for the secondary analyses.
[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 Post Vaccination, Dose 1 [ Time Frame: Days 1-15 ]

Measure Type	Secondary
Measure Name	Number of Participants Reporting AEs Within 14 Days Post Vaccination, 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 was defined as all participants who received at least one dose of investigational product and had any follow-up for safety.

Reporting Groups

Description

Placebo

Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.

MEDI3414 [Influenza A (H1N1) vaccine]

Measured Values

	Placebo	MEDI3414 [Influenza A (H1N1) vaccine]
Number of Participants Analyzed [units:participants]	60	240
Number of Participants Reporting AEs Within 14 Days Post Vaccination, Dose 1 [units: Participants]	10	38

No statistical analysis provided for Number of Participants Reporting AEs Within 14 Days Post Vaccination, Dose 1

10. Secondary Outcome Measure: Number of Participant Using Anti-pyretic and Analgesic Agents Within 14 Days Post Vaccination, Dose 1 [ Time Frame: Days 1-15 ]

Measure Type	Secondary
Measure Name	Number of Participant Using Anti-pyretic and Analgesic Agents Within 14 Days Post Vaccination, 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 was defined as all participants who received at least one dose of investigational product and had any follow-up for safety.

Reporting Groups

Description

Placebo

Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.

MEDI3414 [Influenza A (H1N1) vaccine]

Measured Values

	Placebo	MEDI3414 [Influenza A (H1N1) vaccine]
Number of Participants Analyzed [units:participants]	60	240
Number of Participant Using Anti-pyretic and Analgesic Agents Within 14 Days Post Vaccination, Dose 1 [units: Participants]	3	30

No statistical analysis provided for Number of Participant Using Anti-pyretic and Analgesic Agents Within 14 Days Post Vaccination, Dose 1

11. Secondary Outcome Measure: Number of Participants With Any Solicited Symptom Within 7 Days Post Vaccination, Dose 2 [ Time Frame: Days 29-36 ]

Measure Type	Secondary
Measure Name	Number of Participants With Any Solicited Symptom Within 7 Days Post Vaccination, 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 was defined as all participants who received Dose 2, had any follow-up for safety and had solicited symptom data available during the reporting period.

Reporting Groups

Description

Placebo

Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.

MEDI3414 [Influenza A (H1N1) vaccine]

Measured Values

	Placebo	MEDI3414 [Influenza A (H1N1) vaccine]
Number of Participants Analyzed [units:participants]	55	228
Number of Participants With Any Solicited Symptom Within 7 Days Post Vaccination, Dose 2 [units: Participants]	15	61

Statistical Analysis 1 for Number of Participants With Any Solicited Symptom Within 7 Days Post Vaccination, Dose 2

Groups^[1]	All groups
Non-Inferiority/Equivalence Test^[2]	Yes
Method^[3]	Other [Score]
Other^[5]	-0.5
95% Confidence Interval	( -14.7 to 11.8 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Additional details about a non-inferiority or equivalence analysis:
	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% CIs (Chan and Zhang, 1999) on the rate difference (monovalent vaccine minus placebo) were constructed. There were no prespecified equivalence criteria for the secondary analyses.
[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 Post Vaccination, Dose 2 [ Time Frame: Days 29-36 ]

Measure Type	Secondary
Measure Name	Number of Participants Reporting AEs Within 7 Days Post Vaccination, 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.
Participants in the Safety Population who received Dose 2 and had any follow-up for safety during the reporting period.

Reporting Groups

Description

Placebo

Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.

MEDI3414 [Influenza A (H1N1) vaccine]

Measured Values

	Placebo	MEDI3414 [Influenza A (H1N1) vaccine]
Number of Participants Analyzed [units:participants]	55	228
Number of Participants Reporting AEs Within 7 Days Post Vaccination, Dose 2 [units: Participants]	3	12

No statistical analysis provided for Number of Participants Reporting AEs Within 7 Days Post Vaccination, Dose 2

13. Secondary Outcome Measure: Number of Participants Using Anti-pyretic and Analgesic Agents Within 7 Days Post Vaccination, Dose 2 [ Time Frame: Days 29-36 ]

Measure Type	Secondary
Measure Name	Number of Participants Using Anti-pyretic and Analgesic Agents Within 7 Days Post Vaccination, 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.
Participants in the safety population who received Dose 2 and had any follow-up for safety during the reporting period.

Reporting Groups

Description

Placebo

Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.

MEDI3414 [Influenza A (H1N1) vaccine]

Measured Values

	Placebo	MEDI3414 [Influenza A (H1N1) vaccine]
Number of Participants Analyzed [units:participants]	55	228
Number of Participants Using Anti-pyretic and Analgesic Agents Within 7 Days Post Vaccination, Dose 2 [units: Participants]	2	4

No statistical analysis provided for Number of Participants Using Anti-pyretic and Analgesic Agents Within 7 Days Post Vaccination, Dose 2

14. Secondary Outcome Measure: Number of Participants With Any Solicited Symptom Within 14 Days Post Vaccination, Dose 2 [ Time Frame: Days 29-43 ]

Measure Type	Secondary
Measure Name	Number of Participants With Any Solicited Symptom Within 14 Days Post Vaccination, 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.
Participants in the Safety Population who received Dose 2 and had solicited symptom data available during the reporting period.

Reporting Groups

Description

Placebo

Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.

MEDI3414 [Influenza A (H1N1) vaccine]

Measured Values

	Placebo	MEDI3414 [Influenza A (H1N1) vaccine]
Number of Participants Analyzed [units:participants]	55	228
Number of Participants With Any Solicited Symptom Within 14 Days Post Vaccination, Dose 2 [units: Participants]	17	75

Statistical Analysis 1 for Number of Participants With Any Solicited Symptom Within 14 Days Post Vaccination, Dose 2

Groups^[1]	All groups
Non-Inferiority/Equivalence Test^[2]	Yes
Other^[5]	2.0
95% Confidence Interval	( -12.6 to 14.9 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Additional details about a non-inferiority or equivalence analysis:
	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% CIs (Chan and Zhang, 1999) on the rate difference (monovalent vaccine minus placebo) were constructed. There were no prespecified equivalence criteria for the secondary analyses.
[5]	Other relevant estimation information:
	No text entered.

15. Secondary Outcome Measure: Number of Participants Reporting AEs Within 14 Days Post Vaccination, Dose 2 [ Time Frame: Days 29-43 ]

Measure Type	Secondary
Measure Name	Number of Participants Reporting AEs Within 14 Days Post Vaccination, 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.
Participants in the Safety Population who received Dose 2 and had any follow-up for safety during the reporting period.

Reporting Groups

Description

Placebo

Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.

MEDI3414 [Influenza A (H1N1) vaccine]

Measured Values

	Placebo	MEDI3414 [Influenza A (H1N1) vaccine]
Number of Participants Analyzed [units:participants]	55	228
Number of Participants Reporting AEs Within 14 Days Post Vaccination, Dose 2 [units: Participants]	4	18

No statistical analysis provided for Number of Participants Reporting AEs Within 14 Days Post Vaccination, Dose 2

16. Secondary Outcome Measure: Number of Participants Using Anti-pyretic and Analgesic Agents Within 14 Days Post Vaccination, Dose 2 [ Time Frame: Days 29-43 ]

Measure Type	Secondary
Measure Name	Number of Participants Using Anti-pyretic and Analgesic Agents Within 14 Days Post Vaccination, 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.
Participants in the Safety Population who received Dose 2 and had any follow-up for safety during the reporting period.

Reporting Groups

Description

Placebo

Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.

MEDI3414 [Influenza A (H1N1) vaccine]

Measured Values

	Placebo	MEDI3414 [Influenza A (H1N1) vaccine]
Number of Participants Analyzed [units:participants]	55	228
Number of Participants Using Anti-pyretic and Analgesic Agents Within 14 Days Post Vaccination, Dose 2 [units: Participants]	2	10

No statistical analysis provided for Number of Participants Using Anti-pyretic and Analgesic Agents Within 14 Days Post Vaccination, Dose 2

17. Secondary Outcome Measure: Number of Participants With Serious Adverse Events (SAEs) Through 28 Days Post Vaccination, Dose 1 [ Time Frame: Days 1-29 ]

Measure Type	Secondary
Measure Name	Number of Participants With Serious Adverse Events (SAEs) Through 28 Days Post Vaccination, 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 birth defect 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 was defined as all participants who received at least one dose of investigational product and had any follow-up for safety.

Reporting Groups

Description

Placebo

Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.

MEDI3414 [Influenza A (H1N1) vaccine]

Measured Values

	Placebo	MEDI3414 [Influenza A (H1N1) vaccine]
Number of Participants Analyzed [units:participants]	60	240
Number of Participants With Serious Adverse Events (SAEs) Through 28 Days Post Vaccination, Dose 1 [units: Participants]	0	0

No statistical analysis provided for Number of Participants With Serious Adverse Events (SAEs) Through 28 Days Post Vaccination, Dose 1

18. Secondary Outcome Measure: Number of Participants With New Onset Chronic Diseases (NOCDs) Within 28 Days Post Vaccination, Dose 1 [ Time Frame: Days 1-29 ]

Measure Type	Secondary
Measure Name	Number of Participants With New Onset Chronic Diseases (NOCDs) Within 28 Days Post Vaccination, 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 was defined as all participants who received at least one dose of investigational product and had any follow-up for safety.

Reporting Groups

Description

Placebo

Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.

MEDI3414 [Influenza A (H1N1) vaccine]

Measured Values

	Placebo	MEDI3414 [Influenza A (H1N1) vaccine]
Number of Participants Analyzed [units:participants]	60	240
Number of Participants With New Onset Chronic Diseases (NOCDs) Within 28 Days Post Vaccination, Dose 1 [units: Participants]	0	1

No statistical analysis provided for Number of Participants With New Onset Chronic Diseases (NOCDs) Within 28 Days Post Vaccination, Dose 1

19. Secondary Outcome Measure: Number of Participants With SAEs Through 28 Days Post Vaccination, Dose 2 [ Time Frame: Days 29-57 ]

Measure Type	Secondary
Measure Name	Number of Participants With SAEs Through 28 Days Post Vaccination, 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 birth defect 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.
Participants in the Safety Population for Dose 2 who received Dose 2 and had any follow-up for safety during the reporting period.

Reporting Groups

Description

Placebo

Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.

MEDI3414 [Influenza A (H1N1) vaccine]

Measured Values

	Placebo	MEDI3414 [Influenza A (H1N1) vaccine]
Number of Participants Analyzed [units:participants]	55	228
Number of Participants With SAEs Through 28 Days Post Vaccination, Dose 2 [units: Participants]	0	0

No statistical analysis provided for Number of Participants With SAEs Through 28 Days Post Vaccination, Dose 2

20. Secondary Outcome Measure: Number of Participants With NOCDs Within 28 Days Post Vaccination, Dose 2 [ Time Frame: Days 29-57 ]

Measure Type	Secondary
Measure Name	Number of Participants With NOCDs Within 28 Days Post Vaccination, 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.
Participants in the Safety Population for Dose 2 who received Dose 2 and had any safety follow-up during the reporting period.

Reporting Groups

Description

Placebo

Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.

MEDI3414 [Influenza A (H1N1) vaccine]

Measured Values

	Placebo	MEDI3414 [Influenza A (H1N1) vaccine]
Number of Participants Analyzed [units:participants]	55	228
Number of Participants With NOCDs Within 28 Days Post Vaccination, Dose 2 [units: Participants]	0	0

No statistical analysis provided for Number of Participants With NOCDs Within 28 Days Post Vaccination, Dose 2

21. Secondary Outcome Measure: Number of Participants With SAEs Through 180 Days Post Final Dose [ Time Frame: Days 1-209 ]

Measure Type	Secondary
Measure Name	Number of Participants With SAEs Through 180 Days Post Final Dose
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 birth defect 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 was defined as all participants who received at least one dose of investigational product and had any follow-up for safety.

Reporting Groups

Description

Placebo

Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.

MEDI3414 [Influenza A (H1N1) vaccine]

Measured Values

	Placebo	MEDI3414 [Influenza A (H1N1) vaccine]
Number of Participants Analyzed [units:participants]	60	240
Number of Participants With SAEs Through 180 Days Post Final Dose [units: Participants]	2	3

No statistical analysis provided for Number of Participants With SAEs Through 180 Days Post Final Dose

22. Secondary Outcome Measure: Number of Participants With NOCDs Through 180 Days Post Final Dose. [ Time Frame: Days 1-209 ]

Measure Type	Secondary
Measure Name	Number of Participants With NOCDs Through 180 Days Post Final Dose.
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 was defined as all participants who received at least one dose of investigational product and had any follow-up for safety.

Reporting Groups

Description

Placebo

Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.

MEDI3414 [Influenza A (H1N1) vaccine]

Measured Values

	Placebo	MEDI3414 [Influenza A (H1N1) vaccine]
Number of Participants Analyzed [units:participants]	60	240
Number of Participants With NOCDs Through 180 Days Post Final Dose. [units: Participants]	1	1

No statistical analysis provided for Number of Participants With NOCDs Through 180 Days Post Final Dose.

23. Secondary Outcome Measure: Number of Participants Who Achieved a Post Dose 1 (Day 15) HAI Titer ≥ 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 Achieved a Post Dose 1 (Day 15) HAI Titer ≥ 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 were randomized at a 1:1 ratio to have their post Dose 1 immunogenicity blood draw on either Day 15 or Day 29. Participants who received Dose 1 of the investigational product and had valid HAI measurements from blood samples obtained at baseline and post Dose 1 were included in the analysis.

Reporting Groups

Description

Placebo

Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.

MEDI3414 [Influenza A (H1N1) vaccine]

Measured Values

	Placebo	MEDI3414 [Influenza A (H1N1) vaccine]
Number of Participants Analyzed [units:participants]	30	120
Number of Participants Who Achieved a Post Dose 1 (Day 15) HAI Titer ≥ 32 Against the H1N1 Strain in All Participants Regardless of Baseline Serostatus [units: Participants]	1	11

Statistical Analysis 1 for Number of Participants Who Achieved a Post Dose 1 (Day 15) HAI Titer ≥ 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]	5.8
95% Confidence Interval	( -7.7 to 13.8 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	The number of participants 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 CI 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 Achieved a Post Dose 1 (Day 29) HAI Titer ≥ 32 Against the H1N1 Strain in All Subjects Regardless of Baseline Serostatus [ Time Frame: Day 1, Day 29 ]

Measure Type	Secondary
Measure Name	Number of Participants Who Achieved a Post Dose 1 (Day 29) HAI Titer ≥ 32 Against the H1N1 Strain in All Subjects 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 were randomized at a 1:1 ratio to have their post Dose 1 immunogenicity blood draw on either Day 15 or Day 29. Participants who received Dose 1 of the investigational product and had valid HAI measurements from blood samples obtained at baseline and post Dose 1 were included in the analysis.

Reporting Groups

Description

Placebo

Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.

MEDI3414 [Influenza A (H1N1) vaccine]

Measured Values

	Placebo	MEDI3414 [Influenza A (H1N1) vaccine]
Number of Participants Analyzed [units:participants]	29	115
Number of Participants Who Achieved a Post Dose 1 (Day 29) HAI Titer ≥ 32 Against the H1N1 Strain in All Subjects Regardless of Baseline Serostatus [units: Participants]	4	9

Statistical Analysis 1 for Number of Participants Who Achieved a Post Dose 1 (Day 29) HAI Titer ≥ 32 Against the H1N1 Strain in All Subjects Regardless of Baseline Serostatus

Groups^[1]	All groups
Non-Inferiority/Equivalence Test^[2]	No
Method^[3]	Other [score]
Other^[5]	-6.0
95% Confidence Interval	( -23.5 to 5.3 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	The number of participants 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 CI 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 Achieved a Post Dose 2 (Day 57) HAI Titer ≥ 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 Achieved a Post Dose 2 (Day 57) HAI Titer ≥ 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 investigational product and had valid HAI measurements from blood samples obtained at baseline and post Dose 2 were included in the analysis.

Reporting Groups

Description

Placebo

Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.

MEDI3414 [Influenza A (H1N1) vaccine]

Measured Values

	Placebo	MEDI3414 [Influenza A (H1N1) vaccine]
Number of Participants Analyzed [units:participants]	54	222
Number of Participants Who Achieved a Post Dose 2 (Day 57) HAI Titer ≥ 32 Against the H1N1 Strain in All Participants Regardless of Baseline Serostatus [units: Participants]	6	30

Statistical Analysis 1 for Number of Participants Who Achieved a Post Dose 2 (Day 57) HAI Titer ≥ 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]	2.4
95% Confidence Interval	( -9.3 to 10.8 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	The number of participants 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 CI 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 were randomized at a 1:1 ratio to have their post Dose 1 immunogenicity blood draw on either Day 15 or Day 29. Participants who received Dose 1 of the investigational product and had valid HAI measurements from blood samples obtained at baseline and post Dose 1 were included in the analysis.

Reporting Groups

Description

Placebo

Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.

MEDI3414 [Influenza A (H1N1) vaccine]

Measured Values

	Placebo	MEDI3414 [Influenza A (H1N1) vaccine]
Number of Participants Analyzed [units:participants]	30	120
Serum HAI Geometric Mean Titers (GMTs) in All Participants Regardless of Baseline Serostatus, Dose 1 (Day 15) [units: Titer] Geometric Mean (Full Range)	2.64 (2 to 32)	3.46 (2 to 256)

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 were randomized at a 1:1 ratio to have their post Dose 1 immunogenicity blood draw on either Day 15 or Day 29. Participants who received Dose 1 of the investigational product and had valid HAI measurements from blood samples obtained at baseline and post Dose 1 were included in the analysis.

Reporting Groups

Description

Placebo

Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.

MEDI3414 [Influenza A (H1N1) vaccine]

Measured Values

	Placebo	MEDI3414 [Influenza A (H1N1) vaccine]
Number of Participants Analyzed [units:participants]	29	115
Serum HAI GMTs in All Participants Regardless of Baseline Serostatus, Dose 1 (Day 29) [units: Titer] Geometric Mean (Full Range)	4.96 (2 to 512)	3.44 (2 to 128)

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 29) [ Time Frame: Day 1, Day 57 ]

Measure Type	Secondary
Measure Name	Serum HAI GMTs in All Participants Regardless of Baseline Serostatus, Dose 2 (Day 29)
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 investigational product and had valid HAI measurements from blood samples obtained at baseline and post Dose 2 were included in the analysis.

Reporting Groups

Description

Placebo

Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.

MEDI3414 [Influenza A (H1N1) vaccine]

Measured Values

	Placebo	MEDI3414 [Influenza A (H1N1) vaccine]
Number of Participants Analyzed [units:participants]	54	222
Serum HAI GMTs in All Participants Regardless of Baseline Serostatus, Dose 2 (Day 29) [units: Titer] Geometric Mean (Full Range)	3.90 (2 to 512)	4.86 (2 to 1024)

No statistical analysis provided for Serum HAI GMTs in All Participants Regardless of Baseline Serostatus, Dose 2 (Day 29)

Serious Adverse Events

Time Frame	Safety evaluation consisted of AEs through 7 days and 14 days after each vaccination, SAEs and NOCDs through 28 days after each vaccination, and SAEs and NOCDs through 180 days after the final vaccination.
Additional Description	Telephone contacts were made by site personnel to the subject at various times during the study to assess safety.

Reporting Groups

	Description
H1N1 Monovalent Vaccine Days 1-15	A/California/7/2009 strain of the live, attenuated influenza virus reassortant 10^7 FFU that was propagated in chicken eggs. MEDI3414 contained no preservatives and no adjuvants. Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
Placebo Days 1-15	Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
H1N1 monovalent vaccine Days 29-57	A/California/7/2009 strain of the live, attenuated influenza virus reassortant 10^7 FFU that was propagated in chicken eggs. MEDI3414 contained no preservatives and no adjuvants. Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
Placebo Days 29-57	Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
H1N1 Monovalent Days 58-209	A/California/7/2009 strain of the live, attenuated influenza virus reassortant 10^7 FFU that was propagated in chicken eggs. MEDI3414 contained no preservatives and no adjuvants. Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
Placebo Days 58-209	Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.

Serious Adverse Events

H1N1 Monovalent Vaccine Days 1-15

Placebo Days 1-15

H1N1 monovalent vaccine Days 29-57

Placebo Days 29-57

H1N1 Monovalent Days 58-209

Placebo Days 58-209

Total, serious adverse events

# participants affected / at risk

0/240 (0.00%)

0/60 (0.00%)

0/228 (0.00%)

0/55 (0.00%)

3/240 (1.25%)

2/60 (3.33%)

Hepatobiliary disorders

Gallbladder disorder¹,^†

# participants affected / at risk

0/240 (0.00%)

0/60 (0.00%)

0/228 (0.00%)

0/55 (0.00%)

0/240 (0.00%)

1/60 (1.67%)

# events

Infections and infestations

Cellulitis¹,^†

# participants affected / at risk

0/240 (0.00%)

0/60 (0.00%)

0/228 (0.00%)

0/55 (0.00%)

1/240 (0.42%)

0/60 (0.00%)

# events

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Cervix carcinoma¹,^†

# participants affected / at risk

0/240 (0.00%)

0/60 (0.00%)

0/228 (0.00%)

0/55 (0.00%)

0/240 (0.00%)

1/60 (1.67%)

# events

Pregnancy, puerperium and perinatal conditions

Premature baby¹,^†

# participants affected / at risk

0/240 (0.00%)

0/60 (0.00%)

0/228 (0.00%)

0/55 (0.00%)

1/240 (0.42%)

0/60 (0.00%)

# events

Psychiatric disorders

Depression¹,^†

# participants affected / at risk

0/240 (0.00%)

0/60 (0.00%)

0/228 (0.00%)

0/55 (0.00%)

1/240 (0.42%)

0/60 (0.00%)

# events

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

Other Adverse Events

Time Frame	Safety evaluation consisted of AEs through 7 days and 14 days after each vaccination, SAEs and NOCDs through 28 days after each vaccination, and SAEs and NOCDs through 180 days after the final vaccination.
Additional Description	Telephone contacts were made by site personnel to the subject 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 1-15	A/California/7/2009 strain of the live, attenuated influenza virus reassortant 10^7 FFU that was propagated in chicken eggs. MEDI3414 contained no preservatives and no adjuvants. Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
Placebo Days 1-15	Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
H1N1 monovalent vaccine Days 29-57	A/California/7/2009 strain of the live, attenuated influenza virus reassortant 10^7 FFU that was propagated in chicken eggs. MEDI3414 contained no preservatives and no adjuvants. Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
Placebo Days 29-57	Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
H1N1 Monovalent Days 58-209	A/California/7/2009 strain of the live, attenuated influenza virus reassortant 10^7 FFU that was propagated in chicken eggs. MEDI3414 contained no preservatives and no adjuvants. Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
Placebo Days 58-209	Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.

Other Adverse Events

H1N1 Monovalent Vaccine Days 1-15

Placebo Days 1-15

H1N1 monovalent vaccine Days 29-57

Placebo Days 29-57

H1N1 Monovalent Days 58-209

Placebo Days 58-209

Total, other (not including serious) adverse events

# participants affected / at risk

17/240 (7.08%)

9/60 (15.00%)

13/228 (5.70%)

1/55 (1.82%)

0/240 (0.00%)

0/60 (0.00%)

Gastrointestinal disorders

Diarrhoea¹,^†

# participants affected / at risk

4/240 (1.67%)

2/60 (3.33%)

4/228 (1.75%)

0/55 (0.00%)

0/240 (0.00%)

0/60 (0.00%)

# events

Gastrointestinal disorders

Nausea¹,^†

# participants affected / at risk

5/240 (2.08%)

2/60 (3.33%)

1/228 (0.44%)

0/55 (0.00%)

0/240 (0.00%)

0/60 (0.00%)

# events

Infections and infestations

Ear infection¹,^†

# participants affected / at risk

0/240 (0.00%)

2/60 (3.33%)

0/228 (0.00%)

0/55 (0.00%)

0/240 (0.00%)

0/60 (0.00%)

# events

Respiratory, thoracic and mediastinal disorders

Sneezing¹,^†

# participants affected / at risk

4/240 (1.67%)

2/60 (3.33%)

3/228 (1.32%)

1/55 (1.82%)

0/240 (0.00%)

0/60 (0.00%)

# events

Respiratory, thoracic and mediastinal disorders

Nasal Congestion¹,^†

# participants affected / at risk

4/240 (1.67%)

1/60 (1.67%)

5/228 (2.19%)

0/55 (0.00%)

0/240 (0.00%)

0/60 (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.

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:	Raburn Mallory, MD Senior Director Clinical Development
Organization:	MedImmune, LLC
Phone	301-398-0000
E-mail:	[email protected]

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