A Study to Evaluate the Immunogenicity of Quadrivalent LAIV (MEDI8662) in Adults 18 to 49 Years of Age - MI-CP206

Study identifier:MI-CP206

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Randomized, Partially Blind Active Controlled Study to Evaluate the Immunogenicity of MEDI8662 in Adults 18 to 49 years of Age

Medical condition

healthy or stable underlying chronic medical condition

Phase

Phase 3

Healthy volunteers

Yes

Study drug

Sex

All

Actual Enrollment

1800

Study type

Interventional

Age

18 Years - 49 Years

Date

Study Start Date: 01 Aug 2009

Primary Completion Date: 01 Jan 2010

Study Completion Date: 01 Mar 2010

Study design

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

Verification:

Verified 01 Dec 2011 by MedImmune, LLC

Collaborators

Inclusion and exclusion criteria

Inclusion Criteria

- Male or female, age 18 through 49 years, inclusive (reached their 18th year birthday but not yet reached their 50th year birthday) at the time of randomization
- Females of child-bearing potential, must have used an effective method of avoiding pregnancy for 30 days prior to the first dose of investigational product, and must have agreed to continue using such precautions for 60 days after the dose of investigational product. In addition, the participant must also have had a negative urine or blood pregnancy test at screening and, if screening and Day 0 do not occur on the same day, on the day of vaccination prior to randomization.
- Healthy by medical history and physical examination OR presence of stable underlying chronic medical condition for which hospitalization had not been required in the previous year

Exclusion Criteria

- Acute illness or evidence of significant active infection at randomization
- Fever greater than or equal to 100.4 degrees F (38°C) at randomization
- History of asthma
- Any drug therapy from 15 days prior to randomization or expected drug therapy through 30 days post dose with the exception of contraceptives;
topical corticosteroids or antifungals for uncomplicated dermatitis;
chronic medications (including those taken on an as-needed basis) that were well tolerated and were not initiated and/or did not have a dosage change within 90 days of randomization
- Previous medical history or evidence of an intercurrent illness that may have compromised the safety of the participant in the study
- Current or expected receipt of immunosuppressive medications (inhaled and topical corticosteroids and topical calcineurin inhibitors were permitted) within a 30-day window around the dose
- Receipt of immunoglobulin or blood products within 90 days before randomization into the study or expected receipt during study participation
- Receipt of any investigational drug therapy within 30 days prior to randomization or planned receipt of any investigational drug therapy through 30 days after dosing of investigational product (use of licensed agents for indications not listed in the package insert were permitted)
- Receipt of any nonstudy vaccine within 30 days prior to randomization or planned receipt of nonstudy vaccine through 30 days after dosing
- Receipt of any influenza vaccine (investigational or licensed) in 2009 prior to randomization or anticipated receipt prior to the collection of the post-dose immunogenicity blood sample for this study
- Any known immunosuppressive condition or immune deficiency disease including known or suspected infection with human immunodeficiency virus (HIV)
- History of allergic disease or reactions likely to be exacerbated by any component of Q/LAIV-BFS including allergy to eggs, egg proteins, gentamicin, or gelatin, or serious, life threatening, or severe reactions to previous influenza vaccinations
- History of Guillain-Barré syndrome
- Use of antiviral agents with activity against influenza virus (including amantadine, rimantadine, oseltamivir and zanamivir) within 30 days prior to receipt of investigational product or anticipated use within 30 days after receipt of investigational product
- Known or suspected mitochondrial encephalomyopathy
-Pregnant or lactating female
- Any condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of participant safety or study results
- Participant, legal guardian, or immediate family member of participant who was an employee of the clinical study site or who was otherwise involved with the conduct of the study

Location

Meridian Clinical Research, LLC

Omaha, NE, United States, 68134

Location

Johnson County Clin-Trials

Lenexa, KS, United States, 66219

Location

Avail Clinical Research, LLC

Deland, FL, United States, 32720

Location

Clinical Research Atlanta

Stockbridge, GA, United States, 30281

Location

California Research Foundation

San Diego, CA, United States, 92103-6204

Location

Benchmark Research Austin

Austin, TX, United States, 78705

Location

Rochester Clinical Research Inc.

Rochester, NY, United States, 14609

Location

Benchmark Research

San Francisco, CA, United States, 94102

Arms	Assigned Interventions
Experimental: Q/LAIV-BFS (MEDI8662) Q/LAIV-BFS (quadrivalent influenza vaccine) (MEDI8662) was supplied in the blow-fill-seal delivery system that delivers a nominal dose of 0.2 mL into a single nostril. Each dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), B/Victoria (B/Malaysia/2506/2004), and B/Yamagata (B/Florida/4/2006).	Biological/Vaccine: Q/LAIV-BFS (MEDI8662) A single dose of Q/LAIV-BFS delivered using the BFS delivery system (0.2 mL) on Day 0.
Active Comparator: FluMist/B/Yamagata FluMist/B/Yamagata was administered intranasally using a Becton Dickinson Accuspray™ device. A total volume of 0.2 mL was administered intranasally (approximately 0.1 mL into each nostril). Each dose contained 10^7.0 ± 0.5 FFU of each of 3 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), and B/Yamagata (B/Florida/4/2006)	Biological/Vaccine: FluMist/B/Yamagata FluMist/B/Yamagata - 0.2 mL dose at Day 0
Active Comparator: FluMist/B/Victoria FluMist/B/Victoria was administered intranasally using a BD Accuspray™ device. A total volume of 0.2 mL was administered intranasally (approximately 0.1 mL into each nostril). Each dose contained 10^7.0 ± 0.5 FFU of each of 3 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), and B/Victoria (B/Malaysia/2506/2004).	Biological/Vaccine: FluMist/B/Victoria FluMist/B/Victoria - 0.2 mL dose at Day 0

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were screened for the study within 30 days prior to randomization at investigator clinic sites in the USA. The first and last dates of informed consent were 14Aug2009 and 26Aug2009, respectively.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of 1,888 participants who provided written informed consent and were screened for the study, 88 were screened but were not randomized into the study due to one or more of the following reasons: not meeting the eligibility criteria; study was full; withdrawal of consent; lost to follow-up; unable to obtain a blood sample for immunogenicity testing.

Reporting Groups

	Description
Q/LAIV-BFS (MEDI8662)	Q/LAIV-BFS (quadrivalent influenza vaccine) (MEDI8662) was supplied in the blow-fill-seal delivery system that delivers a nominal dose of 0.2 mL into a single nostril. Each dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), B/Victoria (B/Malaysia/2506/2004), and B/Yamagata (B/Florida/4/2006).
FluMist/B/Yamagata	FluMist/B/Yamagata was administered intranasally using a Becton Dickinson (BD) Accuspray™ device. A total volume of 0.2 mL was administered intranasally (approximately 0.1 mL into each nostril). Each dose contained 10^7.0 ± 0.5 FFU of each of 3 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), and B/Yamagata (B/Florida/4/2006).
FluMist/B/Victoria	FluMist/B/Victoria was administered intranasally using a BD Accuspray™ device. A total volume of 0.2 mL was administered intranasally (approximately 0.1 mL into each nostril). Each dose contained 10^7.0 ± 0.5 FFU of each of 3 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), and B/Victoria (B/Malaysia/2506/2004).

Participant Flow: Overall Study

	Q/LAIV-BFS (MEDI8662)	FluMist/B/Yamagata	FluMist/B/Victoria
STARTED	1202^[1]	300	298
COMPLETED	1169	290	288
NOT COMPLETED	33	10	10
Lost to Follow-up	24	8	9
Withdrawal by Subject	2	1	1
Death	2	0	0
Incarcerated post dose	5	0	0
Exclusion criteria not met pre dose	0	1	0

[1]	Three not treated with Q/LAIV-BFS (1 treated with FluMist/B/Yamagata; 2 withdrew prior to dosing).

Baseline Characteristics

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

Reporting Groups

	Description
Q/LAIV-BFS (MEDI8662)	Q/LAIV-BFS (quadrivalent influenza vaccine) (MEDI8662) was supplied in the blow-fill-seal delivery system that delivers a nominal dose of 0.2 mL into a single nostril. Each dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), B/Victoria (B/Malaysia/2506/2004), and B/Yamagata (B/Florida/4/2006).
FluMist/B/Yamagata	FluMist/B/Yamagata was administered intranasally using a Becton Dickinson Accuspray™ device. A total volume of 0.2 mL was administered intranasally (approximately 0.1 mL into each nostril). Each dose contained 10^7.0 ± 0.5 FFU of each of 3 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), and B/Yamagata (B/Florida/4/2006).
FluMist/B/Victoria	FluMist/B/Victoria was administered intranasally using a BD Accuspray™ device. A total volume of 0.2 mL was administered intranasally (approximately 0.1 mL into each nostril). Each dose contained 10^7.0 ± 0.5 FFU of each of 3 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), and B/Victoria (B/Malaysia/2506/2004).

Baseline Measures

	Q/LAIV-BFS (MEDI8662)	FluMist/B/Yamagata	FluMist/B/Victoria	Total
Number of Participants [units: Participants]	1202	300	298	1800
Age Continuous [units: Years] Mean ± Standard Deviation	33.9 ± 9.5	34.0 ± 9.1	33.8 ± 8.8	33.9 ± 9.3
Gender, Male/Female [units: Participants]
Male	501	131	131	763
Female	701	169	167	1037

Outcome Measures

1. Primary Outcome Measure: The Post Dose Strain-specific Serum Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titers (GMTs) in the Q/LAIV-BFS (MEDI8662) Arm as Compared to Those in the Combined Flumist Arms (All Flumist Group). [ Time Frame: Day 28 to 35 ]

Measure Type	Primary
Measure Name	The Post Dose Strain-specific Serum Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titers (GMTs) in the Q/LAIV-BFS (MEDI8662) Arm as Compared to Those in the Combined Flumist Arms (All Flumist Group).
Measure Description	Noninferior immune response was assessed by evaluating the upper bound of the 2-sided 95% confidence intervals (CIs) for the ratios of strain-specific HAI GMTs for the specified comparisons. The GMT ratio = GMT in comparator (All FluMist group) divided by the GMT in the Q/LAIV-BFS arm.
Time Frame	Day 28 to 35
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.
Of 1199 Q/LAIV-treated and 598 treated participants in the All FluMist group, 1176 and 586 participants, respectively, received a full dose of investigational product, had a post-dose HAI measurement, and had no protocol violation that could have interfered with generation or interpretation of an immune response.

Reporting Groups

	Description
Q/LAIV-BFS (MEDI8662)	Q/LAIV-BFS (quadrivalent influenza vaccine) (MEDI8662) was supplied in the blow-fill-seal delivery system that delivers a nominal dose of 0.2 mL into a single nostril. Each dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), B/Victoria (B/Malaysia/2506/2004), and B/Yamagata (B/Florida/4/2006).
FluMist/B/Yamagata	FluMist/B/Yamagata was administered intranasally using a Becton Dickinson (BD) Accuspray™ device. A total volume of 0.2 mL was administered intranasally (approximately 0.1 mL into each nostril). Each dose contained 10^7.0 ± 0.5 FFU of each of 3 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), and B/Yamagata (B/Florida/4/2006).
FluMist/B/Victoria	FluMist/B/Victoria was administered intranasally using a BD Accuspray™ device. A total volume of 0.2 mL was administered intranasally (approximately 0.1 mL into each nostril). Each dose contained 10^7.0 ± 0.5 FFU of each of 3 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), and B/Victoria (B/Malaysia/2506/2004).
All FluMist	All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm are combined.

Measured Values

	Q/LAIV-BFS (MEDI8662)	FluMist/B/Yamagata	FluMist/B/Victoria	All FluMist
Number of Participants Analyzed [units:participants]	1176	294	292	586
The Post Dose Strain-specific Serum Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titers (GMTs) in the Q/LAIV-BFS (MEDI8662) Arm as Compared to Those in the Combined Flumist Arms (All Flumist Group). [units: Geometric Mean Titer] Geometric Mean (Full Range)
A/H1N1	8.1 (2 to 1448)	7.1 (2 to 512)	8.3 (2 to 1024)	7.7 (2 to 1024)
A/H3N2	8.3 (2 to 1024)	8.0 (2 to 1024)	7.4 (2 to 512)	7.7 (2 to 1024)
B/Yamagata	60.3 (2 to 4096)	54.1 (2 to 2048)	49.8 (2 to 4096)	51.9 (2 to 4096)
B/Victoria	27.4 (2 to 2048)	19.9 (2 to 1024)	26.7 (2 to 1024)	23.0 (2 to 1024)

Statistical Analysis 1 for The Post Dose Strain-specific Serum Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titers (GMTs) in the Q/LAIV-BFS (MEDI8662) Arm as Compared to Those in the Combined Flumist Arms (All Flumist Group).

Groups^[1]	Q/LAIV-BFS (MEDI8662), All FluMist
Non-Inferiority/Equivalence Test^[2]	Yes
Method^[3]	Other [Bootstrapping method]
Other^[5]	0.95
95% Confidence Interval	( 0.87 to 1.03 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Noninferior immune response was assessed by evaluating the upper bound of the 2-sided 95% CIs for the ratio of A/H1N1 GMTs for the specified comparison. Geometric mean titers for the A/H1N1 influenza antigen measurements were calculated as: GMT = antilog^y (mean [log^y x]) where x was the assay result and y was the natural logarithm.
[2]	Additional details about a non-inferiority or equivalence analysis:
	The immune response of Q/LAIV-BFS was declared noninferior to that of trivalent FluMist if the upper bound of the 95% CI for the post dose A/H1N1 GMT ratio was ≤ 1.5. This corresponded to the statistical hypothesis of: Ho: Rj > 1.5 for any j and Ha: Rj ≤ 1.5 for all j, where Rj was the A/H1N1 post-dose GMT ratio: (FluMist B/Yamagata A/H1N1 + FluMist B/Victoria A/H1N1) divided by Q/LAIV-BFS A/H1N1.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	Confidence intervals calculated based on bootstrapping method.
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 2 for The Post Dose Strain-specific Serum Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titers (GMTs) in the Q/LAIV-BFS (MEDI8662) Arm as Compared to Those in the Combined Flumist Arms (All Flumist Group).

Groups^[1]	Q/LAIV-BFS (MEDI8662), All FluMist
Non-Inferiority/Equivalence Test^[2]	Yes
Method^[3]	Other [Bootstrapping method]
Other^[5]	0.93
95% Confidence Interval	( 0.85 to 1.00 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Noninferior immune response was assessed by evaluating the upper bound of the 2-sided 95% CIs for the ratio of A/H3N2 GMTs for the specified comparison. Geometric mean titers for the A/H3N2 influenza antigen measurements were calculated as: GMT = antilog^y (mean [log^y x]) where x was the assay result and y was the natural logarithm.
[2]	Additional details about a non-inferiority or equivalence analysis:
	The immune response of Q/LAIV-BFS was declared noninferior to that of trivalent FluMist if the upper bound of the 95% CI for the post dose A/H3N2 GMT ratio was ≤ 1.5. This corresponded to the statistical hypothesis of: Ho: Rj > 1.5 for any j and Ha: Rj ≤ 1.5 for all j, where Rj was the A/H3N2 post-dose GMT ratio: (FluMist B/Yamagata A/H3N2 + FluMist B/Victoria A/H3N2) divided by Q/LAIV-BFS A/H3N2.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	Confidence intervals calculated based on bootstrapping method.
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 3 for The Post Dose Strain-specific Serum Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titers (GMTs) in the Q/LAIV-BFS (MEDI8662) Arm as Compared to Those in the Combined Flumist Arms (All Flumist Group).

Groups^[1]	Q/LAIV-BFS (MEDI8662), FluMist/B/Yamagata
Non-Inferiority/Equivalence Test^[2]	Yes
Method^[3]	Other [Bootstrapping method]
Other^[5]	0.90
95% Confidence Interval	( 0.79 to 1.02 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Noninferior immune response was assessed by evaluating the upper bound of the 2-sided 95% CIs for the ratio of B/Yamagata GMTs for the specified comparison. Geometric mean titers for the B/Yamagata influenza antigen measurements were calculated as: GMT = antilog^y (mean [log^y x]) where x was the assay result and y was the natural logarithm.
[2]	Additional details about a non-inferiority or equivalence analysis:
	The immune response of Q/LAIV-BFS was declared noninferior to that of trivalent FluMist if the upper bound of the 95% CI for the post dose B/Yamagata GMT ratio was ≤ 1.5. This corresponded to the statistical hypothesis of: Ho: Rj > 1.5 for any j and Ha: Rj ≤ 1.5 for all j, where Rj was the B/Yamagata post-dose GMT ratio: FluMist B/Yamagata divided by Q/LAIV-BFS B/Yamagata.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	Confidence intervals calculated based on bootstrapping method.
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 4 for The Post Dose Strain-specific Serum Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titers (GMTs) in the Q/LAIV-BFS (MEDI8662) Arm as Compared to Those in the Combined Flumist Arms (All Flumist Group).

Groups^[1]	Q/LAIV-BFS (MEDI8662), FluMist/B/Victoria
Non-Inferiority/Equivalence Test^[2]	Yes
Method^[3]	Other [Bootstrapping method]
Other^[5]	0.97
95% Confidence Interval	( 0.87 to 1.10 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Noninferior immune response was assessed by evaluating the upper bound of the 2-sided 95% CIs for the ratio of B/Victoria GMTs for the specified comparison. Geometric mean titers for the B/Victoria influenza antigen measurements were calculated as: GMT = antilog^y (mean [log^y x]) where x was the assay result and y was the natural logarithm.
[2]	Additional details about a non-inferiority or equivalence analysis:
	The immune response of Q/LAIV-BFS was declared noninferior to that of trivalent FluMist if the upper bound of the 95% CI for the post dose B/Victoria GMT ratio was ≤ 1.5. This corresponded to the statistical hypothesis of: Ho: Rj > 1.5 for any j and Ha: Rj ≤ 1.5 for all j, where Rj was the B/Victoria post-dose GMT ratio: FluMist B/Victoria divided by Q/LAIV-BFS B/Victoria.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	Confidence intervals calculated based on bootstrapping method.
[5]	Other relevant estimation information:
	No text entered.

2. Secondary Outcome Measure: The Percentage of Participants Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the A/H1N1 and A/H3N2 Strains in All Participants, Regardless of Baseline Serostatus. [ Time Frame: Day 0 and Day 28-35 ]

Measure Type	Secondary
Measure Name	The Percentage of Participants Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the A/H1N1 and A/H3N2 Strains in All Participants, Regardless of Baseline Serostatus.
Measure Description	Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline. The comparators for seroresponse to the A/H1N1 and A/H3N2 strains were participants in the All FluMist group (combined data for both FluMist arms).
Time Frame	Day 0 and Day 28-35
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.
Of 1199 Q/LAIV-treated and 598 treated participants in the All FluMist group, 1176 and 586 participants, respectively, received a full dose of investigational product, had pre- and post-dose HAI measurements for the 2 A strains, and had no protocol deviation that could have interfered with generation or interpretation of an immune response.

Reporting Groups

Description

Q/LAIV-BFS (MEDI8662)

Q/LAIV-BFS (quadrivalent influenza vaccine) (MEDI8662) was supplied in the blow-fill-seal delivery system that delivers a nominal dose of 0.2 mL into a single nostril. Each dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), B/Victoria (B/Malaysia/2506/2004), and B/Yamagata (B/Florida/4/2006).

All FluMist

All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm are combined.

Measured Values

	Q/LAIV-BFS (MEDI8662)	All FluMist
Number of Participants Analyzed [units:participants]	1176	586
The Percentage of Participants Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the A/H1N1 and A/H3N2 Strains in All Participants, Regardless of Baseline Serostatus. [units: Percentage of Participants]
A/H1N1	5.4	6.5
A/H3N2	4.7	4.8

No statistical analysis provided for The Percentage of Participants Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the A/H1N1 and A/H3N2 Strains in All Participants, Regardless of Baseline Serostatus.

3. Secondary Outcome Measure: The Percentage of Participants Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the B/Yamagata Strain in All Participants, Regardless of Baseline Serostatus. [ Time Frame: Day 0 and Day 28-35 ]

Measure Type	Secondary
Measure Name	The Percentage of Participants Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the B/Yamagata Strain in All Participants, Regardless of Baseline Serostatus.
Measure Description	Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline. The comparator for seroresponse to the B/Yamagata strain was participants in the FluMist/B/Yamagata arm.
Time Frame	Day 0 and Day 28-35
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.
Of 1199 Q/LAIV-treated and 300 FluMist/B/Yamagata-treated participants, 1175 and 294 participants, respectively, received a full dose of investigational product, had pre- and post-dose HAI measurements for B/Yamagata strain, and had no protocol deviation that could have interfered with generation or interpretation of an immune response.

Reporting Groups

Description

Q/LAIV-BFS (MEDI8662)

FluMist/B/Yamagata

FluMist/B/Yamagata was administered intranasally using a Becton Dickinson Accuspray™ device. A total volume of 0.2 mL was administered intranasally (approximately 0.1 mL into each nostril). Each dose contained 10^7.0 ± 0.5 FFU of each of 3 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), and B/Yamagata (B/Florida/4/2006).

Measured Values

	Q/LAIV-BFS (MEDI8662)	FluMist/B/Yamagata
Number of Participants Analyzed [units:participants]	1175	294
The Percentage of Participants Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the B/Yamagata Strain in All Participants, Regardless of Baseline Serostatus. [units: Percentage of Participants]	8.2	9.5

No statistical analysis provided for The Percentage of Participants Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the B/Yamagata Strain in All Participants, Regardless of Baseline Serostatus.

4. Secondary Outcome Measure: The Percentage of Participants Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the B/Victoria Strain in All Participants, Regardless of Baseline Serostatus. [ Time Frame: Day 0 and Day 28-35 ]

Measure Type	Secondary
Measure Name	The Percentage of Participants Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the B/Victoria Strain in All Participants, Regardless of Baseline Serostatus.
Measure Description	Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline. The comparator for seroresponse to the B/Victoria strain was participants in the FluMist/B/Victoria arm.
Time Frame	Day 0 and Day 28-35
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.
Of 1199 Q/LAIV-treated and 298 FluMist/B/Victoria-treated participants, 1176 and 292 participants, respectively, received a full dose of investigational product, had pre- and post-dose HAI measurements for B/Victoria strain, and had no protocol deviation that could have interfered with generation or interpretation of an immune response.

Reporting Groups

Description

Q/LAIV-BFS (MEDI8662)

FluMist/B/Victoria

FluMist/B/Victoria was administered intranasally using a BD Accuspray™ device. A total volume of 0.2 mL was administered intranasally (approximately 0.1 mL into each nostril). Each dose contained 10^7.0 ± 0.5 FFU of each of 3 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), and B/Victoria (B/Malaysia/2506/2004).

Measured Values

	Q/LAIV-BFS (MEDI8662)	FluMist/B/Victoria
Number of Participants Analyzed [units:participants]	1176	292
The Percentage of Participants Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the B/Victoria Strain in All Participants, Regardless of Baseline Serostatus. [units: Percentage of Participants]	7.5	10.3

No statistical analysis provided for The Percentage of Participants Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the B/Victoria Strain in All Participants, Regardless of Baseline Serostatus.

5. Secondary Outcome Measure: The Percentage of Serosusceptible Participants Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the A/H1N1 Strain. [ Time Frame: Day 0 and Day 28-35 ]

Measure Type	Secondary
Measure Name	The Percentage of Serosusceptible Participants Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the A/H1N1 Strain.
Measure Description	Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline. Participants with a baseline HAI titer ≤ 8 were considered to be serosusceptible for that strain. The comparator for seroresponse to the A/H1N1 strain was participants in the All FluMist group (combined data for both FluMist arms).
Time Frame	Day 0 and Day 28-35
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.
Of 1199 Q/LAIV-treated and 598 treated participants in the All FluMist group, 783 and 412, respectively, received a full dose of investigational product, had pre- and post-dose HAI measurements, were serosusceptible to A/H1N1, and had no protocol deviation that could have interfered with generation or interpretation of an immune response.

Reporting Groups

Description

Q/LAIV-BFS (MEDI8662)

All FluMist

All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm are combined.

Measured Values

	Q/LAIV-BFS (MEDI8662)	All FluMist
Number of Participants Analyzed [units:participants]	783	412
The Percentage of Serosusceptible Participants Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the A/H1N1 Strain. [units: Percentage of participants]	7.9	9.0

No statistical analysis provided for The Percentage of Serosusceptible Participants Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the A/H1N1 Strain.

6. Secondary Outcome Measure: The Percentage of Serosusceptible Participants Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the A/H3N2 Strain. [ Time Frame: Day 0 and Day 28-35 ]

Measure Type	Secondary
Measure Name	The Percentage of Serosusceptible Participants Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the A/H3N2 Strain.
Measure Description	Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline. Participants with a baseline HAI titer ≤ 8 were considered to be serosusceptible for that strain. The comparator for seroresponse to the A/H3N2 strain was participants in the All FluMist group (combined data for both FluMist arms).
Time Frame	Day 0 and Day 28-35
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.
Of 1199 Q/LAIV-treated and 598 treated participants in the All FluMist group, 746 and 386, respectively, received a full dose of investigational product, had pre- and post-dose HAI measurements, were serosusceptible to A/H3N2, and had no protocol deviation that could have interfered with generation or interpretation of an immune response.

Reporting Groups

Description

Q/LAIV-BFS (MEDI8662)

All FluMist

All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm are combined.

Measured Values

	Q/LAIV-BFS (MEDI8662)	All FluMist
Number of Participants Analyzed [units:participants]	746	386
The Percentage of Serosusceptible Participants Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the A/H3N2 Strain. [units: Percentage of Participants]	6.3	7.0

No statistical analysis provided for The Percentage of Serosusceptible Participants Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the A/H3N2 Strain.

7. Secondary Outcome Measure: The Percentage of Serosusceptible Participants Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the B/Yamagata strain. [ Time Frame: Day 0 and Day 28-35 ]

Measure Type	Secondary
Measure Name	The Percentage of Serosusceptible Participants Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the B/Yamagata strain.
Measure Description	Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline. Participants with a baseline HAI titer ≤ 8 were considered to be serosusceptible for that strain. The comparator for seroresponse to the B/Yamagata strain was participants in the FluMist/B/Yamagata arm.
Time Frame	Day 0 and Day 28-35
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.
Of 1199 Q/LAIV-treated and 300 FluMist/B/Yamagata-treated participants, 189 and 51, respectively, received a full dose of investigational product, had pre- and post-dose HAI measurements, were serosusceptible to B/Yamagata, and had no protocol deviation that could have interfered with generation or interpretation of an immune response.

Reporting Groups

Description

Q/LAIV-BFS (MEDI8662)

FluMist/B/Yamagata

Measured Values

	Q/LAIV-BFS (MEDI8662)	FluMist/B/Yamagata
Number of Participants Analyzed [units:participants]	189	51
The Percentage of Serosusceptible Participants Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the B/Yamagata strain. [units: Percentage of Participants]	36.0	35.3

No statistical analysis provided for The Percentage of Serosusceptible Participants Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the B/Yamagata strain.

8. Secondary Outcome Measure: The Percentage of Serosusceptible Participants Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the B/Victoria strain. [ Time Frame: Day 0 and Day 28-35 ]

Measure Type	Secondary
Measure Name	The Percentage of Serosusceptible Participants Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the B/Victoria strain.
Measure Description	Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline. Participants with a baseline HAI titer ≤ 8 were considered to be serosusceptible for that strain. The comparator for seroresponse to the B/Victoria strain was participants in the FluMist/B/Victoria arm.
Time Frame	Day 0 and Day 28-35
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.
Of 1199 Q/LAIV-treated and 298 FluMist/B/Victoria-treated participants, 361 and 104, respectively, received a full dose of investigational product, had pre- and post-dose HAI measurements, were serosusceptible to B/Victoria, and had no protocol deviation that could have interfered with generation or interpretation of an immune response.

Reporting Groups

Description

Q/LAIV-BFS (MEDI8662)

FluMist/B/Victoria

Measured Values

	Q/LAIV-BFS (MEDI8662)	FluMist/B/Victoria
Number of Participants Analyzed [units:participants]	361	104
The Percentage of Serosusceptible Participants Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the B/Victoria strain. [units: Percentage of Participants]	20.8	26.0

No statistical analysis provided for The Percentage of Serosusceptible Participants Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the B/Victoria strain.

9. Secondary Outcome Measure: The Percentage of Seropositive Participants Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the A/H1N1 Strain. [ Time Frame: Day 0 and Day 28-35 ]

Measure Type	Secondary
Measure Name	The Percentage of Seropositive Participants Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the A/H1N1 Strain.
Measure Description	Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline. Participants with a baseline HAI titer > 8 were considered to be seropositive for that strain. The comparator for seroresponse to the A/H1N1 strain was participants in the All FluMist group (combined data for both FluMist arms).
Time Frame	Day 0 and Day 28-35
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.
Of 1199 Q/LAIV-treated and 598 treated participants in the All FluMist group, 393 and 174, respectively, received a full dose of investigational product, had pre- and post-dose HAI measurements, were seropositive to A/H1N1, and had no protocol deviation that could have interfered with generation or interpretation of an immune response.

Reporting Groups

Description

Q/LAIV-BFS (MEDI8662)

All FluMist

All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm are combined.

Measured Values

	Q/LAIV-BFS (MEDI8662)	All FluMist
Number of Participants Analyzed [units:participants]	393	174
The Percentage of Seropositive Participants Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the A/H1N1 Strain. [units: Percentage of participants]	0.5	0.6

No statistical analysis provided for The Percentage of Seropositive Participants Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the A/H1N1 Strain.

10. Secondary Outcome Measure: The Percentage of Seropositive Participants Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the A/H3N2 Strain. [ Time Frame: Day 0 and Day 28-35 ]

Measure Type	Secondary
Measure Name	The Percentage of Seropositive Participants Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the A/H3N2 Strain.
Measure Description	Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline. Participants with a baseline HAI titer > 8 were considered to be seropositive for that strain. The comparator for seroresponse to the A/H3N2 strain was participants in the All FluMist group (combined data for both FluMist arms).
Time Frame	Day 0 and Day 28-35
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.
Of 1199 Q/LAIV-treated and 598 treated participants in the All FluMist group, 430 and 200, respectively, received a full dose of investigational product, had pre- and post-dose HAI measurements, were seropositive to A/H3N2, and had no protocol deviation that could have interfered with generation or interpretation of an immune response.

Reporting Groups

Description

Q/LAIV-BFS (MEDI8662)

All FluMist

All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm are combined.

Measured Values

	Q/LAIV-BFS (MEDI8662)	All FluMist
Number of Participants Analyzed [units:participants]	430	200
The Percentage of Seropositive Participants Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the A/H3N2 Strain. [units: Percentage of participants]	1.9	0.5

No statistical analysis provided for The Percentage of Seropositive Participants Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the A/H3N2 Strain.

11. Secondary Outcome Measure: The Percentage of Seropositive Participants Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the B/Yamagata strain. [ Time Frame: Day 0 and Day 28-35 ]

Measure Type	Secondary
Measure Name	The Percentage of Seropositive Participants Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the B/Yamagata strain.
Measure Description	Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline. Participants with a baseline HAI titer > 8 were considered to be seropositive for that strain. The comparator for seroresponse to the B/Yamagata strain was participants in the FluMist/B/Yamagata arm.
Time Frame	Day 0 and Day 28-35
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.
Of 1199 Q/LAIV-treated and 300 FluMist/B/Yamagata-treated participants, 986 and 243, respectively, received a full dose of investigational product, had pre- and post-dose HAI measurements, were seropositive to B/Yamagata, and had no protocol deviation that could have interfered with generation or interpretation of an immune response.

Reporting Groups

Description

Q/LAIV-BFS (MEDI8662)

FluMist/B/Yamagata

Measured Values

	Q/LAIV-BFS (MEDI8662)	FluMist/B/Yamagata
Number of Participants Analyzed [units:participants]	986	243
The Percentage of Seropositive Participants Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the B/Yamagata strain. [units: Percentage of Participants]	2.8	4.1

No statistical analysis provided for The Percentage of Seropositive Participants Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the B/Yamagata strain.

12. Secondary Outcome Measure: The Percentage of Seropositive Subjects Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the B/Victoria strain. [ Time Frame: Day 0 and Day 28-35 ]

Measure Type	Secondary
Measure Name	The Percentage of Seropositive Subjects Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the B/Victoria strain.
Measure Description	Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline. Participants with a baseline HAI titer > 8 were considered to be seropositive for that strain. The comparator for seroresponse to the B/Victoria strain was participants in the FluMist/B/Victoria arm.
Time Frame	Day 0 and Day 28-35
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.
Of 1199 Q/LAIV-treated and 298 FluMist/B/Victoria-treated participants, 815 and 188, respectively, received a full dose of investigational product, had pre- and post-dose HAI measurements, were seropositive to B/Victoria, and had no protocol deviation that could have interfered with generation or interpretation of an immune response.

Reporting Groups

Description

Q/LAIV-BFS (MEDI8662)

FluMist/B/Victoria

Measured Values

	Q/LAIV-BFS (MEDI8662)	FluMist/B/Victoria
Number of Participants Analyzed [units:participants]	815	188
The Percentage of Seropositive Subjects Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the B/Victoria strain. [units: Percentage of Participants]	1.6	1.6

No statistical analysis provided for The Percentage of Seropositive Subjects Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the B/Victoria strain.

13. Secondary Outcome Measure: The Percentage of Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the A/H1N1 and A/H3N2 Strains in All Participants, Regardless of Baseline Serostatus. [ Time Frame: Day 28-35 ]

Measure Type	Secondary
Measure Name	The Percentage of Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the A/H1N1 and A/H3N2 Strains in All Participants, Regardless of Baseline Serostatus.
Measure Description	The comparators to the A/H1N1 and A/H3N2 strains were participants in the All FluMist group (combined data for both FluMist arms).
Time Frame	Day 28-35
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.
Of 1199 Q/LAIV-treated and 598 treated participants in the All FluMist group, 1176 and 586, respectively, received a full dose of investigational product, had post-dose HAI measurement for the 2 A strains, and had no protocol deviation that could have interfered with generation or interpretation of an immune response.

Reporting Groups

Description

Q/LAIV-BFS (MEDI8662)

All FluMist

All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm are combined.

Measured Values

	Q/LAIV-BFS (MEDI8662)	All FluMist
Number of Participants Analyzed [units:participants]	1176	586
The Percentage of Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the A/H1N1 and A/H3N2 Strains in All Participants, Regardless of Baseline Serostatus. [units: Percentage of Participants]
A/H1N1	25.3	22.5
A/H3N2	25.8	23.4

No statistical analysis provided for The Percentage of Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the A/H1N1 and A/H3N2 Strains in All Participants, Regardless of Baseline Serostatus.

14. Secondary Outcome Measure: The Percentage of Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the B/Yamagata Strain in All Participants, Regardless of Baseline Serostatus. [ Time Frame: Day 28-35 ]

Measure Type	Secondary
Measure Name	The Percentage of Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the B/Yamagata Strain in All Participants, Regardless of Baseline Serostatus.
Measure Description	The comparator for the B/Yamagata strain was participants in the FluMist/B/Yamagata arm.
Time Frame	Day 28-35
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.
Of 1199 Q/LAIV-treated and 300 FluMist/B/Yamagata-treated participants, 1176 and 294, respectively, received a full dose of investigational product, had post-dose HAI measurement for B/Yamagata strain, and had no protocol deviation that could have interfered with generation or interpretation of an immune response.

Reporting Groups

Description

Q/LAIV-BFS (MEDI8662)

FluMist/B/Yamagata

Measured Values

	Q/LAIV-BFS (MEDI8662)	FluMist/B/Yamagata
Number of Participants Analyzed [units:participants]	1176	294
The Percentage of Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the B/Yamagata Strain in All Participants, Regardless of Baseline Serostatus. [units: Percentage of subjects]	78.7	75.2

No statistical analysis provided for The Percentage of Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the B/Yamagata Strain in All Participants, Regardless of Baseline Serostatus.

15. Secondary Outcome Measure: The Percentage of Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the B/Victoria Strain in All Participants, Regardless of Baseline Serostatus. [ Time Frame: Day 28-35 ]

Measure Type	Secondary
Measure Name	The Percentage of Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the B/Victoria Strain in All Participants, Regardless of Baseline Serostatus.
Measure Description	The comparator for the B/Victoria strain was participants in the FluMist/B/Victoria arm.
Time Frame	Day 28-35
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.
Of 1199 Q/LAIV-treated and 298 FluMist/B/Victoria-treated participants, 1176 and 292, respectively, received a full dose of investigational product, had post-dose HAI measurement for B/Victoria strain, and had no protocol deviation that could have interfered with generation or interpretation of an immune response.

Reporting Groups

Description

Q/LAIV-BFS (MEDI8662)

FluMist/B/Victoria

Measured Values

	Q/LAIV-BFS (MEDI8662)	FluMist/B/Victoria
Number of Participants Analyzed [units:participants]	1176	292
The Percentage of Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the B/Victoria Strain in All Participants, Regardless of Baseline Serostatus. [units: Percentage of Participants]	55.5	52.7

No statistical analysis provided for The Percentage of Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the B/Victoria Strain in All Participants, Regardless of Baseline Serostatus.

16. Secondary Outcome Measure: The Percentage of Serosusceptible Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the A/H1N1 Strain. [ Time Frame: Day 28-35 ]

Measure Type	Secondary
Measure Name	The Percentage of Serosusceptible Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the A/H1N1 Strain.
Measure Description	Participants with a baseline HAI titer ≤ 8 were considered to be serosusceptible for that strain. The comparator for the A/H1N1 strain was participants in the All FluMist group (combined data for both FluMist arms).
Time Frame	Day 28-35
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.
Of 1199 Q/LAIV-treated and 598 treated participants in the All FluMist group, 783 and 412, respectively, received a full dose of investigational product, had post-dose HAI measurement, were serosusceptible to A/H1N1, and had no protocol deviation that could have interfered with generation or interpretation of an immune response.

Reporting Groups

Description

Q/LAIV-BFS (MEDI8662)

All FluMist

All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm are combined.

Measured Values

	Q/LAIV-BFS (MEDI8662)	All FluMist
Number of Participants Analyzed [units:participants]	783	412
The Percentage of Serosusceptible Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the A/H1N1 Strain. [units: Percentage of participants]	2.7	1.7

No statistical analysis provided for The Percentage of Serosusceptible Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the A/H1N1 Strain.

17. Secondary Outcome Measure: The Percentage of Serosusceptible Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the A/H3N2 Strain. [ Time Frame: Day 28-35 ]

Measure Type	Secondary
Measure Name	The Percentage of Serosusceptible Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the A/H3N2 Strain.
Measure Description	Participants with a baseline HAI titer ≤ 8 were considered to be serosusceptible for that strain. The comparator for the A/H3N2 strain was participants in the All FluMist group (combined data for both FluMist arms).
Time Frame	Day 28-35
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.
Of 1199 Q/LAIV-treated and 598 treated participants in the All FluMist group, 746 and 386, respectively, received a full dose of investigational product, had post-dose HAI measurement, were serosusceptible to A/H3N2, and had no protocol deviation that could have interfered with generation or interpretation of an immune response.

Reporting Groups

Description

Q/LAIV-BFS (MEDI8662)

All FluMist

All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm are combined.

Measured Values

	Q/LAIV-BFS (MEDI8662)	All FluMist
Number of Participants Analyzed [units:participants]	746	386
The Percentage of Serosusceptible Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the A/H3N2 Strain. [units: Percentage of Participants]	1.5	1.8

No statistical analysis provided for The Percentage of Serosusceptible Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the A/H3N2 Strain.

18. Secondary Outcome Measure: The Percentage of Serosusceptible Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the B/Yamagata strain. [ Time Frame: Day 28-35 ]

Measure Type	Secondary
Measure Name	The Percentage of Serosusceptible Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the B/Yamagata strain.
Measure Description	Subjects with a baseline HAI titer ≤ 8 were considered to be serosusceptible for that strain. The comparator for the B/Yamagata strain was participants in the FluMist/B/Yamagata arm.
Time Frame	Day 28-35
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.
Of 1199 Q/LAIV-treated and 300 FluMist/B/Yamagata-treated participants, 189 and 51, respectively, received a full dose of investigational product, had post-dose HAI measurement, were serosusceptible to B/Yamagata strain, and had no protocol deviation that could have interfered with generation or interpretation of an immune response.

Reporting Groups

Description

Q/LAIV-BFS (MEDI8662)

FluMist/B/Yamagata

Measured Values

	Q/LAIV-BFS (MEDI8662)	FluMist/B/Yamagata
Number of Participants Analyzed [units:participants]	189	51
The Percentage of Serosusceptible Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the B/Yamagata strain. [units: Percentage of Participants]	21.7	19.6

No statistical analysis provided for The Percentage of Serosusceptible Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the B/Yamagata strain.

19. Secondary Outcome Measure: The Percentage of Serosusceptible Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the B/Victoria strain. [ Time Frame: Day 28-35 ]

Measure Type	Secondary
Measure Name	The Percentage of Serosusceptible Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the B/Victoria strain.
Measure Description	Participants with a baseline HAI titer ≤ 8 were considered to be serosusceptible for that strain. The comparator for the B/Victoria strain was participants in the FluMist/B/Victoria arm.
Time Frame	Day 28-35
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.
Of 1199 Q/LAIV-treated and 298 FluMist/B/Victoria-treated participants, 361 and 104, respectively, received a full dose of investigational product, had post-dose HAI measurement, were serosusceptible to B/Victoria strain, and had no protocol deviation that could have interfered with generation or interpretation of an immune response.

Reporting Groups

Description

Q/LAIV-BFS (MEDI8662)

FluMist/B/Victoria

Measured Values

	Q/LAIV-BFS (MEDI8662)	FluMist/B/Victoria
Number of Participants Analyzed [units:participants]	361	104
The Percentage of Serosusceptible Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the B/Victoria strain. [units: Percentage of Participants]	9.7	13.5

No statistical analysis provided for The Percentage of Serosusceptible Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the B/Victoria strain.

20. Secondary Outcome Measure: The Percentage of Seropositive Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the A/H1N1 Strain. [ Time Frame: Day 28-35 ]

Measure Type	Secondary
Measure Name	The Percentage of Seropositive Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the A/H1N1 Strain.
Measure Description	Participants with a baseline HAI titer > 8 were considered to be seropositive for that strain. The comparator for the A/H1N1 strain was participants in the All FluMist group (combined data for both FluMist arms).
Time Frame	Day 28-35
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.
Of 1199 Q/LAIV-treated and 598 treated participants in the All FluMist group, 393 and 174, respectively, received a full dose of investigational product, had post-dose HAI measurement, were seropositive to A/H1N1, and had no protocol deviation that could have interfered with generation or interpretation of an immune response.

Reporting Groups

Description

Q/LAIV-BFS (MEDI8662)

All FluMist

All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm are combined.

Measured Values

	Q/LAIV-BFS (MEDI8662)	All FluMist
Number of Participants Analyzed [units:participants]	393	174
The Percentage of Seropositive Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the A/H1N1 Strain. [units: Percentage of participants]	70.2	71.8

No statistical analysis provided for The Percentage of Seropositive Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the A/H1N1 Strain.

21. Secondary Outcome Measure: The Percentage of Seropositive Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the A/H3N2 Strain. [ Time Frame: Day 28-35 ]

Measure Type	Secondary
Measure Name	The Percentage of Seropositive Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the A/H3N2 Strain.
Measure Description	Participants with a baseline HAI titer > 8 were considered to be seropositive for that strain. The comparator for the A/H3N2 strain was participants in the All FluMist group (combined data for both FluMist arms).
Time Frame	Day 28-35
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.
Of 1199 Q/LAIV-treated and 598 treated participants in the All FluMist group, 430 and 200, respectively, received a full dose of investigational product, had post-dose HAI measurement, were seropositive to A/H3N2, and had no protocol deviation that could have interfered with generation or interpretation of an immune response.

Reporting Groups

Description

Q/LAIV-BFS (MEDI8662)

All FluMist

All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm are combined.

Measured Values

	Q/LAIV-BFS (MEDI8662)	All FluMist
Number of Participants Analyzed [units:participants]	430	200
The Percentage of Seropositive Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the A/H3N2 Strain. [units: Percentage of participants]	67.9	65.0

No statistical analysis provided for The Percentage of Seropositive Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the A/H3N2 Strain.

22. Secondary Outcome Measure: The Percentage of Seropositive Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the B/Yamagata Strain. [ Time Frame: Day 28-35 ]

Measure Type	Secondary
Measure Name	The Percentage of Seropositive Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the B/Yamagata Strain.
Measure Description	Participants with a baseline HAI titer > 8 were considered to be seropositive for that strain. The comparator for the B/Yamagata strain was participants in the FluMist/B/Yamagata arm.
Time Frame	Day 28-35
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.
Of 1199 Q/LAIV-treated and 300 FluMist/B/Yamagata-treated participants, 986 and 243, respectively, received a full dose of investigational product, had post-dose HAI measurement, were seropositive to B/Yamagata, and had no protocol deviation that could have interfered with generation or interpretation of an immune response.

Reporting Groups

Description

Q/LAIV-BFS (MEDI8662)

FluMist/B/Yamagata

Measured Values

	Q/LAIV-BFS (MEDI8662)	FluMist/B/Yamagata
Number of Participants Analyzed [units:participants]	986	243
The Percentage of Seropositive Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the B/Yamagata Strain. [units: Percentage of Participants]	89.7	86.8

No statistical analysis provided for The Percentage of Seropositive Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the B/Yamagata Strain.

23. Secondary Outcome Measure: The Percentage of Seropositive Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the B/Victoria strain. [ Time Frame: Day 28-35 ]

Measure Type	Secondary
Measure Name	The Percentage of Seropositive Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the B/Victoria strain.
Measure Description	Participants with a baseline HAI titer > 8 were considered to be seropositive for that strain. The comparator for the B/Victoria strain was participants in the FluMist/B/Victoria arm.
Time Frame	Day 28-35
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.
Of 1199 Q/LAIV-treated and 298 FluMist/B/Victoria-treated participants, 815 and 188, respectively, received a full dose of investigational product, had post-dose HAI measurement, were seropositive to B/Victoria, and had no protocol deviation that could have interfered with generation or interpretation of an immune response.

Reporting Groups

Description

Q/LAIV-BFS (MEDI8662)

FluMist/B/Victoria

Measured Values

	Q/LAIV-BFS (MEDI8662)	FluMist/B/Victoria
Number of Participants Analyzed [units:participants]	815	188
The Percentage of Seropositive Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the B/Victoria strain. [units: Percentage of Participants]	75.8	74.5

No statistical analysis provided for The Percentage of Seropositive Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the B/Victoria strain.

24. Secondary Outcome Measure: The Percentage of Participants Experiencing Each Solicited Symptom From Administration of Investigational Product Through 14 Days Post Dose [ Time Frame: Days 0-14 post dose ]

Measure Type	Secondary
Measure Name	The Percentage of Participants Experiencing Each Solicited Symptom From Administration of Investigational Product Through 14 Days Post Dose
Measure Description
Time Frame	Days 0-14 post dose
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 Evaluable Safety Population for solicited symptoms included all participants who received any investigational product and had any solicited symptom data available during the reporting period.

Reporting Groups

Description

Q/LAIV-BFS (MEDI8662)

All FluMist

Data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined.

Measured Values

	Q/LAIV-BFS (MEDI8662)	All FluMist
Number of Participants Analyzed [units:participants]	1196	595
The Percentage of Participants Experiencing Each Solicited Symptom From Administration of Investigational Product Through 14 Days Post Dose [units: Percentage of Participants]
Any solicited symptom	50.6	54.3
Fever ≥ 100.4°F	1.6	2.0
Fever ≥ 101.3°F	0.7	0.7
Fever ≥ 102.2°F	0.3	0.2
Fever ≥ 103.1°F	0.1	0.0
Fever ≥ 104.0°F	0.0	0.0
Fever ≥ 104.9°F	0.0	0.0
Runny/stuffy nose	31.3	37.6
Sore throat	17.3	15.0
Cough	9.6	7.9
Headache	23.8	24.4
Generalized muscle aches	8.4	11.1
Decreased activity level (lethargy) or tiredness	16.2	17.5
Decreased appetite	5.3	5.7

No statistical analysis provided for The Percentage of Participants Experiencing Each Solicited Symptom From Administration of Investigational Product Through 14 Days Post Dose

25. Secondary Outcome Measure: The Percentage of Participants Reporting Any Adverse Event From Administration of Investigational Product Through 28 Days Post Dose [ Time Frame: Days 0-28 post dose ]

Measure Type	Secondary
Measure Name	The Percentage of Participants Reporting Any Adverse Event From Administration of Investigational Product Through 28 Days Post Dose
Measure Description
Time Frame	Days 0-28 post dose
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 participants who received any investigational product and for whom any follow-up safety data were reported.

Reporting Groups

Description

Q/LAIV-BFS (MEDI8662)

All FluMist

Data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined.

Measured Values

	Q/LAIV-BFS (MEDI8662)	All FluMist
Number of Participants Analyzed [units:participants]	1198	596
The Percentage of Participants Reporting Any Adverse Event From Administration of Investigational Product Through 28 Days Post Dose [units: Percentage of Participants]	15.6	14.9

No statistical analysis provided for The Percentage of Participants Reporting Any Adverse Event From Administration of Investigational Product Through 28 Days Post Dose

26. Secondary Outcome Measure: The Percentage of Participants Reporting Any Serious Adverse Event From Administration of Investigational Product Through 28 Days Post Dose [ Time Frame: Days 0-28 post dose ]

Measure Type	Secondary
Measure Name	The Percentage of Participants Reporting Any Serious Adverse Event From Administration of Investigational Product Through 28 Days Post Dose
Measure Description
Time Frame	Days 0-28 post dose
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 participants who received any investigational product and for whom any follow-up safety data were reported.

Reporting Groups

Description

Q/LAIV-BFS (MEDI8662)

All FluMist

Data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined.

Measured Values

	Q/LAIV-BFS (MEDI8662)	All FluMist
Number of Participants Analyzed [units:participants]	1198	596
The Percentage of Participants Reporting Any Serious Adverse Event From Administration of Investigational Product Through 28 Days Post Dose [units: Percentage of Participants]	0.3	0.0

No statistical analysis provided for The Percentage of Participants Reporting Any Serious Adverse Event From Administration of Investigational Product Through 28 Days Post Dose

27. Secondary Outcome Measure: The Percentage of Participants Reporting Any Serious Adverse Event From Administration of Investigational Product Through 180 Days Post Dose [ Time Frame: Days 0-180 post dose ]

Measure Type	Secondary
Measure Name	The Percentage of Participants Reporting Any Serious Adverse Event From Administration of Investigational Product Through 180 Days Post Dose
Measure Description
Time Frame	Days 0-180 post dose
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 participants who received any investigational product and for whom any follow-up safety data were reported.

Reporting Groups

Description

Q/LAIV-BFS (MEDI8662)

All FluMist

Data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined.

Measured Values

	Q/LAIV-BFS (MEDI8662)	All FluMist
Number of Participants Analyzed [units:participants]	1198	596
The Percentage of Participants Reporting Any Serious Adverse Event From Administration of Investigational Product Through 180 Days Post Dose [units: Percentage of Participants]	1.3	0.3

No statistical analysis provided for The Percentage of Participants Reporting Any Serious Adverse Event From Administration of Investigational Product Through 180 Days Post Dose

28. Secondary Outcome Measure: The Percentage of Participants Reporting New Onset Chronic Diseases From Administration of Investigational Product Through 180 Days Post Dose [ Time Frame: Days 0-180 post dose ]

Measure Type	Secondary
Measure Name	The Percentage of Participants Reporting New Onset Chronic Diseases From Administration of Investigational Product Through 180 Days Post Dose
Measure Description
Time Frame	Days 0-180 post dose
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 participants who received any investigational product and for whom any follow-up safety data were reported.

Reporting Groups

Description

Q/LAIV-BFS (MEDI8662)

All FluMist

Data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined.

Measured Values

	Q/LAIV-BFS (MEDI8662)	All FluMist
Number of Participants Analyzed [units:participants]	1198	596
The Percentage of Participants Reporting New Onset Chronic Diseases From Administration of Investigational Product Through 180 Days Post Dose [units: Percentage of Participants]	0.5	0.5

No statistical analysis provided for The Percentage of Participants Reporting New Onset Chronic Diseases From Administration of Investigational Product Through 180 Days Post Dose

Serious Adverse Events

Time Frame	Serious adverse events, Days 0-180 post dose; other adverse events, Days 0-28 post dose.
Additional Description	Telephone contacts were made by site personnel to the participant at various times during the study to assess safety.

Reporting Groups

Description

Q/LAIV-BFS (MEDI8662)

All FluMist

Data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined.

Serious Adverse Events

Q/LAIV-BFS (MEDI8662)

All FluMist

Total, serious adverse events

# participants affected / at risk

15/1198 (1.25%)

2/596 (0.34%)

Cardiac disorders

Cardiac aneurysm¹,^†

# participants affected / at risk

1/1198 (0.08%)

0/596 (0.00%)

# events

General disorders

Multi-organ failure¹,^†

# participants affected / at risk

1/1198 (0.08%)

0/596 (0.00%)

# events

General disorders

Oedema peripheral¹,^†

# participants affected / at risk

0/1198 (0.00%)

1/596 (0.17%)

# events

Hepatobiliary disorders

Cholecystitis¹,^†

# participants affected / at risk

1/1198 (0.08%)

0/596 (0.00%)

# events

Hepatobiliary disorders

Gallbladder disorder¹,^†

# participants affected / at risk

1/1198 (0.08%)

0/596 (0.00%)

# events

Infections and infestations

Cellulitis¹,^†

# participants affected / at risk

0/1198 (0.00%)

1/596 (0.17%)

# events

Infections and infestations

Gastroenteritis¹,^†

# participants affected / at risk

1/1198 (0.08%)

0/596 (0.00%)

# events

Infections and infestations

Influenza¹,^†

# participants affected / at risk

1/1198 (0.08%)

0/596 (0.00%)

# events

Infections and infestations

Pneumonia¹,^†

# participants affected / at risk

1/1198 (0.08%)

0/596 (0.00%)

# events

Infections and infestations

Pyelonephritis¹,^†

# participants affected / at risk

1/1198 (0.08%)

0/596 (0.00%)

# events

Infections and infestations

Upper respiratory tract infection¹,^†

# participants affected / at risk

1/1198 (0.08%)

0/596 (0.00%)

# events

Investigations

Methycillin-resistant staphylococcal aureus test¹,^†

# participants affected / at risk

0/1198 (0.00%)

1/596 (0.17%)

# events

Musculoskeletal and connective tissue disorders

Arthritis¹,^†

# participants affected / at risk

1/1198 (0.08%)

0/596 (0.00%)

# events

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

Meningioma¹,^†

# participants affected / at risk

1/1198 (0.08%)

0/596 (0.00%)

# events

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

Oesophageal carcinoma¹,^†

# participants affected / at risk

1/1198 (0.08%)

0/596 (0.00%)

# events

Nervous system disorders

Cerebrovascular accident¹,^†

# participants affected / at risk

1/1198 (0.08%)

0/596 (0.00%)

# events

Pregnancy, puerperium and perinatal conditions

Abortion spontaneous¹,^†

# participants affected / at risk

2/1198 (0.17%)

0/596 (0.00%)

# events

Psychiatric disorders

Depression¹,^†

# participants affected / at risk

1/1198 (0.08%)

0/596 (0.00%)

# events

Renal and urinary disorders

Renal failure acute¹,^†

# participants affected / at risk

1/1198 (0.08%)

0/596 (0.00%)

# events

Respiratory, thoracic and mediastinal disorders

Status asthmaticus¹,^†

# participants affected / at risk

1/1198 (0.08%)

0/596 (0.00%)

# events

Metabolism and nutrition disorders

Diabetes mellitus¹,^†

# participants affected / at risk

0/1198 (0.00%)

1/596 (0.17%)

# events

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

Other Adverse Events

Time Frame	Serious adverse events, Days 0-180 post dose; other adverse events, Days 0-28 post dose.
Additional Description	Telephone contacts were made by site personnel to the participant at various times during the study to assess safety.

Frequency Threshold

Threshold above which other adverse events are reported	1%

Reporting Groups

Description

Q/LAIV-BFS (MEDI8662)

All FluMist

Data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined.

Other Adverse Events

Q/LAIV-BFS (MEDI8662)

All FluMist

Total, other (not including serious) adverse events

# participants affected / at risk

100/1198 (8.35%)

45/596 (7.55%)

Gastrointestinal disorders

Vomiting¹,^†

# participants affected / at risk

6/1198 (0.50%)

7/596 (1.17%)

# events

Gastrointestinal disorders

Nausea¹,^†

# participants affected / at risk

14/1198 (1.17%)

4/596 (0.67%)

# events

Gastrointestinal disorders

Diarrhoea¹,^†

# participants affected / at risk

14/1198 (1.17%)

9/596 (1.51%)

# events

Nervous system disorders

Headache¹,^†

# participants affected / at risk

16/1198 (1.34%)

3/596 (0.50%)

# events

Respiratory, thoracic and mediastinal disorders

Cough¹,^†

# participants affected / at risk

18/1198 (1.50%)

5/596 (0.84%)

# events

Respiratory, thoracic and mediastinal disorders

Rhinorrhoea¹,^†

# participants affected / at risk

12/1198 (1.00%)

5/596 (0.84%)

# events

Respiratory, thoracic and mediastinal disorders

Sneezing¹,^†

# participants affected / at risk

12/1198 (1.00%)

6/596 (1.01%)

# events

Infections and infestations

Upper respiratory tract infection¹,^†

# participants affected / at risk

8/1198 (0.67%)

6/596 (1.01%)

# events

†	Events were collected by systematic assessment
1	Term from vocabulary, MedDRA Version 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:	JA Sliman, MD, MPH, Director, Clinical Development
Organization:	MedImmune, LLC
Phone	301-398-0000
E-mail:	[email protected]

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Trial Results Summaries
Available here

Contacts

Contact

Terramika Bellamy

301-398-0000

bellamyt@medimmune.com

Contact Backup

Giselle Gift

301-398-0000

giftg@medimmune.com

Investigators

Principal Investigator

Joseph Sliman

MedImmune LLC

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Meridian Clinical Research, LLC

Johnson County Clin-Trials

Avail Clinical Research, LLC

Clinical Research Atlanta

California Research Foundation

Benchmark Research Austin

Rochester Clinical Research Inc.

Benchmark Research