Trial Outcomes & Findings for A Study to Evaluate the Immunogenicity of Quadrivalent LAIV (MEDI8662) in Adults 18 to 49 Years of Age (NCT NCT00952705)

NCT ID: NCT00952705

Last Updated: 2018-05-03

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 1800 participants
• Primary outcome timeframe: Day 28 to 35
• Results posted on: 2018-05-03

Participant Flow

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.

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.

Participant milestones

Measure	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).
Overall Study STARTED	1202	300	298
Overall Study COMPLETED	1169	290	288
Overall Study NOT COMPLETED	33	10	10

Reasons for withdrawal

Measure	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).
Overall Study Lost to Follow-up	24	8	9
Overall Study Withdrawal by Subject	2	1	1
Overall Study Death	2	0	0
Overall Study Incarcerated post dose	5	0	0
Overall Study Exclusion criteria not met pre dose	0	1	0

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Q/LAIV-BFS (MEDI8662) n=1202 Participants 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 n=300 Participants 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 n=298 Participants 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).	Total n=1800 Participants Total of all reporting groups
Age, Continuous	33.9 Years STANDARD_DEVIATION 9.5 • n=5 Participants	34.0 Years STANDARD_DEVIATION 9.1 • n=7 Participants	33.8 Years STANDARD_DEVIATION 8.8 • n=5 Participants	33.9 Years STANDARD_DEVIATION 9.3 • n=4 Participants
Sex: Female, Male Female	701 Participants n=5 Participants	169 Participants n=7 Participants	167 Participants n=5 Participants	1037 Participants n=4 Participants
Sex: Female, Male Male	501 Participants n=5 Participants	131 Participants n=7 Participants	131 Participants n=5 Participants	763 Participants n=4 Participants

PRIMARY outcome

Timeframe: Day 28 to 35

Population: 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.

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.

Outcome measures

Measure	Q/LAIV-BFS (MEDI8662) n=1176 Participants 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 n=294 Participants 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 n=292 Participants 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 n=586 Participants 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.
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). A/H1N1	8.1 Geometric Mean Titer Interval 2.0 to 1448.0	7.1 Geometric Mean Titer Interval 2.0 to 512.0	8.3 Geometric Mean Titer Interval 2.0 to 1024.0	7.7 Geometric Mean Titer Interval 2.0 to 1024.0
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). A/H3N2	8.3 Geometric Mean Titer Interval 2.0 to 1024.0	8.0 Geometric Mean Titer Interval 2.0 to 1024.0	7.4 Geometric Mean Titer Interval 2.0 to 512.0	7.7 Geometric Mean Titer Interval 2.0 to 1024.0
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). B/Yamagata	60.3 Geometric Mean Titer Interval 2.0 to 4096.0	54.1 Geometric Mean Titer Interval 2.0 to 2048.0	49.8 Geometric Mean Titer Interval 2.0 to 4096.0	51.9 Geometric Mean Titer Interval 2.0 to 4096.0
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). B/Victoria	27.4 Geometric Mean Titer Interval 2.0 to 2048.0	19.9 Geometric Mean Titer Interval 2.0 to 1024.0	26.7 Geometric Mean Titer Interval 2.0 to 1024.0	23.0 Geometric Mean Titer Interval 2.0 to 1024.0

SECONDARY outcome

Timeframe: Day 0 and Day 28-35

Population: 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.

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).

Outcome measures

Measure	Q/LAIV-BFS (MEDI8662) n=1176 Participants 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 n=586 Participants 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.
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. A/H1N1	5.4 Percentage of Participants	6.5 Percentage of Participants	—	—
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. A/H3N2	4.7 Percentage of Participants	4.8 Percentage of Participants	—	—

SECONDARY outcome

Timeframe: Day 0 and Day 28-35

Population: 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.

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.

Outcome measures

Measure	Q/LAIV-BFS (MEDI8662) n=1175 Participants 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 n=294 Participants 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.
The Percentage of Participants Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the B/Yamagata Strain in All Participants, Regardless of Baseline Serostatus.	8.2 Percentage of Participants	9.5 Percentage of Participants	—	—

SECONDARY outcome

Timeframe: Day 0 and Day 28-35

Population: 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.

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.

Outcome measures

Measure	Q/LAIV-BFS (MEDI8662) n=1176 Participants 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 n=292 Participants 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.
The Percentage of Participants Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the B/Victoria Strain in All Participants, Regardless of Baseline Serostatus.	7.5 Percentage of Participants	10.3 Percentage of Participants	—	—

SECONDARY outcome

Timeframe: Day 0 and Day 28-35

Population: 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.

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).

Outcome measures

Measure	Q/LAIV-BFS (MEDI8662) n=783 Participants 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 n=412 Participants 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.
The Percentage of Serosusceptible Participants Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the A/H1N1 Strain.	7.9 Percentage of participants	9.0 Percentage of participants	—	—

SECONDARY outcome

Timeframe: Day 0 and Day 28-35

Population: 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.

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).

Outcome measures

Measure	Q/LAIV-BFS (MEDI8662) n=746 Participants 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 n=386 Participants 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.
The Percentage of Serosusceptible Participants Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the A/H3N2 Strain.	6.3 Percentage of Participants	7.0 Percentage of Participants	—	—

SECONDARY outcome

Timeframe: Day 0 and Day 28-35

Population: 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.

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.

Outcome measures

Measure	Q/LAIV-BFS (MEDI8662) n=189 Participants 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 n=51 Participants 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.
The Percentage of Serosusceptible Participants Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the B/Yamagata Strain.	36.0 Percentage of Participants	35.3 Percentage of Participants	—	—

SECONDARY outcome

Timeframe: Day 0 and Day 28-35

Population: 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.

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.

Outcome measures

Measure	Q/LAIV-BFS (MEDI8662) n=361 Participants 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 n=104 Participants 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.
The Percentage of Serosusceptible Participants Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the B/Victoria Strain.	20.8 Percentage of Participants	26.0 Percentage of Participants	—	—

SECONDARY outcome

Timeframe: Day 0 and Day 28-35

Population: 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.

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).

Outcome measures

Measure	Q/LAIV-BFS (MEDI8662) n=393 Participants 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 n=174 Participants 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.
The Percentage of Seropositive Participants Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the A/H1N1 Strain.	0.5 Percentage of participants	0.6 Percentage of participants	—	—

SECONDARY outcome

Timeframe: Day 0 and Day 28-35

Population: 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.

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).

Outcome measures

Measure	Q/LAIV-BFS (MEDI8662) n=430 Participants 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 n=200 Participants 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.
The Percentage of Seropositive Participants Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the A/H3N2 Strain.	1.9 Percentage of participants	0.5 Percentage of participants	—	—

SECONDARY outcome

Timeframe: Day 0 and Day 28-35

Population: 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.

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.

Outcome measures

Measure	Q/LAIV-BFS (MEDI8662) n=986 Participants 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 n=243 Participants 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.
The Percentage of Seropositive Participants Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the B/Yamagata Strain.	2.8 Percentage of Participants	4.1 Percentage of Participants	—	—

SECONDARY outcome

Timeframe: Day 0 and Day 28-35

Population: 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.

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.

Outcome measures

Measure	Q/LAIV-BFS (MEDI8662) n=815 Participants 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 n=188 Participants 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.
The Percentage of Seropositive Subjects Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the B/Victoria Strain.	1.6 Percentage of Participants	1.6 Percentage of Participants	—	—

SECONDARY outcome

Timeframe: Day 28-35

Population: 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.

The comparators to the A/H1N1 and A/H3N2 strains were participants in the All FluMist group (combined data for both FluMist arms).

Outcome measures

Measure	Q/LAIV-BFS (MEDI8662) n=1176 Participants 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 n=586 Participants 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.
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. A/H1N1	25.3 Percentage of Participants	22.5 Percentage of Participants	—	—
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. A/H3N2	25.8 Percentage of Participants	23.4 Percentage of Participants	—	—

SECONDARY outcome

Timeframe: Day 28-35

Population: 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.

The comparator for the B/Yamagata strain was participants in the FluMist/B/Yamagata arm.

Outcome measures

Measure	Q/LAIV-BFS (MEDI8662) n=1176 Participants 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 n=294 Participants 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.
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.	78.7 Percentage of subjects	75.2 Percentage of subjects	—	—

SECONDARY outcome

Timeframe: Day 28-35

Population: 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.

The comparator for the B/Victoria strain was participants in the FluMist/B/Victoria arm.

Outcome measures

Measure	Q/LAIV-BFS (MEDI8662) n=1176 Participants 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 n=292 Participants 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.
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.	55.5 Percentage of Participants	52.7 Percentage of Participants	—	—

SECONDARY outcome

Timeframe: Day 28-35

Population: 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.

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).

Outcome measures

Measure	Q/LAIV-BFS (MEDI8662) n=783 Participants 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 n=412 Participants 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.
The Percentage of Serosusceptible Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the A/H1N1 Strain.	2.7 Percentage of participants	1.7 Percentage of participants	—	—

SECONDARY outcome

Timeframe: Day 28-35

Population: 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.

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).

Outcome measures

Measure	Q/LAIV-BFS (MEDI8662) n=746 Participants 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 n=386 Participants 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.
The Percentage of Serosusceptible Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the A/H3N2 Strain.	1.5 Percentage of Participants	1.8 Percentage of Participants	—	—

SECONDARY outcome

Timeframe: Day 28-35

Population: 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.

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.

Outcome measures

Measure	Q/LAIV-BFS (MEDI8662) n=189 Participants 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 n=51 Participants 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.
The Percentage of Serosusceptible Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the B/Yamagata Strain.	21.7 Percentage of Participants	19.6 Percentage of Participants	—	—

SECONDARY outcome

Timeframe: Day 28-35

Population: 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.

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.

Outcome measures

Measure	Q/LAIV-BFS (MEDI8662) n=361 Participants 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 n=104 Participants 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.
The Percentage of Serosusceptible Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the B/Victoria Strain.	9.7 Percentage of Participants	13.5 Percentage of Participants	—	—

SECONDARY outcome

Timeframe: Day 28-35

Population: 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.

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).

Outcome measures

Measure	Q/LAIV-BFS (MEDI8662) n=393 Participants 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 n=174 Participants 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.
The Percentage of Seropositive Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the A/H1N1 Strain.	70.2 Percentage of participants	71.8 Percentage of participants	—	—

SECONDARY outcome

Timeframe: Day 28-35

Population: 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.

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).

Outcome measures

Measure	Q/LAIV-BFS (MEDI8662) n=430 Participants 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 n=200 Participants 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.
The Percentage of Seropositive Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the A/H3N2 Strain.	67.9 Percentage of participants	65.0 Percentage of participants	—	—

SECONDARY outcome

Timeframe: Day 28-35

Population: 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.

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.

Outcome measures

Measure	Q/LAIV-BFS (MEDI8662) n=986 Participants 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 n=243 Participants 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.
The Percentage of Seropositive Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the B/Yamagata Strain.	89.7 Percentage of Participants	86.8 Percentage of Participants	—	—

SECONDARY outcome

Timeframe: Day 28-35

Population: 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.

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.

Outcome measures

Measure	Q/LAIV-BFS (MEDI8662) n=815 Participants 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 n=188 Participants 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.
The Percentage of Seropositive Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the B/Victoria Strain.	75.8 Percentage of Participants	74.5 Percentage of Participants	—	—

SECONDARY outcome

Timeframe: Days 0-14 post dose

Population: 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.

Outcome measures

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

SECONDARY outcome

Timeframe: Days 0-28 post dose

Population: The Safety Population included participants who received any investigational product and for whom any follow-up safety data were reported.

Outcome measures

Measure	Q/LAIV-BFS (MEDI8662) n=1198 Participants 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 n=596 Participants 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.
The Percentage of Participants Reporting Any Adverse Event From Administration of Investigational Product Through 28 Days Post Dose	15.6 Percentage of Participants	14.9 Percentage of Participants	—	—

SECONDARY outcome

Timeframe: Days 0-28 post dose

Population: The Safety Population included participants who received any investigational product and for whom any follow-up safety data were reported.

Outcome measures

Measure	Q/LAIV-BFS (MEDI8662) n=1198 Participants 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 n=596 Participants 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.
The Percentage of Participants Reporting Any Serious Adverse Event From Administration of Investigational Product Through 28 Days Post Dose	0.3 Percentage of Participants	0.0 Percentage of Participants	—	—

SECONDARY outcome

Timeframe: Days 0-180 post dose

Population: The Safety Population included participants who received any investigational product and for whom any follow-up safety data were reported.

Outcome measures

Measure	Q/LAIV-BFS (MEDI8662) n=1198 Participants 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 n=596 Participants 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.
The Percentage of Participants Reporting Any Serious Adverse Event From Administration of Investigational Product Through 180 Days Post Dose	1.3 Percentage of Participants	0.3 Percentage of Participants	—	—

SECONDARY outcome

Timeframe: Days 0-180 post dose

Population: The Safety Population included participants who received any investigational product and for whom any follow-up safety data were reported.

Outcome measures

Measure	Q/LAIV-BFS (MEDI8662) n=1198 Participants 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 n=596 Participants 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.
The Percentage of Participants Reporting New Onset Chronic Diseases From Administration of Investigational Product Through 180 Days Post Dose	0.5 Percentage of Participants	0.5 Percentage of Participants	—	—

Adverse Events

Q/LAIV-BFS (MEDI8662)

Serious events: 15 serious events

Other events: 100 other events

Deaths: 0 deaths

All FluMist

Serious events: 2 serious events

Other events: 45 other events

Deaths: 0 deaths

Serious adverse events

Measure	Q/LAIV-BFS (MEDI8662) n=1198 participants at risk 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 n=596 participants at risk Data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined.
Cardiac disorders Cardiac aneurysm	0.08% 1/1198 • Number of events 1 • Serious adverse events, Days 0-180 post dose; other adverse events, Days 0-28 post dose. Telephone contacts were made by site personnel to the participant at various times during the study to assess safety.	0.00% 0/596 • Serious adverse events, Days 0-180 post dose; other adverse events, Days 0-28 post dose. Telephone contacts were made by site personnel to the participant at various times during the study to assess safety.
General disorders Multi-organ failure	0.08% 1/1198 • Number of events 1 • Serious adverse events, Days 0-180 post dose; other adverse events, Days 0-28 post dose. Telephone contacts were made by site personnel to the participant at various times during the study to assess safety.	0.00% 0/596 • Serious adverse events, Days 0-180 post dose; other adverse events, Days 0-28 post dose. Telephone contacts were made by site personnel to the participant at various times during the study to assess safety.
General disorders Oedema peripheral	0.00% 0/1198 • Serious adverse events, Days 0-180 post dose; other adverse events, Days 0-28 post dose. Telephone contacts were made by site personnel to the participant at various times during the study to assess safety.	0.17% 1/596 • Number of events 1 • Serious adverse events, Days 0-180 post dose; other adverse events, Days 0-28 post dose. Telephone contacts were made by site personnel to the participant at various times during the study to assess safety.
Hepatobiliary disorders Cholecystitis	0.08% 1/1198 • Number of events 1 • Serious adverse events, Days 0-180 post dose; other adverse events, Days 0-28 post dose. Telephone contacts were made by site personnel to the participant at various times during the study to assess safety.	0.00% 0/596 • Serious adverse events, Days 0-180 post dose; other adverse events, Days 0-28 post dose. Telephone contacts were made by site personnel to the participant at various times during the study to assess safety.
Hepatobiliary disorders Gallbladder disorder	0.08% 1/1198 • Number of events 1 • Serious adverse events, Days 0-180 post dose; other adverse events, Days 0-28 post dose. Telephone contacts were made by site personnel to the participant at various times during the study to assess safety.	0.00% 0/596 • Serious adverse events, Days 0-180 post dose; other adverse events, Days 0-28 post dose. Telephone contacts were made by site personnel to the participant at various times during the study to assess safety.
Infections and infestations Cellulitis	0.00% 0/1198 • Serious adverse events, Days 0-180 post dose; other adverse events, Days 0-28 post dose. Telephone contacts were made by site personnel to the participant at various times during the study to assess safety.	0.17% 1/596 • Number of events 1 • Serious adverse events, Days 0-180 post dose; other adverse events, Days 0-28 post dose. Telephone contacts were made by site personnel to the participant at various times during the study to assess safety.
Infections and infestations Gastroenteritis	0.08% 1/1198 • Number of events 1 • Serious adverse events, Days 0-180 post dose; other adverse events, Days 0-28 post dose. Telephone contacts were made by site personnel to the participant at various times during the study to assess safety.	0.00% 0/596 • Serious adverse events, Days 0-180 post dose; other adverse events, Days 0-28 post dose. Telephone contacts were made by site personnel to the participant at various times during the study to assess safety.
Infections and infestations Influenza	0.08% 1/1198 • Number of events 1 • Serious adverse events, Days 0-180 post dose; other adverse events, Days 0-28 post dose. Telephone contacts were made by site personnel to the participant at various times during the study to assess safety.	0.00% 0/596 • Serious adverse events, Days 0-180 post dose; other adverse events, Days 0-28 post dose. Telephone contacts were made by site personnel to the participant at various times during the study to assess safety.
Infections and infestations Pneumonia	0.08% 1/1198 • Number of events 1 • Serious adverse events, Days 0-180 post dose; other adverse events, Days 0-28 post dose. Telephone contacts were made by site personnel to the participant at various times during the study to assess safety.	0.00% 0/596 • Serious adverse events, Days 0-180 post dose; other adverse events, Days 0-28 post dose. Telephone contacts were made by site personnel to the participant at various times during the study to assess safety.
Infections and infestations Pyelonephritis	0.08% 1/1198 • Number of events 1 • Serious adverse events, Days 0-180 post dose; other adverse events, Days 0-28 post dose. Telephone contacts were made by site personnel to the participant at various times during the study to assess safety.	0.00% 0/596 • Serious adverse events, Days 0-180 post dose; other adverse events, Days 0-28 post dose. Telephone contacts were made by site personnel to the participant at various times during the study to assess safety.
Infections and infestations Upper respiratory tract infection	0.08% 1/1198 • Number of events 1 • Serious adverse events, Days 0-180 post dose; other adverse events, Days 0-28 post dose. Telephone contacts were made by site personnel to the participant at various times during the study to assess safety.	0.00% 0/596 • Serious adverse events, Days 0-180 post dose; other adverse events, Days 0-28 post dose. Telephone contacts were made by site personnel to the participant at various times during the study to assess safety.
Investigations Methycillin-resistant staphylococcal aureus test	0.00% 0/1198 • Serious adverse events, Days 0-180 post dose; other adverse events, Days 0-28 post dose. Telephone contacts were made by site personnel to the participant at various times during the study to assess safety.	0.17% 1/596 • Number of events 1 • Serious adverse events, Days 0-180 post dose; other adverse events, Days 0-28 post dose. Telephone contacts were made by site personnel to the participant at various times during the study to assess safety.
Musculoskeletal and connective tissue disorders Arthritis	0.08% 1/1198 • Number of events 1 • Serious adverse events, Days 0-180 post dose; other adverse events, Days 0-28 post dose. Telephone contacts were made by site personnel to the participant at various times during the study to assess safety.	0.00% 0/596 • Serious adverse events, Days 0-180 post dose; other adverse events, Days 0-28 post dose. Telephone contacts were made by site personnel to the participant at various times during the study to assess safety.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Meningioma	0.08% 1/1198 • Number of events 1 • Serious adverse events, Days 0-180 post dose; other adverse events, Days 0-28 post dose. Telephone contacts were made by site personnel to the participant at various times during the study to assess safety.	0.00% 0/596 • Serious adverse events, Days 0-180 post dose; other adverse events, Days 0-28 post dose. Telephone contacts were made by site personnel to the participant at various times during the study to assess safety.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal carcinoma	0.08% 1/1198 • Number of events 1 • Serious adverse events, Days 0-180 post dose; other adverse events, Days 0-28 post dose. Telephone contacts were made by site personnel to the participant at various times during the study to assess safety.	0.00% 0/596 • Serious adverse events, Days 0-180 post dose; other adverse events, Days 0-28 post dose. Telephone contacts were made by site personnel to the participant at various times during the study to assess safety.
Nervous system disorders Cerebrovascular accident	0.08% 1/1198 • Number of events 1 • Serious adverse events, Days 0-180 post dose; other adverse events, Days 0-28 post dose. Telephone contacts were made by site personnel to the participant at various times during the study to assess safety.	0.00% 0/596 • Serious adverse events, Days 0-180 post dose; other adverse events, Days 0-28 post dose. Telephone contacts were made by site personnel to the participant at various times during the study to assess safety.
Pregnancy, puerperium and perinatal conditions Abortion spontaneous	0.17% 2/1198 • Number of events 2 • Serious adverse events, Days 0-180 post dose; other adverse events, Days 0-28 post dose. Telephone contacts were made by site personnel to the participant at various times during the study to assess safety.	0.00% 0/596 • Serious adverse events, Days 0-180 post dose; other adverse events, Days 0-28 post dose. Telephone contacts were made by site personnel to the participant at various times during the study to assess safety.
Psychiatric disorders Depression	0.08% 1/1198 • Number of events 1 • Serious adverse events, Days 0-180 post dose; other adverse events, Days 0-28 post dose. Telephone contacts were made by site personnel to the participant at various times during the study to assess safety.	0.00% 0/596 • Serious adverse events, Days 0-180 post dose; other adverse events, Days 0-28 post dose. Telephone contacts were made by site personnel to the participant at various times during the study to assess safety.
Renal and urinary disorders Renal failure acute	0.08% 1/1198 • Number of events 1 • Serious adverse events, Days 0-180 post dose; other adverse events, Days 0-28 post dose. Telephone contacts were made by site personnel to the participant at various times during the study to assess safety.	0.00% 0/596 • Serious adverse events, Days 0-180 post dose; other adverse events, Days 0-28 post dose. Telephone contacts were made by site personnel to the participant at various times during the study to assess safety.
Respiratory, thoracic and mediastinal disorders Status asthmaticus	0.08% 1/1198 • Number of events 1 • Serious adverse events, Days 0-180 post dose; other adverse events, Days 0-28 post dose. Telephone contacts were made by site personnel to the participant at various times during the study to assess safety.	0.00% 0/596 • Serious adverse events, Days 0-180 post dose; other adverse events, Days 0-28 post dose. Telephone contacts were made by site personnel to the participant at various times during the study to assess safety.
Metabolism and nutrition disorders Diabetes mellitus	0.00% 0/1198 • Serious adverse events, Days 0-180 post dose; other adverse events, Days 0-28 post dose. Telephone contacts were made by site personnel to the participant at various times during the study to assess safety.	0.17% 1/596 • Number of events 1 • Serious adverse events, Days 0-180 post dose; other adverse events, Days 0-28 post dose. Telephone contacts were made by site personnel to the participant at various times during the study to assess safety.

Other adverse events

Measure	Q/LAIV-BFS (MEDI8662) n=1198 participants at risk 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 n=596 participants at risk Data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined.
Gastrointestinal disorders Vomiting	0.50% 6/1198 • Number of events 6 • Serious adverse events, Days 0-180 post dose; other adverse events, Days 0-28 post dose. Telephone contacts were made by site personnel to the participant at various times during the study to assess safety.	1.2% 7/596 • Number of events 7 • Serious adverse events, Days 0-180 post dose; other adverse events, Days 0-28 post dose. Telephone contacts were made by site personnel to the participant at various times during the study to assess safety.
Gastrointestinal disorders Nausea	1.2% 14/1198 • Number of events 15 • Serious adverse events, Days 0-180 post dose; other adverse events, Days 0-28 post dose. Telephone contacts were made by site personnel to the participant at various times during the study to assess safety.	0.67% 4/596 • Number of events 4 • Serious adverse events, Days 0-180 post dose; other adverse events, Days 0-28 post dose. Telephone contacts were made by site personnel to the participant at various times during the study to assess safety.
Gastrointestinal disorders Diarrhoea	1.2% 14/1198 • Number of events 15 • Serious adverse events, Days 0-180 post dose; other adverse events, Days 0-28 post dose. Telephone contacts were made by site personnel to the participant at various times during the study to assess safety.	1.5% 9/596 • Number of events 9 • Serious adverse events, Days 0-180 post dose; other adverse events, Days 0-28 post dose. Telephone contacts were made by site personnel to the participant at various times during the study to assess safety.
Nervous system disorders Headache	1.3% 16/1198 • Number of events 16 • Serious adverse events, Days 0-180 post dose; other adverse events, Days 0-28 post dose. Telephone contacts were made by site personnel to the participant at various times during the study to assess safety.	0.50% 3/596 • Number of events 3 • Serious adverse events, Days 0-180 post dose; other adverse events, Days 0-28 post dose. Telephone contacts were made by site personnel to the participant at various times during the study to assess safety.
Respiratory, thoracic and mediastinal disorders Cough	1.5% 18/1198 • Number of events 18 • Serious adverse events, Days 0-180 post dose; other adverse events, Days 0-28 post dose. Telephone contacts were made by site personnel to the participant at various times during the study to assess safety.	0.84% 5/596 • Number of events 5 • Serious adverse events, Days 0-180 post dose; other adverse events, Days 0-28 post dose. Telephone contacts were made by site personnel to the participant at various times during the study to assess safety.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	1.0% 12/1198 • Number of events 12 • Serious adverse events, Days 0-180 post dose; other adverse events, Days 0-28 post dose. Telephone contacts were made by site personnel to the participant at various times during the study to assess safety.	0.84% 5/596 • Number of events 5 • Serious adverse events, Days 0-180 post dose; other adverse events, Days 0-28 post dose. Telephone contacts were made by site personnel to the participant at various times during the study to assess safety.
Respiratory, thoracic and mediastinal disorders Sneezing	1.0% 12/1198 • Number of events 13 • Serious adverse events, Days 0-180 post dose; other adverse events, Days 0-28 post dose. Telephone contacts were made by site personnel to the participant at various times during the study to assess safety.	1.0% 6/596 • Number of events 6 • Serious adverse events, Days 0-180 post dose; other adverse events, Days 0-28 post dose. Telephone contacts were made by site personnel to the participant at various times during the study to assess safety.
Infections and infestations Upper respiratory tract infection	0.67% 8/1198 • Number of events 8 • Serious adverse events, Days 0-180 post dose; other adverse events, Days 0-28 post dose. Telephone contacts were made by site personnel to the participant at various times during the study to assess safety.	1.0% 6/596 • Number of events 6 • Serious adverse events, Days 0-180 post dose; other adverse events, Days 0-28 post dose. Telephone contacts were made by site personnel to the participant at various times during the study to assess safety.

Additional Information

JA Sliman, MD, MPH, Director, Clinical Development

MedImmune, LLC

Phone: 301-398-0000

Email: SlimanJ@medimmune.com

Results disclosure agreements

• Principal investigator is a sponsor employee 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.
• Publication restrictions are in place

Restriction type: OTHER