Trial Outcomes & Findings for A Study to Evaluate the Immunogenicity of Quadrivalent LAIV in Adults 18 to 49 Years of Age (NCT NCT00860067)

NCT ID: NCT00860067

Last Updated: 2011-12-05

Results Overview

Noninferior immune response was defined as having the upper bound of the 2-sided 95% confidence intervals (CIs) for the HAI antibody GMT ratio (FluMist comparator divided by Q/LAIV) ≤ 1.5 for each of the 4 strains.

• Recruitment status: COMPLETED
• Study phase: PHASE2/PHASE3
• Target enrollment: 1800 participants
• Primary outcome timeframe: Day 28-35
• Results posted on: 2011-12-05

Participant Flow

A total of 1,924 participants provided written informed consent and were screened for the study. Of these, 1,800 participants were randomized into the study at 18 sites in the USA from 23Mar2009 and 26Mar2009.

Participants who provided written informed consent and who met the eligibility criteria were randomized by site at a 4:1:1 ratio to receive Q/LAIV, FluMist/B/Yamagata, or FluMist/B/Victoria. The randomization incorporated a block design with a fixed block size of 6.

Participant milestones

Measure	Q/LAIV (MEDI3250) Q/LAIV (quadrivalent influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10\^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza 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 (trivalent influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10\^7.0 ± 0.5 FFU of each of 3 temperate sensitive, cold-adapted, attentuated, 6:2 reassortant influenza 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(trivalent influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10\^7.0 ± 0.5 FFU of each of 3 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 \[A/South Dakota/6/2007\], A/H3N2 \[A/Uruguay/716/2007\], and B/Victoria \[B/Malaysia/2506/2004\]).
Overall Study STARTED	1200	299	301
Overall Study COMPLETED	1149	290	292
Overall Study NOT COMPLETED	51	9	9

Reasons for withdrawal

Measure	Q/LAIV (MEDI3250) Q/LAIV (quadrivalent influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10\^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza 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 (trivalent influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10\^7.0 ± 0.5 FFU of each of 3 temperate sensitive, cold-adapted, attentuated, 6:2 reassortant influenza 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(trivalent influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10\^7.0 ± 0.5 FFU of each of 3 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza 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	46	9	9
Overall Study Withdrawal by Subject	4	0	0
Overall Study Pregnancy	1	0	0

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Q/LAIV (MEDI3250) n=1200 Participants Q/LAIV (quadrivalent influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10\^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza 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=299 Participants FluMist/B/Yamagata (trivalent influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10\^7.0 ± 0.5 FFU of each of 3 temperate sensitive, cold-adapted, attentuated, 6:2 reassortant influenza 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=301 Participants FluMist/B/Victoria(trivalent influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10\^7.0 ± 0.5 FFU of each of 3 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza 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 Participants	32.6 years STANDARD_DEVIATION 9.2 • n=5 Participants	32.8 years STANDARD_DEVIATION 9.2 • n=7 Participants	32.8 years STANDARD_DEVIATION 9.2 • n=5 Participants	32.7 years STANDARD_DEVIATION 9.2 • n=4 Participants
Sex: Female, Male Female	658 Participants n=5 Participants	165 Participants n=7 Participants	171 Participants n=5 Participants	994 Participants n=4 Participants
Sex: Female, Male Male	542 Participants n=5 Participants	134 Participants n=7 Participants	130 Participants n=5 Participants	806 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	264 Participants n=5 Participants	67 Participants n=7 Participants	78 Participants n=5 Participants	409 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	936 Participants n=5 Participants	232 Participants n=7 Participants	223 Participants n=5 Participants	1391 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race/Ethnicity, Customized American Indian or Alaskan Native	5 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants	10 Participants n=4 Participants
Race/Ethnicity, Customized Asian	11 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	15 Participants n=4 Participants
Race/Ethnicity, Customized Black or African American	249 Participants n=5 Participants	66 Participants n=7 Participants	61 Participants n=5 Participants	376 Participants n=4 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	4 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	8 Participants n=4 Participants
Race/Ethnicity, Customized White	916 Participants n=5 Participants	228 Participants n=7 Participants	230 Participants n=5 Participants	1374 Participants n=4 Participants
Race/Ethnicity, Customized Other	8 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	9 Participants n=4 Participants
Race/Ethnicity, Customized Multiracial	7 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	8 Participants n=4 Participants
Region of Enrollment United States	1200 participants n=5 Participants	299 participants n=7 Participants	301 participants n=5 Participants	1800 participants n=4 Participants

PRIMARY outcome

Timeframe: Day 28-35

Population: Participants who received a full dose of investigational product (Q=1198; FY=299; FV=301;All FM=600), had post-dose HAI measurement (Q=1182; FY=292; FV=298; All FM=590), and had no protocol deviation that could have interfered with the generation or interpretation of an immune response (Q=1181; FY=292; FV=297; All FM=589).

Noninferior immune response was defined as having the upper bound of the 2-sided 95% confidence intervals (CIs) for the HAI antibody GMT ratio (FluMist comparator divided by Q/LAIV) ≤ 1.5 for each of the 4 strains.

Outcome measures

Measure	Q/LAIV (MEDI3250) n=1181 Participants Q/LAIV (quadrivalent influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10\^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza 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 (trivalent influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10\^7.0 ± 0.5 FFU of each of 3 temperate sensitive, cold-adapted, attentuated, 6:2 reassortant influenza 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=297 Participants FluMist/B/Victoria(trivalent influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10\^7.0 ± 0.5 FFU of each of 3 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 \[A/South Dakota/6/2007\], A/H3N2 \[A/Uruguay/716/2007\], and B/Victoria \[B/Malaysia/2506/2004\]).	All FluMist n=589 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 were combined.
The 4 Post-dose Strain-specific Serum Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titers (GMT) in the Q/LAIV (MEDI3250) Arm Are Noninferior to Those in the Comparator FluMist Group. A/H1N1	5.9 geometric mean titer Interval 2.0 to 1024.0	NA geometric mean titer The comparators for the GMT ratios for the primary endpoint were subjects in the All FluMist group (combined data for both FluMist arms) for A/H1N1 and A/H3N2 strains.	NA geometric mean titer The comparators for the GMT ratios for the primary endpoint were subjects in the All FluMist group (combined data for both FluMist arms) for A/H1N1 and A/H3N2 strains.	6.5 geometric mean titer Interval 2.0 to 512.0
The 4 Post-dose Strain-specific Serum Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titers (GMT) in the Q/LAIV (MEDI3250) Arm Are Noninferior to Those in the Comparator FluMist Group. A/H3N2	7.5 geometric mean titer Interval 2.0 to 2896.0	NA geometric mean titer The comparators for the GMT ratios for the primary endpoint were subjects in the All FluMist group (combined data for both FluMist arms) for A/H1N1 and A/H3N2 strains.	NA geometric mean titer The comparators for the GMT ratios for the primary endpoint were subjects in the All FluMist group (combined data for both FluMist arms) for A/H1N1 and A/H3N2 strains.	7.8 geometric mean titer Interval 2.0 to 2048.0
The 4 Post-dose Strain-specific Serum Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titers (GMT) in the Q/LAIV (MEDI3250) Arm Are Noninferior to Those in the Comparator FluMist Group. B/Yamagata	51.2 geometric mean titer Interval 2.0 to 2048.0	56.4 geometric mean titer Interval 2.0 to 2048.0	NA geometric mean titer The comparators for the GMT ratios for the primary endpoint were subjects who received FluMist with a matching B strain for B/Yamagata and B/Victoria strains.	NA geometric mean titer The comparators for the GMT ratios for the primary endpoint were subjects who received FluMist with a matching B strain for B/Yamagata and B/Victoria strains.
The 4 Post-dose Strain-specific Serum Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titers (GMT) in the Q/LAIV (MEDI3250) Arm Are Noninferior to Those in the Comparator FluMist Group. B/Victoria	36.5 geometric mean titer Interval 2.0 to 2896.0	NA geometric mean titer The comparators for the GMT ratios for the primary endpoint were subjects who received FluMist with a matching B strain for B/Yamagata and B/Victoria strains.	33.6 geometric mean titer Interval 2.0 to 1024.0	NA geometric mean titer The comparators for the GMT ratios for the primary endpoint were subjects who received FluMist with a matching B strain for B/Yamagata and B/Victoria strains.

SECONDARY outcome

Timeframe: Day 0 and Day 28-35

Population: Participants who received a full dose of investigational product (Q=1198; FY=298; FV=300; All FM=598), had pre-dose and post-dose HAI measurement (Q=1181; FY=292; FV=298; All FM=599), and had no protocol deviation that could have interfered with the generation or interpretation of an immune response (Q=1180; FY=292; FV=297; All FM=589).

Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline.

Outcome measures

Measure	Q/LAIV (MEDI3250) n=1180 Participants Q/LAIV (quadrivalent influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10\^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza 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 (trivalent influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10\^7.0 ± 0.5 FFU of each of 3 temperate sensitive, cold-adapted, attentuated, 6:2 reassortant influenza 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=297 Participants FluMist/B/Victoria(trivalent influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10\^7.0 ± 0.5 FFU of each of 3 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 \[A/South Dakota/6/2007\], A/H3N2 \[A/Uruguay/716/2007\], and B/Victoria \[B/Malaysia/2506/2004\]).	All FluMist n=589 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 were combined.
The Number of Participants (Regardless of Serostatus) Within Each Treatment Arm Who Experience Strain-specific Seroresponse Post Dose. A/H1N1	61 participants	NA participants The comparators for the seroresponse were participants in the All FluMist group (combined data for both FluMist arms) for A/H1N1 and A/H3N2 strains and participants who received FluMist with a matching B strain for B/Yamagata and B/Victoria strains.	NA participants The comparators for the seroresponse were participants in the All FluMist group (combined data for both FluMist arms) for A/H1N1 and A/H3N2 strains and participants who received FluMist with a matching B strain for B/Yamagata and B/Victoria strains.	31 participants
The Number of Participants (Regardless of Serostatus) Within Each Treatment Arm Who Experience Strain-specific Seroresponse Post Dose. A/H3N2	59 participants	NA participants The comparators for the seroresponse were participants in the All FluMist group (combined data for both FluMist arms) for A/H1N1 and A/H3N2 strains and participants who received FluMist with a matching B strain for B/Yamagata and B/Victoria strains.	NA participants The comparators for the seroresponse were participants in the All FluMist group (combined data for both FluMist arms) for A/H1N1 and A/H3N2 strains and participants who received FluMist with a matching B strain for B/Yamagata and B/Victoria strains.	25 participants
The Number of Participants (Regardless of Serostatus) Within Each Treatment Arm Who Experience Strain-specific Seroresponse Post Dose. B/Yamagata	118 participants	30 participants	NA participants The comparators for the seroresponse were participants in the All FluMist group (combined data for both FluMist arms) for A/H1N1 and A/H3N2 strains and participants who received FluMist with a matching B strain for B/Yamagata and B/Victoria strains.	NA participants The comparators for the seroresponse were participants in the All FluMist group (combined data for both FluMist arms) for A/H1N1 and A/H3N2 strains and participants who received FluMist with a matching B strain for B/Yamagata and B/Victoria strains.
The Number of Participants (Regardless of Serostatus) Within Each Treatment Arm Who Experience Strain-specific Seroresponse Post Dose. B/Victoria	145 participants	NA participants The comparators for the seroresponse were participants in the All FluMist group (combined data for both FluMist arms) for A/H1N1 and A/H3N2 strains and participants who received FluMist with a matching B strain for B/Yamagata and B/Victoria strains.	35 participants	NA participants The comparators for the seroresponse were participants in the All FluMist group (combined data for both FluMist arms) for A/H1N1 and A/H3N2 strains and participants who received FluMist with a matching B strain for B/Yamagata and B/Victoria strains.

SECONDARY outcome

Timeframe: Day 0 and Day 28-35

Population: Participants who received a full dose of investigational product (Q=1198; All FM=600), had pre-dose and post-dose HAI measurement (Q=1181; All FM=590), had no protocol deviation that could have interfered with the generation or interpretation of an immune response (Q=1180; All FM=589), and were serosusceptible to the strain (Q=889; All FM=429).

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.

Outcome measures

Measure	Q/LAIV (MEDI3250) n=889 Participants Q/LAIV (quadrivalent influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10\^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza 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=429 Participants FluMist/B/Yamagata (trivalent influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10\^7.0 ± 0.5 FFU of each of 3 temperate sensitive, cold-adapted, attentuated, 6:2 reassortant influenza 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(trivalent influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10\^7.0 ± 0.5 FFU of each of 3 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza 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 were combined.
The Number of Serosusceptible Participants Within Each Treatment Arm Who Experience A/H1N1 Strain-specific Seroresponse Post Dose.	59 participants	30 participants	—	—

SECONDARY outcome

Timeframe: Day 0 and Day 28-35

Population: Participants who received a full dose of investigational product (Q=1198; All FM=600), had pre-dose and post-dose HAI measurement (Q=1181; All FM=590), had no protocol deviation that could have interfered with the generation or interpretation of an immune response (Q=1180; All FM=589), and were serosusceptible to the strain (Q=807; All FM=393).

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.

Outcome measures

Measure	Q/LAIV (MEDI3250) n=807 Participants Q/LAIV (quadrivalent influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10\^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza 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=393 Participants FluMist/B/Yamagata (trivalent influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10\^7.0 ± 0.5 FFU of each of 3 temperate sensitive, cold-adapted, attentuated, 6:2 reassortant influenza 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(trivalent influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10\^7.0 ± 0.5 FFU of each of 3 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza 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 were combined.
The Number of Serosusceptible Participants Within Each Treatment Arm Who Experience A/H3N2 Strain-specific Seroresponse Post Dose.	53 participants	25 participants	—	—

SECONDARY outcome

Timeframe: Day 0 and Day 28-35

Population: Participants who received a full dose of investigational product (Q=1198; FY=299), had pre-dose and post-dose HAI measurement (Q=1181; FY=292), had no protocol deviation that could have interfered with the generation or interpretation of an immune response (Q=1180; FY=292), and were serosusceptible to the strain (Q=197; FY=43).

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.

Outcome measures

Measure	Q/LAIV (MEDI3250) n=197 Participants Q/LAIV (quadrivalent influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10\^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza 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=43 Participants FluMist/B/Yamagata (trivalent influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10\^7.0 ± 0.5 FFU of each of 3 temperate sensitive, cold-adapted, attentuated, 6:2 reassortant influenza 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(trivalent influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10\^7.0 ± 0.5 FFU of each of 3 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza 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 were combined.
The Number of Serosusceptible Participants Within Each Treatment Arm Who Experience B/Yamagata Strain-specific Seroresponse Post Dose.	66 participants	17 participants	—	—

SECONDARY outcome

Timeframe: Day 0 and Day 28-35

Population: Participants who received a full dose of investigational product (Q=1198; FV=301), had pre-dose and post-dose HAI measurement (Q=1181; FV=298), had no protocol deviation that could have interfered with the generation or interpretation of an immune response (Q=1180; FV=297), and were serosusceptible to the strain (Q=250; FV=66).

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.

Outcome measures

Measure	Q/LAIV (MEDI3250) n=250 Participants Q/LAIV (quadrivalent influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10\^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza 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=66 Participants FluMist/B/Yamagata (trivalent influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10\^7.0 ± 0.5 FFU of each of 3 temperate sensitive, cold-adapted, attentuated, 6:2 reassortant influenza 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(trivalent influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10\^7.0 ± 0.5 FFU of each of 3 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza 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 were combined.
The Number of Serosusceptible Participants Within Each Treatment Arm Who Experience B/Victoria Strain-specific Seroresponse Post Dose.	92 participants	28 participants	—	—

SECONDARY outcome

Timeframe: Day 0 and Day 28-35

Population: Participants who received a full dose of investigational product (Q=1198; All FM=600), had pre-dose and post-dose HAI measurement (Q=1181; All FM=590), had no protocol deviation that could have interfered with the generation or interpretation of an immune response (Q=1180; All FM=589), and were seropositive to the strain (Q=291; All FM=160).

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.

Outcome measures

Measure	Q/LAIV (MEDI3250) n=291 Participants Q/LAIV (quadrivalent influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10\^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza 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=160 Participants FluMist/B/Yamagata (trivalent influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10\^7.0 ± 0.5 FFU of each of 3 temperate sensitive, cold-adapted, attentuated, 6:2 reassortant influenza 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(trivalent influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10\^7.0 ± 0.5 FFU of each of 3 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza 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 were combined.
The Number of Seropositive Participants Within Each Treatment Arm Who Experience A/H1N1 Strain-specific Seroresponse Post Dose.	2 participants	1 participants	—	—

SECONDARY outcome

Timeframe: Day 0 and Day 28-35

Population: Participants who received a full dose of investigational product (Q=1198, AFM=600), had pre-dose and post-dose HAI measurement (Q=1181, AFM=590), had no protocol deviation that could have interfered with the generation or interpretation of an immune response (Q=1180; All FM=589), and were seropositive to the strain (Q=373, All FM=196).

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.

Outcome measures

Measure	Q/LAIV (MEDI3250) n=373 Participants Q/LAIV (quadrivalent influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10\^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza 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=196 Participants FluMist/B/Yamagata (trivalent influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10\^7.0 ± 0.5 FFU of each of 3 temperate sensitive, cold-adapted, attentuated, 6:2 reassortant influenza 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(trivalent influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10\^7.0 ± 0.5 FFU of each of 3 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza 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 were combined.
The Number of Seropositive Participants Within Each Treatment Arm Who Experience A/H3N2 Strain-specific Seroresponse Post Dose.	6 participants	0 participants	—	—

SECONDARY outcome

Timeframe: Day 0 and Day 28-35

Population: Participants who received a full dose of investigational product (Q=1198, FY=299), had pre-dose and post-dose HAI measurement (Q=1181, FY=292), had no protocol deviation that could have interfered with the generation or interpretation of an immune response (Q1180; FY=292), and were seropositive to the strain (Q=983, FY=249).

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.

Outcome measures

Measure	Q/LAIV (MEDI3250) n=983 Participants Q/LAIV (quadrivalent influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10\^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza 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=249 Participants FluMist/B/Yamagata (trivalent influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10\^7.0 ± 0.5 FFU of each of 3 temperate sensitive, cold-adapted, attentuated, 6:2 reassortant influenza 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(trivalent influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10\^7.0 ± 0.5 FFU of each of 3 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza 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 were combined.
The Number of Seropositive Participants Within Each Treatment Arm Who Experience B/Yamagata Strain-specific Seroresponse Post Dose.	52 participants	13 participants	—	—

SECONDARY outcome

Timeframe: Day 0 and Day 28-35

Population: Participants who received a full dose of investigational product (Q=1198, FV=301), had pre-dose and post-dose HAI measurement (Q=1181, FV=298), had no protocol deviation that could have interfered with the generation or interpretation of an immune response (Q=1180; FV=297), and were seropositive to the strain (Q=930, FV=231).

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.

Outcome measures

Measure	Q/LAIV (MEDI3250) n=930 Participants Q/LAIV (quadrivalent influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10\^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza 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=231 Participants FluMist/B/Yamagata (trivalent influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10\^7.0 ± 0.5 FFU of each of 3 temperate sensitive, cold-adapted, attentuated, 6:2 reassortant influenza 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(trivalent influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10\^7.0 ± 0.5 FFU of each of 3 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza 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 were combined.
The Number of Seropositive Participants Within Each Treatment Arm Who Experience B/Victoria Strain-specific Seroresponse Post Dose.	53 participants	7 participants	—	—

SECONDARY outcome

Timeframe: Day 28-35

Population: Participants who received a full dose of investigational product (Q=1198; FY=299; FV=301; All FM=600,), had post-dose HAI measurement (Q=1182; FY=292; FV=298; All FM=290), and had no protocol deviation that could have interfered with the generation or interpretation of an immune response (Q=1181; FY=292; FV=298; All FM=590).

Outcome measures

Measure	Q/LAIV (MEDI3250) n=1181 Participants Q/LAIV (quadrivalent influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10\^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza 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 (trivalent influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10\^7.0 ± 0.5 FFU of each of 3 temperate sensitive, cold-adapted, attentuated, 6:2 reassortant influenza 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=297 Participants FluMist/B/Victoria(trivalent influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10\^7.0 ± 0.5 FFU of each of 3 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 \[A/South Dakota/6/2007\], A/H3N2 \[A/Uruguay/716/2007\], and B/Victoria \[B/Malaysia/2506/2004\]).	All FluMist n=589 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 were combined.
The Number of Participants (Regardless of Serostatus) Within Each Treatment Arm Who Achieved a Strain-specific HAI Antibody Titer ≥ 32 Post Dose. A/H1N1	189 participants	NA participants The comparators were participants in the All FluMist group (combined data for both FluMist arms) for A/H1N1 and A/H3N2 strains and participants who received FluMist with a matching B strain for B/Yamagata and B/Victoria strains.	NA participants The comparators were participants in the All FluMist group (combined data for both FluMist arms) for A/H1N1 and A/H3N2 strains and participants who received FluMist with a matching B strain for B/Yamagata and B/Victoria strains.	100 participants
The Number of Participants (Regardless of Serostatus) Within Each Treatment Arm Who Achieved a Strain-specific HAI Antibody Titer ≥ 32 Post Dose. A/H3N2	250 participants	NA participants The comparators were participants in the All FluMist group (combined data for both FluMist arms) for A/H1N1 and A/H3N2 strains and participants who received FluMist with a matching B strain for B/Yamagata and B/Victoria strains.	NA participants The comparators were participants in the All FluMist group (combined data for both FluMist arms) for A/H1N1 and A/H3N2 strains and participants who received FluMist with a matching B strain for B/Yamagata and B/Victoria strains.	133 participants
The Number of Participants (Regardless of Serostatus) Within Each Treatment Arm Who Achieved a Strain-specific HAI Antibody Titer ≥ 32 Post Dose. B/Yamagata	881 participants	226 participants	NA participants The comparators were participants in the All FluMist group (combined data for both FluMist arms) for A/H1N1 and A/H3N2 strains and participants who received FluMist with a matching B strain for B/Yamagata and B/Victoria strains.	NA participants The comparators were participants in the All FluMist group (combined data for both FluMist arms) for A/H1N1 and A/H3N2 strains and participants who received FluMist with a matching B strain for B/Yamagata and B/Victoria strains.
The Number of Participants (Regardless of Serostatus) Within Each Treatment Arm Who Achieved a Strain-specific HAI Antibody Titer ≥ 32 Post Dose. B/Victoria	771 participants	NA participants The comparators were participants in the All FluMist group (combined data for both FluMist arms) for A/H1N1 and A/H3N2 strains and participants who received FluMist with a matching B strain for B/Yamagata and B/Victoria strains.	191 participants	NA participants The comparators were participants in the All FluMist group (combined data for both FluMist arms) for A/H1N1 and A/H3N2 strains and participants who received FluMist with a matching B strain for B/Yamagata and B/Victoria strains.

SECONDARY outcome

Timeframe: Day 28-35

Population: Participants who received a full dose of investigational product (Q=1198, All FM=600), had post-dose HAI measurement (Q=1182; All FM=590), had no protocol deviation that could have interfered with the generation or interpretation of an immune response (Q=1181, All FM=589), and were serosusceptible to the strain(Q=889, All FM=429).

Participants with a strain-specific baseline HAI titer ≤ 8 were considered to be serosusceptible to that strain.

Outcome measures

Measure	Q/LAIV (MEDI3250) n=889 Participants Q/LAIV (quadrivalent influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10\^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza 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=429 Participants FluMist/B/Yamagata (trivalent influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10\^7.0 ± 0.5 FFU of each of 3 temperate sensitive, cold-adapted, attentuated, 6:2 reassortant influenza 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(trivalent influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10\^7.0 ± 0.5 FFU of each of 3 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza 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 were combined.
The Number of Serosusceptible Participants Within Each Treatment Arm Who Achieved a A/H1N1 Strain-specific HAI Antibody Titer ≥ 32 Post Dose.	17 participants	5 participants	—	—

SECONDARY outcome

Timeframe: Day 28-35

Population: Participants who received a full dose of investigational product (Q=1198; All FM=600), had post-dose HAI measurement (Q=1181; All FM=590), had no protocol deviation that could have interfered with the generation or interpretation of an immune response (Q=1181; All FM=589), and were serosusceptible to the strain (Q=807; All FM=393).

Participants with a strain-specific baseline HAI titer ≤ 8 were considered to be serosusceptible to that strain.

Outcome measures

Measure	Q/LAIV (MEDI3250) n=807 Participants Q/LAIV (quadrivalent influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10\^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza 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=393 Participants FluMist/B/Yamagata (trivalent influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10\^7.0 ± 0.5 FFU of each of 3 temperate sensitive, cold-adapted, attentuated, 6:2 reassortant influenza 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(trivalent influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10\^7.0 ± 0.5 FFU of each of 3 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza 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 were combined.
The Number of Serosusceptible Participants Within Each Treatment Arm Who Achieved a A/H3N2 Strain-specific HAI Antibody Titer ≥ 32 Post Dose.	18 participants	11 participants	—	—

SECONDARY outcome

Timeframe: Day 28-35

Population: Participants who received a full dose of investigational product (Q=1198, FY=299), had post-dose HAI measurement (Q=1181, FY=292), had no protocol deviation that could have interfered with the generation or interpretation of an immune response (Q=1181; FY=292), and were serosusceptible to the strain (Q=197, FY=43).

Participants with a strain-specific baseline HAI titer ≤ 8 were considered to be serosusceptible to that strain.

Outcome measures

Measure	Q/LAIV (MEDI3250) n=197 Participants Q/LAIV (quadrivalent influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10\^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza 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=43 Participants FluMist/B/Yamagata (trivalent influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10\^7.0 ± 0.5 FFU of each of 3 temperate sensitive, cold-adapted, attentuated, 6:2 reassortant influenza 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(trivalent influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10\^7.0 ± 0.5 FFU of each of 3 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza 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 were combined.
The Number of Serosusceptible Participants Within Each Treatment Arm Who Achieved a B/Yamagata Strain-specific HAI Antibody Titer ≥ 32 Post Dose.	44 participants	11 participants	—	—

SECONDARY outcome

Timeframe: Day 28-35

Population: Participants who received a full dose of investigational product (Q=1198; FV=301), had post-dose HAI measurement (Q=1181; FV=298), had no protocol deviation that could have interfered with the generation or interpretation of an immune response (Q=1181; FV=297), and serosusceptible (Q=250; FV=66).

Participants with a strain-specific baseline HAI titer ≤ 8 were considered to be serosusceptible to that strain.

Outcome measures

Measure	Q/LAIV (MEDI3250) n=250 Participants Q/LAIV (quadrivalent influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10\^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza 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=66 Participants FluMist/B/Yamagata (trivalent influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10\^7.0 ± 0.5 FFU of each of 3 temperate sensitive, cold-adapted, attentuated, 6:2 reassortant influenza 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(trivalent influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10\^7.0 ± 0.5 FFU of each of 3 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza 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 were combined.
The Number of Serosusceptible Participants Within Each Treatment Arm Who Achieved a B/Victoria Strain-specific HAI Antibody Titer ≥ 32 Post Dose.	57 participants	16 participants	—	—

SECONDARY outcome

Timeframe: Day 28-35

Population: Participants who received a full dose of investigational product (Q=1198; All FM=600), had post-dose HAI measurement (Q=1181; All FM=590) and had no protocol deviation that could have interfered with the generation or interpretation of an immune response (Q=1181; All FM=589), and were seropositive to the strain (Q=291; All FM=160).

Participants with a baseline HAI titer > 8 were considered to be seropositive for that strain.

Outcome measures

Measure	Q/LAIV (MEDI3250) n=291 Participants Q/LAIV (quadrivalent influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10\^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza 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=160 Participants FluMist/B/Yamagata (trivalent influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10\^7.0 ± 0.5 FFU of each of 3 temperate sensitive, cold-adapted, attentuated, 6:2 reassortant influenza 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(trivalent influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10\^7.0 ± 0.5 FFU of each of 3 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza 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 were combined.
The Number of Seropositive Participants Within Each Treatment Arm Who Achieved a A/H1N1 Strain-specific HAI Antibody Titer ≥ 32 Post Dose.	172 participants	95 participants	—	—

SECONDARY outcome

Timeframe: Day 28-35

Population: Participants who received a full dose of investigational product (Q=1198; All FM=600), had post-dose HAI measurement (Q=1182; AFM=590), had no protocol deviation that could have interfered with the generation or interpretation of an immune response (Q=1181; All FM=589), and were seropositive to the strain (Q=373; All FM=196).

Participants with a baseline HAI titer > 8 were considered to be seropositive for that strain.

Outcome measures

Measure	Q/LAIV (MEDI3250) n=373 Participants Q/LAIV (quadrivalent influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10\^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza 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=196 Participants FluMist/B/Yamagata (trivalent influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10\^7.0 ± 0.5 FFU of each of 3 temperate sensitive, cold-adapted, attentuated, 6:2 reassortant influenza 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(trivalent influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10\^7.0 ± 0.5 FFU of each of 3 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza 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 were combined.
The Number of Seropositive Participants Within Each Treatment Arm Who Achieved a A/H3N2 Strain-specific HAI Antibody Titer ≥ 32 Post Dose.	232 participants	122 participants	—	—

SECONDARY outcome

Timeframe: Day 28-35

Population: Participants who received a full dose of investigational product (Q=1198; FY=299), had post-dose HAI measurement (Q=1182; FY=292), had no protocol deviation that could have interfered with the generation or interpretation of an immune response (Q=1181; FY=292), and were seropositive to the strain (Q=983; FY=249).

Participants with a baseline HAI titer > 8 were considered to be seropositive for that strain.

Outcome measures

Measure	Q/LAIV (MEDI3250) n=983 Participants Q/LAIV (quadrivalent influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10\^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza 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=249 Participants FluMist/B/Yamagata (trivalent influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10\^7.0 ± 0.5 FFU of each of 3 temperate sensitive, cold-adapted, attentuated, 6:2 reassortant influenza 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(trivalent influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10\^7.0 ± 0.5 FFU of each of 3 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza 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 were combined.
The Number of Seropositive Participants Within Each Treatment Arm Who Achieved a B/Yamagata Strain-specific HAI Antibody Titer ≥ 32 Post Dose.	837 participants	215 participants	—	—

SECONDARY outcome

Timeframe: Day 28-35

Population: Participants who received a full dose of investigational product (Q=1198; FV=301), had post-dose HAI measurement (Q=1182; FV=298), had no protocol deviation that could have interfered with the generation or interpretation of an immune response (Q=1181; FV=297), and were seropositive to the strain (Q=930; FV=231).

Participants with a baseline HAI titer > 8 were considered to be seropositive for that strain.

Outcome measures

Measure	Q/LAIV (MEDI3250) n=930 Participants Q/LAIV (quadrivalent influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10\^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza 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=231 Participants FluMist/B/Yamagata (trivalent influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10\^7.0 ± 0.5 FFU of each of 3 temperate sensitive, cold-adapted, attentuated, 6:2 reassortant influenza 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(trivalent influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10\^7.0 ± 0.5 FFU of each of 3 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza 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 were combined.
The Number of Seropositive Participants Within Each Treatment Arm Who Achieved a B/Victoria Strain-specific HAI Antibody Titer ≥ 32 Post Dose.	714 participants	175 participants	—	—

SECONDARY outcome

Timeframe: Days 0-14

Population: The Evaluable Safety Population for solicited symptoms included participants who received any investigational product (Q=1198; All FM=600) and for whom any follow-up solicited symptom safety data were recorded during the summarized period (Q=1197; All FM=597).

Solicited symptoms were fever ≥ 100.4°F (38.0°C), runny/stuffy nose, sore throat, cough, headache, generalized muscle aches, decreased activity level (lethargy) OR tiredness/weakness, decreased appetite. Collection of specific solicited symptoms (sore throat, headache, generalized muscle aches) was omitted when, according to the judgment of the investigator, the subject was too young to reliably report a particular symptom.

Outcome measures

Measure	Q/LAIV (MEDI3250) n=1197 Participants Q/LAIV (quadrivalent influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10\^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza 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=597 Participants FluMist/B/Yamagata (trivalent influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10\^7.0 ± 0.5 FFU of each of 3 temperate sensitive, cold-adapted, attentuated, 6:2 reassortant influenza 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(trivalent influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10\^7.0 ± 0.5 FFU of each of 3 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza 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 were combined.
The Number of Participants Experiencing Each Solicited Symptom From Administration of Investigational Product Through 14 Days Post Vaccination Any solicited symptom	713 participants	358 participants	—	—
The Number of Participants Experiencing Each Solicited Symptom From Administration of Investigational Product Through 14 Days Post Vaccination Fever ≥ 100.4°F	16 participants	9 participants	—	—
The Number of Participants Experiencing Each Solicited Symptom From Administration of Investigational Product Through 14 Days Post Vaccination Sore throat	227 participants	118 participants	—	—
The Number of Participants Experiencing Each Solicited Symptom From Administration of Investigational Product Through 14 Days Post Vaccination Cough	163 participants	75 participants	—	—
The Number of Participants Experiencing Each Solicited Symptom From Administration of Investigational Product Through 14 Days Post Vaccination Decreased appetite	77 participants	32 participants	—	—
The Number of Participants Experiencing Each Solicited Symptom From Administration of Investigational Product Through 14 Days Post Vaccination Fever ≥ 101.3°F	9 participants	2 participants	—	—
The Number of Participants Experiencing Each Solicited Symptom From Administration of Investigational Product Through 14 Days Post Vaccination Fever ≥ 102.2°F	4 participants	1 participants	—	—
The Number of Participants Experiencing Each Solicited Symptom From Administration of Investigational Product Through 14 Days Post Vaccination Fever ≥ 103.1°F	1 participants	1 participants	—	—
The Number of Participants Experiencing Each Solicited Symptom From Administration of Investigational Product Through 14 Days Post Vaccination Fever ≥ 104.0°F	0 participants	0 participants	—	—
The Number of Participants Experiencing Each Solicited Symptom From Administration of Investigational Product Through 14 Days Post Vaccination Fever ≥ 104.9°F	0 participants	0 participants	—	—
The Number of Participants Experiencing Each Solicited Symptom From Administration of Investigational Product Through 14 Days Post Vaccination Runny/stuffy nose	522 participants	236 participants	—	—
The Number of Participants Experiencing Each Solicited Symptom From Administration of Investigational Product Through 14 Days Post Vaccination Headache	338 participants	164 participants	—	—
The Number of Participants Experiencing Each Solicited Symptom From Administration of Investigational Product Through 14 Days Post Vaccination Generalized muscle aches	121 participants	59 participants	—	—
The Number of Participants Experiencing Each Solicited Symptom From Administration of Investigational Product Through 14 Days Post Vaccination Decreased activity level (lethargy) or tiredness	211 participants	106 participants	—	—

SECONDARY outcome

Timeframe: Days 0-28 post vaccination

Population: The Safety Population included participants who received any investigational product (Q=1198; All FM=600) and for whom any follow-up safety data were recorded (Q=1198; All FM=598).

Any untoward medical occurrence in a patient or clinical investigation in a subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product

Outcome measures

Measure	Q/LAIV (MEDI3250) n=1198 Participants Q/LAIV (quadrivalent influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10\^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza 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=598 Participants FluMist/B/Yamagata (trivalent influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10\^7.0 ± 0.5 FFU of each of 3 temperate sensitive, cold-adapted, attentuated, 6:2 reassortant influenza 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(trivalent influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10\^7.0 ± 0.5 FFU of each of 3 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza 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 were combined.
The Number of Participants Reporting Any Adverse Event From Administration of Investigational Product Through 28 Days Post Vaccination	210 participants	118 participants	—	—

SECONDARY outcome

Timeframe: Days 0-28 post vaccination

Population: The Safety Population included participants who received any investigational product (Q=1198; All FM=600) and for whom any follow-up safety data were recorded (Q=1198; All FM=598).

Serious adverse events were those that resulted in death; were life-threatening; resulted in inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability or incapacity; were a birth defect in the offspring of a study participant; or were an important medical event that may not have resulted in death, threatened life, or required hospitalization but that, based on appropriate medical judgment, may have jeopardized the subject and may have required medical or surgical intervention to prevent one of the outcomes listed above.

Outcome measures

Measure	Q/LAIV (MEDI3250) n=1198 Participants Q/LAIV (quadrivalent influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10\^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza 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=598 Participants FluMist/B/Yamagata (trivalent influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10\^7.0 ± 0.5 FFU of each of 3 temperate sensitive, cold-adapted, attentuated, 6:2 reassortant influenza 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(trivalent influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10\^7.0 ± 0.5 FFU of each of 3 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza 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 were combined.
Number of Participants Reporting Any Serious Adverse Event From Administration of Investigational Product Through 28 Days Post Vaccination	2 participants	2 participants	—	—

SECONDARY outcome

Timeframe: Days 0-180 post vaccination

Population: The Safety Population included participants who received any investigational product (Q=1198; All FM=600) and for whom any follow-up safety data were recorded (Q=1198; All FM=598).

Serious adverse events were those that resulted in death; were life-threatening; resulted in inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability or incapacity; were a birth defect in the offspring of a study participant; or were an important medical event that may not have resulted in death, threatened life, or required hospitalization but that, based on appropriate medical judgment, may have jeopardized the subject and may have required medical or surgical intervention to prevent one of the outcomes listed above.

Outcome measures

Measure	Q/LAIV (MEDI3250) n=1198 Participants Q/LAIV (quadrivalent influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10\^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza 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=598 Participants FluMist/B/Yamagata (trivalent influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10\^7.0 ± 0.5 FFU of each of 3 temperate sensitive, cold-adapted, attentuated, 6:2 reassortant influenza 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(trivalent influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10\^7.0 ± 0.5 FFU of each of 3 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza 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 were combined.
Number of Participants Reporting Any Serious Adverse Event From Administration of Investigational Product Through 180 Days Post Vaccination	12 participants	6 participants	—	—

SECONDARY outcome

Timeframe: Days 0-180 post vaccination

Population: The Safety Population included participants who received any investigational product (Q=1198; All FM=600) and for whom any follow-up safety data were recorded (Q=1198; All FM=598).

An NOCD was a newly diagnosed medical condition that was of a chronic, ongoing nature and was assessed by the investigator as medically significant.

Outcome measures

Measure	Q/LAIV (MEDI3250) n=1198 Participants Q/LAIV (quadrivalent influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10\^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza 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=598 Participants FluMist/B/Yamagata (trivalent influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10\^7.0 ± 0.5 FFU of each of 3 temperate sensitive, cold-adapted, attentuated, 6:2 reassortant influenza 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(trivalent influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10\^7.0 ± 0.5 FFU of each of 3 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza 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 were combined.
Number of Participants Reporting New Onset Chronic Diseases From Administration of Investigational Product Through 180 Days Post Vaccination	11 participants	4 participants	—	—

Adverse Events

Q/LAIV (MEDI3250)

Serious events: 12 serious events

Other events: 102 other events

Deaths: 0 deaths

All FluMist

Serious events: 6 serious events

Other events: 57 other events

Deaths: 0 deaths

Serious adverse events

Measure	Q/LAIV (MEDI3250) n=1198 participants at risk Q/LAIV (quadrivalent influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10\^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza 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=598 participants at risk Data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined.
Cardiac disorders ARTERIOSPASM CORONARY	0.08% 1/1198 • Number of events 1 • Treatment emergent adverse events were collected from the time of investigational product administration (Day 0) through Day 28. Treatment emergent SAEs were collected from the time of investigational product administration (Day 0) through Day 180.	0.00% 0/598 • Treatment emergent adverse events were collected from the time of investigational product administration (Day 0) through Day 28. Treatment emergent SAEs were collected from the time of investigational product administration (Day 0) through Day 180.
Cardiac disorders CARDIAC FAILURE CONGESTIVE	0.00% 0/1198 • Treatment emergent adverse events were collected from the time of investigational product administration (Day 0) through Day 28. Treatment emergent SAEs were collected from the time of investigational product administration (Day 0) through Day 180.	0.17% 1/598 • Number of events 1 • Treatment emergent adverse events were collected from the time of investigational product administration (Day 0) through Day 28. Treatment emergent SAEs were collected from the time of investigational product administration (Day 0) through Day 180.
Cardiac disorders MYOCARDIAL INFARCTION	0.00% 0/1198 • Treatment emergent adverse events were collected from the time of investigational product administration (Day 0) through Day 28. Treatment emergent SAEs were collected from the time of investigational product administration (Day 0) through Day 180.	0.17% 1/598 • Number of events 1 • Treatment emergent adverse events were collected from the time of investigational product administration (Day 0) through Day 28. Treatment emergent SAEs were collected from the time of investigational product administration (Day 0) through Day 180.
Hepatobiliary disorders CHOLECYSTITIS ACUTE	0.08% 1/1198 • Number of events 1 • Treatment emergent adverse events were collected from the time of investigational product administration (Day 0) through Day 28. Treatment emergent SAEs were collected from the time of investigational product administration (Day 0) through Day 180.	0.00% 0/598 • Treatment emergent adverse events were collected from the time of investigational product administration (Day 0) through Day 28. Treatment emergent SAEs were collected from the time of investigational product administration (Day 0) through Day 180.
Hepatobiliary disorders CHOLELITHIASIS	0.08% 1/1198 • Number of events 1 • Treatment emergent adverse events were collected from the time of investigational product administration (Day 0) through Day 28. Treatment emergent SAEs were collected from the time of investigational product administration (Day 0) through Day 180.	0.00% 0/598 • Treatment emergent adverse events were collected from the time of investigational product administration (Day 0) through Day 28. Treatment emergent SAEs were collected from the time of investigational product administration (Day 0) through Day 180.
Immune system disorders HYPERSENSITIVITY	0.00% 0/1198 • Treatment emergent adverse events were collected from the time of investigational product administration (Day 0) through Day 28. Treatment emergent SAEs were collected from the time of investigational product administration (Day 0) through Day 180.	0.17% 1/598 • Number of events 1 • Treatment emergent adverse events were collected from the time of investigational product administration (Day 0) through Day 28. Treatment emergent SAEs were collected from the time of investigational product administration (Day 0) through Day 180.
Infections and infestations APPENDICITIS	0.08% 1/1198 • Number of events 1 • Treatment emergent adverse events were collected from the time of investigational product administration (Day 0) through Day 28. Treatment emergent SAEs were collected from the time of investigational product administration (Day 0) through Day 180.	0.00% 0/598 • Treatment emergent adverse events were collected from the time of investigational product administration (Day 0) through Day 28. Treatment emergent SAEs were collected from the time of investigational product administration (Day 0) through Day 180.
Infections and infestations BACTERAEMIA	0.08% 1/1198 • Number of events 1 • Treatment emergent adverse events were collected from the time of investigational product administration (Day 0) through Day 28. Treatment emergent SAEs were collected from the time of investigational product administration (Day 0) through Day 180.	0.00% 0/598 • Treatment emergent adverse events were collected from the time of investigational product administration (Day 0) through Day 28. Treatment emergent SAEs were collected from the time of investigational product administration (Day 0) through Day 180.
Infections and infestations CLOSTRIDIUM DIFFICILE COLITIS	0.08% 1/1198 • Number of events 1 • Treatment emergent adverse events were collected from the time of investigational product administration (Day 0) through Day 28. Treatment emergent SAEs were collected from the time of investigational product administration (Day 0) through Day 180.	0.00% 0/598 • Treatment emergent adverse events were collected from the time of investigational product administration (Day 0) through Day 28. Treatment emergent SAEs were collected from the time of investigational product administration (Day 0) through Day 180.
Infections and infestations DIVERTICULITIS	0.17% 2/1198 • Number of events 2 • Treatment emergent adverse events were collected from the time of investigational product administration (Day 0) through Day 28. Treatment emergent SAEs were collected from the time of investigational product administration (Day 0) through Day 180.	0.00% 0/598 • Treatment emergent adverse events were collected from the time of investigational product administration (Day 0) through Day 28. Treatment emergent SAEs were collected from the time of investigational product administration (Day 0) through Day 180.
Infections and infestations GAS GANGRENE	0.08% 1/1198 • Number of events 1 • Treatment emergent adverse events were collected from the time of investigational product administration (Day 0) through Day 28. Treatment emergent SAEs were collected from the time of investigational product administration (Day 0) through Day 180.	0.00% 0/598 • Treatment emergent adverse events were collected from the time of investigational product administration (Day 0) through Day 28. Treatment emergent SAEs were collected from the time of investigational product administration (Day 0) through Day 180.
Infections and infestations LOBAR PNEUMONIA	0.08% 1/1198 • Number of events 1 • Treatment emergent adverse events were collected from the time of investigational product administration (Day 0) through Day 28. Treatment emergent SAEs were collected from the time of investigational product administration (Day 0) through Day 180.	0.00% 0/598 • Treatment emergent adverse events were collected from the time of investigational product administration (Day 0) through Day 28. Treatment emergent SAEs were collected from the time of investigational product administration (Day 0) through Day 180.
Injury, poisoning and procedural complications FIBULA FRACTURE	0.08% 1/1198 • Number of events 1 • Treatment emergent adverse events were collected from the time of investigational product administration (Day 0) through Day 28. Treatment emergent SAEs were collected from the time of investigational product administration (Day 0) through Day 180.	0.00% 0/598 • Treatment emergent adverse events were collected from the time of investigational product administration (Day 0) through Day 28. Treatment emergent SAEs were collected from the time of investigational product administration (Day 0) through Day 180.
Injury, poisoning and procedural complications FOOT FRACTURE	0.08% 1/1198 • Number of events 1 • Treatment emergent adverse events were collected from the time of investigational product administration (Day 0) through Day 28. Treatment emergent SAEs were collected from the time of investigational product administration (Day 0) through Day 180.	0.00% 0/598 • Treatment emergent adverse events were collected from the time of investigational product administration (Day 0) through Day 28. Treatment emergent SAEs were collected from the time of investigational product administration (Day 0) through Day 180.
Injury, poisoning and procedural complications FRACTURE DISPLACEMENT	0.08% 1/1198 • Number of events 1 • Treatment emergent adverse events were collected from the time of investigational product administration (Day 0) through Day 28. Treatment emergent SAEs were collected from the time of investigational product administration (Day 0) through Day 180.	0.00% 0/598 • Treatment emergent adverse events were collected from the time of investigational product administration (Day 0) through Day 28. Treatment emergent SAEs were collected from the time of investigational product administration (Day 0) through Day 180.
Injury, poisoning and procedural complications ILIUM FRACTURE	0.08% 1/1198 • Number of events 1 • Treatment emergent adverse events were collected from the time of investigational product administration (Day 0) through Day 28. Treatment emergent SAEs were collected from the time of investigational product administration (Day 0) through Day 180.	0.00% 0/598 • Treatment emergent adverse events were collected from the time of investigational product administration (Day 0) through Day 28. Treatment emergent SAEs were collected from the time of investigational product administration (Day 0) through Day 180.
Injury, poisoning and procedural complications TIBIA FRACTURE	0.08% 1/1198 • Number of events 1 • Treatment emergent adverse events were collected from the time of investigational product administration (Day 0) through Day 28. Treatment emergent SAEs were collected from the time of investigational product administration (Day 0) through Day 180.	0.00% 0/598 • Treatment emergent adverse events were collected from the time of investigational product administration (Day 0) through Day 28. Treatment emergent SAEs were collected from the time of investigational product administration (Day 0) through Day 180.
Injury, poisoning and procedural complications TRAUMATIC FRACTURE	0.08% 1/1198 • Number of events 1 • Treatment emergent adverse events were collected from the time of investigational product administration (Day 0) through Day 28. Treatment emergent SAEs were collected from the time of investigational product administration (Day 0) through Day 180.	0.00% 0/598 • Treatment emergent adverse events were collected from the time of investigational product administration (Day 0) through Day 28. Treatment emergent SAEs were collected from the time of investigational product administration (Day 0) through Day 180.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) UTERINE LEIOMYOMA	0.00% 0/1198 • Treatment emergent adverse events were collected from the time of investigational product administration (Day 0) through Day 28. Treatment emergent SAEs were collected from the time of investigational product administration (Day 0) through Day 180.	0.33% 2/598 • Number of events 2 • Treatment emergent adverse events were collected from the time of investigational product administration (Day 0) through Day 28. Treatment emergent SAEs were collected from the time of investigational product administration (Day 0) through Day 180.
Psychiatric disorders PSYCHOTIC DISORDER	0.08% 1/1198 • Number of events 1 • Treatment emergent adverse events were collected from the time of investigational product administration (Day 0) through Day 28. Treatment emergent SAEs were collected from the time of investigational product administration (Day 0) through Day 180.	0.00% 0/598 • Treatment emergent adverse events were collected from the time of investigational product administration (Day 0) through Day 28. Treatment emergent SAEs were collected from the time of investigational product administration (Day 0) through Day 180.
Reproductive system and breast disorders MENORRHAGIA	0.00% 0/1198 • Treatment emergent adverse events were collected from the time of investigational product administration (Day 0) through Day 28. Treatment emergent SAEs were collected from the time of investigational product administration (Day 0) through Day 180.	0.17% 1/598 • Number of events 1 • Treatment emergent adverse events were collected from the time of investigational product administration (Day 0) through Day 28. Treatment emergent SAEs were collected from the time of investigational product administration (Day 0) through Day 180.
Respiratory, thoracic and mediastinal disorders ASTHMA	0.00% 0/1198 • Treatment emergent adverse events were collected from the time of investigational product administration (Day 0) through Day 28. Treatment emergent SAEs were collected from the time of investigational product administration (Day 0) through Day 180.	0.17% 1/598 • Number of events 1 • Treatment emergent adverse events were collected from the time of investigational product administration (Day 0) through Day 28. Treatment emergent SAEs were collected from the time of investigational product administration (Day 0) through Day 180.

Other adverse events

Measure	Q/LAIV (MEDI3250) n=1198 participants at risk Q/LAIV (quadrivalent influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10\^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza 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=598 participants at risk Data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined.
Gastrointestinal disorders DIARRHOEA	0.83% 10/1198 • Number of events 10 • Treatment emergent adverse events were collected from the time of investigational product administration (Day 0) through Day 28. Treatment emergent SAEs were collected from the time of investigational product administration (Day 0) through Day 180.	1.0% 6/598 • Number of events 7 • Treatment emergent adverse events were collected from the time of investigational product administration (Day 0) through Day 28. Treatment emergent SAEs were collected from the time of investigational product administration (Day 0) through Day 180.
Gastrointestinal disorders NAUSEA	0.92% 11/1198 • Number of events 11 • Treatment emergent adverse events were collected from the time of investigational product administration (Day 0) through Day 28. Treatment emergent SAEs were collected from the time of investigational product administration (Day 0) through Day 180.	1.0% 6/598 • Number of events 6 • Treatment emergent adverse events were collected from the time of investigational product administration (Day 0) through Day 28. Treatment emergent SAEs were collected from the time of investigational product administration (Day 0) through Day 180.
Infections and infestations UPPER RESPIRATORY TRACT INFECTION	1.2% 14/1198 • Number of events 14 • Treatment emergent adverse events were collected from the time of investigational product administration (Day 0) through Day 28. Treatment emergent SAEs were collected from the time of investigational product administration (Day 0) through Day 180.	1.3% 8/598 • Number of events 8 • Treatment emergent adverse events were collected from the time of investigational product administration (Day 0) through Day 28. Treatment emergent SAEs were collected from the time of investigational product administration (Day 0) through Day 180.
Musculoskeletal and connective tissue disorders BACK PAIN	0.25% 3/1198 • Number of events 3 • Treatment emergent adverse events were collected from the time of investigational product administration (Day 0) through Day 28. Treatment emergent SAEs were collected from the time of investigational product administration (Day 0) through Day 180.	1.0% 6/598 • Number of events 6 • Treatment emergent adverse events were collected from the time of investigational product administration (Day 0) through Day 28. Treatment emergent SAEs were collected from the time of investigational product administration (Day 0) through Day 180.
Nervous system disorders HEADACHE	0.75% 9/1198 • Number of events 9 • Treatment emergent adverse events were collected from the time of investigational product administration (Day 0) through Day 28. Treatment emergent SAEs were collected from the time of investigational product administration (Day 0) through Day 180.	1.2% 7/598 • Number of events 7 • Treatment emergent adverse events were collected from the time of investigational product administration (Day 0) through Day 28. Treatment emergent SAEs were collected from the time of investigational product administration (Day 0) through Day 180.
Respiratory, thoracic and mediastinal disorders COUGH	1.1% 13/1198 • Number of events 13 • Treatment emergent adverse events were collected from the time of investigational product administration (Day 0) through Day 28. Treatment emergent SAEs were collected from the time of investigational product administration (Day 0) through Day 180.	1.0% 6/598 • Number of events 6 • Treatment emergent adverse events were collected from the time of investigational product administration (Day 0) through Day 28. Treatment emergent SAEs were collected from the time of investigational product administration (Day 0) through Day 180.
Respiratory, thoracic and mediastinal disorders OROPHARYNGEAL PAIN	1.3% 15/1198 • Number of events 15 • Treatment emergent adverse events were collected from the time of investigational product administration (Day 0) through Day 28. Treatment emergent SAEs were collected from the time of investigational product administration (Day 0) through Day 180.	0.67% 4/598 • Number of events 4 • Treatment emergent adverse events were collected from the time of investigational product administration (Day 0) through Day 28. Treatment emergent SAEs were collected from the time of investigational product administration (Day 0) through Day 180.
Respiratory, thoracic and mediastinal disorders RHINORRHOEA	0.75% 9/1198 • Number of events 9 • Treatment emergent adverse events were collected from the time of investigational product administration (Day 0) through Day 28. Treatment emergent SAEs were collected from the time of investigational product administration (Day 0) through Day 180.	1.5% 9/598 • Number of events 9 • Treatment emergent adverse events were collected from the time of investigational product administration (Day 0) through Day 28. Treatment emergent SAEs were collected from the time of investigational product administration (Day 0) through Day 180.
Respiratory, thoracic and mediastinal disorders SNEEZING	1.5% 18/1198 • Number of events 18 • Treatment emergent adverse events were collected from the time of investigational product administration (Day 0) through Day 28. Treatment emergent SAEs were collected from the time of investigational product administration (Day 0) through Day 180.	0.84% 5/598 • Number of events 5 • Treatment emergent adverse events were collected from the time of investigational product administration (Day 0) through Day 28. Treatment emergent SAEs were collected from the time of investigational product administration (Day 0) through Day 180.

Additional Information

Judith Falloon, MD/ Sr. Dir. Clinical Development

MedImmune LLC, an affiliate of AstraZeneca AB

Phone: 301-398-0000

Email: falloonj@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.
• Publication restrictions are in place

Restriction type: OTHER