Trial Outcomes & Findings for Safety, Tolerability, and Immunogenicity of the Adjuvanted Trivalent Subunit Influenza Vaccine and the Non-Adjuvanted Trivalent Subunit Influenza Vaccine Compared to the Non-Adjuvanted Trivalent Split Influenza Vaccine in Children 6 to < 72 Months of Age (NCT NCT01346592)

NCT ID: NCT01346592

Last Updated: 2015-03-26

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

6104 participants

Primary outcome timeframe

Day 1, Day 50

Results posted on

2015-03-26

Participant Flow

Participants were enrolled from 8 sites in Argentina, 5 sites in Australia, 2 sites in Chile, 12 sites in Philippines, and 5 sites in South Africa.

4 of the enrolled subjects were not randomized hence were not included in the trial.

Participant milestones

Participant milestones
Measure	aTIV (6 to <72 Months) Subjects received an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV), subjects aged between 6 to \<36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 \& 29	Comparator TIV (6 to <72 Months) Subjects received a licensed comparator trivalent split influenza vaccine (comparator TIV), subjects aged between 6 to \<36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 \& 29	TIV (6 to <72 Months) Subjects received an investigational trivalent split influenza vaccine (TIV), subjects aged between 6 to \<36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 \& 29
Overall Study STARTED	3136	1478	1486
Overall Study COMPLETED	2983	1389	1408
Overall Study NOT COMPLETED	153	89	78

Reasons for withdrawal

Reasons for withdrawal
Measure	aTIV (6 to <72 Months) Subjects received an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV), subjects aged between 6 to \<36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 \& 29	Comparator TIV (6 to <72 Months) Subjects received a licensed comparator trivalent split influenza vaccine (comparator TIV), subjects aged between 6 to \<36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 \& 29	TIV (6 to <72 Months) Subjects received an investigational trivalent split influenza vaccine (TIV), subjects aged between 6 to \<36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 \& 29
Overall Study Lost to Follow-up	62	29	29
Overall Study Protocol Violation	2	1	0
Overall Study Death	1	3	4
Overall Study Adverse Event	0	1	0
Overall Study Withdrawal by Subject	77	51	38
Overall Study Inappropriate enrollment	3	1	1
Overall Study Administrative reason	1	0	0
Overall Study Unable to Classify	7	3	6

Baseline Characteristics

Safety, Tolerability, and Immunogenicity of the Adjuvanted Trivalent Subunit Influenza Vaccine and the Non-Adjuvanted Trivalent Subunit Influenza Vaccine Compared to the Non-Adjuvanted Trivalent Split Influenza Vaccine in Children 6 to < 72 Months of Age

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	aTIV (6 to <72 Months) n=3136 Participants Subjects received an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV), subjects aged between 6 to \<36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 \& 29	Comparator TIV (6 to <72 Months) n=1478 Participants Subjects received a licensed comparator trivalent split influenza vaccine (comparator TIV), subjects aged between 6 to \<36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 \& 29	TIV (6 to <72 Months) n=1486 Participants Subjects received an investigational trivalent split influenza vaccine (TIV), subjects aged between 6 to \<36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 \& 29	Total n=6100 Participants Total of all reporting groups
Age, Continuous	37.1 Months STANDARD_DEVIATION 18.6 • n=5 Participants	30.0 Months STANDARD_DEVIATION 16.9 • n=7 Participants	30.2 Months STANDARD_DEVIATION 16.9 • n=5 Participants	33.7 Months STANDARD_DEVIATION 18.1 • n=4 Participants
Sex: Female, Male Female	1545 Participants n=5 Participants	745 Participants n=7 Participants	731 Participants n=5 Participants	3021 Participants n=4 Participants
Sex: Female, Male Male	1591 Participants n=5 Participants	733 Participants n=7 Participants	755 Participants n=5 Participants	3079 Participants n=4 Participants

PRIMARY outcome

Timeframe: Day 1, Day 50

Population: Analysis was done on the Per Protocol Set (PPS) i.e all subjects in the enrolled population who correctly received the study vaccine, provided evaluable serum samples at relevant time-points and had no major protocol violations as defined prior to unblinding.

Outcome measures

Outcome measures
Measure	Comparator TIV (6 to <36months) n=757 Participants Subjects received two doses of 0.25 mL each, of the licensed trivalent split influenza vaccine (comparator TIV), at Days 1 \& 29	TIV (6 to <36months) n=682 Participants Subjects received two doses of 0.25 mL each, of investigational trivalent split influenza vaccine (TIV), at Days 1 \& 29	TIV (6 to <72 Months) n=765 Participants Subjects received an investigational trivalent split influenza vaccine (TIV), subjects aged between 6 to \<36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 \& 29	aTIV (6 to <36 Months) Subjects received two doses (Day 1 \& 29) of an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV)	Compartor TIV (6 to <36 Months) Subjects received two doses (Day 1 \& 29) of a licensed comparator trivalent split influenza vaccine (comparator TIV)	TIV (6 to <36 Months) Subjects received two doses (Day 1 \& 29) of an investigational trivalent split influenza vaccine (TIV)	aTIV (36 to <72 Months) Subjects received one dose (Day 1) of investigational MF59-adjuvanted trivalent influenza vaccine (aTIV)	Comparator TIV (36 to <72 Months) Subjects received one dose (Day 1) of a licensed comparator trivalent split influenza vaccine (comparator TIV)	TIV (36 to <72 Months) Subjects received one dose (Day 1) of an investigational trivalent split influenza vaccine (TIV)
Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of Geometric Mean Titers (GMTs) Against Homologous Strains H1N1 - Day 1 (N=681,757,765)	24 Titers Interval 21.0 to 28.0	28 Titers Interval 24.0 to 33.0	27 Titers Interval 23.0 to 31.0	—	—	—	—	—	—
Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of Geometric Mean Titers (GMTs) Against Homologous Strains H1N1 - Day 50 (N=681,757,765)	629 Titers Interval 567.0 to 698.0	1537 Titers Interval 1382.0 to 1709.0	480 Titers Interval 433.0 to 532.0	—	—	—	—	—	—
Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of Geometric Mean Titers (GMTs) Against Homologous Strains H3N2 - Day 1	42 Titers Interval 36.0 to 49.0	40 Titers Interval 35.0 to 47.0	44 Titers Interval 38.0 to 51.0	—	—	—	—	—	—
Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of Geometric Mean Titers (GMTs) Against Homologous Strains H3N2 - Day 50	1012 Titers Interval 948.0 to 1080.0	1908 Titers Interval 1785.0 to 2040.0	803 Titers Interval 752.0 to 857.0	—	—	—	—	—	—
Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of Geometric Mean Titers (GMTs) Against Homologous Strains B strain Day 1	10 Titers Interval 9.41 to 11.0	9.87 Titers Interval 9.08 to 11.0	10 Titers Interval 9.33 to 11.0	—	—	—	—	—	—
Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of Geometric Mean Titers (GMTs) Against Homologous Strains B strain Day 50	160 Titers Interval 147.0 to 175.0	492 Titers Interval 450.0 to 537.0	157 Titers Interval 144.0 to 171.0	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Day 50

Population: Analysis was done on the PPS.

The non-inferiority of HI antibody responses of aTIV compared to TIV and comparator TIV assessed in terms of percentage of subjects achieving seroconversion or ≥4-fold increase in HI titers at three weeks after last vaccination against the three homologous vaccine strains. Seroconversion defined as prevaccination HI titer \<10 and postvaccination HI titer ≥40 or at least a 4-fold increase in HI titers from prevaccination HI titer ≥10.

Outcome measures

Outcome measures
Measure	Comparator TIV (6 to <36months) n=757 Participants Subjects received two doses of 0.25 mL each, of the licensed trivalent split influenza vaccine (comparator TIV), at Days 1 \& 29	TIV (6 to <36months) n=682 Participants Subjects received two doses of 0.25 mL each, of investigational trivalent split influenza vaccine (TIV), at Days 1 \& 29	TIV (6 to <72 Months) n=765 Participants Subjects received an investigational trivalent split influenza vaccine (TIV), subjects aged between 6 to \<36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 \& 29	aTIV (6 to <36 Months) Subjects received two doses (Day 1 \& 29) of an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV)	Compartor TIV (6 to <36 Months) Subjects received two doses (Day 1 \& 29) of a licensed comparator trivalent split influenza vaccine (comparator TIV)	TIV (6 to <36 Months) Subjects received two doses (Day 1 \& 29) of an investigational trivalent split influenza vaccine (TIV)	aTIV (36 to <72 Months) Subjects received one dose (Day 1) of investigational MF59-adjuvanted trivalent influenza vaccine (aTIV)	Comparator TIV (36 to <72 Months) Subjects received one dose (Day 1) of a licensed comparator trivalent split influenza vaccine (comparator TIV)	TIV (36 to <72 Months) Subjects received one dose (Day 1) of an investigational trivalent split influenza vaccine (TIV)
Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of Percentage of Subjects Achieving Seroconversion or ≥4-fold Increase in HI Titers Against Homologous Strains H1N1 - (N=680,757,765)	84.5 Percentage of subjects Interval 81.8 to 87.1	92.9 Percentage of subjects Interval 90.8 to 94.8	79.4 Percentage of subjects Interval 76.3 to 82.2	—	—	—	—	—	—
Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of Percentage of Subjects Achieving Seroconversion or ≥4-fold Increase in HI Titers Against Homologous Strains H3N2	92.3 Percentage of subjects Interval 90.2 to 94.1	96.5 Percentage of subjects Interval 94.8 to 97.7	89.4 Percentage of subjects Interval 87.0 to 91.5	—	—	—	—	—	—
Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of Percentage of Subjects Achieving Seroconversion or ≥4-fold Increase in HI Titers Against Homologous Strains B strain	86 Percentage of subjects Interval 83.3 to 88.4	98 Percentage of subjects Interval 96.6 to 98.9	84.6 Percentage of subjects Interval 81.8 to 87.1	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Day 1, Day 50

Population: Analysis was done on the PPS.

The non-inferiority of HI antibody responses of TIV to that of comparator TIV, in subjects aged 6 to \<36 Months, assessed in terms of post vaccination GMTs at three weeks after last vaccination against the three homologous vaccine strains.

Outcome measures

Outcome measures
Measure	Comparator TIV (6 to <36months) n=635 Participants Subjects received two doses of 0.25 mL each, of the licensed trivalent split influenza vaccine (comparator TIV), at Days 1 \& 29	TIV (6 to <36months) n=642 Participants Subjects received two doses of 0.25 mL each, of investigational trivalent split influenza vaccine (TIV), at Days 1 \& 29	TIV (6 to <72 Months) Subjects received an investigational trivalent split influenza vaccine (TIV), subjects aged between 6 to \<36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 \& 29	aTIV (6 to <36 Months) Subjects received two doses (Day 1 \& 29) of an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV)	Compartor TIV (6 to <36 Months) Subjects received two doses (Day 1 \& 29) of a licensed comparator trivalent split influenza vaccine (comparator TIV)	TIV (6 to <36 Months) Subjects received two doses (Day 1 \& 29) of an investigational trivalent split influenza vaccine (TIV)	aTIV (36 to <72 Months) Subjects received one dose (Day 1) of investigational MF59-adjuvanted trivalent influenza vaccine (aTIV)	Comparator TIV (36 to <72 Months) Subjects received one dose (Day 1) of a licensed comparator trivalent split influenza vaccine (comparator TIV)	TIV (36 to <72 Months) Subjects received one dose (Day 1) of an investigational trivalent split influenza vaccine (TIV)
Comparison of Antibody Responses of TIV Versus Comparator TIV in Terms of Geometric Mean Titers (GMTs) Against Homologous Strains (6 to <36 Months) H1N1 - Day 1	20 Titers Interval 17.0 to 23.0	23 Titers Interval 20.0 to 27.0	—	—	—	—	—	—	—
Comparison of Antibody Responses of TIV Versus Comparator TIV in Terms of Geometric Mean Titers (GMTs) Against Homologous Strains (6 to <36 Months) H1N1 - Day 50	487 Titers Interval 431.0 to 551.0	370 Titers Interval 328.0 to 419.0	—	—	—	—	—	—	—
Comparison of Antibody Responses of TIV Versus Comparator TIV in Terms of Geometric Mean Titers (GMTs) Against Homologous Strains (6 to <36 Months) H3N2 - Day 1	28 Titers Interval 24.0 to 33.0	29 Titers Interval 24.0 to 33.0	—	—	—	—	—	—	—
Comparison of Antibody Responses of TIV Versus Comparator TIV in Terms of Geometric Mean Titers (GMTs) Against Homologous Strains (6 to <36 Months) H3N2 - Day 50	912 Titers Interval 849.0 to 980.0	698 Titers Interval 650.0 to 749.0	—	—	—	—	—	—	—
Comparison of Antibody Responses of TIV Versus Comparator TIV in Terms of Geometric Mean Titers (GMTs) Against Homologous Strains (6 to <36 Months) B strain Day 1	9.42 Titers Interval 8.62 to 10.0	9.42 Titers Interval 8.63 to 10.0	—	—	—	—	—	—	—
Comparison of Antibody Responses of TIV Versus Comparator TIV in Terms of Geometric Mean Titers (GMTs) Against Homologous Strains (6 to <36 Months) B -strain Day 50	152 Titers Interval 138.0 to 168.0	144 Titers Interval 130.0 to 159.0	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Day 50

Population: Subjects aged 6 through \<36 months of age - Per Protocol Set (PPS).

The non-inferiority of HI antibody responses of TIV to that of the licensed comparator TIV assessed in terms of percentage of subjects achieving seroconversion or ≥4-fold increase in HI titers at three weeks after last vaccination against the three homologous vaccine strains.

Outcome measures

Outcome measures
Measure	Comparator TIV (6 to <36months) n=635 Participants Subjects received two doses of 0.25 mL each, of the licensed trivalent split influenza vaccine (comparator TIV), at Days 1 \& 29	TIV (6 to <36months) n=642 Participants Subjects received two doses of 0.25 mL each, of investigational trivalent split influenza vaccine (TIV), at Days 1 \& 29	TIV (6 to <72 Months) Subjects received an investigational trivalent split influenza vaccine (TIV), subjects aged between 6 to \<36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 \& 29	aTIV (6 to <36 Months) Subjects received two doses (Day 1 \& 29) of an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV)	Compartor TIV (6 to <36 Months) Subjects received two doses (Day 1 \& 29) of a licensed comparator trivalent split influenza vaccine (comparator TIV)	TIV (6 to <36 Months) Subjects received two doses (Day 1 \& 29) of an investigational trivalent split influenza vaccine (TIV)	aTIV (36 to <72 Months) Subjects received one dose (Day 1) of investigational MF59-adjuvanted trivalent influenza vaccine (aTIV)	Comparator TIV (36 to <72 Months) Subjects received one dose (Day 1) of a licensed comparator trivalent split influenza vaccine (comparator TIV)	TIV (36 to <72 Months) Subjects received one dose (Day 1) of an investigational trivalent split influenza vaccine (TIV)
Comparison of Antibody Responses of TIV Versus Comparator TIV in Terms of Percentage of Subjects Achieving Seroconversion or ≥4-fold Increase in HI Titer Against Homologous Strains in Subjects 6 to <36 Months of Age H1N1	84.1 Percentage of subjects Interval 81.0 to 86.9	78.8 Percentage of subjects Interval 75.5 to 81.9	—	—	—	—	—	—	—
Comparison of Antibody Responses of TIV Versus Comparator TIV in Terms of Percentage of Subjects Achieving Seroconversion or ≥4-fold Increase in HI Titer Against Homologous Strains in Subjects 6 to <36 Months of Age H3N2	92.6 Percentage of subjects Interval 90.3 to 94.5	89.9 Percentage of subjects Interval 87.3 to 92.1	—	—	—	—	—	—	—
Comparison of Antibody Responses of TIV Versus Comparator TIV in Terms of Percentage of Subjects Achieving Seroconversion or ≥4-fold Increase in HI Titer Against Homologous Strains in Subjects 6 to <36 Months of Age B strain	85.5 Percentage of subjects Interval 82.5 to 88.2	82.7 Percentage of subjects Interval 79.6 to 85.6	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Day 1, Day 50

Population: Analysis was done on the Full Analysis Set (FAS) i.e all enrolled subjects who received study vaccination and provided serum samples.

The superiority of HI antibody responses, in subjects 6 to \<24 months of age, of aTIV compared to TIV and comparator TIV assessed in terms of post vaccination GMTs at three weeks after last vaccination against the three homologous vaccine strains.

Outcome measures

Outcome measures
Measure	Comparator TIV (6 to <36months) n=389 Participants Subjects received two doses of 0.25 mL each, of the licensed trivalent split influenza vaccine (comparator TIV), at Days 1 \& 29	TIV (6 to <36months) n=266 Participants Subjects received two doses of 0.25 mL each, of investigational trivalent split influenza vaccine (TIV), at Days 1 \& 29	TIV (6 to <72 Months) n=387 Participants Subjects received an investigational trivalent split influenza vaccine (TIV), subjects aged between 6 to \<36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 \& 29	aTIV (6 to <36 Months) Subjects received two doses (Day 1 \& 29) of an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV)	Compartor TIV (6 to <36 Months) Subjects received two doses (Day 1 \& 29) of a licensed comparator trivalent split influenza vaccine (comparator TIV)	TIV (6 to <36 Months) Subjects received two doses (Day 1 \& 29) of an investigational trivalent split influenza vaccine (TIV)	aTIV (36 to <72 Months) Subjects received one dose (Day 1) of investigational MF59-adjuvanted trivalent influenza vaccine (aTIV)	Comparator TIV (36 to <72 Months) Subjects received one dose (Day 1) of a licensed comparator trivalent split influenza vaccine (comparator TIV)	TIV (36 to <72 Months) Subjects received one dose (Day 1) of an investigational trivalent split influenza vaccine (TIV)
Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of GMTs Against Homologous Strains (6 to <24 Months) H1N1 - Day 1	9.87 Titers Interval 8.36 to 12.0	12 Titers Interval 9.52 to 14.0	12 Titers Interval 9.95 to 14.0	—	—	—	—	—	—
Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of GMTs Against Homologous Strains (6 to <24 Months) H1N1 - Day 50	298 Titers Interval 256.0 to 347.0	1080 Titers Interval 899.0 to 1297.0	205 Titers Interval 176.0 to 238.0	—	—	—	—	—	—
Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of GMTs Against Homologous Strains (6 to <24 Months) H3N2 - Day 1	15 Titers Interval 12.0 to 18.0	15 Titers Interval 12.0 to 19.0	17 Titers Interval 14.0 to 21.0	—	—	—	—	—	—
Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of GMTs Against Homologous Strains (6 to <24 Months) H3N2 - Day 50	758 Titers Interval 694.0 to 828.0	1709 Titers Interval 1536.0 to 1903.0	552 Titers Interval 505.0 to 603.0	—	—	—	—	—	—
Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of GMTs Against Homologous Strains (6 to <24 Months) B strain Day 1	8.18 Titers Interval 7.37 to 9.07	7.75 Titers Interval 6.83 to 8.78	7.92 Titers Interval 7.14 to 8.79	—	—	—	—	—	—
Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of GMTs Against Homologous Strains (6 to <24 Months) B strain Day 50	133 Titers Interval 118.0 to 149.0	616 Titers Interval 534.0 to 711.0	112 Titers Interval 100.0 to 127.0	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Day 50

Population: Analysis was done on the FAS

The superiority of HI antibody responses, in subjects 6 to \<24 months of age, of aTIV compared to TIV and comparator TIV assessed in terms of number of subjects achieving seroconversion at three weeks after last vaccination against the three homologous vaccine strains.

Outcome measures

Outcome measures
Measure	Comparator TIV (6 to <36months) n=389 Participants Subjects received two doses of 0.25 mL each, of the licensed trivalent split influenza vaccine (comparator TIV), at Days 1 \& 29	TIV (6 to <36months) n=266 Participants Subjects received two doses of 0.25 mL each, of investigational trivalent split influenza vaccine (TIV), at Days 1 \& 29	TIV (6 to <72 Months) n=387 Participants Subjects received an investigational trivalent split influenza vaccine (TIV), subjects aged between 6 to \<36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 \& 29	aTIV (6 to <36 Months) Subjects received two doses (Day 1 \& 29) of an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV)	Compartor TIV (6 to <36 Months) Subjects received two doses (Day 1 \& 29) of a licensed comparator trivalent split influenza vaccine (comparator TIV)	TIV (6 to <36 Months) Subjects received two doses (Day 1 \& 29) of an investigational trivalent split influenza vaccine (TIV)	aTIV (36 to <72 Months) Subjects received one dose (Day 1) of investigational MF59-adjuvanted trivalent influenza vaccine (aTIV)	Comparator TIV (36 to <72 Months) Subjects received one dose (Day 1) of a licensed comparator trivalent split influenza vaccine (comparator TIV)	TIV (36 to <72 Months) Subjects received one dose (Day 1) of an investigational trivalent split influenza vaccine (TIV)
Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms Percentage of Subjects Achieving Seroconversion or ≥4-fold Increase in HI Titer Against Homologous Strains (6 to <24 Months) H1N1	85.1 Percentage of subjects Interval 81.2 to 88.5	95.5 Percentage of subjects Interval 92.3 to 97.7	77.8 Percentage of subjects Interval 73.3 to 81.8	—	—	—	—	—	—
Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms Percentage of Subjects Achieving Seroconversion or ≥4-fold Increase in HI Titer Against Homologous Strains (6 to <24 Months) H3N2	95.6 Percentage of subjects Interval 93.1 to 97.4	98.1 Percentage of subjects Interval 95.7 to 99.4	92.5 Percentage of subjects Interval 89.4 to 94.9	—	—	—	—	—	—
Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms Percentage of Subjects Achieving Seroconversion or ≥4-fold Increase in HI Titer Against Homologous Strains (6 to <24 Months) B strain	85.4 Percentage of subjects Interval 81.4 to 88.7	98.1 Percentage of subjects Interval 95.7 to 99.4	79.3 Percentage of subjects Interval 75.0 to 83.3	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Day 1, Day 50

Population: Analysis was done on the FAS

The superiority of HI antibody responses, in subjects 6 to \<72 months of age, of aTIV compared to TIV and comparator TIV assessed in terms of post vaccination GMTs at three weeks after last vaccination against the three homologous vaccine strains.

Outcome measures

Outcome measures
Measure	Comparator TIV (6 to <36months) n=839 Participants Subjects received two doses of 0.25 mL each, of the licensed trivalent split influenza vaccine (comparator TIV), at Days 1 \& 29	TIV (6 to <36months) n=747 Participants Subjects received two doses of 0.25 mL each, of investigational trivalent split influenza vaccine (TIV), at Days 1 \& 29	TIV (6 to <72 Months) n=849 Participants Subjects received an investigational trivalent split influenza vaccine (TIV), subjects aged between 6 to \<36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 \& 29	aTIV (6 to <36 Months) Subjects received two doses (Day 1 \& 29) of an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV)	Compartor TIV (6 to <36 Months) Subjects received two doses (Day 1 \& 29) of a licensed comparator trivalent split influenza vaccine (comparator TIV)	TIV (6 to <36 Months) Subjects received two doses (Day 1 \& 29) of an investigational trivalent split influenza vaccine (TIV)	aTIV (36 to <72 Months) Subjects received one dose (Day 1) of investigational MF59-adjuvanted trivalent influenza vaccine (aTIV)	Comparator TIV (36 to <72 Months) Subjects received one dose (Day 1) of a licensed comparator trivalent split influenza vaccine (comparator TIV)	TIV (36 to <72 Months) Subjects received one dose (Day 1) of an investigational trivalent split influenza vaccine (TIV)
Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of GMTs Against Homologous Strains (6 to <72 Months)-FAS H1N1 - Day 1 (N=746,839,849)	24 Titers Interval 21.0 to 28.0	29 Titers Interval 25.0 to 33.0	27 Titers Interval 23.0 to 31.0	—	—	—	—	—	—
Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of GMTs Against Homologous Strains (6 to <72 Months)-FAS H1N1 - Day 50 (N=746,839,849)	637 Titers Interval 577.0 to 704.0	1519 Titers Interval 1372.0 to 1683.0	473 Titers Interval 428.0 to 522.0	—	—	—	—	—	—
Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of GMTs Against Homologous Strains (6 to <72 Months)-FAS H3N2 - Day 1	42 Titers Interval 37.0 to 49.0	41 Titers Interval 36.0 to 48.0	44 Titers Interval 38.0 to 50.0	—	—	—	—	—	—
Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of GMTs Against Homologous Strains (6 to <72 Months)-FAS H3N2 - Day 50	1016 Titers Interval 954.0 to 1081.0	1909 Titers Interval 1791.0 to 2035.0	796 Titers Interval 748.0 to 847.0	—	—	—	—	—	—
Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of GMTs Against Homologous Strains (6 to <72 Months)-FAS B strain - Day 1	10 Titers Interval 9.49 to 11.0	9.97 Titers Interval 9.2 to 11.0	10 Titers Interval 9.33 to 11.0	—	—	—	—	—	—
Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of GMTs Against Homologous Strains (6 to <72 Months)-FAS B strain-Day 50	164 Titers Interval 151.0 to 178.0	480 Titers Interval 441.0 to 523.0	156 Titers Interval 144.0 to 169.0	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Day 50

Population: Analysis was done on the FAS

The superiority of HI antibody responses, in subjects 6 to \<24 months of age, of aTIV compared to TIV and comparator TIV assessed in terms of number of subjects achieving seroconversion ≥4 fold increase in HI titers at three weeks after last vaccination against the three homologous vaccine strains.

Outcome measures

Outcome measures
Measure	Comparator TIV (6 to <36months) n=839 Participants Subjects received two doses of 0.25 mL each, of the licensed trivalent split influenza vaccine (comparator TIV), at Days 1 \& 29	TIV (6 to <36months) n=747 Participants Subjects received two doses of 0.25 mL each, of investigational trivalent split influenza vaccine (TIV), at Days 1 \& 29	TIV (6 to <72 Months) n=849 Participants Subjects received an investigational trivalent split influenza vaccine (TIV), subjects aged between 6 to \<36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 \& 29	aTIV (6 to <36 Months) Subjects received two doses (Day 1 \& 29) of an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV)	Compartor TIV (6 to <36 Months) Subjects received two doses (Day 1 \& 29) of a licensed comparator trivalent split influenza vaccine (comparator TIV)	TIV (6 to <36 Months) Subjects received two doses (Day 1 \& 29) of an investigational trivalent split influenza vaccine (TIV)	aTIV (36 to <72 Months) Subjects received one dose (Day 1) of investigational MF59-adjuvanted trivalent influenza vaccine (aTIV)	Comparator TIV (36 to <72 Months) Subjects received one dose (Day 1) of a licensed comparator trivalent split influenza vaccine (comparator TIV)	TIV (36 to <72 Months) Subjects received one dose (Day 1) of an investigational trivalent split influenza vaccine (TIV)
Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of Percentage of Subjects Achieving Seroconversion or ≥4 Fold Increase in HI Titers Against Homologous Strains (6 to <72 Months)-FAS H1N1	83.7 Percentage of subjects Interval 81.0 to 86.1	92.8 Percentage of subjects Interval 90.7 to 94.5	78.8 Percentage of subjects Interval 75.9 to 81.5	—	—	—	—	—	—
Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of Percentage of Subjects Achieving Seroconversion or ≥4 Fold Increase in HI Titers Against Homologous Strains (6 to <72 Months)-FAS H3N2	92.3 Percentage of subjects Interval 90.2 to 94.0	96.4 Percentage of subjects Interval 94.8 to 97.6	89.8 Percentage of subjects Interval 87.5 to 91.7	—	—	—	—	—	—
Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of Percentage of Subjects Achieving Seroconversion or ≥4 Fold Increase in HI Titers Against Homologous Strains (6 to <72 Months)-FAS B strain	86.4 Percentage of subjects Interval 83.9 to 88.7	97.5 Percentage of subjects Interval 96.1 to 98.5	84.5 Percentage of subjects Interval 81.8 to 86.8	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Day 1, Day 29, Day 50, Day 209

Population: Analysis was done on FAS (Persistence) i.e. all subjects in the enrolled population who actually received a study vaccination, and provided evaluable serum samples at all relevant timepoints and also at day 209.

The HI antibody titers against the three homologous strains following vaccination with either aTIV, licensed comparator or TIV, at three weeks and at six months after vaccination are reported as GMTs.

Outcome measures

Outcome measures
Measure	Comparator TIV (6 to <36months) n=822 Participants Subjects received two doses of 0.25 mL each, of the licensed trivalent split influenza vaccine (comparator TIV), at Days 1 \& 29	TIV (6 to <36months) n=715 Participants Subjects received two doses of 0.25 mL each, of investigational trivalent split influenza vaccine (TIV), at Days 1 \& 29	TIV (6 to <72 Months) n=820 Participants Subjects received an investigational trivalent split influenza vaccine (TIV), subjects aged between 6 to \<36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 \& 29	aTIV (6 to <36 Months) Subjects received two doses (Day 1 \& 29) of an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV)	Compartor TIV (6 to <36 Months) Subjects received two doses (Day 1 \& 29) of a licensed comparator trivalent split influenza vaccine (comparator TIV)	TIV (6 to <36 Months) Subjects received two doses (Day 1 \& 29) of an investigational trivalent split influenza vaccine (TIV)	aTIV (36 to <72 Months) Subjects received one dose (Day 1) of investigational MF59-adjuvanted trivalent influenza vaccine (aTIV)	Comparator TIV (36 to <72 Months) Subjects received one dose (Day 1) of a licensed comparator trivalent split influenza vaccine (comparator TIV)	TIV (36 to <72 Months) Subjects received one dose (Day 1) of an investigational trivalent split influenza vaccine (TIV)
The HI GMTs Against Homologous Strains, by Vaccine Group H1N1 - Day 1 (N=714,822,820)	24 Titers Interval 20.0 to 27.0	28 Titers Interval 24.0 to 32.0	27 Titers Interval 23.0 to 31.0	—	—	—	—	—	—
The HI GMTs Against Homologous Strains, by Vaccine Group H1N1 - Day 29	159 Titers Interval 139.0 to 182.0	647 Titers Interval 562.0 to 745.0	170 Titers Interval 148.0 to 194.0	—	—	—	—	—	—
The HI GMTs Against Homologous Strains, by Vaccine Group H1N1 - Day 50 (N=714,822,820)	635 Titers Interval 575.0 to 702.0	1507 Titers Interval 1358.0 to 1673.0	475 Titers Interval 429.0 to 525.0	—	—	—	—	—	—
The HI GMTs Against Homologous Strains, by Vaccine Group H1N1 - Day 209 (N=715,822,819)	97 Titers Interval 87.0 to 109.0	276 Titers Interval 246.0 to 311.0	107 Titers Interval 96.0 to 120.0	—	—	—	—	—	—
The HI GMTs Against Homologous Strains, by Vaccine Group H3N2 - Day 1	43 Titers Interval 37.0 to 49.0	42 Titers Interval 36.0 to 48.0	43 Titers Interval 38.0 to 50.0	—	—	—	—	—	—
The HI GMTs Against Homologous Strains, by Vaccine Group H3N2 - Day 29	558 Titers Interval 517.0 to 602.0	1087 Titers Interval 1004.0 to 1176.0	453 Titers Interval 420.0 to 490.0	—	—	—	—	—	—
The HI GMTs Against Homologous Strains, by Vaccine Group H3N2 - Day 50	1013 Titers Interval 952.0 to 1079.0	1920 Titers Interval 1799.0 to 2050.0	810 Titers Interval 760.0 to 862.0	—	—	—	—	—	—
The HI GMTs Against Homologous Strains, by Vaccine Group H3N2 - Day 209	277 Titers Interval 254.0 to 301.0	462 Titers Interval 423.0 to 505.0	242 Titers Interval 222.0 to 263.0	—	—	—	—	—	—
The HI GMTs Against Homologous Strains, by Vaccine Group B - Day 1	10 Titers Interval 9.57 to 11.0	10 Titers Interval 9.29 to 11.0	10 Titers Interval 9.34 to 11.0	—	—	—	—	—	—
The HI GMTs Against Homologous Strains, by Vaccine Group B - Day 29	58 Titers Interval 52.0 to 65.0	119 Titers Interval 106.0 to 134.0	61 Titers Interval 54.0 to 68.0	—	—	—	—	—	—
The HI GMTs Against Homologous Strains, by Vaccine Group B - Day 50	166 Titers Interval 153.0 to 180.0	488 Titers Interval 447.0 to 532.0	159 Titers Interval 146.0 to 173.0	—	—	—	—	—	—
The HI GMTs Against Homologous Strains, by Vaccine Group B- Day 209	57 Titers Interval 53.0 to 62.0	125 Titers Interval 114.0 to 136.0	61 Titers Interval 56.0 to 66.0	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Day 29, Day 50, Day 209

Population: Analysis was done on FAS (Persistence)

The GMR of post-vaccination versus pre-vaccination HI titers against homologous strains, three weeks (day 29/day 1; day 50/day 1)and six months (day 209/day 1) after vaccination with either aTIV, licensed comparator or TIV.

Outcome measures

Outcome measures
Measure	Comparator TIV (6 to <36months) n=822 Participants Subjects received two doses of 0.25 mL each, of the licensed trivalent split influenza vaccine (comparator TIV), at Days 1 \& 29	TIV (6 to <36months) n=715 Participants Subjects received two doses of 0.25 mL each, of investigational trivalent split influenza vaccine (TIV), at Days 1 \& 29	TIV (6 to <72 Months) n=820 Participants Subjects received an investigational trivalent split influenza vaccine (TIV), subjects aged between 6 to \<36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 \& 29	aTIV (6 to <36 Months) Subjects received two doses (Day 1 \& 29) of an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV)	Compartor TIV (6 to <36 Months) Subjects received two doses (Day 1 \& 29) of a licensed comparator trivalent split influenza vaccine (comparator TIV)	TIV (6 to <36 Months) Subjects received two doses (Day 1 \& 29) of an investigational trivalent split influenza vaccine (TIV)	aTIV (36 to <72 Months) Subjects received one dose (Day 1) of investigational MF59-adjuvanted trivalent influenza vaccine (aTIV)	Comparator TIV (36 to <72 Months) Subjects received one dose (Day 1) of a licensed comparator trivalent split influenza vaccine (comparator TIV)	TIV (36 to <72 Months) Subjects received one dose (Day 1) of an investigational trivalent split influenza vaccine (TIV)
Geometric Mean Ratio (GMR) of Post- Versus Pre-vaccination HI Titers Against Homologous Strains B strain, Day 50:Day 1	17 Ratios Interval 15.0 to 18.0	49 Ratios Interval 45.0 to 54.0	16 Ratios Interval 15.0 to 18.0	—	—	—	—	—	—
Geometric Mean Ratio (GMR) of Post- Versus Pre-vaccination HI Titers Against Homologous Strains B strain, Day 209:Day 1	5.76 Ratios Interval 5.26 to 6.3	13 Ratios Interval 12.0 to 14.0	6.15 Ratios Interval 5.62 to 6.73	—	—	—	—	—	—
Geometric Mean Ratio (GMR) of Post- Versus Pre-vaccination HI Titers Against Homologous Strains H1N1, Day 29:Day 1 (N=714,822,820)	6.81 Ratios Interval 5.94 to 7.81	27 Ratios Interval 23.0 to 31.0	7.13 Ratios Interval 6.22 to 8.18	—	—	—	—	—	—
Geometric Mean Ratio (GMR) of Post- Versus Pre-vaccination HI Titers Against Homologous Strains H1N1, Day 50:Day 1 (N=713,822,820)	27 Ratios Interval 24.0 to 31.0	58 Ratios Interval 51.0 to 67.0	19 Ratios Interval 17.0 to 21.0	—	—	—	—	—	—
Geometric Mean Ratio (GMR) of Post- Versus Pre-vaccination HI Titers Against Homologous Strains H1N1, Day 209:Day 1 (N=714,822,819)	4.15 Ratios Interval 3.68 to 4.69	11 Ratios Interval 9.79 to 13.0	4.37 Ratios Interval 3.87 to 4.94	—	—	—	—	—	—
Geometric Mean Ratio (GMR) of Post- Versus Pre-vaccination HI Titers Against Homologous Strains H3N2, Day 29:Day 1	15 Ratios Interval 14.0 to 16.0	29 Ratios Interval 26.0 to 32.0	12 Ratios Interval 11.0 to 13.0	—	—	—	—	—	—
Geometric Mean Ratio (GMR) of Post- Versus Pre-vaccination HI Titers Against Homologous Strains H3N2, Day 50:Day 1 (N=715,822,820)	25 Ratios Interval 23.0 to 28.0	48 Ratios Interval 43.0 to 54.0	20 Ratios Interval 18.0 to 22.0	—	—	—	—	—	—
Geometric Mean Ratio (GMR) of Post- Versus Pre-vaccination HI Titers Against Homologous Strains H3N2, Day 209:Day 1	6.93 Ratios Interval 6.14 to 7.83	12 Ratios Interval 10.0 to 13.0	6.02 Ratios Interval 5.33 to 6.81	—	—	—	—	—	—
Geometric Mean Ratio (GMR) of Post- Versus Pre-vaccination HI Titers Against Homologous Strains B strain, Day 29:Day 1	6.18 Ratios Interval 5.49 to 6.95	12 Ratios Interval 11.0 to 14.0	6.38 Ratios Interval 5.66 to 7.18	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Day 1, Day 29, Day 50, Day 209

Population: Analysis was done on FAS (Persistence)

The percentage of subjects demonstrating HI titers ≥40,against homologous strains, at three weeks and six months after vaccination with aTIV or licensed comparator or TIV.

Outcome measures

Outcome measures
Measure	Comparator TIV (6 to <36months) n=822 Participants Subjects received two doses of 0.25 mL each, of the licensed trivalent split influenza vaccine (comparator TIV), at Days 1 \& 29	TIV (6 to <36months) n=715 Participants Subjects received two doses of 0.25 mL each, of investigational trivalent split influenza vaccine (TIV), at Days 1 \& 29	TIV (6 to <72 Months) n=820 Participants Subjects received an investigational trivalent split influenza vaccine (TIV), subjects aged between 6 to \<36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 \& 29	aTIV (6 to <36 Months) Subjects received two doses (Day 1 \& 29) of an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV)	Compartor TIV (6 to <36 Months) Subjects received two doses (Day 1 \& 29) of a licensed comparator trivalent split influenza vaccine (comparator TIV)	TIV (6 to <36 Months) Subjects received two doses (Day 1 \& 29) of an investigational trivalent split influenza vaccine (TIV)	aTIV (36 to <72 Months) Subjects received one dose (Day 1) of investigational MF59-adjuvanted trivalent influenza vaccine (aTIV)	Comparator TIV (36 to <72 Months) Subjects received one dose (Day 1) of a licensed comparator trivalent split influenza vaccine (comparator TIV)	TIV (36 to <72 Months) Subjects received one dose (Day 1) of an investigational trivalent split influenza vaccine (TIV)
Percentage of Subjects With HI Titers ≥40 Against Homologous Strains, by Vaccine Group H1N1, Day 1 (N=714,822,820)	33.1 Percentage of subjects Interval 29.9 to 36.4	40.6 Percentage of subjects Interval 37.0 to 44.3	36.3 Percentage of subjects Interval 33.0 to 39.7	—	—	—	—	—	—
Percentage of Subjects With HI Titers ≥40 Against Homologous Strains, by Vaccine Group H1N1, Day 29	55 Percentage of subjects Interval 51.5 to 58.4	89.8 Percentage of subjects Interval 87.3 to 91.9	57.9 Percentage of subjects Interval 54.5 to 61.3	—	—	—	—	—	—
Percentage of Subjects With HI Titers ≥40 Against Homologous Strains, by Vaccine Group H1N1, Day 50 (N=714,822,820)	91.1 Percentage of subjects Interval 89.0 to 93.0	99.3 Percentage of subjects Interval 98.4 to 99.8	88.2 Percentage of subjects Interval 85.8 to 90.3	—	—	—	—	—	—
Percentage of Subjects With HI Titers ≥40 Against Homologous Strains, by Vaccine Group H1N1, Day 209 (N=715, 822,819)	59.5 Percentage of subjects Interval 56.0 to 62.9	88.8 Percentage of subjects Interval 86.3 to 91.0	63.2 Percentage of subjects Interval 59.8 to 66.6	—	—	—	—	—	—
Percentage of Subjects With HI Titers ≥40 Against Homologous Strains, by Vaccine Group H3N2, Day 1	45.5 Percentage of subjects Interval 42.1 to 49.0	52.6 Percentage of subjects Interval 48.9 to 56.3	44.6 Percentage of subjects Interval 41.2 to 48.1	—	—	—	—	—	—
Percentage of Subjects With HI Titers ≥40 Against Homologous Strains, by Vaccine Group H3N2, Day 29	95.9 Percentage of subjects Interval 94.3 to 97.1	98.9 Percentage of subjects Interval 97.8 to 99.5	93.5 Percentage of subjects Interval 91.6 to 95.1	—	—	—	—	—	—
Percentage of Subjects With HI Titers ≥40 Against Homologous Strains, by Vaccine Group H3N2, Day 50	99.5 Percentage of subjects Interval 98.8 to 99.9	99.7 Percentage of subjects Interval 99.0 to 100.0	99.4 Percentage of subjects Interval 98.6 to 99.8	—	—	—	—	—	—
Percentage of Subjects With HI Titers ≥40 Against Homologous Strains, by Vaccine Group H3N2, Day 209	94.3 Percentage of subjects Interval 92.5 to 95.8	99.3 Percentage of subjects Interval 98.4 to 99.8	88.4 Percentage of subjects Interval 86.0 to 90.5	—	—	—	—	—	—
Percentage of Subjects With HI Titers ≥40 Against Homologous Strains, by Vaccine Group B strain, Day 1	21.1 Percentage of subjects Interval 18.3 to 24.0	22.1 Percentage of subjects Interval 19.1 to 25.3	20.5 Percentage of subjects Interval 17.8 to 23.4	—	—	—	—	—	—
Percentage of Subjects With HI Titers ≥40 Against Homologous Strains, by Vaccine Group B strain, Day 29	48.2 Percentage of subjects Interval 44.7 to 51.7	69 Percentage of subjects Interval 65.4 to 72.3	45.6 Percentage of subjects Interval 42.2 to 49.1	—	—	—	—	—	—
Percentage of Subjects With HI Titers ≥40 Against Homologous Strains, by Vaccine Group B strain, Day 50	89.1 Percentage of subjects Interval 86.7 to 91.1	98.9 Percentage of subjects Interval 97.8 to 99.5	87 Percentage of subjects Interval 84.5 to 89.2	—	—	—	—	—	—
Percentage of Subjects With HI Titers ≥40 Against Homologous Strains, by Vaccine Group B strain, Day 209	67.9 Percentage of subjects Interval 64.6 to 71.1	93.4 Percentage of subjects Interval 91.4 to 95.1	67 Percentage of subjects Interval 63.6 to 70.2	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Day 29, Day 50, Day 209

Population: Analysis was done on FAS (Persistence)

The percentage of subjects achieving seroconversion ≥4 fold increase in HI titers from baseline, against homologous strains, at three weeks and six months after vaccination with ATIV or licensed comparator or TIV.

Outcome measures

Outcome measures
Measure	Comparator TIV (6 to <36months) n=822 Participants Subjects received two doses of 0.25 mL each, of the licensed trivalent split influenza vaccine (comparator TIV), at Days 1 \& 29	TIV (6 to <36months) n=715 Participants Subjects received two doses of 0.25 mL each, of investigational trivalent split influenza vaccine (TIV), at Days 1 \& 29	TIV (6 to <72 Months) n=820 Participants Subjects received an investigational trivalent split influenza vaccine (TIV), subjects aged between 6 to \<36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 \& 29	aTIV (6 to <36 Months) Subjects received two doses (Day 1 \& 29) of an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV)	Compartor TIV (6 to <36 Months) Subjects received two doses (Day 1 \& 29) of a licensed comparator trivalent split influenza vaccine (comparator TIV)	TIV (6 to <36 Months) Subjects received two doses (Day 1 \& 29) of an investigational trivalent split influenza vaccine (TIV)	aTIV (36 to <72 Months) Subjects received one dose (Day 1) of investigational MF59-adjuvanted trivalent influenza vaccine (aTIV)	Comparator TIV (36 to <72 Months) Subjects received one dose (Day 1) of a licensed comparator trivalent split influenza vaccine (comparator TIV)	TIV (36 to <72 Months) Subjects received one dose (Day 1) of an investigational trivalent split influenza vaccine (TIV)
Percentage of Subjects Achieving Seroconversion or ≥4 Fold Increase in HI Titers, Against Homologous Strains H1N1, Day 29 (N=714,822,820)	48.5 Percentage of subjects Interval 45.1 to 52.1	83.6 Percentage of subjects Interval 80.7 to 86.3	51.5 Percentage of subjects Interval 48.0 to 54.9	—	—	—	—	—	—
Percentage of Subjects Achieving Seroconversion or ≥4 Fold Increase in HI Titers, Against Homologous Strains H1N1, Day 209 (N=714,822,819)	39.5 Percentage of subjects Interval 36.2 to 43.0	71.7 Percentage of subjects Interval 68.3 to 75.0	41.9 Percentage of subjects Interval 38.5 to 45.3	—	—	—	—	—	—
Percentage of Subjects Achieving Seroconversion or ≥4 Fold Increase in HI Titers, Against Homologous Strains H1N1, Day 50 (N=713,822,820)	83.9 Percentage of subjects Interval 81.3 to 86.4	92.6 Percentage of subjects Interval 90.4 to 94.4	79 Percentage of subjects Interval 76.1 to 81.8	—	—	—	—	—	—
Percentage of Subjects Achieving Seroconversion or ≥4 Fold Increase in HI Titers, Against Homologous Strains H3N2, Day 29	90.3 Percentage of subjects Interval 88.0 to 92.2	95.8 Percentage of subjects Interval 94.1 to 97.2	86.7 Percentage of subjects Interval 84.2 to 89.0	—	—	—	—	—	—
Percentage of Subjects Achieving Seroconversion or ≥4 Fold Increase in HI Titers, Against Homologous Strains H3N2, Day 50	92.1 Percentage of subjects Interval 90.0 to 93.8	96.5 Percentage of subjects Interval 94.9 to 97.7	90 Percentage of subjects Interval 87.7 to 92.0	—	—	—	—	—	—
Percentage of Subjects Achieving Seroconversion or ≥4 Fold Increase in HI Titers, Against Homologous Strains H3N2, Day 209	62.5 Percentage of subjects Interval 59.1 to 65.9	77.6 Percentage of subjects Interval 74.4 to 80.6	55.6 Percentage of subjects Interval 52.1 to 59.1	—	—	—	—	—	—
Percentage of Subjects Achieving Seroconversion or ≥4 Fold Increase in HI Titers, Against Homologous Strains B strain, Day 29	47 Percentage of subjects Interval 43.5 to 50.4	68.4 Percentage of subjects Interval 64.8 to 71.8	44 Percentage of subjects Interval 40.6 to 47.5	—	—	—	—	—	—
Percentage of Subjects Achieving Seroconversion or ≥4 Fold Increase in HI Titers, Against Homologous Strains B strain, Day 50	86.6 Percentage of subjects Interval 84.1 to 88.9	97.6 Percentage of subjects Interval 96.2 to 98.6	85 Percentage of subjects Interval 82.4 to 87.4	—	—	—	—	—	—
Percentage of Subjects Achieving Seroconversion or ≥4 Fold Increase in HI Titers, Against Homologous Strains B strain, Day 209	59.7 Percentage of subjects Interval 56.3 to 63.1	87.3 Percentage of subjects Interval 84.6 to 89.6	61.5 Percentage of subjects Interval 58.0 to 64.8	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Day 50

Population: Analysis was done on the PPS.

The non-inferiority of Hemagglutination Inhibition (HI) antibody responses of aTIV compared to TIV and comparator TIV assessed in terms of post vaccination GMTs at three weeks after last vaccination against the three homologous vaccine strains, in subjects with a defined set of underlying medical conditions (at risk) and healthy subjects (not at risk), by age sub group.

Outcome measures

Outcome measures
Measure	Comparator TIV (6 to <36months) n=722 Participants Subjects received two doses of 0.25 mL each, of the licensed trivalent split influenza vaccine (comparator TIV), at Days 1 \& 29	TIV (6 to <36months) n=660 Participants Subjects received two doses of 0.25 mL each, of investigational trivalent split influenza vaccine (TIV), at Days 1 \& 29	TIV (6 to <72 Months) n=739 Participants Subjects received an investigational trivalent split influenza vaccine (TIV), subjects aged between 6 to \<36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 \& 29	aTIV (6 to <36 Months) n=425 Participants Subjects received two doses (Day 1 \& 29) of an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV)	Compartor TIV (6 to <36 Months) n=612 Participants Subjects received two doses (Day 1 \& 29) of a licensed comparator trivalent split influenza vaccine (comparator TIV)	TIV (6 to <36 Months) n=623 Participants Subjects received two doses (Day 1 \& 29) of an investigational trivalent split influenza vaccine (TIV)	aTIV (36 to <72 Months) n=235 Participants Subjects received one dose (Day 1) of investigational MF59-adjuvanted trivalent influenza vaccine (aTIV)	Comparator TIV (36 to <72 Months) n=110 Participants Subjects received one dose (Day 1) of a licensed comparator trivalent split influenza vaccine (comparator TIV)	TIV (36 to <72 Months) n=116 Participants Subjects received one dose (Day 1) of an investigational trivalent split influenza vaccine (TIV)
Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of GMTs Against Homologous Strains, Subjects at Risk/Not at Risk, by Age Subgroup H1N1nonrisk(N=659,722,739,425,612,623,234,110,116)	566 Titers Interval 509.0 to 628.0	1516 Titers Interval 1358.0 to 1692.0	431 Titers Interval 388.0 to 478.0	1341 Titers Interval 1165.0 to 1544.0	478 Titers Interval 425.0 to 537.0	366 Titers Interval 326.0 to 411.0	2111 Titers Interval 1840.0 to 2423.0	1365 Titers Interval 1117.0 to 1668.0	879 Titers Interval 723.0 to 1068.0
Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of GMTs Against Homologous Strains, Subjects at Risk/Not at Risk, by Age Subgroup H3N2nonrisk(N=660,722,739,425,612,623,235,110,116)	1014 Titers Interval 950.0 to 1082.0	1897 Titers Interval 1772.0 to 2030.0	804 Titers Interval 754.0 to 857.0	1863 Titers Interval 1711.0 to 2028.0	912 Titers Interval 849.0 to 979.0	695 Titers Interval 648.0 to 746.0	2311 Titers Interval 2080.0 to 2568.0	1526 Titers Interval 1309.0 to 1780.0	1497 Titers Interval 1289.0 to 1739.0
Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of GMTs Against Homologous Strains, Subjects at Risk/Not at Risk, by Age Subgroup B nonrisk(N=660,722,739,425,612,623,235,110,116)	162 Titers Interval 148.0 to 176.0	492 Titers Interval 450.0 to 539.0	157 Titers Interval 144.0 to 170.0	559 Titers Interval 498.0 to 627.0	149 Titers Interval 136.0 to 164.0	141 Titers Interval 128.0 to 155.0	431 Titers Interval 380.0 to 488.0	226 Titers Interval 188.0 to 272.0	254 Titers Interval 212.0 to 304.0
Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of GMTs Against Homologous Strains, Subjects at Risk/Not at Risk, by Age Subgroup H1N1 at risk(N=22,35,26,12,23,19,10,12,7)	772 Titers Interval 502.0 to 1185.0	1706 Titers Interval 990.0 to 2939.0	631 Titers Interval 383.0 to 1041.0	1414 Titers Interval 658.0 to 3040.0	603 Titers Interval 350.0 to 1040.0	519 Titers Interval 283.0 to 950.0	2187 Titers Interval 956.0 to 5002.0	1241 Titers Interval 583.0 to 2641.0	1030 Titers Interval 383.0 to 2767.0
Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of GMTs Against Homologous Strains, Subjects at Risk/Not at Risk, by Age Subgroup H3N2 at risk(N=22,35,26,12,23,19,10,12,7)	941 Titers Interval 727.0 to 1220.0	2306 Titers Interval 1665.0 to 3194.0	709 Titers Interval 526.0 to 955.0	2323 Titers Interval 1407.0 to 3835.0	794 Titers Interval 552.0 to 1140.0	665 Titers Interval 447.0 to 988.0	2319 Titers Interval 1622.0 to 3315.0	1306 Titers Interval 940.0 to 1815.0	826 Titers Interval 538.0 to 1267.0
Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of GMTs Against Homologous Strains, Subjects at Risk/Not at Risk, by Age Subgroup B at risk(N=22,35,26,12,23,19,10,12,7)	143 Titers Interval 98.0 to 209.0	495 Titers Interval 307.0 to 797.0	179 Titers Interval 116.0 to 278.0	694 Titers Interval 367.0 to 1316.0	125 Titers Interval 79.0 to 199.0	132 Titers Interval 79.0 to 220.0	365 Titers Interval 184.0 to 724.0	200 Titers Interval 108.0 to 372.0	312 Titers Interval 131.0 to 743.0

SECONDARY outcome

Timeframe: Day 50

Population: Analysis was done on the Per Protocol Set.

The non-inferiority of HI antibody responses of aTIV to that of the licensed comparator TIV and to investigational TIV was assessed in terms of percentage of subjects achieving seroconversion or ≥4-fold increase in HI titers at three weeks after last vaccination against the three homologous vaccine strains in subjects with a defined set of underlying medical conditions (at risk) and in healthy subjects (not at risk) , by age sub group.

Outcome measures

Outcome measures
Measure	Comparator TIV (6 to <36months) n=722 Participants Subjects received two doses of 0.25 mL each, of the licensed trivalent split influenza vaccine (comparator TIV), at Days 1 \& 29	TIV (6 to <36months) n=660 Participants Subjects received two doses of 0.25 mL each, of investigational trivalent split influenza vaccine (TIV), at Days 1 \& 29	TIV (6 to <72 Months) n=739 Participants Subjects received an investigational trivalent split influenza vaccine (TIV), subjects aged between 6 to \<36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 \& 29	aTIV (6 to <36 Months) n=425 Participants Subjects received two doses (Day 1 \& 29) of an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV)	Compartor TIV (6 to <36 Months) n=612 Participants Subjects received two doses (Day 1 \& 29) of a licensed comparator trivalent split influenza vaccine (comparator TIV)	TIV (6 to <36 Months) n=623 Participants Subjects received two doses (Day 1 \& 29) of an investigational trivalent split influenza vaccine (TIV)	aTIV (36 to <72 Months) n=235 Participants Subjects received one dose (Day 1) of investigational MF59-adjuvanted trivalent influenza vaccine (aTIV)	Comparator TIV (36 to <72 Months) n=110 Participants Subjects received one dose (Day 1) of a licensed comparator trivalent split influenza vaccine (comparator TIV)	TIV (36 to <72 Months) n=116 Participants Subjects received one dose (Day 1) of an investigational trivalent split influenza vaccine (TIV)
Comparison of Antibody Responses of aTIV Versus Comparator TIV and TIV in Terms of Percentage of Subjects Achieving Seroconversion or ≥4-fold Increase in HI Titer Against Homologous Strains in Subjects at Risk/Not at Risk, by Age Subgroup H3N2 norisk(N=660,722,739,425,612,623,235,110,116)	93 Percentages of subjects Interval 91.0 to 94.0	97 Percentages of subjects Interval 95.0 to 98.0	90 Percentages of subjects Interval 87.0 to 92.0	98 Percentages of subjects Interval 96.0 to 99.0	93 Percentages of subjects Interval 91.0 to 95.0	90 Percentages of subjects Interval 88.0 to 93.0	94 Percentages of subjects Interval 91.0 to 97.0	90 Percentages of subjects Interval 83.0 to 95.0	86 Percentages of subjects Interval 79.0 to 92.0
Comparison of Antibody Responses of aTIV Versus Comparator TIV and TIV in Terms of Percentage of Subjects Achieving Seroconversion or ≥4-fold Increase in HI Titer Against Homologous Strains in Subjects at Risk/Not at Risk, by Age Subgroup B norisk(N=660,722,739,425,612,623,235,110,116)	86 Percentages of subjects Interval 83.0 to 88.0	98 Percentages of subjects Interval 96.0 to 99.0	84 Percentages of subjects Interval 82.0 to 87.0	98 Percentages of subjects Interval 96.0 to 99.0	85 Percentages of subjects Interval 82.0 to 88.0	83 Percentages of subjects Interval 79.0 to 86.0	98 Percentages of subjects Interval 95.0 to 99.0	90 Percentages of subjects Interval 83.0 to 95.0	94 Percentages of subjects Interval 88.0 to 98.0
Comparison of Antibody Responses of aTIV Versus Comparator TIV and TIV in Terms of Percentage of Subjects Achieving Seroconversion or ≥4-fold Increase in HI Titer Against Homologous Strains in Subjects at Risk/Not at Risk, by Age Subgroup H1N1 at risk (N=22,35,26,12,23,19,10,12,7)	83 Percentages of subjects Interval 66.0 to 93.0	82 Percentages of subjects Interval 60.0 to 95.0	85 Percentages of subjects Interval 65.0 to 96.0	92 Percentages of subjects Interval 62.0 to 100.0	87 Percentages of subjects Interval 66.0 to 97.0	89 Percentages of subjects Interval 67.0 to 99.0	70 Percentages of subjects Interval 35.0 to 93.0	75 Percentages of subjects Interval 43.0 to 95.0	71 Percentages of subjects Interval 29.0 to 96.0
Comparison of Antibody Responses of aTIV Versus Comparator TIV and TIV in Terms of Percentage of Subjects Achieving Seroconversion or ≥4-fold Increase in HI Titer Against Homologous Strains in Subjects at Risk/Not at Risk, by Age Subgroup H3N2 at risk(N=22,35,26,12,23,19,10,12,7)	86 Percentages of subjects Interval 70.0 to 95.0	86 Percentages of subjects Interval 65.0 to 97.0	81 Percentages of subjects Interval 61.0 to 93.0	83 Percentages of subjects Interval 52.0 to 98.0	78 Percentages of subjects Interval 56.0 to 93.0	74 Percentages of subjects Interval 49.0 to 91.0	90 Percentages of subjects Interval 55.0 to 100.0	100 Percentages of subjects Interval 74.0 to 100.0	100 Percentages of subjects Interval 59.0 to 100.0
Comparison of Antibody Responses of aTIV Versus Comparator TIV and TIV in Terms of Percentage of Subjects Achieving Seroconversion or ≥4-fold Increase in HI Titer Against Homologous Strains in Subjects at Risk/Not at Risk, by Age Subgroup B at risk(N=22,35,26,12,23,19,10,12,7)	86 Percentages of subjects Interval 70.0 to 98.0	100 Percentages of subjects Interval 85.0 to 100.0	88 Percentages of subjects Interval 70.0 to 98.0	100 Percentages of subjects Interval 74.0 to 100.0	91 Percentages of subjects Interval 72.0 to 99.0	84 Percentages of subjects Interval 60.0 to 97.0	100 Percentages of subjects Interval 69.0 to 100.0	75 Percentages of subjects Interval 43.0 to 95.0	100 Percentages of subjects Interval 59.0 to 100.0
Comparison of Antibody Responses of aTIV Versus Comparator TIV and TIV in Terms of Percentage of Subjects Achieving Seroconversion or ≥4-fold Increase in HI Titer Against Homologous Strains in Subjects at Risk/Not at Risk, by Age Subgroup H1N1 norisk(N=658,722,739,425,612,623,233,110,116)	85 Percentages of subjects Interval 82.0 to 87.0	93 Percentages of subjects Interval 91.0 to 95.0	79 Percentages of subjects Interval 76.0 to 82.0	95 Percentages of subjects Interval 92.0 to 97.0	84 Percentages of subjects Interval 81.0 to 87.0	78 Percentages of subjects Interval 75.0 to 82.0	91 Percentages of subjects Interval 86.0 to 94.0	88 Percentages of subjects Interval 81.0 to 94.0	83 Percentages of subjects Interval 75.0 to 89.0

SECONDARY outcome

Timeframe: Day 50

Population: Analysis was done on the Full Analysis Set.

The superiority of HI antibody responses of aTIV compared to TIV and comparator TIV assessed in terms of of percentage of subjects achieving seroconversion or ≥4-fold increase in HI Titer at three weeks after last vaccination against the three homologous vaccine strains in subjects with a defined set of underlying medical conditions (at risk) and healthy subjects (not at risk), by age sub group.

Outcome measures

Outcome measures
Measure	Comparator TIV (6 to <36months) n=799 Participants Subjects received two doses of 0.25 mL each, of the licensed trivalent split influenza vaccine (comparator TIV), at Days 1 \& 29	TIV (6 to <36months) n=719 Participants Subjects received two doses of 0.25 mL each, of investigational trivalent split influenza vaccine (TIV), at Days 1 \& 29	TIV (6 to <72 Months) n=814 Participants Subjects received an investigational trivalent split influenza vaccine (TIV), subjects aged between 6 to \<36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 \& 29	aTIV (6 to <36 Months) n=459 Participants Subjects received two doses (Day 1 \& 29) of an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV)	Compartor TIV (6 to <36 Months) n=673 Participants Subjects received two doses (Day 1 \& 29) of a licensed comparator trivalent split influenza vaccine (comparator TIV)	TIV (6 to <36 Months) n=688 Participants Subjects received two doses (Day 1 \& 29) of an investigational trivalent split influenza vaccine (TIV)	aTIV (36 to <72 Months) n=260 Participants Subjects received one dose (Day 1) of investigational MF59-adjuvanted trivalent influenza vaccine (aTIV)	Comparator TIV (36 to <72 Months) n=126 Participants Subjects received one dose (Day 1) of a licensed comparator trivalent split influenza vaccine (comparator TIV)	TIV (36 to <72 Months) n=126 Participants Subjects received one dose (Day 1) of an investigational trivalent split influenza vaccine (TIV)
Comparison of Antibody Responses of TIV Versus Comparator TIV in Terms of Percentage of Subjects Achieving Seroconversion or ≥4-fold Increase in HI Titer Against Homologous Strains in Subjects at Risk/Not at Risk, by Age Sub Group-FAS H1N1 norisk(N=717,799,814,459,673,688,258,126,126)	84 Percentages of subjects Interval 81.0 to 86.0	93 Percentages of subjects Interval 91.0 to 95.0	79 Percentages of subjects Interval 76.0 to 81.0	95 Percentages of subjects Interval 92.0 to 96.0	83 Percentages of subjects Interval 80.0 to 86.0	78 Percentages of subjects Interval 75.0 to 81.0	91 Percentages of subjects Interval 87.0 to 94.0	89 Percentages of subjects Interval 82.0 to 94.0	81 Percentages of subjects Interval 73.0 to 87.0
Comparison of Antibody Responses of TIV Versus Comparator TIV in Terms of Percentage of Subjects Achieving Seroconversion or ≥4-fold Increase in HI Titer Against Homologous Strains in Subjects at Risk/Not at Risk, by Age Sub Group-FAS H3N2 norisk(N=719,799,814,459,673,688,260,126,126)	93 Percentages of subjects Interval 91.0 to 94.0	97 Percentages of subjects Interval 95.0 to 98.0	90 Percentages of subjects Interval 88.0 to 92.0	98 Percentages of subjects Interval 96.0 to 99.0	93 Percentages of subjects Interval 91.0 to 95.0	91 Percentages of subjects Interval 88.0 to 93.0	95 Percentages of subjects Interval 91.0 to 97.0	91 Percentages of subjects Interval 85.0 to 96.0	87 Percentages of subjects Interval 79.0 to 92.0
Comparison of Antibody Responses of TIV Versus Comparator TIV in Terms of Percentage of Subjects Achieving Seroconversion or ≥4-fold Increase in HI Titer Against Homologous Strains in Subjects at Risk/Not at Risk, by Age Sub Group-FAS B norisk(N=719,799,814,459,673,688,260,126,126)	86 Percentages of subjects Interval 84.0 to 89.0	97 Percentages of subjects Interval 96.0 to 99.0	84 Percentages of subjects Interval 82.0 to 87.0	98 Percentages of subjects Interval 96.0 to 99.0	85 Percentages of subjects Interval 83.0 to 88.0	83 Percentages of subjects Interval 80.0 to 85.0	97 Percentages of subjects Interval 95.0 to 99.0	91 Percentages of subjects Interval 85.0 to 96.0	94 Percentages of subjects Interval 88.0 to 97.0
Comparison of Antibody Responses of TIV Versus Comparator TIV in Terms of Percentage of Subjects Achieving Seroconversion or ≥4-fold Increase in HI Titer Against Homologous Strains in Subjects at Risk/Not at Risk, by Age Sub Group-FAS H1N1 at risk(N=28,40,35,17,26,26,11,14,9)	83 Percentages of subjects Interval 67.0 to 93.0	79 Percentages of subjects Interval 59.0 to 92.0	83 Percentages of subjects Interval 66.0 to 93.0	82 Percentages of subjects Interval 57.0 to 96.0	85 Percentages of subjects Interval 65.0 to 96.0	85 Percentages of subjects Interval 65.0 to 96.0	73 Percentages of subjects Interval 39.0 to 94.0	79 Percentages of subjects Interval 49.0 to 95.0	78 Percentages of subjects Interval 40.0 to 97.0
Comparison of Antibody Responses of TIV Versus Comparator TIV in Terms of Percentage of Subjects Achieving Seroconversion or ≥4-fold Increase in HI Titer Against Homologous Strains in Subjects at Risk/Not at Risk, by Age Sub Group-FAS H3N2 at risk(N=28,40,35,17,26,26,11,14,9)	85 Percentages of subjects Interval 70.0 to 94.0	89 Percentages of subjects Interval 72.0 to 98.0	83 Percentages of subjects Interval 66.0 to 93.0	88 Percentages of subjects Interval 64.0 to 99.0	77 Percentages of subjects Interval 56.0 to 91.0	77 Percentages of subjects Interval 56.0 to 91.0	91 Percentages of subjects Interval 59.0 to 100.0	100 Percentages of subjects Interval 77.0 to 100.0	100 Percentages of subjects Interval 66.0 to 100.0
Comparison of Antibody Responses of TIV Versus Comparator TIV in Terms of Percentage of Subjects Achieving Seroconversion or ≥4-fold Increase in HI Titer Against Homologous Strains in Subjects at Risk/Not at Risk, by Age Sub Group-FAS B at risk(N=28,40,35,17,26,26,11,14,9)	88 Percentages of subjects Interval 73.0 to 96.0	96 Percentages of subjects Interval 82.0 to 100.0	89 Percentages of subjects Interval 73.0 to 97.0	94 Percentages of subjects Interval 71.0 to 100.0	92 Percentages of subjects Interval 75.0 to 99.0	85 Percentages of subjects Interval 65.0 to 96.0	100 Percentages of subjects Interval 72.0 to 100.0	79 Percentages of subjects Interval 49.0 to 95.0	100 Percentages of subjects Interval 66.0 to 100.0

SECONDARY outcome

Timeframe: Day 50

Population: Analysis was done on Full Analysis Set.

The superiority of HI antibody responses of aTIV compared to TIV and comparator TIV assessed in terms of post vaccination GMTs at three weeks after last vaccination against the three homologous vaccine strains, in subjects with a defined set of underlying medical conditions (at risk) and in healthy subjects (not at risk), by age sub group.

Outcome measures

Outcome measures
Measure	Comparator TIV (6 to <36months) n=799 Participants Subjects received two doses of 0.25 mL each, of the licensed trivalent split influenza vaccine (comparator TIV), at Days 1 \& 29	TIV (6 to <36months) n=719 Participants Subjects received two doses of 0.25 mL each, of investigational trivalent split influenza vaccine (TIV), at Days 1 \& 29	TIV (6 to <72 Months) n=814 Participants Subjects received an investigational trivalent split influenza vaccine (TIV), subjects aged between 6 to \<36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 \& 29	aTIV (6 to <36 Months) n=459 Participants Subjects received two doses (Day 1 \& 29) of an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV)	Compartor TIV (6 to <36 Months) n=673 Participants Subjects received two doses (Day 1 \& 29) of a licensed comparator trivalent split influenza vaccine (comparator TIV)	TIV (6 to <36 Months) n=688 Participants Subjects received two doses (Day 1 \& 29) of an investigational trivalent split influenza vaccine (TIV)	aTIV (36 to <72 Months) n=260 Participants Subjects received one dose (Day 1) of investigational MF59-adjuvanted trivalent influenza vaccine (aTIV)	Comparator TIV (36 to <72 Months) n=126 Participants Subjects received one dose (Day 1) of a licensed comparator trivalent split influenza vaccine (comparator TIV)	TIV (36 to <72 Months) n=126 Participants Subjects received one dose (Day 1) of an investigational trivalent split influenza vaccine (TIV)
Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of GMTs Against Homologous Strains, at Risk/Not at Risk, by Age Sub Group-FAS H1N1 norisk(N=718,799,814,459,673,688,259,126,126)	569 Titers Interval 515.0 to 629.0	1509 Titers Interval 1357.0 to 1677.0	422 Titers Interval 382.0 to 466.0	1336 Titers Interval 1166.0 to 1530.0	474 Titers Interval 424.0 to 530.0	365 Titers Interval 326.0 to 407.0	2077 Titers Interval 1815.0 to 2376.0	1413 Titers Interval 1165.0 to 1713.0	813 Titers Interval 670.0 to 986.0
Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of GMTs Against Homologous Strains, at Risk/Not at Risk, by Age Sub Group-FAS H3N2 norisk(N=719,799,814,459,673,688,260,126,126)	1015 Titers Interval 954.0 to 1080.0	1894 Titers Interval 1775.0 to 2022.0	794 Titers Interval 747.0 to 844.0	1851 Titers Interval 1705.0 to 2010.0	905 Titers Interval 845.0 to 968.0	686 Titers Interval 641.0 to 733.0	2343 Titers Interval 2120.0 to 2589.0	1582 Titers Interval 1370.0 to 1826.0	1475 Titers Interval 1278.0 to 1703.0
Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of GMTs Against Homologous Strains, at Risk/Not at Risk, by Age Sub Group-FAS B norisk(N=719,799,814,459,673,688,260,126,126)	164 Titers Interval 151.0 to 178.0	484 Titers Interval 444.0 to 527.0	155 Titers Interval 143.0 to 168.0	545 Titers Interval 487.0 to 608.0	150 Titers Interval 137.0 to 164.0	139 Titers Interval 127.0 to 152.0	432 Titers Interval 383.0 to 487.0	243 Titers Interval 205.0 to 289.0	253 Titers Interval 212.0 to 300.0
Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of GMTs Against Homologous Strains, at Risk/Not at Risk, by Age Sub Group-FAS H1N1 at risk(N=28,40,35,17,26,26,11,14,9)	830 Titers Interval 553.0 to 1244.0	1541 Titers Interval 948.0 to 2504.0	586 Titers Interval 380.0 to 905.0	1277 Titers Interval 674.0 to 2418.0	617 Titers Interval 370.0 to 1028.0	483 Titers Interval 289.0 to 808.0	1982 Titers Interval 929.0 to 4228.0	1478 Titers Interval 756.0 to 2891.0	1028 Titers Interval 445.0 to 2372.0
Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of GMTs Against Homologous Strains, at Risk/Not at Risk, by Age Sub Group-FAS H3N2 at risk(N=28,40,35,17,26,26,11,14,9)	960 Titers Interval 744.0 to 1237.0	2361 Titers Interval 1743.0 to 3197.0	763 Titers Interval 582.0 to 1001.0	2517 Titers Interval 1633.0 to 3881.0	820 Titers Interval 578.0 to 1164.0	705 Titers Interval 496.0 to 1000.0	2197 Titers Interval 1514.0 to 3187.0	1286 Titers Interval 925.0 to 1788.0	929 Titers Interval 616.0 to 1399.0
Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of GMTs Against Homologous Strains, at Risk/Not at Risk, by Age Sub Group-FAS B at risk(N=28,40,35,17,26,26,11,14,9)	152 Titers Interval 104.0 to 222.0	399 Titers Interval 254.0 to 628.0	183 Titers Interval 122.0 to 274.0	508 Titers Interval 274.0 to 939.0	140 Titers Interval 85.0 to 231.0	147 Titers Interval 89.0 to 242.0	319 Titers Interval 170.0 to 596.0	197 Titers Interval 114.0 to 341.0	241 Titers Interval 118.0 to 493.0

SECONDARY outcome

Timeframe: Day 1, Day 50, Day 209

Population: Analysis was done on the FAS Persistence

The HI antibody titers against the heterologous strains following vaccination with either aTIV, licensed comparator or TIV, at three weeks and at six months after vaccination are reported as GMTs.

Outcome measures

Outcome measures
Measure	Comparator TIV (6 to <36months) n=445 Participants Subjects received two doses of 0.25 mL each, of the licensed trivalent split influenza vaccine (comparator TIV), at Days 1 \& 29	TIV (6 to <36months) n=380 Participants Subjects received two doses of 0.25 mL each, of investigational trivalent split influenza vaccine (TIV), at Days 1 \& 29	TIV (6 to <72 Months) n=431 Participants Subjects received an investigational trivalent split influenza vaccine (TIV), subjects aged between 6 to \<36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 \& 29	aTIV (6 to <36 Months) Subjects received two doses (Day 1 \& 29) of an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV)	Compartor TIV (6 to <36 Months) Subjects received two doses (Day 1 \& 29) of a licensed comparator trivalent split influenza vaccine (comparator TIV)	TIV (6 to <36 Months) Subjects received two doses (Day 1 \& 29) of an investigational trivalent split influenza vaccine (TIV)	aTIV (36 to <72 Months) Subjects received one dose (Day 1) of investigational MF59-adjuvanted trivalent influenza vaccine (aTIV)	Comparator TIV (36 to <72 Months) Subjects received one dose (Day 1) of a licensed comparator trivalent split influenza vaccine (comparator TIV)	TIV (36 to <72 Months) Subjects received one dose (Day 1) of an investigational trivalent split influenza vaccine (TIV)
The HI GMTs Against Heterologous Strains, by Vaccine Group (6 to <72 Months Age Group) H1N1/Jersey - Day 1 (N=380,445,430)	9.75 Titers Interval 8.85 to 11.0	10 Titers Interval 9.37 to 11.0	10 Titers Interval 9.07 to 11.0	—	—	—	—	—	—
The HI GMTs Against Heterologous Strains, by Vaccine Group (6 to <72 Months Age Group) H1N1/Jersey - Day 50	29 Titers Interval 26.0 to 33.0	51 Titers Interval 45.0 to 58.0	31 Titers Interval 27.0 to 36.0	—	—	—	—	—	—
The HI GMTs Against Heterologous Strains, by Vaccine Group (6 to <72 Months Age Group) H1N1/Jersey - Day 209	17 Titers Interval 16.0 to 19.0	21 Titers Interval 19.0 to 23.0	18 Titers Interval 16.0 to 20.0	—	—	—	—	—	—
The HI GMTs Against Heterologous Strains, by Vaccine Group (6 to <72 Months Age Group) H3N2/Uruguay - Day 1 (N=380,445,430)	18 Titers Interval 16.0 to 20.0	17 Titers Interval 15.0 to 20.0	17 Titers Interval 15.0 to 19.0	—	—	—	—	—	—
The HI GMTs Against Heterologous Strains, by Vaccine Group (6 to <72 Months Age Group) H3N2/Uruguay - Day 50	88 Titers Interval 79.0 to 98.0	184 Titers Interval 165.0 to 206.0	71 Titers Interval 63.0 to 79.0	—	—	—	—	—	—
The HI GMTs Against Heterologous Strains, by Vaccine Group (6 to <72 Months Age Group) H3N2/Uruguay- Day 209	31 Titers Interval 28.0 to 34.0	42 Titers Interval 37.0 to 47.0	27 Titers Interval 24.0 to 30.0	—	—	—	—	—	—
The HI GMTs Against Heterologous Strains, by Vaccine Group (6 to <72 Months Age Group) B strain - Day 1	5.8 Titers Interval 5.55 to 6.05	5.98 Titers Interval 5.72 to 6.25	5.85 Titers Interval 5.6 to 6.11	—	—	—	—	—	—
The HI GMTs Against Heterologous Strains, by Vaccine Group (6 to <72 Months Age Group) B strain - Day 50	34 Titers Interval 31.0 to 38.0	99 Titers Interval 89.0 to 111.0	35 Titers Interval 31.0 to 39.0	—	—	—	—	—	—
The HI GMTs Against Heterologous Strains, by Vaccine Group (6 to <72 Months Age Group) B strain Day 209	11 Titers Interval 9.86 to 12.0	20 Titers Interval 18.0 to 22.0	11 Titers Interval 9.94 to 12.0	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Day 50, Day 209

Population: Subjects aged 6 through \<72 months of age - Full Analyses Set (FAS) Persistence

The percentage of subjects achieving seroconversion or ≥4 fold increase in HI titers from baseline, against heterologous strains, at three weeks and six months after last vaccination with aTIV or licensed comparator or TIV.

Outcome measures

Outcome measures
Measure	Comparator TIV (6 to <36months) n=445 Participants Subjects received two doses of 0.25 mL each, of the licensed trivalent split influenza vaccine (comparator TIV), at Days 1 \& 29	TIV (6 to <36months) n=380 Participants Subjects received two doses of 0.25 mL each, of investigational trivalent split influenza vaccine (TIV), at Days 1 \& 29	TIV (6 to <72 Months) n=431 Participants Subjects received an investigational trivalent split influenza vaccine (TIV), subjects aged between 6 to \<36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 \& 29	aTIV (6 to <36 Months) Subjects received two doses (Day 1 \& 29) of an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV)	Compartor TIV (6 to <36 Months) Subjects received two doses (Day 1 \& 29) of a licensed comparator trivalent split influenza vaccine (comparator TIV)	TIV (6 to <36 Months) Subjects received two doses (Day 1 \& 29) of an investigational trivalent split influenza vaccine (TIV)	aTIV (36 to <72 Months) Subjects received one dose (Day 1) of investigational MF59-adjuvanted trivalent influenza vaccine (aTIV)	Comparator TIV (36 to <72 Months) Subjects received one dose (Day 1) of a licensed comparator trivalent split influenza vaccine (comparator TIV)	TIV (36 to <72 Months) Subjects received one dose (Day 1) of an investigational trivalent split influenza vaccine (TIV)
Percentage of Subjects Achieving Seroconversion or ≥4 Fold Increase in HI Titers, Against Heterologous Strains H1N1/Jersey, Day 50 (N=380,445,430)	36.85 Percentage of subjects Interval 32.36 to 41.52	53.16 Percentage of subjects Interval 48.0 to 58.26	36.05 Percentage of subjects Interval 31.5 to 40.78	—	—	—	—	—	—
Percentage of Subjects Achieving Seroconversion or ≥4 Fold Increase in HI Titers, Against Heterologous Strains H1N1/Jersey, Day 209 (N=380,445,430)	19.33 Percentage of subjects Interval 15.76 to 23.31	33.95 Percentage of subjects Interval 29.2 to 38.95	20.70 Percentage of subjects Interval 16.96 to 24.84	—	—	—	—	—	—
Percentage of Subjects Achieving Seroconversion or ≥4 Fold Increase in HI Titers, Against Heterologous Strains H3N2/Uruguay, Day 50 (N=380,445,430)	60.9 Percentage of subjects Interval 56.19 to 65.46	91.84 Percentage of subjects Interval 88.62 to 94.39	53.26 Percentage of subjects Interval 48.42 to 58.05	—	—	—	—	—	—
Percentage of Subjects Achieving Seroconversion or ≥4 Fold Increase in HI Titers, Against Heterologous Strains H3N2/Uruguay, Day 209 (N=380,445,430)	23.82 Percentage of subjects Interval 19.94 to 28.06	40.26 Percentage of subjects Interval 35.29 to 45.39	19.07 Percentage of subjects Interval 15.46 to 23.11	—	—	—	—	—	—
Percentage of Subjects Achieving Seroconversion or ≥4 Fold Increase in HI Titers, Against Heterologous Strains B strain, Day 209	13.93 Percentage of subjects Interval 10.85 to 17.5	30.0 Percentage of subjects Interval 25.43 to 34.88	17.63 Percentage of subjects Interval 14.15 to 21.57	—	—	—	—	—	—
Percentage of Subjects Achieving Seroconversion or ≥4 Fold Increase in HI Titers, Against Heterologous Strains B strain, Day 50	53.71 Percentage of subjects Interval 48.95 to 58.41	92.63 Percentage of subjects Interval 89.53 to 95.05	52.90 Percentage of subjects Interval 48.07 to 57.69	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Day 1, Day 29

Population: Analysis was done on the FAS (Persistence).

To demonstrate the GMTs at three weeks after one dose of aTIV are statistically significantly higher to the corresponding response's of comparator TIV and TIV.

Outcome measures

Outcome measures
Measure	Comparator TIV (6 to <36months) n=822 Participants Subjects received two doses of 0.25 mL each, of the licensed trivalent split influenza vaccine (comparator TIV), at Days 1 \& 29	TIV (6 to <36months) n=715 Participants Subjects received two doses of 0.25 mL each, of investigational trivalent split influenza vaccine (TIV), at Days 1 \& 29	TIV (6 to <72 Months) n=820 Participants Subjects received an investigational trivalent split influenza vaccine (TIV), subjects aged between 6 to \<36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 \& 29	aTIV (6 to <36 Months) Subjects received two doses (Day 1 \& 29) of an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV)	Compartor TIV (6 to <36 Months) Subjects received two doses (Day 1 \& 29) of a licensed comparator trivalent split influenza vaccine (comparator TIV)	TIV (6 to <36 Months) Subjects received two doses (Day 1 \& 29) of an investigational trivalent split influenza vaccine (TIV)	aTIV (36 to <72 Months) Subjects received one dose (Day 1) of investigational MF59-adjuvanted trivalent influenza vaccine (aTIV)	Comparator TIV (36 to <72 Months) Subjects received one dose (Day 1) of a licensed comparator trivalent split influenza vaccine (comparator TIV)	TIV (36 to <72 Months) Subjects received one dose (Day 1) of an investigational trivalent split influenza vaccine (TIV)
Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of GMTs Against Homologous Strains, After One Vaccination H1N1- Day 1 (N=714,822,820)	24 Titers Interval 20.0 to 27.0	28 Titers Interval 24.0 to 32.0	27 Titers Interval 23.0 to 31.0	—	—	—	—	—	—
Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of GMTs Against Homologous Strains, After One Vaccination H1N1- Day 29	159 Titers Interval 139.0 to 182.0	647 Titers Interval 562.0 to 745.0	170 Titers Interval 148.0 to 194.0	—	—	—	—	—	—
Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of GMTs Against Homologous Strains, After One Vaccination H3N2 - Day 1	43 Titers Interval 37.0 to 49.0	42 Titers Interval 36.0 to 48.0	43 Titers Interval 38.0 to 50.0	—	—	—	—	—	—
Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of GMTs Against Homologous Strains, After One Vaccination H3N2 - Day 29	558 Titers Interval 517.0 to 602.0	1087 Titers Interval 1004.0 to 1176.0	453 Titers Interval 420.0 to 490.0	—	—	—	—	—	—
Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of GMTs Against Homologous Strains, After One Vaccination B strain Day 1	10 Titers Interval 9.57 to 11.0	10 Titers Interval 9.29 to 11.0	10 Titers Interval 9.34 to 11.0	—	—	—	—	—	—
Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of GMTs Against Homologous Strains, After One Vaccination B strain Day 29	58 Titers Interval 52.0 to 65.0	119 Titers Interval 106.0 to 134.0	61 Titers Interval 54.0 to 68.0	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Day 1 through Day 7 after any vaccination

Population: Analysis was done on solicited safety set i.e all subjects who had received at least one study vaccine and had provided data on post vaccination solicited AEs

The number of subjects reporting any solicited local and systemic adverse events (AEs), following vaccination with aTIV or licensed comparator or TIV.

Outcome measures

Outcome measures
Measure	Comparator TIV (6 to <36months) n=1453 Participants Subjects received two doses of 0.25 mL each, of the licensed trivalent split influenza vaccine (comparator TIV), at Days 1 \& 29	TIV (6 to <36months) n=3082 Participants Subjects received two doses of 0.25 mL each, of investigational trivalent split influenza vaccine (TIV), at Days 1 \& 29	TIV (6 to <72 Months) n=1451 Participants Subjects received an investigational trivalent split influenza vaccine (TIV), subjects aged between 6 to \<36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 \& 29	aTIV (6 to <36 Months) Subjects received two doses (Day 1 \& 29) of an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV)	Compartor TIV (6 to <36 Months) Subjects received two doses (Day 1 \& 29) of a licensed comparator trivalent split influenza vaccine (comparator TIV)	TIV (6 to <36 Months) Subjects received two doses (Day 1 \& 29) of an investigational trivalent split influenza vaccine (TIV)	aTIV (36 to <72 Months) Subjects received one dose (Day 1) of investigational MF59-adjuvanted trivalent influenza vaccine (aTIV)	Comparator TIV (36 to <72 Months) Subjects received one dose (Day 1) of a licensed comparator trivalent split influenza vaccine (comparator TIV)	TIV (36 to <72 Months) Subjects received one dose (Day 1) of an investigational trivalent split influenza vaccine (TIV)
Number of Subjects Reporting Solicited Adverse Events After Vaccination Any local	292 Participants	1082 Participants	311 Participants	—	—	—	—	—	—
Number of Subjects Reporting Solicited Adverse Events After Vaccination Injection site ecchymosis(N=3075,1450,1446)	72 Participants	191 Participants	86 Participants	—	—	—	—	—	—
Number of Subjects Reporting Solicited Adverse Events After Vaccination Injection site induration (N=3075,1450,1446)	62 Participants	258 Participants	67 Participants	—	—	—	—	—	—
Number of Subjects Reporting Solicited Adverse Events After Vaccination Injection site tenderness (N=1495,1025,1012)	70 Participants	152 Participants	78 Participants	—	—	—	—	—	—
Number of Subjects Reporting Solicited Adverse Events After Vaccination Injection site swelling (N=3075,1450,1446)	1450 Participants	217 Participants	1446 Participants	—	—	—	—	—	—
Number of Subjects Reporting Solicited Adverse Events After Vaccination Injection site pain (N=1580,422,429)	422 Participants	1580 Participants	429 Participants	—	—	—	—	—	—
Number of Subjects Reporting Solicited Adverse Events After Vaccination Any systemic	604 Participants	1487 Participants	569 Participants	—	—	—	—	—	—
Number of Subjects Reporting Solicited Adverse Events After Vaccination chills (N=1578,423,428)	23 Participants	154 Participants	18 Participants	—	—	—	—	—	—
Number of Subjects Reporting Solicited Adverse Events After Vaccination Myalgia (N=1578,423,429)	43 Participants	216 Participants	25 Participants	—	—	—	—	—	—
Number of Subjects Reporting Solicited Adverse Events After Vaccination Arthralgia (N=1578,423,429)	20 Participants	125 Participants	16 Participants	—	—	—	—	—	—
Number of Subjects Reporting Solicited Adverse Events After Vaccination Headache (N=1578,423,429)	46 Participants	282 Participants	38 Participants	—	—	—	—	—	—
Number of Subjects Reporting Solicited Adverse Events After Vaccination Fatigue (N=1578,423,430)	43 Participants	204 Participants	31 Participants	—	—	—	—	—	—
Number of Subjects Reporting Solicited Adverse Events After Vaccination Eating Habit (N=3076,1450,1446)	196 Participants	437 Participants	205 Participants	—	—	—	—	—	—
Number of Subjects Reporting Solicited Adverse Events After Vaccination Diarrhea (N=3075,1450,1447)	231 Participants	423 Participants	220 Participants	—	—	—	—	—	—
Number of Subjects Reporting Solicited Adverse Events After Vaccination Irritability (N=1496,1024,1013)	164 Participants	290 Participants	190 Participants	—	—	—	—	—	—
Number of Subjects Reporting Solicited Adverse Events After Vaccination Crying (N=1463,1001,990)	105 Participants	186 Participants	122 Participants	—	—	—	—	—	—
Number of Subjects Reporting Solicited Adverse Events After Vaccination Sleepiness (N=1495,1024,1012)	150 Participants	229 Participants	153 Participants	—	—	—	—	—	—
Number of Subjects Reporting Solicited Adverse Events After Vaccination Vomiting (N=3075,1451,1446)	100 Participants	249 Participants	104 Participants	—	—	—	—	—	—
Number of Subjects Reporting Solicited Adverse Events After Vaccination Fever (≥38°C) (N=3074,1450,1446)	236 Participants	748 Participants	224 Participants	—	—	—	—	—	—
Number of Subjects Reporting Solicited Adverse Events After Vaccination Any other	310 Participants	1047 Participants	317 Participants	—	—	—	—	—	—
Number of Subjects Reporting Solicited Adverse Events After Vaccination Axillary Temperature (≥40°C) (N=3074,1450,1446)	4 Participants	8 Participants	3 Participants	—	—	—	—	—	—
Number of Subjects Reporting Solicited Adverse Events After Vaccination Analgesic Antipyretic Med. used(N=3076,1448,1444)	285 Participants	984 Participants	282 Participants	—	—	—	—	—	—
Number of Subjects Reporting Solicited Adverse Events After Vaccination Injection site erythema (N=3075,1450,1446)	109 Participants	312 Participants	101 Participants	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Day 1 to Day 394

Population: Analysis was done on the safety population i.e all subjects who had received at least one study vaccine and had postvaccination safety data

The number of subjects reporting any unsolicited adverse events (AEs) between Day 1 to Day 50, serious adverse events (SAEs), AE leading to withdrawal (WD), new onset of chronic disease(NOCD), adverse events of special interest following vaccination with aTIV or licensed comparator or TIV throughout the study (Day 1 to Day 394).

Outcome measures

Outcome measures
Measure	Comparator TIV (6 to <36months) n=1474 Participants Subjects received two doses of 0.25 mL each, of the licensed trivalent split influenza vaccine (comparator TIV), at Days 1 \& 29	TIV (6 to <36months) n=3123 Participants Subjects received two doses of 0.25 mL each, of investigational trivalent split influenza vaccine (TIV), at Days 1 \& 29	TIV (6 to <72 Months) n=1477 Participants Subjects received an investigational trivalent split influenza vaccine (TIV), subjects aged between 6 to \<36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 \& 29	aTIV (6 to <36 Months) Subjects received two doses (Day 1 \& 29) of an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV)	Compartor TIV (6 to <36 Months) Subjects received two doses (Day 1 \& 29) of a licensed comparator trivalent split influenza vaccine (comparator TIV)	TIV (6 to <36 Months) Subjects received two doses (Day 1 \& 29) of an investigational trivalent split influenza vaccine (TIV)	aTIV (36 to <72 Months) Subjects received one dose (Day 1) of investigational MF59-adjuvanted trivalent influenza vaccine (aTIV)	Comparator TIV (36 to <72 Months) Subjects received one dose (Day 1) of a licensed comparator trivalent split influenza vaccine (comparator TIV)	TIV (36 to <72 Months) Subjects received one dose (Day 1) of an investigational trivalent split influenza vaccine (TIV)
Number of Subjects Reporting Unsolicited Adverse Events After Vaccination Any AEs (Day 1 to Day 50)	859 Participants	1541 Participants	808 Participants	—	—	—	—	—	—
Number of Subjects Reporting Unsolicited Adverse Events After Vaccination Possibly/probably related AEs(Day 1 to Day 50)	101 Participants	158 Participants	84 Participants	—	—	—	—	—	—
Number of Subjects Reporting Unsolicited Adverse Events After Vaccination Any SAEs	64 Participants	115 Participants	69 Participants	—	—	—	—	—	—
Number of Subjects Reporting Unsolicited Adverse Events After Vaccination Possibly/probably related SAE	0 Participants	1 Participants	0 Participants	—	—	—	—	—	—
Number of Subjects Reporting Unsolicited Adverse Events After Vaccination AE leading to WD	5 Participants	1 Participants	4 Participants	—	—	—	—	—	—
Number of Subjects Reporting Unsolicited Adverse Events After Vaccination NOCD	31 Participants	48 Participants	24 Participants	—	—	—	—	—	—
Number of Subjects Reporting Unsolicited Adverse Events After Vaccination AESI	0 Participants	1 Participants	0 Participants	—	—	—	—	—	—
Number of Subjects Reporting Unsolicited Adverse Events After Vaccination Deaths	3 Participants	1 Participants	4 Participants	—	—	—	—	—	—

Adverse Events

ATIV (6 to <72 Months)

Serious events: 115 serious events

Other events: 2106 other events

Deaths: 0 deaths

TIV (6 to <72 Months)

Serious events: 69 serious events

Other events: 905 other events

Deaths: 0 deaths

Comparator TIV (6 to <72 Months)

Serious events: 64 serious events

Other events: 917 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Posting Director

Novartis Vaccines and Diagnostics

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60