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

A Phase III, Observer-Blind, Randomized, Multi-center Study to Evaluate the Safety, Tolerability, and Immunogenicity of Fluad and Agriflu Compared to the Non-adjuvanted Trivalent Influenza Vaccine Fluzone in Children 6 to < 72 Months of Age

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01346592

Enrollment

6104

Registered

2011-05-03

Start date

2011-04-30

Completion date

2012-07-31

Last updated

2015-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Influenza Disease

Keywords

Adjuvanted Trivalent Subunit Influenza Vaccine, vaccine, influenza, adjuvant, MF-59, pediatric

Brief summary

This Study Aims to Evaluate the 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.

Interventions

BIOLOGICALTrivalent split influenza vaccine (TIV)

BIOLOGICALMF59-adjuvanted trivalent influenza vaccine (aTIV)

BIOLOGICALLicensed comparator trivalent split influenza vaccine (comparator TIV)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

6 Months to 72 Months

Healthy volunteers

Yes

Inclusion criteria

1.Children 6 months to 72 months of age.

Exclusion criteria

Children 1. Who had been hospitalized at the time of enrollment 2. Who had any serious reaction or hypersensitivity to any vaccine component, eggs, or chicken protein 3. Who had known impairment of the immune function 4. Who had fever interfering with normal daily activities at the time of enrollment 5. Who had received licensed vaccines within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to enrollment in the study 6. Concomitant participation in another clinical study 7. Who had surgery planned during the study period that in the investigator's opinion would have interfered with the study visits schedule.

Design outcomes

Primary

Measure	Time frame	Description
Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of Geometric Mean Titers (GMTs) Against Homologous Strains	Day 1, Day 50	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.
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	Day 50	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.
Comparison of Antibody Responses of TIV Versus Comparator TIV in Terms of Geometric Mean Titers (GMTs) Against Homologous Strains (6 to <36 Months)	Day 1, Day 50	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.
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	Day 50	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.

Secondary

Measure	Time frame	Description
The HI GMTs Against Homologous Strains, by Vaccine Group	Day 1, Day 29, Day 50, 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.
Geometric Mean Ratio (GMR) of Post- Versus Pre-vaccination HI Titers Against Homologous Strains	Day 29, Day 50, Day 209	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.
Percentage of Subjects With HI Titers ≥40 Against Homologous Strains, by Vaccine Group	Day 1, Day 29, Day 50, Day 209	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.
Percentage of Subjects Achieving Seroconversion or ≥4 Fold Increase in HI Titers, Against Homologous Strains	Day 29, Day 50, Day 209	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.
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	Day 50	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.
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	Day 50	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.
Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of GMTs Against Homologous Strains (6 to <24 Months)	Day 1, Day 50	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.
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	Day 50	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.
The HI GMTs Against Heterologous Strains, by Vaccine Group (6 to <72 Months Age Group)	Day 1, Day 50, Day 209	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.
Percentage of Subjects Achieving Seroconversion or ≥4 Fold Increase in HI Titers, Against Heterologous Strains	Day 50, Day 209	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.
Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of GMTs Against Homologous Strains, After One Vaccination	Day 1, Day 29	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.
Number of Subjects Reporting Solicited Adverse Events After Vaccination	Day 1 through Day 7 after any vaccination	The number of subjects reporting any solicited local and systemic adverse events (AEs), following vaccination with aTIV or licensed comparator or TIV.
Number of Subjects Reporting Unsolicited Adverse Events After Vaccination	Day 1 to Day 394	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).
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	Day 50	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.
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)	Day 50	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.
Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of GMTs Against Homologous Strains (6 to <72 Months)-FAS	Day 1, Day 50	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.
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	Day 50	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.

Countries

Argentina, Australia, Chile, Philippines, South Africa

Participant flow

Recruitment details

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.

Pre-assignment details

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

Participants by arm

Arm	Count
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	3,136
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	1,478
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	1,486
Total	6,100

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002
Overall Study	Administrative reason	1	0	0
Overall Study	Adverse Event	0	1	0
Overall Study	Death	1	3	4
Overall Study	Inappropriate enrollment	3	1	1
Overall Study	Lost to Follow-up	62	29	29
Overall Study	Protocol Violation	2	1	0
Overall Study	Unable to Classify	7	3	6
Overall Study	Withdrawal by Subject	77	51	38

Baseline characteristics

Characteristic	aTIV (6 to <72 Months)	Comparator TIV (6 to <72 Months)	TIV (6 to <72 Months)	Total
Age, Continuous	37.1 Months STANDARD_DEVIATION 18.6	30.0 Months STANDARD_DEVIATION 16.9	30.2 Months STANDARD_DEVIATION 16.9	33.7 Months STANDARD_DEVIATION 18.1
Sex: Female, Male Female	1545 Participants	745 Participants	731 Participants	3021 Participants
Sex: Female, Male Male	1591 Participants	733 Participants	755 Participants	3079 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk
deaths Total, all-cause mortality	— / —	— / —	— / —
other Total, other adverse events	2,106 / 3,123	905 / 1,477	917 / 1,474
serious Total, serious adverse events	115 / 3,123	69 / 1,477	64 / 1,474

Outcome results

Primary

Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of Geometric Mean Titers (GMTs) Against Homologous Strains

Time frame: 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.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
aTIV (6 to <72 Months)	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)	1537 Titers
aTIV (6 to <72 Months)	Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of Geometric Mean Titers (GMTs) Against Homologous Strains	H3N2 - Day 1	40 Titers
aTIV (6 to <72 Months)	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	492 Titers
aTIV (6 to <72 Months)	Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of Geometric Mean Titers (GMTs) Against Homologous Strains	H3N2 - Day 50	1908 Titers
aTIV (6 to <72 Months)	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	9.87 Titers
aTIV (6 to <72 Months)	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)	28 Titers
Comparator TIV (6 to <72 Months)	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
Comparator TIV (6 to <72 Months)	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
Comparator TIV (6 to <72 Months)	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
Comparator TIV (6 to <72 Months)	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
Comparator TIV (6 to <72 Months)	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
Comparator TIV (6 to <72 Months)	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
TIV (6 to <72 Months)	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)	27 Titers
TIV (6 to <72 Months)	Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of Geometric Mean Titers (GMTs) Against Homologous Strains	H3N2 - Day 1	44 Titers
TIV (6 to <72 Months)	Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of Geometric Mean Titers (GMTs) Against Homologous Strains	H3N2 - Day 50	803 Titers
TIV (6 to <72 Months)	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	157 Titers
TIV (6 to <72 Months)	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)	480 Titers
TIV (6 to <72 Months)	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

97.6% CI: [2.06, 2.9]

97.6% CI: [1.69, 2.1]

97.6% CI: [2.66, 3.54]

97.6% CI: [2.7, 3.8]

97.6% CI: [2.14, 2.65]

97.6% CI: [2.72, 3.62]

Primary

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

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.

Time frame: Day 50

Population: Analysis was done on the PPS.

Arm	Measure	Group	Value (NUMBER)
aTIV (6 to <72 Months)	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	96.5 Percentage of subjects
aTIV (6 to <72 Months)	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)	92.9 Percentage of subjects
aTIV (6 to <72 Months)	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	98 Percentage of subjects
Comparator TIV (6 to <72 Months)	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
Comparator TIV (6 to <72 Months)	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
Comparator TIV (6 to <72 Months)	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
TIV (6 to <72 Months)	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)	79.4 Percentage of subjects
TIV (6 to <72 Months)	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	84.6 Percentage of subjects
TIV (6 to <72 Months)	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	89.4 Percentage of subjects

97.6% CI: [5.48, 12.69]

97.6% CI: [1.58, 6.55]

97.6% CI: [8.72, 14.92]

97.6% CI: [10.3, 18.13]

97.6% CI: [4.47, 10.14]

97.6% CI: [8.11, 14.1]

Primary

Comparison of Antibody Responses of TIV Versus Comparator TIV in Terms of Geometric Mean Titers (GMTs) Against Homologous Strains (6 to <36 Months)

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.

Time frame: Day 1, Day 50

Population: Analysis was done on the PPS.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
aTIV (6 to <72 Months)	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	29 Titers
aTIV (6 to <72 Months)	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	370 Titers
aTIV (6 to <72 Months)	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	698 Titers
aTIV (6 to <72 Months)	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
aTIV (6 to <72 Months)	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	144 Titers
aTIV (6 to <72 Months)	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	23 Titers
Comparator TIV (6 to <72 Months)	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
Comparator TIV (6 to <72 Months)	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
Comparator TIV (6 to <72 Months)	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
Comparator TIV (6 to <72 Months)	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
Comparator TIV (6 to <72 Months)	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
Comparator TIV (6 to <72 Months)	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

97.4% CI: [0.62, 0.93]

97.4% CI: [0.68, 0.86]

97.4% CI: [0.8, 1.11]

Primary

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

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.

Time frame: Day 50

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

Arm	Measure	Group	Value (NUMBER)
aTIV (6 to <72 Months)	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	78.8 Percentage of subjects
aTIV (6 to <72 Months)	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	82.7 Percentage of subjects
aTIV (6 to <72 Months)	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	89.9 Percentage of subjects
Comparator TIV (6 to <72 Months)	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
Comparator TIV (6 to <72 Months)	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
Comparator TIV (6 to <72 Months)	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

97.4% CI: [-10.13, -0.47]

97.4% CI: [-6.16, 0.5]

97.4% CI: [-7.01, 2]

Secondary

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

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.

Time frame: Day 50

Population: Analysis was done on the Per Protocol Set.

Arm	Measure	Group	Value (NUMBER)
aTIV (6 to <72 Months)	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)	100 Percentages of subjects
aTIV (6 to <72 Months)	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)	82 Percentages of subjects
aTIV (6 to <72 Months)	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
aTIV (6 to <72 Months)	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)	93 Percentages of subjects
aTIV (6 to <72 Months)	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)	98 Percentages of subjects
aTIV (6 to <72 Months)	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)	97 Percentages of subjects
Comparator TIV (6 to <72 Months)	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
Comparator TIV (6 to <72 Months)	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
Comparator TIV (6 to <72 Months)	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
Comparator TIV (6 to <72 Months)	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
Comparator TIV (6 to <72 Months)	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
Comparator TIV (6 to <72 Months)	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
TIV (6 to <72 Months)	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)	84 Percentages of subjects
TIV (6 to <72 Months)	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)	81 Percentages of subjects
TIV (6 to <72 Months)	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)	88 Percentages of subjects
TIV (6 to <72 Months)	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)	90 Percentages of subjects
TIV (6 to <72 Months)	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)	85 Percentages of subjects
TIV (6 to <72 Months)	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)	79 Percentages of subjects
aTIV (6 to <36 Months)	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)	92 Percentages of subjects
aTIV (6 to <36 Months)	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)	95 Percentages of subjects
aTIV (6 to <36 Months)	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)	100 Percentages of subjects
aTIV (6 to <36 Months)	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)	98 Percentages of subjects
aTIV (6 to <36 Months)	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)	83 Percentages of subjects
aTIV (6 to <36 Months)	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)	98 Percentages of subjects
Compartor TIV (6 to <36 Months)	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)	78 Percentages of subjects
Compartor TIV (6 to <36 Months)	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)	87 Percentages of subjects
Compartor TIV (6 to <36 Months)	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)	85 Percentages of subjects
Compartor TIV (6 to <36 Months)	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)	91 Percentages of subjects
Compartor TIV (6 to <36 Months)	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)	84 Percentages of subjects
Compartor TIV (6 to <36 Months)	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
TIV (6 to <36 Months)	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)	83 Percentages of subjects
TIV (6 to <36 Months)	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)	84 Percentages of subjects
TIV (6 to <36 Months)	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)	78 Percentages of subjects
TIV (6 to <36 Months)	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)	90 Percentages of subjects
TIV (6 to <36 Months)	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)	89 Percentages of subjects
TIV (6 to <36 Months)	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)	74 Percentages of subjects
aTIV (36 to <72 Months)	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)	70 Percentages of subjects
aTIV (36 to <72 Months)	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)	94 Percentages of subjects
aTIV (36 to <72 Months)	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)	90 Percentages of subjects
aTIV (36 to <72 Months)	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)	100 Percentages of subjects
aTIV (36 to <72 Months)	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)	98 Percentages of subjects
aTIV (36 to <72 Months)	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)	91 Percentages of subjects
Comparator TIV (36 to <72 Months)	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)	75 Percentages of subjects
Comparator TIV (36 to <72 Months)	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)	75 Percentages of subjects
Comparator TIV (36 to <72 Months)	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)	90 Percentages of subjects
Comparator TIV (36 to <72 Months)	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)	100 Percentages of subjects
Comparator TIV (36 to <72 Months)	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)	88 Percentages of subjects
Comparator TIV (36 to <72 Months)	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)	90 Percentages of subjects
TIV (36 to <72 Months)	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)	100 Percentages of subjects
TIV (36 to <72 Months)	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)	94 Percentages of subjects
TIV (36 to <72 Months)	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)	86 Percentages of subjects
TIV (36 to <72 Months)	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)	100 Percentages of subjects
TIV (36 to <72 Months)	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)	83 Percentages of subjects
TIV (36 to <72 Months)	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)	71 Percentages of subjects

Comparison: No risk subjects.95% CI: [10.7, 17.7]

Comparison: No risk subjects.95% CI: [5.4, 12]

Comparison: No risk subjects.95% CI: [1.8, 6.6]

Comparison: No risk subjects.95% CI: [9.2, 14.8]

Comparison: At risk subjects.95% CI: [-24, 18.7]

Comparison: At risk subjects.95% CI: [-21.2, 18.9]

Comparison: At risk subjects.95% CI: [-1.6, 29.5]

Comparison: No risk subjects.95% CI: [4.6, 9.8]

Comparison: No risk subjects95% CI: [10.7, 16.4]

Comparison: At risk subjects.95% CI: [-26.1, 19.2]

Comparison: At risk subjects.95% CI: [-17.5, 27.3]

Comparison: At risk subjects.95% CI: [-4.4, 29.2]

Comparison: No risk subjects.95% CI: [7.2, 14.5]

Comparison: No risk subjects.95% CI: [2.6, 7.5]

Comparison: No risk subjects.95% CI: [9.5, 15.8]

Comparison: At risk subjects.95% CI: [-24.7, 26.3]

Comparison: At risk subjects.95% CI: [-26.9, 30.3]

Comparison: At risk subjects.95% CI: [-16.9, 27.1]

Comparison: No risk subjects.95% CI: [12.4, 20.2]

Comparison: No risk subjects95% CI: [5.1, 10.5]

Comparison: No risk subjects95% CI: [12, 18.6]

Comparison: At risk subjects95% CI: [-27.1, 25.5]

Comparison: At risk subjects95% CI: [-23.5, 37.2]

Comparison: At risk subjects.95% CI: [-10.7, 38]

Comparison: No risk subjects.95% CI: [-4.2, 10.4]

Comparison: No risk subjects.95% CI: [-1.2, 11.9]

Comparison: No risk subjects.95% CI: [2.9, 15.1]

Comparison: At risk subjects.95% CI: [-42.4, 32]

Comparison: At risk subjects.95% CI: [-41.2, 16.6]

Comparison: At risk subjects.95% CI: [-7.1, 53.9]

Comparison: No risk subjects.95% CI: [1, 16.4]

Comparison: No risk subjects.95% CI: [2, 16.1]

Comparison: No risk subjects.95% CI: [0, 10]

Comparison: At risk subjects.95% CI: [-42.1, 43]

Comparison: At risk subjects95% CI: [-41.5, 28.7]

Comparison: At risk subjects.95% CI: [-29, 36.8]

Secondary

Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of GMTs Against Homologous Strains (6 to <24 Months)

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.

Time frame: 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.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
aTIV (6 to <72 Months)	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	616 Titers
aTIV (6 to <72 Months)	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
aTIV (6 to <72 Months)	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	7.75 Titers
aTIV (6 to <72 Months)	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	1080 Titers
aTIV (6 to <72 Months)	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	1709 Titers
aTIV (6 to <72 Months)	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	12 Titers
Comparator TIV (6 to <72 Months)	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
Comparator TIV (6 to <72 Months)	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
Comparator TIV (6 to <72 Months)	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
Comparator TIV (6 to <72 Months)	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
Comparator TIV (6 to <72 Months)	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
Comparator TIV (6 to <72 Months)	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
TIV (6 to <72 Months)	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	112 Titers
TIV (6 to <72 Months)	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	12 Titers
TIV (6 to <72 Months)	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	205 Titers
TIV (6 to <72 Months)	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	17 Titers
TIV (6 to <72 Months)	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	552 Titers
TIV (6 to <72 Months)	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	7.92 Titers

Comparison: Superiority was concluded if the lower limit of the confidence interval for the day 50 vaccine group GMT ratios for at least 2 homologous strains was \>1.5.95% CI: [2.86, 4.6]

Comparison: superiority was concluded if the lower limit of the confidence interval of the day 50 vaccine group GMT ratios for at least 2 homologous strains was \>1.595% CI: [1.96, 2.59]

Comparison: superiority was concluded if the lower limit of the confidence interval of the day 50 vaccine group GMT ratios for at least 2 homologous strains was \>1.595% CI: [3.86, 5.59]

Comparison: superiority was concluded if the lower limit of the confidence interval of the day 50 vaccine group GMT ratios for at least 2 homologous strains was \>1.595% CI: [4.16, 6.7]

Comparison: superiority was concluded if the lower limit of the confidence interval of the day 50 vaccine group GMT ratios for at least 2 homologous strains was \>1.595% CI: [2.69, 3.56]

Comparison: superiority was concluded if the lower limit of the confidence interval of the day 50 vaccine group GMT ratios for at least 2 homologous strains was \>1.595% CI: [3.86, 5.59]

Secondary

Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of GMTs Against Homologous Strains (6 to <72 Months)-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.

Time frame: Day 1, Day 50

Population: Analysis was done on the FAS

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
aTIV (6 to <72 Months)	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	1909 Titers
aTIV (6 to <72 Months)	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	480 Titers
aTIV (6 to <72 Months)	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)	1519 Titers
aTIV (6 to <72 Months)	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	41 Titers
aTIV (6 to <72 Months)	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	9.97 Titers
aTIV (6 to <72 Months)	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)	29 Titers
Comparator TIV (6 to <72 Months)	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
Comparator TIV (6 to <72 Months)	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
Comparator TIV (6 to <72 Months)	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
Comparator TIV (6 to <72 Months)	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
Comparator TIV (6 to <72 Months)	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
Comparator TIV (6 to <72 Months)	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
TIV (6 to <72 Months)	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)	473 Titers
TIV (6 to <72 Months)	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	156 Titers
TIV (6 to <72 Months)	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
TIV (6 to <72 Months)	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	44 Titers
TIV (6 to <72 Months)	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	796 Titers
TIV (6 to <72 Months)	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)	27 Titers

Comparison: superiority was concluded if the lower limit of the confidence interval of the day 50 vaccine group GMT ratios for at least 2 homologous strains was \>1.595% CI: [2.07, 2.75]

Comparison: superiority was concluded if the lower limit of the confidence interval of the day 50 vaccine group GMT ratios for at least 2 homologous strains was \>1.595% CI: [1.72, 2.06]

Comparison: superiority was concluded if the lower limit of the confidence interval of the day 50 vaccine group GMT ratios for at least 2 homologous strains was \>1.595% CI: [2.6, 3.3]

Comparison: superiority was concluded if the lower limit of the confidence interval of the day 50 vaccine group GMT ratios for at least 2 homologous strains was \>1.595% CI: [2.79, 3.71]

Comparison: superiority was concluded if the lower limit of the confidence interval of the day 50 vaccine group GMT ratios for at least 2 homologous strains was \>1.595% CI: [2.19, 2.62]

Comparison: superiority was concluded if the lower limit of the confidence interval of the day 50 vaccine group GMT ratios for at least 2 homologous strains was \>1.595% CI: [2.73, 3.47]

Secondary

Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of GMTs Against Homologous Strains, After One Vaccination

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.

Time frame: Day 1, Day 29

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

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
aTIV (6 to <72 Months)	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
aTIV (6 to <72 Months)	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)	28 Titers
aTIV (6 to <72 Months)	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	119 Titers
aTIV (6 to <72 Months)	Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of GMTs Against Homologous Strains, After One Vaccination	H3N2 - Day 1	42 Titers
aTIV (6 to <72 Months)	Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of GMTs Against Homologous Strains, After One Vaccination	H1N1- Day 29	647 Titers
aTIV (6 to <72 Months)	Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of GMTs Against Homologous Strains, After One Vaccination	H3N2 - Day 29	1087 Titers
Comparator TIV (6 to <72 Months)	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
Comparator TIV (6 to <72 Months)	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
Comparator TIV (6 to <72 Months)	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
Comparator TIV (6 to <72 Months)	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
Comparator TIV (6 to <72 Months)	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
Comparator TIV (6 to <72 Months)	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
TIV (6 to <72 Months)	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	61 Titers
TIV (6 to <72 Months)	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)	27 Titers
TIV (6 to <72 Months)	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
TIV (6 to <72 Months)	Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of GMTs Against Homologous Strains, After One Vaccination	H3N2 - Day 29	453 Titers
TIV (6 to <72 Months)	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
TIV (6 to <72 Months)	Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of GMTs Against Homologous Strains, After One Vaccination	H1N1- Day 29	170 Titers

Comparison: GMTs were considered to be statistically significantly higher if the lower bound of the 95% confidence interval around the vaccine group ratio was \>1.095% CI: [3.34, 4.95]

Comparison: statistically significantly greater response was concluded if the lower bound of the 95% confidence interval around the vaccine group ratio is \>1.095% CI: [1.74, 2.18]

Comparison: statistically significantly greater response was concluded if the lower bound of the 95% CI around the vaccine group ratio was \>1.095% CI: [1.73, 2.39]

Comparison: statistically significantly greater response was concluded if the lower bound of the 95% CI around the vaccine group ratio was \>1.095% CI: [3.14, 4.64]

Comparison: statistically significantly greater response was concluded if the lower bound of the 95% CI around the vaccine group ratio was \>1.095% CI: [2.15, 2.68]

Comparison: statistically significantly greater response was concluded if the lower bound of the 95% CI around the vaccine group ratio was \>1.095% CI: [1.65, 2.29]

Secondary

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

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.

Time frame: Day 50

Population: Analysis was done on Full Analysis Set.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
aTIV (6 to <72 Months)	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)	2361 Titers
aTIV (6 to <72 Months)	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)	1541 Titers
aTIV (6 to <72 Months)	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)	1509 Titers
aTIV (6 to <72 Months)	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)	399 Titers
aTIV (6 to <72 Months)	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)	1894 Titers
aTIV (6 to <72 Months)	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)	484 Titers
Comparator TIV (6 to <72 Months)	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
Comparator TIV (6 to <72 Months)	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
Comparator TIV (6 to <72 Months)	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
Comparator TIV (6 to <72 Months)	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
Comparator TIV (6 to <72 Months)	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
Comparator TIV (6 to <72 Months)	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
TIV (6 to <72 Months)	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)	422 Titers
TIV (6 to <72 Months)	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)	586 Titers
TIV (6 to <72 Months)	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)	794 Titers
TIV (6 to <72 Months)	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)	183 Titers
TIV (6 to <72 Months)	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)	155 Titers
TIV (6 to <72 Months)	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)	763 Titers
aTIV (6 to <36 Months)	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)	1336 Titers
aTIV (6 to <36 Months)	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)	1851 Titers
aTIV (6 to <36 Months)	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)	508 Titers
aTIV (6 to <36 Months)	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)	2517 Titers
aTIV (6 to <36 Months)	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)	1277 Titers
aTIV (6 to <36 Months)	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)	545 Titers
Compartor TIV (6 to <36 Months)	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)	820 Titers
Compartor TIV (6 to <36 Months)	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)	474 Titers
Compartor TIV (6 to <36 Months)	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)	905 Titers
Compartor TIV (6 to <36 Months)	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)	150 Titers
Compartor TIV (6 to <36 Months)	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)	617 Titers
Compartor TIV (6 to <36 Months)	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)	140 Titers
TIV (6 to <36 Months)	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)	147 Titers
TIV (6 to <36 Months)	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)	705 Titers
TIV (6 to <36 Months)	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)	686 Titers
TIV (6 to <36 Months)	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)	365 Titers
TIV (6 to <36 Months)	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)	139 Titers
TIV (6 to <36 Months)	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)	483 Titers
aTIV (36 to <72 Months)	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)	432 Titers
aTIV (36 to <72 Months)	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)	319 Titers
aTIV (36 to <72 Months)	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)	1982 Titers
aTIV (36 to <72 Months)	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)	2343 Titers
aTIV (36 to <72 Months)	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)	2197 Titers
aTIV (36 to <72 Months)	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)	2077 Titers
Comparator TIV (36 to <72 Months)	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)	1286 Titers
Comparator TIV (36 to <72 Months)	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)	1413 Titers
Comparator TIV (36 to <72 Months)	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)	197 Titers
Comparator TIV (36 to <72 Months)	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)	1582 Titers
Comparator TIV (36 to <72 Months)	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)	243 Titers
Comparator TIV (36 to <72 Months)	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)	1478 Titers
TIV (36 to <72 Months)	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)	813 Titers
TIV (36 to <72 Months)	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)	253 Titers
TIV (36 to <72 Months)	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)	929 Titers
TIV (36 to <72 Months)	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)	241 Titers
TIV (36 to <72 Months)	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)	1475 Titers
TIV (36 to <72 Months)	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)	1028 Titers

Comparison: No risk subjects.95% CI: [1.91, 2.76]

Comparison: No risk subjects.95% CI: [1.35, 1.89]

Comparison: No risk subjects.95% CI: [2.57, 3.31]

Comparison: At risk subjects.95% CI: [0.6, 3.93]

Comparison: At risk subjects.95% CI: [0.89, 4.61]

Comparison: At risk subjects.95% CI: [1.34, 4.67]

Comparison: No risk subjects.95% CI: [2.77, 4.01]

Comparison: No risk subjects95% CI: [1.75, 2.45]

Comparison: No risk subjects95% CI: [2.72, 3.49]

Comparison: At risk subjects.95% CI: [0.65, 4.5]

Comparison: At risk subjects.95% CI: [1.38, 7.51]

Comparison: At risk subjects.95% CI: [1.1, 3.98]

Comparison: No risk subjects.95% CI: [2.1, 3.21]

Comparison: No risk subjects.95% CI: [1.71, 2.52]

Comparison: No risk subjects.95% CI: [3.22, 4.33]

Comparison: At risk subjects.95% CI: [0.45, 4.4]

Comparison: At risk subjects.95% CI: [0.94, 8.66]

Comparison: At risk subjects.95% CI: [0.45, 4.4]

Comparison: No risk subjects.95% CI: [2.97, 4.54]

Comparison: No risk subjects.95% CI: [2.29, 3.37]

Comparison: No risk subjects.95% CI: [3.46, 4.65]

Comparison: At risk subjects.95% CI: [0.45, 4.4]

Comparison: At risk subjects.95% CI: [1.43, 13]

Comparison: At risk subjects.95% CI: [1.67, 8.15]

Comparison: No risk subjects.95% CI: [0.89, 2.04]

Comparison: No risk subjects.95% CI: [1.14, 2.22]

Comparison: No risk subjects.95% CI: [1.3, 2.15]

Comparison: At risk subjects.95% CI: [0.29, 10]

Comparison: At risk subjects.95% CI: [0.33, 4.01]

Comparison: At risk subjects.95% CI: [0.53, 3.94]

Comparison: No risk subjects95% CI: [1.48, 3.39]

Comparison: No risk subjects.95% CI: [1.26, 2.46]

Comparison: No risk subjects95% CI: [1.24, 2.04]

Comparison: At risk subjects.95% CI: [0.34, 18]

Comparison: At risk subjects.95% CI: [0.49, 7.92]

Comparison: At risk subjects.95% CI: [0.23, 2.16]

Secondary

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

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.

Time frame: Day 50

Population: Analysis was done on the PPS.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
aTIV (6 to <72 Months)	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)	492 Titers
aTIV (6 to <72 Months)	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)	495 Titers
aTIV (6 to <72 Months)	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)	2306 Titers
aTIV (6 to <72 Months)	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)	1897 Titers
aTIV (6 to <72 Months)	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)	1516 Titers
aTIV (6 to <72 Months)	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)	1706 Titers
Comparator TIV (6 to <72 Months)	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
Comparator TIV (6 to <72 Months)	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
Comparator TIV (6 to <72 Months)	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
Comparator TIV (6 to <72 Months)	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
Comparator TIV (6 to <72 Months)	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
Comparator TIV (6 to <72 Months)	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
TIV (6 to <72 Months)	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)	631 Titers
TIV (6 to <72 Months)	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)	431 Titers
TIV (6 to <72 Months)	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)	157 Titers
TIV (6 to <72 Months)	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)	804 Titers
TIV (6 to <72 Months)	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)	179 Titers
TIV (6 to <72 Months)	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)	709 Titers
aTIV (6 to <36 Months)	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)	1863 Titers
aTIV (6 to <36 Months)	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)	559 Titers
aTIV (6 to <36 Months)	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)	1414 Titers
aTIV (6 to <36 Months)	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)	2323 Titers
aTIV (6 to <36 Months)	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)	694 Titers
aTIV (6 to <36 Months)	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)	1341 Titers
Compartor TIV (6 to <36 Months)	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)	794 Titers
Compartor TIV (6 to <36 Months)	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)	478 Titers
Compartor TIV (6 to <36 Months)	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)	912 Titers
Compartor TIV (6 to <36 Months)	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)	149 Titers
Compartor TIV (6 to <36 Months)	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)	603 Titers
Compartor TIV (6 to <36 Months)	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)	125 Titers
TIV (6 to <36 Months)	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)	141 Titers
TIV (6 to <36 Months)	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)	132 Titers
TIV (6 to <36 Months)	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)	519 Titers
TIV (6 to <36 Months)	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)	665 Titers
TIV (6 to <36 Months)	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)	366 Titers
TIV (6 to <36 Months)	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)	695 Titers
aTIV (36 to <72 Months)	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)	365 Titers
aTIV (36 to <72 Months)	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)	2311 Titers
aTIV (36 to <72 Months)	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)	2319 Titers
aTIV (36 to <72 Months)	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)	431 Titers
aTIV (36 to <72 Months)	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)	2111 Titers
aTIV (36 to <72 Months)	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)	2187 Titers
Comparator TIV (36 to <72 Months)	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)	226 Titers
Comparator TIV (36 to <72 Months)	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)	1526 Titers
Comparator TIV (36 to <72 Months)	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)	1306 Titers
Comparator TIV (36 to <72 Months)	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)	1241 Titers
Comparator TIV (36 to <72 Months)	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)	1365 Titers
Comparator TIV (36 to <72 Months)	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)	200 Titers
TIV (36 to <72 Months)	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)	1030 Titers
TIV (36 to <72 Months)	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)	1497 Titers
TIV (36 to <72 Months)	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)	312 Titers
TIV (36 to <72 Months)	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)	826 Titers
TIV (36 to <72 Months)	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)	879 Titers
TIV (36 to <72 Months)	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)	254 Titers

Comparison: No risk subjects.95% CI: [2.3, 3.12]

Comparison: No risk subjects.95% CI: [1.7, 2.05]

Comparison: No risk subjects.95% CI: [2.68, 3.44]

Comparison: At risk subjects.95% CI: [1.11, 4.42]

Comparison: At risk subjects.95% CI: [1.61, 3.72]

Comparison: At risk subjects95% CI: [1.88, 6.34]

Comparison: No risk subjects.95% CI: [3.03, 4.1]

Comparison: No risk subjects.95% CI: [2.15, 2.59]

Comparison: No risk subjects.95% CI: [2.78, 3.56]

Comparison: At risk subjects.95% CI: [1.28, 5.68]

Comparison: At risk subjects.95% CI: [2.09, 5.06]

Comparison: At risk subjects.95% CI: [1.44, 5.3]

Comparison: No risk subjects.95% CI: [2.34, 3.37]

Comparison: No risk subjects.95% CI: [1.83, 2.28]

Comparison: No risk subjects95% CI: [3.22, 4.34]

Comparison: At risk subjects.95% CI: [0.92, 6]

Comparison: At risk subjects.95% CI: [1.57, 5.45]

Comparison: At risk subjects95% CI: [2.52, 12]

Comparison: No risk subjects.95% CI: [3.05, 4.39]

Comparison: No risk subjects95% CI: [2.4, 2.99]

Comparison: No risk subjects.95% CI: [3.42, 4.61]

Comparison: At risk subjects.95% CI: [1.02, 7.31]

Comparison: At risk subjects.95% CI: [1.85, 6.62]

Comparison: At risk subjects.95% CI: [2.32, 12]

Comparison: No risk subjects.95% CI: [1.21, 1.97]

Comparison: No risk subjects95% CI: [1.26, 1.82]

Comparison: No risk subjects95% CI: [1.52, 2.38]

Comparison: At risk subjects95% CI: [0.57, 5.4]

Comparison: At risk subjects95% CI: [1.09, 2.89]

Comparison: At risk subjects95% CI: [0.73, 4.54]

Comparison: No risk subjects95% CI: [1.89, 3.05]

Comparison: No risk subjects.95% CI: [1.29, 1.85]

Comparison: No risk subjects95% CI: [1.36, 2.11]

Comparison: At risk subjects.95% CI: [0.58, 7.71]

Comparison: At risk subjects95% CI: [1.61, 4.89]

Comparison: At risk subjects95% CI: [0.37, 3.67]

Secondary

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

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.

Time frame: Day 50

Population: Analysis was done on the FAS

Arm	Measure	Group	Value (NUMBER)
aTIV (6 to <72 Months)	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	96.4 Percentage of subjects
aTIV (6 to <72 Months)	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	92.8 Percentage of subjects
aTIV (6 to <72 Months)	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	97.5 Percentage of subjects
Comparator TIV (6 to <72 Months)	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
Comparator TIV (6 to <72 Months)	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
Comparator TIV (6 to <72 Months)	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
TIV (6 to <72 Months)	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	84.5 Percentage of subjects
TIV (6 to <72 Months)	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	89.8 Percentage of subjects
TIV (6 to <72 Months)	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	78.8 Percentage of subjects

Comparison: superiority was concluded if the lower limit of the confidence interval of day 50 vaccine group difference,for at least 2 homologous strains, was \>10%95% CI: [6.3, 12.4]

Comparison: superiority was concluded if the lower limit of the confidence interval of day 50 vaccine group difference,for at least 2 homologous strains, was \>10%95% CI: [1.8, 5.9]

Comparison: superiority was concluded if the lower limit of the confidence interval of day 50 vaccine group difference,for at least 2 homologous strains, was \>10%95% CI: [8.1, 13.3]

Comparison: superiority was concluded if the lower limit of the confidence interval of day 50 vaccine group difference,for at least 2 homologous strains, was \>10%95% CI: [11.1, 17.7]

Comparison: superiority was concluded if the lower bound of 95% CI of day 50 vaccine group difference,for at least 2 homologous strains, was \>10%95% CI: [4.5, 9.1]

Comparison: superiority was concluded if the lower limit of the confidence interval of day 50 vaccine group difference,for at least 2 homologous strains, was \>10%95% CI: [8.3, 13.4]

Secondary

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)

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.

Time frame: Day 50

Population: Analysis was done on the FAS

Arm	Measure	Group	Value (NUMBER)
aTIV (6 to <72 Months)	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	98.1 Percentage of subjects
aTIV (6 to <72 Months)	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	98.1 Percentage of subjects
aTIV (6 to <72 Months)	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	95.5 Percentage of subjects
Comparator TIV (6 to <72 Months)	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
Comparator TIV (6 to <72 Months)	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
Comparator TIV (6 to <72 Months)	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
TIV (6 to <72 Months)	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	92.5 Percentage of subjects
TIV (6 to <72 Months)	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	77.8 Percentage of subjects
TIV (6 to <72 Months)	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	79.3 Percentage of subjects

Comparison: superiority was concluded if the lower limit of the confidence interval of day 50 vaccine group difference,for at least 2 homologous strains, was \>10%95% CI: [6.1, 14.7]

Comparison: superiority was concluded if the lower limit of the confidence interval of day 50 vaccine group difference,for at least 2 homologous strains, was \>10%95% CI: [-0.12, 5.1]

Comparison: superiority was concluded if the lower limit of the confidence interval of day 50 vaccine group difference,for at least 2 homologous strains, was \>10%95% CI: [8.9, 16.7]

Comparison: superiority was concluded if the lower limit of the confidence interval of day 50 vaccine group difference,for at least 2 homologous strains, was \>10%95% CI: [12.9, 22.6]

Comparison: superiority was concluded if the lower limit of the confidence interval of day 50 vaccine group difference,for at least 2 homologous strains, was \>10%95% CI: [2.5, 8.7]

Comparison: superiority was concluded if the lower limit of the confidence interval of day 50 vaccine group difference,for at least 2 homologous strains, was \>10%95% CI: [14.4, 23.1]

Secondary

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

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.

Time frame: Day 50

Population: Analysis was done on the Full Analysis Set.

Arm	Measure	Group	Value (NUMBER)
aTIV (6 to <72 Months)	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)	79 Percentages of subjects
aTIV (6 to <72 Months)	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)	97 Percentages of subjects
aTIV (6 to <72 Months)	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)	93 Percentages of subjects
aTIV (6 to <72 Months)	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)	97 Percentages of subjects
aTIV (6 to <72 Months)	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)	96 Percentages of subjects
aTIV (6 to <72 Months)	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)	89 Percentages of subjects
Comparator TIV (6 to <72 Months)	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
Comparator TIV (6 to <72 Months)	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
Comparator TIV (6 to <72 Months)	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
Comparator TIV (6 to <72 Months)	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
Comparator TIV (6 to <72 Months)	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
Comparator TIV (6 to <72 Months)	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
TIV (6 to <72 Months)	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)	83 Percentages of subjects
TIV (6 to <72 Months)	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)	79 Percentages of subjects
TIV (6 to <72 Months)	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
TIV (6 to <72 Months)	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)	84 Percentages of subjects
TIV (6 to <72 Months)	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)	90 Percentages of subjects
TIV (6 to <72 Months)	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)	89 Percentages of subjects
aTIV (6 to <36 Months)	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)	98 Percentages of subjects
aTIV (6 to <36 Months)	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)	88 Percentages of subjects
aTIV (6 to <36 Months)	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)	82 Percentages of subjects
aTIV (6 to <36 Months)	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)	94 Percentages of subjects
aTIV (6 to <36 Months)	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)	95 Percentages of subjects
aTIV (6 to <36 Months)	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)	98 Percentages of subjects
Compartor TIV (6 to <36 Months)	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)	77 Percentages of subjects
Compartor TIV (6 to <36 Months)	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)	83 Percentages of subjects
Compartor TIV (6 to <36 Months)	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
Compartor TIV (6 to <36 Months)	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)	85 Percentages of subjects
Compartor TIV (6 to <36 Months)	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)	85 Percentages of subjects
Compartor TIV (6 to <36 Months)	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)	92 Percentages of subjects
TIV (6 to <36 Months)	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)	77 Percentages of subjects
TIV (6 to <36 Months)	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)	83 Percentages of subjects
TIV (6 to <36 Months)	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)	78 Percentages of subjects
TIV (6 to <36 Months)	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)	85 Percentages of subjects
TIV (6 to <36 Months)	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)	85 Percentages of subjects
TIV (6 to <36 Months)	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)	91 Percentages of subjects
aTIV (36 to <72 Months)	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)	97 Percentages of subjects
aTIV (36 to <72 Months)	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)	91 Percentages of subjects
aTIV (36 to <72 Months)	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)	95 Percentages of subjects
aTIV (36 to <72 Months)	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)	91 Percentages of subjects
aTIV (36 to <72 Months)	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)	100 Percentages of subjects
aTIV (36 to <72 Months)	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)	73 Percentages of subjects
Comparator TIV (36 to <72 Months)	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)	91 Percentages of subjects
Comparator TIV (36 to <72 Months)	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)	91 Percentages of subjects
Comparator TIV (36 to <72 Months)	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)	89 Percentages of subjects
Comparator TIV (36 to <72 Months)	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)	100 Percentages of subjects
Comparator TIV (36 to <72 Months)	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)	79 Percentages of subjects
Comparator TIV (36 to <72 Months)	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)	79 Percentages of subjects
TIV (36 to <72 Months)	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)	87 Percentages of subjects
TIV (36 to <72 Months)	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)	81 Percentages of subjects
TIV (36 to <72 Months)	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)	94 Percentages of subjects
TIV (36 to <72 Months)	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)	78 Percentages of subjects
TIV (36 to <72 Months)	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)	100 Percentages of subjects
TIV (36 to <72 Months)	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)	100 Percentages of subjects

Comparison: No risk subjects.95% CI: [6.4, 12.8]

Comparison: No risk subjects.95% CI: [1.8, 6.4]

Comparison: No risk subjects.95% CI: [8.6, 13.9]

Comparison: At risk subjects.95% CI: [-24.7, 14.9]

Comparison: At risk subjects.95% CI: [-14.4, 20.7]

Comparison: At risk subjects.95% CI: [-6.8, 23.4]

Comparison: No risk subjects.95% CI: [11.3, 18.1]

Comparison: No risk subjects.95% CI: [4.2, 9.1]

Comparison: No risk subjects.95% CI: [10.5, 16.1]

Comparison: At risk subjects95% CI: [-25.3, 15.4]

Comparison: At risk subjects.95% CI: [-12.7, 24.2]

Comparison: At risk subjects.95% CI: [-7.8, 23.2]

Comparison: No risk subjects.95% CI: [8.2, 15.3]

Comparison: No risk subjects.95% CI: [2.5, 7.4]

Comparison: No risk subjects.95% CI: [9.2, 15.3]

Comparison: At risk subjects.95% CI: [-28.5, 20.2]

Comparison: At risk subjects.95% CI: [-14.9, 33.5]

Comparison: At risk subjects.95% CI: [-20.7, 19.7]

Comparison: No risk subjects.95% CI: [12.6, 20.1]

Comparison: No risk subjects95% CI: [4.6, 9.8]

Comparison: No risk subjects.95% CI: [11.9, 18.3]

Comparison: At risk subjects.95% CI: [-28.5, 20.2]

Comparison: At risk subjects.95% CI: [-14.9, 33.5]

Comparison: At risk subjects.95% CI: [-14, 29.3]

Comparison: No risk subjects.95% CI: [-3.8, 9.5]

Comparison: No risk subjects.95% CI: [-1.8, 10]

Comparison: No risk subjects.95% CI: [1.5, 12.5]

Comparison: At risk subjects.95% CI: [-40.7, 27.9]

Comparison: At risk subjects.95% CI: [-38.4, 14.3]

Comparison: At risk subjects.95% CI: [-7.9, 48.1]

Comparison: No risk subjects.95% CI: [3, 18.5]

Comparison: No risk subjects.95% CI: [2.2, 15.6]

Comparison: No risk subjects.95% CI: [0, 9.6]

Comparison: At risk subjects.95% CI: [-41.7, 35]

Comparison: At risk subjects.95% CI: [-38.6, 23.4]

Comparison: At risk subjects.95% CI: [-26.9, 31]

Secondary

Geometric Mean Ratio (GMR) of Post- Versus Pre-vaccination HI Titers Against Homologous Strains

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.

Time frame: Day 29, Day 50, Day 209

Population: Analysis was done on FAS (Persistence)

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
aTIV (6 to <72 Months)	Geometric Mean Ratio (GMR) of Post- Versus Pre-vaccination HI Titers Against Homologous Strains	B strain, Day 29:Day 1	12 Ratios
aTIV (6 to <72 Months)	Geometric Mean Ratio (GMR) of Post- Versus Pre-vaccination HI Titers Against Homologous Strains	H3N2, Day 209:Day 1	12 Ratios
aTIV (6 to <72 Months)	Geometric Mean Ratio (GMR) of Post- Versus Pre-vaccination HI Titers Against Homologous Strains	B strain, Day 50:Day 1	49 Ratios
aTIV (6 to <72 Months)	Geometric Mean Ratio (GMR) of Post- Versus Pre-vaccination HI Titers Against Homologous Strains	B strain, Day 209:Day 1	13 Ratios
aTIV (6 to <72 Months)	Geometric Mean Ratio (GMR) of Post- Versus Pre-vaccination HI Titers Against Homologous Strains	H1N1, Day 50:Day 1 (N=713,822,820)	58 Ratios
aTIV (6 to <72 Months)	Geometric Mean Ratio (GMR) of Post- Versus Pre-vaccination HI Titers Against Homologous Strains	H3N2, Day 29:Day 1	29 Ratios
aTIV (6 to <72 Months)	Geometric Mean Ratio (GMR) of Post- Versus Pre-vaccination HI Titers Against Homologous Strains	H1N1, Day 29:Day 1 (N=714,822,820)	27 Ratios
aTIV (6 to <72 Months)	Geometric Mean Ratio (GMR) of Post- Versus Pre-vaccination HI Titers Against Homologous Strains	H1N1, Day 209:Day 1 (N=714,822,819)	11 Ratios
aTIV (6 to <72 Months)	Geometric Mean Ratio (GMR) of Post- Versus Pre-vaccination HI Titers Against Homologous Strains	H3N2, Day 50:Day 1 (N=715,822,820)	48 Ratios
Comparator TIV (6 to <72 Months)	Geometric Mean Ratio (GMR) of Post- Versus Pre-vaccination HI Titers Against Homologous Strains	H3N2, Day 29:Day 1	15 Ratios
Comparator TIV (6 to <72 Months)	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
Comparator TIV (6 to <72 Months)	Geometric Mean Ratio (GMR) of Post- Versus Pre-vaccination HI Titers Against Homologous Strains	B strain, Day 29:Day 1	6.18 Ratios
Comparator TIV (6 to <72 Months)	Geometric Mean Ratio (GMR) of Post- Versus Pre-vaccination HI Titers Against Homologous Strains	B strain, Day 50:Day 1	17 Ratios
Comparator TIV (6 to <72 Months)	Geometric Mean Ratio (GMR) of Post- Versus Pre-vaccination HI Titers Against Homologous Strains	H3N2, Day 209:Day 1	6.93 Ratios
Comparator TIV (6 to <72 Months)	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
Comparator TIV (6 to <72 Months)	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
Comparator TIV (6 to <72 Months)	Geometric Mean Ratio (GMR) of Post- Versus Pre-vaccination HI Titers Against Homologous Strains	B strain, Day 209:Day 1	5.76 Ratios
Comparator TIV (6 to <72 Months)	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
TIV (6 to <72 Months)	Geometric Mean Ratio (GMR) of Post- Versus Pre-vaccination HI Titers Against Homologous Strains	B strain, Day 209:Day 1	6.15 Ratios
TIV (6 to <72 Months)	Geometric Mean Ratio (GMR) of Post- Versus Pre-vaccination HI Titers Against Homologous Strains	H1N1, Day 50:Day 1 (N=713,822,820)	19 Ratios
TIV (6 to <72 Months)	Geometric Mean Ratio (GMR) of Post- Versus Pre-vaccination HI Titers Against Homologous Strains	H3N2, Day 209:Day 1	6.02 Ratios
TIV (6 to <72 Months)	Geometric Mean Ratio (GMR) of Post- Versus Pre-vaccination HI Titers Against Homologous Strains	B strain, Day 29:Day 1	6.38 Ratios
TIV (6 to <72 Months)	Geometric Mean Ratio (GMR) of Post- Versus Pre-vaccination HI Titers Against Homologous Strains	B strain, Day 50:Day 1	16 Ratios
TIV (6 to <72 Months)	Geometric Mean Ratio (GMR) of Post- Versus Pre-vaccination HI Titers Against Homologous Strains	H1N1, Day 29:Day 1 (N=714,822,820)	7.13 Ratios
TIV (6 to <72 Months)	Geometric Mean Ratio (GMR) of Post- Versus Pre-vaccination HI Titers Against Homologous Strains	H1N1, Day 209:Day 1 (N=714,822,819)	4.37 Ratios
TIV (6 to <72 Months)	Geometric Mean Ratio (GMR) of Post- Versus Pre-vaccination HI Titers Against Homologous Strains	H3N2, Day 29:Day 1	12 Ratios
TIV (6 to <72 Months)	Geometric Mean Ratio (GMR) of Post- Versus Pre-vaccination HI Titers Against Homologous Strains	H3N2, Day 50:Day 1 (N=715,822,820)	20 Ratios

Secondary

Number of Subjects Reporting Solicited Adverse Events After Vaccination

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

Time frame: 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

Arm	Measure	Group	Value (NUMBER)
aTIV (6 to <72 Months)	Number of Subjects Reporting Solicited Adverse Events After Vaccination	Injection site ecchymosis(N=3075,1450,1446)	191 Participants
aTIV (6 to <72 Months)	Number of Subjects Reporting Solicited Adverse Events After Vaccination	Any systemic	1487 Participants
aTIV (6 to <72 Months)	Number of Subjects Reporting Solicited Adverse Events After Vaccination	Fever (≥38°C) (N=3074,1450,1446)	748 Participants
aTIV (6 to <72 Months)	Number of Subjects Reporting Solicited Adverse Events After Vaccination	Injection site erythema (N=3075,1450,1446)	312 Participants
aTIV (6 to <72 Months)	Number of Subjects Reporting Solicited Adverse Events After Vaccination	chills (N=1578,423,428)	154 Participants
aTIV (6 to <72 Months)	Number of Subjects Reporting Solicited Adverse Events After Vaccination	Sleepiness (N=1495,1024,1012)	229 Participants
aTIV (6 to <72 Months)	Number of Subjects Reporting Solicited Adverse Events After Vaccination	Crying (N=1463,1001,990)	186 Participants
aTIV (6 to <72 Months)	Number of Subjects Reporting Solicited Adverse Events After Vaccination	Myalgia (N=1578,423,429)	216 Participants
aTIV (6 to <72 Months)	Number of Subjects Reporting Solicited Adverse Events After Vaccination	Any other	1047 Participants
aTIV (6 to <72 Months)	Number of Subjects Reporting Solicited Adverse Events After Vaccination	Any local	1082 Participants
aTIV (6 to <72 Months)	Number of Subjects Reporting Solicited Adverse Events After Vaccination	Arthralgia (N=1578,423,429)	125 Participants
aTIV (6 to <72 Months)	Number of Subjects Reporting Solicited Adverse Events After Vaccination	Axillary Temperature (≥40°C) (N=3074,1450,1446)	8 Participants
aTIV (6 to <72 Months)	Number of Subjects Reporting Solicited Adverse Events After Vaccination	Headache (N=1578,423,429)	282 Participants
aTIV (6 to <72 Months)	Number of Subjects Reporting Solicited Adverse Events After Vaccination	Injection site swelling (N=3075,1450,1446)	217 Participants
aTIV (6 to <72 Months)	Number of Subjects Reporting Solicited Adverse Events After Vaccination	Injection site induration (N=3075,1450,1446)	258 Participants
aTIV (6 to <72 Months)	Number of Subjects Reporting Solicited Adverse Events After Vaccination	Fatigue (N=1578,423,430)	204 Participants
aTIV (6 to <72 Months)	Number of Subjects Reporting Solicited Adverse Events After Vaccination	Injection site pain (N=1580,422,429)	1580 Participants
aTIV (6 to <72 Months)	Number of Subjects Reporting Solicited Adverse Events After Vaccination	Analgesic Antipyretic Med. used(N=3076,1448,1444)	984 Participants
aTIV (6 to <72 Months)	Number of Subjects Reporting Solicited Adverse Events After Vaccination	Eating Habit (N=3076,1450,1446)	437 Participants
aTIV (6 to <72 Months)	Number of Subjects Reporting Solicited Adverse Events After Vaccination	Vomiting (N=3075,1451,1446)	249 Participants
aTIV (6 to <72 Months)	Number of Subjects Reporting Solicited Adverse Events After Vaccination	Irritability (N=1496,1024,1013)	290 Participants
aTIV (6 to <72 Months)	Number of Subjects Reporting Solicited Adverse Events After Vaccination	Diarrhea (N=3075,1450,1447)	423 Participants
aTIV (6 to <72 Months)	Number of Subjects Reporting Solicited Adverse Events After Vaccination	Injection site tenderness (N=1495,1025,1012)	152 Participants
Comparator TIV (6 to <72 Months)	Number of Subjects Reporting Solicited Adverse Events After Vaccination	Diarrhea (N=3075,1450,1447)	231 Participants
Comparator TIV (6 to <72 Months)	Number of Subjects Reporting Solicited Adverse Events After Vaccination	Irritability (N=1496,1024,1013)	164 Participants
Comparator TIV (6 to <72 Months)	Number of Subjects Reporting Solicited Adverse Events After Vaccination	Injection site tenderness (N=1495,1025,1012)	70 Participants
Comparator TIV (6 to <72 Months)	Number of Subjects Reporting Solicited Adverse Events After Vaccination	Crying (N=1463,1001,990)	105 Participants
Comparator TIV (6 to <72 Months)	Number of Subjects Reporting Solicited Adverse Events After Vaccination	Sleepiness (N=1495,1024,1012)	150 Participants
Comparator TIV (6 to <72 Months)	Number of Subjects Reporting Solicited Adverse Events After Vaccination	Vomiting (N=3075,1451,1446)	100 Participants
Comparator TIV (6 to <72 Months)	Number of Subjects Reporting Solicited Adverse Events After Vaccination	Injection site swelling (N=3075,1450,1446)	1450 Participants
Comparator TIV (6 to <72 Months)	Number of Subjects Reporting Solicited Adverse Events After Vaccination	Fever (≥38°C) (N=3074,1450,1446)	236 Participants
Comparator TIV (6 to <72 Months)	Number of Subjects Reporting Solicited Adverse Events After Vaccination	Injection site ecchymosis(N=3075,1450,1446)	72 Participants
Comparator TIV (6 to <72 Months)	Number of Subjects Reporting Solicited Adverse Events After Vaccination	Axillary Temperature (≥40°C) (N=3074,1450,1446)	4 Participants
Comparator TIV (6 to <72 Months)	Number of Subjects Reporting Solicited Adverse Events After Vaccination	Analgesic Antipyretic Med. used(N=3076,1448,1444)	285 Participants
Comparator TIV (6 to <72 Months)	Number of Subjects Reporting Solicited Adverse Events After Vaccination	Injection site pain (N=1580,422,429)	422 Participants
Comparator TIV (6 to <72 Months)	Number of Subjects Reporting Solicited Adverse Events After Vaccination	Any local	292 Participants
Comparator TIV (6 to <72 Months)	Number of Subjects Reporting Solicited Adverse Events After Vaccination	Any systemic	604 Participants
Comparator TIV (6 to <72 Months)	Number of Subjects Reporting Solicited Adverse Events After Vaccination	chills (N=1578,423,428)	23 Participants
Comparator TIV (6 to <72 Months)	Number of Subjects Reporting Solicited Adverse Events After Vaccination	Injection site erythema (N=3075,1450,1446)	109 Participants
Comparator TIV (6 to <72 Months)	Number of Subjects Reporting Solicited Adverse Events After Vaccination	Myalgia (N=1578,423,429)	43 Participants
Comparator TIV (6 to <72 Months)	Number of Subjects Reporting Solicited Adverse Events After Vaccination	Arthralgia (N=1578,423,429)	20 Participants
Comparator TIV (6 to <72 Months)	Number of Subjects Reporting Solicited Adverse Events After Vaccination	Headache (N=1578,423,429)	46 Participants
Comparator TIV (6 to <72 Months)	Number of Subjects Reporting Solicited Adverse Events After Vaccination	Fatigue (N=1578,423,430)	43 Participants
Comparator TIV (6 to <72 Months)	Number of Subjects Reporting Solicited Adverse Events After Vaccination	Injection site induration (N=3075,1450,1446)	62 Participants
Comparator TIV (6 to <72 Months)	Number of Subjects Reporting Solicited Adverse Events After Vaccination	Eating Habit (N=3076,1450,1446)	196 Participants
Comparator TIV (6 to <72 Months)	Number of Subjects Reporting Solicited Adverse Events After Vaccination	Any other	310 Participants
TIV (6 to <72 Months)	Number of Subjects Reporting Solicited Adverse Events After Vaccination	Analgesic Antipyretic Med. used(N=3076,1448,1444)	282 Participants
TIV (6 to <72 Months)	Number of Subjects Reporting Solicited Adverse Events After Vaccination	Any other	317 Participants
TIV (6 to <72 Months)	Number of Subjects Reporting Solicited Adverse Events After Vaccination	Any local	311 Participants
TIV (6 to <72 Months)	Number of Subjects Reporting Solicited Adverse Events After Vaccination	Injection site ecchymosis(N=3075,1450,1446)	86 Participants
TIV (6 to <72 Months)	Number of Subjects Reporting Solicited Adverse Events After Vaccination	Injection site erythema (N=3075,1450,1446)	101 Participants
TIV (6 to <72 Months)	Number of Subjects Reporting Solicited Adverse Events After Vaccination	Injection site induration (N=3075,1450,1446)	67 Participants
TIV (6 to <72 Months)	Number of Subjects Reporting Solicited Adverse Events After Vaccination	Injection site tenderness (N=1495,1025,1012)	78 Participants
TIV (6 to <72 Months)	Number of Subjects Reporting Solicited Adverse Events After Vaccination	Injection site swelling (N=3075,1450,1446)	1446 Participants
TIV (6 to <72 Months)	Number of Subjects Reporting Solicited Adverse Events After Vaccination	Injection site pain (N=1580,422,429)	429 Participants
TIV (6 to <72 Months)	Number of Subjects Reporting Solicited Adverse Events After Vaccination	Any systemic	569 Participants
TIV (6 to <72 Months)	Number of Subjects Reporting Solicited Adverse Events After Vaccination	chills (N=1578,423,428)	18 Participants
TIV (6 to <72 Months)	Number of Subjects Reporting Solicited Adverse Events After Vaccination	Myalgia (N=1578,423,429)	25 Participants
TIV (6 to <72 Months)	Number of Subjects Reporting Solicited Adverse Events After Vaccination	Headache (N=1578,423,429)	38 Participants
TIV (6 to <72 Months)	Number of Subjects Reporting Solicited Adverse Events After Vaccination	Fatigue (N=1578,423,430)	31 Participants
TIV (6 to <72 Months)	Number of Subjects Reporting Solicited Adverse Events After Vaccination	Eating Habit (N=3076,1450,1446)	205 Participants
TIV (6 to <72 Months)	Number of Subjects Reporting Solicited Adverse Events After Vaccination	Diarrhea (N=3075,1450,1447)	220 Participants
TIV (6 to <72 Months)	Number of Subjects Reporting Solicited Adverse Events After Vaccination	Irritability (N=1496,1024,1013)	190 Participants
TIV (6 to <72 Months)	Number of Subjects Reporting Solicited Adverse Events After Vaccination	Crying (N=1463,1001,990)	122 Participants
TIV (6 to <72 Months)	Number of Subjects Reporting Solicited Adverse Events After Vaccination	Sleepiness (N=1495,1024,1012)	153 Participants
TIV (6 to <72 Months)	Number of Subjects Reporting Solicited Adverse Events After Vaccination	Vomiting (N=3075,1451,1446)	104 Participants
TIV (6 to <72 Months)	Number of Subjects Reporting Solicited Adverse Events After Vaccination	Fever (≥38°C) (N=3074,1450,1446)	224 Participants
TIV (6 to <72 Months)	Number of Subjects Reporting Solicited Adverse Events After Vaccination	Axillary Temperature (≥40°C) (N=3074,1450,1446)	3 Participants
TIV (6 to <72 Months)	Number of Subjects Reporting Solicited Adverse Events After Vaccination	Arthralgia (N=1578,423,429)	16 Participants

Secondary

Number of Subjects Reporting Unsolicited Adverse Events After Vaccination

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).

Time frame: 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

Arm	Measure	Group	Value (NUMBER)
aTIV (6 to <72 Months)	Number of Subjects Reporting Unsolicited Adverse Events After Vaccination	Any SAEs	115 Participants
aTIV (6 to <72 Months)	Number of Subjects Reporting Unsolicited Adverse Events After Vaccination	Any AEs (Day 1 to Day 50)	1541 Participants
aTIV (6 to <72 Months)	Number of Subjects Reporting Unsolicited Adverse Events After Vaccination	Possibly/probably related SAE	1 Participants
aTIV (6 to <72 Months)	Number of Subjects Reporting Unsolicited Adverse Events After Vaccination	AESI	1 Participants
aTIV (6 to <72 Months)	Number of Subjects Reporting Unsolicited Adverse Events After Vaccination	Possibly/probably related AEs(Day 1 to Day 50)	158 Participants
aTIV (6 to <72 Months)	Number of Subjects Reporting Unsolicited Adverse Events After Vaccination	AE leading to WD	1 Participants
aTIV (6 to <72 Months)	Number of Subjects Reporting Unsolicited Adverse Events After Vaccination	Deaths	1 Participants
aTIV (6 to <72 Months)	Number of Subjects Reporting Unsolicited Adverse Events After Vaccination	NOCD	48 Participants
Comparator TIV (6 to <72 Months)	Number of Subjects Reporting Unsolicited Adverse Events After Vaccination	Possibly/probably related AEs(Day 1 to Day 50)	101 Participants
Comparator TIV (6 to <72 Months)	Number of Subjects Reporting Unsolicited Adverse Events After Vaccination	NOCD	31 Participants
Comparator TIV (6 to <72 Months)	Number of Subjects Reporting Unsolicited Adverse Events After Vaccination	Any AEs (Day 1 to Day 50)	859 Participants
Comparator TIV (6 to <72 Months)	Number of Subjects Reporting Unsolicited Adverse Events After Vaccination	AESI	0 Participants
Comparator TIV (6 to <72 Months)	Number of Subjects Reporting Unsolicited Adverse Events After Vaccination	Deaths	3 Participants
Comparator TIV (6 to <72 Months)	Number of Subjects Reporting Unsolicited Adverse Events After Vaccination	Any SAEs	64 Participants
Comparator TIV (6 to <72 Months)	Number of Subjects Reporting Unsolicited Adverse Events After Vaccination	Possibly/probably related SAE	0 Participants
Comparator TIV (6 to <72 Months)	Number of Subjects Reporting Unsolicited Adverse Events After Vaccination	AE leading to WD	5 Participants
TIV (6 to <72 Months)	Number of Subjects Reporting Unsolicited Adverse Events After Vaccination	Deaths	4 Participants
TIV (6 to <72 Months)	Number of Subjects Reporting Unsolicited Adverse Events After Vaccination	Any AEs (Day 1 to Day 50)	808 Participants
TIV (6 to <72 Months)	Number of Subjects Reporting Unsolicited Adverse Events After Vaccination	Possibly/probably related AEs(Day 1 to Day 50)	84 Participants
TIV (6 to <72 Months)	Number of Subjects Reporting Unsolicited Adverse Events After Vaccination	Any SAEs	69 Participants
TIV (6 to <72 Months)	Number of Subjects Reporting Unsolicited Adverse Events After Vaccination	Possibly/probably related SAE	0 Participants
TIV (6 to <72 Months)	Number of Subjects Reporting Unsolicited Adverse Events After Vaccination	AE leading to WD	4 Participants
TIV (6 to <72 Months)	Number of Subjects Reporting Unsolicited Adverse Events After Vaccination	NOCD	24 Participants
TIV (6 to <72 Months)	Number of Subjects Reporting Unsolicited Adverse Events After Vaccination	AESI	0 Participants

Secondary

Percentage of Subjects Achieving Seroconversion or ≥4 Fold Increase in HI Titers, Against Heterologous Strains

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.

Time frame: Day 50, Day 209

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

Arm	Measure	Group	Value (NUMBER)
aTIV (6 to <72 Months)	Percentage of Subjects Achieving Seroconversion or ≥4 Fold Increase in HI Titers, Against Heterologous Strains	H1N1/Jersey, Day 50 (N=380,445,430)	53.16 Percentage of subjects
aTIV (6 to <72 Months)	Percentage of Subjects Achieving Seroconversion or ≥4 Fold Increase in HI Titers, Against Heterologous Strains	H1N1/Jersey, Day 209 (N=380,445,430)	33.95 Percentage of subjects
aTIV (6 to <72 Months)	Percentage of Subjects Achieving Seroconversion or ≥4 Fold Increase in HI Titers, Against Heterologous Strains	H3N2/Uruguay, Day 50 (N=380,445,430)	91.84 Percentage of subjects
aTIV (6 to <72 Months)	Percentage of Subjects Achieving Seroconversion or ≥4 Fold Increase in HI Titers, Against Heterologous Strains	H3N2/Uruguay, Day 209 (N=380,445,430)	40.26 Percentage of subjects
aTIV (6 to <72 Months)	Percentage of Subjects Achieving Seroconversion or ≥4 Fold Increase in HI Titers, Against Heterologous Strains	B strain, Day 50	92.63 Percentage of subjects
aTIV (6 to <72 Months)	Percentage of Subjects Achieving Seroconversion or ≥4 Fold Increase in HI Titers, Against Heterologous Strains	B strain, Day 209	30.0 Percentage of subjects
Comparator TIV (6 to <72 Months)	Percentage of Subjects Achieving Seroconversion or ≥4 Fold Increase in HI Titers, Against Heterologous Strains	B strain, Day 209	13.93 Percentage of subjects
Comparator TIV (6 to <72 Months)	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
Comparator TIV (6 to <72 Months)	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
Comparator TIV (6 to <72 Months)	Percentage of Subjects Achieving Seroconversion or ≥4 Fold Increase in HI Titers, Against Heterologous Strains	B strain, Day 50	53.71 Percentage of subjects
Comparator TIV (6 to <72 Months)	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
Comparator TIV (6 to <72 Months)	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
TIV (6 to <72 Months)	Percentage of Subjects Achieving Seroconversion or ≥4 Fold Increase in HI Titers, Against Heterologous Strains	H1N1/Jersey, Day 209 (N=380,445,430)	20.70 Percentage of subjects
TIV (6 to <72 Months)	Percentage of Subjects Achieving Seroconversion or ≥4 Fold Increase in HI Titers, Against Heterologous Strains	H3N2/Uruguay, Day 50 (N=380,445,430)	53.26 Percentage of subjects
TIV (6 to <72 Months)	Percentage of Subjects Achieving Seroconversion or ≥4 Fold Increase in HI Titers, Against Heterologous Strains	B strain, Day 209	17.63 Percentage of subjects
TIV (6 to <72 Months)	Percentage of Subjects Achieving Seroconversion or ≥4 Fold Increase in HI Titers, Against Heterologous Strains	H3N2/Uruguay, Day 209 (N=380,445,430)	19.07 Percentage of subjects
TIV (6 to <72 Months)	Percentage of Subjects Achieving Seroconversion or ≥4 Fold Increase in HI Titers, Against Heterologous Strains	H1N1/Jersey, Day 50 (N=380,445,430)	36.05 Percentage of subjects
TIV (6 to <72 Months)	Percentage of Subjects Achieving Seroconversion or ≥4 Fold Increase in HI Titers, Against Heterologous Strains	B strain, Day 50	52.90 Percentage of subjects

Secondary

Percentage of Subjects Achieving Seroconversion or ≥4 Fold Increase in HI Titers, Against Homologous Strains

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.

Time frame: Day 29, Day 50, Day 209

Population: Analysis was done on FAS (Persistence)

Arm	Measure	Group	Value (NUMBER)
aTIV (6 to <72 Months)	Percentage of Subjects Achieving Seroconversion or ≥4 Fold Increase in HI Titers, Against Homologous Strains	H3N2, Day 29	95.8 Percentage of subjects
aTIV (6 to <72 Months)	Percentage of Subjects Achieving Seroconversion or ≥4 Fold Increase in HI Titers, Against Homologous Strains	H3N2, Day 209	77.6 Percentage of subjects
aTIV (6 to <72 Months)	Percentage of Subjects Achieving Seroconversion or ≥4 Fold Increase in HI Titers, Against Homologous Strains	B strain, Day 50	97.6 Percentage of subjects
aTIV (6 to <72 Months)	Percentage of Subjects Achieving Seroconversion or ≥4 Fold Increase in HI Titers, Against Homologous Strains	B strain, Day 209	87.3 Percentage of subjects
aTIV (6 to <72 Months)	Percentage of Subjects Achieving Seroconversion or ≥4 Fold Increase in HI Titers, Against Homologous Strains	B strain, Day 29	68.4 Percentage of subjects
aTIV (6 to <72 Months)	Percentage of Subjects Achieving Seroconversion or ≥4 Fold Increase in HI Titers, Against Homologous Strains	H1N1, Day 29 (N=714,822,820)	83.6 Percentage of subjects
aTIV (6 to <72 Months)	Percentage of Subjects Achieving Seroconversion or ≥4 Fold Increase in HI Titers, Against Homologous Strains	H1N1, Day 50 (N=713,822,820)	92.6 Percentage of subjects
aTIV (6 to <72 Months)	Percentage of Subjects Achieving Seroconversion or ≥4 Fold Increase in HI Titers, Against Homologous Strains	H3N2, Day 50	96.5 Percentage of subjects
aTIV (6 to <72 Months)	Percentage of Subjects Achieving Seroconversion or ≥4 Fold Increase in HI Titers, Against Homologous Strains	H1N1, Day 209 (N=714,822,819)	71.7 Percentage of subjects
Comparator TIV (6 to <72 Months)	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
Comparator TIV (6 to <72 Months)	Percentage of Subjects Achieving Seroconversion or ≥4 Fold Increase in HI Titers, Against Homologous Strains	H3N2, Day 29	90.3 Percentage of subjects
Comparator TIV (6 to <72 Months)	Percentage of Subjects Achieving Seroconversion or ≥4 Fold Increase in HI Titers, Against Homologous Strains	B strain, Day 29	47 Percentage of subjects
Comparator TIV (6 to <72 Months)	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
Comparator TIV (6 to <72 Months)	Percentage of Subjects Achieving Seroconversion or ≥4 Fold Increase in HI Titers, Against Homologous Strains	B strain, Day 50	86.6 Percentage of subjects
Comparator TIV (6 to <72 Months)	Percentage of Subjects Achieving Seroconversion or ≥4 Fold Increase in HI Titers, Against Homologous Strains	H3N2, Day 209	62.5 Percentage of subjects
Comparator TIV (6 to <72 Months)	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
Comparator TIV (6 to <72 Months)	Percentage of Subjects Achieving Seroconversion or ≥4 Fold Increase in HI Titers, Against Homologous Strains	B strain, Day 209	59.7 Percentage of subjects
Comparator TIV (6 to <72 Months)	Percentage of Subjects Achieving Seroconversion or ≥4 Fold Increase in HI Titers, Against Homologous Strains	H3N2, Day 50	92.1 Percentage of subjects
TIV (6 to <72 Months)	Percentage of Subjects Achieving Seroconversion or ≥4 Fold Increase in HI Titers, Against Homologous Strains	B strain, Day 209	61.5 Percentage of subjects
TIV (6 to <72 Months)	Percentage of Subjects Achieving Seroconversion or ≥4 Fold Increase in HI Titers, Against Homologous Strains	H1N1, Day 209 (N=714,822,819)	41.9 Percentage of subjects
TIV (6 to <72 Months)	Percentage of Subjects Achieving Seroconversion or ≥4 Fold Increase in HI Titers, Against Homologous Strains	H3N2, Day 29	86.7 Percentage of subjects
TIV (6 to <72 Months)	Percentage of Subjects Achieving Seroconversion or ≥4 Fold Increase in HI Titers, Against Homologous Strains	H3N2, Day 50	90 Percentage of subjects
TIV (6 to <72 Months)	Percentage of Subjects Achieving Seroconversion or ≥4 Fold Increase in HI Titers, Against Homologous Strains	H3N2, Day 209	55.6 Percentage of subjects
TIV (6 to <72 Months)	Percentage of Subjects Achieving Seroconversion or ≥4 Fold Increase in HI Titers, Against Homologous Strains	H1N1, Day 50 (N=713,822,820)	79 Percentage of subjects
TIV (6 to <72 Months)	Percentage of Subjects Achieving Seroconversion or ≥4 Fold Increase in HI Titers, Against Homologous Strains	B strain, Day 29	44 Percentage of subjects
TIV (6 to <72 Months)	Percentage of Subjects Achieving Seroconversion or ≥4 Fold Increase in HI Titers, Against Homologous Strains	B strain, Day 50	85 Percentage of subjects
TIV (6 to <72 Months)	Percentage of Subjects Achieving Seroconversion or ≥4 Fold Increase in HI Titers, Against Homologous Strains	H1N1, Day 29 (N=714,822,820)	51.5 Percentage of subjects

Secondary

Percentage of Subjects With HI Titers ≥40 Against Homologous Strains, by Vaccine Group

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.

Time frame: Day 1, Day 29, Day 50, Day 209

Population: Analysis was done on FAS (Persistence)

Arm	Measure	Group	Value (NUMBER)
aTIV (6 to <72 Months)	Percentage of Subjects With HI Titers ≥40 Against Homologous Strains, by Vaccine Group	B strain, Day 50	98.9 Percentage of subjects
aTIV (6 to <72 Months)	Percentage of Subjects With HI Titers ≥40 Against Homologous Strains, by Vaccine Group	H1N1, Day 1 (N=714,822,820)	40.6 Percentage of subjects
aTIV (6 to <72 Months)	Percentage of Subjects With HI Titers ≥40 Against Homologous Strains, by Vaccine Group	H3N2, Day 1	52.6 Percentage of subjects
aTIV (6 to <72 Months)	Percentage of Subjects With HI Titers ≥40 Against Homologous Strains, by Vaccine Group	H1N1, Day 50 (N=714,822,820)	99.3 Percentage of subjects
aTIV (6 to <72 Months)	Percentage of Subjects With HI Titers ≥40 Against Homologous Strains, by Vaccine Group	H3N2, Day 29	98.9 Percentage of subjects
aTIV (6 to <72 Months)	Percentage of Subjects With HI Titers ≥40 Against Homologous Strains, by Vaccine Group	H3N2, Day 209	99.3 Percentage of subjects
aTIV (6 to <72 Months)	Percentage of Subjects With HI Titers ≥40 Against Homologous Strains, by Vaccine Group	B strain, Day 209	93.4 Percentage of subjects
aTIV (6 to <72 Months)	Percentage of Subjects With HI Titers ≥40 Against Homologous Strains, by Vaccine Group	H3N2, Day 50	99.7 Percentage of subjects
aTIV (6 to <72 Months)	Percentage of Subjects With HI Titers ≥40 Against Homologous Strains, by Vaccine Group	B strain, Day 29	69 Percentage of subjects
aTIV (6 to <72 Months)	Percentage of Subjects With HI Titers ≥40 Against Homologous Strains, by Vaccine Group	H1N1, Day 29	89.8 Percentage of subjects
aTIV (6 to <72 Months)	Percentage of Subjects With HI Titers ≥40 Against Homologous Strains, by Vaccine Group	H1N1, Day 209 (N=715, 822,819)	88.8 Percentage of subjects
aTIV (6 to <72 Months)	Percentage of Subjects With HI Titers ≥40 Against Homologous Strains, by Vaccine Group	B strain, Day 1	22.1 Percentage of subjects
Comparator TIV (6 to <72 Months)	Percentage of Subjects With HI Titers ≥40 Against Homologous Strains, by Vaccine Group	H1N1, Day 29	55 Percentage of subjects
Comparator TIV (6 to <72 Months)	Percentage of Subjects With HI Titers ≥40 Against Homologous Strains, by Vaccine Group	B strain, Day 1	21.1 Percentage of subjects
Comparator TIV (6 to <72 Months)	Percentage of Subjects With HI Titers ≥40 Against Homologous Strains, by Vaccine Group	B strain, Day 29	48.2 Percentage of subjects
Comparator TIV (6 to <72 Months)	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
Comparator TIV (6 to <72 Months)	Percentage of Subjects With HI Titers ≥40 Against Homologous Strains, by Vaccine Group	B strain, Day 50	89.1 Percentage of subjects
Comparator TIV (6 to <72 Months)	Percentage of Subjects With HI Titers ≥40 Against Homologous Strains, by Vaccine Group	B strain, Day 209	67.9 Percentage of subjects
Comparator TIV (6 to <72 Months)	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
Comparator TIV (6 to <72 Months)	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
Comparator TIV (6 to <72 Months)	Percentage of Subjects With HI Titers ≥40 Against Homologous Strains, by Vaccine Group	H3N2, Day 29	95.9 Percentage of subjects
Comparator TIV (6 to <72 Months)	Percentage of Subjects With HI Titers ≥40 Against Homologous Strains, by Vaccine Group	H3N2, Day 1	45.5 Percentage of subjects
Comparator TIV (6 to <72 Months)	Percentage of Subjects With HI Titers ≥40 Against Homologous Strains, by Vaccine Group	H3N2, Day 50	99.5 Percentage of subjects
Comparator TIV (6 to <72 Months)	Percentage of Subjects With HI Titers ≥40 Against Homologous Strains, by Vaccine Group	H3N2, Day 209	94.3 Percentage of subjects
TIV (6 to <72 Months)	Percentage of Subjects With HI Titers ≥40 Against Homologous Strains, by Vaccine Group	B strain, Day 209	67 Percentage of subjects
TIV (6 to <72 Months)	Percentage of Subjects With HI Titers ≥40 Against Homologous Strains, by Vaccine Group	H1N1, Day 1 (N=714,822,820)	36.3 Percentage of subjects
TIV (6 to <72 Months)	Percentage of Subjects With HI Titers ≥40 Against Homologous Strains, by Vaccine Group	H1N1, Day 50 (N=714,822,820)	88.2 Percentage of subjects
TIV (6 to <72 Months)	Percentage of Subjects With HI Titers ≥40 Against Homologous Strains, by Vaccine Group	H1N1, Day 209 (N=715, 822,819)	63.2 Percentage of subjects
TIV (6 to <72 Months)	Percentage of Subjects With HI Titers ≥40 Against Homologous Strains, by Vaccine Group	H3N2, Day 1	44.6 Percentage of subjects
TIV (6 to <72 Months)	Percentage of Subjects With HI Titers ≥40 Against Homologous Strains, by Vaccine Group	H3N2, Day 29	93.5 Percentage of subjects
TIV (6 to <72 Months)	Percentage of Subjects With HI Titers ≥40 Against Homologous Strains, by Vaccine Group	H3N2, Day 50	99.4 Percentage of subjects
TIV (6 to <72 Months)	Percentage of Subjects With HI Titers ≥40 Against Homologous Strains, by Vaccine Group	H3N2, Day 209	88.4 Percentage of subjects
TIV (6 to <72 Months)	Percentage of Subjects With HI Titers ≥40 Against Homologous Strains, by Vaccine Group	B strain, Day 1	20.5 Percentage of subjects
TIV (6 to <72 Months)	Percentage of Subjects With HI Titers ≥40 Against Homologous Strains, by Vaccine Group	B strain, Day 29	45.6 Percentage of subjects
TIV (6 to <72 Months)	Percentage of Subjects With HI Titers ≥40 Against Homologous Strains, by Vaccine Group	B strain, Day 50	87 Percentage of subjects
TIV (6 to <72 Months)	Percentage of Subjects With HI Titers ≥40 Against Homologous Strains, by Vaccine Group	H1N1, Day 29	57.9 Percentage of subjects

Secondary

The HI GMTs Against Heterologous Strains, by Vaccine Group (6 to <72 Months Age Group)

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.

Time frame: Day 1, Day 50, Day 209

Population: Analysis was done on the FAS Persistence

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
aTIV (6 to <72 Months)	The HI GMTs Against Heterologous Strains, by Vaccine Group (6 to <72 Months Age Group)	H3N2/Uruguay - Day 1 (N=380,445,430)	17 Titers
aTIV (6 to <72 Months)	The HI GMTs Against Heterologous Strains, by Vaccine Group (6 to <72 Months Age Group)	B strain Day 209	20 Titers
aTIV (6 to <72 Months)	The HI GMTs Against Heterologous Strains, by Vaccine Group (6 to <72 Months Age Group)	H3N2/Uruguay- Day 209	42 Titers
aTIV (6 to <72 Months)	The HI GMTs Against Heterologous Strains, by Vaccine Group (6 to <72 Months Age Group)	H3N2/Uruguay - Day 50	184 Titers
aTIV (6 to <72 Months)	The HI GMTs Against Heterologous Strains, by Vaccine Group (6 to <72 Months Age Group)	H1N1/Jersey - Day 1 (N=380,445,430)	10 Titers
aTIV (6 to <72 Months)	The HI GMTs Against Heterologous Strains, by Vaccine Group (6 to <72 Months Age Group)	B strain - Day 50	99 Titers
aTIV (6 to <72 Months)	The HI GMTs Against Heterologous Strains, by Vaccine Group (6 to <72 Months Age Group)	H1N1/Jersey - Day 209	21 Titers
aTIV (6 to <72 Months)	The HI GMTs Against Heterologous Strains, by Vaccine Group (6 to <72 Months Age Group)	H1N1/Jersey - Day 50	51 Titers
aTIV (6 to <72 Months)	The HI GMTs Against Heterologous Strains, by Vaccine Group (6 to <72 Months Age Group)	B strain - Day 1	5.98 Titers
Comparator TIV (6 to <72 Months)	The HI GMTs Against Heterologous Strains, by Vaccine Group (6 to <72 Months Age Group)	H3N2/Uruguay - Day 50	88 Titers
Comparator TIV (6 to <72 Months)	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
Comparator TIV (6 to <72 Months)	The HI GMTs Against Heterologous Strains, by Vaccine Group (6 to <72 Months Age Group)	H1N1/Jersey - Day 50	29 Titers
Comparator TIV (6 to <72 Months)	The HI GMTs Against Heterologous Strains, by Vaccine Group (6 to <72 Months Age Group)	H1N1/Jersey - Day 209	17 Titers
Comparator TIV (6 to <72 Months)	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
Comparator TIV (6 to <72 Months)	The HI GMTs Against Heterologous Strains, by Vaccine Group (6 to <72 Months Age Group)	H3N2/Uruguay- Day 209	31 Titers
Comparator TIV (6 to <72 Months)	The HI GMTs Against Heterologous Strains, by Vaccine Group (6 to <72 Months Age Group)	B strain - Day 1	5.8 Titers
Comparator TIV (6 to <72 Months)	The HI GMTs Against Heterologous Strains, by Vaccine Group (6 to <72 Months Age Group)	B strain - Day 50	34 Titers
Comparator TIV (6 to <72 Months)	The HI GMTs Against Heterologous Strains, by Vaccine Group (6 to <72 Months Age Group)	B strain Day 209	11 Titers
TIV (6 to <72 Months)	The HI GMTs Against Heterologous Strains, by Vaccine Group (6 to <72 Months Age Group)	H1N1/Jersey - Day 209	18 Titers
TIV (6 to <72 Months)	The HI GMTs Against Heterologous Strains, by Vaccine Group (6 to <72 Months Age Group)	H1N1/Jersey - Day 1 (N=380,445,430)	10 Titers
TIV (6 to <72 Months)	The HI GMTs Against Heterologous Strains, by Vaccine Group (6 to <72 Months Age Group)	B strain - Day 1	5.85 Titers
TIV (6 to <72 Months)	The HI GMTs Against Heterologous Strains, by Vaccine Group (6 to <72 Months Age Group)	H1N1/Jersey - Day 50	31 Titers
TIV (6 to <72 Months)	The HI GMTs Against Heterologous Strains, by Vaccine Group (6 to <72 Months Age Group)	B strain Day 209	11 Titers
TIV (6 to <72 Months)	The HI GMTs Against Heterologous Strains, by Vaccine Group (6 to <72 Months Age Group)	H3N2/Uruguay - Day 50	71 Titers
TIV (6 to <72 Months)	The HI GMTs Against Heterologous Strains, by Vaccine Group (6 to <72 Months Age Group)	H3N2/Uruguay - Day 1 (N=380,445,430)	17 Titers
TIV (6 to <72 Months)	The HI GMTs Against Heterologous Strains, by Vaccine Group (6 to <72 Months Age Group)	B strain - Day 50	35 Titers
TIV (6 to <72 Months)	The HI GMTs Against Heterologous Strains, by Vaccine Group (6 to <72 Months Age Group)	H3N2/Uruguay- Day 209	27 Titers

Secondary

The HI GMTs Against Homologous Strains, by Vaccine Group

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.

Time frame: 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.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
aTIV (6 to <72 Months)	The HI GMTs Against Homologous Strains, by Vaccine Group	B - Day 50	488 Titers
aTIV (6 to <72 Months)	The HI GMTs Against Homologous Strains, by Vaccine Group	H3N2 - Day 1	42 Titers
aTIV (6 to <72 Months)	The HI GMTs Against Homologous Strains, by Vaccine Group	B- Day 209	125 Titers
aTIV (6 to <72 Months)	The HI GMTs Against Homologous Strains, by Vaccine Group	H3N2 - Day 209	462 Titers
aTIV (6 to <72 Months)	The HI GMTs Against Homologous Strains, by Vaccine Group	H1N1 - Day 1 (N=714,822,820)	28 Titers
aTIV (6 to <72 Months)	The HI GMTs Against Homologous Strains, by Vaccine Group	B - Day 1	10 Titers
aTIV (6 to <72 Months)	The HI GMTs Against Homologous Strains, by Vaccine Group	H3N2 - Day 50	1920 Titers
aTIV (6 to <72 Months)	The HI GMTs Against Homologous Strains, by Vaccine Group	H1N1 - Day 29	647 Titers
aTIV (6 to <72 Months)	The HI GMTs Against Homologous Strains, by Vaccine Group	H3N2 - Day 29	1087 Titers
aTIV (6 to <72 Months)	The HI GMTs Against Homologous Strains, by Vaccine Group	B - Day 29	119 Titers
aTIV (6 to <72 Months)	The HI GMTs Against Homologous Strains, by Vaccine Group	H1N1 - Day 50 (N=714,822,820)	1507 Titers
aTIV (6 to <72 Months)	The HI GMTs Against Homologous Strains, by Vaccine Group	H1N1 - Day 209 (N=715,822,819)	276 Titers
Comparator TIV (6 to <72 Months)	The HI GMTs Against Homologous Strains, by Vaccine Group	H1N1 - Day 50 (N=714,822,820)	635 Titers
Comparator TIV (6 to <72 Months)	The HI GMTs Against Homologous Strains, by Vaccine Group	H1N1 - Day 209 (N=715,822,819)	97 Titers
Comparator TIV (6 to <72 Months)	The HI GMTs Against Homologous Strains, by Vaccine Group	H3N2 - Day 29	558 Titers
Comparator TIV (6 to <72 Months)	The HI GMTs Against Homologous Strains, by Vaccine Group	B - Day 50	166 Titers
Comparator TIV (6 to <72 Months)	The HI GMTs Against Homologous Strains, by Vaccine Group	H3N2 - Day 50	1013 Titers
Comparator TIV (6 to <72 Months)	The HI GMTs Against Homologous Strains, by Vaccine Group	B- Day 209	57 Titers
Comparator TIV (6 to <72 Months)	The HI GMTs Against Homologous Strains, by Vaccine Group	H3N2 - Day 1	43 Titers
Comparator TIV (6 to <72 Months)	The HI GMTs Against Homologous Strains, by Vaccine Group	H3N2 - Day 209	277 Titers
Comparator TIV (6 to <72 Months)	The HI GMTs Against Homologous Strains, by Vaccine Group	B - Day 1	10 Titers
Comparator TIV (6 to <72 Months)	The HI GMTs Against Homologous Strains, by Vaccine Group	H1N1 - Day 1 (N=714,822,820)	24 Titers
Comparator TIV (6 to <72 Months)	The HI GMTs Against Homologous Strains, by Vaccine Group	H1N1 - Day 29	159 Titers
Comparator TIV (6 to <72 Months)	The HI GMTs Against Homologous Strains, by Vaccine Group	B - Day 29	58 Titers
TIV (6 to <72 Months)	The HI GMTs Against Homologous Strains, by Vaccine Group	B- Day 209	61 Titers
TIV (6 to <72 Months)	The HI GMTs Against Homologous Strains, by Vaccine Group	H3N2 - Day 1	43 Titers
TIV (6 to <72 Months)	The HI GMTs Against Homologous Strains, by Vaccine Group	H3N2 - Day 209	242 Titers
TIV (6 to <72 Months)	The HI GMTs Against Homologous Strains, by Vaccine Group	B - Day 1	10 Titers
TIV (6 to <72 Months)	The HI GMTs Against Homologous Strains, by Vaccine Group	B - Day 50	159 Titers
TIV (6 to <72 Months)	The HI GMTs Against Homologous Strains, by Vaccine Group	B - Day 29	61 Titers
TIV (6 to <72 Months)	The HI GMTs Against Homologous Strains, by Vaccine Group	H1N1 - Day 1 (N=714,822,820)	27 Titers
TIV (6 to <72 Months)	The HI GMTs Against Homologous Strains, by Vaccine Group	H1N1 - Day 29	170 Titers
TIV (6 to <72 Months)	The HI GMTs Against Homologous Strains, by Vaccine Group	H1N1 - Day 50 (N=714,822,820)	475 Titers
TIV (6 to <72 Months)	The HI GMTs Against Homologous Strains, by Vaccine Group	H1N1 - Day 209 (N=715,822,819)	107 Titers
TIV (6 to <72 Months)	The HI GMTs Against Homologous Strains, by Vaccine Group	H3N2 - Day 29	453 Titers
TIV (6 to <72 Months)	The HI GMTs Against Homologous Strains, by Vaccine Group	H3N2 - Day 50	810 Titers

Source: ClinicalTrials.gov · Data processed: Mar 19, 2026

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

Conditions

Keywords

Brief summary

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Recruitment details

Pre-assignment details

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of Geometric Mean Titers (GMTs) Against Homologous Strains

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

Comparison of Antibody Responses of TIV Versus Comparator TIV in Terms of Geometric Mean Titers (GMTs) Against Homologous Strains (6 to <36 Months)

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

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

Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of GMTs Against Homologous Strains (6 to <24 Months)

Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of GMTs Against Homologous Strains (6 to <72 Months)-FAS

Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of GMTs Against Homologous Strains, After One Vaccination

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

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

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

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)

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

Geometric Mean Ratio (GMR) of Post- Versus Pre-vaccination HI Titers Against Homologous Strains

Number of Subjects Reporting Solicited Adverse Events After Vaccination

Number of Subjects Reporting Unsolicited Adverse Events After Vaccination

Percentage of Subjects Achieving Seroconversion or ≥4 Fold Increase in HI Titers, Against Heterologous Strains

Percentage of Subjects Achieving Seroconversion or ≥4 Fold Increase in HI Titers, Against Homologous Strains

Percentage of Subjects With HI Titers ≥40 Against Homologous Strains, by Vaccine Group

The HI GMTs Against Heterologous Strains, by Vaccine Group (6 to <72 Months Age Group)

The HI GMTs Against Homologous Strains, by Vaccine Group