Safety, Tolerability, and Immunogenicity of the Adjuvante... | NCT01346592

NCT01346592

Status Module

Sponsor/Collaborators Module

Oversight Module

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Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

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Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
aTIV (6 to <72 months)	Active Comparator	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	Biological: MF59-adjuvanted trivalent influenza vaccine (aTIV)
Comparator TIV (6 to <72 months)	Active Comparator	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	Biological: Licensed comparator trivalent split influenza vaccine (comparator TIV)
TIV (6 to <72 months)	Active Comparator	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	Biological: Trivalent split influenza vaccine (TIV)

Name	Type	Description	Arm Group Labels	Other Names
Trivalent split influenza vaccine (TIV)	Biological		TIV (6 to <72 months)	Agriflu

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of Geometric Mean Titers (GMTs) Against Homologous Strains	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.	Day 1, Day 50
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.	Day 50
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.	Day 1, Day 50
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.	Day 50

Secondary Outcomes

Measure	Description	Time Frame
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.	Day 1, Day 50

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Novartis Vaccines	Novartis Vaccines	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
401 Paideia Jeronimo Salguero 2835 Piso 1		Buenos Aires			Argentina
402 Hospital de Ninos Gallo 130

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25223266	Derived	Nolan T, Bravo L, Ceballos A, Mitha E, Gray G, Quiambao B, Patel SS, Bizjajeva S, Bock H, Nazaire-Bermal N, Forleo-Neto E, Cioppa GD, Narasimhan V. Enhanced and persistent antibody response against homologous and heterologous strains elicited by a MF59-adjuvanted influenza vaccine in infants and young children. Vaccine. 2014 Oct 21;32(46):6146-56. doi: 10.1016/j.vaccine.2014.08.068. Epub 2014 Sep 16.

IPD Sharing Statement Module

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No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	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
FG001	Comparator TIV (6 to <72 Months)

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

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Document Section

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Derived Section

Miscellaneous Info Module

Submission Tracking

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No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	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
BG001	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
BG002	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
BG003	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

Months

Title

Denominators

Categories

H1N1 - Day 1 (N=681,757,765)

Title	Measurements
	OG00028(24 to 33) OG00124(21 to 28) OG00227(23 to 31)

H1N1 - Day 50 (N=681,757,765)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001						GMT ratio (H1N1 strain)	2.44			2-Sided	97.6	2.06	2.9				Yes	Non-Inferiority or Equivalence	Noninferiority was established if the lower limit of the confidence interval of the day 50 ratio of GMTs was >0.667
OG000 OG001

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.

Analysis was done on the PPS.

Posted

Number

95% Confidence Interval

Percentage of subjects

Day 50

ID	Title	Description
OG000	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
OG001	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
OG002

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.

Analysis was done on the PPS.

Posted

Geometric Mean

95% Confidence Interval

Titers

Day 1, Day 50

ID	Title	Description
OG000	TIV (6 to <36months)	Subjects received two doses of 0.25 mL each, of investigational trivalent split influenza vaccine (TIV), at Days 1 & 29
OG001	Comparator TIV (6 to <36months)	Subjects received two doses of 0.25 mL each, of the licensed trivalent split influenza vaccine (comparator TIV), at Days 1 & 29

Units	Counts
Participants	OG000

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.

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

Posted

Number

95% Confidence Interval

Percentage of subjects

Day 50

ID	Title	Description
OG000	TIV (6 to <36months)	Subjects received two doses of 0.25 mL each, of investigational trivalent split influenza vaccine (TIV), at Days 1 & 29
OG001	Comparator TIV (6 to <36months)	Subjects received two doses of 0.25 mL each, of the licensed trivalent split influenza vaccine (comparator TIV), at Days 1 & 29

Units	Counts
Participants

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.

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

Posted

Geometric Mean

95% Confidence Interval

Titers

Day 1, Day 50

ID	Title	Description
OG000	aTIV (6 to <24 Months)	Subjects received two doses of 0.25 mL each, of the investigational MF59-adjuvanted trivalent split influenza vaccine (aTIV), at Days 1 & 29
OG001	Comparator TIV (6 to <24 Months)	Subjects received two doses of 0.25 mL each, of the licensed comparator trivalent split influenza vaccine (comparator TIV), at Days 1 & 29
OG002	TIV (6 to <24 Months)	Subjects received two doses of 0.25 mL each, of the investigational trivalent split influenza vaccine (TIV), at Days 1 & 29

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.

Analysis was done on the FAS

Posted

Number

95% Confidence Interval

Percentage of subjects

Day 50

ID	Title	Description
OG000	aTIV (6 to <24 Months)	Subjects received two doses of 0.25 mL each, of the investigational MF59-adjuvanted trivalent split influenza vaccine (aTIV), at Days 1 & 29
OG001	Comparator TIV (6 to <24 Months)	Subjects received two doses of 0.25 mL each, of the licensed comparator trivalent split influenza vaccine (comparator TIV), at Days 1 & 29
OG002	TIV (6 to <24 Months)	Subjects received two doses of 0.25 mL each, of the investigational trivalent split influenza vaccine (TIV), at Days 1 & 29

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.

Analysis was done on the FAS

Posted

Geometric Mean

95% Confidence Interval

Titers

Day 1, Day 50

ID	Title	Description
OG000	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
OG001	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
OG002	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

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.

Analysis was done on the FAS

Posted

Number

95% Confidence Interval

Percentage of subjects

Day 50

ID	Title	Description
OG000	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
OG001	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
OG002	TIV (6 to <72 Months)

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.

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.

Posted

Geometric Mean

95% Confidence Interval

Titers

Day 1, Day 29, Day 50, Day 209

ID	Title	Description
OG000	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
OG001	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
OG002	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

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.

Analysis was done on FAS (Persistence)

Posted

Geometric Mean

95% Confidence Interval

Ratios

Day 29, Day 50, Day 209

ID	Title	Description
OG000	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
OG001	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
OG002	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

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.

Analysis was done on FAS (Persistence)

Posted

Number

95% Confidence Interval

Percentage of subjects

Day 1, Day 29, Day 50, Day 209

ID	Title	Description
OG000	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
OG001	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
OG002	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

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.

Analysis was done on FAS (Persistence)

Posted

Number

95% Confidence Interval

Percentage of subjects

Day 29, Day 50, Day 209

ID	Title	Description
OG000	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
OG001	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
OG002	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

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.

Analysis was done on the PPS.

Posted

Geometric Mean

95% Confidence Interval

Titers

Day 50

ID	Title	Description
OG000	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 (Day 1 & 29) while subjects aged ≥36 months received one dose (at Day 1) of the vaccine
OG001	Compartor 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 (Day 1 & 29) while subjects aged ≥36 months received one dose (at Day 1) of the vaccine
OG002	TIV (6 to <72 Months)

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.

Analysis was done on the Per Protocol Set.

Posted

Number

95% Confidence Interval

Percentages of subjects

Day 50

ID	Title	Description
OG000	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 (Day 1 & 29) while subjects aged ≥36 months received one dose (at Day 1) of the vaccine
OG001	Compartor 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 (Day 1 & 29) while subjects aged ≥36 months received one dose (at Day 1) of the vaccine

Secondary

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.

Analysis was done on the Full Analysis Set.

Posted

Number

95% Confidence Interval

Percentages of subjects

Day 50

ID	Title	Description
OG000	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 (Day 1 & 29) while subjects aged ≥36 months received one dose (at Day 1) of the vaccine
OG001	Compartor 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 (Day 1 & 29) while subjects aged ≥36 months received one dose (at Day 1) of the vaccine
OG002

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.

Analysis was done on Full Analysis Set.

Posted

Geometric Mean

95% Confidence Interval

Titers

Day 50

ID	Title	Description
OG000	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 (Day 1 & 29) while subjects aged ≥36 months received one dose (at Day 1) of the vaccine
OG001	Compartor 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 (Day 1 & 29) while subjects aged ≥36 months received one dose (at Day 1) of the vaccine
OG002	TIV (6 to <72 Months)

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.

Analysis was done on the FAS Persistence

Posted

Geometric Mean

95% Confidence Interval

Titers

Day 1, Day 50, Day 209

ID	Title	Description
OG000	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
OG001	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
OG002	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

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.

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

Posted

Number

95% Confidence Interval

Percentage of subjects

Day 50, Day 209

ID	Title	Description
OG000	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
OG001	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
OG002	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

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.

Analysis was done on the FAS (Persistence).

Posted

Geometric Mean

95% Confidence Interval

Titers

Day 1, Day 29

ID	Title	Description
OG000	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
OG001	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
OG002	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

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.

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

Posted

Number

Participants

Day 1 through Day 7 after any vaccination

ID	Title	Description
OG000	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
OG001	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
OG002	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

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).

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

Posted

Number

Participants

Day 1 to Day 394

ID	Title	Description
OG000	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
OG001	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
OG002	TIV (6 to <72 Months)

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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	115	3,123	2,106	3,123
EG001	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	69	1,477	905	1,477
EG002	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	64	1,474	917	1,474

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Coeliac Disease	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0001 affected3,123 at risk EG0010 affected1,477 at risk EG0020 affected1,474 at risk
Gastritis	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected3,123 at risk EG0010 affected1,477 at risk EG0021 affected1,474 at risk
Upper Gastrointestinal Disorder Hamorrage	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected3,123 at risk EG0010 affected1,477 at risk EG0021 affected1,474 at risk
Drowning	General disorders	MedDRA	Non-systematic Assessment	EG0000 affected3,123 at risk EG0010 affected1,477 at risk EG0021 affected1,474 at risk
Type III Immune Complex Mediated Reaction	Immune system disorders	MedDRA	Non-systematic Assessment	EG0001 affected3,123 at risk EG0010 affected1,477 at risk EG0020 affected1,474 at risk
Abscess	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected3,123 at risk EG0012 affected1,477 at risk EG0020 affected1,474 at risk
Abscess Limb	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected3,123 at risk EG0011 affected1,477 at risk EG0020 affected1,474 at risk
Abscess Neck	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected3,123 at risk EG0011 affected1,477 at risk EG0020 affected1,474 at risk
Amoebiasis	Infections and infestations	MedDRA	Non-systematic Assessment	EG0001 affected3,123 at risk EG0011 affected1,477 at risk EG0020 affected1,474 at risk
Appendicitis	Infections and infestations	MedDRA	Non-systematic Assessment	EG0001 affected3,123 at risk EG0010 affected1,477 at risk EG0021 affected1,474 at risk
Arthritis Bacterial	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected3,123 at risk EG0010 affected1,477 at risk EG0021 affected1,474 at risk
Bacterial Infection	Infections and infestations	MedDRA	Non-systematic Assessment	EG0001 affected3,123 at risk EG0010 affected1,477 at risk EG0020 affected1,474 at risk
Bronchitis	Infections and infestations	MedDRA	Non-systematic Assessment	EG0001 affected3,123 at risk EG0010 affected1,477 at risk EG0021 affected1,474 at risk
Bronchopneumonia	Infections and infestations	MedDRA	Non-systematic Assessment	EG0004 affected3,123 at risk EG0013 affected1,477 at risk EG0026 affected1,474 at risk
Cellulitis	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected3,123 at risk EG0011 affected1,477 at risk EG0021 affected1,474 at risk
Dengue Fever	Infections and infestations	MedDRA	Non-systematic Assessment	EG0005 affected3,123 at risk EG0018 affected1,477 at risk EG0023 affected1,474 at risk
Diarrhoea Infectious	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected3,123 at risk EG0010 affected1,477 at risk EG0021 affected1,474 at risk
Dysentery	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected3,123 at risk EG0011 affected1,477 at risk EG0021 affected1,474 at risk
Encephalitis Viral	Infections and infestations	MedDRA	Non-systematic Assessment	EG0001 affected3,123 at risk EG0010 affected1,477 at risk EG0020 affected1,474 at risk
Gastroenteritis	Infections and infestations	MedDRA	Non-systematic Assessment	EG00018 affected3,123 at risk EG00110 affected1,477 at risk EG00212 affected1,474 at risk
Hepatitis A	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected3,123 at risk EG0010 affected1,477 at risk EG0021 affected1,474 at risk
Lower Respiratory Tract Infection Viral	Infections and infestations	MedDRA	Non-systematic Assessment	EG0001 affected3,123 at risk EG0010 affected1,477 at risk EG0020 affected1,474 at risk
Mastoiditis	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected3,123 at risk EG0011 affected1,477 at risk EG0020 affected1,474 at risk
Measles	Infections and infestations	MedDRA	Non-systematic Assessment	EG0001 affected3,123 at risk EG0010 affected1,477 at risk EG0020 affected1,474 at risk
Meningitis Pneumococcal	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected3,123 at risk EG0010 affected1,477 at risk EG0021 affected1,474 at risk
Nasopharyngitis	Infections and infestations	MedDRA	Non-systematic Assessment	EG0001 affected3,123 at risk EG0011 affected1,477 at risk EG0020 affected1,474 at risk
Otitis Media	Infections and infestations	MedDRA	Non-systematic Assessment	EG0001 affected3,123 at risk EG0011 affected1,477 at risk EG0020 affected1,474 at risk
Otitis Media Bacterial	Infections and infestations	MedDRA	Non-systematic Assessment	EG0001 affected3,123 at risk EG0010 affected1,477 at risk EG0020 affected1,474 at risk
Otitis Media Chronic	Infections and infestations	MedDRA	Non-systematic Assessment	EG0001 affected3,123 at risk EG0010 affected1,477 at risk EG0020 affected1,474 at risk
Parasitic Gastroenteritis	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected3,123 at risk EG0010 affected1,477 at risk EG0021 affected1,474 at risk
Pharyngitis	Infections and infestations	MedDRA	Non-systematic Assessment	EG0001 affected3,123 at risk EG0010 affected1,477 at risk EG0020 affected1,474 at risk
Pharyngotonsillitis	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected3,123 at risk EG0010 affected1,477 at risk EG0021 affected1,474 at risk
Pneumonia	Infections and infestations	MedDRA	Non-systematic Assessment	EG00026 affected3,123 at risk EG00112 affected1,477 at risk EG00213 affected1,474 at risk
Pneumonia Bacterial	Infections and infestations	MedDRA	Non-systematic Assessment	EG0001 affected3,123 at risk EG0010 affected1,477 at risk EG0020 affected1,474 at risk
Pneumonia Viral	Infections and infestations	MedDRA	Non-systematic Assessment	EG0001 affected3,123 at risk EG0010 affected1,477 at risk EG0021 affected1,474 at risk
Pyelonephritis Acute	Infections and infestations	MedDRA	Non-systematic Assessment	EG0001 affected3,123 at risk EG0010 affected1,477 at risk EG0020 affected1,474 at risk
Respiratory Syncytial Virus Infection	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected3,123 at risk EG0010 affected1,477 at risk EG0021 affected1,474 at risk
Respiratory Tract Infection Viral	Infections and infestations	MedDRA	Non-systematic Assessment	EG0001 affected3,123 at risk EG0010 affected1,477 at risk EG0020 affected1,474 at risk
Sepsis	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected3,123 at risk EG0010 affected1,477 at risk EG0022 affected1,474 at risk
Septic Shock	Infections and infestations	MedDRA	Non-systematic Assessment	EG0001 affected3,123 at risk EG0010 affected1,477 at risk EG0020 affected1,474 at risk
Shigella Infection	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected3,123 at risk EG0010 affected1,477 at risk EG0021 affected1,474 at risk
Subcutaneous abscess	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected3,123 at risk EG0011 affected1,477 at risk EG0020 affected1,474 at risk
Tonsillitis	Infections and infestations	MedDRA	Non-systematic Assessment	EG0002 affected3,123 at risk EG0011 affected1,477 at risk EG0020 affected1,474 at risk
Tooth Abscess	Infections and infestations	MedDRA	Non-systematic Assessment	EG0001 affected3,123 at risk EG0010 affected1,477 at risk EG0020 affected1,474 at risk
Thypoid Fever	Infections and infestations	MedDRA	Non-systematic Assessment	EG0001 affected3,123 at risk EG0012 affected1,477 at risk EG0020 affected1,474 at risk
Upper Respiratory Tract Infection	Infections and infestations	MedDRA	Non-systematic Assessment	EG0001 affected3,123 at risk EG0011 affected1,477 at risk EG0020 affected1,474 at risk
Urinary Tract Infection	Infections and infestations	MedDRA	Non-systematic Assessment	EG0004 affected3,123 at risk EG0012 affected1,477 at risk EG0023 affected1,474 at risk
Varicella	Infections and infestations	MedDRA	Non-systematic Assessment	EG0001 affected3,123 at risk EG0010 affected1,477 at risk EG0020 affected1,474 at risk
Viral Infection	Infections and infestations	MedDRA	Non-systematic Assessment	EG0002 affected3,123 at risk EG0010 affected1,477 at risk EG0022 affected1,474 at risk
Viral Rash	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected3,123 at risk EG0011 affected1,477 at risk EG0020 affected1,474 at risk
Accidental Exposure	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0001 affected3,123 at risk EG0010 affected1,477 at risk EG0020 affected1,474 at risk
Animal Bite	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG00022 affected3,123 at risk EG00115 affected1,477 at risk EG00214 affected1,474 at risk
Animal Scratch	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0003 affected3,123 at risk EG0010 affected1,477 at risk EG0020 affected1,474 at risk
Concussion	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0000 affected3,123 at risk EG0011 affected1,477 at risk EG0020 affected1,474 at risk
Craniocerebral Injury	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0000 affected3,123 at risk EG0011 affected1,477 at risk EG0020 affected1,474 at risk
Eye Injury	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0001 affected3,123 at risk EG0010 affected1,477 at risk EG0020 affected1,474 at risk
Fall	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0000 affected3,123 at risk EG0011 affected1,477 at risk EG0020 affected1,474 at risk
Femur Fracture	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0000 affected3,123 at risk EG0011 affected1,477 at risk EG0020 affected1,474 at risk
Forearm Fracture	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0001 affected3,123 at risk EG0010 affected1,477 at risk EG0021 affected1,474 at risk
Head Injury	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0000 affected3,123 at risk EG0010 affected1,477 at risk EG0021 affected1,474 at risk
Humerus Fracture	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0000 affected3,123 at risk EG0011 affected1,477 at risk EG0020 affected1,474 at risk
Multiple Injuries	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0000 affected3,123 at risk EG0011 affected1,477 at risk EG0020 affected1,474 at risk
Radius Fracture	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0000 affected3,123 at risk EG0011 affected1,477 at risk EG0020 affected1,474 at risk
Road Traffic Accident	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0000 affected3,123 at risk EG0011 affected1,477 at risk EG0020 affected1,474 at risk
Skull Fracture	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0000 affected3,123 at risk EG0011 affected1,477 at risk EG0020 affected1,474 at risk
Subdural Haemorrhage	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0000 affected3,123 at risk EG0011 affected1,477 at risk EG0020 affected1,474 at risk
Thermal Burn	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0001 affected3,123 at risk EG0011 affected1,477 at risk EG0020 affected1,474 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA	Non-systematic Assessment	EG0000 affected3,123 at risk EG0011 affected1,477 at risk EG0020 affected1,474 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA	Non-systematic Assessment	EG0000 affected3,123 at risk EG0011 affected1,477 at risk EG0021 affected1,474 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA	Non-systematic Assessment	EG0000 affected3,123 at risk EG0011 affected1,477 at risk EG0020 affected1,474 at risk
Malnutrition	Metabolism and nutrition disorders	MedDRA	Non-systematic Assessment	EG0001 affected3,123 at risk EG0010 affected1,477 at risk EG0020 affected1,474 at risk
Metabolic Acidosis	Metabolism and nutrition disorders	MedDRA	Non-systematic Assessment	EG0000 affected3,123 at risk EG0011 affected1,477 at risk EG0020 affected1,474 at risk
Tetany	Metabolism and nutrition disorders	MedDRA	Non-systematic Assessment	EG0000 affected3,123 at risk EG0010 affected1,477 at risk EG0021 affected1,474 at risk
Acute Lymphocytic Leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0000 affected3,123 at risk EG0012 affected1,477 at risk EG0020 affected1,474 at risk
Cholesteatoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0000 affected3,123 at risk EG0011 affected1,477 at risk EG0020 affected1,474 at risk
Convulsion	Nervous system disorders	MedDRA	Non-systematic Assessment	EG0000 affected3,123 at risk EG0012 affected1,477 at risk EG0020 affected1,474 at risk
Febrile Convulsion	Nervous system disorders	MedDRA	Non-systematic Assessment	EG00013 affected3,123 at risk EG0014 affected1,477 at risk EG0023 affected1,474 at risk
Adenoidal Hypertrophy	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0001 affected3,123 at risk EG0010 affected1,477 at risk EG0020 affected1,474 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0004 affected3,123 at risk EG0013 affected1,477 at risk EG0021 affected1,474 at risk
Asthmatic Crisis	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected3,123 at risk EG0010 affected1,477 at risk EG0021 affected1,474 at risk
Atelectasis	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0001 affected3,123 at risk EG0010 affected1,477 at risk EG0020 affected1,474 at risk
Bronchial Hyperreactivity	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0001 affected3,123 at risk EG0010 affected1,477 at risk EG0020 affected1,474 at risk
Bronchospasm	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0003 affected3,123 at risk EG0011 affected1,477 at risk EG0020 affected1,474 at risk
Tonsillary Hypertrophy	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0001 affected3,123 at risk EG0010 affected1,477 at risk EG0020 affected1,474 at risk
Dermatitis Allergic	Skin and subcutaneous tissue disorders	MedDRA	Non-systematic Assessment	EG0000 affected3,123 at risk EG0010 affected1,477 at risk EG0021 affected1,474 at risk
Swelling Face	Skin and subcutaneous tissue disorders	MedDRA	Non-systematic Assessment	EG0000 affected3,123 at risk EG0011 affected1,477 at risk EG0020 affected1,474 at risk
Finger Amputation	Surgical and medical procedures	MedDRA	Non-systematic Assessment	EG0001 affected3,123 at risk EG0010 affected1,477 at risk EG0020 affected1,474 at risk
Roseola	Infections and infestations	MedDRA	Non-systematic Assessment	EG0001 affected3,123 at risk EG0010 affected1,477 at risk EG0020 affected1,474 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Diarrhea	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG000445 affected3,123 at risk EG001247 affected1,477 at risk EG002231 affected1,474 at risk
Vomiting	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG000257 affected3,123 at risk EG001107 affected1,477 at risk EG002109 affected1,474 at risk
Crying	General disorders	MedDRA	Systematic Assessment	EG000186 affected3,123 at risk EG001105 affected1,477 at risk EG002124 affected1,474 at risk
Fatigue	General disorders	MedDRA	Systematic Assessment	EG000204 affected3,123 at risk EG00143 affected1,477 at risk EG00231 affected1,474 at risk
Injection site erythema	General disorders	MedDRA	Systematic Assessment	EG000312 affected3,123 at risk EG001109 affected1,477 at risk EG002102 affected1,474 at risk
Injection site hemorrhage	General disorders	MedDRA	Systematic Assessment	EG000191 affected3,123 at risk EG00172 affected1,477 at risk EG00286 affected1,474 at risk
Injection site induration	General disorders	MedDRA	Systematic Assessment	EG000258 affected3,123 at risk EG00162 affected1,477 at risk EG00267 affected1,474 at risk
Injection site pain	General disorders	MedDRA	Systematic Assessment	EG000851 affected3,123 at risk EG001177 affected1,477 at risk EG002189 affected1,474 at risk
Injection site swelling	General disorders	MedDRA	Systematic Assessment	EG000217 affected3,123 at risk EG00134 affected1,477 at risk EG00243 affected1,474 at risk
Irritability postvaccinal	General disorders	MedDRA	Systematic Assessment	EG000290 affected3,123 at risk EG001165 affected1,477 at risk EG002191 affected1,474 at risk
Pyrexia	General disorders	MedDRA	Systematic Assessment	EG000795 affected3,123 at risk EG001279 affected1,477 at risk EG002260 affected1,474 at risk
Gastroenteritis	Infections and infestations	MedDRA	Non-systematic Assessment	EG000112 affected3,123 at risk EG00170 affected1,477 at risk EG00284 affected1,474 at risk
Nasopharyngitis	Infections and infestations	MedDRA	Non-systematic Assessment	EG000291 affected3,123 at risk EG001151 affected1,477 at risk EG002175 affected1,474 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA	Non-systematic Assessment	EG000452 affected3,123 at risk EG001237 affected1,477 at risk EG002246 affected1,474 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA	Non-systematic Assessment	EG000437 affected3,123 at risk EG001197 affected1,477 at risk EG002206 affected1,474 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG000216 affected3,123 at risk EG00143 affected1,477 at risk EG00225 affected1,474 at risk
Headache	Nervous system disorders	MedDRA	Systematic Assessment	EG000286 affected3,123 at risk EG00148 affected1,477 at risk EG00240 affected1,474 at risk
Hypersomnia	Nervous system disorders	MedDRA	Systematic Assessment	EG000229 affected3,123 at risk EG001150 affected1,477 at risk EG002153 affected1,474 at risk

ID	Term
D007251	Influenza, Human

ID	Term
D007252	Influenza Vaccines
C478243	fluad vaccine

Units	Counts
Participants	OG000266 OG001389 OG002387

Units	Counts
Participants	OG000266 OG001389 OG002387

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

Subjects received an investigational trivalent split influenza vaccine (TIV), subjects aged between 6 to <36 months received two doses (Day 1 & 29) while subjects aged ≥36 months received one dose (Day 1) of the vaccine

OG004912(849 to 979)

OG005695(648 to 746)

OG0062311(2080 to 2568)

OG0071526(1309 to 1780)

OG0081497(1289 to 1739)

OG004149(136 to 164)

OG005141(128 to 155)

OG006431(380 to 488)

OG007226(188 to 272)

OG008254(212 to 304)

OG004603(350 to 1040)

OG005519(283 to 950)

OG0062187(956 to 5002)

OG0071241(583 to 2641)

OG0081030(383 to 2767)

OG004794(552 to 1140)

OG005665(447 to 988)

OG0062319(1622 to 3315)

OG0071306(940 to 1815)

OG008826(538 to 1267)

OG006365(184 to 724)

OG007200(108 to 372)

OG008312(131 to 743)

OG004905(845 to 968)

OG005686(641 to 733)

OG0062343(2120 to 2589)

OG0071582(1370 to 1826)

OG0081475(1278 to 1703)

OG004150(137 to 164)

OG005139(127 to 152)

OG006432(383 to 487)

OG007243(205 to 289)

OG008253(212 to 300)

OG004617(370 to 1028)

OG005483(289 to 808)

OG0061982(929 to 4228)

OG0071478(756 to 2891)

OG0081028(445 to 2372)

OG004820(578 to 1164)

OG005705(496 to 1000)

OG0062197(1514 to 3187)

OG0071286(925 to 1788)

OG008929(616 to 1399)

OG006319(170 to 596)

OG007197(114 to 341)

OG008241(118 to 493)

ID	Term
D012141	Respiratory Tract Infections
D007239	Infections
D009976	Orthomyxoviridae Infections
D012327	RNA Virus Infections
D014777	Virus Diseases
D012140	Respiratory Tract Diseases

ID	Term
D014765	Viral Vaccines
D014612	Vaccines
D001688	Biological Products
D045424	Complex Mixtures