Clinical Study to Evaluate the Safety, Immunogenicity and Efficacy of Investigational Flu Vaccine Compared to Approved Flu Vaccine in Children.

Influenza Virus Clinical Trial

Official title:

A Phase III, Stratified, Randomized, Observer Blind, Controlled, Multicenter Clinical Study to Evaluate the Safety, Immunogenicity and Efficacy of an Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine Compared to Non-Adjuvanted Comparator Influenza Vaccine in Children ≥6 to < 72 Months of Age.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01964989
• Other study ID #: V118_05
• Secondary ID: 2012-000218-12
• Status: Completed
• Phase: Phase 3
• Start date: November 2013
• Est. completion date: August 2016

Study information

• Verified date: March 2023
• Source: Seqirus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Safety, Immunogenicity and Efficacy of an Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine Compared to Non-Adjuvanted Comparator Influenza Vaccine in Children ≥6 to <72 Months of Age. The study was conducted during the 2013/2014 and 2014/2015 northern hemisphere influenza season.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10644
• Est. completion date: August 2016
• Est. primary completion date: October 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months to 71 Months

Eligibility

Inclusion Criteria:

• Children, males and females, healthy or at high risk of complications from influenza, between =6 months to <72 months of age

• Documented consent provided by the subject's parent(s)/legal guardian(s)

• Subjects and/or subject's parent(s)/legal guardian(s) able to comply with all study procedures.

Exclusion Criteria:

• Children with history of allergy to vaccine components.

• Additional eligibility criteria may be discussed by contacting the site

Related Conditions & MeSH terms

• Influenza Virus
• Influenza, Human

Intervention

Biological:
• Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)
1 or 2 doses (naïve / non-naive subjects) 0.25 ml: =6 months to <36 months, 0.5 ml: =36 months to <72 months
• Non-adjuvanted Trivalent Influenza Vaccine (TIV) / Quadrivalent Influenza Vaccine (QIV)
1 or 2 doses (naïve / non-naive subjects) 0.25 ml: =6 months to <36 months, 0.5 ml: =36 months to <72 months

Locations

Country	Name	City	State
Canada	180, Novartis Investigational Site	Newmarket	Ontario
Canada	186, Novartis Investigational Site	Quebec
Canada	183, Novartis Investigational Site	Québec
Canada	184, Novartis Investigational Site	Sudbury	Ontario
Canada	182,Novartis Investigational Site	Toronto	Ontario
Finland	001, Novartis Investigational Site	Espoo
Finland	002, Novartis Investigational Site	Helsinki
Finland	003, Novartis Investigational Site	Helsinki
Finland	004, Novartis Investigational Site	Järvenpää
Finland	005, Novartis Investigational Site	Kokkola
Finland	006, Novartis Investigational Site	Oulu
Finland	007, Novartis Investigational Site	Pori
Finland	008, Novartis Investigational Site	Seinäjoki
Finland	009, Novartis Investigational Site	Tampere
Finland	010, Novartis Investigational Site	Turku
Finland	011, Novartis Investigational Site	Vantaa
Italy	030, Novartis Investigational Site	Florence
Italy	023, Novartis Investigational Site	Genova
Italy	020, Novartis Investigational Site	Milano
Italy	026, Novartis Investigational Site	Milano
Italy	025, Novartis Investigational Site	Napoli
Italy	021, Novartis Investigational Site	Novara
Italy	022, Novartis Investigational Site	Padova
Italy	024, Novartis Investigational Site	Pisa
Italy	028, Novartis Investigational Site	Sassari
Mexico	176, Novartis Investigational Site	Durango
Mexico	170, Novartis Investigational Site	Mexico
Mexico	175, Novartis Investigational Site	Mexico
Mexico	177, Novartis Investigational Site	Mexico
Mexico	178, Novartis Investigational Site	Mexico
Mexico	173, Novartis Investigational Site	Morelia	Michoacan
Philippines	306, Novartis Investigational Site	Alabang	Muntilupa
Philippines	300, Novartis Investigational Site	Dasmariñas	Cavite
Philippines	301, Novartis Investigational Site	Manila
Philippines	302, Novartis Investigational Site	Manila
Philippines	303, Novartis Investigational Site	Muntinlupa
Philippines	304, Novartis Investigational Site	Muntinlupa
Philippines	305, Novartis Investigational Site	Muntinlupa
Poland	040, Novartis Investigational Site	Debica
Poland	042, Novartis Investigational Site	Katowice
Poland	052, Novartis Investigational Site	Leczna
Poland	048, Novartis Investigational Site	Lodz
Poland	049, Novartis Investigational Site	Lubartow
Poland	051, Novartis Investigational Site	Oborniki Slaskie
Poland	046, Novartis Investigational Site	Osielsko
Poland	043, Novartis Investigational Site	Siemianowice Slaskie
Poland	047, Novartis Investigational Site	Tarnow
Poland	041, Novartis Investigational Site	Warszawa
Poland	050, Novartis Investigational Site	Warszawa
Poland	045, Novartis Investigational Site	Wola
Poland	044, Novartis Investigational Site	Wroclaw
Puerto Rico	257, Novartis Investigational Site	Ponce
Puerto Rico	415, Novartis Investigational Site	San Juan
Puerto Rico	415, Novartis Investigational vaccine	San Juan
Spain	074, Novartis Investigational Site	Granada
Spain	076, Novartis Investigational Site	Madrid
Spain	077, Novartis Investigational Site	Madrid
Spain	79, Novartis Investigational Site	Malaga
Spain	80, Novartis Investigational Site	Sabadell	Barcelona
Spain	075, Novartis Investigational Site	Santiago	Galicia
Spain	078, Novartis Investigational Site	Valencia
Taiwan	343, Novartis Investigational Site	Banciao	New Taipei City
Taiwan	346, Novartis Investigational Site	Datong	Taipei City
Taiwan	344, Novartis Investigational Site	Taichung
Taiwan	345, Novartis Investigational Site	Taichung
Taiwan	340, Novartis Investigational Site	Taipei City
Taiwan	341, Novartis Investigational Site	Taipei City
Taiwan	342, Novartis Investigational Site	Taoyuan
Thailand	320, Novartis Investigational Site	Bangkok
Thailand	324, Novartis Investigational Site	Bangkok
Thailand	321, Novartis Investigational Site	Bangkoknoi	Bangkok
Thailand	322, Novartis Investigational Site	Bangkoknoi	Bangkok
Thailand	326, Novartis Investigational Site	Hat Yai	Songkhia
Thailand	325, Novartis Investigational Site	Pathum Thani	Prathumthani
Thailand	323, Novartis Investigational Site	Pathum Wan	Bangkok
Thailand	327, Novartis Investigational Site	Ratchathewi	Bangkok
United States	240, Novartis Investigational Site	Akron	Ohio
United States	259, Novartis Investigational Site	Anaheim	California
United States	280, Novartis Investigational Site	Anaheim	California
United States	220, Novartis Investigational Site	Anderson	South Carolina
United States	262, Novartis Investigational site	Annapolis	Maryland
United States	401, Novartis iNvestiagtional Site	Atlanta	Georgia
United States	209, Novartis Investigational Site	Augusta	Kansas
United States	208, Novartis Investigational Site	Austin	Texas
United States	213, Novartis Investigational Site	Baldwin Park	California
United States	269, Novartis Investigational Site	Bardstown	Kentucky
United States	406, novartis Investigational Site	Barnwell	South Carolina
United States	221, Novartis Investigational Site	Bellevue	Nebraska
United States	255, Novartis Investigational Site	Binghamton	New York
United States	229, Novartis Investigational Site	Boca Raton	Florida
United States	409, Novartis Investigational Site	Boone	North Carolina
United States	414, Novartis Investigational Site	Brooklyn	New York
United States	251, Novartis Investigational Site	Burke	Virginia
United States	266, Novartis Investigational Site	Cary	North Carolina
United States	222, Novartis Investigational Site	Chandler	Arizona
United States	272, Novartis Investigational Site	Charleston	South Carolina
United States	254, Novartis Investigational Site	Cleveland	Ohio
United States	403, Novartis Investigational Site	Clyde	North Carolina
United States	243, Novartis Investigational Site	Colorado Springs	Colorado
United States	245, Novartis Investigational Site	Dayton	Ohio
United States	281, Novartis Investigational Site	Dayton	Ohio
United States	281, Novartis Investigational vaccines	Dayton	Ohio
United States	299, Novartis Investigational Site	DeKalb	Illinois
United States	249, Novartis Investigational Site	Denver	Colorado
United States	407, Novartis Investigational Site	Downey	California
United States	292, Novartis Investigational Site	Erie	Pennsylvania
United States	217, Novartis Investigational Site	Fort Worth	Texas
United States	247, Novartis Investigational Site	Fort Worth	Texas
United States	263, Novartis Investigational Site	Frederick	Maryland
United States	219, Novartis Investigational Site	Fremont	Nebraska
United States	267, Novartis Investigational Site	Harrisburg	Arkansas
United States	265, Novartis Investigational Site	Haughton	Louisiana
United States	244, Novartis Investigational Site	Henderson	Nevada
United States	287, Novartis Investigational Site	Hialeah	Florida
United States	416, Novartis Investigational Site	Hialeah	Florida
United States	412, Novartis Investigational Site	Homestead	Florida
United States	238, Novartis Investigational Site	La Puente	California
United States	286, Novartis Investigational site	Las Vegas	Nevada
United States	295, Novartis Investigational Site	Layton	Utah
United States	207, Novartis Investigational Site	Louisville	Kentucky
United States	226, Novartis Investigational Site	Louisville	Kentucky
United States	248, Novartis Investigational Site	Louisville	Kentucky
United States	290, Novartis Investigational Site	Louisville	Kentucky
United States	408, Novartis Investigational Site	Mangham	Louisiana
United States	224, Novartis Investigational Site	Melbourne	Florida
United States	225, Novartis Investigational Site	Metairie	Louisiana
United States	233, Novartis Investigational Site	Metairie	Louisiana
United States	277,Novartis Investigational Site	Miami	Florida
United States	285, Novartis Investigational Site	Miami	Florida
United States	404, Novartis Investigational Site	Miami	Florida
United States	417, Novartis Investigational Site	Miami	Florida
United States	232, Novartis Investigational Site	Moncks Corner	South Carolina
United States	418, Novartis Investigational SIte	Monroe	Louisiana
United States	283, Novartis Investigational Site	Nashville	Tennessee
United States	210, Novartis Investigational Site	Newton	Kansas
United States	228, Novartis Investigational Site	Omaha	Nebraska
United States	288, Novartis Investigational Site	Omaha	Nebraska
United States	402, Novartis Investigational Site	Omaha	Nebraska
United States	411, Novartis Investigational Site	Ontario	California
United States	234, Novartis Investigational Site	Opa-locka	Florida
United States	297, Novartis Investigational Site	Orlando	Florida
United States	297, Novartis Investigational vaccine	Orlando	Florida
United States	202, Novartis Investigational Site	Paramount	California
United States	274 Novartis Investigational Site	Park City	Kansas
United States	268, Novartis Investigational Site	Peoria	Illinois
United States	278, Novartis Investigational Site	Saint Paul	Minnesota
United States	212, Novartis Investigational Site	Salt Lake City	Utah
United States	236, Novartis Investigational Site	Salt Lake City	Utah
United States	246, Novartis Investigational Site	Salt Lake City	Utah
United States	214, Novartis Investigational Site	San Angelo	Texas
United States	400, Novartis investigational Site	San Antonio	Texas
United States	250, Novartis Investigational Site	San Diego	California
United States	293, Novartis Investigational Site	San Francisco	California
United States	410, Novartis Investigational Site	Sarasota	Florida
United States	270, Novartis Investigational Site	Scottdale	Pennsylvania
United States	405, Novartis Investigational Site	Silver Spring	Maryland
United States	279, Novartis Investigational Site	Spanish Fork	Utah
United States	291, Novartis Investigational vaccine	Spartanburg	South Carolina
United States	264, Novartis Investigational Site	Syracuse	New York
United States	282, Novartis Investigational Site	Syracuse	Utah
United States	260, Novartis Investigational Site	Tomball	Texas
United States	256, Novartis Investigational Site	Tulsa	Oklahoma
United States	296, Novartis Investigational Site	Vienna	Virginia
United States	294, Novartis Investigational Site	West Haven	Utah
United States	201, Novartis Investigational Site	West Jordan	Utah
United States	271, Novartis Investigational Site	West Jordan	Utah
United States	211, Novartis Investigational Site	Wichita	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
Seqirus	Novartis Vaccines

Countries where clinical trial is conducted

United States,  Canada,  Finland,  Italy,  Mexico,  Philippines,  Poland,  Puerto Rico,  Spain,  Taiwan,  Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy Endpoint: First-Occurrence Reverse Transcription-Polymerase Chain Reaction (RT-PCR) Confirmed Influenza A and/or B of Any Influenza Strain in Subjects =6 to <72 Months of Age	Relative efficacy of aQIV compared to non-adjuvanted comparator (TIV/QIV) was determined by the number of subjects =6 to <72 months of age with RT-PCR confirmed occurrence of influenza A and/or B of any influenza strain that occurred at =21 days and =180 days after the last vaccination or until the end of the influenza season, whichever was longer. Efficacy was determined on influenza cases caused by any of the influenza strains related to the two A subtypes and the B lineage(s) common to aQIV and TIV (i.e. A/H1N1, A/H3N2 and B/Yamagata during first influenza season), and common to aQIV and QIV (i.e. A/H1N1, A/H3N2 and both B lineages during second season and through the end of the trial).	=21 days and =180 days after the last vaccination or until the end of the influenza season (Northern Hemisphere: end of June; Southern Hemisphere: end of December; Philippines/Thailand: end of October), whichever was longer
Secondary	Efficacy Endpoint: First-Occurrence RT-PCR Confirmed Influenza A and/or B of Any Influenza Strain in Subjects =6 to <24 Months, =6 to <36 Months and =36 to <72 Months of Age.	Relative efficacy of aQIV compared to non-adjuvanted comparator (TIV/QIV) was determined by the number of subjects with RT-PCR confirmed occurrence of influenza A and/or B of any influenza strain that occurred at =21 days and =180 days after the last vaccination or until the end of the influenza season, whichever was longer. Efficacy was determined on influenza cases caused by any of the influenza strains related to the two A subtypes and the B lineage(s) common to aQIV and TIV (i.e. A/H1N1, A/H3N2 and B/Yamagata during first influenza season), and common to aQIV and QIV (i.e. A/H1N1, A/H3N2 and both B lineages during second season and through the end of the trial).	=21 days and =180 days after the last vaccination or until the end of the influenza season (Northern Hemisphere: end of June; Southern Hemisphere: end of December; Philippines/Thailand: end of October), whichever was longer
Secondary	Efficacy Endpoint: First-Occurrence Culture Confirmed Influenza A and/or B of Any Influenza Strain in Subjects =6 to <72 Months, =6 to <24 Months, =6 to <36 Months and =36 to <72 Months of Age	Relative efficacy of aQIV compared to non-adjuvanted comparator (TIV/QIV) was determined by the number of subjects with culture confirmed occurrence of influenza A and/or B of any influenza strain that occurred at =21 days and =180 days after the last vaccination or until the end of the influenza season, whichever was longer. Efficacy was determined on influenza cases caused by any of the influenza strains related to the two A subtypes and the B lineage(s) common to aQIV and TIV (i.e. A/H1N1, A/H3N2 and B/Yamagata during first influenza season), and common to aQIV and QIV (i.e. A/H1N1, A/H3N2 and both B lineages during second season and through the end of the trial).	=21 days and =180 days after the last vaccination or until the end of the influenza season (Northern Hemisphere: end of June; Southern Hemisphere: end of December; Philippines/Thailand: end of October), whichever was longer
Secondary	Efficacy Endpoint: First-occurrence RT-PCR and Culture Confirmed Influenza A and/or B of Any Influenza Strain in Subjects at High Risk of Influenza Complications	Relative efficacy of aQIV compared to non-adjuvanted comparator (TIV/QIV) was determined by the number of subjects =6 to <72 months of age with RT-PCR confirmed and culture confirmed occurrence of influenza A and/or B of any influenza strain that occurred at =21 days and =180 days after the last vaccination or until the end of the influenza season, whichever was longer, in healthy subjects and subjects at risk of influenza related complications. Efficacy was determined on influenza cases caused by any of the influenza strains related to the two A subtypes and the B lineage(s) common to aQIV and TIV (i.e. A/H1N1, A/H3N2 and B/Yamagata during first influenza season), and common to aQIV and QIV (i.e. A/H1N1, A/H3N2 and both B lineages during second season and through the end of the trial).	=21 days and =180 days after the last vaccination or until the end of the influenza season (Northern Hemisphere: end of June; Southern Hemisphere: end of December; Philippines/Thailand: end of October), whichever was longer
Secondary	Efficacy Endpoint: First-occurrence RT-PCR and Culture Confirmed Influenza A and/or B of Any Influenza Strain in Naive and Non-naive Subjects Separately	Relative efficacy of aQIV compared to non-adjuvanted comparator (TIV/QIV) was determined by the number of subjects with RT-PCR confirmed occurrence of influenza A and/or B of any influenza strain that occurred at =21 days and =180 days after the last vaccination or until the end of the influenza season, whichever was longer. Efficacy was determined on influenza cases caused by any of the influenza strains related to the two A subtypes and the B lineage(s) common to aQIV and TIV (i.e. A/H1N1, A/H3N2 and B/Yamagata during first influenza season), and common to aQIV and QIV (i.e. A/H1N1, A/H3N2 and both B lineages during second season and through the end of the trial).	=21 days and =180 days after the last vaccination or until the end of the influenza season (Northern Hemisphere: end of June; Southern Hemisphere: end of December; Philippines/Thailand: end of October), whichever was longer
Secondary	Efficacy Endpoint: First-occurrence RT-PCR-confirmed Influenza A and/or B of Any Influenza Strain in Subjects =6 to <72 Months of Age at =7 Days and at =14 Days After First Vaccination up to the Day of Second Vaccination in Vaccine naïve Subjects Only	Relative efficacy of aQIV compared to non-adjuvanted comparator (TIV/QIV) was based on the number of vaccine naive subjects =6 to <72 months of age with RT-PCR confirmed occurrence of influenza A and/or B of any influenza strain that occurred at =7 days and =14 days after the first vaccination up to the day of the second vaccination. TIV was used as the comparator in Season 1; and QIV was used as the comparator in Season 2. Efficacy was determined on influenza cases caused by any of the influenza strains related to the two A subtypes and the B lineage(s) common to aQIV and TIV (i.e. A/H1N1, A/H3N2 and B/Yamagata during first influenza season), and common to aQIV and QIV (i.e. A/H1N1, A/H3N2 and both B lineages during second season and through the end of the trial).	=7 days and at =14 days after first vaccination up to day of second vaccination
Secondary	Efficacy Endpoint: First-occurrence RT-PCR-confirmed Influenza A and/or B of Any Influenza Strain in Subjects =6 to <72 Months of Age Occurring at =7 Days and =21 Days After Last Vaccination, in All Subjects.	Relative efficacy of aQIV compared to non-adjuvanted comparator (TIV/QIV) was based on the number of vaccine naïve subjects =6 to <72 months of age with RT-PCR confirmed occurrence of influenza A and/or B of any influenza strain that occurred at =7 days and =21 after the last vaccination. TIV was used as the comparator in Season 1; and QIV was used as the comparator in Season 2. Efficacy was determined on influenza cases caused by any of the influenza strains related to the two A subtypes and the B lineage(s) common to aQIV and TIV (i.e. A/H1N1, A/H3N2 and B/Yamagata during first influenza season), and common to aQIV and QIV (i.e. A/H1N1, A/H3N2 and both B lineages during second season and through the end of the trial).	=7 days and =21 days after the last vaccination
Secondary	Immunogenicity Endpoint: Hemagglutination Inhibition (HI) Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Geometric Mean Titers (GMTs) and GMT Ratios in Subjects =6 to <72 Months of Age	Pooled GMT values across both naïve and non-naïve subjects are provided for the Day 22/50 (ie, 21 days after last vaccination) and Day 181/209 (ie, 180 days after last vaccination) assessments; Nonadjuvanted TIV administered in Season 1 and nonadjuvanted QIV administered in Season 2; Homologous strains: A/H1N1=A/California/7/2009 pdm09-like virus, A/H3N2=A/Texas/50/2012, B/ Yamagata=B/Massachusetts/2/2012 and B/Victoria=B/Brisbane/60/2008; For B/Victoria results from Season 2 only are presented for both vaccine groups and used in the vaccine comparison analysis.	Baseline (Day 1), Day 29, Day 50 and Day 209 for vaccine naïve subjects; Baseline (Day 1), Day 22 and Day 181 for vaccine non-naïve subjects
Secondary	Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Geometric Mean Titers (GMTs) in Vaccine Naive Subjects =6 to <72 Months of Age	GMTs for vaccine naïve subjects are provided by strain for Day 29 and Day 50; Nonadjuvanted TIV administered in Season 1 and nonadjuvanted QIV administered in Season 2; Homologous strains: A/H1N1=A/California/7/2009 pdm09-like virus, A/H3N2=A/Texas/50/2012, B/ Yamagata=B/Massachusetts/2/2012 and B/Victoria=B/Brisbane/60/2008; For B/Victoria results from Season 2 only are presented for both vaccine groups and used in the vaccine comparison analysis.	Day 29 and Day 50
Secondary	Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms GMT and GMT Ratios at 21 Days After Last Vaccination in Healthy vs High Risk Subjects =6 to <72 Months of Age	HI GMT was assessed on Day 1 and Day 50 for vaccine naïve healthy vs high risk subjects; and HI GMT were assessed on Day 1 and Day 22 for vaccine non-naïve healthy vs high risk subjects; pooled GMT values across both naïve and non-naïve subjects are provided for Day 22/50 (ie, 21 days after last vaccination) assessments.	Baseline (Day 1) and 21 days after the last vaccination (Day 50 for vaccine naive subjects; Day 22 for vaccine non-naïve subjects)
Secondary	Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Geometric Mean Ratios (GMR) in Subjects =6 to <72 Months of Age	The fold-increase in HI antibodies in response to vaccination was assessed as the GMR between all post-vaccination titers (ie, Day 29, 50, 209 for vaccine naïve subjects; Day 22, 181 for vaccine non-naïve subjects) and the baseline (Day 1) titer. Assessed GMRs thus correspond to Day 29/Day 1, Day 50/Day 1, and Day 209/Day 1 for vaccine naïve subjects and Day 22/Day 1 and Day 181/Day 1 for vaccine non-naïve subjects. Pooled GMR values across both naïve and non-naïve subjects are provided for Day (22/50)/Day 1 (ie, 21 days after last vaccination) and Day (181/209)/Day 1 (ie, 180 days after last vaccination); Nonadjuvanted TIV administered in Season 1 and nonadjuvanted QIV administered in Season 2; Homologous strains: A/H1N1=A/California/7/2009 pdm09-like virus, A/H3N2=A/Texas/50/2012, B/Yamagata=B/Massachusetts/2/2012 and B/Victoria=B/Brisbane/60/2008; For B/Victoria results from Season 2 only are presented for both vaccine groups and used in the vaccine comparison analysis.	Baseline (Day 1), Day 29, Day 50 and Day 209 for vaccine naïve subjects; Baseline (Day 1), Day 22 and Day 181 for vaccine non-naïve subjects
Secondary	Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Seroconversion (SC) Rates and Difference in SC Rates at 21 Days in Subjects =6 to <72 Months of Age	SC rates were assessed on Day 1 and Day 50 (ie, 21 days after two vaccinations) for vaccine naïve subjects; and on Day 1 and Day 22 (ie, 21 days after one vaccination) for vaccine non-naïve subjects; values pooled across naive and non-naive subjects are provided. Seroconversion is defined as HI = 1:40 for subjects negative at baseline (ie, HI titer<1:10); or a minimum 4-fold increase in HI titer for subjects positive at baseline (ie, HI titer = 1:10); Nonadjuvanted TIV administered in Season 1 and nonadjuvanted QIV administered in Season 2; Homologous strain: A/H1N1=A/California/7/2009 pdm09-like virus, A/H3N2=A/Texas/50/2012, B/Yamagata=B/Massachusetts/2/2012 and B/Victoria=B/Brisbane/60/2008; For B/Victoria results from Season 2 only are presented for both vaccine groups and used in the vaccine.; comparison analysis (N=745 for aQIV, N=738 for comparator).	Baseline (Day 1) and 21 days after the last vaccination (Day 50 for vaccine naive subjects; Day 22 for vaccine non-naïve subjects)
Secondary	Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Percentage of Subjects With HI Titer = 1:40 and Percentage Differences at 180 Days After Last Vaccination in Subjects =6 to <72 Months of Age	Antibody response was assessed as the percentage of subjects with HI titer of =1:40 at 180 days after last vaccination (ie, Day 209 for vaccine naïve subjects and Day 181 for vaccine non-naïve subjects). Results were then pooled across both vaccine naïve and non-naïve subjects. Homologous strains: A/H1N1=A/California/7/2009 pdm09-like virus, A/H3N2=A/Texas/50/2012, B/Yamagata=B/Massachusetts/2/2012 and B/Victoria=B/Brisbane/60/2008; B/Victoria results from Season 1 and Season 2 (aQIV) and Season 2 (comparator) are presented.	Baseline (Day 1) and 180 days after the last vaccination (Day 209 for vaccine naive subjects; Day 181 for vaccine non-naïve subjects)
Secondary	Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Percentage of Subjects With HI Titers =1:110, =1:151, =1:215, =1:330, and =1:629 in Subjects =6 to <72 Months of Age	Antibody response was assessed as the percentage of subjects and differences of percentage of subjects with HI titers of =1:110, =1:151, =1:215, =1:330, and =1:629 at 21 days after last vaccination (ie, Day 50 for vaccine naïve subjects and Day 22 for vaccine non-naïve subjects). Results were then pooled across both vaccine naïve and non-naïve subjects. Homologous strains: A/H1N1=A/California/7/2009 pdm09-like virus, A/H3N2=A/Texas/50/2012, B/Yamagata=B/Massachusetts/2/2012 and B/Victoria=B/Brisbane/60/2008; B/Victoria results from Season 1 and Season 2 (aQIV) and Season 2 (comparator) are presented.	Baseline (Day 1) and 21 days after the last vaccination (Day 50 for vaccine naive subjects; Day 22 for vaccine non-naïve subjects)
Secondary	Immunogenicity Endpoint: Hemagglutination Inhibition (HI) Antibody Responses to aQIV vs TIV/QIV Against Heterologous Strains in Terms of Geometric Mean Titers (GMTs) in Subjects =6 to <72 Months of Age	HI GMT was assessed 21 days after last vaccination (Day 50 for vaccine naïve subjects and Day 22 for vaccine non-naive subjects) pooled GMT values across both naïve and non-naïve subjects are provided for the Day 22/50 (ie, 21 days after last vaccination); Heterologous strains: H1N1=A/Brisbane/59/2007- like; H3N2 =A/Hong Kong/4801/2014; B/Yamagata=B/Phuket/3073/2013-like; B Victoria=B/Malaysia/2506/2004; For B/Victoria results from Season 2 only are presented for both vaccine groups.	21 days after the last vaccination (Day 50 for vaccine naive subjects; Day 22 for vaccine non-naïve subjects)
Secondary	Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Heterologous Strains in Terms of Seroconversion (SC) Rates in Subjects =6 to <72 Months of Age	SC rates were assessed on Day 50 (ie, 21 days after two vaccinations) for vaccine naïve subjects; and on Day 22 (ie, 21 days after one vaccination) for vaccine non-naïve subjects; values pooled across naive and non-naive subjects are provided. Seroconversion is defined as HI = 1:40 for subjects negative at baseline (ie, HI titer<1:10); or a minimum 4-fold increase in HI titer for subjects positive at baseline (ie, HI titer = 1:10); Heterologous strains include: H1N1=A/Brisbane/59/2007- like; H3N2 =A/Hong Kong/4801/2014; B/Yamagata=B/Phuket/3073/2013- like; B Victoria=B/Malaysia/2506/2004; For B/Victoria results from Season 2 only are presented for both vaccine groups	21 days after the last vaccination (Day 50 for vaccine naive subjects; Day 22 for vaccine non-naïve subjects)
Secondary	Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Heterologous Strains in Terms of Percentage of Subjects With HI Titer = 1:40 in Subjects =6 to <72 Months of Age	Antibody persistence was assessed as the percentage of subjects with HI titer of =1:40 at 21 days after last vaccination (ie, Day 50 for vaccine naïve subjects and Day 22 for vaccine non-naïve subjects). Results were then pooled across both vaccine naïve and non-naïve subjects; Heterologous strains: H1N1=A/Brisbane/59/2007- like; H3N2 =A/Hong Kong/4801/2014; B/Yamagata=B/Phuket/3073/2013- like; B Victoria=B/Malaysia/2506/2004; For B/Victoria results from Season 2 only are presented for both vaccine groups.	21 days after the last vaccination (Day 50 for vaccine naive subjects; Day 22 for vaccine non-naïve subjects)
Secondary	Safety Endpoint: Number of Subjects With Solicited Local and Systemic AEs	Subjects =6 to <72 months of age reporting solicited local and systemic reactions, day 1 to day 7 after vaccination with either aQIV or TIV/QIV.	7 days following each vaccination
Secondary	Safety Endpoint: Number of Subjects With Unsolicited AEs, SAEs, AEs Leading to Withdrawal From the Study or Study Vaccination, NOCDs and AESIs	Safety was assessed in terms of number of subjects =6 to <72 months of age reporting unsolicited reactions (Day 1 to Day 50 for vaccine naïve subjects and from Day 1 to Day 22 for vaccine non-naïve subjects); Serious Adverse Events (SAEs), AEs leading to New Onset of Chronic Diseases,(NOCD), Adverse Events of Special Interests (AESI), AEs leading to withdrawal from the study or study vaccination after vaccination with either aQIV or TIV/QIV were collected up to 12 months after last vaccination.	Day 1 though Day 366 (vaccine non-naive)/Day 390 (vaccine naive)
Secondary	Healthcare Utilization and Health Economic Endpoints: Number of Days of Daycare, School or Preschool Missed by Subjects Associated With RT-PCR-confirmed Influenza		within a window of 14 days after influenza-like illness (ILI)-onset
Secondary	Healthcare Utilization and Health Economic Endpoint: Number of Medical Visit for Respiratory Illness Associated With RT-PCR-confirmed Influenza		within a window of 14 days after ILI-onset
Secondary	Healthcare Utilization and Health Economic Endpoint: Number of Employment Days Missed by Parent(s)/Guardian(s) of Subjects With RT-PCR-confirmed Influenza		within a window of 14 days after ILI-onset
Secondary	Healthcare Utilization and Health Economic Endpoint: First-occurrence of RT-PCR-confirmed Moderate-to-severe Influenza Cases as Per Prespecified Criteria in Subjects =6 to <72 Months of Age in Season 2.		=21 days and =180 days after the last vaccination or until the end of the influenza season (Northern Hemisphere: end of June; Southern Hemisphere: end of December; Philippines/Thailand: end of October), whichever was longer