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

Primary Purpose

Influenza Virus

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)

Non-adjuvanted Trivalent Influenza Vaccine (TIV) / Quadrivalent Influenza Vaccine (QIV)

About this trial

This is an interventional prevention trial for Influenza Virus focused on measuring Influenza, children

Eligibility Criteria

6 Months - 71 Months (Child)All SexesAccepts Healthy Volunteers

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

aQIV

non-adjuvanted comparator

Arm Description

flu vaccine

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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).

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).

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).

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

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).

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).

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.

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.

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.

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.

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).

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.

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.

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.

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

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.

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.

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.

Healthcare Utilization and Health Economic Endpoints: Number of Days of Daycare, School or Preschool Missed by Subjects Associated With RT-PCR-confirmed Influenza

Healthcare Utilization and Health Economic Endpoint: Number of Medical Visit for Respiratory Illness Associated With RT-PCR-confirmed Influenza

Healthcare Utilization and Health Economic Endpoint: Number of Employment Days Missed by Parent(s)/Guardian(s) of Subjects With RT-PCR-confirmed Influenza

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.

Full Information

NCT ID

NCT01964989

First Posted

October 15, 2013

Last Updated

March 22, 2023

Sponsor

Seqirus

Collaborators

Novartis Vaccines

1. Study Identification

Unique Protocol Identification Number

NCT01964989

Brief Title

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

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.

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Completed

Study Start Date

November 2013 (undefined)

Primary Completion Date

October 2015 (Actual)

Study Completion Date

August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Seqirus

Collaborators

Novartis Vaccines

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Influenza Virus

Keywords

Influenza, children

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

10644 (Actual)

8. Arms, Groups, and Interventions

Arm Title

aQIV

Arm Type

Experimental

Arm Description

flu vaccine

Arm Title

non-adjuvanted comparator

Arm Type

Active Comparator

Arm Description

flu vaccine

Intervention Type

Biological

Intervention Name(s)

Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)

Intervention Description

1 or 2 doses (naïve / non-naive subjects) 0.25 ml: ≥6 months to <36 months, 0.5 ml: ≥36 months to <72 months

Intervention Type

Biological

Intervention Name(s)

Non-adjuvanted Trivalent Influenza Vaccine (TIV) / Quadrivalent Influenza Vaccine (QIV)

Intervention Description

1 or 2 doses (naïve / non-naive subjects) 0.25 ml: ≥6 months to <36 months, 0.5 ml: ≥36 months to <72 months

Primary Outcome Measure Information:

Title

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

Description

Time Frame

≥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 Outcome Measure Information:

Title

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.

Description

Time Frame

Title

Description

Time Frame

Title

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

Description

Time Frame

Title

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

Description

Time Frame

Title

Description

Time Frame

≥7 days and at ≥14 days after first vaccination up to day of second vaccination

Title

Description

Time Frame

≥7 days and ≤21 days after the last vaccination

Title

Description

Time Frame

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

Title

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

Description

Time Frame

Day 29 and Day 50

Title

Description

Time Frame

Baseline (Day 1) and 21 days after the last vaccination (Day 50 for vaccine naive subjects; Day 22 for vaccine non-naïve subjects)

Title

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

Description

Time Frame

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

Title

Description

Time Frame

Baseline (Day 1) and 21 days after the last vaccination (Day 50 for vaccine naive subjects; Day 22 for vaccine non-naïve subjects)

Title

Description

Time Frame

Baseline (Day 1) and 180 days after the last vaccination (Day 209 for vaccine naive subjects; Day 181 for vaccine non-naïve subjects)

Title

Description

Time Frame

Baseline (Day 1) and 21 days after the last vaccination (Day 50 for vaccine naive subjects; Day 22 for vaccine non-naïve subjects)

Title

Description

Time Frame

21 days after the last vaccination (Day 50 for vaccine naive subjects; Day 22 for vaccine non-naïve subjects)

Title

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

Description

Time Frame

21 days after the last vaccination (Day 50 for vaccine naive subjects; Day 22 for vaccine non-naïve subjects)

Title

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

Description

Time Frame

21 days after the last vaccination (Day 50 for vaccine naive subjects; Day 22 for vaccine non-naïve subjects)

Title

Safety Endpoint: Number of Subjects With Solicited Local and Systemic AEs

Description

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.

Time Frame

7 days following each vaccination

Title

Safety Endpoint: Number of Subjects With Unsolicited AEs, SAEs, AEs Leading to Withdrawal From the Study or Study Vaccination, NOCDs and AESIs

Description

Time Frame

Day 1 though Day 366 (vaccine non-naive)/Day 390 (vaccine naive)

Title

Healthcare Utilization and Health Economic Endpoints: Number of Days of Daycare, School or Preschool Missed by Subjects Associated With RT-PCR-confirmed Influenza

Time Frame

within a window of 14 days after influenza-like illness (ILI)-onset

Title

Healthcare Utilization and Health Economic Endpoint: Number of Medical Visit for Respiratory Illness Associated With RT-PCR-confirmed Influenza

Time Frame

within a window of 14 days after ILI-onset

Title

Healthcare Utilization and Health Economic Endpoint: Number of Employment Days Missed by Parent(s)/Guardian(s) of Subjects With RT-PCR-confirmed Influenza

Time Frame

within a window of 14 days after ILI-onset

Title

Time Frame

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Months

Maximum Age & Unit of Time

71 Months

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Program Director

Organizational Affiliation

Seqirus

Official's Role

Study Director

Facility Information:

Facility Name

222, Novartis Investigational Site

City

Chandler

State/Province

Arizona

ZIP/Postal Code

85224

Country

United States

Facility Name

267, Novartis Investigational Site

City

Harrisburg

State/Province

Arkansas

ZIP/Postal Code

72432

Country

United States

Facility Name

259, Novartis Investigational Site

City

Anaheim

State/Province

California

ZIP/Postal Code

92801

Country

United States

Facility Name

280, Novartis Investigational Site

City

Anaheim

State/Province

California

ZIP/Postal Code

92804

Country

United States

Facility Name

213, Novartis Investigational Site

City

Baldwin Park

State/Province

California

ZIP/Postal Code

91706

Country

United States

Facility Name

407, Novartis Investigational Site

City

Downey

State/Province

California

ZIP/Postal Code

90241

Country

United States

Facility Name

238, Novartis Investigational Site

City

La Puente

State/Province

California

ZIP/Postal Code

91774

Country

United States

Facility Name

411, Novartis Investigational Site

City

Ontario

State/Province

California

ZIP/Postal Code

91762

Country

United States

Facility Name

202, Novartis Investigational Site

City

Paramount

State/Province

California

ZIP/Postal Code

90723

Country

United States

Facility Name

250, Novartis Investigational Site

City

San Diego

State/Province

California

ZIP/Postal Code

92103

Country

United States

Facility Name

293, Novartis Investigational Site

City

San Francisco

State/Province

California

ZIP/Postal Code

94102

Country

United States

Facility Name

243, Novartis Investigational Site

City

Colorado Springs

State/Province

Colorado

ZIP/Postal Code

80902

Country

United States

Facility Name

249, Novartis Investigational Site

City

Denver

State/Province

Colorado

ZIP/Postal Code

80902

Country

United States

Facility Name

229, Novartis Investigational Site

City

Boca Raton

State/Province

Florida

ZIP/Postal Code

33432

Country

United States

Facility Name

416, Novartis Investigational Site

City

Hialeah

State/Province

Florida

ZIP/Postal Code

33013

Country

United States

Facility Name

287, Novartis Investigational Site

City

Hialeah

State/Province

Florida

ZIP/Postal Code

33106

Country

United States

Facility Name

412, Novartis Investigational Site

City

Homestead

State/Province

Florida

ZIP/Postal Code

34239

Country

United States

Facility Name

224, Novartis Investigational Site

City

Melbourne

State/Province

Florida

ZIP/Postal Code

32935

Country

United States

Facility Name

417, Novartis Investigational Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33015

Country

United States

Facility Name

404, Novartis Investigational Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33144

Country

United States

Facility Name

285, Novartis Investigational Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33172

Country

United States

Facility Name

277,Novartis Investigational Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33412

Country

United States

Facility Name

234, Novartis Investigational Site

City

Opa-locka

State/Province

Florida

ZIP/Postal Code

33054

Country

United States

Facility Name

297, Novartis Investigational Site

City

Orlando

State/Province

Florida

ZIP/Postal Code

32801

Country

United States

Facility Name

297, Novartis Investigational vaccine

City

Orlando

State/Province

Florida

ZIP/Postal Code

32806

Country

United States

Facility Name

410, Novartis Investigational Site

City

Sarasota

State/Province

Florida

ZIP/Postal Code

34239

Country

United States

Facility Name

401, Novartis iNvestiagtional Site

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30322

Country

United States

Facility Name

299, Novartis Investigational Site

City

DeKalb

State/Province

Illinois

ZIP/Postal Code

60115

Country

United States

Facility Name

268, Novartis Investigational Site

City

Peoria

State/Province

Illinois

ZIP/Postal Code

61602

Country

United States

Facility Name

209, Novartis Investigational Site

City

Augusta

State/Province

Kansas

ZIP/Postal Code

67010

Country

United States

Facility Name

210, Novartis Investigational Site

City

Newton

State/Province

Kansas

ZIP/Postal Code

67114

Country

United States

Facility Name

274 Novartis Investigational Site

City

Park City

State/Province

Kansas

ZIP/Postal Code

67219

Country

United States

Facility Name

211, Novartis Investigational Site

City

Wichita

State/Province

Kansas

ZIP/Postal Code

67205

Country

United States

Facility Name

269, Novartis Investigational Site

City

Bardstown

State/Province

Kentucky

ZIP/Postal Code

40004

Country

United States

Facility Name

226, Novartis Investigational Site

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40202

Country

United States

Facility Name

248, Novartis Investigational Site

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40217

Country

United States

Facility Name

207, Novartis Investigational Site

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40291

Country

United States

Facility Name

290, Novartis Investigational Site

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40291

Country

United States

Facility Name

265, Novartis Investigational Site

City

Haughton

State/Province

Louisiana

ZIP/Postal Code

71037

Country

United States

Facility Name

408, Novartis Investigational Site

City

Mangham

State/Province

Louisiana

ZIP/Postal Code

71259

Country

United States

Facility Name

225, Novartis Investigational Site

City

Metairie

State/Province

Louisiana

ZIP/Postal Code

70006

Country

United States

Facility Name

233, Novartis Investigational Site

City

Metairie

State/Province

Louisiana

ZIP/Postal Code

70006

Country

United States

Facility Name

418, Novartis Investigational SIte

City

Monroe

State/Province

Louisiana

ZIP/Postal Code

71201

Country

United States

Facility Name

262, Novartis Investigational site

City

Annapolis

State/Province

Maryland

ZIP/Postal Code

21401

Country

United States

Facility Name

263, Novartis Investigational Site

City

Frederick

State/Province

Maryland

ZIP/Postal Code

21702

Country

United States

Facility Name

405, Novartis Investigational Site

City

Silver Spring

State/Province

Maryland

ZIP/Postal Code

20910

Country

United States

Facility Name

278, Novartis Investigational Site

City

Saint Paul

State/Province

Minnesota

ZIP/Postal Code

55108

Country

United States

Facility Name

221, Novartis Investigational Site

City

Bellevue

State/Province

Nebraska

ZIP/Postal Code

68005

Country

United States

Facility Name

219, Novartis Investigational Site

City

Fremont

State/Province

Nebraska

ZIP/Postal Code

68025

Country

United States

Facility Name

402, Novartis Investigational Site

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68114

Country

United States

Facility Name

288, Novartis Investigational Site

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68131

Country

United States

Facility Name

228, Novartis Investigational Site

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68134

Country

United States

Facility Name

244, Novartis Investigational Site

City

Henderson

State/Province

Nevada

ZIP/Postal Code

89014

Country

United States

Facility Name

286, Novartis Investigational site

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89106

Country

United States

Facility Name

255, Novartis Investigational Site

City

Binghamton

State/Province

New York

ZIP/Postal Code

13901

Country

United States

Facility Name

414, Novartis Investigational Site

City

Brooklyn

State/Province

New York

ZIP/Postal Code

11201

Country

United States

Facility Name

264, Novartis Investigational Site

City

Syracuse

State/Province

New York

ZIP/Postal Code

13057

Country

United States

Facility Name

409, Novartis Investigational Site

City

Boone

State/Province

North Carolina

ZIP/Postal Code

28607

Country

United States

Facility Name

266, Novartis Investigational Site

City

Cary

State/Province

North Carolina

ZIP/Postal Code

27518

Country

United States

Facility Name

403, Novartis Investigational Site

City

Clyde

State/Province

North Carolina

ZIP/Postal Code

28721

Country

United States

Facility Name

240, Novartis Investigational Site

City

Akron

State/Province

Ohio

ZIP/Postal Code

44311

Country

United States

Facility Name

254, Novartis Investigational Site

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44122

Country

United States

Facility Name

245, Novartis Investigational Site

City

Dayton

State/Province

Ohio

ZIP/Postal Code

45406

Country

United States

Facility Name

281, Novartis Investigational Site

City

Dayton

State/Province

Ohio

ZIP/Postal Code

45409

Country

United States

Facility Name

281, Novartis Investigational vaccines

City

Dayton

State/Province

Ohio

ZIP/Postal Code

45409

Country

United States

Facility Name

256, Novartis Investigational Site

City

Tulsa

State/Province

Oklahoma

ZIP/Postal Code

74127

Country

United States

Facility Name

292, Novartis Investigational Site

City

Erie

State/Province

Pennsylvania

ZIP/Postal Code

16505

Country

United States

Facility Name

270, Novartis Investigational Site

City

Scottdale

State/Province

Pennsylvania

ZIP/Postal Code

15683

Country

United States

Facility Name

220, Novartis Investigational Site

City

Anderson

State/Province

South Carolina

ZIP/Postal Code

29621

Country

United States

Facility Name

406, novartis Investigational Site

City

Barnwell

State/Province

South Carolina

ZIP/Postal Code

29812

Country

United States

Facility Name

272, Novartis Investigational Site

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29407

Country

United States

Facility Name

232, Novartis Investigational Site

City

Moncks Corner

State/Province

South Carolina

ZIP/Postal Code

29461

Country

United States

Facility Name

291, Novartis Investigational vaccine

City

Spartanburg

State/Province

South Carolina

ZIP/Postal Code

27262

Country

United States

Facility Name

283, Novartis Investigational Site

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37203

Country

United States

Facility Name

208, Novartis Investigational Site

City

Austin

State/Province

Texas

ZIP/Postal Code

78705

Country

United States

Facility Name

247, Novartis Investigational Site

City

Fort Worth

State/Province

Texas

ZIP/Postal Code

76107

Country

United States

Facility Name

217, Novartis Investigational Site

City

Fort Worth

State/Province

Texas

ZIP/Postal Code

76135

Country

United States

Facility Name

214, Novartis Investigational Site

City

San Angelo

State/Province

Texas

ZIP/Postal Code

76904

Country

United States

Facility Name

400, Novartis investigational Site

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

Facility Name

260, Novartis Investigational Site

City

Tomball

State/Province

Texas

ZIP/Postal Code

77375

Country

United States

Facility Name

295, Novartis Investigational Site

City

Layton

State/Province

Utah

ZIP/Postal Code

84041

Country

United States

Facility Name

236, Novartis Investigational Site

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84109

Country

United States

Facility Name

212, Novartis Investigational Site

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84121

Country

United States

Facility Name

246, Novartis Investigational Site

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84124

Country

United States

Facility Name

279, Novartis Investigational Site

City

Spanish Fork

State/Province

Utah

ZIP/Postal Code

84660

Country

United States

Facility Name

282, Novartis Investigational Site

City

Syracuse

State/Province

Utah

ZIP/Postal Code

84075

Country

United States

Facility Name

294, Novartis Investigational Site

City

West Haven

State/Province

Utah

ZIP/Postal Code

84401

Country

United States

Facility Name

201, Novartis Investigational Site

City

West Jordan

State/Province

Utah

ZIP/Postal Code

84088

Country

United States

Facility Name

271, Novartis Investigational Site

City

West Jordan

State/Province

Utah

ZIP/Postal Code

84088

Country

United States

Facility Name

251, Novartis Investigational Site

City

Burke

State/Province

Virginia

ZIP/Postal Code

22015

Country

United States

Facility Name

296, Novartis Investigational Site

City

Vienna

State/Province

Virginia

ZIP/Postal Code

22180

Country

United States

Facility Name

180, Novartis Investigational Site

City

Newmarket

State/Province

Ontario

ZIP/Postal Code

L3Y 5G8

Country

Canada

Facility Name

184, Novartis Investigational Site

City

Sudbury

State/Province

Ontario

ZIP/Postal Code

P3E 1H5

Country

Canada

Facility Name

182,Novartis Investigational Site

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M9V 4B4

Country

Canada

Facility Name

186, Novartis Investigational Site

City

Quebec

Country

Canada

Facility Name

183, Novartis Investigational Site

City

Québec

ZIP/Postal Code

G1E 7G9

Country

Canada

Facility Name

001, Novartis Investigational Site

City

Espoo

ZIP/Postal Code

FI-02230

Country

Finland

Facility Name

003, Novartis Investigational Site

City

Helsinki

ZIP/Postal Code

FIN-00100

Country

Finland

Facility Name

002, Novartis Investigational Site

City

Helsinki

ZIP/Postal Code

FIN-00930

Country

Finland

Facility Name

004, Novartis Investigational Site

City

Järvenpää

ZIP/Postal Code

FIN-04400

Country

Finland

Facility Name

005, Novartis Investigational Site

City

Kokkola

ZIP/Postal Code

FI-67100

Country

Finland

Facility Name

006, Novartis Investigational Site

City

Oulu

ZIP/Postal Code

90220

Country

Finland

Facility Name

007, Novartis Investigational Site

City

Pori

ZIP/Postal Code

FI-28100

Country

Finland

Facility Name

008, Novartis Investigational Site

City

Seinäjoki

ZIP/Postal Code

FI-60100

Country

Finland

Facility Name

009, Novartis Investigational Site

City

Tampere

ZIP/Postal Code

FIN-33100

Country

Finland

Facility Name

010, Novartis Investigational Site

City

Turku

ZIP/Postal Code

FIN-20520

Country

Finland

Facility Name

011, Novartis Investigational Site

City

Vantaa

ZIP/Postal Code

FIN-01300

Country

Finland

Facility Name

030, Novartis Investigational Site

City

Florence

ZIP/Postal Code

50139

Country

Italy

Facility Name

023, Novartis Investigational Site

City

Genova

ZIP/Postal Code

16132

Country

Italy

Facility Name

020, Novartis Investigational Site

City

Milano

ZIP/Postal Code

20122

Country

Italy

Facility Name

026, Novartis Investigational Site

City

Milano

ZIP/Postal Code

20157

Country

Italy

Facility Name

025, Novartis Investigational Site

City

Napoli

ZIP/Postal Code

80131

Country

Italy

Facility Name

021, Novartis Investigational Site

City

Novara

ZIP/Postal Code

28100

Country

Italy

Facility Name

022, Novartis Investigational Site

City

Padova

ZIP/Postal Code

35128

Country

Italy

Facility Name

024, Novartis Investigational Site

City

Pisa

ZIP/Postal Code

56126

Country

Italy

Facility Name

028, Novartis Investigational Site

City

Sassari

ZIP/Postal Code

07100

Country

Italy

Facility Name

173, Novartis Investigational Site

City

Morelia

State/Province

Michoacan

ZIP/Postal Code

58070

Country

Mexico

Facility Name

176, Novartis Investigational Site

City

Durango

ZIP/Postal Code

34000

Country

Mexico

Facility Name

170, Novartis Investigational Site

City

Mexico

ZIP/Postal Code

04530

Country

Mexico

Facility Name

177, Novartis Investigational Site

City

Mexico

ZIP/Postal Code

06760

Country

Mexico

Facility Name

178, Novartis Investigational Site

City

Mexico

ZIP/Postal Code

14000

Country

Mexico

Facility Name

175, Novartis Investigational Site

City

Mexico

ZIP/Postal Code

7020

Country

Mexico

Facility Name

300, Novartis Investigational Site

City

Dasmariñas

State/Province

Cavite

ZIP/Postal Code

4114

Country

Philippines

Facility Name

306, Novartis Investigational Site

City

Alabang

State/Province

Muntilupa

ZIP/Postal Code

1781

Country

Philippines

Facility Name

302, Novartis Investigational Site

City

Manila

ZIP/Postal Code

1000

Country

Philippines

Facility Name

301, Novartis Investigational Site

City

Manila

ZIP/Postal Code

1001

Country

Philippines

Facility Name

303, Novartis Investigational Site

City

Muntinlupa

ZIP/Postal Code

1781

Country

Philippines

Facility Name

304, Novartis Investigational Site

City

Muntinlupa

ZIP/Postal Code

1781

Country

Philippines

Facility Name

305, Novartis Investigational Site

City

Muntinlupa

ZIP/Postal Code

1781

Country

Philippines

Facility Name

040, Novartis Investigational Site

City

Debica

ZIP/Postal Code

39-200

Country

Poland

Facility Name

042, Novartis Investigational Site

City

Katowice

ZIP/Postal Code

40-018

Country

Poland

Facility Name

052, Novartis Investigational Site

City

Leczna

ZIP/Postal Code

21-010

Country

Poland

Facility Name

048, Novartis Investigational Site

City

Lodz

ZIP/Postal Code

91347

Country

Poland

Facility Name

049, Novartis Investigational Site

City

Lubartow

ZIP/Postal Code

21-100

Country

Poland

Facility Name

051, Novartis Investigational Site

City

Oborniki Slaskie

ZIP/Postal Code

55-120

Country

Poland

Facility Name

046, Novartis Investigational Site

City

Osielsko

ZIP/Postal Code

86-031

Country

Poland

Facility Name

043, Novartis Investigational Site

City

Siemianowice Slaskie

ZIP/Postal Code

41-103

Country

Poland

Facility Name

047, Novartis Investigational Site

City

Tarnow

ZIP/Postal Code

33-100

Country

Poland

Facility Name

041, Novartis Investigational Site

City

Warszawa

ZIP/Postal Code

01809

Country

Poland

Facility Name

050, Novartis Investigational Site

City

Warszawa

ZIP/Postal Code

04-730

Country

Poland

Facility Name

045, Novartis Investigational Site

City

Wola

ZIP/Postal Code

43-225

Country

Poland

Facility Name

044, Novartis Investigational Site

City

Wroclaw

ZIP/Postal Code

51215

Country

Poland

Facility Name

257, Novartis Investigational Site

City

Ponce

ZIP/Postal Code

00716

Country

Puerto Rico

Facility Name

415, Novartis Investigational vaccine

City

San Juan

ZIP/Postal Code

00909

Country

Puerto Rico

Facility Name

415, Novartis Investigational Site

City

San Juan

ZIP/Postal Code

00921

Country

Puerto Rico

Facility Name

80, Novartis Investigational Site

City

Sabadell

State/Province

Barcelona

ZIP/Postal Code

08208

Country

Spain

Facility Name

075, Novartis Investigational Site

City

Santiago

State/Province

Galicia

ZIP/Postal Code

15701

Country

Spain

Facility Name

074, Novartis Investigational Site

City

Granada

ZIP/Postal Code

18009

Country

Spain

Facility Name

076, Novartis Investigational Site

City

Madrid

ZIP/Postal Code

28041

Country

Spain

Facility Name

077, Novartis Investigational Site

City

Madrid

ZIP/Postal Code

28046

Country

Spain

Facility Name

79, Novartis Investigational Site

City

Malaga

ZIP/Postal Code

29011

Country

Spain

Facility Name

078, Novartis Investigational Site

City

Valencia

ZIP/Postal Code

46026

Country

Spain

Facility Name

343, Novartis Investigational Site

City

Banciao

State/Province

New Taipei City

ZIP/Postal Code

220

Country

Taiwan

Facility Name

346, Novartis Investigational Site

City

Datong

State/Province

Taipei City

ZIP/Postal Code

10341

Country

Taiwan

Facility Name

344, Novartis Investigational Site

City

Taichung

ZIP/Postal Code

40447

Country

Taiwan

Facility Name

345, Novartis Investigational Site

City

Taichung

ZIP/Postal Code

40705

Country

Taiwan

Facility Name

340, Novartis Investigational Site

City

Taipei City

ZIP/Postal Code

10041

Country

Taiwan

Facility Name

341, Novartis Investigational Site

City

Taipei City

ZIP/Postal Code

10449

Country

Taiwan

Facility Name

342, Novartis Investigational Site

City

Taoyuan

ZIP/Postal Code

333

Country

Taiwan

Facility Name

321, Novartis Investigational Site

City

Bangkoknoi

State/Province

Bangkok

ZIP/Postal Code

10700

Country

Thailand

Facility Name

322, Novartis Investigational Site

City

Bangkoknoi

State/Province

Bangkok

ZIP/Postal Code

10700

Country

Thailand

Facility Name

323, Novartis Investigational Site

City

Pathum Wan

State/Province

Bangkok

ZIP/Postal Code

10330

Country

Thailand

Facility Name

327, Novartis Investigational Site

City

Ratchathewi

State/Province

Bangkok

ZIP/Postal Code

10400

Country

Thailand

Facility Name

325, Novartis Investigational Site

City

Pathum Thani

State/Province

Prathumthani

ZIP/Postal Code

12120

Country

Thailand

Facility Name

326, Novartis Investigational Site

City

Hat Yai

State/Province

Songkhia

ZIP/Postal Code

90110

Country

Thailand

Facility Name

320, Novartis Investigational Site

City

Bangkok

ZIP/Postal Code

10400

Country

Thailand

Facility Name

324, Novartis Investigational Site

City

Bangkok

ZIP/Postal Code

10400

Country

Thailand

12. IPD Sharing Statement

Citations:

PubMed Identifier

32404782

Citation

Esposito S, Fling J, Chokephaibulkit K, de Bruijn M, Oberye J, Zhang B, Vossen J, Heijnen E, Smolenov I. Immunogenicity and Safety of an MF59-adjuvanted Quadrivalent Seasonal Influenza Vaccine in Young Children at High Risk of Influenza-associated Complications: A Phase III, Randomized, Observer-blind, Multicenter Clinical Trial. Pediatr Infect Dis J. 2020 Aug;39(8):e185-e191. doi: 10.1097/INF.0000000000002727.

Results Reference

derived

PubMed Identifier

29631857

Citation

Vesikari T, Kirstein J, Devota Go G, Leav B, Ruzycky ME, Isakov L, de Bruijn M, Oberye J, Heijnen E. Efficacy, immunogenicity, and safety evaluation of an MF59-adjuvanted quadrivalent influenza virus vaccine compared with non-adjuvanted influenza vaccine in children: a multicentre, randomised controlled, observer-blinded, phase 3 trial. Lancet Respir Med. 2018 May;6(5):345-356. doi: 10.1016/S2213-2600(18)30108-5. Epub 2018 Apr 6.

Results Reference

derived

Learn more about this trial

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

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

Influenza Virus

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial