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

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-000218-12-FI

Enrollment

13620

Registered

2013-08-06

Start date

2013-09-17

Completion date

Unknown

Last updated

2016-06-13

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

Conditions

Prophylaxis for influenza virus MedDRA version: 19.0 Level: PT Classification code 10022000 Term: Influenza System Organ Class: 10021881 - Infections and infestations

Interventions

Product Name: Adjuvanted Quadrivalent Influenza Vaccine (aQIV) -surface antigen, inactivated, adjuvanted with MF59 Product Code: aQIV Pharmaceutical Form: Suspension for injection INN or Proposed INN:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: * Children, males and females, healthy or at high risk of complications from influenza, between =6 months to =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: * Subjects with a history of allergy to vaccine components * Additional eligibility criteria may be discussed by contacting the site

Design outcomes

Primary

Measure	Time frame
Main Objective: The relative efficacy of aQIV compared to comparator vaccine as determined by RT-PCR-confirmed influenza;Secondary Objective: * The relative efficacy of aQIV compared to comparator as determined by the proportion of subjects with culture-confirmed influenza * The relative efficacy of aQIV compared to comparator as determined by RT-PCR-confirmed influenza in age subgroups, in children at risk of influenza, and in children depending on previous vaccination status * The early relative efficacy of aQIV compared to comparator as determined by RT-PCR-confirmed influenza To compare antibody * responses between aQIV and comparator (including assessment of non-inferiority and superiority) * To evaluate healthcare utilization and health economic outcomes * To evaluate safety and tolerability of each study vaccine ;Primary end point(s): The primary endpoint is on RT-PCR-confirmed influenza cases occurring at =21 days and = 180 days after the last vaccination or until the end of the influenza season, whichever is longer. ;Timepoint(s) of evaluation of this end point: Weekly from Day 1 up to 180 days after the last vaccination or until the end of influenza season, whichever is longer.	—

Measure

Time frame

Main Objective: The relative efficacy of aQIV compared to comparator vaccine as determined by RT-PCR-confirmed influenza;Secondary Objective: * The relative efficacy of aQIV compared to comparator as determined by the proportion of subjects with culture-confirmed influenza * The relative efficacy of aQIV compared to comparator as determined by RT-PCR-confirmed influenza in age subgroups, in children at risk of influenza, and in children depending on previous vaccination status * The early relative efficacy of aQIV compared to comparator as determined by RT-PCR-confirmed influenza To compare antibody * responses between aQIV and comparator (including assessment of non-inferiority and superiority) * To evaluate healthcare utilization and health economic outcomes * To evaluate safety and tolerability of each study vaccine ;Primary end point(s): The primary endpoint is on RT-PCR-confirmed influenza cases occurring at =21 days and = 180 days after the last vaccination or until the end of the influenza season, whichever is longer. ;Timepoint(s) of evaluation of this end point: Weekly from Day 1 up to 180 days after the last vaccination or until the end of influenza season, whichever is longer.

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Secondary

Measure	Time frame
Secondary end point(s): Secondary efficacy endpoint: Hazard ratios calculated 1.Occurrence of culture-confirmed influenza cases in all subjects occurring at =21 days and = 180 days after the last vaccination or until the end of the influenza season, whichever is longer, 2. Early occurrence of RT-PCR-confirmed influenza cases in all subjects on first-occurrence of RT-PCR-confirmed influenza cases Secondary Immunogenicity Endpoints The endpoints for immunogenicity measured in aQIV and comparator as determined by HI are as follows: 1.Geometric mean HI titer (GMT). 2.Geometric mean ratio (GMR) 3.Percentage of vaccine naïve and non-naïve subjects achieving seroconversion; 4.Percentage of subjects with HI titer = 1:40 5.Percentage of subjects with higher HI titer thresholds * Other Endpoints (Health Economic Outcome): 1. Number of medical visit for respiratory illness in subjects associated with RT-PCR-confirmed influenza 2.Number of employment days missed by parent(s)/guardian(s) of subjects with RT-PCR-confirmed influenza. 3.Number of days of daycare, school or preschool missed by subjects associated with RT-PCR-confirmed influenza * Safety Endpoints: 1.Percentages of subjects with solicited AEs. 2.Percentages of subjects with all unsolicited AEs. 3.Percentage of subjects with SAEs, AEs leading to withdrawal from the study or study vaccination, New Onset of Chronic Disease (NOCD), Adverse Events of Special Interest(AESI) and all medications associated.;Timepoint(s) of evaluation of this end point: Secondary Immunogenicity Endpoints: 1.vaccine naïve subjects: on Day 1, 29, 50 & 209, vaccine non-naïve subjects: on Day 1, 22 & 181 2.vaccine naïve subjects on Day 29/Day 1, D50/D1 & D209/D1, non-naïve: D22/D1 & D181/D1 3.vaccine naïve subjects: on Day 29 & 50, non-naïve subjects: on Day 22 4.vaccine naïve subjects on Day 29, 50 & 209, non-naïve: Day 22 & 181 5.vaccine naïve subjects on Day 29, 50 & 209, non-naïve: Day 22 & 181 Othe	—

Measure

Time frame

Secondary end point(s): *Secondary efficacy endpoint: Hazard ratios calculated 1.Occurrence of culture-confirmed influenza cases in all subjects occurring at =21 days and = 180 days after the last vaccination or until the end of the influenza season, whichever is longer, 2. Early occurrence of RT-PCR-confirmed influenza cases in all subjects on first-occurrence of RT-PCR-confirmed influenza cases *Secondary Immunogenicity Endpoints The endpoints for immunogenicity measured in aQIV and comparator as determined by HI are as follows: 1.Geometric mean HI titer (GMT). 2.Geometric mean ratio (GMR) 3.Percentage of vaccine naïve and non-naïve subjects achieving seroconversion; 4.Percentage of subjects with HI titer = 1:40 5.Percentage of subjects with higher HI titer thresholds * Other Endpoints (Health Economic Outcome): 1. Number of medical visit for respiratory illness in subjects associated with RT-PCR-confirmed influenza 2.Number of employment days missed by parent(s)/guardian(s) of subjects with RT-PCR-confirmed influenza. 3.Number of days of daycare, school or preschool missed by subjects associated with RT-PCR-confirmed influenza * Safety Endpoints: 1.Percentages of subjects with solicited AEs. 2.Percentages of subjects with all unsolicited AEs. 3.Percentage of subjects with SAEs, AEs leading to withdrawal from the study or study vaccination, New Onset of Chronic Disease (NOCD), Adverse Events of Special Interest(AESI) and all medications associated.;Timepoint(s) of evaluation of this end point: Secondary Immunogenicity Endpoints: 1.vaccine naïve subjects: on Day 1, 29, 50 & 209, vaccine non-naïve subjects: on Day 1, 22 & 181 2.vaccine naïve subjects on Day 29/Day 1, D50/D1 & D209/D1, non-naïve: D22/D1 & D181/D1 3.vaccine naïve subjects: on Day 29 & 50, non-naïve subjects: on Day 22 4.vaccine naïve subjects on Day 29, 50 & 209, non-naïve: Day 22 & 181 5.vaccine naïve subjects on Day 29, 50 & 209, non-naïve: Day 22 & 181 Othe

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Countries

Canada, Finland, Italy, Mexico, Philippines, Poland, Russian Federation, Spain, Taiwan, Thailand, United States

Contacts

Public ContactMary Ellen Ruzycky, MS

Seqirus, Inc

mary_ellen.ruzycky@seqirus.com+1617.871.8226

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026