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

Overview

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.

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: October 2015

Interventions

  • 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
  • Biological: 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

Arms, Groups and Cohorts

  • Experimental: aQIV
    • flu vaccine
  • Active Comparator: non-adjuvanted comparator
    • flu vaccine

Clinical Trial Outcome Measures

Primary Measures

  • RT-PCR-confirmed influenza cases in all subjects
    • Time Frame: Weekly from Day 1 up to 180 days after the last vaccination or until the end of the influenza season, whichever is longer
    • The relative efficacy of aQIV compared to comparator vaccine as determined by RT-PCR-confirmed influenza

Secondary Measures

  • Percentage of subjects with solicited AEs
    • Time Frame: For 7 days following each vaccination
    • To evaluate safety and tolerability of each study vaccine
  • Percentage of subjects with all unsolicited AEs
    • Time Frame: vaccine-naïve subjects: Day 1 to Day 50; vaccine non-naïve subjects: Day 1 to 22
  • Percentage of subjects with SAEs, AEs leading to withdrawal from the study or study vaccination, new onset of chronic disease, Adverse Event of Special Interest (AESI) and all medications associated
    • Time Frame: 12 months after last vaccination
  • Hazard ratios calculated: Occurrence of RT-PCR and culture-confirmed influenza cases in all subjects
    • Time Frame: occurring at ≥ 21 days and ≤ 180 days after the last vaccination or until the end of the influenza season, whichever is longer,
    • Efficacy: 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 and culture-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
  • Hazard ratios calculated: Early occurrence of RT-PCR-confirmed influenza cases in all subjects
    • Time Frame: on first-occurrence of RT-PCR-confirmed influenza cases
  • Geometric mean HI titer (GMT)
    • Time Frame: vaccine naïve subjects: on Day 1, Day 29, Day 50 and Day 209, vaccine non-naïve subjects: on Day 1, Day 22 and Day 181
    • Immunogenicity: To compare antibody responses between aQIV and comparator (including assessment of non-inferiority and superiority) The endpoints for immunogenicity measured in aQIV and comparator as determined by HI.
  • Geometric mean ratio (GMR)
    • Time Frame: vaccine naïve subjects on Day 29/Day 1, Day 50/Day 1 and Day 209/Day 1, vaccine non-naïve: Day 22/Day 1 and Day 181/Day 1
  • Percentage of vaccine naïve and non-naïve subjects achieving seroconversion
    • Time Frame: vaccine naïve subjects: on Day 29 and Day 50, vaccine non-naïve subjects: on Day 22
  • Percentage of subjects with HI titer ≥ 1:40
    • Time Frame: vaccine naïve subjects on Day 29, Day 50 and Day 209, vaccine non-naïve: Day 22 and Day 181
  • Percentage of subjects with higher HI titer thresholds
    • Time Frame: vaccine naïve subjects on Day 29, Day 50 and Day 209, vaccine non-naïve: Day 22 and Day 181
  • Percentage of subjects with all unsolicited AEs
    • Time Frame: from Day 1 to Day 50, vaccine non-naïve subjects from Day 1 to Day 22
  • 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
    • Time Frame: 12 months after last vaccination

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 6 Months

Maximum Age: 72 Months

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Seqirus
  • Collaborator
    • Novartis Vaccines
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Clinical Program Director, Study Director, Seqirus

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