Clinical Study to Evaluate Safety, Immunogenicity of Investigational Flu Vaccine Compared to an Approved Flu Vaccine (QIV) in Children Previously Vaccinated in Trial V118_05

Overview

Safety, Immunogenicity of an Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine Compared to Non-Adjuvanted Comparator Influenza Vaccine in Children Previously Vaccinated in Trial V118_05

Full Title of Study: “A Phase III, Randomized, Observer Blind, Multicenter Study to Evaluate the Safety and Immunogenicity of Repeated Exposure to an Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV), Administered to Subjects Previously Vaccinated in Trial V118_0”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Single (Participant)
  • Study Primary Completion Date: January 2016

Interventions

  • Biological: Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)
    • 1 dose 0.25 ml: ≥6 months to <36 months, 0.5 ml: ≥36 months to <72 months
  • Biological: non-adjuvanted Quadrivalent Influenza Vaccine (QIV)
    • 1 dose 0.25 ml: ≥6 months to <36 months, 0.5 ml: ≥36 months to <72 months

Arms, Groups and Cohorts

  • Experimental: aQIV
    • Adjuvanted Quadrivalent Subunit Influenza
  • Active Comparator: QIV
    • Non-Adjuvanted Quadrivalent Subunit Influenza

Clinical Trial Outcome Measures

Primary Measures

  • Evaluate antibody responses to homologous vaccine strains according to CBER criteria after one dose of either aQIV or QIV
    • Time Frame: 21 days Post-vaccination

Secondary Measures

  • Evaluate antibody responses to heterologous vaccine strains according to CBER criteria after one dose of either aQIV or QIV
    • Time Frame: 180 days Post-vaccination

Participating in This Clinical Trial

Inclusion Criteria

1. Male or female subject who has completed their Day 181 clinic visit for non-naïve subjects or their Day 209 clinic visit for naïve subjects in parent study. 2. Individuals who give written informed consent, who can comply with study procedures, and who are available for follow-up Exclusion Criteria:

1. Individuals recently vaccinated against influenza. 2. Subjects with contraindications to receive influenza vaccine. 3. Please contact the site for additional eligibility criteria.

Gender Eligibility: All

Minimum Age: 12 Months

Maximum Age: 84 Months

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Seqirus
  • Provider of Information About this Clinical Study
    • Sponsor

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