Study of Intradermal Quadrivalent Influenza Vaccine in Adults Aged 18 Through 64 Years
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of the study is to demonstrate safety and immunogenicity of the quadrivalent
      influenza intradermal (QIV-ID) vaccine compared to the trivalent influenza vaccine (TIV)
      containing the B strain from the primary (Yamagata) lineage (TIV-ID1) and the trivalent
      influenza vaccine containing B strain from the alternate (Victoria) lineage (TIV-ID2)
      vaccines in producing protection against four strains of influenza virus.

      Primary Objective:

        -  To demonstrate that QIV-ID induces an immune response (as assessed by hemagglutination
           inhibition (HAI) geometric mean titers (GMTs) and seroconversion rates) that is
           non-inferior to responses induced by TIV-ID1 and TIV-ID2 for the 4 virus strains at 28
           days post-vaccination.

      Secondary Objectives:

        -  To demonstrate that each B strain in QIV-ID induces an immune response (as assessed by
           HAI GMTs and seroconversion rates) that is superior to the response induced by the
           TIV-ID that does not contain the corresponding B strain.

        -  To describe the rate of post-vaccination seroprotection induced by QIV-ID and TIV-ID.

        -  To describe post-vaccination immunogenicity stratified by age (18-49 years and 50-64
           years), race, ethnicity, gender, previous vaccination status, and baseline
           seropositivity status.

        -  To describe the safety profile for subjects who receive QIV-ID and TIV-ID.

      Observational Objectives:

        -  To demonstrate non-inferiority of QIV-ID compared to TIV-ID in terms of all Grade 2 or
           Grade 3 solicited systemic reactions combined

        -  To demonstrate non-inferiority of QIV-ID compared to TIV-ID in terms of all Grade 3
           solicited injection site reactions combined.
    

Detailed description: 
      All participants will receive a single dose of their assigned vaccine on Day 0. A subset of
      the participants will be assessed for immunologic response on Day 0 before vaccination and
      Day 28 after vaccination. All subjects will be monitored for safety for up to 6 months after
      vaccination.
    

Intervention name(s): Influenza Virus Vaccine USP Quadrivalent, (Zonal Purified Subvirion) 2012 2013 Formulation; Influenza Virus Vaccine USP Trivalent Types A and B (Zonal Purified Subvirion) Fluzone® Intradermal; Influenza Virus Vaccine USP Trivalent Types A and B (Zonal Purified Subvirion) Fluzone Intradermal
Intervention type(s): Biological; Biological; Biological
Intervention description(s): 0.1mL, Intradermal; 0.1mL, Intradermal; 0.1mL, Intradermal
Other intervention name(s): QIV ID; Fluzone® Intradermal; Fluzone® Intradermal
Intervention MeSH terms: Fluconazole; Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Influenza; Fluzone® Intradermal vaccine; Influenza Virus Vaccine USP Quadrivalent; Influenza Virus Vaccine USP Trivalent Types A and B