Innate and Acquired Immunity to Influenza Infection and Immunization (SLVP029)
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the study is to get a better understanding of the natural and adaptive immune
      response to the flu virus and to compare the immune cell responses to FDA-licensed flu
      vaccines in nasal mucosal cells and in blood.
    

Detailed description: 
      This is a study of healthy children and adults receive the current seasonal influenza
      vaccine. The volunteers were enrolled into one of 7 groups over a 5-year period. Immunization
      is administered; blood samples and NP swabs are collected at various time points based on
      groups assigned.

      Group A (LAIV4/annual return): Up to six 2-4 year old volunteers are given a quadrivalent
      live, attenuated influenza vaccine (LAIV4). All participants in this group are asked to
      return annually for flu immunization and blood samples on Day 0 and Day 7 post immunization.
      Vaccine naive children returned 30 days later for a second immunization per standard of care.
      This group was discontinued in year 3 due to Advisory Committee on Immunization Practices
      (ACIP) recommendations against the use of LAIV.

      Group B (LAIV4/ single year): Up to twenty 2-4 year old volunteers were given a quadrivalent
      live, attenuated influenza vaccine (LAIV4). Volunteers will participate for a single year.
      All participants in this group were immunized on Day 0. Blood samples were taken on on Day 0
      and Day 7 post immunization. Vaccine naive children returned 30 days later for a second
      immunization per standard of care. This group was discontinued in year 3 due to ACIP
      recommendations against the use of LAIV.

      Group C (LAIV4/NP swab group): Up to twenty 2-4 year old volunteers were given a quadrivalent
      live, attenuated influenza vaccine (LAIV4). Nasopharyngeal samples (NP) swabs were collected
      Day 1 and 21 and 28 post immunization. No blood was collected for this group. Vaccine naive
      children returned 30 days later for a second immunization per standard of care. This group
      was discontinued in year 3 due to ACIP recommendations against the use of LAIV.

      Group D (IIV4/annual return): Up to six 6 month-23 month old (inclusive) volunteers are given
      a quadrivalent inactivated influenza vaccine (IIV4). All participants in this group are asked
      to return annually for flu immunization and blood samples on Day 0 and Day 7 post
      immunization. Vaccine naive children returned 30 days later for a second immunization per
      standard of care.

      Group E (IIV4/single year): Up to twenty 6 month-23 month old (inclusive) volunteers were
      given a quadrivalent inactivated influenza vaccine (IIV4). Volunteers participate for a
      single year. All participants in this group were immunized on Day 0. Blood samples were taken
      on on Day 0 and Day 7 post immunization. Vaccine naive children returned 30 days later for a
      second immunization per standard of care.

      Group F (LAIV4/single year) Up to forty 9-13 year old (n= 20) and 18-49 year old (n= 20)
      volunteers were given live, attenuated influenza vaccine (LAIV). Blood samples were collected
      Days 0, 7, and 28 and NP swabs were collected Days 1 and 28. This group was discontinued in
      year 3 due to ACIP recommendations against the use of LAIV.

      Group G (IIV4/single year) Up to forty, 9-13 year old (n= 20) and 18-49 year old (n= 20)
      volunteers were given a quadrivalent inactivated influenza vaccine (IIV4). Blood samples were
      collected Day 0,7, and 28
    

Intervention name(s): Fluzone®; FluMist®
Intervention type(s): Biological; Biological
Intervention description(s): Fluzone® Quadrivalent: Quadrivalent influenza virus vaccine; FluMist® Quadrivalent: Quadrivalent influenza virus vaccine live, intranasal spray
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Inactivated influenza vaccine; Live, attenuated influenza vaccine; Young children; Adults