Rapid Evaluation of Pandemic H1N1 Influenza Vaccine in Aboriginal Children and Adults
Condition: H1N1/2009 Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to assess the safety and effectiveness (immune response) to a
      licensed H1N12009 influenza vaccine in aboriginal children and adults. The study will enroll
      200 healthy adults (ages 20-59 years) and 75 healthy children (ages 6-35 months). Adults will
      receive one dose of a licensed H1N1 vaccine and children will receive two doses of a licensed
      H1N1 vaccine approximately 3 weeks apart. Study procedures include: medical history, blood
      samples and completing a memory aid. Participants will be involved in study related
      procedures for approximately 3 weeks (adults) or 6 weeks (children).
    

Detailed description: 
      During the first wave of the H1N12009 pandemic in Canada, persons of aboriginal background
      were more often hospitalized with severe infections than were other Canadians. Among First
      Nations members the hospitalization rate was 5 times higher than the national average. Common
      risk factors were young age (children and younger adults) and underlying health conditions. A
      high proportion of aboriginal adults have health conditions that predispose to adverse
      influenza outcomes, including diabetes, asthma, obesity and smoking-related lung diseases.

      Aboriginals could benefit substantially from timely, effective vaccination against pandemic
      influenza and are expected to be among the first Canadians to be offered vaccine when
      available. The vaccine dosing recommendation will be based on limited studies in the general
      population, leaving open the question of whether aboriginals will respond satisfactorily to
      the recommended dosing. Unique social and biological factors among aboriginals could affect
      their responses to vaccination, reducing protection or increasing adverse effects. Thus it
      would be optimal to evaluate the safety and immunogenicity of the pandemic vaccine among the
      earliest aboriginal recipients, to inform the subsequent vaccination of other aboriginal
      groups.

      The objectives of this study are two-fold:

        1. To evaluate the safety and immunogenicity of H1N12009 influenza vaccine in a convenience
           sample of children and adults of aboriginal background (First Nations, Metis and Inuit)
           with emphasis on subgroups at greatest risk of severe disease.

        2. To complete this evaluation soon after the pandemic vaccines become available so as to
           inform the subsequent use of the vaccines in the aboriginal population.
    

Intervention name(s): Arepanrix; Arepanrix
Intervention type(s): Biological; Biological
Intervention description(s): Adults: One dose Arepanrix vaccine given IM (0.5 mL); Children: Two doses of Arepanrix vaccine given IM (0.25 mL) three weeks apart
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: vaccine; H1N1; influenza; H1N1 influenza vaccine; pandemic