H1N1/2009 Influenza Clinical Trial
Official title:
PCIRN Evaluation of Pandemic H1N12009 Influenza Vaccine in Aboriginal Children and Adults
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).
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.
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention