Rapid Evaluation of Pandemic H1N1 Influenza Vaccine in Aboriginal Children and Adults

Study Overview
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Brief Summary
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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
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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: 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. 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.

Official Title
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PCIRN Evaluation of Pandemic H1N12009 Influenza Vaccine in Aboriginal Children and Adults

Conditions
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H1N1/2009 Influenza

Intervention / Treatment
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* Biological: Arepanrix
* Biological: Arepanrix


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Good general health Written informed consent provided by or for the subject Aboriginal ethnicity (First Nations, Metis or Inuit) Adults 20-59 years of age Children 6-35 months of age Exclusion Criteria: Allergies to eggs, thimerosal or gentamicin sulphate Life-threatening reaction to previous Flu vaccine Bleeding disorder Pregnancy Receipt of blood or blood products in past 3 months Compromised immune system Chronic illness Previous lab-confirmed H1N1/2009 infection

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 59 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br>Adults: One doses of H1N12009 vaccine | Biological: Arepanrix<br>* Adults: One dose Arepanrix vaccine given IM (0.5 mL)<br>|
| Other: 2<br>Children: Two doses of H1N12009 vaccine given 3 weeks apart | Biological: Arepanrix<br>* Children: Two doses of Arepanrix vaccine given IM (0.25 mL) three weeks apart<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of adverse events (AEs) for days 0-6 after each vaccination |  | Day 7 and Day 21 post vaccination | 
| Occurrence of serious adverse events (SAEs) and other significant health events up to 21 days after each vaccination |  | Day 7 and Day 21 post vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of baseline and post-immunization antibody titres |  | Day 21 (adults) and Day 42 (children) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vaccine, H1N1, influenza, H1N1 influenza vaccine, pandemic