Rapid Evaluation of Pandemic H1N1 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).
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||PCIRN Evaluation of Pandemic H1N12009 Influenza Vaccine in Aboriginal Children and Adults|
- Occurrence of adverse events (AEs) for days 0-6 after each vaccination [ Time Frame: Day 7 and Day 21 post vaccination ] [ Designated as safety issue: Yes ]
- Occurrence of serious adverse events (SAEs) and other significant health events up to 21 days after each vaccination [ Time Frame: Day 7 and Day 21 post vaccination ] [ Designated as safety issue: Yes ]
- Comparison of baseline and post-immunization antibody titres [ Time Frame: Day 21 (adults) and Day 42 (children) ] [ Designated as safety issue: No ]
|Study Start Date:||November 2009|
|Study Completion Date:||February 2010|
|Primary Completion Date:||February 2010 (Final data collection date for primary outcome measure)|
Adults: One doses of H1N12009 vaccine
Adults: One dose Arepanrix vaccine given IM (0.5 mL)
Children: Two doses of H1N12009 vaccine given 3 weeks apart
Children: Two doses of Arepanrix vaccine given IM (0.25 mL) three weeks apart
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01001026
|Calgary Health Services and Alberta Children's Hospital|
|Calgary, Alberta, Canada|
|Capital Health District, Alberta Health Services|
|Edmonton, Alberta, Canada|
|Canada, British Columbia|
|Child and Family Research Center|
|Vancouver, British Columbia, Canada|
|Vaccine Evaluation Center, University of British Columbia|
|Vancouver, British Columbia, Canada|
|University of Manitoba Health Sciences Centre|
|Winnipeg, Manitoba, Canada|
|Principal Investigator:||David Scheifele, MD||University of British Columbia|
|Study Director:||Ethan Rubinstein, MD||University of Manitoba Health Sciences Centre|
|Study Director:||Gerald Predy, MD||Alberta Health Services, Edmonton|
|Study Director:||Laura Sauve, MD||University of British Columbia|