A Phase 4 interventional study of Arepanrix and Arepanrix in H1N1/2009 Influenza, sponsored by David Scheifele. Completed at 5 sites in Canada. Open to participants aged 6 Months to 59 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-04-10.
Sponsored by David Scheifele · Phase 4, Interventional, and Prevention
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:
2,214 studies on the registry are indexed under Influenza, Human; 164 are open to participants now.
This study's enrollment of 156 is below the median of 238 across 1,853 interventional studies indexed under Influenza, Human.
Browse Influenza, Human studies →David Scheifele is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Adults: One doses of H1N12009 vaccine
Biological: Arepanrix
Children: Two doses of H1N12009 vaccine given 3 weeks apart
Biological: Arepanrix
Adults: One dose Arepanrix vaccine given IM (0.5 mL)
Children: Two doses of Arepanrix vaccine given IM (0.25 mL) three weeks apart
Occurrence of adverse events (AEs) for days 0-6 after each vaccination
Time frame: 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
Time frame: Day 7 and Day 21 post vaccination
Comparison of baseline and post-immunization antibody titres
Time frame: Day 21 (adults) and Day 42 (children)
This study is completed, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.
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David Scheifele