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| Name | Class |
|---|---|
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
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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 adults when given at the same time or prior to the seasonal influenza vaccine. The study will enroll 300 adults (ages 20-59 years). Participants will be randomized into 2 groups. One group will receive one dose of a licensed H1N1 vaccine and one dose of the seasonal influenza vaccine at the same time; the second group will receive the seasonal influenza vaccine 3 weeks after receiving the licensed H1N12009 influenza vaccine. Study procedures include: medical history, blood samples and completing a memory aid. Participants will be involved in study related procedures for approximately 3-6 weeks depending upon the group assignment.
The objectives of this study are two-fold:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Other | Group A: One dose of the licensed H1N1 vaccine and one dose of the seasonal influenza vaccine given concurrently |
|
| 2 | Other | Group B: One dose of seasonal influenza vaccine given 3 weeks after administration of one dose of the licensed H1N1 vaccine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Arepanrix, Vaxigrip 2009/2010 | Biological | Group A: Single dose of Arepanrix and single dose of Vaxigrip 2009/2010 given concurrently |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Immunogenicity: Comparison of baseline and post-immunization antibody titres | Day 21 post vaccination |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Scheifele, MD | University of British Columbia | Principal Investigator |
| Allison McGeer, MD | University of Toronto, Mt Sinai Hospital | Study Director |
| Mark Loeb, MD | McMaster University | Study Director |
| Ian Gemmill, MD | Kingston, Frontenac, Lanark Health Unit | Study Director |
| Marc Dionne, MD | Institut national de sante publique du Quebec | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| McMaster University | Hamilton | Ontario | Canada | |||
| Kingston, Frontenac, Lanark Health Unit |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22652402 | Derived | Scheifele DW, Ward BJ, Dionne M, Vanderkooi OG, Loeb M, Coleman BL, Li Y; PHAC/CIHR Influenza Research Network (PCIRN). Compatibility of ASO3-adjuvanted H1N1pdm09 and seasonal trivalent influenza vaccines in adults: results of a randomized, controlled trial. Vaccine. 2012 Jul 6;30(32):4728-32. doi: 10.1016/j.vaccine.2012.05.029. Epub 2012 May 28. |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| ID | Term |
|---|---|
| C568072 | arepanrix |
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| Arepanrix, Vaxigrip 2009/2010 | Biological | Group B: Single dose of Vaxigrip 2009/2010 given 3 weeks after single dose of Arepanrix |
|
| Kingston |
| Ontario |
| Canada |
| University of Toronto, Mt Sinai Hospital | Toronto | Ontario | Canada |
| Institut national de sante publique du Quebec | Québec | Quebec | Canada |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |