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| Name | Class |
|---|---|
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
| PHAC/CIHR Influenza Research Network | OTHER_GOV |
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The purpose of this study is to compare the safety and effectiveness (immune response) to one or two doses of adjuvanted H1N12009 influenza vaccine in young children. An adjuvant is an additive that can boost the immune response. The study will enroll 300 children (ages 6-35 months). Participants will receive 2 doses of adjuvanted H1N12009 vaccine 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 6 weeks.
The goal of this study is to determine if one or two doses of the H1N12009 influenza vaccine are needed in young children, a population group at high risk of influenza infection and subsequent hospitalization.
The objectives of this study are two-fold:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adjuvanted Arepanrix 2 doses | Active Comparator | Two doses of adjuvanted H1N1 Arepanrix vaccine given 3 weeks apart |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| adjuvanted Arepanrix | Biological | Two doses of adjuvanted Arepanrix vaccine given 3 weeks apart |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and immunogenicity of one and two doses Arepanrix | To compare the safety and immunogenicity of one and two doses of adjuvanted H1N12009 pandemic vaccine in children 6-35 months of age | Day 7 and Day 21 post vaccination measured at day 42 |
| Rapid Trial | To conduct this trial soon after the vaccines become available and share observations with health officials and the public as soon as possible | Day 42 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Scheifele, MD | University of British Columbia | Principal Investigator |
| Marc Dionne, MD | Unité de Recherche en Santé Publique (CHUQ) | Study Director |
| Brian Ward, MD | McGill University Health Center - Vaccine Study Center | Principal Investigator |
| Joanne Langley, MD | Canadian Center for Vaccinology, Dalhousie University | Study Director |
| Otto Vanderkooi, MD | Alberta Children's Hospital, University of Calgary | Study Director |
| Simon Dobson, MD | University of British Columbia | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alberta Children's Hospital, University of Calgary | Calgary | Alberta | Canada | |||
| Child and Family Research Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21178654 | Result | Scheifele DW, Ward BJ, Dionne M, Vanderkooi O, Langley JM, Dobson S, Li Y, Law B, Halperin SA; Public Health Agency of Canada/Canadian Institutes of Health Research Influenza Research Network (PCIRN) Rapid Trials Investigators. Evaluation of adjuvanted pandemic H1N1(2009) influenza vaccine after one and two doses in young children. Pediatr Infect Dis J. 2011 May;30(5):402-7. doi: 10.1097/INF.0b013e3182068f33. |
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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 |
|---|---|
| D007252 | Influenza Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| Vancouver |
| British Columbia |
| Canada |
| Vaccine Evaluation Center, University of British Columbia | Vancouver | British Columbia | Canada |
| Canadian Center for Vaccinology, Dalhousie University | Halifax | Nova Scotia | Canada |
| McGill University Health Center - Vaccine Study Center | Montreal | Quebec | Canada |
| Unité de Recherche en Santé Publique (CHUQ) | Québec | Quebec | Canada |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |