drugset / Trial / NCT01001026
Rapid Evaluation of Pandemic H1N1 Influenza Vaccine in Aboriginal Children and Adults
Phase 4
Completed
156 enrolled
David Scheifele
Canadian Institutes of Health Research (CIHR) · collabPHAC/CIHR Influenza Research Network · collab
Non-randomizedParallel-groupOpen-labelPrevention
Summary
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).
Timeline
- Start
- 2009-11
- Primary completion
- 2010-02
- Completion
- 2010-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Arepanrix | Vaccine | 0.25 ml | Intramuscular |
| Subject | Arepanrix | Vaccine | 0.5 ml | Intramuscular |