drugset / Trial / NCT01000831
Rapid Evaluation of Pandemic H1N1 Influenza Vaccines in Young Children
Phase 4
Completed
167 enrolled
University of British Columbia
Canadian Institutes of Health Research (CIHR) · collabPHAC/CIHR Influenza Research Network · collab
NaSingle-groupOpen-labelPrevention
Summary
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.
Timeline
- Start
- 2009-11
- Primary completion
- 2010-02
- Completion
- 2010-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Arepanrix | Vaccine | 1.9 ug | — |
| Comparator | Arepanrix | Vaccine | 0.25 ml | — |