drugset / Trial / NCT01561768
A Study to Evaluate the Immune Response and Safety of a Seasonal Virus-Like Particle Influenza Vaccine in Healthy Young Adults
RandomizedParallel-groupTriple-blindPrevention
Summary
The purpose of this study is to determine the immune response of three dose levels of the Novavax Quadrivalent vaccine in healthy young adults (18-64). The study is broken down into 5 treatment groups. Each group will enroll 100 subjects, for a total of 500 subjects. Group 1-3 will receive one of three dose levels of the Novavax Quadrivalent vaccine, Group 4 will receive a dose of the Novavax Trivalent vaccine, and Group 5 will receive a commercially available trivalent influenza vaccine (TIV). The study will also evaluate the safety and tolerability of the Novavax Quadrivalent vaccine.
Timeline
- Start
- 2012-03
- Primary completion
- 2013-01
- Completion
- 2013-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Novavax Quadrivalent vaccine | Vaccine | — | Intramuscular |
| Subject | Novavax Trivalent vaccine | Vaccine | — | Intramuscular |
| Subject | cTIV | Vaccine | — | Intramuscular |