drugset / Trial / NCT02307851
Quadrivalent Influenza VLP Vaccine Dose Ranging Study in Young Adults
RandomizedParallel-groupTriple-blindPrevention
Summary
The purpose of this study is to determine the immune response of three dose levels of the Quadrivalent VLP vaccine in healthy young (18-49) adults. The study is broken down into four treatment groups. Each group will enroll 100 subjects, for a total of 400 subjects. Groups A-C will receive one of three dose levels of the Quadrivalent VLP vaccine, and Group D will receive a commercially available trivalent influenza vaccine (TIV). The study will also evaluate the safety and tolerability of the Quadrivalent VLP vaccine formulations.
Timeline
- Start
- 2014-11
- Primary completion
- 2015-06
- Completion
- 2015-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Quadrivalent VLP Vaccine | Vaccine | 0.5 ml | Intramuscular |
| Comparator | TIV | Vaccine | 0.5 ml | Intramuscular |