drugset / Trial / NCT02768805
Immunogenicity of a Quadrivalent Virus-Like Particles (VLP) Influenza Vaccine in Healthy Adults
RandomizedParallel-groupSingle-blindPrevention
Summary
This Phase 2 Quadrivalent VLP Vaccine study is intended to replicate and extend the immunogenicity and safety results obtained in earlier Phase 1-2 and Phase 2 studies. The study is being conducted to demonstrate that the immunogenicity profile of the Quadrivalent VLP Vaccine meets the US Center for Biologics Evaluation and Research (CBER) licensure criteria. The study will also help to define the optimal dose, establish potential competitive advantages, and support the design of future studies.
Timeline
- Start
- 2016-03-02
- Primary completion
- 2016-05-17
- Completion
- 2016-11-26
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | FluLaval® Quadrivalent | Vaccine | 15 ug | Intramuscular |
| Subject | Quadrivalent VLP Vaccine | Vaccine | 15 ug | Intramuscular |
| Subject | Quadrivalent VLP Vaccine | Vaccine | 30 ug | Intramuscular |