drugset / Trial / NCT01014806
Evaluate the Safety and Immunogenicity of a Seasonal Influenza Virus-Like Particle (VLP) Vaccine in Older Adults
RandomizedParallel-groupQuadruple-blindPrevention
Summary
* To assess the tolerability and safety of a single injection of Influenza VLP Vaccine when administered intramuscularly (IM) at 15 µg and 60 µg HA per each strain. * To assess the immunogenicity of Influenza VLP Vaccine administered at 15 µg and 60 µg HA per strain as measured by hemagglutination inhibition (HAI) antibody titers to each of the component viral strains \[A/Brisbane/59/2007 (H1N1); A/Brisbane/10/2007 (H3N2) and B/Brisbane/60/2008\].
Timeline
- Start
- 2009-11
- Primary completion
- 2010-05
- Completion
- 2010-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Influenza VLP Vaccine | Vaccine | 15 ug | Intramuscular |
| Subject | Influenza VLP Vaccine | Vaccine | 60 ug | Intramuscular |
| Comparator | TIV | Vaccine | 15 ug | — |