drugset / Trial / NCT00851643
Broad Spectrum HPV Vaccine Dose Escalation Study (V502-002)
RandomizedParallel-groupDouble-blindPrevention
Summary
This study will examine the safety and tolerability of octavalent Human Papillomavirus (HPV) L1 Virus-Like Particle (VLP) vaccine formulated with amorphous aluminum hydroxysulfate (AAHS) and ISCOMATRIX™ (IMX). Reviews of safety and tolerability will be used to select the dose(s) of IMX for further studies of the octavalent HPV L1 VLP vaccine.
Timeline
- Start
- 2006-04
- Primary completion
- 2007-12
- Completion
- 2009-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Gardasil | Vaccine | 0.5 ml | Intramuscular |
| Subject | Octavalent HPV | Vaccine | 15 ug | Intramuscular |
| Subject | Octavalent HPV | Vaccine | 30 ug | Intramuscular |
| Subject | Octavalent HPV | Vaccine | 60 ug | Intramuscular |
| Subject | Octavalent HPV | Vaccine | 120 ug | Intramuscular |