Trials / Completed
CompletedNCT00851643
Broad Spectrum HPV Vaccine Dose Escalation Study (V502-002)
A Randomized, Double-Blind, Multicenter, Biphasic, Controlled With GARDASIL™ Dose-Escalation Study of Octavalent Human Papillomavirus (HPV) L1 Virus-Like Particle (VLP) Vaccine Adjuvanted With Amorphous Aluminum Hydroxyphosphate Sulfate (AAHS) and ISCOMATRIX™ (IMX)
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 158 (actual)
- Sponsor
- Merck Sharp & Dohme LLC · Industry
- Sex
- Female
- Age
- 18 Years – 24 Years
- Healthy volunteers
- Accepted
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.
Detailed description
The study was performed in 2 staggered phases, Phase A and Phase B. In Phase A, participants were randomized to qHPV, Octavalent HPV with 15 mcg IMX/AAHS, or Octavalent HPV with 30 mcg IMX/AAHS. After the safety for Phase A was reviewed, Phase B was initiated. In Phase B, participants were randomized to qHPV, Octavalent HPV with 60 mcg IMX/AAHS or Octavalent HPV with 120 mcg IMX/AAHS.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Octavalent HPV with 15 mcg IMX / AAHS | 0.5-mL intramuscular injection administered at Day 1, Month 2 and Month 6 |
| BIOLOGICAL | Octavalent HPV with 30 mcg IMX / AAHS | 0.5-mL intramuscular injection administered at Day 1, Month 2 and Month 6 |
| BIOLOGICAL | Octavalent HPV with 60 mcg IMX / AAHS | 0.5-mL intramuscular injection administered at Day 1, Month 2 and Month 6 |
| BIOLOGICAL | Octavalent HPV with 120 mcg IMX / AAHS | 0.5-mL intramuscular injection administered at Day 1, Month 2 and Month 6 |
| BIOLOGICAL | Comparator: Quadrivalent HPV Vaccine (qHPV), (GARDASIL™) | 0.5-mL intramuscular injection administered at Day 1, Month 2 and Month 6 |
Timeline
- Start date
- 2006-04-01
- Primary completion
- 2007-12-01
- Completion
- 2009-11-01
- First posted
- 2009-02-26
- Last updated
- 2016-02-03
- Results posted
- 2011-06-21
Source: ClinicalTrials.gov record NCT00851643. Inclusion in this directory is not an endorsement.