Trials / Completed
CompletedNCT00092495
Study of an Investigational Vaccine in Pre-Adolescents and Adolescents (Gardasil)(V501-016)
A Study to Demonstrate Immunogenicity and Tolerability of Gardasil (V501) Quadrivalent HPV (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) Vaccine in Preadolescents, and To Determine End-Expiry Specifications for the Vaccine
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 3,055 (actual)
- Sponsor
- Merck Sharp & Dohme LLC · Industry
- Sex
- All
- Age
- 10 Years – 23 Years
- Healthy volunteers
- Accepted
Summary
The primary purpose of the study is to determine if an investigational vaccine Gardasil (V501) with 4 components will provide an immune response and will be well tolerated in pre-adolescents and adolescents.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | V501, Gardasil, human papillomavirus (type 6, 11, 16, 18) recombinant vaccine | qHPV Vaccine (20, 40, 60 or 100% dose formulation) 0.5 mL intramuscular injection given at Day 1, Month 2 and Month 6. |
Timeline
- Start date
- 2002-12-01
- Primary completion
- 2004-09-01
- Completion
- 2009-02-01
- First posted
- 2004-09-27
- Last updated
- 2015-01-13
- Results posted
- 2010-03-08
Source: ClinicalTrials.gov record NCT00092495. Inclusion in this directory is not an endorsement.