Trials / Completed
CompletedNCT01073293
A Study of V503 Vaccine Given Concomitantly With REPEVAX™ in 11 to 15 Year Olds (V503-007)
A Phase III Open-Label Clinical Trial to Study the Immunogenicity and Tolerability of V503, a Multivalent Human Papillomavirus (HPV) L1 Virus-Like Particle (VLP) Vaccine, Given Concomitantly With REPEVAX™ in Preadolescents and Adolescents (11 to 15 Year Olds)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 1,054 (actual)
- Sponsor
- Merck Sharp & Dohme LLC · Industry
- Sex
- All
- Age
- 11 Years – 15 Years
- Healthy volunteers
- Accepted
Summary
This study will evaluate whether co-administration of the first dose of V503 and REPEVAX™ is well tolerated and causes a non-inferior immune response when compared to administration of REPEVAX™ one month following the first dose of V503.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | V503 Vaccine | V503 (Multivalent HPV L1 VLP vaccine) given as a 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 |
| BIOLOGICAL | REPEVAX™ (Concomitant) | REPEVAX™ given as a single 0.5 mL intramuscular injection at Day 1 |
| BIOLOGICAL | REPEVAX™ (Non-concomitant) | REPEVAX™ given as a single 0.5 mL intramuscular injection at Month 1 |
Timeline
- Start date
- 2010-04-22
- Primary completion
- 2011-06-16
- Completion
- 2011-06-16
- First posted
- 2010-02-23
- Last updated
- 2018-11-27
- Results posted
- 2014-12-22
Source: ClinicalTrials.gov record NCT01073293. Inclusion in this directory is not an endorsement.