Trials / Completed
CompletedNCT00411749
V501 Immunogenicity Study in Females Age 9 to 17 Years (V501-028)
V501 Phase II Immunogenicity Study in Females Aged 9 to 17 Years
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 107 (actual)
- Sponsor
- Merck Sharp & Dohme LLC · Industry
- Sex
- Female
- Age
- 9 Years – 17 Years
- Healthy volunteers
- Accepted
Summary
The study evaluates the immunogenicity, safety and tolerability of V501 in preadolescent females
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (V501) | V501; Gardasil, 0.5 ml injection in 3 dosing regimen |
| BIOLOGICAL | Comparator: Placebo (unspecified) | Placebo 0.5 ml injection in 3 dosing regimen |
Timeline
- Start date
- 2006-12-11
- Primary completion
- 2009-09-18
- Completion
- 2009-09-18
- First posted
- 2006-12-15
- Last updated
- 2017-04-21
- Results posted
- 2010-08-18
Source: ClinicalTrials.gov record NCT00411749. Inclusion in this directory is not an endorsement.