Trials / Completed
CompletedNCT01544478
V501 Safety and Efficacy Study in Japanese Women Aged 16 to 26 Years (V501-110)
A Phase IV Open-Label, Descriptive Study to Evaluate the Safety and Effectiveness on the Incidence of HPV 6, 11, 16 and 18 Related CIN 2/3 or Worse of the Quadrivalent HPV (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) Vaccine in 16- to 26-Year-Old Japanese Women
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 1,030 (actual)
- Sponsor
- Merck Sharp & Dohme LLC · Industry
- Sex
- Female
- Age
- 16 Years – 26 Years
- Healthy volunteers
- Accepted
Summary
This study evaluated the long-term safety of quadrivalent Human Papillomavirus (HPV) types 6, 11, 16, 18 vaccine and its effectiveness in the prevention of cervical intraepithelial neoplasia (CIN), adenocarcinoma in situ, and cervical cancer related to HPV in Japanese women.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | V501 | HPV types 6, 11, 16, and 18 vaccine 0.5 mL by intramuscular injection at Day 1, Month 2, and Month 6 |
Timeline
- Start date
- 2011-11-25
- Primary completion
- 2016-08-27
- Completion
- 2016-08-27
- First posted
- 2012-03-06
- Last updated
- 2018-11-28
- Results posted
- 2017-07-07
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT01544478. Inclusion in this directory is not an endorsement.