Status:
COMPLETED
Study of Human Papillomavirus (HPV) 16 Vaccine in the Prevention of HPV 16 Infection in 16- to 23-Year-Old Females (V501-005)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
HPV 16 Infection
Eligibility:
FEMALE
16-23 years
Phase:
PHASE2
Brief Summary
Subjects received HPV 16 L1 VLP vaccine or placebo (1:1 ratio). Endpoints included efficacy, immunogenicity, and safety.
Eligibility Criteria
Inclusion
- Healthy, unmarried females age 16 to 23 years with intact uteri
- Not pregnant at enrollment
- Agreed to use effective contraception through Month 7 of the study
- A lifetime history of 0 to 5 male partners with whom the subjects engaged in at least one episode of insertive intercourse
Exclusion
- No prior history of Human Papillomavirus (HPV) vaccination
- No receipt of any other vaccination within 1 month prior to enrollment or plans to receive any other vaccination within 1 month prior to or after any dose of study vaccine
- No prior history of an abnormal Papanicolaou (Pap) test showing Squamous intraepithelial lesion (SIL) or biopsy showing Cervical intraepithelial neoplasia (CIN)
Key Trial Info
Start Date :
September 1 1999
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
2409 Patients enrolled
Trial Details
Trial ID
NCT00365378
Start Date
September 1 1999
End Date
July 1 2009
Last Update
October 23 2015
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.