Status:
COMPLETED
A Study to Evaluate the Safety, Immune Response, and Efficacy of Gardasil (V501, qHPV) in Mid-Adult Women (V501-019)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Healthy Adult Female Participants
Prevention
Eligibility:
FEMALE
24-45 years
Phase:
PHASE3
Brief Summary
This study was conducted to assess the safety, immunogenicity, efficacy and long-term effectiveness of a vaccine being evaluated for the prevention of human papillomavirus (HPV) infection and disease ...
Detailed Description
The Base study vaccination period (V501-019) encompassed Day 1 through Month 7, during which time participants received randomly assigned, blinded Gardasil™ (V501, qHPV vaccine) or placebo at Day 1, M...
Eligibility Criteria
Inclusion
- No history of genital warts, vulvar intraepithelial neoplasia (VIN), or vaginal intraepithelial neoplasia (VaIN)
- Not pregnant and agrees to use effective contraception through Month 7 of the study
- Additional criteria applied
Exclusion
- Pregnant
- Concurrently enrolled in a clinical study involving collection of cervical specimens
- Previously received any HPV vaccine
- History of severe allergic reaction that required medical intervention
- Received any immune globulin or blood-derived products within 3 months prior to the first study injection
- History of splenectomy, known immune disorders, or receiving immunosuppressives
- Immunocompromised or diagnosed with human immunodeficiency virus (HIV) infection
- Known thrombocytopenia or any coagulation disorders that could contraindicate intramuscular injections
- History of recent or ongoing alcohol or drug abuse
- Prior treatment for genital warts, VIN, or VaIN
- History of cervical disease (ie, surgical treatment for cervical lesions)
- Hysterectomy
Key Trial Info
Start Date :
June 16 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 12 2015
Estimated Enrollment :
3819 Patients enrolled
Trial Details
Trial ID
NCT00090220
Start Date
June 16 2004
End Date
November 12 2015
Last Update
April 21 2017
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.