Trial Information
A Randomized, International, Double-Blinded (With In-House Blinding), Controlled With GARDASIL, Dose-Ranging, Tolerability, Immunogenicity, and Efficacy Study of a Multivalent Human Papillomavirus (HPV) L1 Virus-Like Particle (VLP) Vaccine Administered to 16- to 26- Year-Old Women
Inclusion Criteria:
- Female between 16- to 26-years-old
- Has never had Pap testing or has only had normal Pap test results
Exclusion Criteria:
- History of an abnormal cervical biopsy result
- History of a positive test for HPV
- History of external genital/vaginal warts
- Currently a user of any illegal drugs or an alcohol abuser
- History of severe allergic reaction that required medical attention
- Are pregnant
- Received marketed HPV vaccine or participated in an HPV trial
- Currently enrolled in a clinical trial
- Currently has or has a history of certain medical conditions or is currently taking
or has taken certain medications (details will be discussed at the time of consent.)
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
Outcome Measure:
Incidence of HPV-related cervical, vaginal or vulvar disease
Outcome Time Frame:
Up to end of study
Safety Issue:
No
Principal Investigator
Medical Monitor
Investigator Role:
Study Director
Investigator Affiliation:
Merck
Authority:
United States: Food and Drug Administration
Study ID:
2007_538
NCT ID:
NCT00543543
Start Date:
September 2007
Completion Date:
June 2013
Related Keywords:
- Cervical Cancer
- Vulvar Cancer
- Vaginal Cancer
- Genital Warts
- Human Papillomavirus Infection
- Uterine Cervical Neoplasms
- Condylomata Acuminata
- Vaginal Neoplasms
- Vulvar Neoplasms
- Warts
- Papillomavirus Infections