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
Phase 3
16 Years
26 Years
16 Years
26 Years
Open (Enrolling)
Female
Cervical Cancer, Vulvar Cancer, Vaginal Cancer, Genital Warts, Human Papillomavirus Infection
Female
Cervical Cancer, Vulvar Cancer, Vaginal Cancer, Genital Warts, Human Papillomavirus Infection
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
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