Trial Information
A Randomized, Double-Blinded, Tolerability and Immunogenicity Study of a Multivalent Human Papillomavirus (HPV) L1 Virus-Like Particle (VLP) Vaccine Administered Concomitantly With GARDASIL to 16- to 26- Year-Old Women
Inclusion Criteria:
- Females between 16- to 26-years-old
- Has never had Pap testing or has only had normal Pap test results.
- Lifetime history of 0 to 4 sexual partners
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 illegal drugs or an alcohol abuser
- History of severe allergic reaction that required medical attention
- Are pregnant
- Received a marketed HPV vaccine
- 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 Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
Outcome Measure:
Geometric mean titers (GMTs) to HPV types contained in the administered vaccines
Outcome Time Frame:
4 weeks post dose 3
Safety Issue:
No
Principal Investigator
Medical Monitor
Investigator Role:
Study Director
Investigator Affiliation:
Merck
Authority:
United States: Food and Drug Administration
Study ID:
2007_566
NCT ID:
NCT00551187
Start Date:
October 2007
Completion Date:
August 2009
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