A Randomized, International, Double-Blinded (With In-House Blinding), GARDASIL-Controlled, Dose-Ranging Study of Octavalent Human Papillomavirus (HPV) L1 Virus-Like Particle (VLP) Vaccine Administered to 16- to 23- Year-Old Women
16 Years
23 Years
Female
HPV, Cervical Cancer, Premalignancy Anogenital Warts
Trial Information
A Randomized, International, Double-Blinded (With In-House Blinding), GARDASIL-Controlled, Dose-Ranging Study of Octavalent Human Papillomavirus (HPV) L1 Virus-Like Particle (VLP) Vaccine Administered to 16- to 23- Year-Old Women
Inclusion Criteria:
- Lifetime history of 0-4 sexual partners
Exclusion Criteria:
- History of abnormal PAP test or abnormal cervical biopsy result; history of external
genital/vaginal warts; history of positive HPV test
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
Outcome Measure:
The octavalent HPV VLP vaccine, when administered in a 3-dose regimen, induces acceptable responses for specific HPV types at 4 weeks Post dose 3. Immune responses measured by an HPV competitive Luminex immunoassay.
Outcome Time Frame:
4 weeks post dose 3 injection
Safety Issue:
No
Principal Investigator
Medical Monitor
Investigator Role:
Study Director
Investigator Affiliation:
Merck
Authority:
United States: Food and Drug Administration
Study ID:
2005_086
NCT ID:
NCT00260039
Start Date:
December 2005
Completion Date:
February 2008
Related Keywords:
- HPV
- Cervical Cancer
- Premalignancy Anogenital Warts
- Uterine Cervical Neoplasms
- Condylomata Acuminata
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