NCT00092521View on ClinicalTrials.gov

Cervical Intraepithelial Neoplasm (CIN)-Warts Efficacy Trial in Women (Gardasil)(V501-013)(COMPLETED)

PHASE3CompletedINTERVENTIONAL
Enrollment

5,759

Participants

Timeline

Start Date

December 31, 2001

Primary Completion Date

July 31, 2007

Study Completion Date

January 31, 2009

Conditions
Cervical CancerGenital Warts
Interventions
BIOLOGICAL

V501

Final Manufactured Product (FMP) quadrivalent HPV vaccine, a 0.5 mL intramuscular injection given at Day 1, Month 2 and Month 6.

BIOLOGICAL

Comparator: Placebo

a 0.5 mL intramuscular placebo injection given at Day 1, Month 2 and Month 6.

BIOLOGICAL

Human Papillomavirus (HPV) 16 Monovalent

HPV 16 Monovalent vaccine, a 0.5 mL intramuscular injection given at Day 1, Month 2 and Month 6.

All Listed Sponsors
lead

Merck Sharp & Dohme LLC

INDUSTRY

NCT00092521 - Cervical Intraepithelial Neoplasm (CIN)-Warts Efficacy Trial in Women (Gardasil)(V501-013)(COMPLETED) | Biotech Hunter | Biotech Hunter