NCT00090220View on ClinicalTrials.gov

A Study to Evaluate the Safety, Immune Response, and Efficacy of Gardasil (V501, qHPV) in Mid-Adult Women (V501-019)

PHASE3CompletedINTERVENTIONAL

Enrollment

3,819

Participants

Timeline

Start Date

June 16, 2004

Primary Completion Date

May 21, 2009

Study Completion Date

November 12, 2015

Conditions

Healthy Adult Female ParticipantsPreventionPapillomavirus InfectionHuman Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18

Interventions

BIOLOGICAL

Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine

qHPV intramuscular injection in three 0.5 mL doses over 6 months in the Base Study or EXT1

BIOLOGICAL

Comparator: Placebo

Placebo intramuscular injection in three 0.5 mL doses over 6 months.

All Listed Sponsors

lead

Merck Sharp & Dohme LLC

INDUSTRY

NCT00090220 - A Study to Evaluate the Safety, Immune Response, and Efficacy of Gardasil (V501, qHPV) in Mid-Adult Women (V501-019) | Biotech Hunter | Biotech Hunter