At a glance
ClinicalIndex Comparison Record- ✓Female aged 16–23 years
- ✓Intact uterus
- ✓Lifetime sexual history of 0–4 partners
- ✕Prior HPV vaccination
- ✕Prior abnormal cervical cytology (abnormal paps)
- ✕History of genital warts
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Study to Evaluate the Efficacy of Quadrivalent HPV Vaccine in Reducing the Incidence of HPV 6-, 11-, 16-, and 18-Related CIN, AIS, and Cervical Cancer, and HPV 6-, 11-, 16-, and 18-Related External Genital Warts, Vulvar Intraepithelial Neoplasia Vaginal Intraepithelial Neoplasia, Vulvar Cancer, and Vaginal Cancer in 16- to 23-Year-Old Women
In Brief
A Phase 3 clinical trial evaluating V501, Comparator: Placebo, and 1 other intervention for Cervical Cancer and Genital Warts. Completed, enrolled 5,759 participants.
Detailed Summary
The primary purpose of the study is to determine if GARDASIL (V501) with four components is able to prevent cervical cancer, cervical dysplasia, including Cervical Intraepithelial Neoplasia (CIN)(Any Grade) and Adenocarcinoma In Situ (AIS), and genital warts.
Study Details
Timeline
Interventions
Final Manufactured Product (FMP) quadrivalent HPV vaccine, a 0.5 mL intramuscular injection given at Day 1, Month 2 and Month 6.
a 0.5 mL intramuscular placebo injection given at Day 1, Month 2 and Month 6.
HPV 16 Monovalent vaccine, a 0.5 mL intramuscular injection given at Day 1, Month 2 and Month 6.