Phase 3
N=5,759
Cervical Intraepithelial Neoplasm (CIN)-Warts Efficacy Trial in Women (Gardasil)(V501-013)(COMPLETED)
Cervical Cancer · Genital Warts
Bottom Line
View on ClinicalTrials.gov: NCT00092521 ↗Enrolled (actual)
5,759
Serious AEs
1.6%
Results posted
Nov 2009
Primary outcome: Primary: Incidence of HPV 6/11/16/18-related Cervical Intraepithelial Neoplasia (CIN)(Any Grade), Adenocarcinoma In Situ (AIS) or Cervical Cancer — 0; 1.2 incidence rate per 100 person-years
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- V501 (Biological); Comparator: Placebo (Biological); Human Papillomavirus (HPV) 16 Monovalent (Biological)
- Age
- Pediatric, Adult · 16+ yrs
- Sex
- Female
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Jul 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of HPV 6/11/16/18-related Cervical Intraepithelial Neoplasia (CIN)(Any Grade), Adenocarcinoma In Situ (AIS) or Cervical Cancer |
0; 1.2 | — |
| PRIMARY Incidence of HPV 6/11/16/18-related External Genital Lesions (EGL) [Genital Warts, Vulvar/Vaginal Intraepithelial Neoplasia (Any Grade), Vulvar/Vaginal Cancer] |
0; 1.1 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Female with an intact uterus with lifetime history of 0-4 sexual partners
Exclusion Criteria
- Prior Human Papillomavirus (HPV) vaccination
- Prior abnormal paps
- History of genital warts
Data sourced from ClinicalTrials.gov (NCT00092521). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.