Phase 2
Completed N=1,158
Dose-Ranging Study of Quadrivalent Human Papillomavirus (HPV) (Types 6,11,16,18) L1 Virus-Like Particle (VLP) Vaccine (V501-007)(COMPLETED)
Papillomavirus Infections · Genital Diseases, Female
Source: ClinicalTrials.gov NCT00365716 ↗
Enrolled (actual)
1,158
Serious AEs
0.7%
Results posted
Aug 2010
Primary outcomePrimary: Number of Subjects With Injection Site Adverse Experiences — 247; 248; 266; 107 Participants
Summary
This study was conducted in 2 parts. Part A was a randomized, double-blind, placebo-controlled, multicenter, sequential dose-escalating evaluation. Part B was a randomized, double-blind (operating under in-house blinding procedures), placebo-controlled, multicenter, dose-ranging study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With Injection Site Adverse Experiences |
247; 248; 266; 107; 115 | — |
| SECONDARY Incidence of HPV 6-, 11-, 16- or 18-related Persistent Infection or Disease (Cervical Intraepithelial Neoplasia, Vulvar Intraepithelial Neoplasia, Vaginal Intraepithelial Neoplasia, Adenocarcinoma in Situ, Cervical Cancer, and Genital Warts) |
0.7; 6.7 | — |
Eligibility Criteria
Inclusion Criteria
- Healthy females 16 to 23 years of age
- Not pregnant at enrollment and must have agreed to use effective contraception through Month 7 of the study
- Lifetime history of 0 to 4 male sexual partners (individuals with whom penetrative sexual intercourse occurred)
Exclusion Criteria
- No prior receipt of an Human Papillomavirus (HPV) vaccine
- No receipt of inactivated or recombinant vaccines within 14 days prior to enrollment or receipt of live vaccines within 21 days prior to enrollment
- No prior abnormal Pap test showing squamous intraepithelial lesion (SIL) or biopsy showing cervical intraepithelial neoplasia (CIN)
- No prior history of genital warts or treatment for genital warts
Data sourced from ClinicalTrials.gov (NCT00365716). 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. Informational only — not medical advice.