Phase 2
Completed N=2,409
Study of Human Papillomavirus (HPV) 16 Vaccine in the Prevention of HPV 16 Infection in 16- to 23-Year-Old Females (V501-005)
HPV 16 Infection
Source: ClinicalTrials.gov NCT00365378 ↗
Enrolled (actual)
2,409
Serious AEs
1.4%
Results posted
Apr 2010
Primary outcomePrimary: Incidence of Persistent HPV 16 Infection — 0.3; 4.9 Incidence per 100 person-years
Summary
Subjects received HPV 16 L1 VLP vaccine or placebo (1:1 ratio). Endpoints included efficacy, immunogenicity, and safety.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Persistent HPV 16 Infection |
0.3; 4.9 | — |
| PRIMARY Incidence of HPV 16-related CIN1, CIN2 or C1N3 |
0.0; 1.0 | — |
| PRIMARY Serum Anti-HPV 16 Geometric Mean Titers |
1518.8; 6.0 | — |
Eligibility Criteria
Inclusion Criteria
- Healthy, unmarried females age 16 to 23 years with intact uteri
- Not pregnant at enrollment
- Agreed to use effective contraception through Month 7 of the study
- A lifetime history of 0 to 5 male partners with whom the subjects engaged in at least one episode of insertive intercourse
Exclusion Criteria
- No prior history of Human Papillomavirus (HPV) vaccination
- No receipt of any other vaccination within 1 month prior to enrollment or plans to receive any other vaccination within 1 month prior to or after any dose of study vaccine
- No prior history of an abnormal Papanicolaou (Pap) test showing Squamous intraepithelial lesion (SIL) or biopsy showing Cervical intraepithelial neoplasia (CIN)
Data sourced from ClinicalTrials.gov (NCT00365378). 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.