Phase 2 N=2,409 Randomized Double-blind Prevention

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

Bottom Line

View on ClinicalTrials.gov: NCT00365378 ↗

Enrolled (actual)

2,409

Serious AEs

1.4%

Results posted

Apr 2010

Primary outcome: Primary: Incidence of Persistent HPV 16 Infection — 0.3; 4.9 Incidence per 100 person-years

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Comparator: HPV 16 L1 Vaccine (Biological); Comparator: Placebo (Biological)
Age: Pediatric, Adult · 16+ yrs
Sex: Female
Sponsor: Merck Sharp & Dohme LLC
Primary completion: Mar 2004

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	—

Summary

Subjects received HPV 16 L1 VLP vaccine or placebo (1:1 ratio). Endpoints included efficacy, immunogenicity, and safety.

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)

View full record on ClinicalTrials.gov →

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.