NCT00365378

Study of Human Papillomavirus (HPV) 16 Vaccine in the Prevention of HPV 16 Infection in 16- to 23-Year-Old Females (V501-005)

Study of Pilot Manufacturing Lot of HPV 16 Virus-Like Particle (VLP) Vaccine in the Prevention of HPV 16 Infection in 16- to 23-Year-Old Females

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 2,409 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: Female
• Age: 16 Years – 23 Years
• Healthy volunteers: Accepted

Summary

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

Conditions

• HPV 16 Infection

Interventions

Type	Name	Description
BIOLOGICAL	Comparator: HPV 16 L1 Vaccine	A 0.5 intramuscular injection given at Day 1, Month 2, and Month 6
BIOLOGICAL	Comparator: Placebo	A 0.5 intramuscular placebo injection given at Day 1, Month 2, and Month 6

Timeline

• Start date: 1999-09-01
• Primary completion: 2004-03-01
• Completion: 2009-07-01
• First posted: 2006-08-17
• Last updated: 2015-10-23
• Results posted: 2010-04-09