NCT01254643

A Study of the Safety, Tolerability, and Immunogenicity of a 9-valent Human Papillomavirus Vaccine ([9vHPV]; V503) Administered to 9- to 15-Year-Old Japanese Girls (V503-008).

A Phase III Open-label, Safety, Tolerability and Immunogenicity Study of a 9-Valent Human Papillomavirus (HPV) L1 Virus-Like Particle (VLP) Vaccine Administered to 9- to 15-Year-Old Japanese Preadolescent and Adolescent Girls

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: Female
• Age: 9 Years – 15 Years
• Healthy volunteers: Accepted

Summary

This study will evaluate the safety, tolerability, and immunogenicity of V503 in Japanese girls between the ages of 9 and 15 and will determine whether V503 induces an acceptable immune response to all human papillomavirus (HPV) strains contained in the vaccine. The success criterion for the primary analysis requires that point estimates for seroconversion rate be greater than 90% for all 9 HPV types.

Conditions

• Papillomavirus Infections

Interventions

Type	Name	Description
BIOLOGICAL	V503	V503 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6

Timeline

• Start date: 2011-01-12
• Primary completion: 2013-08-10
• Completion: 2013-08-10
• First posted: 2010-12-06
• Last updated: 2018-11-28
• Results posted: 2014-12-22