NCT01047345

A Study of V503, a 9-valent Human Papillomavirus (9vHPV) Vaccine in Females 12-26 Years of Age Who Have Previously Received GARDASIL™ (V503-006)

A Phase III, Randomized, International, Placebo-Controlled, Double-Blind Clinical Trial to Study the Tolerability and Immunogenicity of V503, a Multivalent Human Papillomavirus (HPV) L1 Virus-Like Particle (VLP) Vaccine, Given to Females 12-26 Years of Age Who Have Previously Received GARDASIL™

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 924 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: Female
• Age: 12 Years – 26 Years
• Healthy volunteers: Accepted

Summary

This study will evaluate whether V503 (9vHPV vaccine), is well tolerated in girls and women between 12 and 26 years old who have previously been vaccinated with GARDASIL™. Participants will receive vaccination with 9vHPV vaccine or placebo on Day 1, Month 2, and Month 6 of the Base Study. Participants who receive placebo in the Base Study will be eligible to receive vaccination with 9vHPV vaccine on Day 1, Month 2, and Month 6 of the Extension Study.

Conditions

• Cervical Cancers
• Vulvar Cancers
• Vaginal Cancers
• Genital Warts

Interventions

Type	Name	Description
BIOLOGICAL	V503	V503 (9vHPV) vaccine given as a 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Base Study or the Study Extension
BIOLOGICAL	Placebo to V503	Placebo to V503 (saline) given as a 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Base Study

Timeline

• Start date: 2010-02-24
• Primary completion: 2011-06-10
• Completion: 2015-11-28
• First posted: 2010-01-12
• Last updated: 2018-11-27
• Results posted: 2014-12-22