NCT01651949

Multivalent HPV (Human Papillomavirus) Vaccine Study in 16- to 26-Year Old Men and Women (V503-003)

A Phase III Clinical Trial to Study the Tolerability and Immunogenicity of 9vHPV (V503), a Multivalent Human Papillomavirus (HPV) L1 Virus-Like Particle (VLP) Vaccine, in 16- to 26-Year-Old Men and 16- to 26-Year-Old Women

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,520 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 16 Years – 26 Years
• Healthy volunteers: Accepted

Summary

This study is designed to evaluate the immunogenicity and tolerability of 9vHPV (9-valent HPV vaccine, V503) in 16- to 26-year old men and women. The overall goal is to bridge 9vHPV efficacy findings in young women to young men based on the demonstration of similar immunogenicity and safety profiles. The primary hypothesis is that 9vHPV induces antibody responses at 4 weeks postdose 3 in heterosexual males that are non-inferior to antibody responses in young women.

Detailed description

Study participants will be administered a 3-dose regimen of 9vHPV. They will be assessed for immunogenicity 1 month following completion of vaccination. All participants will be followed for safety for a total of 12 months.

Conditions

• Genital Warts
• Anal Cancer
• Anal Intraepithelial Neoplasia

Interventions

Type	Name	Description
BIOLOGICAL	9vHPV Vaccine	9vHPV, V503 (9-valent HPV \[Types 6, 11, 16, 18, 31, 33, 45, 52, and 58\] L1 virus-like particle vaccine), 0.5 mL injection in 3-dose regimen

Timeline

• Start date: 2012-10-29
• Primary completion: 2014-08-04
• Completion: 2014-08-04
• First posted: 2012-07-27
• Last updated: 2018-11-27
• Results posted: 2015-03-09