NCT02114385

A Study to Compare Immune Response of V503 to Gardasil in 16- to 26-year-old Men (V503-020)

A Randomized, Double-Blinded, Controlled With GARDASIL (Human Papillomavirus Vaccine [HPV] [Types 6, 11, 16, 18] (Recombinant, Adsorbed)), Phase 3 Clinical Trial to Study the Immunogenicity and Tolerability of V503 (9-Valent Human Papillomavirus L1 Virus-Like Particle [VLP] Vaccine) in 16- to 26-year-old Men

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 500 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 16 Years – 26 Years
• Healthy volunteers: Accepted

Summary

Primary objective To demonstrate that administration of V503 induces non-inferior Geometric Mean Titres (GMTs) for serum anti-HPV 6, 11, 16, and 18, compared to GARDASIL in 16- to 26-year-old men

Detailed description

Secondary objectives * To evaluate the tolerability of V503 in 16- to 26-year-old men. * To summarise humoral immune responses, including anti-HPV 6, 11, 16, 18, 31, 33, 45, 52, 58 GMTs and seroconversion rates at 4 weeks post-dose 3, in 16- to 26-year-old men who received V503 or GARDASIL

Conditions

• Papilloma Viral Infection

Interventions

Type	Name	Description
BIOLOGICAL	V503	9-valent HPV \[Types 6, 11, 16, 18, 31, 33, 45, 52, and 58\] L1 virus-like particle vaccine, 0.5-mL intramuscular injection
BIOLOGICAL	GARDASIL	Quadrivalent HPV \[Types 6, 11, 16, and 18\] L1 virus-like particle vaccine, 0.5-mL intramuscular injection

Timeline

• Start date: 2014-03-24
• Primary completion: 2015-04-22
• Completion: 2015-04-22
• First posted: 2014-04-15
• Last updated: 2018-11-01
• Results posted: 2018-11-01

Locations

7 sites across 3 countries: Belgium, Germany, Netherlands