NCT00543543

Broad Spectrum HPV (Human Papillomavirus) Vaccine Study in 16-to 26-Year-Old Women (V503-001)

A Randomized, International, Double-Blinded (With In-House Blinding), Controlled With GARDASIL, Dose-Ranging, Tolerability, Immunogenicity, and Efficacy Study of a Multivalent Human Papillomavirus (HPV) L1 Virus-Like Particle (VLP) Vaccine Administered to 16- to 26- Year-Old Women

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 14,840 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: Female
• Age: 16 Years – 26 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study was to evaluate the safety, efficacy, and immunogenicity of V503 in comparison to GARDASIL. The primary hypotheses tested in the study were 1) V503 administered to 16- to 26-year-old adolescents and young women is generally well-tolerated, 2) V503 reduces combined incidence of Human Papillomavirus (HPV) Type 31/33/45/52/58-related disease compared with GARDASIL, and 3) V503 induces non-inferior geometric mean titers for HPV Type 6/11/16/18 antibodies compared with GARDASIL.

Detailed description

The study included a dose-finding evaluation of a 3-dose regimen of V503 and GARDASIL, a safety/efficacy evaluation of a 3-dose regimen of the selected V503 dose formulation and GARDASIL, and an extension consisting of 2 substudies: an evaluation of immune memory in participants receiving a fourth vaccination with V503 (Cohort 1), and an opportunity for participants who received GARDASIL in the Base Study to receive a 3-dose regimen of V503 (Cohort 2).

Conditions

• Cervical Cancer
• Vulvar Cancer
• Vaginal Cancer
• Genital Warts
• Human Papillomavirus Infection

Interventions

Type	Name	Description
BIOLOGICAL	Comparator: GARDASIL	GARDASIL (quadrivalent HPV \[Types 6, 11, 16, and 18\] L1 virus-like particle vaccine), 0.5 mL injection in 3 dose regimen
BIOLOGICAL	Experimental: V503	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 (and a fourth injection for Cohort 1 only).

Timeline

• Start date: 2007-09-24
• Primary completion: 2013-04-10
• Completion: 2016-07-07
• First posted: 2007-10-15
• Last updated: 2018-11-27
• Results posted: 2014-12-19

Regulatory

• FDA-regulated drug study