Overview

This trial is active, not recruiting.

Conditions genital warts, anal cancer, anal intraepithelial neoplasia
Treatment v503 vaccine
Phase phase 3
Sponsor Merck Sharp & Dohme Corp.
Start date October 2012
End date July 2014
Trial size 2500 participants
Trial identifier NCT01651949, 2012-002758-22, V503-003

Summary

This study is designed to evaluate the immunogenicity and tolerability of V503 in 16- to 26-year old men and women. The overall goal is to bridge V503 efficacy findings in young women to young men based on the demonstration of similar immunogenicity and safety profiles.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Active Comparator)
v503 vaccine
Multivalent HPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6
(Experimental)
v503 vaccine
Multivalent HPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6
(Experimental)
v503 vaccine
Multivalent HPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6

Primary Outcomes

Measure
Geometric mean titers (GMTs) to the HPV types contained in the V503 vaccine
time frame: Four weeks post vaccination 3
Number of participants with injection-site adverse experiences of erythema, pain, and swelling
time frame: Day 1 through Day 5 following any vaccination
Number of participants with elevated body temperature (≥100° F)
time frame: Day 1 through Day 5 following any vaccination

Secondary Outcomes

Measure
Number of participants with seroconversion to the HPV types in the V503 vaccine
time frame: Four weeks post vaccination 3

Eligibility Criteria

Male or female participants from 16 years up to 26 years old.

Inclusion Criteria: - Good physical health - Has never had Pap testing (cervical or anal) or has only had normal Pap test results - Other inclusion criteria will be discussed with the investigator Exclusion Criteria: - History of severe allergic reaction that required medical intervention - Currently enrolled in a clinical trial - If participant is female, pregnant - Currently immunocompromised or having received immunosuppressive therapy in the last year - Positive test for HPV - History of HPV-related external genital lesions or HPV-related anal lesions or anal cancer - If participant is female, history of abnormal cervical biopsy results - Other exclusion criteria will be discussed with the investigator

Additional Information

Official title A Phase III Clinical Trial to Study the Tolerability and Immunogenicity of 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
Description Study participants will be administered a 3-dose regimen of V503. 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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2014.
Information provided to ClinicalTrials.gov by Merck Sharp & Dohme Corp..