A Study to Evaluate the Efficacy of Quadrivalent HPV (Types 6, 11, 16, and 18) L1 Virus-Like Particle (VLP) in Reducing the Incidence of HPV 6-, 11-, 16-, and 18-Related Anogenital Warts, and the Incidence of HPV 6-, 11-, 16-, and 18-Related Genital Infection in 16- to 23-Year-Old Men - HPV Vaccine Efficacy Study in Young Me

Phase 1

• Conditions: Prevention of Human Papillomavirus Infections; MedDRA version: 7.0Level: LLTClassification code 10063001

• Registration Number: EUCTR2004-002945-10-DE
• Lead Sponsor: Merck & Co., Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-05-24
• Last Update Posted: 8 January 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 2020

Inclusion Criteria

Inclusion Criteria for the study Vaccination Extension
a. No Temperature >= 100°F or >= 37.8°C (oral) within 24 hours prior to vaccination
b. Must agree to provide study personnel with a primary telephone number as well as an alternate numer for follow-up purposes
c. Must have received either the placebo or an incomplete series of HPV-vaccination in the original study, based on unblinding information provided to the Primary Investigator by the sponsor.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Exclusion Criteria for the Study Vaccination Extension
a. History of known or prior vaccination with HPV-Vaccination (except for subjects who received an incomplete series, i.e. 1 or 2 doses, of HPV-Vaccination in the original study).
b. History of any condition that in the opinion of the Primary Investigaotr would contraindicated receipt of HPV-Vaccination
c. Inability to give informed consent.
d. Receipt of inactivated vaccines within 14 days prior to enrollment or receipt of live virus vaccines within 21 days prior to enrollment.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified