An Investigational Study of Gardasil (V501) in Reducing the Incidence of Anogenital Warts in Young Men - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

August 25, 2004

Last Updated Date

October 31, 2008

Start Date ^†

September 2004

Current Primary Outcome Measures ^†

Incidence of HPV related external genital warts, PIN, penile, perianal or perineal cancer. [ Time Frame: Duration of Treatment ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00090285 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Persistent HPV 6, 11, 16, and 18 infection.; HPV 6, 11, 16, and 18 detection. [ Time Frame: Duration of Treatment ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^†

Reduction in the incidence of persistent HPV 6, 11, 16, and 18 infection.
Reduction in the incidence of HPV 6, 11, 16, and 18 detection at one or more visits

Descriptive Information

Brief Title ^†

An Investigational Study of Gardasil (V501) in Reducing the Incidence of Anogenital Warts in Young Men

Official Title ^†

An Investigational Vaccine in Reducing the Incidence of Anogenital Warts in Young Men

Brief Summary

This study is to evaluate an investigational vaccine with the following objectives: To demonstrate that the vaccine is well-tolerated in young men; To demonstrate that the vaccine reduces incidence of Condylomata Acuminata (anogenital warts) in young men; and To demonstrate that the vaccine reduces incidence of human papillomavirus (HPV) infection in young men.

Detailed Description

Study Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study

Condition ^†

Condylomata Acuminata

Intervention ^†

Biological: (Gardasil) human papillomavirus (types 6, 11, 16, 18) recombinant vaccine
Biological: Comparator: placebo (unspecified)

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Active, not recruiting

Estimated Enrollment ^†

2700

Completion Date

Estimated Primary Completion Date

May 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^†

Inclusion Criteria:

Healthy males between the ages of 16 and 26
No known history of genital warts
Additional criteria will be discussed with you by the physician

Exclusion Criteria:

Female
Cannot have a history of known prior vaccination with an HPV

Gender

Male

Ages

16 Years to 26 Years

Accepts Healthy Volunteers

Yes

Contacts ^††

Location Countries ^†

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00090285

Responsible Party

Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.

Secondary IDs ^††

Formerly-0904HPVHMES, V501-020

Study Sponsor ^†

Merck

Collaborators ^††

Investigators ^†

Study Director:

Medical Monitor

Merck

Information Provided By

Merck

Verification Date

October 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.