This study is to evaluate an investigational vaccine with the following objectives:

1) To demonstrate that the vaccine is well-tolerated in young men;

2) To demonstrate that the vaccine reduces incidence of Condylomata Acuminata (anogenital warts) in young men; and

3) To demonstrate that the vaccine reduces incidence of human papillomavirus (HPV) infection in young men.

Condition	Treatment or Intervention	Phase
Condylomata Acuminata	Vaccine: investigational vaccine	Phase II Phase III

Ages Eligible for Study:  16 Years   -   23 Years,  Genders Eligible for Study:  Male

Accepts Healthy Volunteers

Criteria

Inclusion Criteria:

• 16-23 years old men, with 1-5 lifetime sexual partners.
• Male

Exclusion Criteria:

• female

Toll Free Number      1-888-577-8839 

California
      Call for Information, Davis,  California,  95616,  United States; Recruiting
      Call for Information, Alhambra,  California,  91801,  United States; Recruiting
      Call for Information, Paramount,  California,  90723,  United States; Recruiting
      Call for Information, Spring Valley,  California,  91978,  United States; Recruiting
      Call for Information, San Francisco,  California,  94143,  United States; Recruiting
Florida
      Call for Information, Tampa,  Florida,  33612,  United States; Recruiting
Georgia
      Call for Information, Augusta,  Georgia,  30912,  United States; Recruiting
Illinois
      Call for Information, Chicago,  Illinois,  60613,  United States; Recruiting
Indiana
      Call for Information, Indianapolis,  Indiana,  46202,  United States; Recruiting
Louisiana
      Call for Information, Baton Rouge,  Louisiana,  70805,  United States; Recruiting
Maryland
      Call for Information, Greenbelt,  Maryland,  20770,  United States; Recruiting
Massachusetts
      Call for Information, Boston,  Massachusetts,  02115,  United States; Recruiting
Michigan
      Call for Information, Southfield,  Michigan,  48034,  United States; Recruiting
Nebraska
      Call for Information, Omaha,  Nebraska,  68131,  United States; Recruiting
New York
      Call for Information, New York,  New York,  10011,  United States; Recruiting
      Call for Information, Poughkeepsie,  New York,  12601,  United States; Recruiting
North Carolina
      Call for Information, Chapel Hill,  North Carolina,  27599,  United States; Recruiting
Pennsylvania
      Call for International Site Information, Horsham,  Pennsylvania,  19044,  United States; Recruiting
      Call for Information, Pittsburgh,  Pennsylvania,  15241,  United States; Recruiting
Rhode Island
      Call for Information, Wakefield,  Rhode Island,  02879,  United States; Recruiting
Utah
      Call for Information, Salt Lake City,  Utah,  84109,  United States; Recruiting
      Call for Information, Salt Lake City,  Utah,  84124,  United States; Recruiting
Wisconsin
      Call for information, La Crosse,  Wisconsin,  54601,  United States; Recruiting
      Call for Information, Milwaukee,  Wisconsin,  53209,  United States; Recruiting

Study ID Numbers:  0904HPVHMES
Record last reviewed:  March 2005
Last Updated:  March 21, 2005
Record first received:  August 25, 2004
ClinicalTrials.gov Identifier:  NCT00090285
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08