An Investigational Study of Gardasil™ (qHPV, V501) Vaccine in Reducing the Incidence of Anogenital Warts in Young Men (V501-020)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00090285
First received: August 25, 2004
Last updated: August 28, 2014
Last verified: August 2014
Results First Received: October 14, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Prevention
Condition: Condylomata Acuminata
Interventions: Biological: (Gardasil™) human papillomavirus (types 6, 11, 16, 18) recombinant vaccine
Biological: Comparator: placebo (unspecified)

  Participant Flow


  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
qHPV Vaccine Participants who started the base study vaccination period
Placebo Participants who started the base study vaccination period
Total Total of all reporting groups

Baseline Measures
    qHPV Vaccine     Placebo     Total  
Number of Participants  
[units: participants]
  2032     2033     4065  
Age  
[units: years]
Mean ± Standard Deviation
  20.6  ± 2.0     20.5  ± 2.0     20.5  ± 2.0  
Age [1]
[units: Years]
Median ( Full Range )
  20  
  ( 16 to 26 )  
  20  
  ( 15 to 27 )  
  20  
  ( 15 to 27 )  
Gender  
[units: participants]
     
Female     0     0     0  
Male     2032     2033     4065  
Race/Ethnicity, Customized  
[units: participants]
     
Asian     201     205     406  
Black     405     400     805  
Hispanic American     412     423     835  
Native American     1     2     3  
White     719     712     1431  
Multi-Racial     291     283     574  
Indian (subcontinent)     1     8     9  
Polynesian     2     0     2  
[1] Although the upper age limit for this study was 26 years old, one subject age 27 was randomized into the study.



  Outcome Measures
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1.  Primary:   Incidence of Human Papillomavirus (HPV) Related External Genital Warts, Perineal Intraepithelial Neoplasia (PIN), Penile, Perianal or Perineal Cancer   [ Time Frame: Base study: through Month 36 ]

2.  Primary:   Number of Participants With Severe Injection Site Adverse Experiences (AEs)   [ Time Frame: Base study: through Day 5 after any vaccination ]

3.  Primary:   Number of Participants With Vaccine-Related Serious Adverse Events (SAEs)   [ Time Frame: Base study: through Month 36 ]

4.  Secondary:   Incidence of HPV 6/11/16/18-related Persistent Infection   [ Time Frame: Base study: through Month 36 ]

5.  Secondary:   Incidence of HPV 6/11/16/18-related Deoxyribonucleic Acid (DNA) Detection   [ Time Frame: Base study: through Month 36 ]

6.  Other Pre-specified:   Substudy to Evaluate the Incidence of HPV 6/11/16/18-related Anal Intraepithelial Neoplasia (AIN) and Anal Cancer in Men Having Sex With Men (MSM)   [ Time Frame: Base study: through Month 36 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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