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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: October 17, 2016
Last verified: October 2016
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 
Overall Participants Analyzed 
[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) 
[1] Although the upper age limit for this study was 26 years old, one subject age 27 was randomized into the study.
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 


  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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