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: February 21, 2014
Last verified: February 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
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Overall study: first participant visit 03-Sept-2004; EXT1: first participant visit 16-Nov-2009, last participant visit 23-Sept-2011; EXT2: first participant visit 10-Aug-2010, last participant visit (estimated) 30-Dec-2017; study is currently ongoing

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
qHPV Vaccine in Base Study

The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time participants received qHPV vaccination at Day 1, Month 2 and Month 6.

Follow-up for the base study encompassed Month 7 through Month 36.

Placebo in Base Study

The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time participants received placebo at Day 1, Month 2 and Month 6.

Follow-up for the base study encompassed Month 7 through Month 36.

EXT1: Placebo in Base Study Participants in the placebo arm in the base study were offered 3 doses of open-label qHPV vaccine at EXT1 Day 1, Month 2 and Month 6. Participants were followed to EXT1 Month 7.
EXT1: Incomplete qHPV Regimen in Base Study Participants who received placebo and participants who received only 1 dose of qHPV vaccine in the base study were offered a complete 3-dose qHPV vaccine regimen (administered at EXT1 Day 1, Month 2 and Month 6). Participants who received only 2 doses of qHPV vaccine in the base study were offered a single additional dose of qHPV vaccine (administered at EXT1 Day 1). Participants were followed to EXT1 Month 7.

Participant Flow for 3 periods

Period 1:   Base Study Vaccination Period
    qHPV Vaccine in Base Study     Placebo in Base Study     EXT1: Placebo in Base Study     EXT1: Incomplete qHPV Regimen in Base Study  
STARTED     2032     2033     0     0  
Vaccinated     2025     2030     0     0  
COMPLETED     1818     1814     0     0  
NOT COMPLETED     214     219     0     0  
Randomized Not Vaccinated                 7                 3                 0                 0  
Adverse Event                 2                 4                 0                 0  
Lost to Follow-up                 111                 112                 0                 0  
Protocol Violation                 2                 3                 0                 0  
Withdrawal by Subject                 64                 69                 0                 0  
Uncooperative                 2                 2                 0                 0  
Moved                 20                 21                 0                 0  
Site Terminated                 1                 0                 0                 0  
Unspecified                 2                 2                 0                 0  
Subject Incarcerated                 2                 2                 0                 0  
HIV positive                 1                 1                 0                 0  

Period 2:   Base Study Follow-up Period
    qHPV Vaccine in Base Study     Placebo in Base Study     EXT1: Placebo in Base Study     EXT1: Incomplete qHPV Regimen in Base Study  
STARTED     1822 [1]   1821 [2]   0     0  
COMPLETED     1487     1479     0     0  
NOT COMPLETED     335     342     0     0  
Adverse Event                 3                 10                 0                 0  
Lost to Follow-up                 232                 226                 0                 0  
Withdrawal by Subject                 53                 64                 0                 0  
Moved                 41                 36                 0                 0  
Unspecified                 2                 0                 0                 0  
Protocol Violation                 1                 0                 0                 0  
Uncooperative                 3                 4                 0                 0  
Subject Incarcerated                 0                 2                 0                 0  
[1] 4 subjects who did not receive 3 doses of vaccine in base study continued into the Follow-up Period
[2] 7 subjects who did not receive 3 doses of placebo in base study continued into the Follow-up Period

Period 3:   Extension 1
    qHPV Vaccine in Base Study     Placebo in Base Study     EXT1: Placebo in Base Study     EXT1: Incomplete qHPV Regimen in Base Study  
STARTED     0     0     1098 [1]   16 [1]
COMPLETED     0     0     1041     15  
NOT COMPLETED     0     0     57     1  
Adverse Event                 0                 0                 2                 0  
Lost to Follow-up                 0                 0                 35                 0  
Withdrawal by Subject                 0                 0                 13                 1  
Other Reason                 0                 0                 4                 0  
Moved                 0                 0                 3                 0  
[1] Participation in EXT1 was voluntary; not all participants eligible for EXT1 enrolled.



  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.
No text entered.

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 ]
  Hide Outcome Measure 4

Measure Type Secondary
Measure Title Incidence of HPV 6/11/16/18-related Persistent Infection
Measure Description Subjects with HPV 6/11/16/18-related persistent infection per 100 person-years of follow-up.
Time Frame Base study: through Month 36  
Safety Issue No  

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.
Per-protocol population: subjects must have no major protocol violations, must be seronegative to the relevant HPV type at Day 1 and PCR negative to the relevant HPV type Day 1 through Month 7, and must provide follow-up data after Month 7.

Reporting Groups
  Description
qHPV Vaccine

The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time participants received qHPV vaccination at Day 1, Month 2 and Month 6.

Follow-up for the base study encompassed Month 7 through Month 36. Not all participants reached Month 36 prior to the cut-off for the pre-specified analysis.

Placebo

The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time participants received placebo at Day 1, Month 2 and Month 6.

Follow-up for the base study encompassed Month 7 through Month 36. Not all participants reached Month 36 prior to the cut-off for the pre-specified analysis.


Measured Values
    qHPV Vaccine     Placebo  
Number of Participants Analyzed  
[units: participants]
  1390     1402  
Incidence of HPV 6/11/16/18-related Persistent Infection  
[units: Infection per 100 person-years]
  0.7     4.8  


Statistical Analysis 1 for Incidence of HPV 6/11/16/18-related Persistent Infection
Groups [1] All groups
Percent Relative Risk Reduction [2] 85.5
95% Confidence Interval ( 77.0 to 91.3 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant estimation information:
  CI based on binomial tail probabilities and not from a dispersion parameter. Hochberg multiplicity adjustment applied to the CI.



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
No text entered.


  More Information