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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: November 13, 2014
Last verified: November 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
  Show All Outcome Measures

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
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Time Frame Base study: all AEs were collected systematically from Day 1 through Month 36. Extension 1: SAEs were collected systematically from Day 1 through Month 7. Other AEs were not solicited during EXT1.
Additional Description

Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, and MedDRA version 14.1 was used during EXT1.

Although non-serious AEs were not solicited during EXT1, 1 participant voluntarily reported the non-serious AE of viral gastroenteritis (incidence <1%).


Frequency Threshold
Threshold above which other adverse events are reported   1%  

Reporting Groups
  Description
qHPV Vaccine: 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. The at-risk population was participants who received ≥ 1 qHPV vaccination in the base study.

Placebo: 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. The at-risk population was participants who received ≥ 1 placebo injection in the base study.

qHPV Vaccine: EXT1 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. The at-risk population was participants who received ≥ 1 qHPV vaccination in EXT1 and had follow-up data.

Other Adverse Events
    qHPV Vaccine: Base Study     Placebo: Base Study     qHPV Vaccine: EXT1  
Total, other (not including serious) adverse events        
# participants affected / at risk     1278/2020     1185/2029     0/0  
Gastrointestinal disorders        
Abdominal pain upper      
# participants affected / at risk     19/2020 (0.94%)     23/2029 (1.13%)     0/0 (0.00%)  
Diarrhoea      
# participants affected / at risk     40/2020 (1.98%)     36/2029 (1.77%)     0/0 (0.00%)  
Nausea      
# participants affected / at risk     27/2020 (1.34%)     16/2029 (0.79%)     0/0 (0.00%)  
General disorders        
Fatigue      
# participants affected / at risk     13/2020 (0.64%)     19/2029 (0.94%)     0/0 (0.00%)  
Pyrexia      
# participants affected / at risk     120/2020 (5.94%)     125/2029 (6.16%)     0/0 (0.00%)  
Injection Site Erythema      
# participants affected / at risk     304/2020 (15.05%)     275/2029 (13.55%)     0/0 (0.00%)  
Injection Site Pain      
# participants affected / at risk     1113/2020 (55.10%)     991/2029 (48.84%)     0/0 (0.00%)  
Injection Site Pruritus      
# participants affected / at risk     22/2020 (1.09%)     24/2029 (1.18%)     0/0 (0.00%)  
Injection Site Swelling      
# participants affected / at risk     219/2020 (10.84%)     187/2029 (9.22%)     0/0 (0.00%)  
Infections and infestations        
Influenza      
# participants affected / at risk     42/2020 (2.08%)     44/2029 (2.17%)     0/0 (0.00%)  
Nasopharyngitis      
# participants affected / at risk     44/2020 (2.18%)     50/2029 (2.46%)     0/0 (0.00%)  
Pharyngitis      
# participants affected / at risk     22/2020 (1.09%)     20/2029 (0.99%)     0/0 (0.00%)  
Upper respiratory tract infection      
# participants affected / at risk     27/2020 (1.34%)     20/2029 (0.99%)     0/0 (0.00%)  
Nervous system disorders        
Dizziness      
# participants affected / at risk     19/2020 (0.94%)     18/2029 (0.89%)     0/0 (0.00%)  
Headache      
# participants affected / at risk     179/2020 (8.86%)     207/2029 (10.20%)     0/0 (0.00%)  
Respiratory, thoracic and mediastinal disorders        
Oropharyngeal pain      
# participants affected / at risk     38/2020 (1.88%)     37/2029 (1.82%)     0/0 (0.00%)  
Events were collected by systematic assessment



  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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