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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: February 7, 2017
Last verified: February 2017
Results First Received: October 14, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Participant, 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 
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.
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      0   0.0%      0   0.0%      0   0.0% 
Male      2032 100.0%      2033 100.0%      4065 100.0% 
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
  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
  Hide Other Adverse Events

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 (63.27%)   1185/2029 (58.40%)   0/0 
Gastrointestinal disorders       
Abdominal pain upper †       
# participants affected / at risk   19/2020 (0.94%)   23/2029 (1.13%)   0/0 
Diarrhoea †       
# participants affected / at risk   40/2020 (1.98%)   36/2029 (1.77%)   0/0 
Nausea †       
# participants affected / at risk   27/2020 (1.34%)   16/2029 (0.79%)   0/0 
General disorders       
Fatigue †       
# participants affected / at risk   13/2020 (0.64%)   19/2029 (0.94%)   0/0 
Pyrexia †       
# participants affected / at risk   120/2020 (5.94%)   125/2029 (6.16%)   0/0 
Injection Site Erythema †       
# participants affected / at risk   304/2020 (15.05%)   275/2029 (13.55%)   0/0 
Injection Site Pain †       
# participants affected / at risk   1113/2020 (55.10%)   991/2029 (48.84%)   0/0 
Injection Site Pruritus †       
# participants affected / at risk   22/2020 (1.09%)   24/2029 (1.18%)   0/0 
Injection Site Swelling †       
# participants affected / at risk   219/2020 (10.84%)   187/2029 (9.22%)   0/0 
Infections and infestations       
Influenza †       
# participants affected / at risk   42/2020 (2.08%)   44/2029 (2.17%)   0/0 
Nasopharyngitis †       
# participants affected / at risk   44/2020 (2.18%)   50/2029 (2.46%)   0/0 
Pharyngitis †       
# participants affected / at risk   22/2020 (1.09%)   20/2029 (0.99%)   0/0 
Upper respiratory tract infection †       
# participants affected / at risk   27/2020 (1.34%)   20/2029 (0.99%)   0/0 
Nervous system disorders       
Dizziness †       
# participants affected / at risk   19/2020 (0.94%)   18/2029 (0.89%)   0/0 
Headache †       
# participants affected / at risk   179/2020 (8.86%)   207/2029 (10.20%)   0/0 
Respiratory, thoracic and mediastinal disorders       
Oropharyngeal pain †       
# participants affected / at risk   38/2020 (1.88%)   37/2029 (1.82%)   0/0 
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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