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

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ClinicalTrials.gov Identifier: NCT00090285
Recruitment Status : Completed
First Posted : August 27, 2004
Results First Posted : November 19, 2009
Last Update Posted : April 24, 2018
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (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

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 4164 participants were screened and 4065 were randomized

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 quadrivalent human papillomavirus (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 Extension 1 (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 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.

LTFU (EXT2): Early Vaccination Group Participants received ≥1 dose of qHPV vaccine in Base Study and were followed up to a total of 10 years after their first dose of qHPV vaccine. No vaccinations were administered during Long-term Follow-up (LTFU) (EXT2).
LTFU (EXT2): Catch-up Vaccination Group Participants received placebo in Base Study and qHPV vaccine in EXT1 and were followed up to a total of 7 years after their first dose of qHPV vaccine. No vaccinations were administered during LTFU (EXT2).

Participant Flow for 4 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   LTFU (EXT2): Early Vaccination Group   LTFU (EXT2): Catch-up Vaccination Group
STARTED   2032   2033   0   0   0   0 
Vaccinated   2025   2030   0   0   0   0 
COMPLETED   1818   1814   0   0   0   0 
NOT COMPLETED   214   219   0   0   0   0 
Randomized Not Vaccinated                7                3                0                0                0                0 
Adverse Event                2                4                0                0                0                0 
Lost to Follow-up                111                112                0                0                0                0 
Protocol Violation                2                3                0                0                0                0 
Withdrawal by Subject                64                69                0                0                0                0 
Uncooperative                2                2                0                0                0                0 
Moved                20                21                0                0                0                0 
Site Terminated                1                0                0                0                0                0 
Other                2                2                0                0                0                0 
Subject Incarcerated                2                2                0                0                0                0 
HIV positive                1                1                0                0                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   LTFU (EXT2): Early Vaccination Group   LTFU (EXT2): Catch-up Vaccination Group
STARTED   1822 [1]   1821 [2]   0   0   0   0 
COMPLETED   1487   1479   0   0   0   0 
NOT COMPLETED   335   342   0   0   0   0 
Adverse Event                3                10                0                0                0                0 
Lost to Follow-up                232                226                0                0                0                0 
Withdrawal by Subject                53                64                0                0                0                0 
Moved                41                36                0                0                0                0 
Other                2                0                0                0                0                0 
Protocol Violation                1                0                0                0                0                0 
Uncooperative                3                4                0                0                0                0 
Subject Incarcerated                0                2                0                0                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   LTFU (EXT2): Early Vaccination Group   LTFU (EXT2): Catch-up Vaccination Group
STARTED   0   0   1098 [1]   16 [1]   0   0 
COMPLETED   0   0   1041   15   0   0 
NOT COMPLETED   0   0   57   1   0   0 
Adverse Event                0                0                2                0                0                0 
Lost to Follow-up                0                0                35                0                0                0 
Withdrawal by Subject                0                0                13                1                0                0 
Other                0                0                4                0                0                0 
Moved                0                0                3                0                0                0 
[1] Participation in EXT1 was voluntary; not all participants eligible for EXT1 enrolled.

Period 4:   Long-term Follow-up (EXT2)
    qHPV Vaccine in Base Study   Placebo in Base Study   EXT1: Placebo in Base Study   EXT1: Incomplete qHPV Regimen in Base Study   LTFU (EXT2): Early Vaccination Group   LTFU (EXT2): Catch-up Vaccination Group
STARTED   0   0   0   0   936 [1]   867 [1] 
COMPLETED   0   0   0   0   709   664 
NOT COMPLETED   0   0   0   0   227   203 
Adverse Event                0                0                0                0                5                2 
Lost to Follow-up                0                0                0                0                156                143 
Withdrawal by Subject                0                0                0                0                60                53 
Physician Decision                0                0                0                0                6                5 
[1] Not all eligible participants enrolled in LTFU (EXT2)



  Baseline Characteristics

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 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.

Total Total of all reporting groups

Baseline Measures
   qHPV Vaccine in Base Study   Placebo in Base Study   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

1.  Primary:   Base Study: Incidence of Human Papillomavirus (HPV) Type 6/11/16/18-related External Genital Warts, Penile/Perianal/Perineal Intraepithelial Neoplasia (PIN), Penile, Perianal or Perineal Cancer   [ Time Frame: Base study: through Month 36 ]

2.  Primary:   Overall Study: Incidence of HPV Type 6/11-related Genital Warts   [ Time Frame: Up to 10 years after the first dose of qHPV vaccine ]
  Hide Outcome Measure 2

Measure Type Primary
Measure Title Overall Study: Incidence of HPV Type 6/11-related Genital Warts
Measure Description Incidence of HPV Type 6/11-related genital warts is expressed as events per 10,000 person-years of follow-up.
Time Frame Up to 10 years after the first dose of qHPV vaccine  

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.
Participants must have received 3 doses of qHPV vaccine, have no protocol violations that could interfere with the effects of the vaccine, be seronegative at Day 1 and PCR negative Day 1 through Month 7 for the relevant HPV type, and must provide data after Month 7. This endpoint applied only to participants in the Base Study qHPV vaccine group.

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.

Measured Values
   qHPV Vaccine in Base Study 
Participants Analyzed   1243 
Overall Study: Incidence of HPV Type 6/11-related Genital Warts 
[Units: Incidence per 10,000 person-years]
Number (95% Confidence Interval)
 4.3 
 (0.9 to 12.5) 

No statistical analysis provided for Overall Study: Incidence of HPV Type 6/11-related Genital Warts



3.  Primary:   Overall Study: Incidence of HPV Type 6/11/16/18-related External Genital Warts, PIN, Penile, Perianal or Perineal Cancer   [ Time Frame: Up to 10 years after the first dose of qHPV vaccine ]

4.  Primary:   Overall Study: Incidence of HPV Type 6/11/16/18-related Anal Intraepithelial Neoplasia (AIN) and Anal Cancer   [ Time Frame: Up to 10 years after the first dose of qHPV vaccine ]

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

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

7.  Primary:   LTFU (EXT2): Number of Participants With Vaccine-Related SAEs   [ Time Frame: LTFU (EXT2): Early Vaccination Group: up to 12 years after last dose of qHPV vaccine; LTFU (EXT2) Catch-up Vaccination Group: up to 7 years after last dose of qHPV vaccine ]

8.  Primary:   LTFU (EXT2): Number of Participants Who Died   [ Time Frame: LTFU (EXT2): Early Vaccination Group: up to 12 years after last dose of qHPV vaccine; LTFU (EXT2) Catch-up Vaccination Group: up to 7 years after last dose of qHPV vaccine ]

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

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

11.  Secondary:   Geometric Mean Titers to HPV Types 6, 11, 16, and 18 at Month 7 Assessed by Competitive Luminex Immunoassay (cLIA)   [ Time Frame: Month 7 ]

12.  Secondary:   Geometric Mean Titers to HPV Types 6, 11, 16, and 18 at Month 36 Assessed by cLIA   [ Time Frame: Month 36 ]

13.  Secondary:   Geometric Mean Titers to HPV Types 6, 11, 16, and 18 at Month 72 Assessed by cLIA   [ Time Frame: Month 72 ]

14.  Secondary:   Geometric Mean Titers to HPV Types 6, 11, 16, and 18 at Month 120 Assessed by cLIA   [ Time Frame: Month 120 ]

15.  Secondary:   Percentage of Participants Seropositive for HPV Type 6, 11, 16, and 18 at Month 7 Assessed by cLIA   [ Time Frame: Month 7 ]

16.  Secondary:   Percentage of Participants Seropositive for HPV Type 6, 11, 16, and 18 at Month 36 Assessed by cLIA   [ Time Frame: Month 36 ]

17.  Secondary:   Percentage of Participants Seropositive for HPV Type 6, 11, 16, and 18 at Month 72 Assessed by cLIA   [ Time Frame: Month 72 ]

18.  Secondary:   Percentage of Participants Seropositive for HPV Type 6, 11, 16, and 18 at Month 120 Assessed by cLIA   [ Time Frame: Month 120 ]

19.  Secondary:   Geometric Mean Titers to HPV Types 6, 11, 16, and 18 at Month 120 Assessed by Immunoglobulin G Luminex Immunoassay (IgG LIA)   [ Time Frame: Month 120 ]

20.  Secondary:   Percentage of Participants Seropositive for HPV Type 6, 11, 16, and 18 at Month 120 Assessed by IgG LIA   [ Time Frame: Month 120 ]

21.  Other Pre-specified:   Base Study: 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

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