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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


  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.
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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 ]

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
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  More Information