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 : August 23, 2018
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Study Type | Interventional |
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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) |
Enrollment | 4065 |
Recruitment Details | |
Pre-assignment Details | A total of 4164 participants were screened and 4065 were randomized |
Arm/Group Title | 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 |
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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. |
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. |
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. |
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. |
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). | 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). |
Period Title: Base Study Vaccination Period | ||||||
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 |
Reason Not Completed | ||||||
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 Title: Base Study Follow-up Period | ||||||
Started | 1822 [1] | 1821 [2] | 0 | 0 | 0 | 0 |
Completed | 1487 | 1479 | 0 | 0 | 0 | 0 |
Not Completed | 335 | 342 | 0 | 0 | 0 | 0 |
Reason Not Completed | ||||||
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
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Period Title: Extension 1 | ||||||
Started | 0 | 0 | 1098 [1] | 16 [1] | 0 | 0 |
Completed | 0 | 0 | 1041 | 15 | 0 | 0 |
Not Completed | 0 | 0 | 57 | 1 | 0 | 0 |
Reason Not Completed | ||||||
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.
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Period Title: Long-term Follow-up (EXT2) | ||||||
Started | 0 | 0 | 0 | 0 | 936 [1] | 867 [1] |
Completed | 0 | 0 | 0 | 0 | 709 | 664 |
Not Completed | 0 | 0 | 0 | 0 | 227 | 203 |
Reason Not Completed | ||||||
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)
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Arm/Group Title | qHPV Vaccine in Base Study | Placebo in Base Study | Total | |
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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 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 of all reporting groups | |
Overall Number of Baseline Participants | 2032 | 2033 | 4065 | |
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[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 2032 participants | 2033 participants | 4065 participants | |
20.6 (2.0) | 20.5 (2.0) | 20.5 (2.0) | ||
Age, Continuous
[1] Median (Full Range) Unit of measure: Years |
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Number Analyzed | 2032 participants | 2033 participants | 4065 participants | |
20
(16 to 26)
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20
(15 to 27)
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20
(15 to 27)
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[1]
Measure Description: Although the upper age limit for this study was 26 years old, one subject age 27 was randomized into the study.
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 2032 participants | 2033 participants | 4065 participants | |
Female |
0 0.0%
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0 0.0%
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0 0.0%
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Male |
2032 100.0%
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2033 100.0%
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4065 100.0%
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Race/Ethnicity, Customized
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 2032 participants | 2033 participants | 4065 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 |
Name/Title: | Vice President, Late Stage Development Group Leader |
Organization: | Merck Sharp & Dohme Corp. |
Phone: | 1-800-672-6372 |
EMail: | ClinicalTrialsDisclosure@merck.com |
Responsible Party: | Merck Sharp & Dohme LLC |
ClinicalTrials.gov Identifier: | NCT00090285 |
Other Study ID Numbers: |
V501-020 Formerly-0904HPVHMES 2004_103 2004-002945-10 ( EudraCT Number ) V501-020 ( Other Identifier: Merck Protocol Number ) |
First Submitted: | August 25, 2004 |
First Posted: | August 27, 2004 |
Results First Submitted: | October 14, 2009 |
Results First Posted: | November 19, 2009 |
Last Update Posted: | August 23, 2018 |