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

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

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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
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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.
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
Other	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
Other	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.
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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

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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 ]

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2. Primary:

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

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3. Primary:

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

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4. Secondary:

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

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5. Secondary:

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

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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 ]

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  Serious Adverse Events

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  Other Adverse Events

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  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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  More Information

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Certain Agreements:  

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is: The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo. The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo. Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.; Restriction Description: The sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the sponsor as confidential must be deleted prior to submission.

Results Point of Contact:  

Name/Title: Vice President, Late Stage Development Group Leader
Organization: Merck Sharp & Dohme Corp
phone: 1-800-672-6372
e-mail: ClinicalTrialsDisclosure@merck.com

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Goldstone SE, Jessen H, Palefsky JM, Giuliano AR, Moreira ED Jr, Vardas E, Aranda C, Hillman RJ, Ferris DG, Coutlee F, Marshall JB, Vuocolo S, Haupt RM, Guris D, Garner E. Quadrivalent HPV vaccine efficacy against disease related to vaccine and non-vaccine HPV types in males. Vaccine. 2013 Aug 20;31(37):3849-55. doi: 10.1016/j.vaccine.2013.06.057. Epub 2013 Jul 2.

Palefsky JM, Giuliano AR, Goldstone S, Moreira ED Jr, Aranda C, Jessen H, Hillman R, Ferris D, Coutlee F, Stoler MH, Marshall JB, Radley D, Vuocolo S, Haupt RM, Guris D, Garner EI. HPV vaccine against anal HPV infection and anal intraepithelial neoplasia. N Engl J Med. 2011 Oct 27;365(17):1576-85. doi: 10.1056/NEJMoa1010971.

Giuliano AR, Palefsky JM, Goldstone S, Moreira ED Jr, Penny ME, Aranda C, Vardas E, Moi H, Jessen H, Hillman R, Chang YH, Ferris D, Rouleau D, Bryan J, Marshall JB, Vuocolo S, Barr E, Radley D, Haupt RM, Guris D. Efficacy of quadrivalent HPV vaccine against HPV Infection and disease in males. N Engl J Med. 2011 Feb 3;364(5):401-11. doi: 10.1056/NEJMoa0909537. Erratum in: N Engl J Med. 2011 Apr 14;364(15):1481.

Responsible Party:	Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:	NCT00090285 History of Changes
Other Study ID Numbers:	V501-020; Formerly-0904HPVHMES; 2004_103
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:	May 19, 2017