A Study to Evaluate the Safety, Immune Response, and Efficacy of Gardasil (V501) in Women (V501-019 AM4, EXT1, EXT2 [AM1])

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Merck

ClinicalTrials.gov Identifier:

NCT00090220

First received: August 25, 2004

Last updated: August 14, 2012

Last verified: August 2012

History of Changes

Results First Received: October 30, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Prevention
Conditions:	Healthy Papillomavirus Infection
Interventions:	Biological: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine Biological: Comparator: Placebo

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
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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 48.
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 48.
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
STARTED	1911	1908
Vaccinated	1910	1907
COMPLETED	1847	1845
NOT COMPLETED	64	63
Randomized not Vaccinated	1	1
Adverse Event	6	1
Lost to Follow-up	24	28
Withdrawal by Subject	23	27
Patient Moved	6	2
Deviation from Protocol	1	0
Unspecified	3	4

Period 2: Base Study Follow-up Period

	qHPV Vaccine in Base Study	Placebo in Base Study
STARTED	1855 ^[1]	1851 ^[2]
COMPLETED	1684 ^[3]	1677 ^[4]
NOT COMPLETED	171	174
Adverse Event	6	1
Lost to Follow-up	88	78
Physician Decision	0	1
Withdrawal by Subject	27	36
Patient Moved	20	28
No Final Visit before study cutoff date	12	12
Unspecified	7	8
Study Still Ongoing	11	10

[1]	8 participants did not complete the Vaccination Period but did enter the Follow-up Period.
[2]	5 participants did not complete the Vaccination Period but did enter the Follow-up Period.
[3]	11 participants continued in base study follow-up as of 30 April 2009
[4]	10 participants continued in base study follow-up as of 30 April 2009

Period 3: Extension 1 (EXT1)

	EXT1: Placebo in Base Study	EXT1: Incomplete qHPV Regimen in Base Study
STARTED	1322 ^[1]	7 ^[1]
Vaccinated	1321	7
COMPLETED	1267	5
NOT COMPLETED	55	2
Adverse Event	4	0
Lost to Follow-up	22	0
Pregnancy	1	0
Moved	2	1
Withdrawal by Subject	25	0
Protocol Violation	0	1
Other reason	1	0

[1]	Participation in EXT1 was voluntary; not all participants eligible for EXT1 enrolled.

Baseline Characteristics

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Reporting Groups

	Description
qHPV Vaccine in Base Study	Participants who started the base study vaccination period
Placebo in Base Study	Participants who started the base study vaccination period
Total	Total of all reporting groups

Baseline Measures

	qHPV Vaccine in Base Study	Placebo in Base Study	Total
Number of Participants [units: participants]	1911	1908	3819
Age [units: years] Mean ± Standard Deviation	34.3 ± 6.3	34.3 ± 6.3	34.3 ± 6.3
Age ^[1] [units: Years] Median ( Full Range )	35 ( 24 to 45 )	34 ( 21 to 46 )	34 ( 21 to 46 )
Gender [units: participants]
Female	1911	1908	3819
Male	0	0	0
Race/Ethnicity, Customized [units: participants]
Asian	596	596	1192
Black	100	82	182
Hispanic American	822	827	1649
Native American	2	1	3
White	388	397	785
Multi-Racial	3	4	7
Polynesian	0	1	1

[1]	Although the upper age limit for this study was 45 years old, one subject 46 years of age was randomized into the study.

Outcome Measures

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1. Primary:

Combined Incidence of HPV 6/11/16/18 Related Persistent Infection, Genital Warts, Vulvar Intraepithelial Neoplasia (VIN), Vaginal Intraepithelial Neoplasia (VaIN), Vulvar Cancer, Vaginal Cancer, Cervical Dysplasia, AIS, and Cervical Cancer [ Time Frame: Base Study: through Month 48 ]

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2. Primary:

Number of Participants With Vaccine-Related Serious Adverse Events (SAEs) [ Time Frame: Base Study: through Month 48 ]

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3. Secondary:

Combined Incidence of HPV 6/11 Related Persistent Infection, Genital Warts, VIN, VaIN, Vulvar Cancer, Vaginal Cancer, Cervical Dysplasia, Adenocarcinoma In Situ (AIS), and Cervical Cancer [ Time Frame: Base Study: through Month 48 ]

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4. Secondary:

Combined Incidence of HPV 31/33/35/52/58 Related Persistent Infection, Genital Warts, VIN, VaIN, Vulvar Cancer, Vaginal Cancer, Cervical Dysplasia, Cervical AIS, and Cervical Cancer [ Time Frame: Base Study: through Month 48 ]

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5. Other Pre-specified:

Combined Incidence of HPV 16/18 Related Persistent Infection, Genital Warts, VIN, VaIN, Vulvar Cancer, Vaginal Cancer, Cervical Dysplasia, Cervical AIS, and Cervical Cancer [ Time Frame: Base Study: through Month 48 ]

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Serious Adverse Events

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Other Adverse Events

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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 or presentation

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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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:

Muñoz N, Manalastas R Jr, Pitisuttithum P, Tresukosol D, Monsonego J, Ault K, Clavel C, Luna J, Myers E, Hood S, Bautista O, Bryan J, Taddeo FJ, Esser MT, Vuocolo S, Haupt RM, Barr E, Saah A. Safety, immunogenicity, and efficacy of quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine in women aged 24-45 years: a randomised, double-blind trial. Lancet. 2009 Jun 6;373(9679):1949-57. Epub 2009 Jun 1.

Velicer C, Zhu X, Vuocolo S, Liaw KL, Saah A. Prevalence and Incidence of HPV Genital Infection in Women. Sex Transm Dis. 2009 Jul 31; [Epub ahead of print]

Publications automatically indexed to this study:

Matys K, Mallary S, Bautista O, Vuocolo S, Manalastas R, Pitisuttithum P, Saah A. Mother-infant transfer of anti-human papillomavirus (HPV) antibodies following vaccination with the quadrivalent HPV (type 6/11/16/18) virus-like particle vaccine. Clin Vaccine Immunol. 2012 Jun;19(6):881-5. Epub 2012 Apr 18.

Garland SM, Ault KA, Gall SA, Paavonen J, Sings HL, Ciprero KL, Saah A, Marino D, Ryan D, Radley D, Zhou H, Haupt RM, Garner EI; Quadrivalent Human Papillomavirus Vaccine Phase III Investigators. Pregnancy and infant outcomes in the clinical trials of a human papillomavirus type 6/11/16/18 vaccine: a combined analysis of five randomized controlled trials. Obstet Gynecol. 2009 Dec;114(6):1179-88.

Responsible Party:	Merck
ClinicalTrials.gov Identifier:	NCT00090220 History of Changes
Other Study ID Numbers:	V501-019, 2004_013
Study First Received:	August 25, 2004
Results First Received:	October 30, 2009
Last Updated:	August 14, 2012
Health Authority:	United States: Food and Drug Administration

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