A Study to Evaluate the Safety, Immune Response, and Efficacy of Gardasil (V501) in Women

This study is ongoing, but not recruiting participants.

Study NCT00090220 Information provided by Merck

First Received on August 25, 2004. Last Updated on June 14, 2010 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
First Patient In: 18-Jun-2004; Last Patient Last Visit (LPLV) for Pre-specified Primary Analysis: 13 Jul 2007; LPLV for End of Study Analysis: 30-Apr-2009. At the time of LPLV, there were 21 subjects who had not reported pregnancy outcome. These subjects are to be followed for safety outcomes.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
Quadrivalent Human Papillomavirus Vaccine	The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 1 were vaccinated (at Day 1, Month 2 and Month 6) with the Quadrivalent HPV vaccine. The Follow-up Period for the study encompasses the follow-up of subjects who have received the Quadrivalent HPV vaccine; from Month 7 through Month 48 of the study.
Placebo	The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 2 were vaccinated (at Day 1, Month 2 and Month 6) with placebo. The Follow-up Period for the study encompasses the follow-up of subjects who have received placebo; from Month 7 through Month 48 of the study.

Description

Quadrivalent Human Papillomavirus Vaccine

The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 1 were vaccinated (at Day 1, Month 2 and Month 6) with the Quadrivalent HPV vaccine.

The Follow-up Period for the study encompasses the follow-up of subjects who have received the Quadrivalent HPV vaccine; from Month 7 through Month 48 of the study.

Placebo

The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 2 were vaccinated (at Day 1, Month 2 and Month 6) with placebo.

The Follow-up Period for the study encompasses the follow-up of subjects who have received placebo; from Month 7 through Month 48 of the study.

Participant Flow for 2 periods

Period 1: Vaccination Period (Day 1 to Month 7)

	Quadrivalent Human Papillomavirus Vaccine	Placebo
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: Follow-up Period (Month 7 to Month 48)

	Quadrivalent Human Papillomavirus Vaccine	Placebo
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 subjects did NOT complete the Vaccination Period but did enter the Follow-up Period.
[2]	5 subjects did NOT complete the Vaccination Period but did enter the Follow-up Period.
[3]	11 Participants are continuing in the Trial
[4]	10 Participants are continuing in the Trial

Baseline Characteristics

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Reporting Groups

	Description
Quadrivalent Human Papillomavirus Vaccine	The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 1 were vaccinated (at Day 1, Month 2 and Month 6) with the Quadrivalent HPV vaccine. The Follow-up Period for the study encompasses the follow-up of subjects who have received the Quadrivalent HPV vaccine; from Month 7 through Month 48 of the study.
Placebo	The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 2 were vaccinated (at Day 1, Month 2 and Month 6) with placebo. The Follow-up Period for the study encompasses the follow-up of subjects who have received placebo; from Month 7 through Month 48 of the study.

Description

Quadrivalent Human Papillomavirus Vaccine

The Follow-up Period for the study encompasses the follow-up of subjects who have received the Quadrivalent HPV vaccine; from Month 7 through Month 48 of the study.

Placebo

The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 2 were vaccinated (at Day 1, Month 2 and Month 6) with placebo.

The Follow-up Period for the study encompasses the follow-up of subjects who have received placebo; from Month 7 through Month 48 of the study.

Baseline Measures

	Quadrivalent Human Papillomavirus Vaccine	Placebo	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] Mean ( Full Range )	35 ( 24 to 45 )	34 ( 21 to 46 )	34.3 ( 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: Day 1 to Month 48 ]

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2. 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: Day 1 to Month 48 ]

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3. 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: Day 1 to 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: 48 months ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No

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: Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.

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
The numbers of subjects in the analysis population does not match the number of participants because there were 2 subjects who were randomized but never received a vaccination and 7 subjects who were cross treated.

Results Point of Contact:

Name/Title: Executive Vice President, Clinical and Quantitative Sciences
Organization: Merck Sharp & Dohme Corp
phone: 1-800-672-6372

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:

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:	Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier:	NCT00090220 History of Changes
Other Study ID Numbers:	2004_013, V501-019
Study First Received:	August 25, 2004
Results First Received:	October 30, 2009
Last Updated:	June 14, 2010
Health Authority:	United States: Food and Drug Administration