An Immunogenicity and Safety Study of Gardasil® in Chinese Subjects (V501-030)(COMPLETED)

This study has been completed.

Sponsor:

Information provided by:

Merck

ClinicalTrials.gov Identifier:

NCT00496626

First received: July 3, 2007

Last updated: April 2, 2013

Last verified: April 2013

History of Changes

Results First Received: February 8, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Prevention
Condition:	Papillomavirus Infections
Interventions:	Biological: Quadrivalent Human Papillomavirus (HPV, Types 6, 11, 16, 18) Recombinant Vaccine (Gardasil®) 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
Vaccine (Gardasil®) Group	Human Papillomavirus (HPV) (Type 6, 11, 16, 18) Recombinant Vaccine (Gardasil®), 0.5mL, 3 Dose of intramuscular injection at Day 1, Month 2 and Month 6
Placebo Group	Placebo aluminum-containing, 0.5mL, 3 Dose of intramuscular injection at Day 1, Month 2 and Month 6

Participant Flow: Overall Study

	Vaccine (Gardasil®) Group	Placebo Group
STARTED	302	298
COMPLETED	296	292
NOT COMPLETED	6	6
Lost to Follow-up	0	1
Protocol Violation	1	0
Withdrawal by Subject	5	4
Relocated	0	1

Baseline Characteristics

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Reporting Groups

	Description
Vaccine (Gardasil®) Group	Human Papillomavirus (HPV) (Type 6, 11, 16, 18) Recombinant Vaccine (Gardasil®), 0.5mL, 3 Dose of intramuscular injection at Day 1, Month 2 and Month 6
Placebo Group	Placebo aluminum-containing, 0.5mL, 3 Dose of intramuscular injection at Day 1, Month 2 and Month 6
Total	Total of all reporting groups

Baseline Measures

	Vaccine (Gardasil®) Group	Placebo Group	Total
Number of Participants [units: participants]	302	298	600
Age [units: years] Mean ± Standard Deviation	24.5 ± 10.9	24.8 ± 11.0	24.6 ± 10.9
Age, Customized [units: Participants]
9-15 Years of Age	101	99	200
16-26 Years of Age	76	74	150
27-34 Years of Age	63	62	125
35-45 Years of Age	62	63	125
Gender [units: Participants]
Female	251	249	500
Male	51	49	100
Body Temperature [units: Degrees Celsius] Mean ± Standard Deviation	36.5 ± 0.31	36.5 ± 0.31	36.5 ± 0.31
Pulse [units: Beats per minute (BPM)] Mean ± Standard Deviation	74.4 ± 11.9	74.6 ± 11.2	74.5 ± 11.2

Outcome Measures

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1. Primary:

Geometric Mean Titer (GMT) of Anti-HPV 6, 11, 16 , 18 at Day 1 and Month 7 (1 Month After Completion of Administration of a 6-month 3-dose Regimen of Vaccines) [ Time Frame: Collect blood sample for anti-HPV 6, 11, 16, 18 titers testing at Day 1 prior to vaccination, and Month 7 ]

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2. Secondary:

Number of Participants Who Were Seronegative at Baseline and Developed Seropositive at Month 7 [ Time Frame: Collect blood sample for anti-HPV 6, 11, 16, 18 titers testing at Day 1 prior to vaccination and Month 7 ]

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3. Secondary:

Serious Adverse Experiences and Systemic Adverse Experiences Occurring Within 14 Days After Each Vaccination, and Injection-site Complaints Occurring Day 1 Through Day 5 After Each Vaccination [ Time Frame: For serious adverse experiences and systemic adverse experiences: 14 days follow-up after each dose of vaccination; For injection-site adverse experiences: 5 days follow-up after each dose of vaccination ]

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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: 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
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Results Point of Contact:

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

No publications provided

Responsible Party:	Vice President, Late Stage Development Group Leader, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier:	NCT00496626 History of Changes
Obsolete Identifiers:	NCT00926822
Other Study ID Numbers:	V501-030, 2007_021
Study First Received:	July 3, 2007
Results First Received:	February 8, 2010
Last Updated:	April 2, 2013
Health Authority:	China: Food and Drug Administration

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