A Study of 2 Doses of VAQTA™ in Healthy Children 12 to 23 Months of Age

This study has been completed.

Sponsor:

Information provided by:

Merck

ClinicalTrials.gov Identifier:

NCT00835380

First received: January 30, 2009

Last updated: April 21, 2010

Last verified: April 2010

History of Changes

Results First Received: October 19, 2009

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Prevention
Condition:	Hepatitis A Virus Infection
Intervention:	Biological: Hepatitis A Vaccine, Purified Inactivated (VAQTA™)

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
114 subjects were enrolled for vaccination screening. Subject eligibility was reviewed according to the inclusion/exclusion criteria, and blood samples were collected for HAV (hepatitis A virus) antibody and ALT (alanine aminotransferase) testing. Finally 80 HAV-susceptible subjects with normal ALT were administered vaccines at the Day 1

Reporting Groups

	Description
VAQTA™	Subjects be given a 25-U/0.5-ml intramuscular injection of VAQTA™ at the Day 1 and Month 6 visits respectively.

Participant Flow: Overall Study

	VAQTA™
STARTED	80
COMPLETED	78
NOT COMPLETED	2
Withdrawal by Subject	2

Baseline Characteristics

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Reporting Groups

	Description
VAQTA™	Subjects be given a 25-U/0.5-ml intramuscular injection of VAQTA™ at the Day 1 and Month 6 visits respectively.

Baseline Measures

	VAQTA™
Number of Participants [units: participants]	80
Age [units: Months] Mean ± Standard Deviation	14.7 ± 1.6
Gender [units: participants]
Female	37
Male	43
Body Temperature [units: Degrees Celsius] Mean ± Standard Deviation	35.56 ± 0.31
Pulse [units: Beats per minute (BPM)] Mean ± Standard Deviation	80.05 ± 5.04

Outcome Measures

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1. Primary:

Hepatitis A Virus (HAV) Seroconversion Rate, i.e. the Percentage of Subjects Who Were Seronegative at Baseline and Developed Seropositive at Month 7 After Administration of a 2-dose Regime of Vaccines. [ Time Frame: Collect blood sample for HAV antibody testing at Day 0 prior to vaccination, and Month 7 (4 weeks after administration of a 2-dose regimen of vaccines at Month 6) ]

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

No publications provided

Responsible Party:	Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier:	NCT00835380 History of Changes
Other Study ID Numbers:	2009_531, V251-069
Study First Received:	January 30, 2009
Results First Received:	October 19, 2009
Last Updated:	April 21, 2010
Health Authority:	China: Ministry of Health

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