Long-term Persistence of Immunity Against Hepatitis B in 7-8 Years Old Children After Hepatitis B Vaccination.

This study has been completed.

Study NCT00519649 Information provided by GlaxoSmithKline

First Received on August 21, 2007. Last Updated on March 24, 2011 History of Changes

Results First Received: December 17, 2008

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Prevention
Conditions:	Hepatitis B Hepatitis B Vaccine
Intervention:	Biological: Engerix™-B Kinder

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
One additional subject, enrolled but not vaccinated, was not included in the number of subjects under "STARTED"

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
Group Engerix	Subjects received a single challenge dose of Engerix™ (hepatitis-B [HBV] vaccine)

Participant Flow: Overall Study

	Group Engerix
STARTED	300
COMPLETED	299
NOT COMPLETED	1
Withdrawal by Subject	1

Baseline Characteristics

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Reporting Groups

	Description
Group Engerix	Subjects received a single challenge dose of Engerix™ (hepatitis-B [HBV] vaccine)

Baseline Measures

	Group Engerix
Number of Participants [units: participants]	300
Age [units: years] Mean ± Standard Deviation	7.7 ± 0.46
Gender [units: participants]
Female	136
Male	164

Outcome Measures

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1. Primary:

Number of Participants With Anti-hepatitis B Surface Antigen (HBs) Antibody Concentrations Above the Cut-off Value [ Time Frame: One month after the challenge dose of HBV vaccine ]

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2. Secondary:

Number of Participants With Anti-HBs Antibody Concentrations Above the Cut-off Value [ Time Frame: Before challenge dose of HBV vaccine ]

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3. Secondary:

Number of Participants Reporting Solicited Local Symptoms [ Time Frame: During the 4-day follow-up period after the challenge dose of HBV vaccine. ]

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4. Secondary:

Number of Participants Reporting Solicited General Symptoms [ Time Frame: During the 4-day follow-up period after the challenge dose of HBV vaccine. ]

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5. Secondary:

Number of Participants Reporting Unsolicited Adverse Events [ Time Frame: During the 31-day follow-up period after the challenge dose of HBV vaccine. ]

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6. Secondary:

Number of Participants Reporting Serious Adverse Events (SAE) [ Time Frame: After the challenge dose of HBV vaccine. ]

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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: GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK 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: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343

Publications:

Disselhoff J et al. Immune memory against hepatitis B persists in 7-8 year olds primed with 3 doses of HBV vaccine in routine clinical practice. Abstract presented at the 27th annual ESPID meeting, Brussels, Belgium, 9-13 June 2009.

Responsible Party:	Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier:	NCT00519649 History of Changes
Other Study ID Numbers:	110474
Study First Received:	August 21, 2007
Results First Received:	December 17, 2008
Last Updated:	March 24, 2011
Health Authority:	Germany: Paul-Ehrlich-Institut