Long-term Immune Persistence of GSK Biologicals' Combined Hepatitis A & B Vaccine Injected According to a 0,1,6 Mth Schedule in Healthy Adults

This study has been completed.

Study NCT00289770 Information provided by GlaxoSmithKline

First Received on February 9, 2006. Last Updated on November 10, 2011 History of Changes

Results First Received: November 30, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Prevention
Conditions:	Hepatitis B Hepatitis A
Intervention:	Biological: Twinrix™

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
Subjects who came back at a follow-up, did not necessarily come back at an earlier timepoint. Therefore amount of subjects who completed the previous timepoint does not always correspond with amount of subjects who entered follow-up. As Year 15 has enrolled the most subjects, baseline measures are given for Year 15, to be as complete as possible.

Reporting Groups

	Description
Twinrix Group	Subjects who were vaccinated with either Lot 1, Lot 2 or Lot 3 of Twinrix in the primary study according to a 0, 1, 6-Month schedule

Participant Flow for 5 periods

Period 1: Year 11

	Twinrix Group
STARTED	37
COMPLETED	37
NOT COMPLETED	0

Period 2: Year 12

	Twinrix Group
STARTED	40
COMPLETED	40
NOT COMPLETED	0

Period 3: Year 13

	Twinrix Group
STARTED	37
COMPLETED	37
NOT COMPLETED	0

Period 4: Year 14

	Twinrix Group
STARTED	43
COMPLETED	43
NOT COMPLETED	0

Period 5: Year 15

	Twinrix Group
STARTED	50
COMPLETED	49
NOT COMPLETED	1
Withdrawal by Subject	1

Baseline Characteristics

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Reporting Groups

	Description
Twinrix Group	Subjects who were vaccinated with either Lot 1, Lot 2 or Lot 3 of Twinrix in the primary study according to a 0, 1, 6-Month schedule

Baseline Measures

	Twinrix Group
Number of Participants [units: participants]	50
Age [units: Years] Mean ± Standard Deviation	34.4 ± 2.66
Gender [units: Participants]
Female	39
Male	11

Outcome Measures

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1. Primary:

Number of Subjects With Anti-hepatitis A (Anti-HAV) Antibody Concentrations Equal to or Above Cut-off Value [ Time Frame: Years 11, 12, 13, 14 and 15 ]

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2. Primary:

Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Equal to or Above Cut-off Values [ Time Frame: Years 11, 12, 13, 14 and 15 ]

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3. Primary:

Anti-HAV and Anti-HBs Antibody Concentrations [ Time Frame: Years 11, 12, 13, 14 and 15 ]

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4. Primary:

Anti-HBs Antibody Concentrations [ Time Frame: at Year 11, pre-additional vaccine, after additional dose of Engerix ]

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5. Primary:

Number of Subjects, Receiving an Additional Vaccination of Engerix, With an Anamnestic Response [ Time Frame: 30 days post additional dose of Engerix ]

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6. Primary:

Number of Subjects With Solicited Local and General Symptoms Assessed [ Time Frame: During the 4-day follow-up period after additional vaccination with Engerix ]

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7. Primary:

Number of Subjects With Unsolicited Symptoms [ Time Frame: During the 30-day follow-up period after additional Engerix vaccination ]

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8. Primary:

Number of Subjects With Serious Adverse Events (SAEs) [ Time Frame: During the 30-day follow-up period after additional Engerix vaccination ]

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9. Primary:

Number of Subjects With Serious Adverse Events (SAEs) Determined by the Investigator to Have a Causal Relationship to Primary Vaccination or Due to Lack of Vaccine Efficacy [ Time Frame: up to Year 11, 12, 13, 14, 15 ]

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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
No text entered.

Results Point of Contact:

Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343

Publications:

Van Herck K, Leroux-Roels G, Van Damme P, Srinivasa K, Hoet B. Ten-year antibody persistence induced by hepatitis A and B vaccine (Twinrix) in adults. Travel Med Infect Dis. 2007 May;5(3):171-5. Epub 2006 Sep 20.

Van Damme P, Leroux-Roels G, Law B, Diaz-Mitoma F, Desombere I, Collard F, Tornieporth N, Van Herck K. Long-term persistence of antibodies induced by vaccination and safety follow-up, with the first combined vaccine against hepatitis A and B in children and adults. J Med Virol. 2001 Sep;65(1):6-13.

Publications automatically indexed to this study:

Van Damme P, Leroux-Roels G, Crasta P, Messier M, Jacquet JM, Van Herck K. Antibody persistence and immune memory in adults, 15 years after a three-dose schedule of a combined hepatitis A and B vaccine. J Med Virol. 2012 Jan;84(1):11-7. Epub 2011 Nov 3.

Responsible Party:	Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier:	NCT00289770 History of Changes
Other Study ID Numbers:	100551 (EXT Y11), 100552 (EXT Y12), 100553 (EXT Y13), 100554 (EXT Y14), 100555 (EXT Y15)
Study First Received:	February 9, 2006
Results First Received:	November 30, 2010
Last Updated:	November 10, 2011
Health Authority:	Belgium: Institutional Review Board