Evaluation of Immune Memory to Twinrix or Comparator by Challenge Dose Administration 4 Years After Primary Vaccination

This study has been completed.

Study NCT00684671 Information provided by GlaxoSmithKline

First Received on May 23, 2008. Last Updated on February 12, 2010 History of Changes

Results First Received: October 29, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Prevention
Conditions:	Hepatitis A Hepatitis B
Interventions:	Biological: Engerix-B Biological: Havrix Biological: Twinrix Biological: HBVAXPRO Biological: 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
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Reporting Groups

	Description
Twinrix Group	Subjects received a single challenge dose of combined hepatitis A/hepatitis B vaccine (Twinrix).
Engerix + Havrix Group	Subjects received separate administration of a single challenge dose of hepatitis B vaccine (Engerix) and hepatitis A vaccine (Havrix).
HB VAX PRO + Vaqta Group	Subjects received separate administration of a single challenge dose of hepatitis B vaccine (HB VAX PRO) and hepatitis A vaccine (Vaqta).

Participant Flow: Overall Study

	Twinrix Group	Engerix + Havrix Group	HB VAX PRO + Vaqta Group
STARTED	172	170	164
COMPLETED	169	170	164
NOT COMPLETED	3	0	0
Adverse Event	1	0	0
Lost to Follow-up	1	0	0
Alcoholic dependance	1	0	0

Baseline Characteristics

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Reporting Groups

	Description
Twinrix Group	Subjects received a single challenge dose of combined hepatitis A/hepatitis B vaccine (Twinrix).
Engerix + Havrix Group	Subjects received separate administration of a single challenge dose of hepatitis B vaccine (Engerix) and hepatitis A vaccine (Havrix).
HB VAX PRO + Vaqta Group	Subjects received separate administration of a single challenge dose of hepatitis B vaccine (HB VAX PRO) and hepatitis A vaccine (Vaqta).

Baseline Measures

	Twinrix Group	Engerix + Havrix Group	HB VAX PRO + Vaqta Group	Total
Number of Participants [units: participants]	172	170	164	506
Age [units: years] Mean ± Standard Deviation	58.4 ± 8.70	59.5 ± 10.18	59.1 ± 9.16	59.0 ± 9.36
Gender [units: Subjects]
Female	85	83	85	253
Male	87	87	79	253

Outcome Measures

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1. Primary:

Number of Subjects With Anamnestic Response to the Challenge Dose for Anti-hepatitis A (Anti-HAV) Antibodies [ Time Frame: One month after the challenge dose. ]

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2. Primary:

Number of Subjects With Anamnestic Response to the Challenge Dose for Anti-hepatitis B Surface Antigen (Anti-HBs) Antibodies [ Time Frame: One month after the challenge dose. ]

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3. Secondary:

Anti-hepatitis A (Anti-HAV) and Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations [ Time Frame: Prior to administration of challenge dose ]

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4. Secondary:

Anti-hepatitis A (Anti-HAV) and Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations [ Time Frame: Two weeks and one month after the challenge dose ]

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5. Secondary:

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

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6. Secondary:

Number of Subjects Reporting Unsolicited Symptoms [ Time Frame: During the 31-day follow-up period after the challenge dose. ]

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7. Secondary:

Number of Subjects With Serious Adverse Events (SAEs) Since the Last Study Visit of the HAB-160 (NCT00603252) Long-term Follow-up Study Considered by the Investigator to Have a Causal Relationship to Primary Vaccination [ Time Frame: Since the last study visit of the primary study long-term follow-up study up to challenge dose administration (1 year) ]

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8. Secondary:

Number of Subjects Reporting Serious Adverse Events (SAEs) [ Time Frame: During one month following the administration of the challenge dose ]

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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

No publications provided by GlaxoSmithKline

Publications automatically indexed to this study:

Chlibek R, von Sonnenburg F, Van Damme P, Smetana J, Tichy P, Gunapalaiah B, Leyssen M, Jacquet JM. Antibody persistence and immune memory 4 years post-vaccination with combined hepatitis A and B vaccine in adults aged over 40 years. J Travel Med. 2011 Mar-Apr;18(2):145-8. Epub 2011 Feb 7.

Responsible Party:	Study Director, GSK
ClinicalTrials.gov Identifier:	NCT00684671 History of Changes
Other Study ID Numbers:	111572
Study First Received:	May 23, 2008
Results First Received:	October 29, 2009
Last Updated:	February 12, 2010
Health Authority:	Belgium: Federal Agency for Medicinal Products and Health Products