Long-Term Follow-Up Studies at Year 6, 7, 8, 9, 10: 2 Formulations of Combined Hepatitis A/B Vaccine Compared in Subjects Aged 12-15 Years

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

244 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-05-31

Study Completion Date

2004-06-30

Brief Summary

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To evaluate the persistence of anti-hepatitis A virus (anti-HAV) and anti-hepatitis B surface antigen (anti-HBs) antibodies up to 6, 7, 8, 9 and 10 years after administration of the first dose of the study vaccine.

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Detailed Description

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Open, randomized, long-term antibody persistence studies. Immune persistence was compared between subjects who received one of the two formulations of GlaxoSmithKline Biologicals' combined hepatitis A and hepatitis B vaccine according to a two-dose or three-dose schedule. These long-term follow-up studies involved taking blood samples at approximately 6, 7, 8, 9 and 10 years after the primary vaccination of combined hepatitis A and B vaccine, to assess antibody persistence and a retrospective safety follow-up.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Conditions

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Hepatitis B Hepatitis A

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Group Twinrix Adult

Subjects received Twinrix™ Adult (720/20) in a 0, 6 month schedule in the primary study.

Group Type ACTIVE_COMPARATOR

Twinrix™ Adult

Intervention Type BIOLOGICAL

Intramuscular administration in the deltoid region (2 doses).

Group Twinrix Junior

Subjects received Twinrix™ Junior (360/10) in a 0, 1, 6 month schedule in the primary study.

Group Type ACTIVE_COMPARATOR

Twinrix™ Junior

Intervention Type BIOLOGICAL

Intramuscular administration in the deltoid region (3 doses).

Interventions

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Twinrix™ Adult

Intramuscular administration in the deltoid region (2 doses).

Intervention Type BIOLOGICAL

Twinrix™ Junior

Intramuscular administration in the deltoid region (3 doses).

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Healthy male and female volunteers vaccinated in study HAB-084.
* Written informed consent obtained from the subject before the blood sampling visit of each year.

Exclusion Criteria

• none

Minimum Eligible Age

12 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Brussels, , Belgium

Site Status

GSK Investigational Site

Hradec Králové, , Czechia

Site Status

Countries

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Belgium Czechia

References

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Beran J, Kervyn D, Wertzova V, Hobzova L, Tichy P, Kuriyakose S, Leyssen M, Jacquet JM. Comparison of long-term (10 years) immunogenicity of two- and three-dose regimens of a combined hepatitis A and B vaccine in adolescents. Vaccine. 2010 Aug 23;28(37):5993-7. doi: 10.1016/j.vaccine.2010.06.104. Epub 2010 Jul 15.

Reference Type BACKGROUND

PMID: 20637766 (View on PubMed)

Study Documents

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Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register. The results of this study 100566 are summarised with studies 100567, 100568, 100569, and 100570 on the GSK Clinical Study Register.

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