Long Term Follow-up Study at Years 2, 3, 4 and 5 Where 2 Dosing Schedules of the Combined Hepatitis A and B Vaccine Were Compared

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

276 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-11-01

Study Completion Date

2004-03-10

Brief Summary

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To evaluate the persistence of anti-hepatitis A virus (HAV) and anti-hepatitis B surface antigen (HBs) antibodies up to 2, 3, 4 and 5 years after administration of the first dose of the study vaccine.

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

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Detailed Description

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Open, randomised, self-contained, multicentric, multinational, long-term antibody persistence studies. Immune persistence was compared between subjects who received either two dose or three doses of GSK Biologicals combined hepatitis A and hepatitis B vaccine. The long-term follow-up studies involved taking blood samples at approximately 2, 3, 4 and 5 years after the primary vaccination of combined hepatitis A and B vaccine to assess antibody persistence. No additional subjects will be recruited during the long term follow-up period.

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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Twinrix Junior

Subjects previously received 3 doses of combined hepatitis A / hepatitis B vaccine (junior formulation).

Group Type EXPERIMENTAL

Twinrix™ Junior

Intervention Type BIOLOGICAL

Intramuscular injection in the left deltoid, 3 doses, junior formulation in primary study.

Twinrix Adult

Subjects previously received 2 doses of combined hepatitis A / hepatitis B vaccine (adult formulation).

Group Type ACTIVE_COMPARATOR

Twinrix™ Adult

Intervention Type BIOLOGICAL

Intramuscular injection in the left deltoid, 2 doses, Adult formulation in primary study.

Interventions

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Twinrix™ Adult

Intramuscular injection in the left deltoid, 2 doses, Adult formulation in primary study.

Intervention Type BIOLOGICAL

Twinrix™ Junior

Intramuscular injection in the left deltoid, 3 doses, junior formulation in primary study.

Intervention Type BIOLOGICAL

Other Intervention Names

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Combined hepatitis A and B vaccine Combined hepatitis A and B vaccine

Eligibility Criteria

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Inclusion Criteria

* Participation in primary study
* Written informed consent obtained before each long term follow up visit.

Minimum Eligible Age

3 Years

Maximum Eligible Age

13 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

North Adelaide, South Australia, Australia

Site Status

GSK Investigational Site

Carlton, Victoria, Australia

Site Status

GSK Investigational Site

Brussels, , Belgium

Site Status

GSK Investigational Site

Barcelona, , Spain

Site Status

GSK Investigational Site

Blanes (Girona), , Spain

Site Status

GSK Investigational Site

Cerdanyola Del Vallés / Barcelona, , Spain

Site Status

GSK Investigational Site

Valencia, , Spain

Site Status

Countries

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Australia Belgium Spain

References

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Marshall H, Nolan T, Diez Domingo J, Rombo L, Sokal EM, Mares J, Casanovas JM, Kuriyakose S, Leyssen M, Jacquet JM. Long-term (5-year) antibody persistence following two- and three-dose regimens of a combined hepatitis A and B vaccine in children aged 1-11 years. Vaccine. 2010 Jun 17;28(27):4411-5. doi: 10.1016/j.vaccine.2010.04.040. Epub 2010 Apr 29.

Reference Type BACKGROUND

PMID: 20434544 (View on PubMed)

Study Documents

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