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

Phase 3

Completed

• Conditions: Hepatitis B; Hepatitis A
• Interventions: Biological: Twinrix™ Adult; Biological: Twinrix™ Junior

• Registration Number: NCT00197119
• Lead Sponsor: GlaxoSmithKline

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2004-05
• Primary Completion: 2004-06
• Study Completion: 2004-06
• Study First Submitted: 2005-09-14
• Study First Submitted QC: 2005-09-14
• Study First Posted: 2005-09-20
• Results First Submitted: 2009-07-02
• Results First Submitted QC: 2009-07-02
• Results First Posted: 2009-08-14
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-21
• Last Update Posted: 2017-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 244

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.

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Exclusion Criteria

• none

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group Twinrix Adult	Twinrix™ Adult	Subjects received Twinrix™ Adult (720/20) in a 0, 6 month schedule in the primary study.
Group Twinrix Junior	Twinrix™ Junior	Subjects received Twinrix™ Junior (360/10) in a 0, 1, 6 month schedule in the primary study.

Primary Outcome Measures

Name	Time	Method
Number of Subjects With Anti-Hepatitis B Surface Antigen (HBs) Antibody Concentrations Above the Cut-Off Value	Year 6, 7, 8, 9 and 10 after the first vaccine dose of a two-dose or three-dose primary vaccination	Anti-HBs antibody concentration cut-off value assessed was ≥ 3.3 mIU/mL.
Number of Subjects With Anti-hepatitis A Virus (HAV) Antibody Concentrations Above the Cut-off Value	Year 6, 7, 8, 9 and 10 after the first vaccine dose of a two-dose or three-dose primary vaccination	Anti-HAV antibody concentration cut-off value assessed was ≥ 15 milli-International Units per milliliter (mIU/mL).
Serious Adverse Events (SAE) Causally Related to Primary Vaccination or Related to Hepatitis A or B Infection or Related to Study Participation (Blood Sampling)	From Year 6 through to Year 10	An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/ incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.

Trial Locations

Locations (1)

GSK Investigational Site; 🇨🇿 Hradec Kralove, Czech Republic