Long-Term Immune Persistence of GSK Biologicals' Combined Hepatitis A & B Vaccine Injected According to a 0,6 Month Schedule

Phase 3

Completed

• Conditions: Hepatitis A; Hepatitis B
• Interventions: Biological: TWINRIX™ ADULT; Biological: Engerix TM

• Registration Number: NCT00289744
• Lead Sponsor: GlaxoSmithKline

Brief Summary

The aim of this study is to evaluate the long-term persistence of hepatitis A and B antibodies at Years 6, 7, 8, 9 and 10 after subjects received their first two doses primary vaccination schedule of combined hepatitis A/hepatitis B vaccine.

This protocol posting deals with objectives \& outcome measures of the extension phase at year 6 through to 10.

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

Detailed Description

To evaluate the long-term antibody persistence, volunteers will be bled at Years 6, 7, 8, 9 and 10 after the first vaccine dose of the primary vaccination course to determine their anti-HAV and anti-HBs antibody concentrations.

If a subject has become seronegative for anti-HAV antibodies or lost anti-HBs seroprotection concentrations at the long-term blood sampling time point (i.e. Years 6, 7, 8, 9 or 10), he/ she will be offered an additional vaccine dose.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2004-02-16
• Study First Submitted: 2006-02-09
• Study First Submitted QC: 2006-02-09
• Study First Posted: 2006-02-10
• Primary Completion: 2009-04-15
• Study Completion: 2009-04-15
• Results First Submitted: 2010-04-08
• Results First Submitted QC: 2010-07-29
• Results First Posted: 2010-08-26
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-19
• Last Update Posted: 2018-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 178

Inclusion Criteria

• Subjects participating in this study should have participated in the primary study with combined hepatitis A/ hepatitis B vaccine.
• Written informed consent will be obtained from each subject and/ or parent or guardian of the subject before the blood sampling visit of each year.

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Twinrix Group	TWINRIX™ ADULT	Subjects who received 2 doses (at Day 0 and Month 6) of Twinrix in the primary study (208127/076)
Engerix-B Additional Dose (Adult)	Engerix TM	Subjects aged 16 years and above who received an additional dose of EngerixTM-B (adult dose).
Engerix-B Additional Dose (Pediatric)	Engerix TM	Subjects under the age of 16 years who received an additional dose of EngerixTM-B (pediatric dose).

Primary Outcome Measures

Name	Time	Method
Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration	Before and 1 month after the additional dose administration
Anti-hepatitis A Virus (Anti-HAV) Antibody Concentration	Years 6, 7, 8, 9, and 10.
Number of Subjects With Immune Response to the Additional Dose of Engerix™-B	One month after the additional dose administration	Immune response was defined as: * anti-hepatitis B surface antigen (anti-HBs) antibody concentration equal or above to 10 milli-international units per milliliter (mIU/mL) at 1 month post-challenge dose in subjects seronegative at the pre-challenge time-points; * at least a 4-fold increase in anti-HBs antibody concentrations at 1 month post-challenge dose in subjects seropositive at the pre-challenge time-points.
Number of Subjects Reporting Serious Adverse Events (SAEs) Assessed by the Investigator as Causally Related to Primary Vaccination, Study Procedures or Lack of Vaccine Efficacy	At Year 6, 7, 8, 9 and 10	Serious adverse events (SAEs) assessed include medical occurrences that result in death, is life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
Number of Subjects Reporting Solicited Local and General Symptoms	During the 4-day follow-up period after additional dose	Solicited local symptoms assessed include pain, redness and swelling. Solicited general symptoms assessed include fatigue, fever, gastrointestinal symptoms and headache.
Number of Subjects Reporting Unsolicited Adverse Events	During the 30-day follow-up period after additional dose	Unsolicited adverse event (AE) covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
Number of Subjects Reporting Serious Adverse Events (SAEs)	During the 30-day follow-up period after additional dose	Serious adverse events (SAEs) assessed include medical occurrences that result in death, is life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.

Trial Locations

Locations (1)

GSK Investigational Site; 🇧🇪 Wilrijk, Belgium