Long Term F/U Studies at Y5&6 to Demonstrate the Equivalence of 2 Vaccination Schedules of Combined Hepatitis A & B Vaccine

This study has been completed.
Information provided by:
ClinicalTrials.gov Identifier:
First received: September 14, 2005
Last updated: September 29, 2011
Last verified: September 2011
To evaluate the persistence of immune response 5 years and 6 years after the first vaccine dose.

Condition Intervention Phase
Hepatitis B
Hepatitis A
Biological: Combined Hepatitis A and B vaccine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Evaluate the Persistence of Immune Response of GSK Biologicals' TWINRIX™ ADULT, Administered According to 0,6 m Schedule and 0,12 m Schedule, in Volunteers Aged 12-15 y Inclusive at the Time of First Vaccine Dose

Resource links provided by NLM:

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Immune persistence in terms of anti-HAV and anti-HBs antibodies and GMCs, 5 and 6 years after administration of first vaccine dose. An additional dose of the study vaccine will be given (between 6 to 12 months after the Year 6 time point) to subjects who [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To record the SAEs that was reported since the last time point. [ Designated as safety issue: No ]

Enrollment: 143
Study Start Date: September 2003
Study Completion Date: December 2003
Primary Completion Date: December 2003 (Final data collection date for primary outcome measure)
Detailed Description:
Open, randomised, long-term antibody persistence studies, conducted in 2 centers. Immune persistence was compared between subjects who received two doses of GSK Biologicals combined hepatitis A and hepatitis B vaccine at either 0, 6 month schedule or 0, 12 month schedule. These long-term follow-up studies involved taking blood samples at approximately 5 and 6 years after the primary vaccination of combined hepatitis A and B vaccine, to assess antibody persistence and a retrospective safety follow-up.

Ages Eligible for Study:   12 Years to 15 Years   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Subjects who received GSK Biologicals' combined hepatitis A and B vaccine in the primary study (HAB-082). Subjects were aged 12 to 15 years at the time of the first vaccination.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00197171

Australia, New South Wales
GSK Investigational Site
Paramatta, New South Wales, Australia, 2124
Australia, Victoria
GSK Investigational Site
Melbourne, Victoria, Australia, 3001
Sponsors and Collaborators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT00197171     History of Changes
Other Study ID Numbers: 100386 (EXT Y5)  100387 
Study First Received: September 14, 2005
Last Updated: September 29, 2011
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Additional relevant MeSH terms:
Hepatitis A
Hepatitis B
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 25, 2016