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
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.
  Contacts and Locations
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

No publications provided

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

ClinicalTrials.gov processed this record on April 15, 2014