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

Hepatitis B Clinical Trial

Official title:

Evaluate the Persistence of Immune Response of GSK Biologicals' TWINRIX™ ADULT, Administered According to 0,6 Month Schedule and 0,12 Month Schedule, in Volunteers Aged 12-15 Years Inclusive at the Time of First Vaccine Dose

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00197171
• Other study ID #: 100386 (EXT Y5)
• Secondary ID: 100387
• Status: Completed
• Phase: Phase 3
• First received: September 14, 2005
• Last updated: September 6, 2016
• Start date: September 2003
• Est. completion date: December 2003

Study information

• Verified date: September 2016
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial Summary

To evaluate the persistence of immune response 5 years and 6 years after the first vaccine dose.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 143
• Est. completion date: December 2003
• Est. primary completion date: December 2003
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 12 Years to 15 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B

Intervention

Biological:
• Combined Hepatitis A and B vaccine

Locations

Country	Name	City	State
Australia	GSK Investigational Site	Melbourne	Victoria
Australia	GSK Investigational Site	Paramatta	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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			No
Secondary	To record the SAEs that was reported since the last time point.			No

External Links

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