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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00289744 |
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.
Condition | Intervention | Phase |
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Hepatitis A Hepatitis B |
Biological: TWINRIX™ ADULT |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Long-Term Follow-up Study to Evaluate the Immune Persistence of GSK Biologicals' Combined Hepatitis A / Hepatitis B Vaccine in Healthy Children |
Enrollment: | 178 |
Study Start Date: | February 2004 |
Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Group A: Experimental |
Biological: TWINRIX™ ADULT
2 doses IM injection in primary study
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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.
Ages Eligible for Study: | 7 Years to 17 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Responsible Party: | GSK Biologicals ( Isabelle Harpigny ) |
Study ID Numbers: | 100561 (Y6), 100562 (Year 7), 100563 (Year 8), 100564 (Year 9), 100565 (Year 10) |
Study First Received: | February 9, 2006 |
Last Updated: | August 14, 2008 |
ClinicalTrials.gov Identifier: | NCT00289744 |
Health Authority: | Belgium: Institutional Review Board |
Hepatitis A Hepatitis B TWINRIX™ ADULT |
Virus Diseases Hepatitis Liver Diseases Digestive System Diseases Hepatitis B Picornaviridae Infections |
Hepatitis, Viral, Human Hepatitis A DNA Virus Infections Healthy Enterovirus Infections |
RNA Virus Infections Hepadnaviridae Infections |