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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00657657 |
In this study, subjects who received primary neonatal vaccination with hepatitis B vaccine at 0, 1, 2, 12 months, 20 years ago in the 103860/272 primary study will be evaluated for immunological memory to hepatitis B vaccine via assessment of the response to a vaccine challenge dose.
Condition | Intervention | Phase |
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Hepatitis B |
Biological: Engerix™-B |
Phase IV |
Study Type: | Interventional |
Study Design: | Prevention, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Immune Response to a Hepatitis B Vaccine Challenge Dose in Healthy Subjects Who Received Primary Vaccination of GlaxoSmithKline Biologicals' Hepatitis B Vaccine, Approximately 20 Years Ago. |
Enrollment: | 29 |
Study Start Date: | April 2008 |
Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Experimental |
Biological: Engerix™-B
A challenge dose of hepatitis B vaccine will be administered to all subjects as a deep intramuscular injection in the deltoid region of the non-dominant arm.
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Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | 110071 |
Study First Received: | April 8, 2008 |
Last Updated: | October 30, 2008 |
ClinicalTrials.gov Identifier: | NCT00657657 |
Health Authority: | Thailand: NA |
Hepatitis vaccine |
Virus Diseases Hepatitis Liver Diseases Digestive System Diseases |
Hepatitis B Hepatitis, Viral, Human DNA Virus Infections Healthy |
Hepadnaviridae Infections |