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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00519649 |
The purpose of this study is to assess the persistence of immunity to hepatitis B in children who received three consecutive doses of HBV vaccine (EngerixTM-B) in infancy. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Condition | Intervention | Phase |
---|---|---|
Hepatitis B |
Biological: Engerix™-B Kinder |
Phase IV |
Study Type: | Interventional |
Study Design: | Prevention, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Long-Term Persistence of Hepatitis B Antibodies & Immune Response to a Hepatitis B Vaccine Challenge in 7-8 Year Old Children, Previously Vaccinated in Infancy With GlaxoSmithKline (GSK) Biologicals' HBV Vaccine. |
Enrollment: | 301 |
Study Start Date: | August 2007 |
Study Completion Date: | December 2007 |
Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Group A: Experimental |
Biological: Engerix™-B Kinder
Intramuscular injection, 1 dose
|
Ages Eligible for Study: | 7 Years to 8 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Germany | |
GSK Investigational Site | |
Berlin, Germany, 10967 | |
GSK Investigational Site | |
Berlin, Germany, 13055 | |
Germany, Baden-Wuerttemberg | |
GSK Investigational Site | |
Oberstenfeld, Baden-Wuerttemberg, Germany, 71720 | |
GSK Investigational Site | |
Ettenheim, Baden-Wuerttemberg, Germany, 77955 | |
GSK Investigational Site | |
Tuttlingen, Baden-Wuerttemberg, Germany, 78532 | |
GSK Investigational Site | |
Stuttgart, Baden-Wuerttemberg, Germany, 70469 | |
GSK Investigational Site | |
Karlsruhe, Baden-Wuerttemberg, Germany, 76189 | |
GSK Investigational Site | |
Offenburg, Baden-Wuerttemberg, Germany, 77654 | |
GSK Investigational Site | |
Pforzheim, Baden-Wuerttemberg, Germany, 75172 | |
Germany, Bayern | |
GSK Investigational Site | |
Lohr, Bayern, Germany, 97816 | |
GSK Investigational Site | |
Bindlach, Bayern, Germany, 95463 | |
GSK Investigational Site | |
Tegernsee, Bayern, Germany, 83684 | |
Germany, Nordrhein-Westfalen | |
GSK Investigational Site | |
Minden, Nordrhein-Westfalen, Germany, 32427 | |
GSK Investigational Site | |
Muenster, Nordrhein-Westfalen, Germany, 48163 | |
GSK Investigational Site | |
Porta Westfalica, Nordrhein-Westfalen, Germany, 32457 | |
Germany, Rheinland-Pfalz | |
GSK Investigational Site | |
Frankenthal, Rheinland-Pfalz, Germany, 67227 | |
GSK Investigational Site | |
Worms, Rheinland-Pfalz, Germany, 67547 | |
Germany, Schleswig-Holstein | |
GSK Investigational Site | |
Bredstedt, Schleswig-Holstein, Germany, 25821 | |
GSK Investigational Site | |
Flensburg, Schleswig-Holstein, Germany, 24943 | |
GSK Investigational Site | |
Husum, Schleswig-Holstein, Germany, 25813 | |
GSK Investigational Site | |
Flensburg, Schleswig-Holstein, Germany, 24937 | |
GSK Investigational Site | |
Kiel, Schleswig-Holstein, Germany, 24161 |
Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | 110474 |
Study First Received: | August 21, 2007 |
Last Updated: | November 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00519649 |
Health Authority: | Germany: Paul-Ehrlich-Institut |
Challenge dose Hepatitis B vaccine |
Virus Diseases Hepatitis Antibodies Liver Diseases Digestive System Diseases |
Hepatitis B Antibodies Hepatitis B Hepatitis, Viral, Human DNA Virus Infections Immunoglobulins |
Hepadnaviridae Infections |