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Sponsored by: |
GlaxoSmithKline |
Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00411697 |
The purpose of this study is to determine at 5 years of age the persistence of immunity to hepatitis B that was conferred by infant vaccination with Infanrix hexa™.
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 |
MedlinePlus related topics: | Hepatitis Hepatitis B |
ChemIDplus related topics: | Hepatitis B Vaccines |
Study Type: | Interventional |
Study Design: | Prevention, Non-Randomized, Open Label, Single Group Assignment, Efficacy Study |
Official Title: | Assess Long-Term Persistence of Hepatitis B Antibodies & Immune Response to a Hepatitis B Vaccine (Engerix-B Kinder) Challenge in Children Aged 4-5 Yrs (Previously Primed & Boosted in the 1st 2 Yrs of Life With DTPa-HBV-IPV/Hib Vaccine) |
Enrollment: | 301 |
Study Start Date: | December 2006 |
Primary Completion Date: | May 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
Group A: Experimental |
Biological: Engerix™-B Kinder
Intramuscular injection, 1 dose
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Ages Eligible for Study: | 4 Years to 5 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Germany | |||||
GSK Investigational Site | |||||
Berlin, Germany, 13355 | |||||
GSK Investigational Site | |||||
Berlin, Germany, 13055 | |||||
GSK Investigational Site | |||||
Berlin, Germany, 12679 | |||||
GSK Investigational Site | |||||
Berlin, Germany, 13507 | |||||
GSK Investigational Site | |||||
Berlin, Germany, 10315 | |||||
Germany, Baden-Wuerttemberg | |||||
GSK Investigational Site | |||||
Boennigheim, Baden-Wuerttemberg, Germany, 74357 | |||||
GSK Investigational Site | |||||
Offenburg, Baden-Wuerttemberg, Germany, 77654 | |||||
GSK Investigational Site | |||||
Stuttgart, Baden-Wuerttemberg, Germany, 70469 | |||||
GSK Investigational Site | |||||
Ehingen, Baden-Wuerttemberg, Germany, 89584 | |||||
GSK Investigational Site | |||||
Tettnang, Baden-Wuerttemberg, Germany, 88069 | |||||
GSK Investigational Site | |||||
Tuttlingen, Baden-Wuerttemberg, Germany, 78532 | |||||
GSK Investigational Site | |||||
Kehl, Baden-Wuerttemberg, Germany, 77694 | |||||
GSK Investigational Site | |||||
Ettenheim, Baden-Wuerttemberg, Germany, 77955 | |||||
GSK Investigational Site | |||||
Bietigheim/Bissingen, Baden-Wuerttemberg, Germany, 74321 | |||||
GSK Investigational Site | |||||
Pforzheim, Baden-Wuerttemberg, Germany, 75172 | |||||
GSK Investigational Site | |||||
Oberstenfeld, Baden-Wuerttemberg, Germany, 71720 | |||||
GSK Investigational Site | |||||
Bad Saulgau, Baden-Wuerttemberg, Germany, 88348 | |||||
GSK Investigational Site | |||||
Kirchzarten, Baden-Wuerttemberg, Germany, 79199 | |||||
Germany, Bayern | |||||
GSK Investigational Site | |||||
Cham, Bayern, Germany, 93413 | |||||
GSK Investigational Site | |||||
Olching, Bayern, Germany, 82140 | |||||
GSK Investigational Site | |||||
Muenchen, Bayern, Germany, 81241 | |||||
GSK Investigational Site | |||||
Muenchen, Bayern, Germany, 81735 | |||||
GSK Investigational Site | |||||
Tegernsee, Bayern, Germany, 83684 | |||||
Germany, Rheinland-Pfalz | |||||
GSK Investigational Site | |||||
Trier, Rheinland-Pfalz, Germany, 54294 | |||||
GSK Investigational Site | |||||
Trier, Rheinland-Pfalz, Germany, 54290 | |||||
GSK Investigational Site | |||||
Frankenthal, Rheinland-Pfalz, Germany, 67227 | |||||
Germany, Sachsen | |||||
GSK Investigational Site | |||||
Leipzig, Sachsen, Germany, 04317 |
GlaxoSmithKline |
Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | 106789 |
First Received: | December 13, 2006 |
Last Updated: | October 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00411697 |
Health Authority: | Germany: Paul-Ehrlich-Institut |
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