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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00289731 |
The focus of this study is to evaluate how risk factors like age, gender, body mass index, smoking, alcohol consumption, etc. can influence immune response when subjects are vaccinated with GSK Biologicals' combined hepatitis A/hepatitis B vaccine or monovalent hepatitis A and B vaccines (from GSK Biologicals' or different manufacturers). 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: Vaqta™ Biological: TWINRIX™ Biological: Engerix™-B Biological: HAVRIX™ Biological: HB VAX PRO™ |
Phase IV |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Evaluate the Effect of Several Risk Factors That Are Likely to Influence the Immunogenicity of GSK Biologicals' Combined Hepatitis A & B Vaccine, vs Separately Administered Monovalent Hepatitis A and Hepatitis B Vaccines |
Enrollment: | 596 |
Study Start Date: | November 2003 |
Primary Completion Date: | December 2004 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Group A: Experimental
GSK Biologicals' combined Hepatitis A and B vaccine was administered.
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Biological: TWINRIX™
Intramuscular injection, 3 doses
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Group C: Active Comparator
Aventis Pasteur's monovalent hepatitis A and hepatitis B vaccines were administered separately.
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Biological: Vaqta™
Intramuscular injection, 2 doses
Biological: HB VAX PRO™
Intramuscular injection, 3 doses
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Group B: Active Comparator
GSK Biologicals' monovalent hepatitis A and hepatitis B vaccines were administered separately.
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Biological: Engerix™-B
Intramuscular injection, 3 doses
Biological: HAVRIX™
Intramuscular injection, 2 doses
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The study will also evaluate the persistence of hepatitis A and hepatitis B antibodies at months 12, 24 and 36 after the first dose of primary vaccination course.
Ages Eligible for Study: | 41 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion criteria:
Exclusion criteria:
Belgium | |
GSK Investigational Site | |
Wilrijk, Belgium, 2610 | |
Czech Republic | |
GSK Investigational Site | |
Hradec Kralove, Czech Republic, 500 01 | |
Germany, Brandenburg | |
GSK Investigational Site | |
Finsterwalde, Brandenburg, Germany, 03238 | |
Germany, Sachsen | |
GSK Investigational Site | |
Geringswalde, Sachsen, Germany, 09326 | |
GSK Investigational Site | |
Dresden, Sachsen, Germany, 01129 | |
GSK Investigational Site | |
Pirna, Sachsen, Germany, 01796 | |
Germany, Schleswig-Holstein | |
GSK Investigational Site | |
Bad Bramstedt, Schleswig-Holstein, Germany, 24576 | |
GSK Investigational Site | |
Bad Segeberg, Schleswig-Holstein, Germany, 23795 | |
GSK Investigational Site | |
Elmshorn, Schleswig-Holstein, Germany, 25335 |
Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | 100382, 100383 (Y1), 100384 (Y2), 100385 (Y3) |
Study First Received: | February 9, 2006 |
Last Updated: | October 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00289731 History of Changes |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Hepatitis A Hepatitis B Combined hepatitis A and hepatitis B vaccine Monovalent hepatitis A and hepatitis B vaccines |
Virus Diseases Hepatitis Liver Diseases Digestive System Diseases Hepatitis B |
Picornaviridae Infections Hepatitis, Viral, Human Hepatitis A DNA Virus Infections Enterovirus Infections |
Virus Diseases Hepatitis RNA Virus Infections Liver Diseases Digestive System Diseases Hepatitis B |
Picornaviridae Infections Hepatitis, Viral, Human Hepatitis A DNA Virus Infections Enterovirus Infections Hepadnaviridae Infections |