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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00603252 |
This protocol posting describes the booster phase of the study. The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00289731)
Condition | Intervention | Phase |
---|---|---|
Hepatitis A Hepatitis B |
Biological: Twinrix Biological: Engerix-B Biological: Havrix Biological: HBVAXPRO Biological: Vaqta |
Phase IV |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Evaluate the Effect of Risk Factors That Influence the Immunogenicity of GSK Bios' Twinrix Compared to Hepatitis A and Hepatitis B Vaccines Given Separately and to Show the Non-Inferiority Between the Vaccines in Adults. |
Estimated Enrollment: | 495 |
Study Start Date: | January 2008 |
Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
All subjects will receive a dose of the vaccine that they received in the primary study (100382), approximately 4 years after the first dose. Blood samples will be taken before and after the administration of the vaccine dose to evaluate the anti-HAV and anti-HBs antibody response.
Ages Eligible for Study: | 41 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Germany, Brandenburg | |
GSK Investigational Site | |
Finsterwalde, Brandenburg, Germany, 03238 | |
Germany, Sachsen | |
GSK Investigational Site | |
Dresden, Sachsen, Germany, 01129 | |
GSK Investigational Site | |
Pirna, Sachsen, Germany, 01796 | |
GSK Investigational Site | |
Geringswalde, Sachsen, Germany, 09326 | |
Germany, Schleswig-Holstein | |
GSK Investigational Site | |
Elmshorn, Schleswig-Holstein, Germany, 25335 | |
GSK Investigational Site | |
Bad Segeberg, Schleswig-Holstein, Germany, 23795 | |
GSK Investigational Site | |
Bad Bramstedt, Schleswig-Holstein, Germany, 24576 |
Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | 111149 |
Study First Received: | January 16, 2008 |
Last Updated: | October 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00603252 |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
combined hepatitis A and B vaccine risk factors |
Virus Diseases Hepatitis Liver Diseases Digestive System Diseases Hepatitis B |
Picornaviridae Infections Hepatitis, Viral, Human Hepatitis A DNA Virus Infections Enterovirus Infections |
RNA Virus Infections Hepadnaviridae Infections |