|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | GlaxoSmithKline |
|---|---|
| Information provided by: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00289731 |
Purpose
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 |
|---|---|---|
|
Hepatitis B Hepatitis A |
Biological: TWINRIX™ Biological: Engerix™-B Biological: HAVRIX™ Biological: HB VAX PRO™ Biological: Vaqta™ |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| 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: | 577 |
| Study Start Date: | November 2003 |
| Study Completion Date: | May 2007 |
| Primary Completion Date: | May 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Group A
GSK Biologicals' combined Hepatitis A and B vaccine was administered.
|
Biological: TWINRIX™
Intramuscular injection, 3 doses
|
|
Active Comparator: Group B
GSK Biologicals' monovalent hepatitis A and hepatitis B vaccines were administered separately.
|
Biological: Engerix™-B
Intramuscular injection, 3 doses
Biological: HAVRIX™
Intramuscular injection, 2 doses
|
|
Active Comparator: Group C
Aventis Pasteur's monovalent hepatitis A and hepatitis B vaccines were administered separately.
|
Biological: HB VAX PRO™
Intramuscular injection, 3 doses
Biological: Vaqta™
Intramuscular injection, 2 doses
|
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.
Eligibility| Ages Eligible for Study: | 41 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion criteria:
Exclusion criteria:
Contacts and Locations| Belgium | |
| GSK Investigational Site | |
| Wilrijk, Belgium, 2610 | |
| Czech Republic | |
| GSK Investigational Site | |
| Hradec Kralove, Czech Republic, 500 01 | |
| Germany | |
| GSK Investigational Site | |
| Finsterwalde, Brandenburg, Germany, 03238 | |
| GSK Investigational Site | |
| Dresden, Sachsen, Germany, 01129 | |
| GSK Investigational Site | |
| Geringswalde, Sachsen, Germany, 09326 | |
| GSK Investigational Site | |
| Pirna, Sachsen, Germany, 01796 | |
| 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 |
More Information
| Responsible Party: | Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure |
| ClinicalTrials.gov Identifier: | NCT00289731 History of Changes |
| Other Study ID Numbers: | 100382, 100383, 100384, 100385 |
| Study First Received: | February 9, 2006 |
| Last Updated: | October 27, 2011 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
|
Combined hepatitis A and hepatitis B vaccine Hepatitis B Hepatitis A Monovalent hepatitis A and hepatitis B vaccines |
|
Hepatitis Hepatitis A Hepatitis B Liver Diseases Digestive System Diseases Hepatitis, Viral, Human |
Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections Hepadnaviridae Infections DNA Virus Infections |