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| Sponsor: | GlaxoSmithKline |
|---|---|
| Information provided by: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00684671 |
Purpose
Only subjects who participated in the primary study will be invited to participate in the extension phase and the challenge dose phase of this study.
| Condition | Intervention | Phase |
|---|---|---|
|
Hepatitis A Hepatitis B |
Biological: Engerix-B Biological: Havrix Biological: Twinrix Biological: HBVAXPRO 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: | Challenge Dose Administration of Twinrix™ or Comparator 4 Years After Primary Vaccination. |
| Enrollment: | 506 |
| Study Start Date: | May 2008 |
| Study Completion Date: | November 2008 |
| Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
HB VAX PRO + Vaqta Group: Active Comparator
Subjects received separate administration of a single challenge dose of hepatitis B vaccine (HB VAX PRO) and hepatitis A vaccine (Vaqta).
|
Biological: HBVAXPRO
Intramuscular injection, single dose in the left deltoid.
Biological: Vaqta
Intramuscular injection, single dose in right deltoid.
|
|
Engerix + Havrix Group: Active Comparator
Subjects received separate administration of a single challenge dose of hepatitis B vaccine (Engerix) and hepatitis A vaccine (Havrix).
|
Biological: Engerix-B
Intramuscular injection, single dose in left deltoid.
Biological: Havrix
Intramuscular injection, single dose in right deltoid.
|
|
Twinrix Group: Experimental
Subjects received a single challenge dose of combined hepatitis A/hepatitis B vaccine (Twinrix).
|
Biological: Twinrix
Intramuscular injection, single dose in left deltoid.
|
Eligibility| Ages Eligible for Study: | 41 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
The following criteria should be checked at the time of study entry. If any apply, the subject must not be included in the study:
Contacts and Locations| Belgium | |
| GSK Investigational Site | |
| Wilrijk, Belgium, 2610 | |
| Czech Republic | |
| GSK Investigational Site | |
| Hradec Kralove, Czech Republic, 500 01 | |
| Study Director: | GSK Clinical Trials | GlaxoSmithKline |
More Information
| Responsible Party: | GSK ( Study Director ) |
| Study ID Numbers: | 111572 |
| Study First Received: | May 23, 2008 |
| Results First Received: | October 29, 2009 |
| Last Updated: | February 12, 2010 |
| ClinicalTrials.gov Identifier: | NCT00684671 History of Changes |
| Health Authority: | Belgium: Federal Agency for Medicinal Products and Health Products |
|
Combined hepatitis A and B vaccine Immune memory > 41 years old |
|
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 |