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Sponsored by: |
GlaxoSmithKline |
---|---|
Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00875485 |
This study will evaluate the immune response against HAV and HBs (hepatitis B surface) antigen in healthy subjects aged 12 to 15 years (at the time of primary vaccination), who received vaccination course with GSK Biologicals' Twinrix Adult and Twinrix Junior vaccine, approximately 10 years ago in the primary study. The subjects will be invited for blood sampling at 11, 12, 13, 14 and 15 years after primary vaccination to evaluate the persistence of immune response. For subjects detected with decreased immunity, the presence of immune memory against hepatitis A & B antigens will be investigated by the administration of a challenge dose of the appropriate vaccine 6 to 12 months after the Year 15 follow-up time-point.
No new subjects will be recruited during this booster phase of the study.
Condition | Intervention | Phase |
---|---|---|
Hepatitis A Hepatitis B |
Procedure: Blood sampling Biological: Havrix™ |
Phase IV |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Parallel Assignment, Efficacy Study |
Official Title: | Study to Evaluate Antibody Persistence & Immune Memory in Subjects Vaccinated During Adolescence With Twinrix™. |
Estimated Enrollment: | 235 |
Study Start Date: | May 2009 |
Estimated Study Completion Date: | March 2014 |
Estimated Primary Completion Date: | March 2014 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Group A: Experimental |
Procedure: Blood sampling
Blood sampling at Years 11, 12, 13, 14, 15 and at the time of challenge dose administration and one month after challenge dose administration.
Biological: Havrix™
Intramuscular injection, single challenge dose. This challenge dose will be administered to seronegative subjects for anti-HAV antibodies.
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Group B: Experimental |
Procedure: Blood sampling
Blood sampling at Years 11, 12, 13, 14, 15 and at the time of challenge dose administration and one month after challenge dose administration.
Biological: Havrix™
Intramuscular injection, single challenge dose. This challenge dose will be administered to seronegative subjects for anti-HAV antibodies.
|
Ages Eligible for Study: | 12 Years to 15 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
All subjects must satisfy the following criteria at entry into the challenge dose phase:
Exclusion Criteria:
The following criteria should be checked at each follow-up visit. If any apply at study entry, the subject must not be included at that long-term follow-up visit.
The following criteria should be checked before the challenge dose phase. If any apply, the subject must not be included in the challenge dose phase:
Contact: US GSK Clinical Trials Call Center | 877-379-3718 |
Belgium | |
GSK Investigational Site | |
Bruxelles, Belgium, 1200 | |
Czech Republic | |
GSK Investigational Site | |
Hradec Kralove, Czech Republic, 500 03 |
Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | 110699, 110700, 110701, 110702, 110703, 110704 |
Study First Received: | April 2, 2009 |
Last Updated: | April 9, 2009 |
ClinicalTrials.gov Identifier: | NCT00875485 History of Changes |
Health Authority: | Belgium: Direction Générale de la Protection de la Santé Publique Médicaments; Czech: State Institute for Drug Control |
Monovalent Hepatitis A hepatitis B vaccine Belgium and Czech Republic |
Liver Diseases Immunologic Factors Hepatitis, Viral, Human Picornaviridae Infections Hepatitis Virus Diseases Antibodies |
Digestive System Diseases Hepatitis B Hepatitis A DNA Virus Infections Enterovirus Infections Immunoglobulins |
Liver Diseases RNA Virus Infections Immunologic Factors Physiological Effects of Drugs Hepatitis, Viral, Human Picornaviridae Infections Hepadnaviridae Infections Pharmacologic Actions |
Hepatitis Virus Diseases Antibodies Digestive System Diseases Hepatitis B Hepatitis A DNA Virus Infections Enterovirus Infections |