Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
GlaxoSmithKline |
---|---|
Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00291876 |
The aim of this study is to evaluate the persistence of hepatitis A antibodies at 138, 150, 162, 174 and 186 months after subjects received their first dose of a 2 dose vaccination schedule of hepatitis A vaccine. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
This protocol posting deals with objectives & outcome measures of the extension phase at year 11 through to 15.
No additional subjects will be recruited during this long-term follow-up.
Condition | Intervention | Phase |
---|---|---|
Hepatitis A |
Biological: Havrix™ |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Long-Term Follow-up Study to Evaluate the Immune Persistence of GSK Biologicals' Inactivated Hepatitis A Vaccine Containing 1440 EL.U of Antigen Per ml and Injected According to a 0, 12 Month Schedule in Healthy Adult Volunteers. |
Enrollment: | 107 |
Study Start Date: | January 2004 |
Estimated Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Group A: Experimental
Subjects received 2 doses of Havrix™ in the primary study
|
Biological: Havrix™
2 doses at 12 months interval
|
Group B: Experimental
Subjects received 2 doses of Havrix™ in the primary study
|
Biological: Havrix™
2 doses at 12 months interval
|
This is a long-term follow-up study at Months 138, 150, 162, 174 and 186 after primary vaccination with GSK Biologicals' hepatitis A vaccine (two-dose schedule). To evaluate the long-term antibody persistence, volunteers will be bled at Months 138, 150, 162, 174 and 186 after the first vaccine dose of the primary vaccination course to determine their anti-HAV antibody concentrations.
If a subject has become seronegative for anti-HAV antibodies during any of the long-term blood sampling time point (i.e. Months 138, 150, 162, 174 or 186), he/ she will be offered an additional vaccine dose. A blood sample will be taken on the day of the additional vaccination and after one month to evaluate the immune response following this vaccination.
Ages Eligible for Study: | 29 Years to 51 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Responsible Party: | GSK Biologicals ( Isabelle Harpigny ) |
Study ID Numbers: | 100571 (M138), 100572 (M150), 100573 (M162), 100574 (M174), 100575 (M186) |
Study First Received: | February 14, 2006 |
Last Updated: | August 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00291876 |
Health Authority: | Belgium: Institutional Review Board |
Hepatitis A HAVRIX™ |
Virus Diseases Hepatitis Liver Diseases Digestive System Diseases Picornaviridae Infections |
Hepatitis, Viral, Human Hepatitis A Healthy Enterovirus Infections |
RNA Virus Infections |