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| Sponsored by: |
GlaxoSmithKline |
|---|---|
| Information provided by: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00240539 |
Purpose
This study is performed to evaluate the persistence of anti-hepatitis B surface antigen (HBs) antibodies up to 16, 17, 18, 19 and 20 years after administration of the first dose of the study vaccine, Engerix-B™. No new subjects will be recruited in this long-term follow-up study. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
| Condition | Intervention | Phase |
|---|---|---|
|
Hepatitis B |
Procedure: Blood sampling |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Prevention, Non-Randomized, Open Label, Parallel Assignment, Efficacy Study |
| Official Title: | Long-Term F-U Studies at Yrs 16-20, to Evaluate the Persistence of Immune Response of GSK Biologicals' Hepatitis B Vaccine in Newborns of HBeAg+ and HBsAg+ Mothers in Comparison With a Historical Control Group |
| Enrollment: | 84 |
| Study Start Date: | October 2003 |
| Study Completion Date: | July 2008 |
| Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Group 1: Experimental
Newborns of HBsAg (+) and HBeAg (+) mothers who received 5 vaccination doses
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Procedure: Blood sampling
A blood sample will be taken yearly at each long-term follow-up time point (i.e. Year 16 through Year 20) after the first dose of Engerix-B vaccine.
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Group 4: Experimental
Newborns of HBsAg (+) and HBeAg (-) mothers who received 4 vaccination doses
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Procedure: Blood sampling
A blood sample will be taken yearly at each long-term follow-up time point (i.e. Year 16 through Year 20) after the first dose of Engerix-B vaccine.
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Group 2: Experimental
Newborns of HBsAg (+) and HBeAg (+) mothers who received 4 vaccination doses
|
Procedure: Blood sampling
A blood sample will be taken yearly at each long-term follow-up time point (i.e. Year 16 through Year 20) after the first dose of Engerix-B vaccine.
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Group 6: Experimental
Newborns of HBsAg (-) and HBeAg (-) mothers who received 4 vaccination doses
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Procedure: Blood sampling
A blood sample will be taken yearly at each long-term follow-up time point (i.e. Year 16 through Year 20) after the first dose of Engerix-B vaccine.
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The primary study was to evaluate the immunogenicity and protective efficacy of hepatitis B vaccine administered according to a 0, 1, 2, 12 month schedule in newborns of HBeAg+ and HBsAg+ mothers. Results from the primary study have shown that the vaccine was immunogenic and protected neonates of HBeAg positive mothers against hepatitis B chronic carriage. The present study is carried out to evaluate the anti-HBs persistence and the prevalence and incidence of other hepatitis B markers (HBsAg, anti-HBc, HBeAg, anti-HBe, ALT/AST), and the clinical significance of the HBsAg and anti-HBc positive cases observed during the long-term from year 16-20. No vaccine will be administered during the long term follow up period.
Eligibility| Ages Eligible for Study: | 16 Years to 20 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Contacts and Locations More Information
| Responsible Party: | GSK ( Study Director ) |
| Study ID Numbers: | 100449 |
| Study First Received: | October 13, 2005 |
| Last Updated: | May 21, 2009 |
| ClinicalTrials.gov Identifier: | NCT00240539 History of Changes |
| Health Authority: | Thailand: Ministry of Public Health |
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Hepatitis B |
|
Virus Diseases Hepatitis Liver Diseases Digestive System Diseases |
Hepatitis B Hepatitis, Viral, Human DNA Virus Infections |
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Virus Diseases Hepatitis Liver Diseases Digestive System Diseases |
Hepatitis B Hepatitis, Viral, Human DNA Virus Infections Hepadnaviridae Infections |
