Follow-up Study 16-20 Years After Primary Vaccination Against Hepatitis B of Newborns From HBeAg+ & HBsAg+ Mothers

Hepatitis B Clinical Trial

Official title:

Long-Term F-U Study at Yrs 16-20, to Evaluate the Persistence of Immune Response of GSK Biologicals' Hepatitis B Vaccine in Newborns of HBeAg+ and HBsAg+ Mothers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00240500
• Other study ID #: 100448
• Status: Completed
• Phase: Phase 4
• First received: October 13, 2005
• Last updated: May 28, 2009
• Start date: October 2003
• Est. completion date: November 2007

Study information

• Verified date: May 2009
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ministry of Public Health
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the persistence of anti-hepatitis B surface antigen (anti-HBs) antibodies 16, 17, 18, 19 and 20 years after administration of the first dose of the study vaccine. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Description:

The primary study was designed to evaluate the immunogenicity and protective efficacy of hepatitis B vaccine in newborns of HBeAg+ and HBsAg+ mothers in comparison with a historical control group.

The present study is carried out to evaluate the anti-HBs persistence 16-20 years after the first vaccine dose and to further investigate the prevalence and incidence of other hepatitis B markers and the clinical significance of these at all time points from Year 16-20.

No additional subjects will be recruited during this long-term follow-up study and no vaccine will be administered.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 109
• Est. completion date: November 2007
• Est. primary completion date: November 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 16 Years to 20 Years

Eligibility

Inclusion Criteria:

• Subjects who had received at least one dose of the study vaccine in the primary study (103860/064)

• Written informed consent obtained from each subject before each blood sampling visit

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B

Intervention

Biological:
• Engerix™-B
In the primary study, subjects received HBV (10 milligram) vaccine according to a 0, 1 and 2 month schedule with a booster dose at Month 12. Subjects in the 5-dose vaccination regimen received a booster dose of HBV vaccine at Month 60.

Locations

Country	Name	City	State
Thailand	GSK Investigational Site	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anti-Hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations		Years 17, 18, 19 and 20.	No
Primary	Prevalence of Serological Markers for Hepatitis B Infection		Years 17, 18, 19 and 20.	No
Primary	Clinical Review for Hepatitis B Infection Status		Over the entire 4 year follow up period (17 - 20 years)	No