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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00240500
First received: October 13, 2005
Last updated: November 3, 2016
Last verified: November 2016

October 13, 2005
November 3, 2016
October 2003
November 2007   (Final data collection date for primary outcome measure)
  • Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations [ Time Frame: Years 17, 18, 19 and 20. ]
    During this follow-up study, it was planned to collect data from Year 16 through to Year 20 after primary vaccination. By the time the study protocol was approved, it was too late to collect data on Year 16. Therefore, the table presents mean concentrations expressed in milli-international units/milliliter (mIU/mL) at years 17, 18, 19 and 20.
  • Prevalence of Serological Markers for Hepatitis B Infection [ Time Frame: Years 17, 18, 19 and 20. ]
    It was initially planned to collect data from Year 16 through to Year 20 after primary vaccination. By the time the study protocol was approved, it was too late to collect data on Year 16. Only the subjects positive for HBsAg or anti Hepatitis B core antigen (anti-HBc) were tested for HBeAg & anti-HBe
  • Clinical Review for Hepatitis B Infection Status [ Time Frame: Over the entire 4 year follow up period (17 - 20 years) ]
    Chronic hepatitis B (HB) carrier is defined as positive for anti-HBc AND HBsAg at two or more consecutive time points
To evaluate the anti-HBs persistence, prevalence and incidence of other hepatitis B markers (HBsAg, anti-HBc, HBeAg, anti-HBe) up to Year 20 after the first vaccine dose of the primary vaccination.
Complete list of historical versions of study NCT00240500 on ClinicalTrials.gov Archive Site
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Follow-up Study 16-20 Years After Primary Vaccination Against Hepatitis B of Newborns From HBeAg+ & HBsAg+ Mothers
Long-Term Follow Up Study at Years 16-20, to Evaluate the Persistence of Immune Response of GlaxoSmithKline Biologicals' Hepatitis B Vaccine in Newborns of HBeAg+ and HBsAg+ Mothers
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.

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.

Interventional
Phase 4
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Hepatitis B
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.
  • Experimental: HBV-1 Group
    neonates born to HBsAg+ and HBeAg+ mothers who received a 5-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12 and again a booster dose at Month 60)
    Intervention: Biological: Engerix™-B
  • Experimental: HBV-2 Group
    neonates born to HBsAg+ and HBeAg+ mothers who received a 4-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12)
    Intervention: Biological: Engerix™-B
  • Experimental: HBV-3 Group
    neonates born to HBsAg+ and HBeAg- mothers who received a 5-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12 and again a booster dose at Month 60)
    Intervention: Biological: Engerix™-B
  • Experimental: HBV-4 Group
    neonates born to HBsAg+ and HBeAg- mothers who received a 4-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12)
    Intervention: Biological: Engerix™-B
  • Experimental: HBV-5 Group
    neonates born to HBsAg- and HBeAg- mothers who received a 5-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12 and again a booster dose at Month 60)
    Intervention: Biological: Engerix™-B
  • Experimental: HBV-6 Group
    neonates born to HBsAg- and HBeAg- mothers who received a 4-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12)
    Intervention: Biological: Engerix™-B

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
109
November 2007
November 2007   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
16 Years to 20 Years   (Child, Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Thailand
 
 
NCT00240500
100448
Not Provided
Not Provided
Yes
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP