Long Term Follow-Up Study 16-20 Years After Hepatitis B Vaccination in Newborns of Mothers Who Were Seropositive for Hepatitis B Envelope Antigen (HBeAg) & Hepatitis B Surface Antigen (HBsAg)

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00240539
First received: October 13, 2005
Last updated: December 10, 2009
Last verified: December 2009
  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 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Long-term Follow-Up Studies at Years 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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Number of Subjects Seropositive for Anti-hepatitis B Surface Antigen (Anti-HBs) Antibodies [ Time Frame: At Years 16, 17, 18, 19 and 20 after primary vaccination ] [ Designated as safety issue: No ]
  • Number of Subjects Who Tested Positive for Markers of Infection With Hepatitis B Virus [ Time Frame: At Years 16, 17, 18,19 and 20 after primary vaccination ] [ Designated as safety issue: No ]
  • Number of Subjects With Chronic and With Clinical HBV Infection [ Time Frame: From year 16 through to year 20 ] [ Designated as safety issue: No ]

Enrollment: 36
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
Experimental: HBsAg(+) & HBeAg(+) 5-dose Group
Newborns of anti-hepatitis B surface antigen positive [HBsAg(+)] and hepatitis B envelope antigen positive [HBeAg(+)] mothers, who received 5 doses of Engerix™ in the primary study.
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.
Experimental: HBsAg(+) & HBeAg(-) 4-dose Group
Newborns of anti-hepatitis B surface antigen positive [HBsAg(+)] and hepatitis B envelope antigen negative [HBeAg(-)] mothers, who received 4 doses of Engerix™ in the primary study.
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.
Experimental: HBsAg(+) & HBeAg(+) 4-dose Group
Newborns of anti-hepatitis B surface antigen positive [HBsAg(+)] and hepatitis B envelope antigen positive [HBeAg(+)] mothers, who received 4 doses of Engerix™ in the primary study.
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.
Experimental: HBsAg(-) & HBeAg(-) 4-dose Group
Newborns of anti-hepatitis B surface antigen negative [HBsAg(-)] and hepatitis B envelope antigen negative [HBeAg(-)] mothers, who received 4 doses of Engerix™ in the primary study.
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.

Detailed Description:

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 anti-hepatitis B envelope antigen positive (HBeAg+) and anti-hepatitis B surface antigen positive (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-hepatitis B core antigen {anti-HBc}, HBeAg, Alanine aminotransferase/Aspartate aminotransferase {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
Criteria

Inclusion Criteria:

  • Subjects who had participated in the primary study.
  • Written informed consent obtained from the subject.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00240539

Locations
Thailand
GSK Investigational Site
Bangkok, Thailand, 10330
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided by GlaxoSmithKline

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00240539     History of Changes
Other Study ID Numbers: 100449
Study First Received: October 13, 2005
Results First Received: July 16, 2009
Last Updated: December 10, 2009
Health Authority: Thailand: Ministry of Public Health

Keywords provided by GlaxoSmithKline:
Hepatitis B

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections

ClinicalTrials.gov processed this record on September 16, 2014