LT F-Up Study Yrs 16-20 After Primary Vaccination Against Hepatitis B of Newborns From HBeAg+ & HBsAg+ Mothers - Full Text View

Purpose

To evaluate the persistence of 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.

Condition	Intervention	Phase
Hepatitis B	Biological: Engerix™-B	Phase IV

MedlinePlus related topics:

Hepatitis Hepatitis B

ChemIDplus related topics:

Hepatitis B Vaccines

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Non-Randomized, Open Label, Parallel Assignment, Efficacy Study

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

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Anti-HBs antibody concentrations [ Time Frame: Years 16, 17, 18, 19 and 20. ]
Prevalence of serological markers for hepatitis B infection [ Time Frame: Years 16, 17, 18, 19 and 20. ]
Clinical review for hepatitis B infection status [ Time Frame: Over the entire follow up period ]

Enrollment:	109
Study Start Date:	October 2003
Primary Completion Date:	November 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Group E: Experimental 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)	Biological: Engerix™-B
Group B: Experimental 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)	Biological: Engerix™-B
Group A: Experimental 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)	Biological: Engerix™-B
Group D: Experimental 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)	Biological: Engerix™-B
Group C: Experimental 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)	Biological: Engerix™-B
Group F: Experimental 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)	Biological: Engerix™-B

Detailed 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.

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 received at least one dose of the study vaccine in the primary study
Written informed consent obtained from each subject before each blood sampling visit

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00240500

Locations


Thailand
	GSK Investigational Site
	Bangkok, Thailand, 10330

Sponsors and Collaborators

GlaxoSmithKline

Investigators


Study Director:	GSK Clinical Trials	GlaxoSmithKline

More Information

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	100448
First Received:	October 13, 2005
Last Updated:	October 9, 2008
ClinicalTrials.gov Identifier:	NCT00240500
Health Authority:	Thailand: Ministry of Public Health

Keywords provided by GlaxoSmithKline:

Hepatitis B antibody persistence, long-term follow-up

Study placed in the following topic categories:

Virus Diseases

Hepatitis

Antibodies

Liver Diseases

Digestive System Diseases

Hepatitis B Antibodies

Hepatitis B

Hepatitis, Viral, Human

DNA Virus Infections

Additional relevant MeSH terms:

Hepadnaviridae Infections

ClinicalTrials.gov processed this record on October 17, 2008

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00240500