Persistence of the Immune Response to Hepatitis B in 7-9 Years Old Children Previously Vaccinated With DTPa-HBV-IPV/Hib

This study has been completed.

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00356564

Purpose

Persistence of seroprotective antibody concentrations & immunological memory shown by the ability to mount a response to a challenge dose of HBV vaccine

Condition	Intervention	Phase
Hepatitis B	Biological: hepatitis B vaccine	Phase IV

MedlinePlus related topics: Hepatitis Hepatitis B

Drug Information available for: Hepatitis B Vaccines Immunoglobulins Globulin, Immune

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Non-Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	Multicentre Study to Assess Persistence of Antibodies Against Hepatitis B & Immune Response to a Hepatitis B Challenge Dose in Healthy Children 7 to 9 Yrs Old Previously Vaccinated With 4 Doses of GSK Biologicals' DTPa-HBV-IPV/Hib Vaccine

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Anti-HBs antibody concentration

Secondary Outcome Measures:

Persistence of antibodies to the other DTPa-HBV-IPV/Hib vaccine antigens.
Sol & unsol symptoms after HBV vaccination, SAEs

Estimated Enrollment:	350
Study Start Date:	July 2006

Eligibility

Ages Eligible for Study:	7 Years to 9 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

A male or female aged 7 to 9 years at the time of study entry .
Subjects who have received a total of 4 doses of DTPa-HBV-IPV/Hib vaccine or a total of 4 doses of HBV vaccine in previous vaccination studies.
Evidence of previous hepatitis B booster vaccination or disease since administration of the fourth dose of DTPa-HBV-IPV/Hib or HBV vaccine.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00356564

Show 41 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	106744
Study First Received:	July 25, 2006
Last Updated:	October 9, 2008
ClinicalTrials.gov Identifier:	NCT00356564
Health Authority:	Germany: Paul-Ehrlich-Institut

Keywords provided by GlaxoSmithKline:

Prophylaxis for hepatitis B disease

Study placed in the following topic categories:

Virus Diseases
Hepatitis
Antibodies
Liver Diseases
Digestive System Diseases

Hepatitis B
Hepatitis, Viral, Human
DNA Virus Infections
Healthy
Immunoglobulins

Additional relevant MeSH terms:

Hepadnaviridae Infections

ClinicalTrials.gov processed this record on January 16, 2009