Persistence of the Immune Response to Hepatitis B in 4-6 Years Old Children Previously Vaccinated With DTPa-HBV-IPV/Hib - Full Text View

Persistence of the Immune Response to Hepatitis B in 4-6 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:	NCT00335881

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

ChemIDplus related topics:

Hepatitis B Vaccines

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 4 to 6 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:	300
Study Start Date:	June 2006

Eligibility

Ages Eligible for Study:	4 Years to 6 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

A male or female aged 4 to 6 years at the time of study entry .
Subjects who have received a total of 4 doses of DTPa-HBV-IPV/Hib 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 vaccine.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00335881

Show 35 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators


Study Director:	GSK Clinical Trials	GlaxoSmithKline

More Information

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	106745
First Received:	June 9, 2006
Last Updated:	October 9, 2008
ClinicalTrials.gov Identifier:	NCT00335881
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

Additional relevant MeSH terms:

Hepadnaviridae Infections

ClinicalTrials.gov processed this record on October 14, 2008