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

GlaxoSmithKline300 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

300

Conditions

Hepatitis B

Interventions

hepatitis B vaccineBIOLOGICAL

Eligibility

Sex: ALLMin age: 4 YearsMax age: 6 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (38)

Outcomes

Primary Outcomes

Anti-HBs antibody concentration

Secondary Outcomes

Persistence of antibodies to the other DTPa-HBV-IPV/Hib vaccine antigens.

Sol & unsol symptoms after HBV vaccination, SAEs

Data from ClinicalTrials.gov

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GSK Investigational Site

Bad Saulgau, Baden-Wurttemberg, Germany

GSK Investigational Site

Bönnigheim, Baden-Wurttemberg, Germany

GSK Investigational Site

Ettenheim, Baden-Wurttemberg, Germany

GSK Investigational Site

Kehl, Baden-Wurttemberg, Germany

GSK Investigational Site

Oberkirch, Baden-Wurttemberg, Germany

GSK Investigational Site

Offenburg, Baden-Wurttemberg, Germany

GSK Investigational Site

Schwäbisch Hall, Baden-Wurttemberg, Germany

GSK Investigational Site

Stuttgart, Baden-Wurttemberg, Germany

GSK Investigational Site

Tuttlingen, Baden-Wurttemberg, Germany

GSK Investigational Site

Cham, Bavaria, Germany

...and 28 more locations