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

GlaxoSmithKline350 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

350

Conditions

Hepatitis B

Interventions

hepatitis B vaccineBIOLOGICAL

Eligibility

Sex: ALLMin age: 7 YearsMax age: 9 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (42)

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

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

Aichach, Bavaria, Germany

GSK Investigational Site

Bobingen, Bavaria, Germany

GSK Investigational Site

Erding, Bavaria, Germany

GSK Investigational Site

Kaufering, Bavaria, Germany

GSK Investigational Site

Kempten (Allgäu), Bavaria, Germany

GSK Investigational Site

Landsberg am Lech, Bavaria, Germany

...and 32 more locations