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Long-term Persistence of Immunity Against Hepatitis B in 7-8 Years Old Children After Hepatitis B Vaccination. | Clinical Trials | Clareo Health

COMPLETEDPHASE4

Long-term Persistence of Immunity Against Hepatitis B in 7-8 Years Old Children After Hepatitis B Vaccination.

An Open, Phase IV, Single-group, Multicentre Study to Assess the Long-term Persistence of Antibodies Against Hepatitis B and the Immune Response to a Hepatitis B (HBV) Vaccine Challenge in Children Aged 7-8 Years of Age and Previously Vaccinated in Infancy With GSK Biologicals' HBV Vaccine (Engerix™-B).

NCT00519649•GlaxoSmithKline

View on ClinicalTrials.gov

Summary

The purpose of this study is to assess the persistence of immunity to hepatitis B in children who received three consecutive doses of HBV vaccine (EngerixTM-B) in infancy. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Eligibility

Age

7 - 8 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.
•A male or female of 7 to 8 years of age (from and including the 7th birthday up to but excluding the 9th birthday) at the time of enrolment.
•With documented evidence of previous vaccination with three consecutive doses of Engerix™-B in Germany
•Written informed consent obtained from the parents or guardians of the subject at the time of enrolment.
•Healthy subjects as established by medical history and clinical examination before entering into the study.

Exclusion Criteria

•Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product
•Evidence of previous hepatitis B booster vaccination since administration of the third dose of Engerix™-B vaccine.
•History of or intercurrent hepatitis B disease.
•Hepatitis B vaccination at birth.
•Planned administration/administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before HBV vaccine challenge and ending 30 days after.
•Administration of immunoglobulins and/or any blood products within the three months preceding HBV vaccine challenge or planned administration during the study period.
•Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the HBV vaccine challenge.
•Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination

Locations (35)

GSK Investigational Site

Birkenfeld, Baden-Wurttemberg, Germany

GSK Investigational Site

Ettenheim, Baden-Wurttemberg, Germany

GSK Investigational Site

Heidelberg, Baden-Wurttemberg, Germany

GSK Investigational Site

Karlsruhe, Baden-Wurttemberg, Germany

GSK Investigational Site

Oberkirch, Baden-Wurttemberg, Germany

GSK Investigational Site

Oberstenfeld, Baden-Wurttemberg, Germany

GSK Investigational Site

Offenburg, Baden-Wurttemberg, Germany

GSK Investigational Site

Pforzheim, Baden-Wurttemberg, Germany

GSK Investigational Site

Stuttgart, Baden-Wurttemberg, Germany

GSK Investigational Site

Tuttlingen, Baden-Wurttemberg, Germany

Key Dates

Start Date

August 31, 2007

Primary Completion Date

December 31, 2007

Completion Date

December 31, 2007

Last Updated

August 17, 2018

Enrollment

301

ACTUAL participants

Conditions

Hepatitis B Vaccine

Interventions

Engerix™-B Kinder

BIOLOGICAL

Immunogenicity and Safety of DTP-HB-Hib Using New Hepatitis B Bulk (Bio Farma)

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Diphtheria Vaccine Adverse ReactionTetanus Vaccine Adverse Reaction+3 more

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COMPLETEDPHASE1/PHASE2

Intralesional Versus Intramuscular Hepatitis B Vaccine Immunotherapy for Warts

NCT05326152

Intralesional Versus Intramuscular Hepatitis B Vaccine for Multiple Common Warts

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 17, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Long-term Persistence of Immunity Against Hepatitis B in 7-8 Years Old Children After Hepatitis B Vaccination.

Inclusion Criteria

Exclusion Criteria

Immunogenicity and Safety of DTP-HB-Hib Using New Hepatitis B Bulk (Bio Farma)

Intralesional Versus Intramuscular Hepatitis B Vaccine Immunotherapy for Warts

Efficacy of Hepatitis B Vaccine Boosters Among Neonatally Vaccinated Children in Chongqing

Robust Antibody and Cytokine Response to Hepatitis B Vaccine Among Not-in-treatment Patients With Chronic Hepatitis C：An Open-label Control Study in China