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

Hepatitis B Vaccine Clinical Trial

Official title:

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).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00519649
• Other study ID #: 110474
• Status: Completed
• Phase: Phase 4
• Start date: August 31, 2007
• Est. completion date: December 31, 2007

Study information

• Verified date: November 2016
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 301
• Est. completion date: December 31, 2007
• Est. primary completion date: December 31, 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years to 8 Years

Eligibility

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B Vaccine

Intervention

Biological:
• Engerix™-B Kinder
Intramuscular injection, 1 dose

Locations

Country	Name	City	State
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Bindlach	Bayern
Germany	GSK Investigational Site	Birkenfeld	Baden-Wuerttemberg
Germany	GSK Investigational Site	Bredstedt	Schleswig-Holstein
Germany	GSK Investigational Site	Ettenheim	Baden-Wuerttemberg
Germany	GSK Investigational Site	Flensburg	Schleswig-Holstein
Germany	GSK Investigational Site	Flensburg	Schleswig-Holstein
Germany	GSK Investigational Site	Flensburg	Schleswig-Holstein
Germany	GSK Investigational Site	Frankenthal	Rheinland-Pfalz
Germany	GSK Investigational Site	Heidelberg	Baden-Wuerttemberg
Germany	GSK Investigational Site	Husum	Schleswig-Holstein
Germany	GSK Investigational Site	Karlsruhe	Baden-Wuerttemberg
Germany	GSK Investigational Site	Kaufering	Bayern
Germany	GSK Investigational Site	Kiel	Schleswig-Holstein
Germany	GSK Investigational Site	Leipzig	Sachsen
Germany	GSK Investigational Site	Loehne	Nordrhein-Westfalen
Germany	GSK Investigational Site	Lohr	Bayern
Germany	GSK Investigational Site	Mainz	Rheinland-Pfalz
Germany	GSK Investigational Site	Minden	Nordrhein-Westfalen
Germany	GSK Investigational Site	Muenchen	Bayern
Germany	GSK Investigational Site	Muenchen	Bayern
Germany	GSK Investigational Site	Muenster	Nordrhein-Westfalen
Germany	GSK Investigational Site	Oberkirch	Baden-Wuerttemberg
Germany	GSK Investigational Site	Oberstenfeld	Baden-Wuerttemberg
Germany	GSK Investigational Site	Offenburg	Baden-Wuerttemberg
Germany	GSK Investigational Site	Pforzheim	Baden-Wuerttemberg
Germany	GSK Investigational Site	Porta Westfalica	Nordrhein-Westfalen
Germany	GSK Investigational Site	Stuttgart	Baden-Wuerttemberg
Germany	GSK Investigational Site	Tegernsee	Bayern
Germany	GSK Investigational Site	Trier	Rheinland-Pfalz
Germany	GSK Investigational Site	Tuttlingen	Baden-Wuerttemberg
Germany	GSK Investigational Site	Worms	Rheinland-Pfalz

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Anti-hepatitis B Surface Antigen (HBs) Antibody Concentrations Above the Cut-off Value	Anti-HBs antibody cut-off value assessed was 100 milli-international unit per milliliter (mIU/mL)	One month after the challenge dose of HBV vaccine
Secondary	Number of Participants With Anti-HBs Antibody Concentrations Above the Cut-off Value	Anti-HBs antibody cut-off values assessed include 3.3, 10 and 100 mIU/mL	Before challenge dose of HBV vaccine
Secondary	Number of Participants Reporting Solicited Local Symptoms	Solicited local symptoms assessed include pain, redness and swelling	During the 4-day follow-up period after the challenge dose of HBV vaccine.
Secondary	Number of Participants Reporting Solicited General Symptoms	Solicited general symptoms assessed include fatigue, fever, gastrointestinal symptoms, and headache	During the 4-day follow-up period after the challenge dose of HBV vaccine.
Secondary	Number of Participants Reporting Unsolicited Adverse Events	An Adverse Event is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.	During the 31-day follow-up period after the challenge dose of HBV vaccine.
Secondary	Number of Participants Reporting Serious Adverse Events (SAE)	An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.	After the challenge dose of HBV vaccine.

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