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

Study Overview
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Brief Summary
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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.

Official Title
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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).

Conditions
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Hepatitis B Vaccine

Intervention / Treatment
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* Biological: Engerix™-B Kinder


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 8 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group Engerix<br>Subjects received a single challenge dose of Engerix™ (hepatitis-B [HBV] vaccine) | Biological: Engerix™-B Kinder<br>* Intramuscular injection, 1 dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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. | 
| 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. | 
| 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. | 
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Challenge dose, Hepatitis B vaccine