Persistence of Hepatitis B Antibody Levels & Immune Response to a Hepatitis B Vaccine Challenge

Study Overview
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Brief Summary
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The purpose of this study is to determine at 5 years of age the persistence of immunity to hepatitis B that was conferred by infant vaccination with Infanrix hexa™. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Official Title
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Assess Long-term Persistence of Hepatitis B Antibodies & Immune Response to a Hepatitis B Vaccine (Engerix-B Kinder) Challenge in Children Aged 4-5 Years (Previously Primed & Boosted in the 1st 2 Years of Life With DTPa-HBV-IPV/Hib Vaccine)

Conditions
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Hepatitis B

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 4 to 5 years of age at the time of enrolment. With documented evidence of previous vaccination with four consecutive doses of Infanrix hexa™ 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 fourth dose of Infanrix hexa™ booster in the second year of life. 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 booster vaccination and ending 30 days after. Administration of immunoglobulins and/or any blood products within the three months preceding booster vaccination 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.

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 5 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 A<br> | 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 |
| --- | --- | --- |
| Anti-hepatitis B surface antigen (HBs) antibody concentrations |  | One month after the challenge dose of HBV vaccine | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anti-HBs antibody concentrations |  | Before and after challenge dose of HBV vaccine | 
| Occurrence of serious adverse events |  | During the entire study period. |