Hepatitis B
Conditions
Brief summary
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.
Interventions
BIOLOGICALEngerix™-B Kinder
Intramuscular injection, 1 dose
Sponsors
GlaxoSmithKline
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
4 Years to 5 Years
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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Anti-hepatitis B surface antigen (HBs) antibody concentrations | One month after the challenge dose of HBV vaccine |
Secondary
| Measure | Time frame |
|---|---|
| Anti-HBs antibody concentrations | Before and after challenge dose of HBV vaccine |
| Occurrence of serious adverse events | During the entire study period. |
Countries
Germany
Outcome results
None listed