NCT00411697CompletedPhase 4
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
Interventions
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- GlaxoSmithKline
- Enrollment
- 301
- Locations
- 36
- Primary Endpoint
- Anti-hepatitis B surface antigen (HBs) antibody concentrations
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 4 Years to 5 Years (Child)
- Sex
- All
- Accepts 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.
Arms & Interventions
Group A
Experimental
Intervention: Engerix™-B Kinder (Biological)
Outcomes
Primary Outcomes
Anti-hepatitis B surface antigen (HBs) antibody concentrations
Time Frame: One month after the challenge dose of HBV vaccine
Secondary Outcomes
- Anti-HBs antibody concentrations(Before and after challenge dose of HBV vaccine)
- Occurrence of serious adverse events(During the entire study period.)
Investigators
Study Sites (36)
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