Status:
COMPLETED
Persistence of Hepatitis B Antibody Levels & Immune Response to a Hepatitis B Vaccine Challenge
Lead Sponsor:
GlaxoSmithKline
Conditions:
Hepatitis B
Eligibility:
All Genders
4-5 years
Phase:
PHASE4
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 upda...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2007
Estimated Enrollment :
301 Patients enrolled
Trial Details
Trial ID
NCT00411697
Start Date
December 1 2006
End Date
May 1 2007
Last Update
October 28 2016
Active Locations (36)
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1
GSK Investigational Site
Bad Saulgau, Baden-Wurttemberg, Germany, 88348
2
GSK Investigational Site
Bietigheim-Bissingen, Baden-Wurttemberg, Germany, 74321
3
GSK Investigational Site
Bönnigheim, Baden-Wurttemberg, Germany, 74357
4
GSK Investigational Site
Ehingen, Baden-Wurttemberg, Germany, 89584