Status:
COMPLETED
Immune Response to Hepatitis B Vaccine Challenge Dose in Subjects Who Received a Primary Neonatal Hepatitis B Vaccine.
Lead Sponsor:
GlaxoSmithKline
Conditions:
Hepatitis B
Eligibility:
All Genders
20-21 years
Phase:
PHASE4
Brief Summary
The current study will evaluate immunological memory to hepatitis B antigen in subjects who received primary neonatal vaccination of hepatitis B vaccine (Engerix™-B ), 20 years ago in the primary stud...
Eligibility Criteria
Inclusion
- Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.
- A male or female adult who received the complete neonatal primary vaccination course of hepatitis B vaccine in primary study approximately 20 years earlier.
- Documented level of anti-HBs antibody concentrations \< specified concentration at the previous long-term time point for which serological results are available for that subject.
- Written informed consent obtained from the subject.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
- If the subject is female, she must be of non-childbearing potential or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for 2 months after completion of the hepatitis B challenge dose.
Exclusion
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the hepatitis B vaccine challenge dose.
- Administration of a vaccine not foreseen by the study protocol during the study period.
- Administration of immunoglobulins and/or any blood products during the study period.
- Drug and/or alcohol abuse.
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2008
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT00456625
Start Date
April 1 2007
End Date
January 1 2008
Last Update
December 16 2016
Active Locations (1)
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1
GSK Investigational Site
Bangkok, Thailand, 10330