Status:
COMPLETED
Observational Study of Immune Response to Hepatitis B Childhood Booster
Lead Sponsor:
University of Oxford
Conditions:
Healthy
Eligibility:
All Genders
41-7 years
Brief Summary
The UK immunisation guidelines recommend that children immunised with an accelerated course of hepatitis B vaccine (i.e. vaccination at 0, 1, 2 and 12 months) receive an additional booster dose of vac...
Detailed Description
This is an observational, open label study of children immunised in infancy against Hepatitis B virus (HBV),evaluating the persistence of immunity and the immune response to a scheduled booster dose o...
Eligibility Criteria
Inclusion
- Parent/guardian is willing and able to give informed consent for participation in the study.
- Male or Female, aged 3 years 4 months or above.
- Commenced Hepatitis B post exposure prophylaxis at birth.
- Able (in the Investigators opinion) and willing to comply with all study requirements.
- Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the study.
Exclusion
- Parent/guardian is not willing or able to give informed consent for participation in the study.
- The child is currently enrolled in any other interventional research study
- History of a confirmed anaphylactic reaction to a previous dose of hepatitis B containing vaccine or a confirmed reaction to any component of the vaccine
- Evidence of infection with HBV on previous blood tests.
- Previous receipt of booster doses of HBV vaccine within the 2 years prior to study enrolment.
- Significant renal or hepatic impairment.
- Participant who is terminally ill.
- Any other significant disease or disorder which, in the opinion of the Investigator, may either put the patient/participant at risk because of participation in the study, or may influence the result of the study, or the patient/participant's ability to participate in the study.
Key Trial Info
Start Date :
February 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT00873652
Start Date
February 1 2009
End Date
January 1 2011
Last Update
December 8 2017
Active Locations (1)
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1
Oxford Vaccine Group, Centre for Clinical Vaccinology and Tropical Medicine (CCVTM), Churchill Hospital
Oxford, Oxfordshire, United Kingdom, OX3 7LJ