An observational study of children immunised in infancy against hepatitis B virus, evaluating the persistence of immunity and the immune response to a scheduled booster dose of hepatitis B vaccine - Hepatitis B childhood booster study

Conditions: The intended application of Engerix B is active immunisation against Hepatitis B virus infection caused by all known subtypes in non immune subjects.
MedDRA version: 9.1Level: LLTClassification code 10052552Term: Hepatitis B virus

Registration Number: EUCTR2008-004785-98-GB

Lead Sponsor: niversity of Oxford

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 55

Inclusion Criteria

•Parent/guardian is willing and able to give informed consent for participation in the study.
•Male or Female, aged 3 years 4 months and 10 years.
•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.
•At ongoing risk of Hepatitis B exposure.

Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the percentage of children immunised according to the UK accelerated HBV schedule with antiHBs concentrations = 10mIU/ml before and after a booster dose of HBV vaccine.;Primary end point(s): Measurement of anti Hepatitis B surface antibody (antiHBs IgG) 4 weeks following booster immunisation with Hepatitis B vaccine.;Secondary Objective: 1. To assess for the presence of immunological memory in children immunised according to the UK accelerated HBV schedule with antiHBs concentrations < 10mIU/ml.<br><br>2. To assess the percentage of children immunised with incomplete accelerated HBV immunisation schedules with antiHBs concentrations = 10mIU/ml before and after a booster dose of HBV vaccine.<br><br>3. To assess for the presence of immunological memory in children immunised with incomplete accelerated HBV immunisation schedules with antiHBs concentrations < 10mIU/ml.<br><br>

Secondary Outcome Measures