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

niversity of Oxford0 个研究点目标入组 55 人开始时间: 2009年1月20日最近更新: 2012年3月19日

试验速览

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•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

•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.

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