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: 9.1 Level: LLT Classification code 10052552 Term: Hepatitis B virus
Conditions
Interventions
Trade Name: Engerix B
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: HEPATITIS B SURFACE ANTIGEN ADSORBED
Other descriptive name: HEPATITIS B SURFACE ANTIGEN ADSORBED
Concentratio
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. 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. 3. To assess for the presence of immunological memory in children immunised with incomplete accelerated HBV immunisation schedules with antiHBs concentrations < 10mIU/ml. | — |
Countries
United Kingdom
Outcome results
None listed