E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
The intended application of Engerix B is active immunisation against Hepatitis B virus infection caused by all known subtypes in non immune subjects. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10052552 |
E.1.2 | Term | Hepatitis B virus |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
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.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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.
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E.4 | Principal 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.
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E.5 End points |
E.5.1 | Primary end point(s) |
Measurement of anti Hepatitis B surface antibody (antiHBs IgG) 4 weeks following booster immunisation with Hepatitis B vaccine. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
Immune response to immunisation with Hepatitis B vaccine |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The end of trial is the date of the last visit of the last participant |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 10 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |