E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Antibody persistence and hepatitis B vaccine challenge in children 7-8 years of age, previously vaccinated with 3 doses of GSK Biologicals’ HBV vaccine in routine vaccination practice in Germany. |
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MedDRA Classification |
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 anti-HBs antibody response to a challenge dose of HBV vaccine (Engerix-B Kinder) in subjects, 7-8 years of age, previously vaccinated with three doses of Engerix-B in infancy. |
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E.2.2 | Secondary objectives of the trial |
To assess the persistence of anti-HBs antibodies in subjects, 7-8 years of age, previously vaccinated with three doses of Engerix-B in infancy. To evaluate the safety and reactogenicity of a challenge dose of HBV vaccine (Engerix-B Kinder) in terms of solicited symptoms, unsolicited symptoms and serious adverse events (SAEs) during the study period.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
A male or female of 7 to 8 years of age (from and including the 7th birthday up to but excluding the 9th birthday) at the time of enrolment. With documented evidence of previous vaccination with three consecutive doses of Engerix™-B in Germany: with the first two doses received by 9 months of age and the third dose received by 18 months of age. Written informed consent obtained from the parents or guardians of the subject at the time of enrolment.
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E.4 | Principal exclusion criteria |
Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device). Evidence of previous hepatitis B booster vaccination since administration of the third dose of Engerix™-B vaccine. Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required). |
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E.5 End points |
E.5.1 | Primary end point(s) |
One month after the challenge dose of HBV vaccine: Anti-HBs antibody concentrations >= 100 mIU/ml.
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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 | Yes |
E.6.5 | Efficacy | Yes |
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 | No |
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 | Yes |
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 | 31 |
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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 1 |
E.8.9.1 | In the Member State concerned days | 0 |