E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
Inflammation of the liver due to viral infection |
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E.1.1.2 | Therapeutic area | Diseases [C] - Virus Diseases [C02] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10019731 |
E.1.2 | Term | Hepatitis B |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
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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 anti-HBs antibody response to a challenge dose of Engerix-B Kinder in subjects 15-16 years of age vaccinated with three doses of Engerix-B Kinder in infancy. |
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E.2.2 | Secondary objectives of the trial |
To assess the persistence of anti-HBs antibodies in subjects 15-16 years of age vaccinated with three doses of Engerix-B Kinder in infancy.
To evaluate the safety and reactogenicity of challenge dose of Engerix-B Kinder in terms of solicited symptoms, unsolicited symptoms and serious adverse events (SAEs) |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
A male or female between, and including, 15 and 16 years of age (from and including the 15th birthday up to but excluding the 17th birthday) at the time of the vaccination.
Healthy subjects as established by medical history and clinical examination before entering into the study.
Documented evidence of previous vaccination with three consecutive doses of Engerix™-B Kinder in Germany: with the first two doses received by 9 months of age and the third dose received by 18 months of age (up to but excluding the first day of the 10th and 19th month, respectively).
Written informed consent obtained from the parent(s)/LAR(s) of the subject.
Written informed assent obtained from the subject in addition to the informed consent signed by the parent(s)/LAR(s). |
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E.4 | Principal exclusion criteria |
•Child in care.
•Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the dose of study vaccine, or planned use during the study period.
•Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs within six months prior to the vaccine dose. For corticosteroids, this will mean prednisone >= 20 mg/day, or equivalent. Inhaled and topical steroids are allowed.
•Previous hepatitis B vaccination since administration of the third dose of Engerix™-B Kinder.
•History of hepatitis B disease.
•Administration of a vaccine not foreseen by the study protocol within the period starting 30 days before study vaccine dose, or planned administration during the study period.
•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 vaccine/product (pharmaceutical product or device).
•History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
•Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
•Acute disease and/or fever at the time of enrolment.
-Fever is defined as temperature >= 37.5°C for oral, axillary or tympanic route, or >= 38.0°C on rectal route. The preferred route for recording temperature in this study will be axillary.
-Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may be enrolled at the discretion of the investigator.
•Administration of immunoglobulins and/or any blood products within the 3 months preceding the study vaccine dose or planned administration during the study period.
•Pregnant or lactating female.
•Female planning to become pregnant or planning to discontinue contraceptive precautions. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Evaluation of anti-HBs immune status in terms of antibody concentrations. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
One month after the challenge dose (Month 1) |
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E.5.2 | Secondary end point(s) |
Evaluation of anti-HBs immune status in terms of antibody concentrations.
Occurrence of solicited local and general symptoms
Occurrence of unsolicited adverse events
Occurrence of serious adverse events (SAEs) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Anti-HBs immune status: Before (Day 0) and one month after the challenge dose (Month 1).
Solicited local and general symptoms: During the 4-day (Days 0-3) follow-up period after the challenge dose
unsolicited symptoms: During the 31-day (Days 0-30) follow-up period after the challenge dose
SAEs: After challenge dose, up to study end (Month 1) |
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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 | 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 | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
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 | 14 |
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 | No |
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 |