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 aged 7–8 years, previously primed and boosted with 4 doses of GSK Biologicals’ DTPa-HBV-IPV/Hib vaccine (Infanrix hexa) as part of routine vaccination practice in Germany. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10019731 |
E.1.2 | Term | Hepatitis B |
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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 HBV vaccine (Engerix-B Kinder) in subjects 7–8 years of age, previously vaccinated with four doses of Infanrix hexa in the first two years of life. |
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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 four doses of Infanrix hexa in the first two years of life.
•To evaluate the safety and reactogenicity of a challenge dose of HBV vaccine (Engerix-B Kinder) in terms of solicited symptoms (local and general), unsolicited symptoms and serious adverse events during the study period.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
•Subjects who the investigator believes that their parent(s)/LAR(s) can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for the follow-up visit). •A male or female 7 to 8 years of age (from and including the 7th birthday up to, but excluding the 9th birthday) at the time of enrolment. •Subjects with documented evidence of previous vaccination with four consecutive doses of Infanrix hexa as part of routine vaccination in Germany: three doses of primary vaccination received by 9 months of age and one booster dose received between 11 and 18 months of age. •Written informed consent obtained from the parents/LAR(s) of the subject at the time of enrolment. •In addition to the informed consent that will be signed by the parent(s)/LAR(s), written informed assent of the subject will be sought when the subject is judged able to understand by the investigator (optional). •Healthy subjects as established by medical history and clinical examination before entering into the study.
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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. •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 fourth dose of Infanrix hexa booster in the second year of life. •History of or intercurrent hepatitis B disease. •Hepatitis B vaccination at birth. •Planned administration/administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before and ending 30 days after the HBV challenge dose. •Administration of immunoglobulins and/or any blood products within the three months preceding challenge dose or planned administration 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 challenge dose of HBV vaccine. For corticosteroids, prednisone < 0.5 mg/kg/day, inhaled and topical steroids are allowed. •History of any reaction or hypersensitivity likely to be exacerbated by any component of the HBV vaccine, or evidence of hypersensitivity after previous immunisation with a vaccine containing the hepatitis B component. •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 on oral, axillary or tympanic setting, or ≥ 38.0 C on rectal setting. 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 and vaccinated at the discretion of the investigator. |
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E.5 End points |
E.5.1 | Primary end point(s) |
•Immunogenicity with respect to components of the study vaccine. - Subjects with anti-HBs antibody concentrations ≥ 100 mIU/mL, one month after the challenge dose of HBV 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 | Yes |
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 | Yes |
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 |
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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 | 12 |
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 | 7 |
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 |