E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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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 |
Seropositivity rate, measured by ELISA and/or NT (according to Adner et al., 2001), approximately 3 years after the first booster vaccination with FSME-IMMUN 0.25 ml Junior |
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E.2.2 | Secondary objectives of the trial |
- Seropositivity rate, measured by ELISA, approximately 3 years after the first booster vaccination with FSME-IMMUN 0.25 ml Junior; - Seropositivity rate, measured by NT according to Adner et al., 2001, approximately 3 years after the first booster vaccination with FSME-IMMUN 0.25 ml Junior; - Seropositivity rate, measured by NT according to Holzmann et al., 1996, approximately 3 years after the first booster vaccination with FSME-IMMUN 0.25 ml Junior; - Antibody concentration approximately 3 years after the first booster vaccination with FSME-IMMUN 0.25 ml Junior as measured by ELISA; - Antibody titer approximately 3 years after the first booster vaccination with FSME-IMMUN 0.25 ml Junior as measured by NT according to Adner et al., 2001; - Antibody titer approximately 3 years after the first booster vaccination with FSME-IMMUN 0.25 ml Junior as measured by NT according to Holzmann et al., 1996.
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
Male and female children who participated in Study IMAG-146A will be eligible for participation in this study if: - they and/or their parents/legal guardians understand the nature of the study and agree to its provisions; - written informed consent is available from the child (according to age and capacity of understanding) and the parents/legal guardians; - they received the complete 3-immunization primary vaccination series with either 0.5 ml or 0.25 ml TicoVac in Study IMAG-146A; - they received FSME-IMMUN 0.25 ml Junior for their first booster vaccination approximately 3 to 4 years after their third vaccination in Study IMAG-146A.
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E.4 | Principal exclusion criteria |
Subjects will be excluded from participation in this study if: - they have received any further TBE vaccination since their first TBE booster vaccination; - they have a history of infection with, or vaccination against, other flaviviruses (e.g. dengue fever, yellow fever and/or japanese B encephalitis virus) since their third vaccination in Study IMAG-146A; - they suffered from a disease (e.g. autoimmune disease) or have undergone a form of treatment (e.g. systemic corticosteroids) that can be expected to influence immunological functions within 30 days before and after their first TBE booster vaccination; - they are known to be HIV positive (a special HIV test is not required for the purpose of the study) since their third vaccination in Study IMAG-146A; - they have received a blood transfusion or immunoglobulins within 30 days of study entry.
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E.5 End points |
E.5.1 | Primary end point(s) |
- Seropositivity rate, measured by ELISA and/or NT (according to Adner et al., 2001), approximately 3 years after the first booster vaccination with FSME-IMMUN 0.25 ml Junior |
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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 | Information not present in EudraCT |
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 |
Seropersistence of TBE antibodies |
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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 | 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) | 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.8.5 | 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 | Information not present in EudraCT |
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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see protocol section 6.10 and 6.11 page 28 |
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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 | |
E.8.9.1 | In the Member State concerned months | 12 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 12 |