E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
JE can be fatal or lead to long-term disability. Vaccination should therefore be considered for people who are at risk of exposure to JEV by travelling to endemic regions. The study within which no IMP will be administered, will benefit the pediatric population as it will provide information on potential need of booster doses of IC51 in children and adolescents. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 17.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10023123 |
E.1.2 | Term | Japanese encephalitis |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 17.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10023120 |
E.1.2 | Term | Japanese B viral encephalitis |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 17.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10023122 |
E.1.2 | Term | Japanese B virus encephalitis |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 17.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10023119 |
E.1.2 | Term | Japanese B encephalitis |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 17.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10014596 |
E.1.2 | Term | Encephalitis Japanese 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 long-term immunity following vaccination with purified inactivated Japanese Encephalitis (JE) vaccine IC51 in terms of geometric mean titers (GMTs) and rate of subjects with a PRNT50 ≥ 1:10 in a pediatric population from regions where JE is not endemic. |
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E.2.2 | Secondary objectives of the trial |
- To assess the long-term safety profile of IC51 in a pediatric population from regions where JE is not endemic. - To assess age-dependent differences in persistence of immunity and the long- term safety profile of IC51. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Subjects who have received two vaccinations of IC51 in study IC51-322. 2. Subjects who were enrolled as part of the immunogenicity subgroup of study IC51-322. 3. Male or female healthy subjects aged ≥ 9 months to < 21 years at the time of enrolment into this study.* 4. Written informed consent by the subject, the subject's legal representative(s), according to local requirements, and written informed assent of the subject, if applicable.
*Date and time of enrolment will be defined as the time point at which the investigator confirms eligibility of the subject for inclusion in the study, i.e., all of the inclusion criteria and none of the exclusion criteria are fulfilled (to be checked at visit 1). |
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E.4 | Principal exclusion criteria |
1. History of or clinical manifestation of any Flavivirus disease during study IC51-322. 2. Vaccination against JE virus (except with IC51) at any time prior or planned during this study. 3. Participation in another study with an investigational product during study IC51-322 or IC51-324. 4. History of development of an immunodeficiency including post-organ-transplantation after inclusion into study IC51-322. 5. History of an development of an autoimmune disease during study IC51-322. 6. Administration of chronic immunosuppresants (>14 days) or other immune-modifying medications started during study IC51-322 up to first visit of study IC51-324. 7. Known infection with HIV, HBV or HCV. 8. Illicit drug use and/or a history of drug or alcohol addiction and/or current drug or alcohol addiction. 9. Inability or unwillingness by the legal representative(s) and/or the subject (where applicable) to provide informed consent/assent and to abide by the requirements of this study. 10. Persons who are committed to an institution (by virtue of an order issued either by the judicial or the administrative authorities). |
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E.5 End points |
E.5.1 | Primary end point(s) |
Rate of subjects with PRNT50 titers of ≥ 1:10 at month 12 after the first IC51 vaccination (in study IC51-322) |
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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 | No |
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 | 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 |
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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) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
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 | 2 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 5 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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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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End of trial is 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 | 3 |
E.8.9.1 | In the Member State concerned months | 10 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 10 |