E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Japanese encephalitis. This study is a follow-up to the pivotal immunogenicity and safety studies IC51-301 and IC51-302.
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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 investigate the immunogenicity of IC51 (JE-PIV) in subjects 24 months after the first vaccination. |
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E.2.2 | Secondary objectives of the trial |
To investigate the immunogenicity of IC51 (JE-PIV) in subjects 6, 12, 36, 48 and 60 months after the first vaccination. To analyze the safety of IC51 (JE-PIV) 6 months after the first immunization. To investigate the frequency of vaccination-related 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 correctly included in and having completed clinical studies IC51-301 or IC51-302 with at least one vaccination. -Written informed consent for study IC51-303.
Only for the immunogenicity part: -Subjects correctly included in and having completed study IC51-301 or IC51-302 according to the protocol with the required amount of injections (IC51-301: 3 / IC51-302: 2).
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E.4 | Principal exclusion criteria |
-Inability or unwillingness to provide informed consent and to abide by the requirements of the study.
Only for the immunogenicity part: -Known negative (< 1:10) anti-JEV neutralizing antibody titer (PRNT) 28 days after the last vaccination in the preceding study or thereafter. -Subjects with any condition which in the opinion of the Investigator makes the subject unsuitable for inclusion. -Known randomization to JE-VAX® or placebo
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E.5 End points |
E.5.1 | Primary end point(s) |
Immunogenicity: -Percentage of subjects with seroconversion rate (anti-JEV neutralizing antibody titer equal to or greater than 1:10) 24 months after the first vaccination.
Safety: -Frequency of possibly or probably vaccination related adverse events. -Rate of serious adverse events and medically attended adverse events up to 6 months after the start of the immunization.
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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 |
To investigate the immunogenicity of IC51 up to 60 months after first vaccination |
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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 | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
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 | 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 | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 20 |
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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 5 |
E.8.9.1 | In the Member State concerned months | 8 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 5 |
E.8.9.2 | In all countries concerned by the trial months | 8 |