E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Japanese Encephalitis (JE) |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10014596 |
E.1.2 | Term | Encephalitis Japanese B |
|
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 immunogenicity of a commercial IC51 batch at 3 different time points post filling (12, 18, 24 months) in terms of Geometric Mean Titers (GMT) for anti-JEV neutralizing antibody at Day 56 after the first vaccination. |
|
E.2.2 | Secondary objectives of the trial |
-To assess the seroconversion rate (SCR) of a commercial IC51 batch at 3 different time points post filling (12, 18, 24 months) at Day 56 after the first vaccination -To assess GMTs for anti-JEV neutralizing antibody and SCRs of a commercial IC51 batch at 3 different time points post filling (12, 18, 24 months) at Day 28, Month 6 and Month 12 after the first vaccination -To investigate the safety of a commercial IC51 batch at 3 different time points post filling (12, 18, 24 months) in terms of percentage of treatment emergent AEs (including serious and medically attended adverse events) as well as possible changes in laboratory parameters -To investigate local and systemic tolerability of a commercial IC51 batch at 3 different time points post filling (12, 18, 24 months) |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
-Male and female healthy adults -Aged at least 18 years -With written informed consent obtained prior to study entry (subjects could give their consent themselves) -In female subjects, either no childbearing potential or negative serum pregnancy test and the willingness not to become pregnant during the entire study period by practicing reliable methods of contraception or childbearing potential terminated by surgery or 1 year post-menopausal |
|
E.4 | Principal exclusion criteria |
-History of clinical manifestation of any flavivirus infection -Use of any other investigational or non-registered drug (except the study vaccine) within 30 days prior to IC51 vaccination and during the study period -Vaccination against JE (including study participation in any previous or current IC51 clinical study), Yellow fever, Dengue fever or West Nile virus at any time prior or during the study -Administration of a vaccine against tick-borne encephalitis (TBE) between IC51 vaccination at Visit (Day 0) and Visit 3 (Day 56) -History of immunodeficiency or immunesuppressive therapy -Infection with HIV (a negative test result within 30 days before screening is acceptable), HBV (Hepatitis B surface antigen [HBsAg]) or HCV -Acute infections or exacerbation of chronic infection within 4 weeks prior to IC51 vaccination at Visit 1 requiring specific treatment -Drug addiction within 6 months prior to Visit 0 (including alcohol dependence) -Pregnancy (positive pregnancy test during screening or at Visit 1), lactation or unreliable contraception in female subjects with child-bearing potential -History of severe hypersensitivity reactions, in particular to a component of the IC51 vaccine
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
-Geometric Mean Titers (GMT) for anti-JEV neutralizing antibody at Day 56 after the first vaccination with batch IC51/07F/008A |
|
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 | Yes |
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) | 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 | 3 |
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
|
When last subject in cohort 3 has completed Visit 5 |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 3 |