E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Healthy volunteers: Immunization against Japanese Encephalitis virus (JEV) |
|
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 |
The main objective is to analyze the long term persistence of immunogenicity of IC51 (JE-PIV) (2 x 6 mcg), IC51 (JE-PIV) (1 x 12 mcg) or IC51 (JE-PIV) (1 x 6 mcg) in terms of seroconversion rate in volunteers 24 months after the primary vaccination |
|
E.2.2 | Secondary objectives of the trial |
a) To investigate the immunogenicity of a booster dose of IC51 (JE-PIV) (1 x 6 mcg) applied 11 months and/or 23 months after the primary vaccination in subjects with a negative PRNT result at month 6 and/or month 12 b) To analyze the immunogenicity of IC51 (JE-PIV) (2 x 6 mcg), IC51 (JE-PIV) (1 x 12 mcg) or IC51 (JE-PIV) (1 x 6 mcg) in volunteers 6 and 12 months after the primary vaccination c) To compare Geometric Mean Antibody Titers of both dose regimes d) To confirm the safety profile of IC51 (JE-PIV)
|
|
E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
1. Written informed consent obtained prior to study entry (subjects should give their consent themselves, consent by legal representatives is allowed). Written informed consent should be obtained during participation of IC51-304 study. 2. Subjects correctly included in and having completed study IC51-304 according to the protocol. |
|
E.4 | Principal exclusion criteria |
1. Use of any investigational or non-registered drug or vaccine other than the study vaccine during the study period 2. Planned administration of another vaccine during the study period 3. Immunodeficiency including post-organ-transplantation or immunosuppressive therapy 4. Administration of chronic (defined as more than 14 days) immunosuppressants or other immune-modifying drugs since last visit of study IC51-304. (For corticosteroids, this will mean prednisone, or equivalent, greater than 0.5 mg/kg/day. Topical and inhaled steroids are allowed.) 5. Positive Pregnancy test, lactation or unreliable contraception, childbearing potential, and willingness to become pregnant, in female subjects up to 30 days after the last vaccination (for details please refer to protocol section 6.4) 6. Inability or unwillingness to provide informed consent and to abide by the requirements of the study
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
Seroconversion rate (anti-JEV neutralizing antibody titer greater than or equal to 1:10) 24 months after the primary vaccination |
|
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 | 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 | Information not present in EudraCT |
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 | No |
E.8.1.2 | Open | Yes |
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 | Yes |
E.8.1.7.1 | Other trial design description |
|
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 | Yes |
E.8.2.3.1 | Comparator description |
|
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 | Yes |
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
|
Last visit of the last patient. |
|
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 | 2 |
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 | 2 |