E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
The aim of this project is to investigate humoral and cellular immune responses before and after immunisation with the Japanese encephalitis vaccine IXIARO in subjects above 65 years of age in comparison to subjects aged between 18 and 40 years. |
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E.1.1.1 | Medical condition in easily understood language |
We study the efficacy of the Japanese Encephalitis vaccination in subjects above 65 years of age compared to subjects aged between 18 and 40 years. |
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E.1.1.2 | Therapeutic area | Body processes [G] - Immune system processes [G12] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10069544 |
E.1.2 | Term | Japanese encephalitis immunization |
E.1.2 | System Organ Class | 10042613 - Surgical and medical procedures |
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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 |
Antibody titres 10 weeks after the first vaccination (=6 weeks after the 2. vaccination) |
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E.2.2 | Secondary objectives of the trial |
Cellular immunity (cytokine production) 7 days after the second japanese encephalitis vaccination. Cellular markers of different lymphocyte subsets. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
adults (18-40 years and ≥65 years with no upper age limit), both sexes, willingness to sign written informed consent form |
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E.4 | Principal exclusion criteria |
age below 18 years, age between 41 and 64 years; prior japanese encephalitis, TBE, dengue, yellow fever or West Nile virus infection, yellow fever vaccination within the last 10 years, TBE vaccination within the last 30 days; vaccination against dengue or West Nile Virus; current acute infection (body temperature above 37,9°C)
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E.5 End points |
E.5.1 | Primary end point(s) |
Antibody titres 10 weeks after the first vaccination (=6 weeks after the 2. vaccination)
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
visit 3: d70(+/-4) 6 weeks after the second vaccination |
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E.5.2 | Secondary end point(s) |
cellular immunity (cytokine production upon stimulation with Japanese Encephalitis Virus Antigen) 7 days after the 2. vaccination (visit 2). |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
visit 2: 7 days after the 2. vaccination ( (d35+2))
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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 | 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) | 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 | 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
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
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 | No |
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 the study is when the last subject gets his last blood draw |
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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 | 2 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |