E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
18-64 years old volunteers with general good health |
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E.1.1.1 | Medical condition in easily understood language |
18-64 years old volunteers with general good health |
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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 study whether one dose of intradermally given Ixiaro elicits a non-inferior immune response as compared to intramuscular administration of the same vaccine. The immune response is measured as levels of neutralizing serum antibodies (PRNT). |
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E.2.2 | Secondary objectives of the trial |
- To study whether two doses of intradermally administered Ixiaro elicits a non-inferior immune response as compared to one dose of intramuscular administration of the same vaccine. - To compare the immune responses to one vs. two doses of intradermally administered Ixiaro - To study whether intradermally given Ixiaro has a non-inferior adverse event profile as compared to intramuscular administration of the same vaccine. - To study circulating plasmablasts (ELISPOT) and cell-mediated immune responses after intradermal vs. intramuscular Ixiaro.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Male or female subjects aged 18-64 2. General good health as established by medical history and physical examination 3. Written informed consent 4. Females of childbearing potential must agree to use an efficacious hormonal or barrier method of birth control during the study. Abstinence is acceptable. 5. Available for all visits scheduled in this study. 6. No previous Japanese encephalitis vaccination
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E.4 | Principal exclusion criteria |
1. Previous Japanese encephalitis vaccination 2. Chronic administration of immunosuppressants or other immune-modifying drugs within 6 months before the first dose of IMP; oral corticosteroids in dosages of ≥0.5 mg/kg/d prednisolone or equivalent are excluded; inhaled or topical steroids are allowed 3. Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection 4. Pregnancy or lactation 5. Acute disease at the time of enrollment (defined as the presence of a moderate or severe illness with or without fever (fever is defined as body temperature of ≥38 °C). 6. Alcohol or drug abuse 7. Suspected non-compliance 8. Use of any investigational drug or any investigational vaccine within 30 days preceding the study vaccine, or planned use during the study period 9. Any clinically significant history of known or suspected anaphylaxis or hypersensitivity reaction based on the judgement of the investigator 10. Employee at the investigational site, relative or spouse of the investigator 11. Any other criteria which, in the investigator’s opinion, would compromise the ability of the subject to participate in the study, the subject’s well-being, or the outcome of the study
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E.5 End points |
E.5.1 | Primary end point(s) |
Measurement of levels of neutralizing serum antibodies (PRNT) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
One month after vaccination. |
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E.5.2 | Secondary end point(s) |
-To study circulating plasmablasts (ELISPOT) and cell-mediated immune responses after intradermal vs. intramuscular Ixiaro. - To study adverse event profiles |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
From seven day to one month after vaccination to plasmablast and cell-mediated studies and from vaccine injection to 6 month to study adverse events. |
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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 | 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 | Yes |
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) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
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 | 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 | Yes |
E.8.2.3.1 | Comparator description |
IMP administered as on days 0 and 7 or 0 and 28 i.d. or i.m |
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E.8.2.4 | Number of treatment arms in the trial | 4 |
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 | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 2 |
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 | Yes |
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 | 3 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 3 |