E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Japanese encephalitis (JE) is the most common viral encephalitis, with over 50,000 cases reported annually. It is a considerable public health problem for many Asian countries (WHO 1997). Close to 3 billion people now live in regions at risk for the disease, particularly in rural areas where JE occurs sporadically in epidemics of variable magnitude. Vaccination against JE remains the single most important control measure worldwide. |
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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 safety and tolerability of IC51 (JE-PIV) compared with an inactive control |
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E.2.2 | Secondary objectives of the trial |
To analyze the rates of serious adverse events and medically attended adverse events in individuals before and after immunization with IC51
To assess possible changes in laboratory parameters
To assess the seroconversion rates and geometric mean antibody titers (GMTs) of subjects with concomitant vaccinations within the time period of 30 days before study entry and up to day 56 (this analysis will be postponed and performed, if deemed meaningful, with regards to the results of study IC51-308, which investigates the safety and immunogenicity of concomitant vaccinations with IC51)
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
At least 18 years of age
In female subjects either childbearing potential terminated by surgery or one year post-menopausal, or a negative serum pregnancy test during screening and the willingness not to become pregnant during the study period and 30 days after the last vaccination by practicing reliable methods of contraception as specified in protocol section 6.4
Written informed consent obtained prior to study entry. (subjects should give their consent themselves. Consent by legal representatives is allowed.)
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E.4 | Principal exclusion criteria |
Use of any investigational or non-registered drug or vaccine other than the study vaccine during the study period or within 30 days preceding the first dose of study vaccine.
History of any previous JE vaccination (e.g. JE-VAX).
Administration of yellow fever vaccine 30 days before or up to 30 days after study treatment
Immunodeficiency including post-organ-transplantation or immunosuppressive therapy
A family history of congenital or hereditary immunodeficiency
History of autoimmune disease
Administration of chronic (defined as more than 14 days) immunosuppressants or other immune-modifying drugs within six months of vaccination. (For corticosteroids, this will mean prednisone, or equivalent, more than or equal to 0.05 mg/kg/day. Topical and inhaled steroids, are allowed.)
Any acute infections within 2 weeks prior to enrollment
History of severe hypersensitivity reactions (in particular to a component of the IC51 vaccine, e.g. protamine sulphate), anaphylaxis or severe cases of atopy requiring emergency treatment or hospital admission
Known or suspected HIV Infection
Drug addiction within 6 months prior to enrollment (including alcohol dependence, i.e. more than approx. 60 g alcohol per day, or conditions which might interfere with the study conduct)
Inability or unwillingness to avoid more than the usual alcohol intake during the 48 hours after vaccination.
Subjects with any condition which in the opinion of the investigator makes the subject unsuitable for inclusion
Pregnancy (positive pregnancy test during screening or at baseline), lactation or unreliable contraception in female subjects (for details please refer to protocol section 6.4)
Inability or unwillingness to provide informed consent and to abide by the requirements of the study
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E.5 End points |
E.5.1 | Primary end point(s) |
Rate of serious adverse events and medically attended adverse events during the vaccination period until 4 weeks after the last vaccination (day 56) compared with an inactive control. |
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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 | 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 | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
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 | Yes |
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.8.5 | 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 | 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 | 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
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last visit of the last patient 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 | 0 |
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 | 0 |
E.8.9.2 | In all countries concerned by the trial months | 8 |