E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Japanese Encephalitis (JE) |
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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 demonstrate equivalence of three commercial IC51 batches in terms of geometric mean titers (GMT) for anti-JEV neutralizing antibody |
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E.2.2 | Secondary objectives of the trial |
- To assess the seroconversion rates (SCRs) of three commercial IC51 batches - To investigate the safety of three commercial IC51 batches during a period of 56 days after the first vaccination - To investigate tolerability of three commercial IC51 batches during a period of 56 days after the first vaccination - To analyze the rates of serious adverse events (SAEs) and medically attended adverse events (AEs) in individuals after immunization with IC51 - To assess possible changes in laboratory parameters
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- At least 18 years of age - In female subjects, either childbearing potential terminated by surgery or 1 year post menopausal, or a negative serum pregnancy test during screening and the willingness not to become pregnant during the entire study period 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)
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E.4 | Principal exclusion criteria |
- History of clinical manifestation of any flavivirus infection - History of vaccination against JE (including study participation in any previous or current IC51 clinical study), Yellow fever and Dengue fever - Use of any other investigational or non-registered drug or vaccine in addition to the study vaccine during the study period or within 30 days preceding the first dose of study vaccine - Administration of any other vaccine within 4 weeks before randomization and during the study period - 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 6 months of vaccination. (For corticosteroids, this will mean prednisone, or equivalent, >/= 0.05 mg/kg/day. Topical and inhaled steroids are allowed.) - Any acute infections within 4 weeks prior to randomization - History of severe hypersensitivity reactions, in particular to a component of the IC51 vaccine (e.g. protamine sulfate), anaphylaxis or severe cases of atopy requiring emergency treatment or hospital admission - Infection with HIV (a negative test result within 30 days before screening is acceptable), HBV (Hepatitis B surface antigen [HBsAg]) or HCV - History of urticaria after hymenoptera envenomation, drugs, physical or other provocations, or of idiopathic cause - Drug addiction within 6 months prior to enrollment (including alcohol dependence, i.e. more than approximately 60 g alcohol per day, or conditions which might interfere with the study conduct) - Inability or unwillingness to avoid more than the usual intake of alcohol during the 48 hours after vaccination - Diabetes mellitus in subjects receiving insulin therapy, severe cardiopulmonary disorders, or history of malignancy in the past 5 years - Pregnancy (positive pregnancy test during screening or at baseline), lactation or unreliable contraception in female subjects with child-bearing potential (for details, please refer to Section 6.4) - Subjects with any condition which in the opinion of the investigator makes the subject unsuitable for inclusion - Inability or unwillingness to provide informed consent and to abide by the requirements of the study - Persons who have been committed to an institution (by a court or by an authority) will not participate in the study
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E.5 End points |
E.5.1 | Primary end point(s) |
- GMT for serum dilution giving a 50% reduction in JEV-plaque counts in a plaque reduction neutralization test [PRNT50] at Day 56 |
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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 | 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 | Yes |
E.6.13.1 | Other scope of the trial description |
Comparison of 3 batches of IC51 in terms of geometric mean titers for anti-JEV neutralizing antibody |
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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 | Yes |
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 |
3 different batches of IC51 will be compared |
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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 | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 4 |
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
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When last patient has completed visit 3 |
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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 | 4 |
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 | 4 |
E.8.9.2 | In all countries concerned by the trial days | 0 |