E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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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 IC51 (JE-PIV) batches in terms of Geometric Mean Titers (GMT) for anti-JEV neutralizing antibody. |
|
E.2.2 | Secondary objectives of the trial |
-To assess the seroconversion rates of three IC51 (JE-PIV) batches -To investigate the safety of three IC51 (JE-PIV) batches during a vaccination period of 28 days until 6 months after the first vaccination -To investigate tolerability of three IC51 (JE-PIV) batches during a vaccination period of 28 days until 4 weeks after the last vaccination -To analyze the rates of serious adverse events and medically attended adverse eventsin individuals after immunization with IC51 (JE-PIV) -To assess possible changes in laboratory parameters. |
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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 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 Japanese encephalitis (incl. study participation in any 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 another 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 six 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 sulphate), 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), Hepatitis B (HBsAg) or Hepatitis C 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 approx. 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, 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. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Geometric Mean Titers (GMT) for anti-JEV neutralizing antibody 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 | 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 | Yes |
E.6.13.1 | Other scope of the trial description |
Comparison of 3 production batches of JE-PIV with regards to GMTs and seroconversion rates |
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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 | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
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 production 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.8.5 | 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
|
A final clinical evaluation will take place after 4 weeks of follow-up (day 56, Visit 3), a scripted telephone call is scheduled 6 months after the first vaccination. |
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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 |