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 | Information not present in EudraCT |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To demonstrate the non-inferiority of IC51 (2 x 6 mcg) + HAVRIX® 1440 as compared to IC51 (JE-PIV) (2 x 6 mcg) + placebo in terms of the GMT at day 56 and IC51 (2 x 6 mcg) + HAVRIX® 1440 compared to HAVRIX® 1440 + placebo in terms of the GMT at day 28; 4 weeks after the last vaccination. |
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E.2.2 | Secondary objectives of the trial |
To compare - the seroconversion rate (SCR) of the combined vaccination vs. IC51 + placebo at day 56 and the combined vaccination vs. HAVRIX® 1440 + placebo at day 28 - the immunogenicity of the combined vaccination vs. IC51 + placebo at day 28 and the combined vaccination vs. HAVRIX® 1440 + placebo at day 56 in terms of the GMT and SCR for anti-JEV antibody titer (PRNT)/HAV antibodies - the safety and tolerability of the combined vaccination vs. IC51 + placebo and HAVRIX® 1440 + placebo up to 6 months after the first vaccination
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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 |
History of clinical manifestation of any flavivirus infection History of vaccination against Japanese encephalitis (JE), Yellow fever and Dengue fever (an anti-JEV neutralizing antibody titer 1:10 at baseline is acceptable for inclusion, these subjects will be part of the safety population, but will not be analyzed for immunogenicity in the per-protocol analysis) History of any previous Hepatitis A vaccination 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 Planned administration of another vaccine 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 enrollment History of severe hypersensitivity reactions in particular to a component of the IC51 vaccine (e.g. protamine sulphate) or HAVRIX® 1440, anaphylaxis or severe cases of atopy requiring emergency treatment or hospital admission Infection with HIV (a negative test result within 30 days before enrollment is acceptable), Hepatitis B (HBsAg) or Hepatitis C History of thrombocytopenia or a bleeding disorder 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 Known hypersensitivity to neomycin 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 (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 antibody Titers (GMT) for anti-JEV neutralizing antibody at day 56 / HAV antibody at day 28 |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | Information not present in EudraCT |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Information not present in EudraCT |
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) | Information not present in EudraCT |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | Information not present in EudraCT |
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 | Yes |
E.8.1.4 | Double blind | No |
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) | Yes |
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
| 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.8.6 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
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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 | 1 |
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 | 1 |