Japanese Encephalitis (JE)
Conditions
Sponsors
Intercell AG
Eligibility
Sex/Gender
All
Inclusion criteria
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) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate equivalence of three commercial IC51 batches in terms of geometric mean titers (GMT) for anti-JEV neutralizing antibody;Secondary Objective: - 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 ;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 | — |
Countries
Austria, Germany
Outcome results
None listed