Japanese encephalitis
Conditions
Interventions
Product Name: Japanese Encephalitis Purified Inactivated Vaccine
Product Code: JE-PIV
Pharmaceutical Form: Suspension for injection
Current Sponsor code: IC51
Other descriptive name: JE-PIV
Concentrat
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 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.) 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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate equivalence of three IC51 (JE-PIV) batches in terms of Geometric Mean Titers (GMT) for anti-JEV neutralizing antibody.;Secondary Objective: -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.;Primary end point(s): Geometric Mean Titers (GMT) for anti-JEV neutralizing antibody at day 56 | — |
Countries
Austria, Germany
Outcome results
None listed