Japanese encephalitis (JE) is the most common viral encephalitis, with over 50,000 cases reported annually. It is a considerable public health problem for many Asian countries (WHO 1997). Close to 3 billion people now live in regions at risk for the disease, particularly in rural areas where JE occurs sporadically in epidemics of variable magnitude. Vaccination against JE remains the single most important control measure worldwide.
Conditions
Interventions
Product Name: Japanese Encephalitis Purified Inactivated Vaccine
Product Code: IC51 (JE-PIV)
Pharmaceutical Form: Suspension for injection
Current Sponsor code: IC51
Other descriptive name: Japanese
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 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.) 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: Use of any investigational or non-registered drug or vaccine other than the study vaccine during the study period or within 30 days preceding the first dose of study vaccine. History of any previous JE vaccination (e.g. JE-VAX). Administration of yellow fever vaccine 30 days before or up to 30 days after study treatment 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, more than or equal to 0.05 mg/kg/day. Topical and inhaled steroids, are allowed.) Any acute infections within 2 weeks prior to enrollment 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 Known or suspected HIV Infection 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 alcohol intake during the 48 hours after vaccination. Subjects with any condition which in the opinion of the investigator makes the subject unsuitable for inclusion Pregnancy (positive pregnancy test during screening or at baseline), lactation or unreliable contraception in female subjects (for details please refer to protocol section 6.4) 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 investigate the safety and tolerability of IC51 (JE-PIV) compared with an inactive control;Secondary Objective: To analyze the rates of serious adverse events and medically attended adverse events in individuals before and after immunization with IC51 To assess possible changes in laboratory parameters To assess the seroconversion rates and geometric mean antibody titers (GMTs) of subjects with concomitant vaccinations within the time period of 30 days before study entry and up to day 56 (this analysis will be postponed and performed, if deemed meaningful, with regards to the results of study IC51-308, which investigates the safety and immunogenicity of concomitant vaccinations with IC51) ;Primary end point(s): Rate of serious adverse events and medically attended adverse events during the vaccination period until 4 weeks after the last vaccination (day 56) compared with an inactive control. | — |
Countries
Germany, United Kingdom
Outcome results
None listed