Japanese Encephalitis (JE) MedDRA version: 9.1 Level: PT Classification code 10014596 Term: Encephalitis Japanese B
Conditions
Interventions
Product Name: Japanese Encephalitis Purified Inactivated Vaccine
Product Code: IC51
Pharmaceutical Form: Suspension for injection
Current Sponsor code: IC51-314
Other descriptive name: Japanese Enceph
Sponsors
Intercell AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Male and female healthy adults -Aged at least 18 years -With written informed consent obtained prior to study entry (subjects could give their consent themselves) -In female subjects, either no childbearing potential or negative serum pregnancy test and the willingness not to become pregnant during the entire study period by practicing reliable methods of contraception or childbearing potential terminated by surgery or 1 year post-menopausal 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 -Use of any other investigational or non-registered drug (except the study vaccine) within 30 days prior to IC51 vaccination and during the study period -Vaccination against JE (including study participation in any previous or current IC51 clinical study), Yellow fever, Dengue fever or West Nile virus at any time prior or during the study -Administration of a vaccine against tick-borne encephalitis (TBE) between IC51 vaccination at Visit (Day 0) and Visit 3 (Day 56) -History of immunodeficiency or immunesuppressive therapy -Infection with HIV (a negative test result within 30 days before screening is acceptable), HBV (Hepatitis B surface antigen [HBsAg]) or HCV -Acute infections or exacerbation of chronic infection within 4 weeks prior to IC51 vaccination at Visit 1 requiring specific treatment -Drug addiction within 6 months prior to Visit 0 (including alcohol dependence) -Pregnancy (positive pregnancy test during screening or at Visit 1), lactation or unreliable contraception in female subjects with child-bearing potential -History of severe hypersensitivity reactions, in particular to a component of the IC51 vaccine
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: -To assess immunogenicity of a commercial IC51 batch at 3 different time points post filling (12, 18, 24 months) in terms of Geometric Mean Titers (GMT) for anti-JEV neutralizing antibody at Day 56 after the first vaccination.;Secondary Objective: -To assess the seroconversion rate (SCR) of a commercial IC51 batch at 3 different time points post filling (12, 18, 24 months) at Day 56 after the first vaccination -To assess GMTs for anti-JEV neutralizing antibody and SCRs of a commercial IC51 batch at 3 different time points post filling (12, 18, 24 months) at Day 28, Month 6 and Month 12 after the first vaccination -To investigate the safety of a commercial IC51 batch at 3 different time points post filling (12, 18, 24 months) in terms of percentage of treatment emergent AEs (including serious and medically attended adverse events) as well as possible changes in laboratory parameters -To investigate local and systemic tolerability of a commercial IC51 batch at 3 different time points post filling (12, 18, 24 months);Primary end point(s): -Geometric Mean Titers (GMT) for anti-JEV neutralizing antibody at Day 56 after the first vaccination with batch IC51/07F/008A | — |
Countries
Austria, Germany
Outcome results
None listed