ENCEPHALITIS, JAPANESE, INACTIVATED, WHOLE VIRUS for Japanese encephalitis (vaccination)

Inclusion criteria

• {"criterion_text":"- 1. Male or female subjects aged 18-64\n- 2. General good health as established by medical history and physical examination\n- 3. Written informed consent\n- 4. Females of childbearing potential must agree to use an efficacious hormonal or barrier method of birth control during the study. Abstinence is acceptable.\n- 5. Available for all visits scheduled in this study.\n- 6. No previous Japanese encephalitis vaccination"}

Exclusion criteria

• {"criterion_text":"- 1. Previous Japanese encephalitis vaccination\n- 2. Chronic administration of immunosuppressants or other immunemodifying drugs within 6 months before the first dose of IMP; oral corticosteroids in dosages of ≥0.5 mg/kg/d prednisolone or equivalent are excluded; inhaled or topical steroids are allowed\n- 3. Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection\n- 4. Pregnancy or lactation\n- 5. Acute disease at the time of enrollment (defined as the presence of a moderate or severe illness with or without fever (fever is defined as body temperature of ≥38 °C).\n- 6. Alcohol or drug abuse\n- 7. Suspected non-compliance\n- 8. Use of any investigational drug or any investigational vaccine within 30 days preceding the study vaccine, or planned use during the study period\n- 9. Any clinically significant history of known or suspected anaphylaxis or hypersensitivity reaction based on the judgement of the investigator\n- 10. Employee at the investigational site, relative or spouse of the investigator\n- 11. Any other criteria which, in the investigator's opinion, would compromise the ability of the subject to participate in the study, the subject's well-being, or the outcome of the study E.5"}

Primary endpoints

• {"endpoint_text":"- Measurement of levels of neutralizing serum antibodies (PRNT)..","definition_or_measurement_approach":"Levels of neutralizing serum antibodies measured by PRNT (plaque reduction neutralization test) as stated in the main objective: 'measured as levels of neutralizing serum antibodies (PRNT)'."}

Secondary endpoints

• {"endpoint_text":"-To study circulating plasmablasts (ELISPOT) and cell-mediated immuneresponses after intradermal vs. intramuscular Ixiaro.\n- To study adverse event profiles","definition_or_measurement_approach":"Circulating plasmablasts measured by ELISPOT and cell-mediated immune responses (ELISPOT described); adverse event profiles assessed by comparison of AE occurrence/profile between intradermal and intramuscular administration (specific AE measurement methods not detailed)."}

Finland

Earliest CTIS Part Ii Submission Date

12-12-2024

Latest Decision Or Authorization Date

10-01-2025

Processing Time Days

29

Number Of Sites

1

Number Of Participants

240

Primary sponsor

Full Name

HUS-Yhtymae

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Finland