Safety and Tolerability of the Japanese Encephalitis Vaccine IC51. Double Blind, Randomized, Placebo Controlled Phase 3 Study

IC51-302

The objective is to investigate the safety and tolerability of Japanese Encephalitis vaccine IC51 with an inactive control in healthy subjects aged \> or = 18 years

2005-10-01

2006-11-01

Completed

Early phase I

2675

Inclusion Criteria: * At least 18 years of age * Written informed consent obtained prior to study entry Exclusion Criteria: * 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 * History of any previous JE vaccination (e.g. JE-VAX®) * Immunodeficiency including post-organ-transplantation or immunosuppressive therapy * A family history of congenital or hereditary immunodeficiency * History of autoimmune disease * Any acute infections within 2 weeks prior to enrollment * Known or suspected HIV Infection * Pregnancy, lactation or unreliable contraception in female subjects

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 2675, 'type': 'ACTUAL'}}

2024-03-21