Japanese Encephalitis Clinical Trial
Official title:
Randomised, Double-blind, Phase II Evaluation of the Safety and Immunogenicity Following Administration of Live Attenuated JE Vaccine (ChimeriVax™-JE) and Yellow Fever Vaccine (STAMARIL®)
The purpose of this study is to obtain safety, tolerability, and immunogenicity data on the
co-administration or sequential administration of Chimeravax™-JE vaccine and STAMARIL®.
Objectives:
Safety:
- Obtain safety and tolerability data of a single, fixed dose of ChimeriVax™-JE
administered concurrently, one month before or one month after STAMARIL® to adult
volunteers (≥ 18 to ≤ 55 years) without prior Japanese encephalitis (JE) or yellow
fever (YF) vaccination.
Immunogenicity:
- Obtain data on the antibody response to a single, fixed dose of ChimeriVax™-JE
administered concurrently, one month before or one month after STAMARIL® to adult
volunteers without prior JE (or YF) vaccination.
- Assess the durability of the immune response in adult volunteers 6 months after
administration of ChimeriVax™-JE and STAMARIL®.
All participants will receive two injections, one to each arm on Days 0 and 30, respectively. Immunogenicity will be tested on Days 0, 15, 30, 45, and 60, and at Month 6. ;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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