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JE-CV administered in Study JEC02 · 1 trial · 2 indications
Seroprotection was defined as the proportion of participants with Japanese encephalitis virus neutralizing antibody titers ≥10 1/dil as measured by a JE 50% plaque reduction neutralization test (PRNT50).
Geometric mean titers of Japanese encephalitis virus antibodies were assessed using the PRNT50 test.
| Arm | Type | Description |
|---|---|---|
| Study group | EXPERIMENTAL | Participants received a single dose of JE-CV administered in Study JEC02. In Study JEC05 there were yearly visits with blood samples taken for immunogenicity assessment. |
| Name | Type | Description |
|---|---|---|
| Blood sample | OTHER | Blood sample for immunogenicity assessment |
| JE-CV administered in Study JEC02 | BIOLOGICAL | Participants received a single dose of JE-CV at 12 to 18 months of age in Study JEC02. No vaccination was administered in Study JEC05 |
Inclusion Criteria : * Provision of Informed Consent Form signed by at least one parent or other legally acceptable representative, and by at least one independent witness if required by local regulations. * Participant who was vaccinated with JE-CV in JEC02 trial and had a pre-vaccination blood sa...
JE-CV administered in Study JEC02 is an investigational monoclonal antibody developed by Sanofi for encephalitis. It was evaluated in a Phase 3 study that enrolled 596 participants. The trial, conducted in the Philippines and Thailand, was a long-term follow-up of immunogenicity following a single dose of Japanese encephalitis chimeric virus vaccine in toddlers.
JE-CV administered in Study JEC02 is being studied for encephalitis, specifically Japanese encephalitis. The Phase 3 trial enrolled 596 healthy toddlers aged 2 years and older in the Philippines and Thailand. It evaluated long-term immunogenicity after a single dose of Japanese encephalitis chimeric virus vaccine.
JE-CV administered in Study JEC02 is developed by Sanofi, which trades under the ticker SNY. Sanofi is the sponsor behind the Phase 3 clinical program evaluating this monoclonal antibody for encephalitis.
JE-CV administered in Study JEC02 is in Phase 3 clinical development. The program includes one completed Phase 3 trial, NCT01001988, which enrolled 596 participants. It is an investigational agent and is not described as approved.
JE-CV administered in Study JEC02 was evaluated in one Phase 3 trial, NCT01001988, titled Long-term Follow-up of Immunogenicity of a Single Dose of Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) in Toddlers. The trial is completed, enrolled 596 participants, and was conducted in the Philippines and Thailand.