Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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...