Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
IMOJEV · 1 trial · 1 indication
JE virus neutralizing antibodies were measured using a 50% plaque reduction neutralization test (PRNT50). Seroprotection status for antibody levels against JE virus before and after IMOJEV vaccination was defined as antibody titers ≥ 10 (1/dilution).
JE virus neutralizing antibodies were measured using PRNT50. Seroconversion was defined as a pre-vaccination titer \<10 (1/dilution) and post-vaccination titer ≥10 (1/dilution, or pre-vaccination titer ≥10 (1/dilution) and a ≥4-fold increase of titers from pre- to post-vaccination.
JE virus neutralizing antibodies were measured using PRNT50 test.
JE virus neutralizing antibodies were measured using PRNT50.
JE virus neutralizing antibodies were measured using PRNT50. Seroprotection was defined as neutralizing antibody titer ≥ 10 (1/dilution).
JE virus neutralizing antibodies were measured using PRNT50. Seroconversion was defined as a pre-vaccination titer \<10 (1/dilution) and post-vaccination titer ≥10 (1/dilution, or pre-vaccination titer ≥10 (1/dilution) and a ≥4 fold increase from pre- to post-vaccination.
JE virus neutralizing antibodies were measured using PRNT50.
JE virus neutralizing antibodies were measured using PRNT50.
| Arm | Type | Description |
|---|---|---|
| IMOJEV Group | EXPERIMENTAL | Participants who received a single dose of IMOJEV in study JEC12 (NCT01396512) will receive a booster dose in this study. |
| Name | Type | Description |
|---|---|---|
| IMOJEV | BIOLOGICAL | 0.5 mL, Subcutaneous |
Inclusion Criteria: * Must have participated in study JEC12 and received 1 dose of IMOJEV at least 12 months before booster vaccination * Age 2 to 4 years on the day of inclusion * In good general health at the time of inclusion * Informed Concent Form signed and dated by parent(s) or another legal...
IMOJEV is a vaccine used for Japanese Encephalitis, a viral infection of the brain spread by mosquitoes. It is being developed by Sanofi and is currently in Phase 3 clinical development. The drug is intended for use in healthy children, as studied in a clinical trial in South Korea.
IMOJEV is being developed by Sanofi, a global biopharmaceutical company listed on the stock exchange under the ticker SNY. The company is conducting clinical trials to evaluate the vaccine for the prevention of Japanese Encephalitis.
IMOJEV is in Phase 3 clinical development. It is an investigational vaccine, meaning it has not yet been approved by regulatory authorities. The Phase 3 trial has been completed, and the vaccine is being studied for use in Japanese Encephalitis.
IMOJEV has one completed Phase 3 clinical trial with the identifier NCT01900444. The trial, titled 'Study of a Booster Dose of IMOJEV® One Year After Primary Immunization in Healthy Children in South Korea,' enrolled 119 participants and was conducted in South Korea.
Yes, IMOJEV is classified as a monoclonal antibody. It is being developed as a vaccine for Japanese Encephalitis, a mosquito-borne viral infection. The drug is currently in Phase 3 clinical trials and is intended for use in healthy children.