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JE-CV Vaccine · 1 trial · 2 indications
The presence of JE virus neutralizing antibodies was measured using a 50% plaque reduction neutralization test (PRNT50). Seroprotection status for antibody levels against JE virus before (on Day 0) and after JE-CV vaccination (Day 7 and Day 28) was defined as neutralizing antibody titer ≥ 10 (1/dilution).
The presence of JE virus neutralizing antibodies was measured using a PRNT50 assay. Seroconversion was defined as participants with a pre-vaccination titer \<10 (1/dilution) and post-vaccination titer ≥10 (1/dilution, or participants with pre vaccination titer ≥10 (1/dilution) and a ≥4-fold increase from pre- to post-vaccination.
The presence of JE virus neutralizing antibodies was measured using a PRNT50 assay.
The presence of JE virus neutralizing antibodies was measured using a PRNT50 assay.
The presence of JE virus neutralizing antibodies was measured using a PRNT50 assay. Flavivirus positive was defined as titers against JE virus ≥10 (1/dilution) or titers against at least 1 dengue serotype ≥10 (1/dilution). Flavivirus negative was defined as titers against JE virus \<10 (1/dilution) and titers against the 4 dengue serotypes \<10 (1/dilution).
The presence of JE virus neutralizing antibodies was measured using a PRNT50 assay. Seroprotection status for antibody levels against JE virus before (on Day 0) and after JE-CV vaccination (Days 7 and 28 and Years 1, 2, 3, 4, and 5) was defined as neutralizing antibody titer ≥ 10 (1/dilution).
The presence of JE virus neutralizing antibodies was measured using a PRNT50 assay.
The presence of JE virus neutralizing antibodies was measured using a PRNT50 assay.
Injection-site reactions: Pain, Erythema, and Swelling. Systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia. Grade 3 Injection-site reactions: Pain, Incapacitating, unable to perform usual activities. Erythema and Swelling, ≥5 cm. Grade 3 Systemic reactions: Fever, 39.0°C; Headache, Malaise, and Myalgia, Significant; prevents daily activities.
| Arm | Type | Description |
|---|---|---|
| Group 1: JE-CV Vaccine Booster | EXPERIMENTAL | Participants previously vaccinated with JE-CV vaccine will receive a booster dose of JE-CV vaccine on Day 0. |
| Group 2: JE-CV Vaccine First Dose | EXPERIMENTAL | JE-CV vaccine naïve participants will receive a single dose of JE-CV vaccine on Day 0. |
| Group 3: Varicella Vaccine | ACTIVE_COMPARATOR | JE-CV vaccine naïve participants will receive one dose of Varicella vaccine on Day 0. |
| Name | Type | Description |
|---|---|---|
| JE-CV Vaccine | BIOLOGICAL | 0.5 mL (single dose), Subcutaneous |
| Varicella Vaccine | BIOLOGICAL | 0.5 mL (single dose), Subcutaneous |
An individual had to fulfill all of the following criteria in order to be eligible for trial enrollment: All Participants * Aged 36 to 42 months on the day of inclusion * Provision of Informed Consent Form signed by at least one parent or other legally acceptable representative * Participant and p...
JE-CV Vaccine is used for Japanese Encephalitis, a viral infection that causes brain inflammation. It is being studied in children who were previously immunized with JE-CV, as part of a Phase 3 clinical trial. The vaccine is designed to provide protection against this serious disease.
JE-CV Vaccine targets the Japanese Encephalitis virus. It is a chimeric virus vaccine, meaning it uses a related virus backbone to express Japanese Encephalitis virus proteins, stimulating the immune system to produce a protective response against the virus.
JE-CV Vaccine is developed by Sanofi, a global biopharmaceutical company. Sanofi is conducting clinical trials to evaluate the vaccine's safety and efficacy in preventing Japanese Encephalitis in children.
JE-CV Vaccine 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 is completed and involved 454 participants in the Philippines.
JE-CV Vaccine has one completed Phase 3 clinical trial, NCT01190228, which studied the vaccine in children previously immunized with JE-CV. The trial was conducted in the Philippines and enrolled 454 healthy children aged 36 months and older.
JE-CV Vaccine is a specific chimeric virus vaccine developed by Sanofi. It is distinct from other Japanese Encephalitis vaccines, which may use inactivated or live-attenuated virus platforms. JE-CV is designed to provide immunity through a different mechanism.