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Also known as IMOJEV™
Live attenuated Japanese encephalitis chimeric virus vaccine · 2 trials · 2 indications
Solicited injection-site: ≤ 23 months age: Tenderness, Erythema, and Swelling. For ≥ 2 years age: Pain, Erythema, and Swelling. Solicited systemic reactions: ≤ 23 months age, Fever (temperature) Vomiting, Crying abnormal, Drowsiness, Appetite loss, Irritability, For ≥ 2 years age, Fever (temperature) Headache, Malaise, and Myalgia. Grade 3: Tenderness, Cries when injected limb is moved; Pain, Incapacitating, unable to perform usual activities or Significant; prevents daily activity (≥ 12 years); Erythema and Swelling (≤23 months to 11 years), ≥50 mm or \>100 mm (≥ 12 years). Grade 3 Fever, \> 39.5°C (≤ 23 months) or ≥39.0°C (≥ 2 years); Vomiting, ≥ 6 episodes per 24 hours; Crying abnormal, \> 3 hours; Drowsiness, Sleeping most of the time; Appetite loss, Refuses ≥ 3 feeds / meals; Irritability, Inconsolable. Headache, Malaise, and Myalgia, Significant; prevents daily activity.
Neutralizing antibodies were measured using a Japanese encephalitis chimeric virus (JE CV) 50% plaque reduction neutralization test (PRNT50). Seroprotection was defined as antibody titer levels ≥10 (1/dil).
Neutralizing antibodies were measured using a Japanese encephalitis chimeric virus (JE CV) 50% plaque reduction neutralization test (PRNT50). Seroconversion was defined as participants with a pre-vaccination titer \<10 (1/dil) and post-vaccination titer ≥10 (1/dil) or participants with pre vaccination titer ≥10 (1/dil) and a ≥4-fold increase from pre- to post-vaccination.
Neutralizing antibodies were measured using a Japanese encephalitis chimeric virus (JE CV) 50% plaque reduction neutralization test (PRNT50).
Immunogenicity assessed using a Japanese encephalitis chimeric virus (JE-CV) 50% Plaque Reduction Neutralization Test (PRNT50). Seroconversion was defined as the percentage of participants who developed neutralizing antibody titers above 10 (1/dil) when seronegative at baseline (\<1/10) or who presented a ≥4-fold rise in their neutralizing antibody titers when seropositive (≥1/10) at baseline.
| Arm | Type | Description |
|---|---|---|
| Age 9 Months through 4 Years Group | EXPERIMENTAL | Participants age 9 Months through 4 Years old at enrollment |
| Age 5 Years through 11 Years Group | EXPERIMENTAL | Participants age 5 Years through 11 Years old at enrollment |
| Age 12 Years through 17 Years Group | EXPERIMENTAL | Participants age 12 Years through 17 Years old at enrollment |
| Age 18 Years through 60 Years Group | EXPERIMENTAL | Participants age 18 Years through 60 Years old at enrollment |
| IMOJEV™ Vaccine Group | EXPERIMENTAL | Participants will receive a single dose of the Live attenuated Japanese encephalitis chimeric virus vaccine (IMOJEV™) on Day 0. |
| CD.JEVAX ™ Vaccine Group | ACTIVE_COMPARATOR | Participants will receive a single dose of the Japanese encephalitis live attenuated vaccine (SA14 14 2 vaccine), CD.JEVAX™ on Day 0 |
| Name | Type | Description |
|---|---|---|
| Live attenuated Japanese encephalitis chimeric virus vaccine (IMOJEV®) | BIOLOGICAL | 0.5 mL, Subcutaneous |
| Live attenuated Japanese encephalitis chimeric virus vaccine | BIOLOGICAL | 0.5 mL, Subcutaneous |
| Japanese encephalitis live attenuated vaccine (SA14 14 2 vaccine) | BIOLOGICAL | 0.5 mL, Subcutaneous |
Inclusion Criteria: * Aged 9 months through 60 years on the day of inclusion. * For adults: Informed consent form has been signed and dated by the subject. For minors: Informed consent form has been signed and dated by the parent or legally acceptable representative. In addition, in accordance with...
It is used to prevent Japanese encephalitis, a viral disease of the brain spread by mosquitoes. The vaccine is given to healthy people, including young children, to protect them against Japanese encephalitis virus infection. It is a single primary dose vaccine developed by Sanofi.
Sanofi develops and makes the live attenuated Japanese encephalitis chimeric virus vaccine, which is marketed under the brand name IMOJEV. Sanofi trades on the New York Stock Exchange under the ticker SNY. The vaccine is a chimeric virus vaccine designed to protect against Japanese encephalitis.
Yes. IMOJEV is the brand name for the live attenuated Japanese encephalitis chimeric virus vaccine. People searching for IMOJEV, IMOJEV vaccine, or the Sanofi Japanese encephalitis vaccine are looking at the same product. It is also written as IMOJEV with a registered trademark symbol.
The vaccine has been studied in Phase 3 clinical development. Two Phase 3 trials have been completed, and no trials are currently active. It is an investigational-stage asset in the clinical development record, with completed studies in healthy volunteers and toddlers.
Two completed Phase 3 trials are registered. NCT02492165 studied a single primary dose in 250 healthy subjects in Vietnam, including children from 9 months of age. NCT01396512 compared the vaccine with CD.JEVAX in 274 toddlers in South Korea from 12 months of age. Both were randomized, double-blind, and controlled.
The two completed Phase 3 trials enrolled a total of 524 participants. NCT02492165 enrolled 250 healthy subjects in Vietnam, and NCT01396512 enrolled 274 toddlers in South Korea. Both studies were randomized, double-blind, and controlled, and both included male and female participants.