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