Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Japanese encephalitis vaccine Hepatitis A vaccine · 1 trial · 2 indications
12 to 24 months - Injection site: Tenderness, Erythema, and Swelling; Systemic reactions: Fever, Vomiting, Crying Abnormal, Drowsiness, Appetite lost, and Irritability. Grade 3: Tenderness, Cries if limb is moved; Erythema and Swelling, ≥5 cm; Fever, \>39.5˚C; Vomiting, ≥ 6 times/day; Abnormal crying, \>3 hours; Drowsiness, Sleeping often; Appetite lost, Refuses ≥3 feeds/meals; Irritability, Inconsolable. 2 to 5 years - Injection site: Pain, Erythema, and Swelling; Systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia. Grade 3: Pain, Incapacitating; Erythema and Swelling, ≥5 cm; Fever, \>39˚C; Headache, Malaise, and Myalgia, Prevents activities.
12 to 24 months - Injection site: Tenderness, Erythema, and Swelling; Systemic reactions: Fever, Vomiting, Crying Abnormal, Drowsiness, Appetite lost, and Irritability. Grade 3: Tenderness, Cries if limb is moved; Erythema and Swelling, ≥5 cm; Fever, \>39.5˚C; Vomiting, ≥ 6 times/day; Abnormal crying, \>3 hours; Drowsiness, Sleeping often; Appetite lost, Refuses ≥3 feeds/meals; Irritability, Inconsolable. 2 to 5 years - Injection site: Pain, Erythema, and Swelling; Systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia. Grade 3: Pain, Incapacitating; Erythema and Swelling, ≥5 cm; Fever, \>39˚C; Headache, Malaise, and Myalgia, Prevents activities.
| Arm | Type | Description |
|---|---|---|
| JE-CV/Hepatitis A (Group 1) | EXPERIMENTAL | Participants aged 2 to 5 years at enrollment; to receive Japanese encephalitis vaccine (Day 0) and Hepatitis A vaccine (Day 28) |
| Hepatitis A/JE-CV (Group 2) | EXPERIMENTAL | Participants aged 2 to 5 years at enrollment; to receive Hepatitis A vaccine (Day 0) and Japanese encephalitis vaccine (Day 28) |
| JE-CV/Hepatitis A (Group 3) | EXPERIMENTAL | Participants aged 12 to 24 months at enrollment; to receive Japanese encephalitis vaccine (Day 0) and Hepatitis A vaccine (Day 28) |
| Hepatitis A/JE-CV (Group 4) | EXPERIMENTAL | Participants aged 12 to 24 months at enrollment; to receive Hepatitis A vaccine (Day 0) and Japanese encephalitis vaccine (Day 28) |
| Name | Type | Description |
|---|---|---|
| Japanese encephalitis vaccine (Day 0) Hepatitis A vaccine (Day 28) | BIOLOGICAL | ≥4.0 Log10 Plaque forming units (PFU), Subcutaneous (SC; Day 0); 0.5 mL intramuscular (IM; Day 28) |
| Hepatitis A vaccine (Day 0) Japanese encephalitis vaccine (Day 28) | BIOLOGICAL | 0.5 mL IM (Day 0); ≥4.0 Log10 PFU SC (Day 28) |
Inclusion Criteria: * Provision of consent form signed by at least one parent or another legally acceptable representative, and by at least one independent witness. * Completion of vaccinations according to the national immunization schedule * Subject and parent/legally acceptable representative ab...