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...
It is a study regimen that combines a Japanese encephalitis vaccine given on Day 0 with a hepatitis A vaccine given on Day 28. Sanofi developed this sequential vaccination approach, which was evaluated in a Phase 2 clinical trial in Thai toddlers and children.
The regimen is being studied for protection against Japanese encephalitis and hepatitis A. The Phase 2 trial enrolled healthy toddlers and children in Thailand, with the Japanese encephalitis vaccine dose administered on Day 0 and the hepatitis A vaccine dose on Day 28.
Sanofi, which trades under the ticker SNY, is the developer of this combined Japanese encephalitis and hepatitis A vaccine regimen. The company sponsored the Phase 2 study conducted in Thailand.
The regimen is in Phase 2 development. Its only listed trial, NCT00621764, has been completed, and no trials are currently active. It is an investigational vaccine candidate and is not described as approved.
One trial has evaluated the regimen: NCT00621764, titled Immunogenicity and Safety of ChimeriVax Japanese Encephalitis Vaccine in Thai Toddlers and Children. The Phase 2 study was completed, enrolled 300 participants aged 12 months and older in Thailand, and used a controlled, randomized design.
Yes. The regimen is also referred to as Japanese encephalitis vaccine (Day 0) and hepatitis A vaccine (Day 28), reflecting the dosing schedule. The Japanese encephalitis vaccine is given first, followed by the hepatitis A vaccine four weeks later.