Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Three doses of Rabies vaccine and two JE vaccine · 1 trial · 3 indications
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | - |
| 2 | EXPERIMENTAL | - |
| 3 | EXPERIMENTAL | - |
| 4 | EXPERIMENTAL | - |
| 5 | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Three 1 mL doses of Rabies vaccine and two JE vaccine | BIOLOGICAL | Vaccination with purified chick embryo cell rabies vaccine 1.0 mL intramuscularly on Day 0, Day 7 and Day 28 (a total of 3 doses) and Beijing 1 strain of inactivated, lyophilized Japanese Encephalitis vaccine 0.25 mL subcutaneously on Day 0 and Day 7 (a total of 2 doses) |
| Three 0.5 mL doses of Rabies vaccine and two JE vaccine | BIOLOGICAL | Vaccination with purified chick embryo cell rabies vaccine 0.5 mL intramuscularly on Day 0, Day 7 and Day 28 (a total of 3 doses) and Beijing 1 strain of inactivated, lyophilized Japanese Encephalitis vaccine 0.25 mL subcutaneously on Day 0 and Day 7 (a total of 2 doses) |
| Three 0.1mL doses of Rabies Vaccine and two JE vaccine | BIOLOGICAL | Vaccination with purified chick embryo cell rabies vaccine 0.1 mL intradermally at one site on Day 0, Day 7 and Day 28 (a total of 3 doses) and Beijing 1 strain of inactivated, lyophilized Japanese Encephalitis vaccine 0.25 mL subcutaneously on Day 0 and Day 7 (a total of 2 doses) |
| Two 0.1mL doses of Rabies vaccine and two JE vaccine | BIOLOGICAL | Vaccination with purified chick embryo cell rabies vaccine 0.1 mL intradermally at one site on Day 0 and Day 28 (a total of 2 doses) and Beijing 1 strain of inactivated, lyophilized Japanese Encephalitis vaccine 0.25 mL subcutaneously on Day 0 and Day 7 (a total of 2 doses) |
| Two doses of JE vaccine | BIOLOGICAL | Vaccination with Beijing 1 strain of inactivated, lyophilized Japanese Encephalitis vaccine 0.25 mL only subcutaneously on Day 0 and Day 7 (a total of 2 doses) |
Inclusion Criteria: * Male and female 12-18 months old toddlers if they * are in good health at time of entry into the study * are available for all the visits scheduled in the study * have been granted a written informed consent, signed by their parents Exclusion Criteria: * a history of rabies ...
It is a Phase 2 study regimen combining three 1 mL doses of a rabies vaccine with two doses of a Japanese encephalitis vaccine. The combination was evaluated for immunogenicity, safety, and booster response in toddlers, with the aim of protecting against rabies and Japanese encephalitis at the same time.
The regimen is used for pre-exposure prophylaxis against rabies and Japanese encephalitis. It combines three 1 mL doses of rabies vaccine with two doses of JE vaccine, given to toddlers to build immune protection against both diseases before potential exposure.
Novartis AG, which trades under the ticker NVS, is the developer of the three-dose rabies vaccine and two-dose JE vaccine regimen. The company sponsored the Phase 2 study evaluating the combination in toddlers.
The regimen is in Phase 2 development. It is investigational and has not been approved. One Phase 2 trial has been completed, and no trials are currently active. The completed study enrolled 200 participants and was randomized, active-controlled, and conducted in Thailand.
The regimen was studied in NCT00694460, titled Evaluation of Immunogenicity, Safety and Booster Response of a Rabies Vaccine Administered Concomitantly With Japanese Encephalitis Vaccine in Toddlers. The Phase 2 trial enrolled 200 healthy toddlers aged 12 months and older in Thailand and has been completed.