Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Rabies · 1 trial · 2 indications
Immune response was measured as the percentage of subjects with rabies virus neutralizing antibody (RVNA) concentrations ≥0.5 IU/mL, evaluated using the rapid fluorescent focus inhibition test at day 7 after last active vaccination, i.e. the third out of four vaccinations given in the accelerated Rabies vaccine schedule and the fourth out of four vaccinations given in the conventional Rabies vaccine schedule. As per study design, this primary immunogenicity outcome measure aimed to demonstrate non-inferiority of R/JE - Acc Vs R - Conv.
Immune response was measured as the percentages of subjects with a titer of ≥1:10 in a 50% plaque reduction neutralization test (PRNT50) 28 days after last active vaccination, ie, the second out of three vaccinations given in the accelerated JE vaccine schedule and the third out of three vaccinations given in the conventional JE vaccine schedule. As per study design, this primary immunogenicity outcome measure aimed to demonstrate non-inferiority of R/JE - Acc Vs JE - Conv.
| Arm | Type | Description |
|---|---|---|
| R/JE - Conv | ACTIVE_COMPARATOR | Subjects received Rabies and Japanese Encephalitis (JE) vaccines following the conventional schedule, ie, Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg; and JE vaccination on day 1 and 29, and placebo on day 8 in the left arm. |
| R/JE - Acc | EXPERIMENTAL | Subjects received Rabies and JE vaccines following the accelerated schedule, ie, Rabies vaccination on days 1, 4, and 8, and placebo on day 29 in the right arm or leg; and JE vaccination on days 1 and 8, and placebo on day 29 in the left arm. |
| R - Conv | ACTIVE_COMPARATOR | Subjects received Rabies vaccine following the conventional schedule, ie, Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg; and placebo on days 1, 8 and 29 in the left arm. |
| JE - Conv | ACTIVE_COMPARATOR | Subjects received JE vaccine following the conventional schedule, ie, placebo on days 1, 4, 8 and 29 in the right arm or leg; and JE vaccination on days 1 and 29 and placebo injection on day 8 in the left arm. |
| Name | Type | Description |
|---|---|---|
| Rabies | BIOLOGICAL | Subjects received three doses of Rabies, whole virus vaccine (inactivated, Germany). |
| Japanese Encephalitis | BIOLOGICAL | Subjects received two doses of Japanese Encephalitis vaccine. |
| Placebo | OTHER | Subjects received either two, three, four or five doses of normal saline, 0.9% w/v sodium chloride depending on the vaccine group. |
Inclusion Criteria: 1. Males and females between 18 and 65 years of age (inclusive). 2. Subjects who have given written consent. 3. Individuals in good health as per investigator judgement. Exclusion Criteria: 1. If female, pregnancy or unwillingness to practice acceptable contraception. 2. If fe...
Rabies is a monoclonal antibody developed by Novartis AG for the prevention and treatment of rabies infection, including post-exposure prophylaxis. It is currently in Phase 3 clinical development for rabies post-exposure prophylaxis, rabies infection, and rabies. The drug is being studied in healthy volunteers and patients.
Rabies is used for post-exposure prophylaxis and treatment of rabies infection. It is being investigated in Phase 3 clinical trials for rabies post-exposure prophylaxis, rabies infection, and rabies. The drug is intended to prevent the onset of rabies after exposure and to treat active infection.
Rabies targets the rabies virus. As a monoclonal antibody, it is designed to neutralize the rabies virus, preventing it from infecting cells and spreading. This mechanism is being evaluated in clinical trials for post-exposure prophylaxis and treatment of rabies infection.
Rabies is developed by Novartis AG, a multinational pharmaceutical company. Novartis is conducting Phase 3 clinical trials to evaluate the safety and immunogenicity of Rabies in various populations, including healthy adults and children, for the prevention and treatment of rabies.
Rabies is in Phase 3 clinical development. It is not yet approved by regulatory authorities and remains investigational. The drug is being studied in completed Phase 3 trials for rabies post-exposure prophylaxis and rabies infection, with a total enrollment of 885 participants across multiple studies.
Rabies has been studied in three Phase 3 clinical trials: NCT00345319, NCT01662440, and NCT02177032. These trials evaluated the safety and immunogenicity of rabies vaccines and regimens in healthy volunteers and patients with rabies infection, across countries including China, Austria, Germany, Switzerland, Philippines, and Thailand.