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Rabies vaccine · 2 trials · 2 indications
Vaccine group differences are calculated assuming a binomial distribution and the associated confidence interval for the differences in percentage was based on M-N method. Non-inferiority of the immune response of the new "4-sites, 1-week" ID PEP regimen of the PCEC vaccine, with or without HRIG administration, to that of the currently recommended "2-sites, TRC" ID PEP regimen of the PCEC rabies vaccine with or without HRIG administration, as measured by the percentage of subjects with RVNA titer ≥ 0.5 IU/ml at day 50 in the whole study population.
| Arm | Type | Description |
|---|---|---|
| 4-sites, 1-week without HRIG | EXPERIMENTAL | PCEC rabies vaccine, administered ID according to the "4-sites, 1-week" regimen |
| 4-sites, 1-week with HRIG | EXPERIMENTAL | PCEC rabies vaccine, administered ID to adults, according to the "4-sites, 1-week" regimen plus HRIG |
| 2-sites, TRC without HRIG | ACTIVE_COMPARATOR | PCEC rabies vaccine, administered ID according to the "2-sites, TRC" regimen |
| 2-sites, TRC with HRIG | ACTIVE_COMPARATOR | PCEC rabies vaccine, administered ID to adults , according to the "2-sites, TRC" regimen plus HRIG |
| Group 1 | ACTIVE_COMPARATOR | - |
| Group 2 | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Rabies vaccine | BIOLOGICAL | 12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) according to the "4-sites, 1-week" regimen (i.e. 4 doses of vaccine; in both deltoids and anterolateral thigh areas, administered on days 1, 4, and 8). |
| Rabies vaccines + Rabies immunoglobulins | BIOLOGICAL | 12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) to adults only, according to the "4-sites, 1-week" regimen (i.e. 4 doses of vaccine; in both deltoids and anterolateral thigh areas, administered on days 1, 4, and 8). HRIG will be administered on day 1 (before the first dose of the vaccine) in a dose of 20 IU/kg body weight intramuscularly into the gluteal muscle. |
Inclusion Criteria: 1. Healthy males and females ≥ 1 years of age 2. Individuals/ individual's parents or legal guardians who have given written consent 3. Individuals in good health 4. Individuals who can comply with study procedures Exclusion Criteria: 1. Behavioral or cognitive impairment or p...
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.