Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Zagreb · 1 trial · 1 indication
Immunogenicity was measured as the geometric mean concentrations (GMCs) of rabies virus neutralizing antibody (RVNA) titer , evaluated using the rapid fluorescent focus inhibition test, before vaccination and 14 days after first vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule.
Immunogenicity was measured as the GMCs of Rabies Virus Neutralizing Antibody (RVNA) titer , evaluated using the rapid fluorescent focus inhibition test, before vaccination and 14 days after first vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule.
Safety was assessed as the number of children who reported solicited local and systemic adverse events from day 1 up to and including day 7 after any vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule.
Safety was assessed as the number of subjects who reported solicited local and systemic adverse events from day 1 up to and including day 7 after any vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule.
The safety of Rabipur was assessed in terms of subjects(Children) exposed to study vaccine who reported all Unsolicited AEs (including serious adverse events \[SAE\]s and AEs leading to subject withdrawal) from V1/day 1 (postvaccination) through V7/study termination day 43.
The safety of Rabipur was assessed in terms of subjects(Older Adults) exposed to study vaccine who reported all Unsolicited AEs (including serious adverse events \[SAE\]s and AEs leading to subject withdrawal) from V1/day 1 (postvaccination) through V7/study termination day 43.
| Arm | Type | Description |
|---|---|---|
| Zagreb(≥6 to ≤17 Years) | EXPERIMENTAL | - |
| Zagreb(≥51 Years) | EXPERIMENTAL | - |
| Essen(≥6 to ≤17 Years) | ACTIVE_COMPARATOR | - |
| Essen(≥51 Years) | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Zagreb | BIOLOGICAL | Subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22 |
| Essen | BIOLOGICAL | Subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29 |
Inclusion Criteria: * Individuals between 6-17 years of age and 51 years of age or older * Individuals who were in good health * Provided consent, complied with study procedures and duration of follow-up Exclusion Criteria: * Contraindications to vaccination with rabies vaccine * Body temperature...
Zagreb is a monoclonal antibody being developed for rabies, an infectious disease. It is currently in Phase 3 clinical development and is being studied for use in rabies prevention and treatment.
Zagreb is being developed by Novartis AG, a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVS.
Zagreb is in Phase 3 clinical development. It has completed one Phase 3 trial, and it remains an investigational drug that has not yet been approved for commercial use.
Zagreb has been studied in a Phase 3 clinical trial with the identifier NCT01680016. This trial was a randomized, open-label study that compared two different rabies vaccine schedules in Chinese children and older adults, enrolling 644 participants.
Zagreb is the name of the drug being developed by Novartis AG for rabies. No alternative names for this drug have been disclosed in the available clinical trial information.