Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Abbreviated Zagreb 2-1-1 schedule · 1 trial · 1 indication
Rabies virus neutralizing antibody concentrations of the abbreviated Zagreb regimen compared with the conventional Essen regimen. Results are presented on log2 scale. For results on original geometric (multiplicative) scale please raise numbers to the basis of 2.
Specified local and systemic reactions were solicited for 7 days after each vaccination. Number of participants were calculated who reported a local or systemic reaction after any of the vaccinations.
| Arm | Type | Description |
|---|---|---|
| Zagreb (2-1-1) | EXPERIMENTAL | Rabies PCEC vaccine was applied according Zagreb schedule with 2 vaccinations on day 0, 1 vaccination on day 7 and day 21, respectively |
| Essen (1-1-1-1-1) | ACTIVE_COMPARATOR | Rabies PCEC vaccine was applied according Essen schedule, i.e. 1 vaccination on day 0, day 3, day 7, day 14 and day 28, respectively. |
| Name | Type | Description |
|---|---|---|
| Abbreviated Zagreb 2-1-1 schedule | BIOLOGICAL | Subjects received the abbreviated Zagreb 2-1-1 schedule in a safety-lead-in phase. |
| Standard Essen 1-1-1-1-1 schedule | BIOLOGICAL | Subjects received the standard Essen regimen. |
Inclusion Criteria: * Male and female subjects 18-50 years of age who: * are in good health at the time of entry into the study as determined by medical history, physical examination and clinical judgment of the investigator; * volunteer for the simulated post-exposure vaccination courses and blood...
Abbreviated Zagreb 2-1-1 is an investigational monoclonal antibody being studied for rabies prophylaxis. It is administered as a purified chick embryo cell vaccine in an abbreviated schedule, compared to a conventional schedule, to assess safety and immunogenicity. It is not approved and remains in clinical development.
Abbreviated Zagreb 2-1-1 is developed by Novartis AG, traded on the New York Stock Exchange under the ticker NVS. The company is conducting clinical trials to evaluate the vaccine's safety and immunogenicity for rabies prevention.
Abbreviated Zagreb 2-1-1 is in Phase 3 clinical development. It is an investigational vaccine for rabies and has not been approved by regulatory authorities. One Phase 3 trial has been completed, with no active trials currently ongoing.
Abbreviated Zagreb 2-1-1 was studied in a completed Phase 3 trial, NCT00825305, which enrolled 825 healthy volunteers in China. The trial compared the safety and immunogenicity of the vaccine in a conventional versus an abbreviated schedule for rabies.
Abbreviated Zagreb 2-1-1 is a purified chick embryo cell vaccine administered in an abbreviated 2-1-1 schedule, whereas a conventional schedule involves a different dosing regimen. The Phase 3 trial was designed to test non-inferiority of the abbreviated schedule compared to the conventional one.