Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00825305 | Safety and Immunogenicity (Non-inferiority) of a Purified Chick Embryo Cell Vaccine Vaccine Administered in Two Different Schedules (Conventional Versus Abbreviated Schedule) | PHASE3 | COMPLETED | 825 | — | — | Nov 1, 2008 | Jan 1, 2009 | Dec 13, 2011 | 1 | China |
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...