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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01680016 | A Randomized, Open-label Study Comparing Two Different Rabies Vaccine Schedules in Chinese Children and Older Adults | PHASE3 | COMPLETED | 644 | — | — | Sep 1, 2012 | Jan 1, 2013 | May 20, 2014 | 1 | China |
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...