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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02956421 | Efficacy and Safety of a PIKA Rabies Vaccine Containing the PIKA Adjuvant With an Accelerated Regimen | PHASE2 | COMPLETED | 126 | — | — | Feb 1, 2016 | Oct 1, 2016 | Nov 8, 2016 | 2 | Singapore |
| NCT02657161 | Safety and Efficacy of a PIKA Rabies Vaccine Containing the PIKA Adjuvant | PHASE1 | COMPLETED | 37 | — | — | Feb 1, 2015 | Jul 1, 2015 | Jan 15, 2016 | 1 | Singapore |
Evaluation of the accelerated regimen is studied to check if the levels of anti-rabies antibodies (serum RVNA titer) will be better than a classic course with control commercialized vaccine.
Assessment of safety based on the identification of any adverse events for all the treatment groups, Group A, Group B and Group C through to the end of the study at day 42.
To analyze the titer level of RVNA from serum at day 14 and 42 after the first injection and with RVNA titer meeting the 0.5 IU(International units) /ml World Health Organization (WHO) requirement
| Arm | Type | Description |
|---|---|---|
| RABIPUR® | ACTIVE_COMPARATOR | Comparator vaccine RABIPUR® Healthy volunteers received rabies vaccination intramuscularly on days 0,3,7 and 14 |
| PIKA Rabies vaccine | EXPERIMENTAL | PIKA Rabies vaccine with an accelerated regimen Healthy volunteers received rabies vaccination intramuscularly on days 0 (2 Doses), 3 (2 Doses), and day 7 (1 Dose) |
| Group A | ACTIVE_COMPARATOR | Comparator vaccine RABIPUR® Healthy volunteers received rabies vaccination intramuscularly on days 0,3,7 and 14 |
| Group B | EXPERIMENTAL | PIKA Rabies vaccine Healthy volunteers received rabies vaccination intramuscularly on days 0,3,7 and 14 |
| Group C | EXPERIMENTAL | PIKA Rabies vaccine with an accelerated regimen Healthy volunteers received rabies vaccination intramuscularly on days 0 (2 Doses), 3 (2 Doses), and day 7 (1 Dose) |
| Name | Type | Description |
|---|---|---|
| RABIPUR® | BIOLOGICAL | Biological rabies vaccine |
| PIKA rabies vaccine | BIOLOGICAL | Biological rabies vaccine |
| PIKA rabies vaccine with an accelerated regimen | BIOLOGICAL | Biological rabies vaccine |
Inclusion Criteria: * Informed consent form has been signed and dated * Able to attend all scheduled visits and comply with all trial procedures. * Never received rabies vaccine before. * Refrain from blood donation during the course of the study. * Able to attend all scheduled visits and comply wi...