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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03700242 | Imovax® Rabies and VERORAB® Immunogenicity and Safety After One Week 2-sites Intradermal or 1-site Intramuscular Pre-Exposure Prophylaxis Regimens, Followed by a Simulated Post-Exposure Prophylaxis Regimen at One Year | PHASE3 | COMPLETED | 570 | — | — | Sep 26, 2018 | Apr 8, 2020 | Apr 25, 2022 | 2 | Philippines |
Rabies virus neutralizing antibodies (RVNA) titer ≥ 0.5 IU/mL
| Arm | Type | Description |
|---|---|---|
| Group 1 | EXPERIMENTAL | 1 IM dose of human diploid cell vaccine (HDCV) on D0 and D7 (short HDCV IM PrEP regimen), followed by 1 IM dose of HDCV on Year (Y)1 and Y1 + 3 days |
| Group 2 | ACTIVE_COMPARATOR | 1 IM dose of HDCV on D0, D7, and D21 (reference), followed by 1 IM dose of HDCV on Y1 and Y1 + 3 days |
| Group 3 | EXPERIMENTAL | 2 intradermal (ID) doses of HDCV on D0 and D7 (short HDCV ID PrEP regimen), followed by 1 ID dose of HDCV on Y1 and Y1 + 3 days |
| Group 4 | EXPERIMENTAL | 1 IM dose of purified Vero cell rabies vaccine (PVRV) on D0 and D7 (short PVRV IM PrEP regimen), followed by 1 IM dose of PVRV on Y1 and Y1 + 3 days |
| Group 5 | EXPERIMENTAL | 2 ID doses of PVRV on D0 and D7 (short PVRV ID PrEP regimen), followed by 1 ID dose of PVRV on Y1 and Y1 + 3 days |
| Name | Type | Description |
|---|---|---|
| HDCV | BIOLOGICAL | Pharmaceutical form:Solution for injection Route of administration: Intramuscular |
| PVRV | BIOLOGICAL | Pharmaceutical form:Solution for injection Route of administration: Intramuscular |
Inclusion criteria : * Aged ≥ 2 years on the day of inclusion * Participant aged \< 18 years: Assent form has been signed and dated by the subject (as appropriate, according to country-specific institution requirements), and informed consent form (ICF) signed and dated by the parent or another lega...