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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02177032 | Safety and Immunogenicity of Two Intradermal Rabies Vaccine Regimens Administered With and Without Human Rabies Immunoglobulin in Subjects ≥ 1 Years of Age | PHASE3 | COMPLETED | 885 | — | — | Jun 1, 2014 | Aug 1, 2015 | Apr 7, 2017 | 6 | Philippines, Thailand |
Vaccine group differences are calculated assuming a binomial distribution and the associated confidence interval for the differences in percentage was based on M-N method. Non-inferiority of the immune response of the new "4-sites, 1-week" ID PEP regimen of the PCEC vaccine, with or without HRIG administration, to that of the currently recommended "2-sites, TRC" ID PEP regimen of the PCEC rabies vaccine with or without HRIG administration, as measured by the percentage of subjects with RVNA titer ≥ 0.5 IU/ml at day 50 in the whole study population.
| Arm | Type | Description |
|---|---|---|
| 4-sites, 1-week without HRIG | EXPERIMENTAL | PCEC rabies vaccine, administered ID according to the "4-sites, 1-week" regimen |
| 4-sites, 1-week with HRIG | EXPERIMENTAL | PCEC rabies vaccine, administered ID to adults, according to the "4-sites, 1-week" regimen plus HRIG |
| 2-sites, TRC without HRIG | ACTIVE_COMPARATOR | PCEC rabies vaccine, administered ID according to the "2-sites, TRC" regimen |
| 2-sites, TRC with HRIG | ACTIVE_COMPARATOR | PCEC rabies vaccine, administered ID to adults , according to the "2-sites, TRC" regimen plus HRIG |
| Name | Type | Description |
|---|---|---|
| Rabies vaccine | BIOLOGICAL | 12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) according to the "4-sites, 1-week" regimen (i.e. 4 doses of vaccine; in both deltoids and anterolateral thigh areas, administered on days 1, 4, and 8). |
| Rabies vaccines + Rabies immunoglobulins | BIOLOGICAL | 12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) to adults only, according to the "4-sites, 1-week" regimen (i.e. 4 doses of vaccine; in both deltoids and anterolateral thigh areas, administered on days 1, 4, and 8). HRIG will be administered on day 1 (before the first dose of the vaccine) in a dose of 20 IU/kg body weight intramuscularly into the gluteal muscle. |
Inclusion Criteria: 1. Healthy males and females ≥ 1 years of age 2. Individuals/ individual's parents or legal guardians who have given written consent 3. Individuals in good health 4. Individuals who can comply with study procedures Exclusion Criteria: 1. Behavioral or cognitive impairment or p...