Rabies infection/prophylaxis
Conditions
Brief summary
Proportion of participants that have an adequate immune response (Rapid Fluorescent Focus Inhibition Test (RFFIT) levels ≥ 0.5 IU/mL, WHO standard) on Day 7 after the booster.
Detailed description
Proportion of participants with RFFIT levels ≥ 0.5 IU/mL on Day 14 after the booster., Proportion of participants with RFFIT levels ≥ 0.5 IU/mL on the day of the booster (Day 0)., Proportion of participants with RFFIT levels ≥ 3.0 IU/mL on Day 7 after the booster, Proportion of participants with RFFIT levels ≥ 3.0 IU/mL on Day 14 after the booster., Proportion of participants with RFFIT levels ≥ 10 IU/mL on Day 7 after the booster, Proportion of participants with RFFIT levels ≥ 10 IU/mL on Day 14 after the booster, geometric mean titers (GMTs) at all visits for all arms and the ratio with baseline GMTs per arm, Proportion of participants with swelling, pain, redness, headache, fever, or fatigue per arm., Proportion of participants with unsolicited (i.e., other) Adverse events per arm. Proportion of participants with unsolicited local reactions per arm., Proportion of participants with SAEs per arm throughout the study period after sPEP vaccination session. (EOT)
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of participants that have an adequate immune response (Rapid Fluorescent Focus Inhibition Test (RFFIT) levels ≥ 0.5 IU/mL, WHO standard) on Day 7 after the booster. | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of participants with RFFIT levels ≥ 0.5 IU/mL on Day 14 after the booster., Proportion of participants with RFFIT levels ≥ 0.5 IU/mL on the day of the booster (Day 0)., Proportion of participants with RFFIT levels ≥ 3.0 IU/mL on Day 7 after the booster, Proportion of participants with RFFIT levels ≥ 3.0 IU/mL on Day 14 after the booster., Proportion of participants with RFFIT levels ≥ 10 IU/mL on Day 7 after the booster, Proportion of participants with RFFIT levels ≥ 10 IU/mL on Day 14 after the booster, geometric mean titers (GMTs) at all visits for all arms and the ratio with baseline GMTs per arm, Proportion of participants with swelling, pain, redness, headache, fever, or fatigue per arm., Proportion of participants with unsolicited (i.e., other) Adverse events per arm. Proportion of participants with unsolicited local reactions per arm., Proportion of participants with SAEs per arm throughout the study period after sPEP vaccination session. (EOT) | — |