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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01662440 | Safety and Immunogenicity of 2 Different Vaccination Schedules of Rabies and Japanese Encephalitis Vaccines in Healthy Adult Subjects | PHASE3 | COMPLETED | 661 | — | — | Aug 1, 2012 | Oct 1, 2013 | Dec 8, 2014 | 3 | Austria, Germany +1 |
Immune response was measured as the percentage of subjects with rabies virus neutralizing antibody (RVNA) concentrations ≥0.5 IU/mL, evaluated using the rapid fluorescent focus inhibition test at day 7 after last active vaccination, i.e. the third out of four vaccinations given in the accelerated Rabies vaccine schedule and the fourth out of four vaccinations given in the conventional Rabies vaccine schedule. As per study design, this primary immunogenicity outcome measure aimed to demonstrate non-inferiority of R/JE - Acc Vs R - Conv.
Immune response was measured as the percentages of subjects with a titer of ≥1:10 in a 50% plaque reduction neutralization test (PRNT50) 28 days after last active vaccination, ie, the second out of three vaccinations given in the accelerated JE vaccine schedule and the third out of three vaccinations given in the conventional JE vaccine schedule. As per study design, this primary immunogenicity outcome measure aimed to demonstrate non-inferiority of R/JE - Acc Vs JE - Conv.
| Arm | Type | Description |
|---|---|---|
| R/JE - Conv | ACTIVE_COMPARATOR | Subjects received Rabies and Japanese Encephalitis (JE) vaccines following the conventional schedule, ie, Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg; and JE vaccination on day 1 and 29, and placebo on day 8 in the left arm. |
| R/JE - Acc | EXPERIMENTAL | Subjects received Rabies and JE vaccines following the accelerated schedule, ie, Rabies vaccination on days 1, 4, and 8, and placebo on day 29 in the right arm or leg; and JE vaccination on days 1 and 8, and placebo on day 29 in the left arm. |
| R - Conv | ACTIVE_COMPARATOR | Subjects received Rabies vaccine following the conventional schedule, ie, Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg; and placebo on days 1, 8 and 29 in the left arm. |
| JE - Conv | ACTIVE_COMPARATOR | Subjects received JE vaccine following the conventional schedule, ie, placebo on days 1, 4, 8 and 29 in the right arm or leg; and JE vaccination on days 1 and 29 and placebo injection on day 8 in the left arm. |
| Name | Type | Description |
|---|---|---|
| Rabies | BIOLOGICAL | Subjects received three doses of Rabies, whole virus vaccine (inactivated, Germany). |
| Japanese Encephalitis | BIOLOGICAL | Subjects received two doses of Japanese Encephalitis vaccine. |
| Placebo | OTHER | Subjects received either two, three, four or five doses of normal saline, 0.9% w/v sodium chloride depending on the vaccine group. |
Inclusion Criteria: 1. Males and females between 18 and 65 years of age (inclusive). 2. Subjects who have given written consent. 3. Individuals in good health as per investigator judgement. Exclusion Criteria: 1. If female, pregnancy or unwillingness to practice acceptable contraception. 2. If fe...