At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 162 enrolled
Drug / intervention
HRIG +2 moredrug
Likely dose
HRIG 20 IUfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Prospective, Randomized, Double-Blind Parallel-group, Non-inferiority Phase II/III Study of the Safety and Effectiveness of BPL HRIG With Co Administration of Active Rabies Vaccine in Healthy Subjects
In Brief
A Phase 3 clinical trial evaluating HRIG, HyperRAB, and 1 other intervention for Healthy. Completed, enrolled 162 participants across 2 sites.
Detailed Summary
A prospective, randomized, blinded, parallel-group, non-inferiority, phase II/III study of the safety and effectiveness of simulated post-exposure prophylaxis with BPL HRIG with co-administration of active rabies vaccine in healthy subjects.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedAug 2017
Enrollment StartDec 2017
Primary CompletionMar 2018
Study CompletionJul 2018
TodayJul 2026
First PostedAug 29, 2017
Enrollment StartDec 8, 2017
Primary CompletionMar 2, 2018
Study CompletionJul 13, 2018
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 8.8 years ago
Interventions
HRIGdrug
A 20 IU/kg dose of BPL HRIG will be given on Day 0 via IM injection.
HyperRABdrug
A 20 IU/kg dose of Comparator HRIG will be given on Day 0 via IM injection.
RabAvertbiological
A 1.0 ml dose of active vaccine (2.5 IU/ml) will be given IM on 5 occasions: on Days 0, 3, 7, 14, and 28.