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Safety and Effectiveness of BPL HRIG With Active Rabies Vaccine in Healthy Subjects

Healthy Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial Description

Each subject will undergo a total of 9 visits. Subjects' eligibility will be assessed at Screening, which can occur up to 28 days prior to dosing. Following a repeat eligibility check at Day 0, eligible subjects will be randomized and dosed with the randomized treatment (BPL HRIG + vaccine or Comparator HRIG + vaccine) on Day 0. Further assessments will be conducted on Days 3, 5, 7, 14, 28, 49 and the end of study assessment on Day 140. Vaccine will be administered on Day 0, 3, 7, 14 and 28. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03264157
Study type Interventional
Source Bio Products Laboratory
Contact
Status Completed
Phase Phase 2/Phase 3
Start date December 8, 2017
Completion date July 13, 2018
View Details
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