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

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.

Timeline

Start

2017-12-08

Primary completion

2018-03-02

Completion

2018-07-13

Outcome

Met primary endpoint

registry description: Non-inferiority in terms of the proportion of subjects with anti-rabies antibody titer of ≥0.5 IU/mL after study drug administration using a non-inferiority margin of 10%. NCT03264157 ↗

registry analysis (non-inferiority test); BPL HRIG + RabAvert vs Comparator HyperRab + RabAvert; p = 0.0006; lower 95% CI -0.05; NCT03264157 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	HRIG	Unknown	20 iu/kg	Intramuscular
Comparator	HyperRAB	Unknown	20 iu/kg	Intramuscular
Background	Rabipur	Vaccine	1 ml	Intramuscular

Indications

No indication recorded.