drugset / Trial / NCT02040090

Phase II/III Study of the Safety and Effectiveness of HRIG With Active Rabies Vaccine in Healthy Subjects

NCT02040090

Phase 2/3 Completed 118 enrolled Kamada, Ltd.
RandomizedParallel-groupDouble-blindHealth-services research

Summary

The purpose of this study is to: 1. Evaluate the safety and tolerability of KamRAB in comparison with Human rabies immune globulin (HRIG) comparator product. 2. To assess whether KamRAB interferes with the development of self active antibodies when given simultaneously with active rabies vaccine, as compared to the HRIG comparator product, also given in conjunction with the active rabies vaccine.

Timeline

Start
2013-04
Primary completion
2014-08
Completion
2014-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Rabies vaccine Vaccine 1 ml Intramuscular

Indications