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

NCT02040090 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 118

Last updated 2021-09-29

Study results available
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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.

Conditions

  • Rabies

Interventions

DRUG

Active rabies vaccine (US-FDA approved)

A 1.0 ml dose of active vaccine (2.5 IU/ml), will be given on 5 occasions, on Days 0, 3, 7, 14, and 28 On day 0, the day when the HRIG is given, the first vaccine dose could be given within few minutes from the time of HRIG injection was given and never be administered into the same anatomical site as the HRIG.

Sponsors & Collaborators

  • Kamada, Ltd.

    lead INDUSTRY

Principal Investigators

  • Mark Matson, M.D. · Prism Research Inc

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2014-08-31
Completion
2014-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02040090 on ClinicalTrials.gov