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A Prospective, Randomized, Double-Blind, Non Inferiority, Phase II/III Study of the Safety and Effectiveness of Simulated Post-Exposure Prophylaxis With Kamada Human Rabies Immune Globulin (KamRAB) With Co-administration of Active Rabies Vaccine in Healthy Subjects

Trial Profile

A Prospective, Randomized, Double-Blind, Non Inferiority, Phase II/III Study of the Safety and Effectiveness of Simulated Post-Exposure Prophylaxis With Kamada Human Rabies Immune Globulin (KamRAB) With Co-administration of Active Rabies Vaccine in Healthy Subjects

Status: Active, no longer recruiting
Phase of Trial: Phase II/III

Latest Information Update: 29 Oct 2019

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At a glance

  • Drugs Rabies immune globulin (Primary) ; Rabies vaccine
  • Indications Rabies
  • Focus Pharmacodynamics; Registrational
  • Sponsors Kamada
  • Most Recent Events

    • 29 Oct 2019 Results published in the Kamada, Kedrion Biopharma Media Release
    • 29 Oct 2019 According to an Kamada, Kedrion Biopharma media release, results from this study were in Human Vaccines & Immunotherapeutics Medical Journal.
    • 25 Aug 2017 According to a Kedrion media release, based on the data from this trial, KEDRAB [rabies immune globulin (Human)] has received U.S. Food and Drug Administration (FDA) approval for passive, transient post-exposure prophylaxis of rabies infection, when given immediately after contact with a rabid or possibly rabid animal. KEDRAB should be administered concurrently with a full course of rabies vaccine.
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