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A Phase III, Randomized, Comparator-Controlled, Double-Blind, Multicenter Study to Evaluate the Immunogenicity, Safety and Lot to Lot Consistency of Three Lots of a PIKA Rabies VaccineVero Cellfor Human Use,Freeze-dried in Healthy Adults Using a Post-Exposure Prophylaxis Schedule

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Trial Profile

A Phase III, Randomized, Comparator-Controlled, Double-Blind, Multicenter Study to Evaluate the Immunogenicity, Safety and Lot to Lot Consistency of Three Lots of a PIKA Rabies VaccineVero Cellfor Human Use,Freeze-dried in Healthy Adults Using a Post-Exposure Prophylaxis Schedule

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

Latest Information Update: 12 Apr 2024

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At a glance

  • Drugs Rabies vaccine Yisheng Biopharma (Primary)
  • Indications Rabies
  • Focus Adverse reactions; Pharmacodynamics; Registrational
  • Sponsors Yisheng Biopharma; YS Biopharma

    • Most Recent Events

    • 09 Apr 2024 Primary endpoint has been met. (Primary Immunogenicity: geometric mean titers (GMTs) of rabies virus neutralizing antibodies (RVNA) at Day 14) , according to results published in a Yisheng Biopharma media release
    • 09 Apr 2024 According to a Yisheng Biopharma media release, company remain committed to working closely with drug regulatory agencies in various countries including the Philippines, Pakistan, Singapore, China, and other jurisdictions regarding the product registration and marketing application and anticipates the early approval of this innovative therapy for the benefit of patients worldwide.
    • 09 Apr 2024 Primary endpoint has been met. (Primary Immunogenicity: RVNA seroconversion rate at Day 14) , according to results published in a Yisheng Biopharma media release
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