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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: 11 Nov 2024

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At a glance

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

Most Recent Events

  • 07 Nov 2024 According to a LakeShore Biopharma media release, company announced the initiation of its Biologics License Application (BLA) submission to the Drug Regulatory Authority of Pakistan (DRAP) for the conditional approval of its PIKA rabies vaccine for post-exposure prophylaxis, based on results from this trial.
  • 15 Aug 2024 According to a LakeShore Biopharma media release, Subject to successful completion of the Phase III clinical trial, the Company plans to submit the New Drug Applications/Biologics License Applications to relevant regulatory authorities throughout Asia, Africa, Europe, and the Americas.
  • 24 May 2024 According to a YS Biopharma media release, YS Biopharma company name changed to LakeShore Biopharma.

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