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A Phase I-II, Randomized, Double-Blind, Study to Evaluate the Safety, Tolerability, and Immunogenicity of Different Formulations of V114 in Healthy Adults and Infants

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Trial Profile

A Phase I-II, Randomized, Double-Blind, Study to Evaluate the Safety, Tolerability, and Immunogenicity of Different Formulations of V114 in Healthy Adults and Infants

Status: Completed
Phase of Trial: Phase I/II

Latest Information Update: 12 May 2022

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At a glance

  • Drugs V 114 (Primary) ; Pneumococcal 13-valent CRM197 vaccine conjugate
  • Indications Pneumococcal infections
  • Focus Adverse reactions; Pharmacodynamics
  • Sponsors Merck Sharp & Dohme

    • Most Recent Events

    • 30 Jan 2019 According to a Merck & Co media release, the US FDA has granted Breakthrough Therapy designation to V 114 for the treatment of pneumococcal disease caused by the vaccine serotypes in pediatric patients 6 weeks to 18 years of age. The FDA's decision was informed in part by immunogenicity data from the phase I/II 005 trial and phase II 008 trial.
    • 29 Aug 2016 Planned primary completion date changed from 1 Mar 2017 to 1 Jun 2017.
    • 10 Mar 2016 Planned End Date changed from 1 Aug 2017 to 1 Jun 2017, according to ClinicalTrials.gov record.
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