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A Phase 1, Multicenter, Randomized, Active-Controlled, Observer-Blind, Study to Evaluate the Safety, Tolerability, and Immunogenicity of Inventprise's 25-Valent Pneumococcal Conjugate Vaccine in Healthy PCV-Naïve Adults (18 Through 40 Years)

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Trial Profile

A Phase 1, Multicenter, Randomized, Active-Controlled, Observer-Blind, Study to Evaluate the Safety, Tolerability, and Immunogenicity of Inventprise's 25-Valent Pneumococcal Conjugate Vaccine in Healthy PCV-Naïve Adults (18 Through 40 Years)

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 01 Sep 2023

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At a glance

  • Drugs IVT-25 (Primary) ; PCV 20; Pneumococcal 13-valent CRM197 vaccine conjugate
  • Indications Otitis media; Pneumococcal infections
  • Focus Adverse reactions; First in man
  • Sponsors Inventprise
  • Most Recent Events

    • 28 Aug 2023 Phase changed from phase 1/2 to phase 1. Lower age limit increased from 8 weeks to 18 years. Primary end-points for young children and infants removed. Number of treatment arms decreased from 6 to 2 by the removal of young children and infant experimental sections. Study design changed from sequential to parallel.
    • 28 Aug 2023 Status changed from recruiting to completed.
    • 10 Nov 2022 According to an Inventprise media release, satisfactory Phase 1 results will trigger Phase 2, which will evaluate the IVT PCV-25, first, in young children and then, pending satisfactory data, in infants. Phase 2 will use an authorized infant 13-valent PCV as comparator.
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