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A Randomized, Observer-blind, First-in-Human Phase 1/2a Study to Evaluate the Safety, Reactogenicity and Immunogenicity of Three Different Doses of VAC52416 (ExPEC10V) in Adults Aged 60 to 85 Years in Stable Health

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Trial Profile

A Randomized, Observer-blind, First-in-Human Phase 1/2a Study to Evaluate the Safety, Reactogenicity and Immunogenicity of Three Different Doses of VAC52416 (ExPEC10V) in Adults Aged 60 to 85 Years in Stable Health

Status: Completed
Phase of Trial: Phase I/II

Latest Information Update: 24 Mar 2025

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At a glance

  • Drugs VAC 52416 (Primary) ; JNJ 63871860; Pneumococcal 13-valent CRM197 vaccine conjugate
  • Indications Bacterial infections; Escherichia coli infections
  • Focus Adverse reactions; First in man; Pharmacodynamics
  • Sponsors Janssen Research & Development

Most Recent Events

  • 19 Mar 2025 Status changed from active, no longer recruiting to completed.
  • 25 Oct 2022 Planned End Date changed from 10 Nov 2023 to 30 Dec 2024.
  • 21 Dec 2021 Planned End Date changed from 23 Nov 2023 to 10 Nov 2023.

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