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A Phase II Randomized, Observer-Blind, Placebo-Controlled Study to Evaluate the Immunogenicity and Safety of a Respiratory Syncytial Virus (RSV) Recombinant F Nanoparticle Vaccine in Healthy Older Adult Subjects Previously Treated With the Same Vaccine, or Placebo, in the Prior Year; and to Estimate the Incidence Rate of RSV Disease and Vaccine Efficacy in Subjects Based on Their RSV F Vaccine Experience Over Two Consecutive Years.

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Trial Profile

A Phase II Randomized, Observer-Blind, Placebo-Controlled Study to Evaluate the Immunogenicity and Safety of a Respiratory Syncytial Virus (RSV) Recombinant F Nanoparticle Vaccine in Healthy Older Adult Subjects Previously Treated With the Same Vaccine, or Placebo, in the Prior Year; and to Estimate the Incidence Rate of RSV Disease and Vaccine Efficacy in Subjects Based on Their RSV F Vaccine Experience Over Two Consecutive Years.

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 30 May 2022

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At a glance

  • Drugs RSV F protein vaccine-Novavax (Primary)
  • Indications Respiratory syncytial virus infections
  • Focus Adverse reactions; Pharmacodynamics
  • Sponsors Novavax

Most Recent Events

  • 16 Jan 2017 Status changed from active, no longer recruiting to completed.
  • 15 Sep 2016 Results published in the Novavax Media Release
  • 29 Feb 2016 According to a Novavax media release, top-line data are expected in the second half of 2016.

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