A Phase II Randomized, Observer-Blind, Placebo-Controlled, Study to Evaluate the Safety and Immunogenicity of a Respiratory Syncytial Virus (RSV) F Nanoparticle Vaccine With Aluminum, in Healthy Third-trimester Pregnant Women and to Assess the Impact of Maternal Immunization on Infant Safety Through One Year of Life.

Trial Profile

A Phase II Randomized, Observer-Blind, Placebo-Controlled, Study to Evaluate the Safety and Immunogenicity of a Respiratory Syncytial Virus (RSV) F Nanoparticle Vaccine With Aluminum, in Healthy Third-trimester Pregnant Women and to Assess the Impact of Maternal Immunization on Infant Safety Through One Year of Life.

Completed
Phase of Trial: Phase II

Latest Information Update: 08 Jun 2017

At a glance

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

    • 14 Sep 2016 Status changed from active, no longer recruiting to completed.
    • 27 Apr 2016 Planned End Date changed from 1 Jan 2016 to 1 Jun 2016.
    • 27 Apr 2016 Planned primary completion date changed from 1 Jan 2016 to 1 Jun 2016.
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