A Phase 3, Randomized, Observer-Blind, Placebo-Controlled, Group-Sequential Study to Determine the Immunogenicity and Safety of a Respiratory Syncytial Virus (RSV) F Nanoparticle Vaccine With Aluminum in Healthy Third-trimester Pregnant Women; and Safety and Efficacy of Maternally Transferred Antibodies in Preventing RSV Disease in Their Infants

Trial Profile

A Phase 3, Randomized, Observer-Blind, Placebo-Controlled, Group-Sequential Study to Determine the Immunogenicity and Safety of a Respiratory Syncytial Virus (RSV) F Nanoparticle Vaccine With Aluminum in Healthy Third-trimester Pregnant Women; and Safety and Efficacy of Maternally Transferred Antibodies in Preventing RSV Disease in Their Infants

Recruiting
Phase of Trial: Phase III

Latest Information Update: 14 Jan 2018

At a glance

  • Drugs RSV F protein vaccine (Primary)
  • Indications Respiratory syncytial virus infections
  • Focus Registrational; Therapeutic Use
  • Acronyms Prepare
  • Sponsors Novavax
  • Most Recent Events

    • 18 Dec 2017 According to a Novavax media release, the company has completed an informational analysis of this trial in fourth quarter of 2017 and accelerating enrollment into 2018. 3,000 volunteers have been enrolled till date. Interim analysis expected in mid-2018 and primary endpoint readout in early 2019.
    • 24 Jul 2017 According to a Novavax media release, company continues enrollment into the third global season of this trial.
    • 11 Dec 2015 New trial record
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