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: 02 Apr 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

    • 02 Apr 2018 According to a Novavax media release, clinical data will be presented at the World Vaccine Congress, April 2018.
    • 14 Mar 2018 According to a Novavax media release, company anticipated to enroll approximately 4,600 participants, including approximately 3,000 actively vaccinated mothers in the second quarter of 2018 and interim analysis with results is expected in early 2019.
    • 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.
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