NCT04424316

A Trial to Evaluate the Efficacy and Safety of RSVpreF in Infants Born to Women Vaccinated During Pregnancy.

A PHASE 3, RANDOMIZED, DOUBLE-BLINDED, PLACEBO-CONTROLLED TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF A RESPIRATORY SYNCYTIAL VIRUS (RSV) PREFUSION F SUBUNIT VACCINE IN INFANTS BORN TO WOMEN VACCINATED DURING PREGNANCY

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 14,727 (actual)
• Sponsor: Pfizer · Industry
• Sex: Female
• Age: 0 Years – 49 Years
• Healthy volunteers: Accepted

Summary

This randomized, double-blinded, placebo-controlled Phase 3 study is designed to evaluate the efficacy and safety of maternal immunization with RSVpreF against medically attended lower respiratory tract illness (MA-LRTI) in infants.

Detailed description

This is a Phase 3, multicenter, randomized, double-blinded, placebo-controlled study to assess the efficacy, safety, and immunogenicity of RSVpreF or placebo (1:1 randomization) in infants born to healthy women vaccinated during pregnancy, as well as the safety and immunogenicity in the pregnant women. This will be a global study which will span multiple RSV seasons.

Conditions

• Respiratory Tract Infection

Interventions

Type	Name	Description
BIOLOGICAL	RSVpreF	RSV vaccine (RSVpreF)
BIOLOGICAL	Placebo	Placebo

Timeline

• Start date: 2020-06-17
• Primary completion: 2023-10-27
• Completion: 2023-10-27
• First posted: 2020-06-09
• Last updated: 2025-02-11
• Results posted: 2025-02-11

Locations

464 sites across 18 countries: United States, Argentina, Australia, Brazil, Canada, Chile, Denmark, Finland, Japan, Mexico, Netherlands, New Zealand, Philippines, South Africa, South Korea, Spain, Taiwan, The Gambia

Regulatory

• FDA-regulated drug study