NCT04032093

A PHASE 2B PLACEBO-CONTROLLED, RANDOMIZED STUDY OF A RESPIRATORY SYNCYTIAL VIRUS (RSV) VACCINE IN PREGNANT WOMEN

A PHASE 2B, RANDOMIZED, PLACEBO-CONTROLLED, OBSERVER-BLINDED TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A RESPIRATORY SYNCYTIAL VIRUS (RSV) VACCINE IN PREGNANT WOMEN 18 THROUGH 49 YEARS OF AGE AND THEIR INFANTS

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1,153 (actual)
• Sponsor: Pfizer · Industry
• Sex: Female
• Age: 18 Years – 49 Years
• Healthy volunteers: Accepted

Summary

This Phase 2b study will evaluate the safety, tolerability, and immunogenicity of an RSV vaccine in pregnant participants who receive either one of 2 dose levels of the vaccine, formulated with or without aluminum hydroxide, or placebo, and investigate safety and characteristics of antibodies in their infants.

Detailed description

This Phase 2b, multicenter, randomized, placebo-controlled study will evaluate the safety, tolerability, and immunogenicity of a respiratory syncytial virus stabilized prefusion F subunit vaccine (RSV vaccine) in pregnant participants who receive either one of 2 dose levels of the vaccine, formulated with or without aluminum hydroxide, or placebo, as well as assess safety and characteristics of transplacentally transferred antibodies in their infants.

Conditions

• Respiratory Tract Infection

Interventions

Type	Name	Description
BIOLOGICAL	RSV vaccine	RSV vaccine
BIOLOGICAL	Placebo	Normal saline solution for injection (0.9% sodium chloride injection)

Timeline

• Start date: 2019-08-07
• Primary completion: 2021-09-30
• Completion: 2021-09-30
• First posted: 2019-07-25
• Last updated: 2022-10-18
• Results posted: 2022-10-18

Locations

159 sites across 5 countries: United States, Argentina, Chile, New Zealand, South Africa

Regulatory

• FDA-regulated drug study