Clinical Trials Logo

Clinical Trial Summary

Efficacy Study: This randomized, double-blinded, placebo-controlled Phase 3 study is designed to assess the safety, immunogenicity, and efficacy of a single dose of RSVpreF in the prevention of LRTI-RSV in adults: - At a dose of 120µg. - In adults 60 years of age and older. - The duration of the study for each participant will be up to approximately 24 months. - The study will be conducted in the United States, Canada, Netherlands, Finland, Argentina, Japan and South Africa. Substudy A: This study is an extension of the efficacy study and was designed to evaluate the safety and immunogenicity of a second dose of RSVpreF when administered after a dosing interval of approximately 2 years: - At a dose of 120µg (as studied in the Phase 3 Efficacy Study) - Blood samples will be collected for antibody testing. - The duration of the study for each participant will be up to approximately 18 months. - The study will be conducted in the United States and Argentina. Substudy B: This study was designed to evaluate the safety and immunogenicity of a second dose of RSVpreF when administered after a dosing interval of approximately 1 year: - At a dose of 120µg (as studied in the Phase 3 Efficacy Study) - Blood samples will be collected for antibody testing. - The duration of the study for each participant will be up to approximately 18 months. - The study will be conducted in Argentina.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT05035212
Study type Interventional
Source Pfizer
Contact Pfizer CT.gov Call Center
Phone 1-800-718-1021
Email ClinicalTrials.gov_Inquiries@pfizer.com
Status Recruiting
Phase Phase 3
Start date August 31, 2021
Completion date June 12, 2026

See also
  Status Clinical Trial Phase
Completed NCT03756753 - The RAPID Trial: Assessing Point-of-care Influenza and Other Respiratory Virus Diagnostics N/A