A Study of an Adenovirus Serotype 26 Pre-fusion Conformation-stabilized F Protein (Ad26. RSV. preF) Based Respiratory Syncytial Virus (RSV) Vaccine in the Prevention of Lower Respiratory Tract Disease in Adults Aged 60 Years and Older (EVERGREEN)

NCT04908683 PHASE3 COMPLETED Results posted

The study will enroll up to 27,200 participants in order to demonstrate the efficacy of the active Ad26.RSV.preF-based study vaccine in the prevention of Reverse Transcription Polymerase Chain Reaction (RT-PCR) confirmed Respiratory Syncytial Virus (RSV)-mediated Lower Respiratory Tract Disease (LRTD) when compared to placebo in adults aged 60 years and above.

Details

Lead sponsor	Janssen Vaccines & Prevention B.V.
Phase	PHASE3
Status	COMPLETED
Enrolment	25236
Start date	Wed Jul 21 2021 00:00:00 GMT+0000 (Coordinated Universal Time)
Completion	Fri Jul 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

• Respiratory Syncytial Viruses
• Lower Respiratory Tract Disease

Interventions

• Adenovirus serotype 26 (Ad26)-based respiratory syncytial virus (RSV). preF
• Placebo

Countries

New Zealand, South Africa, Finland, Chile, Taiwan, Estonia, United Kingdom, Poland, Canada, Thailand, Australia, China, United States, Brazil