drugset / Trial / NCT04908683

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

NCT04908683

Phase 3 Completed 25236 enrolled Janssen Vaccines & Prevention B.V.
RandomizedParallel-groupDouble-blindPrevention

Summary

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.

Timeline

Start
2021-07-21
Primary completion
2023-07-21
Completion
2023-07-21

Drugs

EvaluationDrugModalityDoseRoute
Subject Ad26.RSV.preF Vaccine Intramuscular