NCT06890429

Phase 2 Study of the RSV/Flu-01E Vaccine Against Respiratory Syncytial Virus Infection in Older Adults

Randomized, Double-blind, Placebo-controlled Phase 2 Trial of RSV/Flu-01E Vaccine for the Prevention of Respiratory Syncytial Virus Infection in Volunteers Over 60 Years

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Research Institute of Influenza, Russia · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Accepted

Summary

The aim of the study is to investigate immunogenicity and safety of the RSV/Flu-01E intranasal vaccine for the prevention of respiratory syncytial virus infection in volunteers over 60 years

Detailed description

Study includes 120 participants over 60 years randomized at 3:1 ratio, to receive single intranasal dose of RSV/Flu-01E vaccine or placebo, correspondingly. Duration of the study for each participant is about 4 months (118±3 days)

Conditions

• Respiratory Synctial Virus Infections

Interventions

Type	Name	Description
BIOLOGICAL	RSV/Flu-01E	Participants will receive single intranasal injection of RSV/Flu-01E vaccine in 0.5 ml, containing 8.4 lg EID50 of A/H1N1pdm09 recombinant attenuated influenza vector with modified NS gene, encoding for the F antigen of respiratory syncytial virus
OTHER	Placebo	Participants will receive single intranasal injection of physiological buffer solution in 0.5 ml

Timeline

• Start date: 2023-12-07
• Primary completion: 2024-01-08
• Completion: 2024-04-08
• First posted: 2025-03-24
• Last updated: 2025-03-24

Locations

3 sites across 1 country: Russia