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

PHASE2CompletedINTERVENTIONAL
Enrollment

120

Participants

Timeline

Start Date

December 7, 2023

Primary Completion Date

January 8, 2024

Study Completion Date

April 8, 2024

Conditions
Respiratory Synctial Virus Infections
Interventions
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

Trial Locations (3)

197022

Pavlov First Saint Petersburg State Medical University, Saint Petersburg

Smorodintsev Research Institute of Influenza, Saint Petersburg

197198

St. Petersburg City Polyclinic No. 34, Saint Petersburg

All Listed Sponsors
collaborator

Pavlov First Saint Petersburg State Medical University

OTHER

collaborator

St. Petersburg City Polyclinic No. 34

UNKNOWN

lead

Research Institute of Influenza, Russia

OTHER

NCT06890429 - Phase 2 Study of the RSV/Flu-01E Vaccine Against Respiratory Syncytial Virus Infection in Older Adults | Biotech Hunter | Biotech Hunter