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

NCT06890429 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2025-03-24

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Pavlov First Saint Petersburg State Medical University

    collaborator OTHER

  • St. Petersburg City Polyclinic No. 34

    collaborator UNKNOWN

  • Research Institute of Influenza, Russia

    lead OTHER

Principal Investigators

  • Marina Stukova, Dr · Smorodintsev Research Institute of Influenza

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-12-07
Primary Completion
2024-01-08
Completion
2024-04-08

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06890429 on ClinicalTrials.gov