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Evaluation of RSV/Flu-01E Vaccine for the Prevention of RSV Infection in Volunteers Aged 18 to 59 Years and Over 60 Years

NCT05970744 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-04-18

No results posted yet for this study

Summary

The aim of the study is to investigate the safety and immunogenicity of the RSV/Flu-01E vaccine for the prevention of respiratory syncytial virus infection in volunteers aged18 to 59 years and over 60 years.

Conditions

  • Respiratory Syncytial Virus Infections

Interventions

BIOLOGICAL

RSV/Flu-01E low dose

Participants will receive single intranasal injection of A/H1N1pdm09 recombinant attenuated influenza vector (7.7 lg EID50) with modified NS gene coding for the F antigen of respiratory syncytial virus

BIOLOGICAL

RSV/Flu-01E high dose

Participants will receive single intranasal injection of A/H1N1pdm09 recombinant attenuated influenza vector (8.4 lg EID50) with modified NS gene coding for the F antigen of respiratory syncytial virus

BIOLOGICAL

Placebo

Participants will receive single intranasal injection of Placebo

Sponsors & Collaborators

  • Tatyana Zubkova

    lead OTHER

Principal Investigators

  • Tatiana Zubkova, PhD · Smorodintsev Research Institute of Influenza

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-05-10
Primary Completion
2023-06-19
Completion
2023-09-18

Countries

  • Russia

Study Locations

More Related Trials

Entities

Drugs

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 NCT05970744 on ClinicalTrials.gov