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Tolerability, Safety and Immunogenicity Trial of the FLU-M® Tetra

NCT05308212 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 633

Last updated 2022-11-08

No results posted yet for this study

Summary

Comparative assessment of the tolerability, safety, and immunogenicity of the FLU-M® Tetra quadrivalent inactivated split influenza vaccine and the Ultrix® vaccine in volunteers aged 60 years and above.

Conditions

Interventions

BIOLOGICAL

Flu-M Tetra [Inactivated split influenza vaccine] w/p

solution for intramuscular injection, 0.5 ml

BIOLOGICAL

Flu-M Tetra [Inactivated split influenza vaccine] w/o/p

solution for intramuscular injection, 0.5 ml

BIOLOGICAL

Ultrix [Inactivated split influenza vaccine]

solution for intramuscular injection, 0.5 ml

Sponsors & Collaborators

  • St. Petersburg Research Institute of Vaccines and Sera

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-03-04
Primary Completion
2021-07-30
Completion
2021-09-06

Countries

  • Russia

Study Locations

More Related Trials

Entities

Diseases

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 NCT05308212 on ClinicalTrials.gov