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The Objectives of This Study Are Study the Safety, Reactogenicity and Obtain Preliminary Data on the Immunogenicity of Flu-M Quadro, 4-valent Inactivated Split Influenza Vaccine, in Healthy Volunteers

NCT05152017 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2022-01-06

No results posted yet for this study

Summary

The study the safety, reactogenicity and obtain preliminary data on the immunogenicity of Flu-M Quadro, 4-valent inactivated split influenza vaccine, in healthy volunteers

Conditions

Interventions

BIOLOGICAL

Flu-M Quadro [inactivated split influenza vaccine] with preservative

solution for intramuscular injection, 0.5 ml

BIOLOGICAL

Flu-M Quadro [inactivated split influenza vaccine] without preservative

solution for intramuscular injection, 0.5 ml

BIOLOGICAL

Placebo

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
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-11-16
Primary Completion
2020-01-22
Completion
2020-01-24

Countries

  • Russia

Study Locations

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Entities

Drugs
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 NCT05152017 on ClinicalTrials.gov