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The Objectives of This Study Are Comparative Assessment of the Tolerability, Safety and Immunogenicity of the Flu-M Vaccine vs. the Ultrix® Vaccine by Single Vaccination of Children Aged 6 to 17 Years.

NCT05317767 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 600

Last updated 2022-04-08

No results posted yet for this study

Summary

Comparative assessment of the tolerability, safety and immunogenicity of the Flu-M vaccine vs. the Ultrix® vaccine by single vaccination of children aged 6 to 17 years.

Conditions

Interventions

BIOLOGICAL

Flu-M [Inactivated split influenza vaccine]

solution for intramuscular injection, 0.5 ml

BIOLOGICAL

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
DIAGNOSTIC
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-02-10
Primary Completion
2020-07-05
Completion
2020-09-14

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 NCT05317767 on ClinicalTrials.gov