Completed PHASE3 INTERVENTIONAL 4-arm NCT05470582

Trial of Tolerability, Safety and Immunogenicity of the Flu-M Vaccine in Children Between 6 Months and 9 Years Old

Randomized, Double-blind, Comparative, Controlled Trial of Tolerability, Safety and Immunogenicity of the Flu-M Vaccine in Children Between 6 Months and 9 Years Old

Sponsor: St. Petersburg Research Institute of Vaccines and Sera

Conditions Influenza, Human Vaccination; Infection Vaccines

Interventions Flu-M, Inactivated split influenza vaccine 0.25 mL Flu-M, Inactivated split influenza vaccine 0.5 mL Vaxigrip, Inactivated split influenza vaccine 0.25 mL Vaxigrip, Inactivated split influenza vaccine 0.5 mL

Updated 4 times since 2022 Last updated: Jul 19, 2022 Started: Feb 16, 2021 Primary completion: Oct 29, 2021 Completion: Dec 24, 2021

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE3 clinical study on Influenza, Human and Vaccination; Infection, this trial is completed. The trial is conducted by St. Petersburg Research Institute of Vaccines and Sera and has accumulated 4 data snapshots since 2021. Infectious disease trials contribute critical data for public health response and treatment development.

Status Flow

Change History

4 versions recorded

Sep 2025 — Present [monthly]

Completed PHASE3
Sep 2024 — Sep 2025 [monthly]

Completed PHASE3
Jul 2024 — Sep 2024 [monthly]

Completed PHASE3
Sep 2022 — Jul 2024 [monthly]

Completed PHASE3

First recorded

Feb 2021

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

St. Petersburg Research Institute of Vaccines and Sera

Data source: St. Petersburg Research Institute of Vaccines and Sera

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

• Saint Petersburg, Russia