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Tolerability, Safety and Immunogenicity Trial of the Flu-M Tetra Vaccine in Children

NCT05739474 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 948

Last updated 2023-08-30

No results posted yet for this study

Summary

The goal of this clinical trial is to assess tolerability, reactogenicity, safety and immunogenicity of the Flu-M Tetra vaccine as compared to the VaxigripTetra vaccine in terms of prevention of influenza in children aged 6 months to 17 years old inclusive.

Conditions

  • Influenza
  • Influenza, Human
  • Influenza Viral Infections
  • Vaccine Reaction

Interventions

BIOLOGICAL

Influenza vaccine [inactivated]

solution for intramuscular injection, 1 dose (0.5 mL)

BIOLOGICAL

Influenza vaccine [inactivated]

suspension for intramuscular and subcutaneous injection, 1 dose (0.5 mL)

Sponsors & Collaborators

  • St. Petersburg Research Institute of Vaccines and Sera

    lead OTHER_GOV

Principal Investigators

  • Ellina Ruzanova, PhD · St. Petersburg Research Institute of Vaccines and Sera

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2022-01-19
Primary Completion
2023-06-30
Completion
2023-12-30

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 NCT05739474 on ClinicalTrials.gov