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Tolerability, Safety and Immunogenicity Trial of the Flu-M Quadro, Tetravalent Inactivated Split Influenza Vaccine

NCT05869201 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 450

Last updated 2023-05-22

No results posted yet for this study

Summary

The goal of this clinical trial is to assess tolerability, safety and immunogenicity of the Flu-M Quadro vaccine as compared to the Ultrix® Quadri vaccine in volunteers aged between 18 and 60.

Participants were given Flu-M Quadro \[inactivated split influenza vaccine\] with preservative or Flu-M Quadro \[inactivated split influenza vaccine\] without preservative or Ultrix® Quadri vaccine.The volunteers of each group were vaccinated with a single dose vaccine.

Researchers assessed the tolerability, safety and immunogenicity of the Flu-M Quadro quadrivalent inactivated split influenza vaccine.

Researchers performed a comparative assessment of the tolerability, safety, and immunogenicity of the Flu-M Quadro quadrivalent inactivated split influenza vaccine and the Ultrix® Quadri vaccine.

Conditions

  • Influenza
  • Influenza, Human
  • Influenza Viral Infections
  • Vaccine Reaction
  • Vaccination; Infection

Interventions

BIOLOGICAL

Influenza vaccine [inactivated]

Solution for intramuscular injection, 0.5 ml (1 dose) Vaccination with a single dose vaccine

BIOLOGICAL

Influenza vaccine [inactivated]

Solution for intramuscular injection, 0.5 ml (1 dose) Vaccination with a single dose vaccine

BIOLOGICAL

Influenza vaccine [inactivated]

Solution for intramuscular injection, 0.5 ml (1 dose) Vaccination with a single dose vaccine

Sponsors & Collaborators

  • St. Petersburg Research Institute of Vaccines and Sera

    lead OTHER_GOV

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2020-10-06
Primary Completion
2020-12-08
Completion
2020-12-08

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 NCT05869201 on ClinicalTrials.gov