NCT05869201

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

Double-blind Comparative Randomized Tolerability, Safety and Immunogenicity Trial of the Flu-M Quadro Tetravalent Inactivated Split Influenza Vaccine, Solution for Intramuscular Injection, FSUE SPbSRIVS FMBA of Russia, in Volunteers Aged 18-60 Years

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 450 (actual)
• Sponsor: St. Petersburg Research Institute of Vaccines and Sera · Other Government
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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

Timeline

• Start date: 2020-10-06
• Primary completion: 2020-12-08
• Completion: 2020-12-08
• First posted: 2023-05-22
• Last updated: 2023-05-22

Locations

5 sites across 1 country: Russia