NCT05739474

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

Randomized, Double-blind, Comparative, Controlled Trial of Tolerability, Safety and Immunogenicity of the Flu-M Tetra Vaccine in Children Between 6 Months and 17 Years Old

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 948 (estimated)
• Sponsor: St. Petersburg Research Institute of Vaccines and Sera · Other Government
• Sex: All
• Age: 6 Months – 17 Years
• Healthy volunteers: Accepted

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.

Detailed description

The trial will be conducted in three stages. • Stage I Participants - children aged 10 to 17 years (10 years 0 months 0 days - 17 years 11 months 30 days), will be vaccinated a single 0.5 mL dose of the Flu-M Tetra vaccine or the VaxigripTetra vaccine intramuscularly. Once reviewed by the Sponsor, the report will be submitted to the supervisory executive authorities alongside the notice of commencement of Stage II trial. • Stage II Participants - children aged 3 to 9 years (3 years 0 months 0 days - 9 years 11 months 30 days), will be vaccinated a single 0.5 mL dose of the Flu-M Tetra vaccine or the VaxigripTetra vaccine intramuscularly (double dose for volunteers who have not been vaccinated before). Once reviewed by the Sponsor, the report will be submitted to the supervisory executive authorities alongside the notice of commencement of Stage III trial. • Stage III Participants - children aged 6 to 35 months (6 months 0 days - 35 months 30 days), will be vaccinated twice 0.25 mL dose of the Flu-M Tetra vaccine or the VaxigripTetra vaccine intramuscularly.

Conditions

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

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2022-01-19
• Primary completion: 2023-06-30
• Completion: 2023-12-30
• First posted: 2023-02-22
• Last updated: 2023-08-30

Locations

7 sites across 1 country: Russia