NCT05317767

The Objectives of This Study Are Comparative Assessment of the Tolerability, Safety and Immunogenicity of the Flu-M Vaccine vs. the Ultrix® Vaccine by Single Vaccination of Children Aged 6 to 17 Years.

Double-blind, Comparative, Randomized Tolerability, Safety and Immunogenicity Trial of Flu-M [Inactivated Split Influenza Vaccine], vs. the Ultrix® Vaccine in Children Aged 6 to 17 Years (Inclusive)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 600 (actual)
• Sponsor: St. Petersburg Research Institute of Vaccines and Sera · Other Government
• Sex: All
• Age: 6 Years – 17 Years
• Healthy volunteers: Accepted

Summary

Comparative assessment of the tolerability, safety and immunogenicity of the Flu-M vaccine vs. the Ultrix® vaccine by single vaccination of children aged 6 to 17 years.

Detailed description

At Stage I of the trial, it is planned to screen not more than 350 children aged 12 to 17 years (12 years 0 months 0 days - 17 years 11 months 30 days), of which it is planned to include and randomize 300 children meeting the inclusion and non-inclusion criteria. Based on findings from tolerability and safety assessment in respect of the Flu-M vaccine vs. the Ultrix® vaccine in the first 7 days after the vaccination of volunteers, during Phase I, an "Opinion on Tolerability and Safety Assessment for the Flu-M Vaccine vs. the Ultrix® Vaccine Involving Children Aged 12-17 Years (12 Years 0 Months 0 Days - 17 Years 11 Months 30 Days) will be prepared/ During Phase II , the trial for Phase I volunteers will continue in full in accordance with the Clinical Trial Regulations. During the trial, not more than 350 children aged between 6 - 11 years (6 years 0 months - 0 days - 11 years 11 months 30 days) will be further screened, of which it is planned to include and randomize 300 children meeting the inclusion criteria and not falling under the non-inclusion criteria.

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	Flu-M [Inactivated split influenza vaccine]	solution for intramuscular injection, 0.5 ml
BIOLOGICAL	Inactivated Split Influenza Vaccine	solution for intramuscular injection, 0.5 ml

Timeline

• Start date: 2020-02-10
• Primary completion: 2020-07-05
• Completion: 2020-09-14
• First posted: 2022-04-08
• Last updated: 2022-04-08

Locations

2 sites across 1 country: Russia