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.

NCT05317767 | Completed Phase 3

• 1 other identifier: FLU-III-D-07/19
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Influenza

Keywords

influenza; flu; vaccine; Flu-M; FluM; Ultrix; SPbSRIVS

Outcome Measures

Primary Outcomes (4)

• Change from Baseline Geometric mean antibodies titer (GMT) at 28 days

  Days 0-28

• Change from Baseline Seroconversion rate at 28 days

  An increase in the geometric mean titers of antibodies at Day 28 vs. the baseline level, expressed in the fold rise. Seroconversion level ≥ 40%.

  Days 0-28

• Change from Baseline Seroprotection rate at 28 days

  The percentage of subjects with a generated protective influenza haemagglutinin antibody titer (HA titer) (at least 1:40) vs. the baseline level. Seroprotection level ≥ 70%.

  Days 0-28

• Change from Baseline Seroconversion factor at 28 days

  The percentage of subjects who have a prevaccination titer of HA titer \<1:10 and a post-vaccination HA titer \>1:40 OR a prevaccination HA titer \> 1:10 and at least a fourfold increase in post-vaccination HA titer vs. the baseline. Seroconversion factor ≥ 2.5.

  Days 0-28

Secondary Outcomes (3)

• Immediate adverse events

  During 2 hours after vaccination

• Adverse events

  During 7 days after vaccination

• Incidence of severe adverse events during the trial

  Measurements will be taken then up to 28 days post-vaccination

Study Arms (2)

Flu-M

EXPERIMENTAL

300 children that will be vaccinated with a single dose of the Flu-M vaccine intramuscularly at a dose of 0.5 mL (150 children aged 12 to 17 years, 150 children aged 6 to 11 years)

Biological: Flu-M [Inactivated split influenza vaccine]

Ultrix

ACTIVE COMPARATOR

300 children that will be vaccinated with a single dose of the Ultrix® vaccine intramuscularly at a dose of 0.5 mL (150 children aged 12 to 17 years, 150 children aged 6 to 11 years)

Biological: Inactivated Split Influenza Vaccine

Interventions

Flu-M [Inactivated split influenza vaccine] BIOLOGICAL

solution for intramuscular injection, 0.5 ml

Flu-M

Inactivated Split Influenza Vaccine BIOLOGICAL

solution for intramuscular injection, 0.5 ml

Ultrix

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• For volunteers aged 12 to 17 years:
• Healthy children1 of both sexes aged 12 to 17 years (12 years 0 months 0 days - 17 years 11 months 30 days);
• The written and dated informed consent of the volunteer (children aged 14-17 years) one of the parents for participation in the trial;
• If the volunteer has sexual relations, effective contraception methods must be used during the 30 days preceding vaccination and consent must be obtained to continue using these contraceptive methods during the trial and for two months after vaccination;
• The girls with mensis in the medical history shall have a negative pregnancy test result.
• For volunteers aged 6 to 11 years:
• Healthy children of both sexes aged 6 to 11 years (6 years 0 months 0 days - 11 years 11 months 30 days);
• The written and dated informed consent of one of the parents for participation in the trial;
• For all volunteers:
• Ability of a volunteer / volunteer's parents to fulfill the requirements of the Protocol (i.e. to fill out the Patient Diary, come to visit with the volunteer)

You may not qualify if:

• History of influenza or previous influenza vaccination during 6 months before the trial;
• Vaccination with any vaccine less than 30 days before participating in the trial or scheduled vaccination with any vaccine within 30 days after vaccination with the trial vaccines;
• A serious post-vaccination reaction (temperature above 40 °C, hyperemia or edema more than 8 cm in diameter) or complications (collapse or shock-like condition that developed within 48 hours after vaccination; convulsions accompanied or not accompanied by a fever due to any previous vaccination);
• Allergic reactions to vaccine components or any previous vaccination;
• History of allergic reaction to chicken protein;
• Encephalopathy that developed within 7 days of a previous vaccine administration;
• History of hematopoietic system, cancer;
• Carriage of HIV, syphilis, hepatitis B and C in the medical history, including by parents;
• Children who received immunoglobulin products or transfusions of whole blood or its components less than 3 months before the start of the trial;
• Long-term use (for more than 14 days) of any immunomodulating drugs (immunoregulating peptides, cytokines, interferons, immune system effector proteins (immunoglobulins), interferon inducers (cycloferon)) less than 3 months prior to the commencement of the trial;
• Any confirmed or suspected immunosuppressive or immunodeficiency condition;
• History of chronic diseases of the cardiovascular, bronchopulmonary, endocrine systems, blood in the acute stage (recovery less than 4 weeks before vaccination) or in the decompensation stage;
• History of progressive neurological pathology, convulsive syndrome, afebrile convulsions;
• Acute infectious or non-infectious diseases less than 2 weeks before vaccination;
• Participation in another clinical trial less than 3 months before the start of the trial;

Sponsors & Collaborators

• St. Petersburg Research Institute of Vaccines and Sera: lead

Study Sites (2)

Perm State Medical University named after Academician E. A. Wagner

Perm, Russia

Location

LLC "Meditsinskie Tehnologii"

Saint Petersburg, Russia

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2021
• First Posted: April 8, 2022
• Study Start: February 10, 2020
• Primary Completion: July 5, 2020
• Study Completion: September 14, 2020
• Last Updated: April 8, 2022

Record last verified: 2021-10

Locations

RU (2)