Clinical trial NCT05470582: Trial of Tolerability, Safety and Immunogenicity of the Flu-M Vaccine in Children Between 6 Months and 9 Years Old
Official title: Randomized, Double-blind, Comparative, Controlled Trial of Tolerability, Safety and Immunogenicity of the Flu-M Vaccine in Children Between 6 Months and 9 Years Old
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Influenza, Human
Vaccination; Infection
Vaccines
Keywords: Influenza
Flu
Vaccine
FLU-M
SPbSRIVS
Vaxigrip
Children
Lead sponsor: St. Petersburg Research Institute of Vaccines and Sera
Sponsor class: OTHER_GOV
First posted: 2022-07-22
Enrollment: 1066
Sex: ALL
Minimum age (years): 6
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Comparative trial of tolerability, reactogenicity, safety and immunogenicity of the Flu-M vaccine as compared to the Vaxigrip® vaccine in terms of prevention of influenza in children aged 6 months to 9 years (at the time of the first vaccination).

Detailed description: The trial includes 2 stages (stage I, II). At stage I children aged 3-9 years will be included. Based on findings from tolerability and safety assessment in respect of the Flu-M vaccine vs. the Vaxigrip® vaccine for the first 7 days after vaccination of volunteers during Stage I, an intermediate report will be prepared. The report will be submitted to the supervisory executive authorities alongside the notice of commencement of Stage II of the trial - the continuation of trial on children aged 3-9 years and the commencement of trial on children aged between 6 months and 35 months. During Stage II, the trial for Stage I volunteers will continue in full and also children aged between 6 and 35 months will be included in the trial.

Eligibility criteria: Inclusion Criteria:

* For volunteers aged 3 to 9 years:

  * Healthy children of both sexes aged 3 to 9 years (3 years 0 months 0 days - 8 years 11 months 30 days);
  * The written and dated informed consent of one of the parents for participation in the trial;
* For volunteers aged 6 to 35 months:

  * Healthy children of both genders aged 6 to 35 months, inclusive (6 months 0 days - 35 months 30 days);
  * The written and dated informed consent of one of the parents for participation in the trial;
  * The trial subject of the was born full-term, with the Apgar score of 7-10 points.
* For all volunteers:

Ability of a volunteer's parents to fulfill the requirements of the Protocol (i.e. to fill out the Patient Diary, come to visit with the volunteer).

Exclusion Criteria:

1. History of influenza (including in mothers for children aged 6 to 35 months) or previous influenza vaccination during 6 months before the trial;
2. Positive result of the SARS-CoV-2 test;
3. Vaccination of the pregnant woman in the 2nd-3rd trimester (for the age group of 6 - 35 months) with an influenza vaccine;
4. 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;
5. A serious post-vaccination reaction (temperature above 40 °C, hyperemia or edema more than 8 cm in diameter at the injection site) 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), encephalopathy;
6. Allergic reactions to vaccine components or any previous vaccination;
7. History of allergic reaction to chicken protein;
8. History of cancer, leukemia, tuberculosis, autoimmune diseases;
9. Carriage of HIV, syphilis, hepatitis B and C in the medical history, including by parents;
10. Children who received immunoglobulin products or transfusions of whole blood or its components less than 3 months before the start of the trial;
11. Long-term use (more than 14 days) of any immunomodulating medicines less than 3 months before the start of the trial;
12. Any confirmed or suspected immunosuppressive or immunodeficiency condition;
13. 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;
14. Children with hemophilia who may develop bleeding after intramuscular injection;
15. History of progressive neurological pathology, convulsive syndrome, afebrile convulsions;
16. History of acute infectious diseases (fever ≥ 37.5°С): recovery less than 2 weeks before vaccination;
17. Participation in another clinical trial less than 3 months before the start of the trial;
18. History of mental illness of the child and the volunteer's parents;
19. The history of the volunteer's parent being registered with a tuberculosis dispensary and/or a narcological dispensary;
20. Maternal history of drug use or alcohol abuse during pregnancy and/or breastfeeding;
21. Pronounced congenital malformations in a child;
22. Suspected developmental delay in a child.

Primary outcomes:
measure: Change from Baseline seroconversion level
timeFrame: Days 0 (screening), 28, 56, 180 after vaccination/revaccination
Secondary outcomes:
measure: Change from Baseline Geometric mean titer (GMT) of antibodies
timeFrame: Days 0 (screening), 28 after vaccination/revaccination
measure: Change from Baseline Seroconversion factor
timeFrame: Days 0 (screening), 28, 56, 180 after vaccination/revaccination
measure: Change from Baseline Seroprotection rate
timeFrame: Days 0 (screening), 28, 56, 180 after vaccination/revaccination
measure: Change from Baseline Seroconversion rate for each virus strain
timeFrame: Days 0 (screening), 28, 56, 180 after vaccination/revaccination
measure: Incidence of immediate adverse events (allergic reactions)
timeFrame: 2 hours after vaccination/revaccination
measure: Incidence of local adverse events
timeFrame: Day 1 (2 and 5-8 hours after vaccination/revaccination), days 2-180
measure: Incidence of systemic adverse events
timeFrame: Day 1 (2 and 5-8 hours after vaccination/revaccination), days 2-180
measure: Incidence of severe adverse events during the trial
timeFrame: Day 1 (2 and 5-8 hours after vaccination/revaccination), days 2-180
measure: Number of participants with abnormal changes in physical examination data
timeFrame: Days 0 (screening), 3, 7, 28, 56
measure: Number of participants with abnormal changes of neurological status
timeFrame: Days 0 (screening), 3, 7, 28, 56
measure: Number of participants with abnormal changes in vital signs - Blood pressure (BP)
timeFrame: Days 0 (screening), 3, 7, 28, 56
measure: Number of participants with abnormal changes in vital signs - Heart rate (HR)
timeFrame: Days 0 (screening), 3, 7, 28, 56
measure: Number of participants with abnormal changes in vital signs - Respiratory rate (RR)
timeFrame: Days 0 (screening), 3, 7, 28, 56
measure: Number of participants with abnormal changes in vital signs - Body temperature
timeFrame: Day 0 (screening); 10 min before, 20 min and 2 hours after vaccination; days 3, 7, 28, 56
measure: Number of participants with clinically significant abnormalities - Complete blood count (CBC)
timeFrame: Days 0 (screening), 3
measure: Number of participants with clinically significant abnormalities - Biochemical blood test (BBT)
timeFrame: Days 0 (screening), 3
measure: Number of participants with clinically significant abnormalities - Urinalysis
timeFrame: Days 0 (screening), 3
measure: Number of participants with abnormal changes of total IgE
timeFrame: Days 0 (screening), 3, 56
Other outcomes:
Locations:
city: Saint Petersburg
country: Russian Federation
facility: LLC "Energiya zdorov'ya"
city: Saint Petersburg
country: Russian Federation
facility: St. Petersburg State Budgetary Institution of Health Care "Children's City Polyclinic No. 45" of the Nevsky District
Study officials:
affiliation: St. Petersburg Research Institute of Vaccines and Sera
name: Ellina Ruzanova, PhD
role: STUDY_DIRECTOR
References: