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

Primary Purpose

Influenza, Influenza, Human, Influenza Viral Infections

Status
Recruiting
Phase
Phase 3
Locations
Russian Federation
Study Type
Interventional
Intervention
Influenza vaccine [inactivated]
Influenza vaccine [inactivated]
Sponsored by
St. Petersburg Research Institute of Vaccines and Sera
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Influenza focused on measuring Influenza, Flu, Vaccine, Vaccination, SPbSRIVS, Flu-M Tetra

Eligibility Criteria

6 Months - 17 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria: For volunteers aged 10 to 17 years: Healthy children of both sexes aged 10 to 17 years (10 years 0 months 0 days - 17 years 11 months 30 days); The availability of written and dated informed consent of the volunteer (children aged 14 to 17 years) and their parent / legally acceptable representative 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 menses in the medical history shall have a negative pregnancy test result. For volunteers aged 3 to 9 years: Healthy children of both sexes aged 3 to 9 years (3 years 0 months 0 days - 9 years 11 months 30 days); The availability of written and dated informed consent of a parent / legally acceptable representative 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 availability of written and dated informed consent of a parent / legally acceptable representative 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: The ability of a volunteer's parents / legally acceptable representatives to perform the requirements of the Protocol (i.e., fill out the Patient Diary, attend visits together with the volunteer). Exclusion Criteria: History of influenza (including in mothers for children aged 6 to 35 months) or previous influenza vaccination during 6 months before the trial; Vaccination of the pregnant woman in the 2nd-3rd trimester (for the age group of 6 - 35 months) with an influenza vaccine Positive result of the SARS-CoV-2 test; 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 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; Allergic reactions to vaccine components or any previous vaccination; History of allergic reaction to chicken protein; History of cancer, leukemia, tuberculosis, autoimmune diseases; Carriage of HIV, syphilis, hepatitis B and C in the medical history, including by parents / legally acceptable representatives; 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 (more than 14 days) of any immunomodulating medicines less than 3 months before the start 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; Children with hemophilia who may develop bleeding after intramuscular injection; History of progressive neurological pathology, convulsive syndrome, afebrile convulsions; History of acute infectious diseases (fever ≥ 37.5°С): recovery less than 2 weeks before vaccination; Participation in another clinical trial less than 3 months before the start of the trial; History of mental illness of the child and the volunteer's parents; The history of the volunteer's parent / legally acceptable representative being registered with a tuberculosis dispensary and/or a narcological dispensary; Maternal history of drug use or alcohol abuse during pregnancy and/or breastfeeding; Pronounced congenital malformations in a child; Suspected developmental delay in a child.

Sites / Locations

  • State Autonomous Health Care Institution of the Sverdlovsk Region "Children's City Clinical Hospital No. 11"
  • State Autonomous Health Care Institution "Engels City Clinical Hospital No1"Recruiting
  • Llc "Olla-Med"Recruiting
  • LLC "Professorskaya Clinica"
  • State Budgetary Healthcare Institution of the Perm Territory "City Children's Clinical Clinic No. 5"
  • LLC PiterClinicaRecruiting
  • LLC "DNA Research Center"Recruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Active Comparator

Experimental

Active Comparator

Experimental

Active Comparator

Arm Label

Flu-M Tetra vaccine, children aged 10 to 17 years old

VaxigripTetra vaccine, children aged 10 to 17 years old

Flu-M Tetra vaccine, children aged 3 to 9 years old

VaxigripTetra vaccine, children aged 3 to 9 years old

Flu-M Tetra vaccine, children aged 6 to 35 months old

VaxigripTetra vaccine, children aged 6 to 35 months old

Arm Description

Сhildren will be vaccinated a single 0.5 mL dose of the Flu-M Tetra vaccine intramuscularly

Сhildren will be vaccinated a single 0.5 mL dose of the VaxigripTetra vaccine intramuscularly

Сhildren will be vaccinated a single 0.5 mL dose of the Flu-M Tetra vaccine intramuscularly or double dose for volunteers who have not been vaccinated before

Сhildren will be vaccinated a single 0.5 mL dose of the VaxigripTetra vaccine intramuscularly or double dose for volunteers who have not been vaccinated before

Сhildren will be vaccinated twice 0.25 mL dose of the Flu-M Tetra vaccine intramuscularly

Сhildren will be vaccinated twice 0.25 mL dose of the VaxigripTetra vaccine intramuscularly

Outcomes

Primary Outcome Measures

Change from Baseline Geometric mean titer (GMT) ratio of antibodies for each virus strain (A (H1N1), A (H3N2) and B)
Geometric mean titer (GMT) of antibodies in the blood serums of vaccinated participants in haemagglutination inhibition assay

Secondary Outcome Measures

Change from Baseline Seroconversion factor for each virus strain (A (H1N1), A (H3N2) and B)
Seroconversion factor is an increase in the geometric mean titers of antibodies at Day 28 vs. the baseline level, expressed in the fold rise
Change from Baseline Seroprotection rate for each virus strain (A (H1N1), A (H3N2) and B)
Seroprotection rate refers to the percentage of subjects with a generated protective HA titer (at least 1:40) vs. the baseline level
Change from Baseline Seroconversion rate for each virus strain (A (H1N1), A (H3N2) and B)
Seroconversion rate refers to the percentage of subjects who have a prevaccination titer of influenza haemagglutinin antibody titer (HA titer) ≤ 1:10 and a post-vaccination HA titer ≥ 1:40 or a prevaccination HA titer > 1:10 and at least a 4-fold increase in post-vaccination HA titer vs. the baseline
Incidence of immediate adverse events (allergic reactions)
Incidence of local adverse events
Incidence of systemic adverse events
Incidence of other adverse reactions
Incidence of severe adverse events
Withdrawal of a volunteer from the trial due to development of an AE/SAE associated with the use of the trial products
Number of participants with abnormal physical examination findings
Physical examination of volunteers includes an interview, discovery of complaints and symptoms, when required, palpation, auscultation, percussion. It is necessary to conduct an examination of the following organs and systems: skin, mucosa, eyes, oral cavity and pharynx, lungs/chest, heart/cardiovascular system, abdominal organs, nervous system, lymph nodes, musculoskeletal system
Number of participants with abnormal changes in vital signs - Blood pressure (BP)
BP is assessed in children aged 36 months and older. BP measurements include the systolic and diastolic blood pressure.
Number of participants with abnormal changes in vital signs - Heart rate (HR)
HR is measured using a phonendoscope at the apex of the heart during 1 minute.
Number of participants with abnormal changes in vital signs - Respiratory rate (RR)
RR is counted with a hand placed on the child's chest or abdomen or by holding a stethoscope at the child's nose. The measurement is conducted during one minute.
Number of participants with abnormal changes in vital signs - Body temperature
The body temperature is measured with a digital thermometer.
Number of participants with clinically significant abnormalities - Complete blood count (CBC)
Hemoglobin, Hematocrit, Erythrocytes, Leukocytes, Leukocytic Formula, Platelets, Erythrocyte Sedimentation Rate (ESR)
Number of participants with clinically significant abnormalities - Biochemical blood test (BBT)
ALT, AST, Alkaline Phosphatase, Total Bilirubin, Total Protein, Urea, Glucose
Number of participants with clinically significant abnormalities - Urinalysis
pH, Color, Relative Density/Specific Gravity, Protein, Glucose, Red Blood Cells, White Blood Cells
Number of participants with abnormal changes of total IgE
Number of participants with abnormal neurological examinations

Full Information

First Posted
February 13, 2023
Last Updated
August 29, 2023
Sponsor
St. Petersburg Research Institute of Vaccines and Sera
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1. Study Identification

Unique Protocol Identification Number
NCT05739474
Brief Title
Tolerability, Safety and Immunogenicity Trial of the Flu-M Tetra Vaccine in Children
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 19, 2022 (Actual)
Primary Completion Date
June 30, 2023 (Actual)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
St. Petersburg Research Institute of Vaccines and Sera

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza, Influenza, Human, Influenza Viral Infections, Vaccine Reaction
Keywords
Influenza, Flu, Vaccine, Vaccination, SPbSRIVS, Flu-M Tetra

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
948 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Flu-M Tetra vaccine, children aged 10 to 17 years old
Arm Type
Experimental
Arm Description
Сhildren will be vaccinated a single 0.5 mL dose of the Flu-M Tetra vaccine intramuscularly
Arm Title
VaxigripTetra vaccine, children aged 10 to 17 years old
Arm Type
Active Comparator
Arm Description
Сhildren will be vaccinated a single 0.5 mL dose of the VaxigripTetra vaccine intramuscularly
Arm Title
Flu-M Tetra vaccine, children aged 3 to 9 years old
Arm Type
Experimental
Arm Description
Сhildren will be vaccinated a single 0.5 mL dose of the Flu-M Tetra vaccine intramuscularly or double dose for volunteers who have not been vaccinated before
Arm Title
VaxigripTetra vaccine, children aged 3 to 9 years old
Arm Type
Active Comparator
Arm Description
Сhildren will be vaccinated a single 0.5 mL dose of the VaxigripTetra vaccine intramuscularly or double dose for volunteers who have not been vaccinated before
Arm Title
Flu-M Tetra vaccine, children aged 6 to 35 months old
Arm Type
Experimental
Arm Description
Сhildren will be vaccinated twice 0.25 mL dose of the Flu-M Tetra vaccine intramuscularly
Arm Title
VaxigripTetra vaccine, children aged 6 to 35 months old
Arm Type
Active Comparator
Arm Description
Сhildren will be vaccinated twice 0.25 mL dose of the VaxigripTetra vaccine intramuscularly
Intervention Type
Biological
Intervention Name(s)
Influenza vaccine [inactivated]
Other Intervention Name(s)
Flu-M Tetra Inactivated Split Quadrivalent Influenza Vaccine
Intervention Description
solution for intramuscular injection, 1 dose (0.5 mL)
Intervention Type
Biological
Intervention Name(s)
Influenza vaccine [inactivated]
Other Intervention Name(s)
VaxigripTetra (inactivated split influenza vaccine)
Intervention Description
suspension for intramuscular and subcutaneous injection, 1 dose (0.5 mL)
Primary Outcome Measure Information:
Title
Change from Baseline Geometric mean titer (GMT) ratio of antibodies for each virus strain (A (H1N1), A (H3N2) and B)
Description
Geometric mean titer (GMT) of antibodies in the blood serums of vaccinated participants in haemagglutination inhibition assay
Time Frame
Baseline (day 1) and 28 days after vaccination (Stage I, II, III) and revaccination (Stage II, III)
Secondary Outcome Measure Information:
Title
Change from Baseline Seroconversion factor for each virus strain (A (H1N1), A (H3N2) and B)
Description
Seroconversion factor is an increase in the geometric mean titers of antibodies at Day 28 vs. the baseline level, expressed in the fold rise
Time Frame
Baseline (day 1) and 28 days after vaccination (Stage I, II, III) and revaccination (Stage II, III)
Title
Change from Baseline Seroprotection rate for each virus strain (A (H1N1), A (H3N2) and B)
Description
Seroprotection rate refers to the percentage of subjects with a generated protective HA titer (at least 1:40) vs. the baseline level
Time Frame
Baseline (day 1) and 28 days after vaccination (Stage I, II, III) and revaccination (Stage II, III)
Title
Change from Baseline Seroconversion rate for each virus strain (A (H1N1), A (H3N2) and B)
Description
Seroconversion rate refers to the percentage of subjects who have a prevaccination titer of influenza haemagglutinin antibody titer (HA titer) ≤ 1:10 and a post-vaccination HA titer ≥ 1:40 or a prevaccination HA titer > 1:10 and at least a 4-fold increase in post-vaccination HA titer vs. the baseline
Time Frame
Baseline (day 1) and 28 days after vaccination (Stage I, II, III) and revaccination (Stage II, III)
Title
Incidence of immediate adverse events (allergic reactions)
Time Frame
2 hours after vaccination
Title
Incidence of local adverse events
Time Frame
7 days after vaccination
Title
Incidence of systemic adverse events
Time Frame
7 days after vaccination
Title
Incidence of other adverse reactions
Time Frame
Days 8 to 28 after vaccination
Title
Incidence of severe adverse events
Time Frame
Days 1 to 28+3 (for participants with 1 vaccination), Day 1 to 56±3 (for participants with vaccination and revaccination)
Title
Withdrawal of a volunteer from the trial due to development of an AE/SAE associated with the use of the trial products
Time Frame
Days 1 to 28+3 (for participants with 1 vaccination), Day 1 to 56±3 (for participants with vaccination and revaccination)
Title
Number of participants with abnormal physical examination findings
Description
Physical examination of volunteers includes an interview, discovery of complaints and symptoms, when required, palpation, auscultation, percussion. It is necessary to conduct an examination of the following organs and systems: skin, mucosa, eyes, oral cavity and pharynx, lungs/chest, heart/cardiovascular system, abdominal organs, nervous system, lymph nodes, musculoskeletal system
Time Frame
Days 1, 3, 7, 28+3 (for participants with 1 vaccination), Days 1,3,7,28+3,56±3 (for participants with vaccination and revaccination)
Title
Number of participants with abnormal changes in vital signs - Blood pressure (BP)
Description
BP is assessed in children aged 36 months and older. BP measurements include the systolic and diastolic blood pressure.
Time Frame
Days 1, 3, 7, 28+3 (for participants with 1 vaccination), Days 1,3,7,28+3,56±3 (for participants with vaccination and revaccination)
Title
Number of participants with abnormal changes in vital signs - Heart rate (HR)
Description
HR is measured using a phonendoscope at the apex of the heart during 1 minute.
Time Frame
Days 1, 3, 7, 28+3 (for participants with 1 vaccination), Days 1,3,7,28+3,56±3 (for participants with vaccination and revaccination)
Title
Number of participants with abnormal changes in vital signs - Respiratory rate (RR)
Description
RR is counted with a hand placed on the child's chest or abdomen or by holding a stethoscope at the child's nose. The measurement is conducted during one minute.
Time Frame
Days 1, 3, 7, 28+3 (for participants with 1 vaccination), Days 1,3,7,28+3,56±3 (for participants with vaccination and revaccination)
Title
Number of participants with abnormal changes in vital signs - Body temperature
Description
The body temperature is measured with a digital thermometer.
Time Frame
Days 1, 3, 7, 28+3 (for participants with 1 vaccination), Days 1,3,7,28+3,56±3 (for participants with vaccination and revaccination)
Title
Number of participants with clinically significant abnormalities - Complete blood count (CBC)
Description
Hemoglobin, Hematocrit, Erythrocytes, Leukocytes, Leukocytic Formula, Platelets, Erythrocyte Sedimentation Rate (ESR)
Time Frame
Days 1, 3
Title
Number of participants with clinically significant abnormalities - Biochemical blood test (BBT)
Description
ALT, AST, Alkaline Phosphatase, Total Bilirubin, Total Protein, Urea, Glucose
Time Frame
Days 1, 3
Title
Number of participants with clinically significant abnormalities - Urinalysis
Description
pH, Color, Relative Density/Specific Gravity, Protein, Glucose, Red Blood Cells, White Blood Cells
Time Frame
Days 1, 3
Title
Number of participants with abnormal changes of total IgE
Time Frame
Days 1, 3
Title
Number of participants with abnormal neurological examinations
Time Frame
Days 1, 3, 7, 28+3 (for participants with 1 vaccination), Days 1,3,7,28+3,56±3 (for participants with vaccination and revaccination)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: For volunteers aged 10 to 17 years: Healthy children of both sexes aged 10 to 17 years (10 years 0 months 0 days - 17 years 11 months 30 days); The availability of written and dated informed consent of the volunteer (children aged 14 to 17 years) and their parent / legally acceptable representative 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 menses in the medical history shall have a negative pregnancy test result. For volunteers aged 3 to 9 years: Healthy children of both sexes aged 3 to 9 years (3 years 0 months 0 days - 9 years 11 months 30 days); The availability of written and dated informed consent of a parent / legally acceptable representative 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 availability of written and dated informed consent of a parent / legally acceptable representative 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: The ability of a volunteer's parents / legally acceptable representatives to perform the requirements of the Protocol (i.e., fill out the Patient Diary, attend visits together with the volunteer). Exclusion Criteria: History of influenza (including in mothers for children aged 6 to 35 months) or previous influenza vaccination during 6 months before the trial; Vaccination of the pregnant woman in the 2nd-3rd trimester (for the age group of 6 - 35 months) with an influenza vaccine Positive result of the SARS-CoV-2 test; 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 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; Allergic reactions to vaccine components or any previous vaccination; History of allergic reaction to chicken protein; History of cancer, leukemia, tuberculosis, autoimmune diseases; Carriage of HIV, syphilis, hepatitis B and C in the medical history, including by parents / legally acceptable representatives; 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 (more than 14 days) of any immunomodulating medicines less than 3 months before the start 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; Children with hemophilia who may develop bleeding after intramuscular injection; History of progressive neurological pathology, convulsive syndrome, afebrile convulsions; History of acute infectious diseases (fever ≥ 37.5°С): recovery less than 2 weeks before vaccination; Participation in another clinical trial less than 3 months before the start of the trial; History of mental illness of the child and the volunteer's parents; The history of the volunteer's parent / legally acceptable representative being registered with a tuberculosis dispensary and/or a narcological dispensary; Maternal history of drug use or alcohol abuse during pregnancy and/or breastfeeding; Pronounced congenital malformations in a child; Suspected developmental delay in a child.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ellina Ruzanova, PhD
Phone
(812) 660-06-39
Email
e.a.ruzanova@niivs.ru
First Name & Middle Initial & Last Name or Official Title & Degree
Alla Emelyanova, PhD
Phone
(812) 660-06-39
Email
a.b.emelyanova@niivs.ru
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ellina Ruzanova, PhD
Organizational Affiliation
St. Petersburg Research Institute of Vaccines and Sera
Official's Role
Study Director
Facility Information:
Facility Name
State Autonomous Health Care Institution of the Sverdlovsk Region "Children's City Clinical Hospital No. 11"
City
Ekaterinburg
Country
Russian Federation
Individual Site Status
Active, not recruiting
Facility Name
State Autonomous Health Care Institution "Engels City Clinical Hospital No1"
City
Engel's
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Oksana Nesterenko, PhD
Facility Name
Llc "Olla-Med"
City
Moscow
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Plekhanova, MD
Facility Name
LLC "Professorskaya Clinica"
City
Perm
Country
Russian Federation
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Svetlana Teplykh, PhD
Facility Name
State Budgetary Healthcare Institution of the Perm Territory "City Children's Clinical Clinic No. 5"
City
Perm
Country
Russian Federation
Individual Site Status
Active, not recruiting
Facility Name
LLC PiterClinica
City
Saint Petersburg
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tatiana Pak, PhD
Facility Name
LLC "DNA Research Center"
City
Saratov
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Inna Gamova, PhD

12. IPD Sharing Statement

Learn more about this trial

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

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