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A Clinical Trial of Quadrivalent Influenza Vaccine in Children Aged 3-8 Years Old

Primary Purpose

Seasonal Influenza

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Two doses of quadrivalent influenza vaccine
One dose of quadrivalent influenza vaccine
Sponsored by
Sinovac Biotech Co., Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Seasonal Influenza

Eligibility Criteria

3 Years - 8 Years (Child)All SexesAccepts Healthy Volunteers

vaccine-unprimed children

Inclusion Criteria:

  • Healthy children aged 3-8 years;
  • The subjects' guardians can understand and voluntarily sign the informed consent form;
  • Proven legal identity.

Exclusion Criteria:

  • Received any circulating seasonal influenza vaccine prior to enrollment or had an influenza vaccine schedule during the study;
  • Suffering from seasonal influenza in the past 6 moths;
  • History of asthma, history of allergy to the vaccine or vaccine components, or serious adverse reactions to the vaccine, such as urticaria, dyspnea, and angioedema;
  • Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.;
  • Autoimmune disease or immunodeficiency / immunosuppression;
  • Severe chronic diseases, severe cardiovascular diseases, hypertension and diabetes that cannot be controlled by drugs, liver or kidney diseases, malignant tumors, etc.;
  • Severe neurological disease (epilepsy, convulsions or convulsions) or mental illness;
  • Thyroid disease or history of thyroidectomy, asplenia,functional asplenia, asplenia or splenectomy resulting from any condition;
  • Diagnosed abnormal blood coagulation function (eg, lack of blood coagulation factors, blood coagulopathy, abnormal platelets) or obvious bruising or blood coagulation;
  • Immunosuppressive therapy, cytotoxic therapy, inhaled corticosteroids (excluding allergic rhinitis corticosteroid spray therapy, acute noncomplicated dermatitis superficial corticosteroid therapy) in the past 6 months;
  • History of drug abuse;
  • Receipt of blood products within in the past 3 months;
  • Receipt of other investigational drugs in the past 30 days;
  • Receipt of inactivated or subunit vaccines in the past 7 days;
  • Acute diseases or acute exacerbation of chronic diseases in the past 7 days;
  • Axillary temperature >37.0°C;
  • According to the investigator's judgment, the subject has any other factors that are not suitable for participating in the clinical trial. vaccine-primed children

Inclusion Criteria:

  • Healthy children aged 3-8 years;
  • The subjects' guardians can understand and voluntarily sign the informed consent form;
  • Proven legal identity;
  • Received at least 1 dose of seasonal influenza vaccine in previous epidemic seasons

Exclusion Criteria:

  • Received an seasonal influenza vaccine for the current epidemic season (2020-2021 epidemic season) prior to enrollment, or had an influenza vaccine schedule during the study;
  • Suffering from seasonal influenza in the past 6 moths;
  • History of asthma, history of allergy to the vaccine or vaccine components, or serious adverse reactions to the vaccine, such as urticaria, dyspnea, and angioedema;
  • Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.;
  • Autoimmune disease or immunodeficiency / immunosuppression;
  • Severe chronic diseases, severe cardiovascular diseases, hypertension and diabetes that cannot be controlled by drugs, liver or kidney diseases, malignant tumors, etc.;
  • Severe neurological disease (epilepsy, convulsions or convulsions) or mental illness;
  • Thyroid disease or history of thyroidectomy, asplenia, functional asplenia, asplenia or splenectomy resulting from any condition;
  • Diagnosed abnormal blood coagulation function (eg, lack of blood coagulation factors, blood coagulopathy, abnormal platelets) or obvious bruising or blood coagulation;
  • Immunosuppressive therapy, cytotoxic therapy, inhaled corticosteroids (excluding allergic rhinitis corticosteroid spray therapy, acute noncomplicated dermatitis superficial corticosteroid therapy) in the past 6 months;
  • History of drug abuse;
  • Receipt of blood products within in the past 3 months;
  • Receipt of other investigational drugs in the past 30 days;
  • Receipt of attenuated live vaccines in the past 14 days;
  • Receipt of inactivated or subunit vaccines in the past 7 days;
  • Acute diseases or acute exacerbation of chronic diseases in the past 7 days;
  • Axillary temperature >37.0°C;
  • According to the investigator's judgment, the subject has any other factors that are not suitable for participating in the clinical trial.

Sites / Locations

  • Huaiyin Center for Disease Control and Prevention

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Experimental Group ：Vaccine-unprimed subjects with two doses

Experimental Group ：Vaccine-unprimed subjects with one dose

Experimental Group：Vaccine-primed subjects with one dose

Arm Description

200 vaccine-unprimed children will receive two doses of quadrivalent influenza vaccine on the immunization schedule of day 0,28.

200 vaccine-unprimed children will receive one dose of quadrivalent influenza vaccine.

200 vaccine-primed children will receive one dose of quadrivalent influenza vaccine.

Outcomes

Primary Outcome Measures

Immunogenicity index of the seroconversion rate
The seroconversion rate of each influenza strain after each dose of quadrivalent influenza vaccine
Immunogenicity index of the seroprotective rate
The seroprotective rate of each influenza strain after each dose of quadrivalent influenza vaccine
Immunogenicity index of the GMT
The GMT of each influenza strain after each dose of quadrivalent influenza vaccine
Immunogenicity index of the GMI
The GMI of each influenza strain after each dose of quadrivalent influenza vaccine
Safety index of the incidence of adverse reactions
The incidence of adverse reactions within 0-7 days after each dose
Safety index of the incidence of adverse reactions
The incidence of adverse reactions within 0-28 days after each dose
Safety index of the incidence of serious adverse events(SAEs)
The incidence of serious adverse events from the beginning of vaccination to 28 days after the last dose

Secondary Outcome Measures

Full Information

First Posted
August 2, 2021
Last Updated
August 9, 2022
Sponsor
Sinovac Biotech Co., Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT04997239
Brief Title
A Clinical Trial of Quadrivalent Influenza Vaccine in Children Aged 3-8 Years Old
Official Title
An Exploratory Clinical Trial to Evaluate the Immunogenicity and Safety of One vs Two Doses of Quadrivalent Influenza Vaccine in Children Aged 3-8 Years Old
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
October 10, 2021 (Actual)
Primary Completion Date
October 30, 2021 (Actual)
Study Completion Date
November 20, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sinovac Biotech Co., Ltd

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
This is an open-label, randomized and controlled phase Ⅳ clinical trial of quadrivalent influenza vaccine manufactured by Sinovac Biotech Co. , the purpose of this study is to compare the immunogenicity and safety after 1 dose of quadrivalent influenza vaccine with that of 2 doses in vaccine-unprimed children aged 3-8 years old,to compare the immunogenicity and safety after 1 dose of quadrivalent influenza vaccine in vaccine-unprimed children aged 3-8 years old with that of 1 dose in vaccine-primed children and to compare the immunogenicity and safety after 2 doses of quadrivalent influenza vaccine in vaccine-unprimed children aged 3-8 years old with that of 1 dose in vaccine-primed children.
Detailed Description
This study is open-label, randomized and controlled phase Ⅳ clinical trial of quadrivalent influenza vaccine.The purpose of this study is to compare the immunogenicity and safety after 1 dose of quadrivalent influenza vaccine with that of 2 doses in vaccine-unprimed children aged 3-8 years old,to compare the immunogenicity and safety after 1 dose of quadrivalent influenza vaccine in vaccine-unprimed children aged 3-8 years old with that of 1 dose in vaccine-primed children and to compare the immunogenicity and safety after 2 doses of quadrivalent influenza vaccine in vaccine-unprimed children aged 3-8 years old with that of 1 dose in vaccine-primed children.A total of 600 subjects including 400 vaccine-unprimed children and 200 vaccine-primed children will be enrolled,400 vaccine-unprimed children will be randomly divided into two groups in a 1:1 ratio.Subjects in group 1(experimental group 1 ) will receive two doses of quadrivalent influenza vaccine on the immunization schedule of day 0,28 and subjects in group 2 (experimental group 2) will receive one dose of quadrivalent influenza vaccine.200 vaccine-primed children (experimental group 3) will receive one dose of quadrivalent influenza vaccine.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Seasonal Influenza

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
600 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental Group ：Vaccine-unprimed subjects with two doses
Arm Type
Experimental
Arm Description
200 vaccine-unprimed children will receive two doses of quadrivalent influenza vaccine on the immunization schedule of day 0,28.
Arm Title
Experimental Group ：Vaccine-unprimed subjects with one dose
Arm Type
Experimental
Arm Description
200 vaccine-unprimed children will receive one dose of quadrivalent influenza vaccine.
Arm Title
Experimental Group：Vaccine-primed subjects with one dose
Arm Type
Experimental
Arm Description
200 vaccine-primed children will receive one dose of quadrivalent influenza vaccine.
Intervention Type
Biological
Intervention Name(s)
Two doses of quadrivalent influenza vaccine
Intervention Description
15ug hemagglutinin (HA) of each of the four influenza strains in 0.5 mL of sodium chloride, disodium hydrogen phosphate, sodium dihydrogen phosphate per injection.The routine of administation is Intramuscular injection into deltoid region.And the immunization schedule is two doses of quadrivalent influenza vaccine on day 0, 28.
Intervention Type
Biological
Intervention Name(s)
One dose of quadrivalent influenza vaccine
Intervention Description
15ug hemagglutinin (HA) of each of the four influenza strains in 0.5 mL of sodium chloride, disodium hydrogen phosphate, sodium dihydrogen phosphate per injection.The routine of administation is Intramuscular injection into deltoid region.And the immunization schedule is one dose of quadrivalent influenza vaccine on day 0.
Primary Outcome Measure Information:
Title
Immunogenicity index of the seroconversion rate
Description
The seroconversion rate of each influenza strain after each dose of quadrivalent influenza vaccine
Time Frame
28 days after the vaccination of the last dose
Title
Immunogenicity index of the seroprotective rate
Description
The seroprotective rate of each influenza strain after each dose of quadrivalent influenza vaccine
Time Frame
28 days after the vaccination of the last dose
Title
Immunogenicity index of the GMT
Description
The GMT of each influenza strain after each dose of quadrivalent influenza vaccine
Time Frame
28 days after the vaccination of the last dose
Title
Immunogenicity index of the GMI
Description
The GMI of each influenza strain after each dose of quadrivalent influenza vaccine
Time Frame
28 days after the vaccination of the last dose
Title
Safety index of the incidence of adverse reactions
Description
The incidence of adverse reactions within 0-7 days after each dose
Time Frame
From day 0 to day 7 after each dose vaccination
Title
Safety index of the incidence of adverse reactions
Description
The incidence of adverse reactions within 0-28 days after each dose
Time Frame
From day 0 to day 28 after each dose vaccination
Title
Safety index of the incidence of serious adverse events(SAEs)
Description
The incidence of serious adverse events from the beginning of vaccination to 28 days after the last dose
Time Frame
From the beginning of the vaccination to 28 days after the whole-schedule vaccination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
vaccine-unprimed children Inclusion Criteria: Healthy children aged 3-8 years; The subjects' guardians can understand and voluntarily sign the informed consent form; Proven legal identity. Exclusion Criteria: Received any circulating seasonal influenza vaccine prior to enrollment or had an influenza vaccine schedule during the study; Suffering from seasonal influenza in the past 6 moths; History of asthma, history of allergy to the vaccine or vaccine components, or serious adverse reactions to the vaccine, such as urticaria, dyspnea, and angioedema; Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.; Autoimmune disease or immunodeficiency / immunosuppression; Severe chronic diseases, severe cardiovascular diseases, hypertension and diabetes that cannot be controlled by drugs, liver or kidney diseases, malignant tumors, etc.; Severe neurological disease (epilepsy, convulsions or convulsions) or mental illness; Thyroid disease or history of thyroidectomy, asplenia,functional asplenia, asplenia or splenectomy resulting from any condition; Diagnosed abnormal blood coagulation function (eg, lack of blood coagulation factors, blood coagulopathy, abnormal platelets) or obvious bruising or blood coagulation; Immunosuppressive therapy, cytotoxic therapy, inhaled corticosteroids (excluding allergic rhinitis corticosteroid spray therapy, acute noncomplicated dermatitis superficial corticosteroid therapy) in the past 6 months; History of drug abuse; Receipt of blood products within in the past 3 months; Receipt of other investigational drugs in the past 30 days; Receipt of inactivated or subunit vaccines in the past 7 days; Acute diseases or acute exacerbation of chronic diseases in the past 7 days; Axillary temperature >37.0°C; According to the investigator's judgment, the subject has any other factors that are not suitable for participating in the clinical trial. vaccine-primed children Inclusion Criteria: Healthy children aged 3-8 years; The subjects' guardians can understand and voluntarily sign the informed consent form; Proven legal identity; Received at least 1 dose of seasonal influenza vaccine in previous epidemic seasons Exclusion Criteria: Received an seasonal influenza vaccine for the current epidemic season (2020-2021 epidemic season) prior to enrollment, or had an influenza vaccine schedule during the study; Suffering from seasonal influenza in the past 6 moths; History of asthma, history of allergy to the vaccine or vaccine components, or serious adverse reactions to the vaccine, such as urticaria, dyspnea, and angioedema; Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.; Autoimmune disease or immunodeficiency / immunosuppression; Severe chronic diseases, severe cardiovascular diseases, hypertension and diabetes that cannot be controlled by drugs, liver or kidney diseases, malignant tumors, etc.; Severe neurological disease (epilepsy, convulsions or convulsions) or mental illness; Thyroid disease or history of thyroidectomy, asplenia, functional asplenia, asplenia or splenectomy resulting from any condition; Diagnosed abnormal blood coagulation function (eg, lack of blood coagulation factors, blood coagulopathy, abnormal platelets) or obvious bruising or blood coagulation; Immunosuppressive therapy, cytotoxic therapy, inhaled corticosteroids (excluding allergic rhinitis corticosteroid spray therapy, acute noncomplicated dermatitis superficial corticosteroid therapy) in the past 6 months; History of drug abuse; Receipt of blood products within in the past 3 months; Receipt of other investigational drugs in the past 30 days; Receipt of attenuated live vaccines in the past 14 days; Receipt of inactivated or subunit vaccines in the past 7 days; Acute diseases or acute exacerbation of chronic diseases in the past 7 days; Axillary temperature >37.0°C; According to the investigator's judgment, the subject has any other factors that are not suitable for participating in the clinical trial.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hongxing Pan, Master
Organizational Affiliation
Jiangsu Provincial Center for Disease Prevention and Control
Official's Role
Principal Investigator
Facility Information:
Facility Name
Huaiyin Center for Disease Control and Prevention
City
Huai'an
State/Province
Jiangsu
ZIP/Postal Code
223300
Country
China

12. IPD Sharing Statement

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A Clinical Trial of Quadrivalent Influenza Vaccine in Children Aged 3-8 Years Old

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