Clinical trial NCT04997239: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Seasonal Influenza
Lead sponsor: Sinovac Biotech Co., Ltd
Sponsor class: INDUSTRY
First posted: 2021-08-09
Enrollment: 600
Sex: ALL
Minimum age (years): 3
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Immunogenicity index of the seroconversion rate
timeFrame: 28 days after the vaccination of the last dose
measure: Immunogenicity index of the seroprotective rate
timeFrame: 28 days after the vaccination of the last dose
measure: Immunogenicity index of the GMT
timeFrame: 28 days after the vaccination of the last dose
measure: Immunogenicity index of the GMI
timeFrame: 28 days after the vaccination of the last dose
measure: Safety index of the incidence of adverse reactions
timeFrame: From day 0 to day 7 after each dose vaccination
measure: Safety index of the incidence of adverse reactions
timeFrame: From day 0 to day 28 after each dose vaccination
measure: Safety index of the incidence of serious adverse events(SAEs)
timeFrame: From the beginning of the vaccination to 28 days after the whole-schedule vaccination
Secondary outcomes:
Other outcomes:
Locations:
city: Huai'an
country: China
facility: Huaiyin Center for Disease Control and Prevention
state: Jiangsu
Study officials:
affiliation: Jiangsu Provincial Center for Disease Prevention and Control
name: Hongxing Pan, Master
role: PRINCIPAL_INVESTIGATOR
References: