Clinical trial NCT05245552: A Clinical Trial of Quadrivalent Influenza Vaccine in Healthy Subjects Aged 6 to 35 Months
Official title: An Open Phase I and Randomized, Double-blind, Controlled Phase III Clinical Trial to Evaluate the Safety and Immunogenicity of Quadrivalent Influenza Vaccine in Healthy Subjects Aged 6 to 35months.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Seasonal Influenza
Lead sponsor: Sinovac Biotech Co., Ltd
Sponsor class: INDUSTRY
First posted: 2022-02-18
Enrollment: 217
Sex: ALL
Minimum age (years): 6
Maximum age (years): 35
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The study of quadrivalent influenza vaccine manufactured by Sinovac Biotech Co., Ltd will conduct in two phases,the phaseⅠclinical trial of the study will be open-label design,and the phase III clinical trial of the study will be randomized, double-blind, active controlled design.the purpose of this study is to evaluate the safety and immunogenicity of quadrivalent influenza vaccine in healthy subjects aged 6 to 35 months.

Detailed description: This study of quadrivalent influenza vaccine will be open-label design in phase Ⅰ and randomized, double-blind, active controlled design in phase III.The quadrivalent influenza vaccine was manufactured by Sinovac Biotech Co., Ltd.

The purpose of this study is to evaluate the safety and immunogenicity of quadrivalent influenza vaccine(0.25ml and 0.5ml) manufactured by Sinovac Biotech Co., Ltd in healthy infants aged from 6 to 35 months. A total of 3330 subjects including 30 subjects in phase Ⅰ and 3300 subjects in phase III will be enrolled. The subjects in phase Ⅰ will receive 2 doses of quadrivalent influenza vaccine(0.5ml) on the immunization schedule of day 0,28.The subjects in phase III will be randomly assigned to 4 groups in a 2:2:1:1 ratio and subjects will receive two doses of quadrivalent influenza vaccine(0.25ml or 0.5ml) or trivalent influenza vaccine(BV or BY), respectively,on the immunization schedule of day 0,28 in each group.

Eligibility criteria: Inclusion Criteria:

* Healthy infants aged 6-35 months;
* Proven vaccination certificate and birth certificate;
* The subjects' guardians can understand and voluntarily sign the informed consent form.

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;
* Axillary temperature \>37.0°C;
* 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.;
* Severe chronic diseases(Such as down syndrome, diabetes, sickle cell anaemia or neurological disorders);
* Severe neurological disease (epilepsy, convulsions or convulsions) or mental illness;
* Autoimmune disease or immunodeficiency / immunosuppression;
* 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;
* Acute diseases or acute exacerbation of chronic diseases in the past 3 days;
* 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;
* Participated in other clinical trials before enrollment and in the follow-up period, or plans to participate in other clinical trials during the clinical trial;
* 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 seroconversion rate
timeFrame: 28 days after full schedule immunization
measure: Immunogenicity index of seroprotection rate
timeFrame: 28 days after full schedule immunization
measure: Immunogenicity index of GMT
timeFrame: 28 days after full schedule immunization
measure: Safety index of the incidence of adverse reaction
timeFrame: 0-28 days after each dose
measure: Safety index of the incidence of adverse reaction
timeFrame: 0-7 days after each dose
measure: Safety index of the incidence of abnormal blood biochemical indexes
timeFrame: 3 days after each dose
measure: Safety index of the incidence of SAE
timeFrame: Since the beginning of vaccination until 6 months after full course vaccination
Secondary outcomes:
measure: Safety index of the incidence of AESI
timeFrame: Since the beginning of vaccination until 6 months after full course vaccination
Other outcomes:
Locations:
city: Huai'an
country: China
facility: Huaiyin Center for Diseases Control and Prevention
state: Jiangsu
city: Lianyungang
country: China
facility: Ganyu District Center for Disease Control and Prevention
state: Jiangsu
city: Lianyungang
country: China
facility: Donghai District Center for Disease Prevention and Control
state: Jiangsu
city: Yancheng
country: China
facility: Binhai District 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: