Clinical trial NCT06049927: A Phase III Clinical Trial of Quadrivalent Influenza Vaccine in Healthy Subjects Aged 6 to 35 Months
Official title: An 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: 2023-09-22
Enrollment: 3300
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: A phase III clinical trial of the study of quadrivalent influenza vaccine developed by Sinovac Biotech will be conducted in Chinese children aged 6 to 35 months. The trial is an randomized, double-blind and active controlled study. The objective of this study is to evaluate the Immunogenicity and safety of the vaccine.

Detailed description: A phase III clinical trial of the study of quadrivalent influenza vaccine developed by Sinovac Biotech will be conducted in Chinese children aged 6 to 35 months. The trial is an randomized, double-blind and active controlled study. The objective 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 3300 subjects will be enrolled. The subjects 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, according to 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 allergy to the vaccine or vaccine components, or serious adverse reactions to the vaccine, such as urticaria, dyspnea, angioedema and asthma;
* 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 (such as systemic lupus erythematosus) or immunodeficiency / immunosuppression (such as HIV, after organ transplantation)
* 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;
* Continuous use of corticosteroids or other immunosuppressive agents for ≥ 14 days within the past 6 months (excluding allergic rhinitis corticosteroid spray therapy, acute noncomplicated dermatitis superficial corticosteroid therapy) and cytotoxic 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: Seroconversion rates of HI antibody
timeFrame: 28 days after full schedule immunization
measure: Geometric Mean Titers (GMTs) of HI antibody
timeFrame: 28 days after full schedule immunization
measure: Number of Participants With Seroprotection to Influenza Vaccine Antigens
timeFrame: 28 days after full schedule immunization
Secondary outcomes:
measure: GMIs of HI antibody
timeFrame: 28 days after full schedule immunization
measure: Incidence of adverse reactions
timeFrame: 0-30 days after each dose
measure: Incidence of adverse reactions
timeFrame: 0-7 days after each dose
measure: Incidence of Serious adverse events
timeFrame: Since the beginning of vaccination until 6 months after the last dose
measure: Incidence of AESI
timeFrame: since the beginning of vaccination until 6 months after the last dose
Other outcomes:
Locations:
city: Lu'an
country: China
facility: Huoqiu County Center for Disease Control and Prevention
state: Anhui
city: Shiyan
country: China
facility: Zhushan County Center for Diseases Control and Prevention
state: Hubei
city: Xiangyang
country: China
facility: Nanzhang County Center for Disease Prevention and Control
state: Hubei
city: Xiangyang
country: China
facility: Laohekou Center for Disease Control and Prevention
state: Hubei
city: Yichang
country: China
facility: Digui County Center for Disease Control and Prevention
state: Hubei
Study officials:
affiliation: Hubei Provincial Center for Disease Prevention and Control
name: Lei Wang
role: PRINCIPAL_INVESTIGATOR
affiliation: Anhui Provincial Center for Disease Prevention and Control
name: Jihai Tang
role: PRINCIPAL_INVESTIGATOR
References: