A Clinical Trial of Quadrivalent Influenza Vaccine in Healthy Subjects Aged 6 to 35 Months

Sinovac

Status and phase: Completed; Phase 3

Conditions: Seasonal Influenza

Treatments: Biological: Trivalent influenza vaccine(BY); Biological: Trivalent influenza vaccine(BV); Biological: Quadrivalent influenza vaccine(0.5ml); Biological: Quadrivalent influenza vaccine(0.25ml)

Study type: Interventional

Funder types: Industry

Identifiers

NCT05245552

PRO-QINF-3003

Details and patient eligibility

About

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.

Full 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.

Enrollment: 217 patients

Sex: All

Ages: 6 to 35 months old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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217 participants in 5 patient groups

Safety group

Experimental group

Description:

PhaseⅠ,30 subjects will receive two doses of quadrivalent influenza vaccine(0.5ml) on the immunization schedule of day 0,28.

Treatment:

Biological: Quadrivalent influenza vaccine(0.25ml)

Experimental Group of quadrivalent influenza vaccine(0.25ml)

Experimental group

Description:

1100 subjects phase III will receive two doses of quadrivalent influenza vaccine(0.25ml) on the immunization schedule of day 0,28.

Treatment:

Biological: Quadrivalent influenza vaccine(0.25ml)

Experimental Group of quadrivalent influenza vaccine(0.5ml)

Experimental group

Description:

1100 subjects phase III will receive two doses of quadrivalent influenza vaccine(0.5ml) on the immunization schedule of day 0,28.

Treatment:

Biological: Quadrivalent influenza vaccine(0.5ml)

Control Group of trivalent influenza vaccine(BV)

Active Comparator group

Description:

550 subjects phase III will receive two doses of trivalent influenza vaccine(BV) on the immunization schedule of day 0,28.

Treatment:

Biological: Trivalent influenza vaccine(BV)

Control Group of trivalent influenza vaccine(BY)

Active Comparator group

Description:

550 subjects phase III will receive two doses of trivalent influenza vaccine(BY) on the immunization schedule of day 0,28.

Treatment:

Biological: Trivalent influenza vaccine(BY)