A Phase III Clinical Trial of Quadrivalent Influenza Vaccine in Healthy Subjects Aged 6 to 35 Months
Seasonal Influenza
About this trial
This is an interventional prevention trial for Seasonal Influenza
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
Sites / Locations
- Huoqiu County Center for Disease Control and Prevention
- Zhushan County Center for Diseases Control and PreventionRecruiting
- Nanzhang County Center for Disease Prevention and ControlRecruiting
- Laohekou Center for Disease Control and PreventionRecruiting
- Digui County Center for Disease Control and PreventionRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Active Comparator
Active Comparator
Experimental Group of quadrivalent influenza vaccine(0.25ml)
Experimental Group of quadrivalent influenza vaccine(0.5ml)
Control Group of trivalent influenza vaccine(BV)
Control Group of trivalent influenza vaccine(BY)
1100 subjects phase III will receive two doses of quadrivalent influenza vaccine(0.25ml) according to the immunization schedule of day 0,28
1100 subjects phase III will receive two doses of quadrivalent influenza vaccine(0.5ml) according to the immunization schedule of day 0,28
550 subjects phase III will receive two doses of trivalent influenza vaccine(BV) according to the immunization schedule of day 0,28.
550 subjects phase III will receive two doses of trivalent influenza vaccine(BY) according to the immunization schedule of day 0,28.