Status:
COMPLETED
A Phase III Clinical Trial of Quadrivalent Influenza Vaccine in Healthy Subjects Aged 6 to 35 Months
Lead Sponsor:
Sinovac Biotech Co., Ltd
Conditions:
Seasonal Influenza
Eligibility:
All Genders
6-35 years
Phase:
PHASE3
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-bli...
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-bli...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 16 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 23 2024
Estimated Enrollment :
3300 Patients enrolled
Trial Details
Trial ID
NCT06049927
Start Date
September 16 2023
End Date
May 23 2024
Last Update
August 14 2025
Active Locations (5)
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1
Huoqiu County Center for Disease Control and Prevention
Lu'an, Anhui, China, 237400
2
Zhushan County Center for Diseases Control and Prevention
Shiyan, Hubei, China, 442200
3
Nanzhang County Center for Disease Prevention and Control
Xiangyang, Hubei, China, 441500
4
Laohekou Center for Disease Control and Prevention
Xiangyang, Hubei, China, 441800