Status:
COMPLETED
A 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
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 clinic...
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 manufacture...
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 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
Key Trial Info
Start Date :
August 8 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 4 2023
Estimated Enrollment :
217 Patients enrolled
Trial Details
Trial ID
NCT05245552
Start Date
August 8 2022
End Date
August 4 2023
Last Update
May 28 2024
Active Locations (4)
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1
Huaiyin Center for Diseases Control and Prevention
Huai'an, Jiangsu, China, 223300
2
Ganyu District Center for Disease Control and Prevention
Lianyungang, Jiangsu, China, 222100
3
Donghai District Center for Disease Prevention and Control
Lianyungang, Jiangsu, China, 222300
4
Binhai District Center for Disease Control and Prevention
Yancheng, Jiangsu, China, 224500