Seasonal Influenza Clinical Trial
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
Verified date | May 2024 |
Source | Sinovac Biotech Co., Ltd |
Contact | Lei Wang |
Phone | 18986142864 |
372491281[@]qq.com | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Recruiting |
Enrollment | 3300 |
Est. completion date | May 31, 2024 |
Est. primary completion date | May 31, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 6 Months to 35 Months |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
China | Huoqiu County Center for Disease Control and Prevention | Lu'an | Anhui |
China | Zhushan County Center for Diseases Control and Prevention | Shiyan | Hubei |
China | Laohekou Center for Disease Control and Prevention | Xiangyang | Hubei |
China | Nanzhang County Center for Disease Prevention and Control | Xiangyang | Hubei |
China | Digui County Center for Disease Control and Prevention | Yichang | Hubei |
Lead Sponsor | Collaborator |
---|---|
Sinovac Biotech Co., Ltd |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Seroconversion rates of HI antibody | Anti-influenza antibodies were measured using HAI assay for 4 strains: H1N1, H3N2, B Victoria and B Yamagata. Seroconversion was defined as pre-vaccination titer <1:10 and post-vaccination titer =1:40, and Significant increase was defined as pre-vaccination titer=1:40 and = 4-fold increase of post-vaccination titer. | 28 days after full schedule immunization | |
Primary | Geometric Mean Titers (GMTs) of HI antibody | Anti-influenza antibody levels were measured using hemagglutination inhibition (HAI) assay for 4 strains: H1N1, H3N2, B Victoria, B Yamagata. | 28 days after full schedule immunization | |
Primary | Number of Participants With Seroprotection to Influenza Vaccine Antigens | Anti-influenza antibodies were measured using HAI assay for 4 strains: H1N1, H3N2, B Victoria and B Yamagata. Seroprotection was defined as an antibody titer =1:40 at pre-vaccination and at post-final vaccination. | 28 days after full schedule immunization | |
Secondary | GMIs of HI antibody | Anti-influenza antibody were measured using hemagglutination inhibition (HAI) assay for 4 strains: H1N1, H3N2, B Victoria, B Yamagata. GMI is the increase fold of GMT post vaccination compared with pre vaccination | 28 days after full schedule immunization | |
Secondary | Incidence of adverse reactions | Incidence of adverse reaction 0-30 days after each dose | 0-30 days after each dose | |
Secondary | Incidence of adverse reactions | Incidence of adverse reaction 0-7 days after each dose | 0-7 days after each dose | |
Secondary | Incidence of Serious adverse events | Incidence of serious adverse events from beginning of vaccination until 6 months after the last dose | Since the beginning of vaccination until 6 months after the last dose | |
Secondary | Incidence of AESI | Incidence of AESI since the beginning of vaccination until 6 months after the last dose | since the beginning of vaccination until 6 months after the last dose |
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