Study on Combined Vaccination With SARS-CoV-2 Inactivated Vaccine and Quadrivalent Influenza Vaccine
- Conditions
- COVID-19Influenza
- Registration Number
- NCT04801888
- Lead Sponsor
- Sinovac Research and Development Co., Ltd.
- Brief Summary
This study is an open-label, single-center, randomized phase IV clinical trial of the SARS-CoV-2 inactivated vaccine manufactured by Sinovac Research \& Development Co., Ltd. The purpose of this study is to evaluate the safety and immunogenicity of concomitant administration of the SARS-CoV-2 Inactivated Vaccine (Vero cell) with Quadrivalent Influenza Vaccine in adults aged from 18 to 59 Years
- Detailed Description
This study is an open-label, single-center, randomized phase IV clinical trial of the SARS-CoV-2 inactivated vaccine (Vero cell) manufactured by Sinovac Research \& Development Co., Ltd. The purpose of this study is to evaluate the safety and immunogenicity of concomitant administration of the SARS-CoV-2 Inactivated Vaccine (Vero cell) with Quadrivalent Influenza Vaccine in adults aged from 18 to 59 Years. 480 healthy adults as participants are randomly assigned into two groups in the ratio 1:1. The first group was the combined immunization group, which is randomly divided into two subgroups, 120 subjects in each group. The combined immunization subgroup Ⅰ receive SARS-CoV-2 inactivated vaccine \&Quadrivalent Influenza Vaccine on day 0 and SARS-CoV-2 inactivated vaccine (second dose) on day 28.The combined immunization subgroup Ⅱ receive SARS-CoV-2 inactivated vaccine on day 0 and SARS-CoV-2 inactivated vaccine (second dose) \& Quadrivalent Influenza Vaccine on day 28. The second group was the non combined immunization group，which receive SARS-CoV-2 inactivated vaccine (first dose) on day 0, Quadrivalent Influenza Vaccine on day 14 and SARS-CoV-2 inactivated vaccine (second dose) on day 28.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 480
- Healthy adults aged 18-59 years;
- The subject can understand and voluntarily sign the informed consent form;
- Proven legal identity
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Travel history / residence history of communities with case reports within 14 days;
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History of contact with a SARS-CoV-2 infection (positive in nucleic acid test) within 14 days;
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Have contacted patients with fever or respiratory symptoms from communities with case reports within 14 days;
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Two or more cases of fever and / or respiratory symptoms in a small contact area of volunteers, such as home, office etc. within 14 days;
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History of SARS-CoV-2 infection;
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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;
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Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.;
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Autoimmune disease or immunodeficiency / immunosuppression;
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Severe chronic diseases, severe cardiovascular diseases, hypertension and diabetes that cannot be controlled by drugs, liver or kidney diseases, malignant tumors, etc.;
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Severe neurological disease (epilepsy, convulsions or convulsions) or mental illness;
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Thyroid disease or history of thyroidectomy, spleenlessness, functional spleenlessness, spleenlessness or splenectomy resulting from any condition;
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Diagnosed abnormal blood coagulation function (eg, lack of blood coagulation factors, blood coagulopathy, abnormal platelets) or obvious bruising or blood coagulation;
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Immunosuppressive therapy, cytotoxic therapy, inhaled corticosteroids (excluding allergic rhinitis corticosteroid spray therapy, acute noncomplicated dermatitis superficial corticosteroid therapy) in the past 6 months;
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Physical examination has clinically significant abnormal hematology and biochemistry laboratory test results that exceed the reference value range (only applicable to phase I clinical trials):
- Blood routine test: white blood cell count, hemoglobin, platelet count;
- Detection of blood biochemical indicators: alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin (TBIL), creatinine (CR), fasting blood glucose;
- Urine routine index: urine protein (PRO);
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History of alcohol or drug abuse;
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Receipt of blood products within in the past 3 months;
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Receipt of other investigational drugs in the past 30 days;
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Receipt of attenuated live vaccines in the past 14 days;
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Receipt of inactivated or subunit vaccines in the past 7 days;
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Acute diseases or acute exacerbation of chronic diseases in the past 7 days;
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Axillary temperature >37.0°C;
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Already pregnant (including a positive urine pregnancy test) or are breastfeeding, planning to get pregnant within 3 months;
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According to the investigator's judgment, the subject has any other factors that are not suitable for participating in the clinical trial.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Safety index-incidence of adverse reactions within 7 days after each dose Day 0-7 after each dose vaccination Incidence of adverse reactions within 7 days after each dose
Immunogenicity index-seroconversion rates of neutralizing antibody against SARS-CoV-2 The 28th day after the second dose vaccination of the inactivated SARS-CoV-2 vaccine Neutralizing antibody assay will be performed using the micro-neutralization method. Seroconversion will be defined as a change from seronegative (\<1:8) to seropositive (≥1:8), or ≥4 fold increase from baseline.
- Secondary Outcome Measures
Name Time Method Immunogenicity index-geometric mean ratio (GMR) of neutralizing antibody against SARS-CoV-2 The 28th day after each dose vaccination Neutralizing antibody assay will be performed using the micro-neutralization method. Ratio of post-vaccination titer divided by baseline titer will be calculated.
Safety index-incidence of adverse reactions within 56 days after the first dose vaccination Day 0-56 after the first dose vaccination Incidence of adverse reactions within 56 days after the first dose vaccination
Safety index-incidence of serious adverse events Day 0-56 after the first dose vaccination SAE will be collected throughout the clinical trial.
Immunogenicity index-seropositive rates of neutralizing antibody against SARS-CoV-2 The 28th day after each dose vaccination Neutralizing antibody assay will be performed using the micro-neutralization method, and subjects with a antibody titer ≥1:8 will defined as seropositive.
Immunogenicity index-geometric mean titer (GMT) of influenza HI antibodies The 28th day after the vaccination influenza HI antibodies assay will be performed using the micro hemagglutination inhibition test
Immunogenicity index-geometric mean titer (GMT) of neutralizing antibody against SARS-CoV-2 The 28th day after each dose vaccination Neutralizing antibody assay will be performed using the micro-neutralization method.
Immunogenicity index-seroconversion rates of influenza HI antibodies The 28th day after the vaccination Seroconversion will be defined as a change from seronegative (\<1:10) to protective (≥1:40), or ≥4 fold increase from baseline(≥1:10).
Immunogenicity index-geometric mean ratio (GMR) of influenza HI antibodies The 28th day after the vaccination influenza HI antibodies assay will be performed using the micro hemagglutination inhibition test
Immunogenicity index-protective rates of influenza HI antibodies The 28th day after the vaccination The standard of reaching the protective rate is that the antibody titer ≥1:40.
Trial Locations
- Locations (1)
Kaihua county Center for Disease Control and Prevention
🇨🇳Quzhou, Zhejiang, China
Kaihua county Center for Disease Control and Prevention🇨🇳Quzhou, Zhejiang, China