Study on Combined Vaccination With SARS-CoV-2 Inactivated Vaccine and Quadrivalent Influenza Vaccine
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Combined immunization group The combined immunization group is randomly divided into two subgroups, 120 subjects in each group. The combined immunization subgroup Ⅰ receive SARS-CoV-2 inactivated vaccine (Vero cell)&Quadrivalent Influenza Vaccine on day0 and SARS-CoV-2 inactivated vaccine (Vero cell) (second dose) on day 28.The combined immunization subgroup Ⅱ receive SARS-CoV-2 inactivated vaccine (Vero cell) on day 0 and SARS-CoV-2 inactivated vaccine (Vero cell) (second dose) & Quadrivalent Influenza Vaccine on day 28. |
Biological: Two doses of inactivated SARS-CoV-2 vaccine at the schedule of day 0,28 and one dose Quadrivalent Influenza Vaccine on day 0 or day 28.
The inactivated SARS-CoV-2 vaccine was manufactured by Sinovac Research & Development Co., Ltd., with a antigen content of 600SU/0.5ml. The Quadrivalent Influenza Vaccine manufactured by Sinovac Biotech Co.,Ltd. including 4 antigens H1N1, H3N2, BV and BY, 15μg for each, 0.5ml per dose.
|
| Experimental: Non combined immunization group The non combined immunization group receive SARS-CoV-2 inactivated vaccine (Vero cell)(first dose) on day 0, Quadrivalent Influenza Vaccine on day 14 and SARS-CoV-2 inactivated vaccine (Vero cell)(second dose) on day 28. |
Biological: Two doses of inactivated SARS-CoV-2 vaccine at the schedule of day 0,28 and one dose Quadrivalent Influenza Vaccine on day 14.
The inactivated SARS-CoV-2 vaccine was manufactured by Sinovac Research & Development Co., Ltd., with a antigen content of 600SU/0.5ml. The Quadrivalent Influenza Vaccine manufactured by Sinovac Biotech Co.,Ltd. including 4 antigens H1N1, H3N2, BV and BY, 15μg for each, 0.5ml per dose.
|
Outcome Measures
Primary Outcome Measures
- 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
- 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 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-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.
- 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-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.
- 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 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
Eligibility Criteria
Criteria
Inclusion Criteria:
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Healthy adults aged 18-59 years;
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The subject can understand and voluntarily sign the informed consent form;
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Proven legal identity
Exclusion Criteria:
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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):
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Blood routine test: white blood cell count, hemoglobin, platelet count;
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Detection of blood biochemical indicators: alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin (TBIL), creatinine (CR), fasting blood glucose;
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Kaihua county Center for Disease Control and Prevention | Quzhou | Zhejiang | China | 324300 |
Sponsors and Collaborators
- Sinovac Research and Development Co., Ltd.
Investigators
- Principal Investigator: Huakun Lv, Master, Zhejiang Provincial Center for Disease Control and Prevention
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PRO-QINF-4001