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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Combined immunization group | Experimental | 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. |
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| Non combined immunization group | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. | Biological | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety index-incidence of adverse reactions within 7 days after each dose | Incidence of adverse reactions within 7 days after each dose | Day 0-7 after each dose vaccination |
| Immunogenicity index-seroconversion rates of neutralizing antibody against SARS-CoV-2 | 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. | The 28th day after the second dose vaccination of the inactivated SARS-CoV-2 vaccine |
| Measure | Description | Time Frame |
|---|---|---|
| Safety index-incidence of adverse reactions within 56 days after the first dose vaccination | Incidence of adverse reactions within 56 days after the first dose vaccination | Day 0-56 after the first dose vaccination |
| Safety index-incidence of serious adverse events |
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Inclusion Criteria:
Exclusion Criteria:
Travel history / residence history of communities with case reports within 14 days;
History of contact with a SARS-CoV-2 infection (positive in nucleic acid test) within 14 days;
Have contacted patients with fever or respiratory symptoms from communities with case reports within 14 days;
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;
History of SARS-CoV-2 infection;
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.;
Autoimmune disease or immunodeficiency / immunosuppression;
Severe chronic diseases, severe cardiovascular diseases, hypertension and diabetes that cannot be controlled by drugs, liver or kidney diseases, malignant tumors, etc.;
Severe neurological disease (epilepsy, convulsions or convulsions) or mental illness;
Thyroid disease or history of thyroidectomy, spleenlessness, functional spleenlessness, spleenlessness 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;
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):
History of alcohol or drug abuse;
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;
Acute diseases or acute exacerbation of chronic diseases in the past 7 days;
Axillary temperature >37.0°C;
Already pregnant (including a positive urine pregnancy test) or are breastfeeding, planning to get pregnant within 3 months;
According to the investigator's judgment, the subject has any other factors that are not suitable for participating in the clinical trial.
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| Name | Affiliation | Role |
|---|---|---|
| Huakun Lv, Master | Zhejiang Provincial Center for Disease Control and Prevention | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaihua county Center for Disease Control and Prevention | Quzhou | Zhejiang | 324300 | China |
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|
| Two doses of inactivated SARS-CoV-2 vaccine at the schedule of day 0,28 and one dose Quadrivalent Influenza Vaccine on day 14. | Biological | 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. |
|
SAE will be collected throughout the clinical trial. |
| Day 0-56 after the first dose vaccination |
| Immunogenicity index-seropositive rates of neutralizing antibody against SARS-CoV-2 | Neutralizing antibody assay will be performed using the micro-neutralization method, and subjects with a antibody titer ≥1:8 will defined as seropositive. | The 28th day after each dose vaccination |
| Immunogenicity index-geometric mean titer (GMT) of neutralizing antibody against SARS-CoV-2 | Neutralizing antibody assay will be performed using the micro-neutralization method. | The 28th day after each dose vaccination |
| Immunogenicity index-geometric mean ratio (GMR) of neutralizing antibody against SARS-CoV-2 | Neutralizing antibody assay will be performed using the micro-neutralization method. Ratio of post-vaccination titer divided by baseline titer will be calculated. | The 28th day after each dose vaccination |
| Immunogenicity index-seroconversion rates of influenza HI antibodies | Seroconversion will be defined as a change from seronegative (<1:10) to protective (≥1:40), or ≥4 fold increase from baseline(≥1:10). | The 28th day after the vaccination |
| Immunogenicity index-protective rates of influenza HI antibodies | The standard of reaching the protective rate is that the antibody titer ≥1:40. | The 28th day after the vaccination |
| Immunogenicity index-geometric mean titer (GMT) of influenza HI antibodies | influenza HI antibodies assay will be performed using the micro hemagglutination inhibition test | The 28th day after the vaccination |
| Immunogenicity index-geometric mean ratio (GMR) of influenza HI antibodies | influenza HI antibodies assay will be performed using the micro hemagglutination inhibition test | The 28th day after the vaccination |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D009976 | Orthomyxoviridae Infections |
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