Study on Combined Vaccination With SARS-CoV-2 Inactivated Vaccine and Quadrivalent Influenza Vaccine

COVID-19 Clinical Trial

Official title:

A Study 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04801888
• Other study ID #: PRO-QINF-4001
• Status: Completed
• Phase: Phase 4
• Start date: March 23, 2021
• Est. completion date: May 28, 2021

Study information

• Verified date: March 2021
• Source: Sinovac Biotech Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Completed
• Enrollment: 480
• Est. completion date: May 28, 2021
• Est. primary completion date: May 28, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 59 Years

Eligibility

Inclusion Criteria:

• Healthy adults aged 18-59 years;
• The subject can understand and voluntarily sign the informed consent form;
• Proven legal identity

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):

1. Blood routine test: white blood cell count, hemoglobin, platelet count;

2. Detection of blood biochemical indicators: alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin (TBIL), creatinine (CR), fasting blood glucose;

3. Urine routine index: urine protein (PRO);

• 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.

Related Conditions & MeSH terms

• COVID-19
• Influenza
• Influenza, Human

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Kaihua county Center for Disease Control and Prevention	Quzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Sinovac Research and Development Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Secondary	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
Secondary	Safety index-incidence of serious adverse events	SAE will be collected throughout the clinical trial.	Day 0-56 after the first dose vaccination
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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