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

Primary Purpose

COVID-19, Influenza

Status

Completed

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

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.

Two doses of inactivated SARS-CoV-2 vaccine at the schedule of day 0,28 and one dose Quadrivalent Influenza Vaccine on day 14.

About this trial

This is an interventional prevention trial for COVID-19

Eligibility Criteria

18 Years - 59 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Kaihua county Center for Disease Control and Prevention

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Combined immunization group

Non combined immunization group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Safety index-incidence of adverse reactions within 7 days after each dose

Incidence of adverse reactions within 7 days after each dose

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.

Secondary Outcome Measures

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

Safety index-incidence of serious adverse events

SAE will be collected throughout the clinical trial.

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.

Immunogenicity index-geometric mean titer (GMT) of neutralizing antibody against SARS-CoV-2

Neutralizing antibody assay will be performed using the micro-neutralization method.

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.

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).

Immunogenicity index-protective rates of influenza HI antibodies

The standard of reaching the protective rate is that the antibody titer ≥1:40.

Immunogenicity index-geometric mean titer (GMT) of influenza HI antibodies

influenza HI antibodies assay will be performed using the micro hemagglutination inhibition test

Immunogenicity index-geometric mean ratio (GMR) of influenza HI antibodies

influenza HI antibodies assay will be performed using the micro hemagglutination inhibition test

Full Information

NCT ID

NCT04801888

First Posted

March 15, 2021

Last Updated

July 23, 2021

Sponsor

Sinovac Research and Development Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT04801888

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2021

Overall Recruitment Status

Completed

Study Start Date

March 23, 2021 (Actual)

Primary Completion Date

May 28, 2021 (Actual)

Study Completion Date

May 28, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sinovac Research and Development Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

COVID-19, Influenza

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

480 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Combined immunization group

Arm Type

Experimental

Arm Description

Arm Title

Non combined immunization group

Arm Type

Experimental

Arm Description

Intervention Type

Biological

Intervention Name(s)

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.

Intervention Description

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.

Intervention Type

Biological

Intervention Name(s)

Two doses of inactivated SARS-CoV-2 vaccine at the schedule of day 0,28 and one dose Quadrivalent Influenza Vaccine on day 14.

Intervention Description

Primary Outcome Measure Information:

Title

Safety index-incidence of adverse reactions within 7 days after each dose

Description

Incidence of adverse reactions within 7 days after each dose

Time Frame

Day 0-7 after each dose vaccination

Title

Immunogenicity index-seroconversion rates of neutralizing antibody against SARS-CoV-2

Description

Time Frame

The 28th day after the second dose vaccination of the inactivated SARS-CoV-2 vaccine

Secondary Outcome Measure Information:

Title

Safety index-incidence of adverse reactions within 56 days after the first dose vaccination

Description

Incidence of adverse reactions within 56 days after the first dose vaccination

Time Frame

Day 0-56 after the first dose vaccination

Title

Safety index-incidence of serious adverse events

Description

SAE will be collected throughout the clinical trial.

Time Frame

Day 0-56 after the first dose vaccination

Title

Immunogenicity index-seropositive rates of neutralizing antibody against SARS-CoV-2

Description

Neutralizing antibody assay will be performed using the micro-neutralization method, and subjects with a antibody titer ≥1:8 will defined as seropositive.

Time Frame

The 28th day after each dose vaccination

Title

Immunogenicity index-geometric mean titer (GMT) of neutralizing antibody against SARS-CoV-2

Description

Neutralizing antibody assay will be performed using the micro-neutralization method.

Time Frame

The 28th day after each dose vaccination

Title

Immunogenicity index-geometric mean ratio (GMR) of neutralizing antibody against SARS-CoV-2

Description

Neutralizing antibody assay will be performed using the micro-neutralization method. Ratio of post-vaccination titer divided by baseline titer will be calculated.

Time Frame

The 28th day after each dose vaccination

Title

Immunogenicity index-seroconversion rates of influenza HI antibodies

Description

Seroconversion will be defined as a change from seronegative (<1:10) to protective (≥1:40), or ≥4 fold increase from baseline(≥1:10).

Time Frame

The 28th day after the vaccination

Title

Immunogenicity index-protective rates of influenza HI antibodies

Description

The standard of reaching the protective rate is that the antibody titer ≥1:40.

Time Frame

The 28th day after the vaccination

Title

Immunogenicity index-geometric mean titer (GMT) of influenza HI antibodies

Description

influenza HI antibodies assay will be performed using the micro hemagglutination inhibition test

Time Frame

The 28th day after the vaccination

Title

Immunogenicity index-geometric mean ratio (GMR) of influenza HI antibodies

Description

influenza HI antibodies assay will be performed using the micro hemagglutination inhibition test

Time Frame

The 28th day after the vaccination

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

59 Years

Accepts Healthy Volunteers

Eligibility Criteria

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): 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); 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Huakun Lv, Master

Organizational Affiliation

Zhejiang Provincial Center for Disease Control and Prevention

Official's Role

Principal Investigator

Facility Information:

Facility Name

Kaihua county Center for Disease Control and Prevention

City

Quzhou

State/Province

Zhejiang

ZIP/Postal Code

324300

Country

China

12. IPD Sharing Statement

Learn more about this trial

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

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