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

Phase 4

Completed

• Conditions: COVID-19; Influenza
• Interventions: 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.; 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.

• 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.

Study Timeline

• Status Verified: 2021-03
• Study First Submitted: 2021-03-15
• Study First Submitted QC: 2021-03-15
• Study First Posted: 2021-03-17
• Study Start: 2021-03-23
• Primary Completion: 2021-05-28
• Study Completion: 2021-05-28
• Last Update Submitted: 2021-07-23
• Last Update Posted: 2021-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 480

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Combined immunization group	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 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.
Non combined immunization group	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 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.

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