Immunogenicity And Safety of COVID-19 Vaccine , Inactivated Co -Administration With EV71 Vaccine (Vero Cell)

A Randomized and Controlled Ⅳ Clinical Trial to Evaluate the Immunogenicity and Safety of COVID-19 Vaccine (Vero Cell), Inactivated Co-administrated With EV71 Vaccine (Vero Cell) in Children Aged 3-5 Years Old

This study is a randomized and controlled phase Ⅳ clinical trial of the COVID-19 vaccine (Vero cell), Inactivated manufactured by Sinovac Research & Development Co., Ltd. The purpose of this study is to evaluate the immunogenicity and safety of COVID-19 vaccine (Vero cell), Inactivated co-administration with EV71 vaccine

Study Overview

• Status: Completed
• Conditions: COVID-19
• Intervention / Treatment: Biological: Experimental Group; Biological: Control Group

Detailed Description

This study is a randomized and controlled phase Ⅳ clinical trial in children aged 3-5 years old. The purpose of this study is to evaluate the immunogenicity and safety of COVID-19 vaccine (Vero cell), Inactivated co-administration with EV71 vaccine.The COVID-19 vaccine was manufactured by Sinovac Research & Development Co., Ltd, and the EV71 vaccine was manufactured by Sinovac Biotech Co.A total of 520 subjects aged 3-5 years old will be enrolled.Subjects will be randomly divided into 2 groups in a ratio of 1:1.The experimental group is the combined immunization group, which will receive the first dose of COVID-19 vaccine and the second dose of COVID-19 vaccine and EV71 vaccine on day 28;Control group is the Non-combined immunization group , which will receive the first dose of COVID-19 vaccine on day 0 ，the first dose of EV71 vaccine on day 14 ，the second dose of COVID-19 vaccine on day 28 and the second dose of EV71 vaccine on day 42.

• Study Type: Interventional
• Enrollment (Actual): 520
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Yangchun, Guangdong, China, 529699
      • Yangchun Center for Disease Control and Prevention
    • Zhanjiang, Guangdong, China, 524005
      • Zhanjiang Center for Disease Control and Prevention

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 3 years (Child)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Children aged 3-5 years ;
• The subject and/or guardian can understand and voluntarily sign the informed consent form
• Proven legal identity;

Exclusion Criteria:

• History of contact with a SARS-CoV-2 infection (positive in nucleic acid test) within 14 days;
• History of multiple system inflammatory syndrome (MIS-C);
• History of hand, foot and mouth disease, herpetic angina or EV71 vaccination;
• 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 (Systemic lupus erythematosus)or immunodeficiency / immunosuppression(HIV,history after organ transplantation)；
• 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, asplenia,functional asplenia, asplenia 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;
• History of 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;
• Severe neurological disease (epilepsy, convulsions or convulsions) or mental illness;
• Axillary temperature >37.0°C;
• The subjects participated in other clinical trials during the follow-up period, or will be planned 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Group; The experimental group is also called the combined immunization group .260 participants will receive the first dose of COVID-19 vaccine and EV71 vaccine on day 0 and the second dose of COVID-19 vaccine and EV71 vaccine on day 28.	Biological: Experimental Group; The COVID-19 vaccine was manufactured by Sinovac Research & Development Co., Ltd, and the EV71 vaccine was manufactured by Sinovac Biotech Co. The COVID-19 vaccine:600SU inactivated virus in 0.5 mL of aluminium hydroxide solution per injection;The EV71 vaccine:Inactivated EV71 virus antigen no less than 3.0EU in 0.5 mL of aluminium hydroxide solution per injection.; Other Names: Combined immunization group
Active Comparator: Control Group; The control group is also called the Non-combined immunization group.260 participants will receive the first dose of COVID-19 vaccine on day 0,the first dose of EV71 vaccine on day 14,the second dose of COVID-19 vaccine on day 28 and the second dose of EV71 vaccine on day 42.	Biological: Control Group; The COVID-19 vaccine was manufactured by Sinovac Research & Development Co., Ltd, and the EV71 vaccine was manufactured by Sinovac Biotech Co. The COVID-19 vaccine:600SU inactivated virus in 0.5 mL of aluminium hydroxide solution per injection;The EV71 vaccine:Inactivated EV71 virus antigen no less than 3.0EU in 0.5 mL of aluminium hydroxide solution per injection.; Other Names: Non-combined immunization group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Immunogenicity index-Seroconversion rate of the neutralizing antibody to live SARS-CoV-2	Seroconversion rate of the neutralizing antibody to live SARS-CoV-2 at day 28 after the second dose of COVID-19 vaccine	Day 28 after the second dose of COVID-19 vaccine
Immunogenicity index-Seroconversion rate of the neutralizing antibody to EV71	Seroconversion rate of the neutralizing antibody to EV71 at day 28 after the second dose of EV71 vaccine	Day 28 after the second dose of EV71 vaccine

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Immunogenicity index-Seropositivity rate of the neutralizing antibody to live SARS-CoV-2	Seropositivity rate of the neutralizing antibody to live SARS-CoV-2 at day 28 after the second dose of COVID-19 vaccine.	Day 28 after the second dose of COVID-19 vaccine
Immunogenicity index- GMT of the neutralizing antibody to live SARS-CoV-2	GMT of the neutralizing antibody to live SARS-CoV-2 at day 28 after after the second dose of COVID-19 vaccine.	Day 28 after the second dose of COVID-19 vaccine
Immunogenicity index-GMI of the neutralizing antibody to live SARS-CoV-2	GMI of the neutralizing antibody to live SARS-CoV-2 at day 28 after after the second dose of COVID-19 vaccine.	Day 28 after the second dose of COVID-19 vaccine
Immunogenicity index-Seropositive rate of the neutralizing antibody to EV71	Seropositive rate of the neutralizing antibody to EV71 at day 28 after the second dose of EV71	Day 28 after the second dose of EV71
Immunogenicity index-GMT of the neutralizing antibody to EV71	GMT of the neutralizing antibody to EV71 at day 28 after the second dose of EV71	Day 28 after the second dose of EV71
Immunogenicity index-GMI of the neutralizing antibody to EV71	GMI of the neutralizing antibody to EV71 at day 28 after the second dose of EV71	Day 28 after the second dose of EV71
Safety index-Incidence of the adverse reactions	Incidence of the adverse reactions from day 0 to day 7 after each dose	From day 0 to day 7 after each dose
Safety index-Incidence of the adverse reactions	Incidence of the adverse reactions from day 0 to 28 days after the last dose	From day 0 to 28 days after the last dose
Safety index-Incidence of the serious adverse events and the adverse events of special interest	Incidence of the serious adverse events and the adverse events of special interest from the beginning vaccination to 6 months after the last dose	From the beginning vaccination to 6 months after the last dose

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Immunogenicity index-Seropositive rate of the neutralizing antibody to live SARS-CoV-2	Seropositive rate and GMT of the neutralizing antibody to live SARS-CoV-2 6 months after the second dose of COVID-19 vaccine	6 months after the second dose of COVID-19 vaccine
Immunogenicity index- GMT of the neutralizing antibody to live SARS-CoV-2	GMT of the neutralizing antibody to live SARS-CoV-2 6 months after the second dose of COVID-19 vaccine	6 months after the second dose of COVID-19 vaccine
Immunogenicity index-Seropositive rate of the neutralizing antibody to EV71	Seropositive rate of the neutralizing antibody to EV71 6 months after the second dose of EV71 vaccine	6 months after the second dose of EV71 vaccine
Immunogenicity index-GMT of the neutralizing antibody to EV71	GMT of the neutralizing antibody to EV71 6 months after the second dose of EV71 vaccine.	6 months after the second dose of EV71 vaccine

Collaborators and Investigators

• Sponsor: Sinovac Research and Development Co., Ltd.
• Investigators: Principal Investigator: Zhuhang Huang, Master, Guangdong Center for Disease Prevention and Control

Study record dates

Study Major Dates

• Study Start (Actual): November 5, 2021
• Primary Completion (Actual): July 14, 2022
• Study Completion (Actual): July 14, 2022

Study Registration Dates

• First Submitted: August 2, 2021
• First Submitted That Met QC Criteria: August 4, 2021
• First Posted (Actual): August 6, 2021

Study Record Updates

• Last Update Posted (Estimated): October 10, 2023
• Last Update Submitted That Met QC Criteria: October 7, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: PRO-nCOV-4002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No