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

NCT04993365 | Completed Phase 4

• 1 other identifier: PRO-nCOV-4002
• Study Type: interventional
• Target: 520
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

COVID-19

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (9)

• Immunogenicity index-Seropositivity rate of the neutralizing antibody to live SARS-CoV-2

  Day 28 after the second dose of COVID-19 vaccine

• Immunogenicity index- GMT of the neutralizing antibody to live SARS-CoV-2

  Day 28 after the second dose of COVID-19 vaccine

• Immunogenicity index-GMI of the neutralizing antibody to live SARS-CoV-2

  Day 28 after the second dose of COVID-19 vaccine

• Immunogenicity index-Seropositive rate of the neutralizing antibody to EV71

  Day 28 after the second dose of EV71

• Immunogenicity index-GMT of the neutralizing antibody to EV71

  Day 28 after the second dose of EV71

Other Outcomes (4)

• Immunogenicity index-Seropositive rate of the neutralizing antibody to live SARS-CoV-2

  6 months after the second dose of COVID-19 vaccine

• Immunogenicity index- GMT of the neutralizing antibody to live SARS-CoV-2

  6 months after the second dose of COVID-19 vaccine

• Immunogenicity index-Seropositive rate of the neutralizing antibody to EV71

  6 months after the second dose of EV71 vaccine

Study Arms (2)

Experimental Group

EXPERIMENTAL

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

Control Group

ACTIVE COMPARATOR

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

Interventions

Experimental Group BIOLOGICAL

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.

Also known as: Combined immunization group

Experimental Group

Control Group BIOLOGICAL

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.

Also known as: Non-combined immunization group

Control Group

Eligibility Criteria

• Age: 3 Years - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Sinovac Research and Development Co., Ltd.: lead

Study Sites (2)

Yangchun Center for Disease Control and Prevention

Yangchun, Guangdong, 529699, China

Location

Zhanjiang Center for Disease Control and Prevention

Zhanjiang, Guangdong, 524005, China

Location

Related Publications (1)

• Shu Y, Sun Z, Gao F, Huang Z, Meng X, Chen S, Shu Q, Wang L, Zhang H, Ying Z, Zhang J. Immunogenicity and safety of an inactivated COVID-19 vaccine (CoronaVac(R)) co-administered with an inactivated enterovirus type 71 vaccine (Inlive(R)): A phase 4, randomized, controlled trial. Hum Vaccin Immunother. 2024 Dec 31;20(1):2402644. doi: 10.1080/21645515.2024.2402644. Epub 2024 Sep 23.

  PMID: 39313857 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Zhuhang Huang, Master

  Guangdong Center for Disease Prevention and Control

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2021
• First Posted: August 6, 2021
• Study Start: November 5, 2021
• Primary Completion: July 14, 2022
• Study Completion: July 14, 2022
• Last Updated: October 10, 2023

Record last verified: 2023-10

Locations

CN (2)