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A Study of Booster Immunization With COVID-19 Vaccine,Inactivated Co -Administration With Influenza Vaccine and Pneumococcal Polysaccharide Vaccine

Primary Purpose

COVID-19

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Adult group in immunogenicity and safety study of combined immunization
Elderly group in immunogenicity and safety study of combined immunization
Adult group in safety observation study of combined immunization
Elderly group in safety observation study of combined immunization
Sponsored by
Sinovac Biotech Co., Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for COVID-19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy adults aged 18 years and above;
  • Have been received two doses of inactivated SARS-CoV-2 vaccine(CoronaVac)manufactured by Sinovac Research & Development Co., Ltd at an interval of 6 months or more;
  • Participants should be capable of understanding the informed consent form, and such form should be signed prior to enrolment ;
  • Proven legal identity;

Exclusion Criteria:

  • History of SARS-CoV-2 infection;
  • Have been received two doses of inactivated SARS-CoV-2 vaccine(CoronaVac)manufactured by Sinovac Research & Development Co., Ltd at an interval of less than 6 months;
  • Have received received any circulating seasonal influenza vaccine;
  • Have received any pneumococcal vaccine within 5 years;
  • 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;
  • History of uncontrolled epilepsy and other serious neurological diseases such as transverse myelitis, Guillain-Barre syndrome, demyelinating diseases;
  • History of fever at the time of vaccination, or acute onset of chronic disease, or severe uncontrolled chronic disease, or acute disease;
  • Already pregnant (including a positive urine pregnancy test) or are breastfeeding, planning to get pregnant within 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;
  • According to the investigator's judgment, the subject has any other factors that are not suitable for participating in the clinical trial.

Sites / Locations

  • Beijing Centers for Diseases Control and Prevention

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Adult group in immunogenicity and safety study of combined immunization

Elderly group in immunogenicity and safety study of combined immunization

Adult group in safety observation study of combined immunization

Elderly group in safety observation study of combined immunization

Arm Description

300 participants will be randomly divided into 3 subgroups of 100 people per group, each subject will receive 1 dose of COVID-19 vaccine, 1 dose of influenza vaccine and 1 dose of pneumonia vaccine

300 participants will be randomly divided into 3 subgroups of 100 people per group, each subject will receive 1 dose of COVID-19 vaccine, 1 dose of influenza vaccine and 1 dose of pneumonia vaccine

1200 participants will be randomly divided into 2 subgroups of 600 people per group, each subject will receive 1 dose of COVID-19 vaccine, 1 dose of influenza vaccine and 1 dose of pneumonia vaccine

1200 participants will be randomly divided into 2 subgroups of 600 people per group, each subject will receive 1 dose of COVID-19 vaccine, 1 dose of influenza vaccine and 1 dose of pneumonia vaccine

Outcomes

Primary Outcome Measures

Immunogenicity index of seroconversion rate of the neutralizing antibody
Seroconversion rate of the neutralizing antibody to live SARS-CoV-2 28 days after the booster immunization with the third single dose of COVID-19 vaccine

Secondary Outcome Measures

Immunogenicity index of seropositivity rate of the neutralizing antibody
Seropositivity rate of the neutralizing antibody to live SARS-CoV-2 28 days after combined immunization
Immunogenicity index of GMT of the neutralizing antibody
GMT of the neutralizing antibody to live SARS-CoV-2 28 days after combined immunization
Immunogenicity index of GMI of the neutralizing antibody
GMI of the neutralizing antibody to live SARS-CoV-2 28 days after combined immunization.
Immunogenicity index of seroconversion rate of 23 pneumonia antibodies
Seroconversion rate of 23 pneumonia antibodies 28 days after single and combined vaccination of 23 valent pneumonia vaccine.
Immunogenicity index of GMC increase of 23 pneumonia antibodies
GMC increase of 23 pneumonia antibodies 28 days after single and combined vaccination of 23 valent pneumonia vaccine
Immunogenicity index of seroconversion rate of 4 influenza antibodies
Seroconversion rate of 4 influenza antibodies 28 days after single and combined vaccination
Immunogenicity index of GMT of 4 influenza antibodies
GMT of 4 influenza antibodies 28 days after single and combined vaccination
Immunogenicity index of GMI of 4 influenza antibodies
GMI of 4 influenza antibodies 28 days after single and combined vaccination
Immunogenicity index of protection rate of 4 influenza antibodies
Protection rate of 4 influenza antibodies 28 days after single and combined vaccination

Full Information

First Posted
August 9, 2022
Last Updated
August 10, 2022
Sponsor
Sinovac Biotech Co., Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT05499351
Brief Title
A Study of Booster Immunization With COVID-19 Vaccine,Inactivated Co -Administration With Influenza Vaccine and Pneumococcal Polysaccharide Vaccine
Official Title
A Single Center, Randomized ,Controlled and Open Clinical Trial to Evaluate the Immunogenicity and Safety of the Booster Immunization With the Third Dose of COVID-19 Vaccine,Inactivated Co -Administration With Influenza Vaccine and Pneumococcal Polysaccharide Vaccine
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
October 15, 2021 (Actual)
Primary Completion Date
December 5, 2021 (Actual)
Study Completion Date
May 5, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sinovac Biotech Co., Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study is a single center , randomized ,controlled and open-label phase Ⅳclinical trial of the booster immunization with the third dose of inactivated COVID-19 vaccine(CoronaVac)manufactured by Sinovac Research & Development Co.,Ltd. The purpose of this study is to evaluate the immunogenicity and safety of the third dose of COVID-19 vaccine,inactivated (Vero Cell) co-administration with influenza vaccine and pneumococcal polysaccharide vaccine in healthy population aged 18 years and older.
Detailed Description
This study is a single center , randomized ,controlled and open-label phase Ⅳclinical trial in healthy adult aged 18 years and older. The purpose of this study is to evaluate the immunogenicity and safety of the third dose of COVID-19 vaccine,inactivated (Vero Cell) co-administration with influenza vaccine and pneumococcal polysaccharide vaccine.The COVID-19 vaccine was manufactured by Sinovac Research &Development Co., Ltd,and the quadrivalent influenza vaccine and 23-valent pneumococcal polysaccharide vaccine(PPV23) were manufactured by Sinovac Biotech Co.A total of 3000 subjects will be enrolled, with 300 aged 18~59years(adult group) and 300 aged 60 years and above(adult group) in the section of immunogenicity and safety of combined immunization ,with 1200 aged 18~59 years(adult group) and 1200 aged 60 years and above(elderly Group) in the section of safety observation study of combined immunization.Each age group will be randomly divided into 3 subgroups of 100 people per group, each subject will receive 1 dose of COVID-19 vaccine, 1 dose of influenza vaccine and 1 dose of pneumonia vaccine in the section of immunogenicity and safety of combined immunization and each age group will be randomly divided into 2 subgroups of 600 people per group, each subject will receive 1 dose of COVID-19 vaccine, 1 dose of influenza vaccine and 1 dose of pneumonia vaccine in the section of safety observation study of combined immunization.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3000 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Adult group in immunogenicity and safety study of combined immunization
Arm Type
Experimental
Arm Description
300 participants will be randomly divided into 3 subgroups of 100 people per group, each subject will receive 1 dose of COVID-19 vaccine, 1 dose of influenza vaccine and 1 dose of pneumonia vaccine
Arm Title
Elderly group in immunogenicity and safety study of combined immunization
Arm Type
Experimental
Arm Description
300 participants will be randomly divided into 3 subgroups of 100 people per group, each subject will receive 1 dose of COVID-19 vaccine, 1 dose of influenza vaccine and 1 dose of pneumonia vaccine
Arm Title
Adult group in safety observation study of combined immunization
Arm Type
Experimental
Arm Description
1200 participants will be randomly divided into 2 subgroups of 600 people per group, each subject will receive 1 dose of COVID-19 vaccine, 1 dose of influenza vaccine and 1 dose of pneumonia vaccine
Arm Title
Elderly group in safety observation study of combined immunization
Arm Type
Experimental
Arm Description
1200 participants will be randomly divided into 2 subgroups of 600 people per group, each subject will receive 1 dose of COVID-19 vaccine, 1 dose of influenza vaccine and 1 dose of pneumonia vaccine
Intervention Type
Biological
Intervention Name(s)
Adult group in immunogenicity and safety study of combined immunization
Intervention Description
The COVID-19 vaccine was manufactured by Sinovac Research & Development Co., Ltd,and the quadrivalent influenza vaccine and the 23-valent pneumococcal polysaccharide vaccine(PPV23) were manufactured by Sinovac Biotech Co.The COVID-19 vaccine:600SU inactivated virus in 0.5 mL of aluminium hydroxide solution per injection;The quadrivalent influenza vaccine:15ug hemagglutinin (HA) of each of the four influenza strains in 0.5 mL of sodium chloride, disodium hydrogen phosphate, sodium dihydrogen phosphate per injection;PPV23:capsular polysaccharides of 23 serotypes of pneumococcus in 0.5 mL of Sodium chloride, disodium hydrogen phosphate, sodium dihydrogen phosphate per injection.
Intervention Type
Biological
Intervention Name(s)
Elderly group in immunogenicity and safety study of combined immunization
Intervention Description
The COVID-19 vaccine was manufactured by Sinovac Research & Development Co., Ltd,and the quadrivalent influenza vaccine and the 23-valent pneumococcal polysaccharide vaccine(PPV23) were manufactured by Sinovac Biotech Co.The COVID-19 vaccine:600SU inactivated virus in 0.5 mL of aluminium hydroxide solution per injection;The quadrivalent influenza vaccine:15ug hemagglutinin (HA) of each of the four influenza strains in 0.5 mL of sodium chloride, disodium hydrogen phosphate, sodium dihydrogen phosphate per injection;PPV23:capsular polysaccharides of 23 serotypes of pneumococcus in 0.5 mL of Sodium chloride, disodium hydrogen phosphate, sodium dihydrogen phosphate per injection.
Intervention Type
Biological
Intervention Name(s)
Adult group in safety observation study of combined immunization
Intervention Description
The COVID-19 vaccine was manufactured by Sinovac Research & Development Co., Ltd,and the quadrivalent influenza vaccine and the 23-valent pneumococcal polysaccharide vaccine(PPV23) were manufactured by Sinovac Biotech Co.The COVID-19 vaccine:600SU inactivated virus in 0.5 mL of aluminium hydroxide solution per injection;The quadrivalent influenza vaccine:15ug hemagglutinin (HA) of each of the four influenza strains in 0.5 mL of sodium chloride, disodium hydrogen phosphate, sodium dihydrogen phosphate per injection;PPV23:capsular polysaccharides of 23 serotypes of pneumococcus in 0.5 mL of Sodium chloride, disodium hydrogen phosphate, sodium dihydrogen phosphate per injection.
Intervention Type
Biological
Intervention Name(s)
Elderly group in safety observation study of combined immunization
Intervention Description
The COVID-19 vaccine was manufactured by Sinovac Research & Development Co., Ltd,and the quadrivalent influenza vaccine and the 23-valent pneumococcal polysaccharide vaccine(PPV23) were manufactured by Sinovac Biotech Co.The COVID-19 vaccine:600SU inactivated virus in 0.5 mL of aluminium hydroxide solution per injection;The quadrivalent influenza vaccine:15ug hemagglutinin (HA) of each of the four influenza strains in 0.5 mL of sodium chloride, disodium hydrogen phosphate, sodium dihydrogen phosphate per injection;PPV23:capsular polysaccharides of 23 serotypes of pneumococcus in 0.5 mL of Sodium chloride, disodium hydrogen phosphate, sodium dihydrogen phosphate per injection.
Primary Outcome Measure Information:
Title
Immunogenicity index of seroconversion rate of the neutralizing antibody
Description
Seroconversion rate of the neutralizing antibody to live SARS-CoV-2 28 days after the booster immunization with the third single dose of COVID-19 vaccine
Time Frame
28 days after the booster immunization with the third dose of COVID-19 vaccine
Secondary Outcome Measure Information:
Title
Immunogenicity index of seropositivity rate of the neutralizing antibody
Description
Seropositivity rate of the neutralizing antibody to live SARS-CoV-2 28 days after combined immunization
Time Frame
28 days after combined immunization
Title
Immunogenicity index of GMT of the neutralizing antibody
Description
GMT of the neutralizing antibody to live SARS-CoV-2 28 days after combined immunization
Time Frame
28 days after combined immunization
Title
Immunogenicity index of GMI of the neutralizing antibody
Description
GMI of the neutralizing antibody to live SARS-CoV-2 28 days after combined immunization.
Time Frame
28 days after combined immunization
Title
Immunogenicity index of seroconversion rate of 23 pneumonia antibodies
Description
Seroconversion rate of 23 pneumonia antibodies 28 days after single and combined vaccination of 23 valent pneumonia vaccine.
Time Frame
28 days after single and combined vaccination of 23 valent pneumonia vaccine
Title
Immunogenicity index of GMC increase of 23 pneumonia antibodies
Description
GMC increase of 23 pneumonia antibodies 28 days after single and combined vaccination of 23 valent pneumonia vaccine
Time Frame
28 days after single and combined vaccination of 23 valent pneumonia vaccine
Title
Immunogenicity index of seroconversion rate of 4 influenza antibodies
Description
Seroconversion rate of 4 influenza antibodies 28 days after single and combined vaccination
Time Frame
28 days after single and combined vaccination
Title
Immunogenicity index of GMT of 4 influenza antibodies
Description
GMT of 4 influenza antibodies 28 days after single and combined vaccination
Time Frame
28 days after single and combined vaccination
Title
Immunogenicity index of GMI of 4 influenza antibodies
Description
GMI of 4 influenza antibodies 28 days after single and combined vaccination
Time Frame
28 days after single and combined vaccination
Title
Immunogenicity index of protection rate of 4 influenza antibodies
Description
Protection rate of 4 influenza antibodies 28 days after single and combined vaccination
Time Frame
28 days after single and combined vaccination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy adults aged 18 years and above; Have been received two doses of inactivated SARS-CoV-2 vaccine(CoronaVac)manufactured by Sinovac Research & Development Co., Ltd at an interval of 6 months or more; Participants should be capable of understanding the informed consent form, and such form should be signed prior to enrolment ; Proven legal identity; Exclusion Criteria: History of SARS-CoV-2 infection; Have been received two doses of inactivated SARS-CoV-2 vaccine(CoronaVac)manufactured by Sinovac Research & Development Co., Ltd at an interval of less than 6 months; Have received received any circulating seasonal influenza vaccine; Have received any pneumococcal vaccine within 5 years; 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; History of uncontrolled epilepsy and other serious neurological diseases such as transverse myelitis, Guillain-Barre syndrome, demyelinating diseases; History of fever at the time of vaccination, or acute onset of chronic disease, or severe uncontrolled chronic disease, or acute disease; Already pregnant (including a positive urine pregnancy test) or are breastfeeding, planning to get pregnant within 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; 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
Jiang Wu, Master
Organizational Affiliation
Beijing Center for Disease Control and Prevention
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Centers for Diseases Control and Prevention
City
Beijing
ZIP/Postal Code
100013
Country
China

12. IPD Sharing Statement

Learn more about this trial

A Study of Booster Immunization With COVID-19 Vaccine,Inactivated Co -Administration With Influenza Vaccine and Pneumococcal Polysaccharide Vaccine

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