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Evaluation of Immunogenicity and Safety of Combined Immunization of COVID-19 Vaccine (Produced in Beijing) and PPV23 / IIV4

Primary Purpose

Influenza, Human, Pneumonia, Pneumococcal, Covid19

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
COVAX+IIV4; COVAX+PPV23
COVAX only (1st and 2nd dose)
IIV4 for the 1st dose and PPV23 for the 2nd dose
Sponsored by
China National Biotec Group Company Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Influenza, Human

Eligibility Criteria

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

Inclusion criteria:

  • ≥18 years old when enrolled;
  • Participants signing the informed consent;
  • Being able to participate in all planned follow-ups and accomplish all research procedures including completing a diary card and coming back for interview;
  • Having not been administered any pneumonia vaccine or COVID-19 vaccine, and having not been administered an influenza vaccine in the current season before enrollment;
  • ≥14 days from the most recent vaccination;
  • Before enrollment, the body temperature is ≤37.0C as confirmed by medical history and clinical examination.

Exclusion criteria for the first dose:

  • Having a history of COVID-19 or a positive nucleic acid test for COVID-19;
  • Having a history or a family history of allergy, convulsion, epilepsy, brain disease, or mental illness;
  • Being allergic to any component of vaccines, or having a history of severe allergic reaction to any vaccine;
  • Having immunodeficiency disorder, during treatment of malignant tumor, having immunodeficiency induced by immunosuppressants (oral steroid hormones) or HIV, or having a family member with close contact who suffers from congenital immune disorder;
  • Having injection of non-specific immunoglobulin within 1 month prior to enrollment;
  • Having acute febrile illness or communicable disease;
  • Having a history of confirmed thrombocytopenia or other coagulation disorders, which may cause contraindications for a subcutaneous injection;
  • Having severe chronic disease or acute exacerbation of chronic disease, or having uncontrolled hypertension or diabetes;
  • Having various infectious, pyogenic, or allergic skin diseases;
  • Women in pregnancy or lactation or participants who plan for a baby within 3 months after vaccination should delay the vaccination;
  • Having any condition that may affect trial assessment as determined by researchers.

Exclusion criteria for the second dose:

  • Having any serious adverse event related to the first dose vaccination;
  • After vaccination, having systemic adverse reaction or allergic reaction with a severity of grade 3 or higher as determined by researchers;
  • Having a newly emerging condition that meets the exclusion criteria for the first dose;
  • Having any condition that may affect trial assessment as determined by researchers.

Sites / Locations

  • Sichuan Center for Disease Control and Prevention
  • Shanghai Municipal Center for Disease Control and Prevention
  • Shanxi Provincial Center for Disease Control and Prevention

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Experimental group

Control group A

Control group B

Arm Description

Experimental Group (384 subjects) will receive: 1st dose : combined vaccination of COVAX+IIV4; 2nd dose: combined vaccination of COVAX+PPV23

Control Group A (384 subjects) will receive: 1st dose: COVAX only; 2nd dose: COVAX only

Control Group B (384 subjects) will receive: 1st dose: IIV4 only; 2nd dose: PPV23 only

Outcomes

Primary Outcome Measures

Seroconversion rate (COVAX)
the rate of positive seroconversion against coronavirus
Seroconversion rate (COVAX)
the rate of positive seroconversion against coronavirus
Neutralizing antibody level (COVAX)
neutralizing antibody level against coronavirus
Neutralizing antibody level (COVAX)
neutralizing antibody level against coronavirus
Neutralizing antibody level (COVAX)
neutralizing antibody level against coronavirus
Seropositive rate (IIV4)
the rate of positive seroconversion against influenza A (H3N2, H1N1) type and B (BY, BV) type viruses
Seroconversion rate (IIV4)
the rate of positive seroconversion against influenza A (H3N2, H1N1) type and B (BY, BV) type viruses
Seroconversion rate (IIV4)
the rate of positive seroconversion against influenza A (H3N2, H1N1) type and B (BY, BV) type viruses
Hemmagglution inhibition antibody level (IIV4)
Hemmagglution inhibition antibody levels against influenza A (H3N2, H1N1) type and B (BY, BV) type viruses
Hemmagglution inhibition antibody level (IIV4)
Hemmagglution inhibition antibody levels against influenza A (H3N2, H1N1) type and B (BY, BV) type viruses
Hemmagglution inhibition antibody level (IIV4)
Hemmagglution inhibition antibody levels against influenza A (H3N2, H1N1) type and B (BY, BV) type viruses
Seroconversion rate (PPV23)
the rate of positive seroconversion against 23 pneumococcal serotypes
Seroconversion rate (PPV23)
the rate of positive seroconversion against 23 pneumococcal serotypes
Neutralizing antibody level (PPV23)
Neutralizing antibody level against 23 pneumococcal serotypes
Neutralizing antibody level (PPV23)
Neutralizing antibody level against 23 pneumococcal serotypes
Neutralizing antibody level (PPV23)
Neutralizing antibody level against 23 pneumococcal serotypes

Secondary Outcome Measures

Adverse events following vaccination
analyse the incidence of adverse events following immunization, both solicited and unsolicited

Full Information

First Posted
March 8, 2021
Last Updated
October 12, 2021
Sponsor
China National Biotec Group Company Limited
Collaborators
Chengdu Institute of Biological Products Co.,Ltd., Changchun Institute of Biological Products Co., Ltd., Beijing Institute of Biological Products Co Ltd., Sichuan Center for Disease Control and Prevention, Shanghai Municipal Center for Disease Control and Prevention, Shanxi Center for Disease Control and Prevention
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1. Study Identification

Unique Protocol Identification Number
NCT04790851
Brief Title
Evaluation of Immunogenicity and Safety of Combined Immunization of COVID-19 Vaccine (Produced in Beijing) and PPV23 / IIV4
Official Title
A Randomized, Controlled, Multicenter Phase 4 Clinic Trial to Evaluate the Immunogenicity and Safety of Combined Immunization of Inactivated SARS-CoV-2 Vaccines (Vero Cell) (COVAX) (Produced in Beijing) and 23-valent Pneumococcal Polysaccharide Vaccine (PPV23) or Quadrivalent Inactivated Influenza Vaccine (IIV4)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
March 10, 2021 (Actual)
Primary Completion Date
September 5, 2021 (Actual)
Study Completion Date
September 5, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
China National Biotec Group Company Limited
Collaborators
Chengdu Institute of Biological Products Co.,Ltd., Changchun Institute of Biological Products Co., Ltd., Beijing Institute of Biological Products Co Ltd., Sichuan Center for Disease Control and Prevention, Shanghai Municipal Center for Disease Control and Prevention, Shanxi Center for Disease Control and Prevention

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
Subjects will be recruited and divided into 3 groups: Experimental Group (384 subjects): 1st dose : combined vaccination of COVAX+IIV4, 2nd dose: combined vaccination of COVAX+PPV23; Control Group A (384 subjects): 1st dose: COVAX only, 2nd dose: COVAX only; Control Group B (384 subjects): 1st dose: IIV4 only, 2nd dose: PPV23 only. Blood samples will be collected 3 times: before the 1st dose of vaccinatioin; before the 2nd dose of vaccination; 28 days after the 2nd dose of vaccination. The immunogenicity and safety of both experimental and control groups will be analyzed.
Detailed Description
This randomized, parallel, controlled study is designed to evaluate the immunogenicity and safety of simultaneously immunization of COVAX + PPV23 and COVAX + IIV4. 1152 subjects are divided into 3 groups, including 1 experimental group and 2 control groups (control group A and B). Each group includes 384 subjects respectively. Experimental Group (384 subjects) will receive: 1st dose : combined vaccination of COVAX+IIV4, 2nd dose: combined vaccination of COVAX+PPV23; Control Group A (384 subjects) will receive: 1st dose: COVAX only, 2nd dose: COVAX only; Control Group B (384 subjects) will receive: 1st dose: IIV4 only, 2nd dose: PPV23 only. Specifically, each group will be divided again. Each 384-subject group is divided again into 2 age-based subgroups: (1) 18-59 years old; (2) ≥60 years old. Each subgroup includes 192 subjects respectively. Blood samples will be collected 3 times: (1) before the 1st dose of vaccinatioin; (2) before the 2nd dose of vaccination; (3) 28 days after the 2nd dose of vaccination. To evaluate the immunogenicity, the investigators will detect and compare the neutralizing antibody levels, the seroconversion rates and antibody geometric mean concentrations. The safety of all groups will be monitored as well.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza, Human, Pneumonia, Pneumococcal, Covid19

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
serum testing technicians were masked.
Allocation
Randomized
Enrollment
1133 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Description
Experimental Group (384 subjects) will receive: 1st dose : combined vaccination of COVAX+IIV4; 2nd dose: combined vaccination of COVAX+PPV23
Arm Title
Control group A
Arm Type
Active Comparator
Arm Description
Control Group A (384 subjects) will receive: 1st dose: COVAX only; 2nd dose: COVAX only
Arm Title
Control group B
Arm Type
Active Comparator
Arm Description
Control Group B (384 subjects) will receive: 1st dose: IIV4 only; 2nd dose: PPV23 only
Intervention Type
Biological
Intervention Name(s)
COVAX+IIV4; COVAX+PPV23
Intervention Description
1st dose : combined vaccination of COVAX+IIV4; 2nd dose: combined vaccination of COVAX+PPV23
Intervention Type
Biological
Intervention Name(s)
COVAX only (1st and 2nd dose)
Intervention Description
1st dose: COVAX only; 2nd dose: COVAX only
Intervention Type
Biological
Intervention Name(s)
IIV4 for the 1st dose and PPV23 for the 2nd dose
Intervention Description
1st dose: IIV4 only; 2nd dose: PPV23 only
Primary Outcome Measure Information:
Title
Seroconversion rate (COVAX)
Description
the rate of positive seroconversion against coronavirus
Time Frame
Results obtained 28 days after the first dose (= right before the second dose)
Title
Seroconversion rate (COVAX)
Description
the rate of positive seroconversion against coronavirus
Time Frame
Results obtained after the second dose of vaccination (= 56 days after the first dose, or 28 days after the second dose)
Title
Neutralizing antibody level (COVAX)
Description
neutralizing antibody level against coronavirus
Time Frame
Baseline (before vaccination) results
Title
Neutralizing antibody level (COVAX)
Description
neutralizing antibody level against coronavirus
Time Frame
Results obtained 28 days after the first dose (= right before the second dose)
Title
Neutralizing antibody level (COVAX)
Description
neutralizing antibody level against coronavirus
Time Frame
Results obtained after the second dose of vaccination (= 56 days after the first dose, or 28 days after the second dose)
Title
Seropositive rate (IIV4)
Description
the rate of positive seroconversion against influenza A (H3N2, H1N1) type and B (BY, BV) type viruses
Time Frame
Baseline (before vaccination) results
Title
Seroconversion rate (IIV4)
Description
the rate of positive seroconversion against influenza A (H3N2, H1N1) type and B (BY, BV) type viruses
Time Frame
Results obtained 28 days after the first dose (= right before the second dose)
Title
Seroconversion rate (IIV4)
Description
the rate of positive seroconversion against influenza A (H3N2, H1N1) type and B (BY, BV) type viruses
Time Frame
Results obtained after the second dose of vaccination (= 56 days after the first dose, or 28 days after the second dose)
Title
Hemmagglution inhibition antibody level (IIV4)
Description
Hemmagglution inhibition antibody levels against influenza A (H3N2, H1N1) type and B (BY, BV) type viruses
Time Frame
Baseline (before vaccination) results
Title
Hemmagglution inhibition antibody level (IIV4)
Description
Hemmagglution inhibition antibody levels against influenza A (H3N2, H1N1) type and B (BY, BV) type viruses
Time Frame
Results obtained 28 days after the first dose (= right before the second dose)
Title
Hemmagglution inhibition antibody level (IIV4)
Description
Hemmagglution inhibition antibody levels against influenza A (H3N2, H1N1) type and B (BY, BV) type viruses
Time Frame
Results obtained after the second dose of vaccination (= 56 days after the first dose, or 28 days after the second dose)
Title
Seroconversion rate (PPV23)
Description
the rate of positive seroconversion against 23 pneumococcal serotypes
Time Frame
Results obtained 28 days after the first dose (= right before the second dose)
Title
Seroconversion rate (PPV23)
Description
the rate of positive seroconversion against 23 pneumococcal serotypes
Time Frame
Results obtained after the second dose of vaccination (= 56 days after the first dose, or 28 days after the second dose)
Title
Neutralizing antibody level (PPV23)
Description
Neutralizing antibody level against 23 pneumococcal serotypes
Time Frame
Baseline (before vaccination) results
Title
Neutralizing antibody level (PPV23)
Description
Neutralizing antibody level against 23 pneumococcal serotypes
Time Frame
Results obtained 28 days after the first dose (= right before the second dose)
Title
Neutralizing antibody level (PPV23)
Description
Neutralizing antibody level against 23 pneumococcal serotypes
Time Frame
Results obtained after the second dose of vaccination (= 56 days after the first dose, or 28 days after the second dose)
Secondary Outcome Measure Information:
Title
Adverse events following vaccination
Description
analyse the incidence of adverse events following immunization, both solicited and unsolicited
Time Frame
0-6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria: ≥18 years old when enrolled; Participants signing the informed consent; Being able to participate in all planned follow-ups and accomplish all research procedures including completing a diary card and coming back for interview; Having not been administered any pneumonia vaccine or COVID-19 vaccine, and having not been administered an influenza vaccine in the current season before enrollment; ≥14 days from the most recent vaccination; Before enrollment, the body temperature is ≤37.0C as confirmed by medical history and clinical examination. Exclusion criteria for the first dose: Having a history of COVID-19 or a positive nucleic acid test for COVID-19; Having a history or a family history of allergy, convulsion, epilepsy, brain disease, or mental illness; Being allergic to any component of vaccines, or having a history of severe allergic reaction to any vaccine; Having immunodeficiency disorder, during treatment of malignant tumor, having immunodeficiency induced by immunosuppressants (oral steroid hormones) or HIV, or having a family member with close contact who suffers from congenital immune disorder; Having injection of non-specific immunoglobulin within 1 month prior to enrollment; Having acute febrile illness or communicable disease; Having a history of confirmed thrombocytopenia or other coagulation disorders, which may cause contraindications for a subcutaneous injection; Having severe chronic disease or acute exacerbation of chronic disease, or having uncontrolled hypertension or diabetes; Having various infectious, pyogenic, or allergic skin diseases; Women in pregnancy or lactation or participants who plan for a baby within 3 months after vaccination should delay the vaccination; Having any condition that may affect trial assessment as determined by researchers. Exclusion criteria for the second dose: Having any serious adverse event related to the first dose vaccination; After vaccination, having systemic adverse reaction or allergic reaction with a severity of grade 3 or higher as determined by researchers; Having a newly emerging condition that meets the exclusion criteria for the first dose; Having any condition that may affect trial assessment as determined by researchers.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaodong Sun
Organizational Affiliation
Shanghai Municipal Center for Disease Control and Prevention
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sichuan Center for Disease Control and Prevention
City
Chengdu
ZIP/Postal Code
610041
Country
China
Facility Name
Shanghai Municipal Center for Disease Control and Prevention
City
Shanghai
ZIP/Postal Code
200336
Country
China
Facility Name
Shanxi Provincial Center for Disease Control and Prevention
City
Taiyuan
ZIP/Postal Code
030012
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
35931636
Citation
Chen H, Huang Z, Chang S, Hu M, Lu Q, Zhang Y, Wang H, Xiao Y, Wang H, Ge Y, Zou Y, Cui F, Han S, Zhang M, Wang S, Zhu X, Zhang B, Li Z, Ren J, Chen X, Ma R, Zhang L, Guo X, Luo L, Sun X, Yang X. Immunogenicity and safety of an inactivated SARS-CoV-2 vaccine (Sinopharm BBIBP-CorV) coadministered with quadrivalent split-virion inactivated influenza vaccine and 23-valent pneumococcal polysaccharide vaccine in China: A multicentre, non-inferiority, open-label, randomised, controlled, phase 4 trial. Vaccine. 2022 Aug 26;40(36):5322-5332. doi: 10.1016/j.vaccine.2022.07.033. Epub 2022 Jul 29.
Results Reference
derived

Learn more about this trial

Evaluation of Immunogenicity and Safety of Combined Immunization of COVID-19 Vaccine (Produced in Beijing) and PPV23 / IIV4

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