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)
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Enrollment
- 1,133
- Locations
- 3
- Primary Endpoint
- Seroconversion rate (COVAX)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
Masking Description
serum testing technicians were masked.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Seroconversion rate (COVAX)
Time Frame: Results obtained after the second dose of vaccination (= 56 days after the first dose, or 28 days after the second dose)
the rate of positive seroconversion against coronavirus
Neutralizing antibody level (COVAX)
Time Frame: Results obtained after the second dose of vaccination (= 56 days after the first dose, or 28 days after the second dose)
neutralizing antibody level against coronavirus
Seropositive rate (IIV4)
Time Frame: Baseline (before vaccination) results
the rate of positive seroconversion against influenza A (H3N2, H1N1) type and B (BY, BV) type viruses
Seroconversion rate (IIV4)
Time Frame: Results obtained after the second dose of vaccination (= 56 days after the first dose, or 28 days after the second dose)
the rate of positive seroconversion against influenza A (H3N2, H1N1) type and B (BY, BV) type viruses
Hemmagglution inhibition antibody level (IIV4)
Time Frame: Results obtained after the second dose of vaccination (= 56 days after the first dose, or 28 days after the second dose)
Hemmagglution inhibition antibody levels against influenza A (H3N2, H1N1) type and B (BY, BV) type viruses
Seroconversion rate (PPV23)
Time Frame: Results obtained after the second dose of vaccination (= 56 days after the first dose, or 28 days after the second dose)
the rate of positive seroconversion against 23 pneumococcal serotypes
Neutralizing antibody level (PPV23)
Time Frame: Results obtained after the second dose of vaccination (= 56 days after the first dose, or 28 days after the second dose)
Neutralizing antibody level against 23 pneumococcal serotypes
Secondary Outcomes
- Adverse events following vaccination(0-6 months)