Subjects will be recruited and divided into 3 groups: Experimental Group (468 subjects): 1st dose : combined vaccination of COVAX+PPV23, 2nd dose: combined vaccination of COVAX+IIV4; Control Group A (468 subjects): 1st dose: COVAX only, 2nd dose: COVAX only; Control Group B (468 subjects): 1st dose: PPV23 only, 2nd dose: IIV4 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.
This randomized, parallel, controlled study is designed to evaluate the immunogenicity and safety of simultaneously immunization of COVAX + PPV23 and COVAX + IIV4. 1404 subjects are divided into 3 groups, including 1 experimental group and 2 control groups (control group A and B). Each group includes 468 subjects respectively. Experimental Group (468 subjects) will receive: 1st dose : combined vaccination of COVAX+PPV23, 2nd dose: combined vaccination of COVAX+IIV4; Control Group A (468 subjects) will receive: 1st dose: COVAX only, 2nd dose: COVAX only; Control Group B (468 subjects) will receive: 1st dose: PPV23 only, 2nd dose: IIV4 only. Specifically, each group will be divided again. Each 468-subject group is divided again into 2 age-based subgroups: (1) 18-59 years old; (2) ≥60 years old. Each subgroup includes 234 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
1,404
1st dose : combined vaccination of COVAX+PPV23; 2nd dose: combined vaccination of COVAX+IIV4
1st dose: COVAX only; 2nd dose: COVAX only
1st dose: PPV23 only; 2nd dose: IIV4 only
Guangdong Center for Disease Control and Prevention
Guangzhou, Guangdong, China
Henan Center for Disease Control and Prevention
Zhengzhou, Henan, China
Hubei Center for Disease Control and Prevention
Wuhan, Hubei, China
Seroconversion rate (COVAX)
the rate of positive seroconversion against coronavirus
Time frame: Results obtained 28 days after the first dose (= right before the second dose)
Seroconversion rate (COVAX)
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)
Neutralizing antibody level (COVAX)
neutralizing antibody level against coronavirus
Time frame: Baseline (before vaccination) results
Neutralizing antibody level (COVAX)
neutralizing antibody level against coronavirus
Time frame: Results obtained 28 days after the first dose (= right before the second dose)
Neutralizing antibody level (COVAX)
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)
Seropositive rate (IIV4)
the rate of positive seroconversion against influenza A (H3N2, H1N1) type and B (BY, BV) type viruses
Time frame: Baseline (before vaccination) results
Seroconversion rate (IIV4)
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)
Seroconversion rate (IIV4)
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)
Hemmagglution inhibition antibody level (IIV4)
Hemmagglution inhibition antibody levels against influenza A (H3N2, H1N1) type and B (BY, BV) type viruses
Time frame: Baseline (before vaccination) results
Hemmagglution inhibition antibody level (IIV4)
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)
Hemmagglution inhibition antibody level (IIV4)
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)
Seroconversion rate (PPV23)
the rate of positive seroconversion against 23 pneumococcal serotypes
Time frame: Results obtained 28 days after the first dose (= right before the second dose)
Seroconversion rate (PPV23)
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)
Neutralizing antibody level (PPV23)
Neutralizing antibody level against 23 pneumococcal serotypes
Time frame: Baseline (before vaccination) results
Neutralizing antibody level (PPV23)
Neutralizing antibody level against 23 pneumococcal serotypes
Time frame: Results obtained 28 days after the first dose (= right before the second dose)
Neutralizing antibody level (PPV23)
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)
Adverse events following vaccination
analyse the incidence of adverse events following immunization, both solicited and unsolicited
Time frame: 0-6 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.