Evaluation of Immunogenicity and Safety of Combined Immunization of COVID-19 Vaccine (Produced in Beijing) and PPV23 / IIV4
- Conditions
- Pneumonia, PneumococcalCovid19Influenza, Human
- Interventions
- Biological: IIV4 for the 1st dose and PPV23 for the 2nd doseBiological: COVAX only (1st and 2nd dose)Biological: COVAX+IIV4; COVAX+PPV23
- Registration Number
- NCT04790851
- Lead Sponsor
- China National Biotec Group Company Limited
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1133
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control group B IIV4 for the 1st dose and PPV23 for the 2nd dose Control Group B (384 subjects) will receive: 1st dose: IIV4 only; 2nd dose: PPV23 only Control group A COVAX only (1st and 2nd dose) Control Group A (384 subjects) will receive: 1st dose: COVAX only; 2nd dose: COVAX only Experimental group COVAX+IIV4; COVAX+PPV23 Experimental Group (384 subjects) will receive: 1st dose : combined vaccination of COVAX+IIV4; 2nd dose: combined vaccination of COVAX+PPV23
- Primary Outcome Measures
Name Time Method Seroconversion rate (COVAX) 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) 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) Baseline (before vaccination) results the rate of positive seroconversion against influenza A (H3N2, H1N1) type and B (BY, BV) type viruses
Seroconversion rate (IIV4) 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) 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) 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) 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 Outcome Measures
Name Time Method Adverse events following vaccination 0-6 months analyse the incidence of adverse events following immunization, both solicited and unsolicited
Trial Locations
- Locations (3)
Shanghai Municipal Center for Disease Control and Prevention
🇨🇳Shanghai, China
Shanxi Provincial Center for Disease Control and Prevention
🇨🇳Taiyuan, China
Sichuan Center for Disease Control and Prevention
🇨🇳Chengdu, China