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| Name | Class |
|---|---|
| Chengdu Institute of Biological Products Co.,Ltd. | INDUSTRY |
| Changchun Institute of Biological Products Co., Ltd. | INDUSTRY |
| Wuhan Institute of Biological Products Co., Ltd | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental | Experimental Group (468 subjects) will receive: 1st dose : combined vaccination of COVAX+PPV23; 2nd dose: combined vaccination of COVAX+IIV4 |
|
| Control group A | Active Comparator | Control Group A (468 subjects) will receive: 1st dose: COVAX only; 2nd dose: COVAX only |
|
| Control group B | Active Comparator | Control Group B (468 subjects) will receive: 1st dose: PPV23 only; 2nd dose: IIV4 only |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| COVAX+PPV23;COVAX+IIV4 | Biological | 1st dose : combined vaccination of COVAX+PPV23; 2nd dose: combined vaccination of COVAX+IIV4 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Seroconversion rate (COVAX) | the rate of positive seroconversion against coronavirus | Results obtained 28 days after the first dose (= right before the second dose) |
| Seroconversion rate (COVAX) | the rate of positive seroconversion against coronavirus | 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 | Baseline (before vaccination) results |
| Neutralizing antibody level (COVAX) | neutralizing antibody level against coronavirus | Results obtained 28 days after the first dose (= right before the second dose) |
| Neutralizing antibody level (COVAX) | neutralizing antibody level against coronavirus | 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 | Baseline (before vaccination) results |
| Seroconversion rate (IIV4) | the rate of positive seroconversion against influenza A (H3N2, H1N1) type and B (BY, BV) type viruses |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events following vaccination | analyse the incidence of adverse events following immunization, both solicited and unsolicited | 0-6 months |
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Inclusion Criteria:
Exclusion Criteria:
Exclusion criteria for the second dose:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangdong Center for Disease Control and Prevention | Guangzhou | Guangdong | China | |||
| Henan Center for Disease Control and Prevention |
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| Hubei Provincial Center for Disease Control and Prevention | OTHER |
| Guangdong Center for Disease Prevention and Control | OTHER_GOV |
| Henan Center for Disease Control and Prevention | OTHER_GOV |
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Serum testing technicians were masked.
| COVAX only (1st and 2nd dose) | Biological | 1st dose: COVAX only; 2nd dose: COVAX only |
|
| PPV23 for the 1st dose and IIV4 for the 2nd dose | Biological | 1st dose: PPV23 only; 2nd dose: IIV4 only |
|
| 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 | 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 | 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 | 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 | 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 | 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 | 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 | Baseline (before vaccination) results |
| Neutralizing antibody level (PPV23) | Neutralizing antibody level against 23 pneumococcal serotypes | Results obtained 28 days after the first dose (= right before the second dose) |
| Neutralizing antibody level (PPV23) | Neutralizing antibody level against 23 pneumococcal serotypes | Results obtained after the second dose of vaccination (= 56 days after the first dose, or 28 days after the second dose) |
| Zhengzhou |
| Henan |
| China |
| Hubei Center for Disease Control and Prevention | Wuhan | Hubei | China |
| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| D011018 | Pneumonia, Pneumococcal |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| D011008 | Pneumococcal Infections |
| D013290 | Streptococcal Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D018410 | Pneumonia, Bacterial |
| D011014 | Pneumonia |
| D008171 | Lung Diseases |
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