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| Name | Class |
|---|---|
| Chengdu Institute of Biological Products Co.,Ltd. | INDUSTRY |
| Changchun Institute of Biological Products Co., Ltd. | INDUSTRY |
| Beijing Institute of Biological Products Co Ltd. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental | Experimental Group (384 subjects) will receive: 1st dose : combined vaccination of COVAX+IIV4; 2nd dose: combined vaccination of COVAX+PPV23 |
|
| Control group A | Active Comparator | Control Group A (384 subjects) will receive: 1st dose: COVAX only; 2nd dose: COVAX only |
|
| Control group B | Active Comparator | Control Group B (384 subjects) will receive: 1st dose: IIV4 only; 2nd dose: PPV23 only |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| COVAX+IIV4; COVAX+PPV23 | Biological | 1st dose : combined vaccination of COVAX+IIV4; 2nd dose: combined vaccination of COVAX+PPV23 |
|
| 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 for the first dose:
Exclusion criteria for the second dose:
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| Name | Affiliation | Role |
|---|---|---|
| Xiaodong Sun | Shanghai Municipal Center for Disease Control and Prevention | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sichuan Center for Disease Control and Prevention | Chengdu | 610041 | China | |||
| Shanghai Municipal Center for Disease Control and Prevention |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35931636 | Derived | 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. |
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| Sichuan Center for Disease Control and Prevention | OTHER_GOV |
| Shanghai Municipal Center for Disease Control and Prevention | OTHER |
| Centers for Disease Control and Prevention, China | 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 |
|
| IIV4 for the 1st dose and PPV23 for the 2nd dose | Biological | 1st dose: IIV4 only; 2nd dose: PPV23 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) |
| Shanghai |
| 200336 |
| China |
| Shanxi Provincial Center for Disease Control and Prevention | Taiyuan | 030012 | China |
| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| D011018 | Pneumonia, Pneumococcal |
| D000086382 | COVID-19 |
| 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 |
| D011024 | Pneumonia, Viral |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
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