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| Name | Class |
|---|---|
| Center for Disease Control and Prevention, Fujian | OTHER |
| Chengdu Institute of Biological Products Co.,Ltd. | INDUSTRY |
| Changchun Institute of Biological Products Co., Ltd. | INDUSTRY |
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Subjects will be recruited and divided into 3 groups:
All blood samples will be collected before and one month after vaccinatioin. The immunogenicity and safety of both experimental and control groups will be compared and the data be analyzed.
To evaluate the safety and immunogenicity of simultaneously immunization of 23-valent pneumococcal polysaccharide vaccine (PPV23) and quadrivalent inactivated influenza vaccine (IIV4) , we design this randomized, parallel controlled study . 1224 subjects are divided into 3 groups, including 1 experimental group and 2 control groups (control group A and B), each group includes 408 subjects respectively.
Each 408-subject group is divided again into 4 age-based subgroups: â‘ 3-8 years old; â‘¡ 9-18 years old; â‘¢ 19-49 years old ; â‘£ over 50 years old; each subgroup includes 102 subjects respectively.
408 subjects from experimental group will be simultaneously administrated with one dose of IIV (0.5 ml) and one dose of PPV23 (0.5 ml). Blood samples are collected before vaccination and one month (30 days) later.
408 subjects from control group A will be only administrated with one dose of IIV (0.5 ml). Blood samples are collected before vaccination and one month (30 days) later.
408 subjects from control group B will be only administrated with one dose of PPV23 (0.5 ml). Blood samples are collected before vaccination and one month (30 days) later.
To evaluate the immunogenicity, we will detect and compare the neutralization antibody levels, the seroprotection 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 | 408 subjects from experimental group will be simultaneously administrated with one dose of IIV (0.5 ml) and one dose of PPV23 (0.5 ml). Blood samples are collected before vaccination and one month (30 days) later. |
|
| control group A | Active Comparator | 408 subjects from control group A will be only administrated with one dose of IIV (0.5 ml). Blood samples are collected before vaccination and one month (30 days) later. |
|
| control group B | Active Comparator | 408 subjects from control group B will be only administrated with one dose of PPV23 (0.5 ml). Blood samples are collected before vaccination and one month (30 days) later. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IIV4 and PPV23 | Biological | imultaneously immunization of 23-valent pneumococcal polysaccharide vaccine (PPV23) and quadrivalent inactivated influenza vaccine (IIV4) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Seroconversion 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 | Results obtained 1 month after vaccination |
| Seroconversion rate (PPV23) | the rate of positive seroconversion against 23 pneumococcal serotypes | Baseline (before vaccination) results |
| Seroconversion rate (PPV23) | the rate of positive seroconversion against 23 pneumococcal serotypes | Results obtained 1 month after vaccination |
| Geometric Mean Concentration (GMC) (IIV4) | GMCs of influenza A (H3N2, H1N1) type and B (BY, BV) type viruses | Baseline (before vaccination) results |
| Geometric Mean Concentration (GMC) (IIV4) | GMCs of influenza A (H3N2, H1N1) type and B (BY, BV) type viruses | Results obtained 1 month after vaccination |
| Geometric Mean Concentration (GMC) (PPV23) | GMCs of 23 pneumococcal serotypes | Baseline (before vaccination) results |
| Geometric Mean Concentration (GMC) (PPV23) |
| Measure | Description | Time Frame |
|---|---|---|
| adverse events following vaccination | analyse the incidence of adverse events following immunization, both solicited and unsolicited | 0-1 month (30 days) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shanying Zhang | Center for Disease Control and Prevention, Fujian | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Liucheng Community Health Services Center | Quanzhou | Fujian | 350001 | China | ||
| Luodong County Health Center |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| D011018 | Pneumonia, Pneumococcal |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| National Institutes for Food and Drug Control, China | OTHER |
| Guizhou Center for Disease Control and Prevention | OTHER |
| Hunan Provincial Center for Disease Control and Prevention | OTHER |
| Peking University | OTHER |
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| IIV4 | Biological | administrated with IIV4 only |
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| PPV23 | Biological | administrated with PPV23 only |
|
GMCs of 23 pneumococcal serotypes |
| Results obtained 1 month after vaccination |
| Quanzhou |
| Fujian |
| China |
| Qingzhen Center for Disease Control and Prevention | Qingzhen | Guizhou | China |
| Qidong County Center for Disease Control and Prevention | Hongqiao | Hunan | China |
| 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 |