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| Name | Class |
|---|---|
| Chengdu Institute of Biological Products Co.,Ltd. | INDUSTRY |
| Shanghai Institute Of Biological Products | INDUSTRY |
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The 23-valent pneumococcal Polysaccharide vaccine (23vPPV) has been developed for children and adults to prevent pneumococcal diseases such as pneumonia (inflammation of the lungs), meningitis (inflammation of the brain lining), and septicemia (blood poisoning) since 2006 in China. Also, the trivalent influenza vaccine (TIV) is frequently administered to the children and adults. The main objective of this study is to show that both vaccines can safely be administered together without affecting the immune response of protecting against disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 23-valent Pneumococcal Polysaccharide vaccine | Active Comparator | 0.5ml 23-valent pneumococcal Polysaccharide vaccine made by Chengdu Institute of Biological Products Co.,Ltd. lot number: 20130106-1, duration:JAN,17,2015. |
|
| Trivalent Influenza Vaccine | Active Comparator | 0.5ml trivalent influenza vaccine made by Shanghai Institute of Biological Products Co.,Ltd. lot number:20130713, duration:Jul,1,2014. |
|
| 23vPPV+TIV | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 23-valent pneumococcal polysaccharide vaccine | Biological | Single 0.5ml 23-valent pneumococcal polysaccharide vaccine was administered intramuscularly (IM) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Immunogenicity of 23vPPV | IgG GMC measured by enzyme-linked immunosorbent assay (ELISA) and expressed in micrograms per mL (mcg/mL) for serotypes 1,2,5,6B,14,19F,23F,which were frequently detected in patients in Chinese. | 1 month after 23vPPV vaccination |
| Immunogenicity of TIV | Percentage of participants achieving at Least a 4-fold Increase in the Titer of the Standard Hemagglutination Inhibition Assay (HAI) | 1 month after TIV vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| adverse events following the immunization (AEFI) | 28 days after 23vPPV and TIV vaccination |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| ma fubao, doctor | Jiangsu CDC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yangzhong Center for Disease Control and Prevention | Zhenjiang | Jiangsu | 212200 | China |
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| trivalent influenza vaccine | Biological | Single 0.5ml trivalent influenza vaccine was administered IM |
|
| 23vPPV+TIV | Biological | Single 0.5 ml 23-valent pneumococcal polysaccharide vaccine (23vPPV) and a single 0.5 ml trivalent inactivated influenza vaccine (TIV) were administered IM, in one day. |
|
| ID | Term |
|---|---|
| D011008 | Pneumococcal Infections |
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D013290 | Streptococcal Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D012141 | Respiratory Tract Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C414006 | 23-valent pneumococcal capsular polysaccharide vaccine |
| D007252 | Influenza Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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