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| Name | Class |
|---|---|
| Henan Center for Disease Control and Prevention | OTHER_GOV |
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Streptococcus pneumoniae is a major cause of morbidity and mortality in children worldwide, resulting in up to 1 million pediatric deaths every year.Since the licensure of PCV7 and PCV13,the reported overall decline in invasive pneumococcal disease in hospitalized children younger than 5 years several years is approximately 60% in Western countries.This is a single center,blind, randomized, positive-controlled clinical trial.The purpose of this study is to preliminary evaluate the safety of PCV13i vaccine in subjects at age of 7 months and above,and to investigate the safety and immunogenicity of PCV13i vaccine at age of 2 and 3 months,compared to PCV13.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| vaccine 1A | Experimental | Subjects received one dose of PCV13i at 18 to 49 years old |
|
| vaccine 2A | Experimental | Subjects received one dose of PCV13i at 50 years old and above |
|
| vaccine 3A | Experimental | Subjects received one dose of PCV13i at 6 to 17 years old |
|
| vaccine 4A | Experimental | Subjects received one dose of PCV13i at 2 to 5 years old |
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| vaccine 5A | Experimental | Subjects received two doses of PCV13i at 7 months to 2 years old |
|
| vaccine 6A |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine（CRM197,TT） | Biological | 0.5mL,Intramuscular other name:PCV13i |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety items of adverse reactions | Occurrence of adverse reactions of each subject(Arm 1A-7B) | within 7 days post each vaccination |
| Safety items of SAE | Occurrence of SAE of each subject(Arm 1A-7B) | within 6 months post last vaccination |
| Safety items of Hematological examination | Occurrence of abnormal changes of Hematological examination in subjects of 2 years old and above(Arm 1A-4A) | day 4 post vaccination |
| Safety items of Urine test | Occurrence of abnormal changes of Urine test in subjects of 2 years old and above(Arm 1A-4A) | day 4 post vaccination |
| Safety items of Blood chemistry test | Occurrence of abnormal changes of Blood chemistry test in subjects of 2 years old and above(Arm 1A-4A) | day 4 post vaccination |
| Safety items of pressure value | Occurrence of abnormal changes of pressure valus in subjects of 18 years old and above(Arm 1A-2A) | day 4 post vaccination |
| Safety items of heart rate | Occurrence of abnormal changes of heart rate in subjects of 18 years old and above(Arm 1A-2A) | day 4 post vaccination |
| Safety items of adverse reactions |
| Measure | Description | Time Frame |
|---|---|---|
| immunogencity items of seropositivity rates by ELISA | Serotype-specific seropositivity rates of Immunoglobulin G concentrations above 0.35ug/ml in subjects aged 2 and 3 months post last vaccination(Arm 6A-7B) | day 30 post last vaccination |
| immunogencity items of GMC by ELISA |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xia Shengli | Henan Province Center for Disease Control and Prevention | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neihuang Center for Disease Control and Prevention | Anyang | Henan | 450016 | China |
In order to maintain the rights of the subject, do not open the IPD
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| Experimental |
Subjects received three doses of PCV13i at 3,4,5 months of age |
|
| vaccine 7A | Experimental | Subjects received three doses of PCV13i at 2,4,6 months of age |
|
| vaccine 7B | Active Comparator | Subjects received three doses of PCV13 at 2,4,6 months of age |
|
| 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine | Biological | 0.5mL,Intramuscular other name:Prevnar |
|
Occurrence of adverse reactions of each subject(Arm 1A-7B) |
| within 30 days post each vaccination |
Serotype specific IgG GMC of each the pneumococcal serotypes in subjects aged 2 and 3 months post last vaccination(Arm 6A-7B) |
| day 30 post last vaccination |
| immunogencity items of GMI by ELISA | Serotype-specific GMI value pneumococcfor each of the pneunococcal serotypes in subjects aged 2 and 3 months post last vaccination(Arm 6A-7B) | day 30 post last vaccination |
| immunogencity items of GMT | Serological response in terms of GMT for each of the pneumococcal serotypes tested by OPA in subjects aged 2 months post last vaccination(7A、7B) | day 30 post last vaccination |
| ID | Term |
|---|---|
| D011008 | Pneumococcal Infections |
| D013290 | Streptococcal Infections |
| D001424 | Bacterial Infections |
| ID | Term |
|---|---|
| D016908 | Gram-Positive Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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