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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 |
|---|---|---|---|
| 1A | Experimental | Subjects received four doses of PCV13i at 2 months of age (At least 6 weeks old) |
|
| 1B | Active Comparator | Subjects received four doses of PCV13 at 2 months of age (At least 6 weeks old) |
|
| 2A | Experimental | Subjects received four doses of PCV13i at 3 months of age |
|
| 3A | Experimental | Subject received three doses of PCV13i at 7 to 11 months of age |
|
| 3B | Active Comparator | Subject received three doses of PCV13 at 7 to 11 months of age |
|
| 4A |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine（CRM197,TT） | Biological | 0.5mL,Intramuscular |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety of PCV13i in preventing pneumococcal infections | Occurance of adverse reactions in all subjects | Within 7 days post each vaccination |
| Safety of PCV13i in preventing pneumococcal infections | Occurance of adverse reactions in all subjects | Within 30 days post each vaccination |
| Immunogenicity of PCV13i in subjects of 2 months (at least 6 weeks) old (Arm 1A-1B) | Serotype-specific seropositivity rates of Immunoglobulin G GMC concentrations above 0.35ug/ml | 30 days post three doses |
| Immunogenicity of PCV13i in subjects of 7 to 11 months old (Arm 4A-4B) | Serotype-specific seropositivity rates of Immunoglobulin G GMC concentrations above 0.35ug/ml | 30 days post three doses |
| Immunogenicity of PCV13i in subjects of 12 months to 5 years old (Arm 5A, 5B, 6A, 6B) | Serotype-specific seropositivity rates of Immunoglobulin G GMC concentrations above 0.35ug/ml | 30 days post last dose of vaccination |
| Immunogenicity of PCV13i in subjects of age 50 years old and above (Arm 6A, 6B, 7A, 7B) | Serotype-specific seropositivity rates of Immunoglobulin G GMC concentrations above 0.35ug/ml | 30 days post vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Immuogenicity in terms of GMT in subjects of 2 months (at least 6 weeks) old (Arm 1A-1B) | GMT of serotype-specific OPA antibody with the titer of ≥1:8 ratio | 30 days post three doses |
| Immunogenicity in terms of IgG concentration in subjects of 2 months (at least 6 weeks) old (Arm 1A-1B) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shengli Xia | 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 |
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Subjects received two doses of PCV13i at 12 to 23 months of age |
|
| 4B | Active Comparator | Subjects received two doses of PCV13 at 12 to 23 months of age |
|
| 5A | Active Comparator | Subjects received one dose of PCV13i at 2 to 5 years old. |
|
| 5B | Active Comparator | Subjects received one dose of PCV13 at 2 to 5 years old. |
|
|
| 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine | Biological | 0.5mL,Intramuscular |
|
|
Serotype-specific Immunoglobulin G with a concentration of ≥1.0μg/ml |
| 30 days post three doses |
| Safety of PCV13i in terms of in subjects of 2 months (at least 6 weeks) old (Arm 1A-1B) | Occurance of SAE in subjects of this age group | 6 months post one to three doses of vaccination |
| Immuogenicity in terms of GMT in subjects of 7 to 11 months old (Arm 3A-3B) | GMT of serotype-specific OPA antibody with the titer of ≥1:8 ratio | 30 days post two doses |
| Immuogenicity in terms of GMT in subjects of 12 months to 5 years old (Arm 4A, 4B, 5A, 5B) | GMT of serotype-specific OPA antibody with the titer of ≥1:8 ratio | 30 days post last dose of vaccination |
| Immunogenicity in terms of IgG concentration in subjects of 7 to 11 months old (Arm 3A-3B) | Serotype-specific Immunoglobulin G with a concentration of ≥1.0μg/ml | 30 days post two doses |
| Immunogenicity in terms of IgG concentration in subjects of 12 months to 5 years old (Arm 4A, 4B, 5A, 5B) | Serotype-specific Immunoglobulin G with a concentration of ≥1.0μg/ml | 30 days post last dose of vaccination |
| Safety of PCV13i in terms of SAE in subjects of 7 to 11 months old (Arm 3A-3B) | Occurance of SAE in subjects of this age group | 6 months post two doses |
| Safety of PCV13i in terms of SAE in subjects of 12 months to 5 years old (Arm 4A, 4B, 5A, 5B) | Occurance of SAE in subjects of this age group | 6 months post last dose of 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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| ID | Term |
|---|---|
| D000069443 | Heptavalent Pneumococcal Conjugate Vaccine |
| ID | Term |
|---|---|
| D022242 | Pneumococcal Vaccines |
| D022541 | Streptococcal Vaccines |
| D001428 | Bacterial Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D017778 | Vaccines, Combined |
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