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The Phase II clinical trial of the 24-valent pneumococcal polysaccharide conjugate vaccine (RZ700) will be carried out in infants and young children aged 2 months (minimum 6 weeks) to 71 months. The purpose of this study is to evaluate the immunogenicity and safety of the 24-valent pneumococcal polysaccharide conjugate vaccine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort I :2 months (minimum 6 weeks)of age. | Experimental | Subjects aged 2 months (minimum 6 weeks) will receive the experimental vaccine or comparator control vaccine according to 0, 2, and 4-month immunization schedule, followed by a booster dose at 12-15 months of age. |
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| Cohort II : 7~23 months of age. | Experimental | Subjects aged 7-11 months will receive the experimental vaccine or comparator control vaccine according to the 0 and 2-month immunization schedule. A booster dose will be administered at 12-15 months of age. Accprdingly, subjects aged 12-23 months will receive the experimental vaccine or comparator control vaccine according to the 0 and 2-month immunization schedule. |
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| Cohort III : 24~71 months of age. | Experimental | Subjects aged 24-71 months will receive a single intramuscular injection of the experimental vaccine or comparator control vaccineon the day of enrollment. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 24-Valent Pneumococcal Polysaccharide Conjugate Vaccine (RZ700) | Biological | 24-Valent Pneumococcal Polysaccharide Conjugate Vaccine (RZ700) consisting of polysaccahrides from 24 pneumococcal serotypes: 1, 2, 3, 4, 5, 6A, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, and 33F conjugated two carrier proteins. Each dose contains 0.5 ml vaccine in a prefilled syringe. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects with the pneumococcal serotype-specific IgG antibody concentration ≥0.35 μg/ml. | Proportion of subjects with the pneumococcal serotype-specific IgG antibody concentration ≥0.35 μg/ml. | 30 days post the primary and booster immunization. |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of subjects with serum IgG antibody concentration ≥1.0 μg/ml against 24 serotypes of Streptococcus pneumoniae. | The proportion of subjects aged 2 months (minimum 6 weeks old) and 7~71 months old with serum IgG antibody concentration ≥1.0 μg/ml against 24 serotypes of Streptococcus pneumoniae. | 30 days after completion of the primary immunization schedule |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Principal Investigator ,Yunong Zhang,Master | Contact | 13485383983 | 474584051@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Yunong Zhang, Master | Shanxi Province Center for Disease Control and Prevention | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Luzhou District Center for Disease Control and Prevention | Recruiting | Changzhi | Shanxi | 046011 | China |
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| 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine (Prevnar 13) | Biological | 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine (Prevnar 13) consisting of plosaccharides from 13 pneumococcal serotypes: 1, , 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F conjugated CRM197. Each dose contains 0.5 ml vaccine in a prefilled syringe. |
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| Pneumococcal serotype-specific IgG antibody geometric mean fold rise (GMFR) against 24 serotypes post immunization compared with pre-immunization. | Pneumococcal serotype-specific IgG antibody geometric mean fold rise (GMFR) against 24 serotypes in subjects aged 2 months (minimum 6 weeks old) and 7~71 months old compared with pre-immunization. | 30 days after completion of the primary immunization schedule. |
| Pneumococcal serotype-specific IgG antibody geometric mean concentration (GMC) . | Pneumococcal serotype-specific IgG antibody geometric mean concentration (GMC) for each serotype (1, 2, 3, 4, 5, 6A, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, and 33F) in subjects aged 2 months (minimum 6 weeks old) and 7~71 months old at 30 days after completion of the primary immunization. | 30 days after completion of the primary immunization schedule |
| The proportion of subjects with serum IgG antibody concentration ≥1.0 μg/ml against 24 serotypes of Streptococcus pneumoniae. | The proportion of subjects aged 2 months (minimum 6 weeks old) and 7~11 months old with serum IgG antibody concentration ≥1.0 μg/ml against 24 serotypes of Streptococcus pneumoniae. | 30 days after completion of the booster immunization schedule |
| The proportion of subjects with serum MOPA titer ≥1:8 against Streptococcus pneumoniae. | The proportion of subjects in the MOPA testing subgroup aged 24~71 months with serum MOPA titer ≥1:8 against Streptococcus pneumoniae. | 30 days after vaccination |
| Geometric Mean Titer (GMT) of pneumococcal serotype-specific MOPA antibodies in serum. | Pneumococcal serotype-specific MOPA geometric mean titer (GMT) in serum of subjects aged 24~71 months in the MOPA testing subgroup. | 30 days after vaccination |
| Pneumococcal serotype-specific MOPA geometric mean titer fold rise (GMFR) in serum. | Pneumococcal serotype-specific MOPA geometric mean titer fold rise (GMFR) in serum of subjects aged 24~71 months in the MOPA testing subgroup. | 30 days after vaccination |
| Incidence rate of all adverse events (AEs). | Incidence rate of all adverse events (AEs) within 30 minutes, 7 days, and 30 days after each dose of vaccination in each age group. | Within 30 days after each dose of vaccination |
| Occurrence of serious adverse events (SAEs) and adverse events of special interest (AESIs). | 12~71 months old: Occurrence of serious adverse events (SAEs) and adverse events of special interest (AESIs). | From the first dose of vaccination to 6 months after completion of the full vaccination course |
| Occurrence of serious adverse events (SAEs) and adverse events of special interest (AESIs). | 2 months old (minimum 6 weeks old)and 7 to 11 months old: Occurrence of serious adverse events (SAEs) and adverse events of special interest (AESIs). | From the first dose of the primary immunization course to 6 months after completion of the booster immunization |
| Qinxian County Center for Disease Control and Prevention | Recruiting | Changzhi | Shanxi | 046400 | China |
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| Kuangqu District Center for Disease Control and Prevention of Yangquan City | Recruiting | Yangquan | Shanxi | 045000 | China |
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| Xinjiang County Center for Disease Control and Prevention | Recruiting | Yuncheng | Shanxi | 043100 | China |
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| Jishan County Center for Disease Control and Prevention | Recruiting | Yuncheng | Shanxi | 043200 | China |
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| Yongji City Center for Disease Control and Prevention | Recruiting | Yuncheng | Shanxi | 044500 | China |
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| Shangdang District Center for Disease Control and Prevention of Changzhi City | Recruiting | Yuncheng | Shanxi | 047100 | China |
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| ID | Term |
|---|---|
| D011008 | Pneumococcal Infections |
| ID | Term |
|---|---|
| D013290 | Streptococcal Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C538862 | 13-valent pneumococcal vaccine |
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