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This study is a randomized, blinded, parallel controlled phase 3 clinical trial to evaluate the immunogenicity and safety of the 23-valent pneumococcal polysaccharide vaccine in healthy people aged 2 years and above.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Group | Experimental | 1 dose vaccination of study vaccine |
|
| Control Group | Other | 1 dose vaccination of control vaccine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 23-valent pneumococcal polysaccharide vaccine | Biological | 23-valent pneumococcal polysaccharide vaccine from Aimei Vacin BioPharm (Zhejiang) Co., Ltd. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 2-fold growth rate of IgG antibodies to 23 pneumococcal serotypes on 30 days after vaccination, | 2-fold growth rate of IgG antibodies to 23 pneumococcal serotypes on 30 days after vaccination, | 30 days |
| Geometric mean concentration (GMC) of IgG antibodies to 23 pneumococcal serotypes on 30 days after vaccination | Geometric mean concentration (GMC) of IgG antibodies to 23 pneumococcal serotypes on 30 days after vaccination | 30 days |
| Incidence of adverse reactions/events within 30 minutes of vaccination | Incidence of adverse reactions/events within 30 minutes of vaccination | 30 min after vaccination |
| Incidence of adverse reactions/events on days 0 to 7 after vaccination | Incidence of adverse reactions/events on days 0 to 7 after vaccination | 7 days |
| Incidence of adverse reaction/event on days 0 to 30 after vaccination | Incidence of adverse reaction/event on days 0 to 30 after vaccination | 30 days |
| Incidence of serious adverse events (SAE) within 6 months after vaccination | Incidence of serious adverse events (SAE) within 6 months after vaccination | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric mean fold increase (GMFI) of IgG antibodies against 23 pneumococcal serotypes 30 days after vaccination | Geometric mean fold increase (GMFI) of IgG antibodies against 23 pneumococcal serotypes 30 days after vaccination | 30 days |
| GMC of 23 pneumococcal serotype IgG antibodies in the 3rd and 6th year after vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of subjects with ≥0.35ug/mL IgG antibodies to 23 pneumococcal serotypes 30 days after vaccination, | The proportion of subjects with ≥0.35ug/mL IgG antibodies to 23 pneumococcal serotypes 30 days after vaccination, | 30 days |
Inclusion Criteria:
Exclusion Criteria:
14. * Have received attenuated live vaccines within 14 days before vaccination, and received inactivated vaccines within 7 days; 15. Are participating in or plan to participate in clinical studies of other drugs or vaccines within 6 months after vaccination (immune persistence observation subjects in the vaccine who plan to vaccinate any marketed or unmarketed pneumococcal vaccine within 6 years after vaccination need to be excluded); 16. The investigators evaluate that they are not suitable for participating in the study.
For criteria marked with an asterisk (*), if the subject has the conditions specified in the criterion, the visit can be rescheduled when they no longer have those conditions.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xuecheng LIU | Contact | +86 189 8195 8206 | 534210793@qq.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sichuan Center For Disease Control and Prevention | Recruiting | Chengdu | Sichuan | China |
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| control pneumococcal polysaccharide vaccine | Biological | 23-valent pneumococcal polysaccharide vaccine from Merck Sharp & Dohme Corp |
|
GMC of 23 pneumococcal serotype IgG antibodies in the 3rd and 6th year after vaccination |
| 3, 6 years after vaccination |
| 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 |
|---|---|
| C414006 | 23-valent pneumococcal capsular polysaccharide vaccine |
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