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The research objective is to evaluate lot-to-lot consistency and immune persistence of three commercial batches of 23 valent pneumococcal polysaccharide vaccine.
This study adopted a randomized, double-blind, equivalency design with different batches of experimental vaccine. 990 individuals aged 18-59 were included and divided into three groups at a ratio of 1:1:1, with 330 individuals in each group receiving three batches of experimental vaccines, respectively. All subjects were vaccinated with 1 dose of 0.5ml, intramuscularly injected into the lateral deltoid muscle of the upper arm.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 23 Valent Pneumococcal Polysaccharide Vaccine (lot 1) | Experimental | Batch number: Y202112011 |
|
| 23 Valent Pneumococcal Polysaccharide Vaccine (lot 2) | Experimental | Batch number: Y202112012 |
|
| 23 Valent Pneumococcal Polysaccharide Vaccine (lot 3) | Experimental | Batch number: Y202112013 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 23 Valent Pneumococcal Polysaccharide Vaccine (lot 1) | Biological | All subjects were vaccinated with 1 dose of 23 Valent Pneumococcal Polysaccharide Vaccine (batch number: Y202112011), intramuscularly injected into the lateral deltoid muscle of the upper arm. |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric mean concentration (GMC) levels | Geometric mean concentration (GMC) levels of 23 serotype specific IgG antibodies | 30 days after immunization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lin Du | Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sichuan Center for Disease Control and Prevention | Chengdu | Sichuan | 610041 | China |
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| 23 Valent Pneumococcal Polysaccharide Vaccine (lot 2) | Biological | All subjects were vaccinated with 1 dose of 23 Valent Pneumococcal Polysaccharide Vaccine (batch number: Y202112012), intramuscularly injected into the lateral deltoid muscle of the upper arm. |
|
| 23 Valent Pneumococcal Polysaccharide Vaccine (lot 3) | Biological | All subjects were vaccinated with 1 dose of 23 Valent Pneumococcal Polysaccharide Vaccine (batch number: Y202112013), intramuscularly injected into the lateral deltoid muscle of the upper arm. |
|