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| Name | Class |
|---|---|
| Shanghai Municipal Center for Disease Control and Prevention | OTHER |
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Objective: To evaluate the safety and immunogenicity of PPV23 vaccine revaccinated in 60-70 years old in Shanghai.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study group | Experimental | The subjects in the study group had been vaccinated with 23 valent pneumococcal polysaccharide vaccine made in China for more than 5 years. |
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| Control group | Placebo Comparator | The control group had never been vaccinated with any pneumococcal vaccine. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 23-valent pneumococcal polysaccharide vaccine | Biological | The study group and the control group were vaccinated with one dose of vaccine and blood was collected after 28-40 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Antibody doubling rate | The difference of serum antibody double growth level between the two groups was compared. | The blood collection time was 28-40 days after vaccination. |
| Measure | Description | Time Frame |
|---|---|---|
| Antibody GMC level | The difference of serum antibody GMC level between the two groups was compared. | The blood collection time was 28-40 days after vaccination. |
| Incidence of adverse reactions |
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Inclusion Criteria:
Exclusion Criteria:
4.Administration of immunoglobulins within 30 days prior to this study; 5.Acute febrile disease(temperature ≥ 37.0°C) or infectious disease; 6.With a clearly diagnosed history of thrombocytopenia or other coagulopathy, may cause contraindications for subcutaneous injection; 7.With any serious chronic illness, acute infectious diseases, or respiratory diseases; 8.Suffering from serious cardiovascular diseases (pulmonary heart disease, pulmonary edema, hypertension can not be controlled to normal by drugs), liver and kidney diseases, diabetes with complications; 9.With any kind of infectious, purulent, or allergic skin diseases; 10.With any other factor that makes the investigator determines the subject is unsuitable for this study.
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| Name | Affiliation | Role |
|---|---|---|
| Xiang Guo | Shanghai Municipal Center for Disease Control and Prevention | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai municipal center for disease control and prevention | Shanghai | Shanghai Municipality | China |
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| ID | Term |
|---|---|
| C414006 | 23-valent pneumococcal capsular polysaccharide vaccine |
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Study group is PPV23 revaccination and control group PPV23-vaccination.
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Adverse reactions were collected during the observation period.
| Within 30 days after vaccination. |