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| Name | Class |
|---|---|
| Sichuan Center for Disease Control and Prevention | OTHER_GOV |
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To evaluate the the immunogenicity and safety of 23-valent pneumococcal polysaccharide vaccine revaccinations in the elderly
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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 injected with a dose of 23-valent pneumococcal polysaccharide vaccine. One month later, blood was collected and serum was separated. |
| Measure | Description | Time Frame |
|---|---|---|
| 2-fold growth rate of antibody | The serum antibody level of pneumococci was determined by modified enzyme-linked immunosorbent assay. The double growth rate of serum antibody level was calculated. | The blood collection time was 28-40 days after vaccination. |
| Measure | Description | Time Frame |
|---|---|---|
| Antibody GMC level | The serum antibody level of pneumococci was determined by modified enzyme-linked immunosorbent assay. | The blood collection time was 28-40 days after vaccination. |
| Incidence of adverse reactions |
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Inclusion Criteria:
1.The age was 60-65 years old on the day of enrollment;2.The subjects have signed the informed consent and signed the date;3.The subjects are able to participate in all planned follow-up visits and were able to follow all trial procedures (e.g. complete diary card / contact card, return to visit);4.The subjects in the study group had been vaccinated with 23 valent pneumococcal polysaccharide vaccine made in China for more than 5 years; 5.The control group had never been vaccinated with any pneumococcal vaccine; 6.Axillary temperature ≤37.0℃.
Exclusion Criteria:
1.With a medical history with hypersensitiveness, eclampsia, epilepsy, cerebropathia and neurological illness; 2.Allergic to any ingredient of vaccine or with allergy history to any vaccine; 3.Subjects with immunodeficency or suspected impairment of immunologic function (e.g. caused by HIV), or subjects are in the process of immunosuppressor therapy(Taking orally injecting of steroid hormone); 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 |
|---|---|---|
| Qianli Ma | Sichuan Center for Disease Control and Prevention | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sichuan Center for Disease Control and Prevention | Chengdu | Sichuan | 610041 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40746543 | Derived | Qiu J, Li Z, Huang F, Huang Z, Liang X, Li J, Liao Y, Guo X, Sun X. Immunogenicity and safety study of 23-valent pneumococcal polysaccharide vaccine revaccination among elderly individuals aged 60-70 years in Shanghai, China. Front Immunol. 2025 Jul 17;16:1623611. doi: 10.3389/fimmu.2025.1623611. eCollection 2025. |
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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. |