Sichuan Center for Disease Control and Prevention
Chengdu, Sichuan, 610041, China
NCT Number: NCT04701788
To evaluate the the immunogenicity and safety of 23-valent pneumococcal polysaccharide vaccine revaccinations in the elderly
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Notify Me60 year–65 year
All sexes
Interventional
Phase 4
Chengdu, Sichuan, 610041, China
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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.
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.
Time frame: The blood collection time was 28-40 days after vaccination.
The serum antibody level of pneumococci was determined by modified enzyme-linked immunosorbent assay. The double growth rate of serum antibody level was calculated.
Time frame: The blood collection time was 28-40 days after vaccination.
The serum antibody level of pneumococci was determined by modified enzyme-linked immunosorbent assay.
Time frame: Within 30 days after vaccination.
Adverse reactions were collected during the observation period.
China National Biotec Group Company Limited
Industry
A Phase Ⅳ Clinical Trial to Evaluate the Immunogenicity and Safety of 23-valent Pneumococcal Polysaccharide Vaccine Revaccinations in the Elderly
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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