A Clinical Trial to Evaluate the Immunogenicity and Safety of PPV23 Vaccine Revaccinations in the Elderly
- Conditions
- Vaccination
- Registration Number
- NCT04701788
- Lead Sponsor
- China National Biotec Group Company Limited
- Brief Summary
To evaluate the the immunogenicity and safety of 23-valent pneumococcal polysaccharide vaccine revaccinations in the elderly
- Detailed Description
1. Antibody double growth rate in 28-40 days after immunization;
2. Antibody GMC level in 28-40days after immunization;
3. Incidence of adverse reactions in 0-30days.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 331
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℃.
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 2-fold growth rate of antibody 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.
- Secondary Outcome Measures
Name Time Method Incidence of adverse reactions Within 30 days after vaccination. Adverse reactions were collected during the observation period.
Antibody GMC level The blood collection time was 28-40 days after vaccination. The serum antibody level of pneumococci was determined by modified enzyme-linked immunosorbent assay.
Trial Locations
- Locations (1)
Sichuan Center for Disease Control and Prevention
🇨🇳Chengdu, Sichuan, China
Sichuan Center for Disease Control and Prevention🇨🇳Chengdu, Sichuan, China