Vaccination
Conditions
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.
Interventions
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.
Sponsors
Sichuan Center for Disease Control and Prevention
China National Biotec Group Company Limited
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Study group is PPV23 revaccination and control group PPV23-vaccination.
Eligibility
Sex/Gender
ALL
Age
60 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Incidence of adverse reactions | Within 30 days after vaccination. | Adverse reactions were collected during the observation period. |
Countries
China
Outcome results
None listed