Vaccination
Conditions
Keywords
safety, immunogenicity
Brief summary
Objective: To evaluate the safety and immunogenicity of PPV23 vaccine revaccinated in 60-70 years old in Shanghai.
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 vaccinated with one dose of vaccine and blood was collected after 28-40 days.
Sponsors
Shanghai Municipal 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 70 Years
Healthy volunteers
Yes
Inclusion criteria
1. The age was 60-70 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 |
|---|---|---|
| Antibody doubling rate | The blood collection time was 28-40 days after vaccination. | The difference of serum antibody double growth level between the two groups was compared. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Antibody GMC level | The blood collection time was 28-40 days after vaccination. | The difference of serum antibody GMC level between the two groups was compared. |
| Incidence of adverse reactions | Within 30 days after vaccination. | Adverse reactions were collected during the observation period. |
Countries
China
Outcome results
None listed