Status:
COMPLETED
A Clinical Trial to Evaluate the Safety and Immunogenicity of PPV23 Vaccine Revaccinated in 60-70 Years Old
Lead Sponsor:
China National Biotec Group Company Limited
Collaborating Sponsors:
Shanghai Municipal Center for Disease Control and Prevention
Conditions:
Vaccination
Eligibility:
All Genders
60-70 years
Phase:
PHASE4
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.
Eligibility Criteria
Inclusion
- The age was 60-70 years old on the day of enrollment;
- The subjects have signed the informed consent and signed the date;
- 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);
- The subjects in the study group had been vaccinated with 23 valent pneumococcal polysaccharide vaccine made in China for more than 5 years;
- The control group had never been vaccinated with any pneumococcal vaccine; 6.Axillary temperature ≤37.0℃.
Exclusion
- With a medical history with hypersensitiveness, eclampsia, epilepsy, cerebropathia and neurological illness;
- 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);
- 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.
Key Trial Info
Start Date :
March 21 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 13 2022
Estimated Enrollment :
330 Patients enrolled
Trial Details
Trial ID
NCT04700618
Start Date
March 21 2021
End Date
February 13 2022
Last Update
February 16 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Shanghai municipal center for disease control and prevention
Shanghai, Shanghai Municipality, China