Shanghai municipal center for disease control and prevention
Shanghai, Shanghai Municipality, China
NCT Number: NCT04700618
Objective: To evaluate the safety and immunogenicity of PPV23 vaccine revaccinated in 60-70 years old in Shanghai.
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Notify Me60 year–70 year
All sexes
Interventional
Phase 4
Shanghai, Shanghai Municipality, China
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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 vaccinated with one dose of vaccine and blood was collected after 28-40 days.
Time frame: The blood collection time was 28-40 days after vaccination.
The difference of serum antibody double growth level between the two groups was compared.
Time frame: The blood collection time was 28-40 days after vaccination.
The difference of serum antibody GMC level between the two groups was compared.
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 Safety and Immunogenicity of 23 Valent Pneumococcal Polysaccharide Vaccine Revaccinated in 60-70 Years Old in Shanghai
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