Pneumococcal disease caused by Streptococcus pneumoniae
Conditions
Interventions
group 1:Vaccination with one dose of PPSV23 (lot 1)
group 2:Vaccination with one dose of PPSV23 (lot 2)
group 3:Vaccination with one dose of PPSV23 (lot 3)
Sponsors
Guangxi Center for Disease Prevention and Control
Eligibility
Sex/Gender
All
Age
40 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Healthy volunteers aged 40-65 (including 40 and 65 years old); 2. Subjects who voluntarily participate and agree to sign the informed consent form; 3. Subjects who agree to follow the requirements defined in the clinical protocol, and to complete the planned follow-up; 4. For those who have not been vaccinated with pneumococcal vaccine, the time from last vaccination with live attenuated vaccine shall be >=14 days, and >=7 days for other subunits or inactivated vaccine; 5. Who has no pregnancy plan in the next three months; 6. Objects whose axillary temperature is less than 37.3 degree C.
Exclusion criteria
Exclusion criteria: 1. With history or family history of nervous system and mental diseases such as convulsion, epilepsy, encephalopathy and psychosis; 2. With previous history of vaccination or serious drug allergy (including but not limited to: anaphylactic shock, anaphylactic laryngeal edema, anaphylactoid purpura, thrombocytopenic purpura, local anaphylactic necrosis reaction ); 3. With known allergic reactions to certain components (mainly including pneumococcal polysaccharide, sodium chloride, disodium hydrogen phosphate and sodium dihydrogen phosphate) of the vaccine used in this clinical study; 4. With serious cardiovascular diseases (heart disease, pulmonary heart disease, pulmonary edema, hypertension (systolic blood pressure >=140 mmHg and / or diastolic blood pressure >=90 mmHg)) and diabetes mellitus diagnosed by physicians; 5. With autoimmune disease or immunodeficiency or HIV infection; 6. Asplenia, including functional asplenia, and asplenia or splenectomy due to any reason; 7. Malignant tumor, active or has been treated while without definite evidence of cure, or may relapse during the study period; 8. With prior immunosuppressive therapy, cytotoxic therapy and corticosteroid therapy (excluding corticosteroid spray therapy for allergic rhinitis, and topical corticosteroid therapy for acute non-concurrent dermatitis) in the past 1 month (interval =54 years or with menopause >=12 months, or women who have undergone hysterectomy or bilateral oophorectomy, or who have medical evidence of ovarian failure that are exempt from urine pregnancy test); 15. Any other conditions that may affect the evaluations of clinical trial by the judgement of investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum IgG antibody of 23 pnuemococcal serotypes; | — |
Countries
China
Contacts
Public ContactZhen Huang
Yuxi Walvax Biotechnology Co., LTD
Outcome results
None listed