Invasive and non-invasive pneumococcal disease caused by 23 Streptococcus pneumoniae infections
Conditions
Interventions
Sponsors
Hubei Provincial Center for Disease Control and Prevention
Eligibility
Sex/Gender
All
Age
2 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Subjects aged 2 years and above, who are considered healthy by medical history, physical examination and clinical examination, are eligible for immunization with this product; 2. Informed consent was obtained from the subjects or their guardians, and the informed consent form was signed; 3. According to the opinion of the investigator, the subject or his/her guardian can comply with the requirements of the clinical trial protocol; 4. Armpit body temperature < 37.3?.
Exclusion criteria
Exclusion criteria: 1. A history of vaccination with pneumococcal polysaccharide vaccine or pneumococcal conjugate vaccine; 2. Patients who were pregnant or lactating or planned to become pregnant within 30 days; 3. Patients with known allergies to any component of the vaccine; 4. Had received blood products within 3 months before receiving the test vaccine; 5. Received other study drugs or vaccines within 30 days before receiving the trial vaccine; 6. Those who received live attenuated vaccine within 14 days before receiving the trial vaccine; 7. Received subunit or inactivated vaccine or allergy treatment within 7 days before receiving the test vaccine; 8. Patients with severe heart and lung disease; 9. Abnormal coagulation function (such as coagulation factor deficiency, coagulation disease, platelet abnormality) or obvious bruising or coagulation disorder diagnosed by the doctor; 10. Fever (armpit temperature >=37.3 ?) within 3 days before vaccination or any acute illness requiring systemic antibiotic or antiviral therapy in the past 7 days; 11. Grade 2 or higher hypertension, defined as systolic blood pressure >=160 and/or diastolic blood pressure >=100; 12. Patients with mental illness in the past or present due to their psychological condition unable to comply with the test requirements; 13. In the judgment of the investigator, due to various medical, psychological, social, occupational or other conditions, which are contrary to the trial protocol or affect the signing of informed consent by the patient.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse reactions and adverse events;Positive conversion rate of pneumococcal IgG antibody of each serotype;Geometric mean concentration of pneumococcal IgG antibodies of each serotype;Geometric mean concentration of serotype antibodies;Geometric mean increase fold of serotype antibody; | — |
Countries
China
Contacts
Public ContactZhang Xianfeng
Outcome results
None listed