Pneumococcal disease caused by Streptococcus pneumoniae
Conditions
Interventions
group 1:Vaccination with one dose of 13-valent pneumococcal polysaccharide conjugate vaccine (lot 1)
group 2:Vaccination with one dose of 13-valent pneumococcal polysaccharide conjugate vaccine (lot 2)
group 3:Vaccination with one dose of 13-valent pneumococcal polysaccharide conjugate vaccine (lot 3)
Sponsors
Guangxi Center for Disease Prevention and Control
Eligibility
Sex/Gender
All
Age
2 Years to 5 Years
Inclusion criteria
Inclusion criteria: 1. Healthy children who meet the observation age of this clinical study (2~5 years old); 2. The legal guardian of the subject voluntarily agreed to allow his child to participate in the study and signed the informed consent form; 3. The subjects and their legal guardians can comply with the relevant requirements of the clinical research protocol; 4. Have not been vaccinated with any pneumococcal vaccine in the past; 5. The interval between the vaccination day and other subunit vaccines and inactivated vaccines should be = 7 days, and the interval between the vaccination day and other live attenuated vaccines should be = 14 days; 6. Underarm temperature<37.3 ?.
Exclusion criteria
Exclusion criteria: 1. Have a history of invasive disease caused by pneumococcal bacteria confirmed by culture in the past; 2. Known to be allergic to certain components of the vaccine used in this clinical study (including pneumococcal capsular polysaccharide, tetanus toxoid, etc.); 3. Previous history of vaccination or severe drug allergy (such as but not limited to: anaphylactic shock, anaphylactic laryngeal edema, anaphylactic purpura, local anaphylactic necrosis reaction (Arthur reaction)); 4. Have a history of convulsions or convulsions, epilepsy, encephalopathy and other neurological diseases or family history; 5. Have a clearly diagnosed history of thrombocytopenia, thrombocytopenic purpura or other coagulation disorders, which may cause contraindication of intramuscular injection; 6. In the past 3 days, he has suffered from acute disease or is in the acute attack period of chronic disease or has used antipyretic, analgesic and antiallergic drugs (such as acetaminophen, ibuprofen, aspirin, loratadine, cetirizine, etc.); 7. Known or suspected to have immunological function defects, including being treated with immunosuppressive agents (such as radiotherapy, chemotherapy, corticosteroids, antimetabolics, cytotoxic drugs, etc.) and HIV infection, except for short-term (continuous time less than 2 weeks) use of corticosteroids (such as inhaled or topical steroids); 8 Known congenital malformations, developmental disorders or clinically diagnosed serious chronic diseases (such as Down's syndrome, diabetes, sickle cell anemia or thalassemia, neurological diseases, Guillain Barre syndrome, etc.); 9. Known or suspected diseases include: serious respiratory disease, acute infection or chronic disease active stage, serious cardio-cerebrovascular disease, liver and kidney disease, malignant tumor, serious skin disease, active tuberculosis; 10. Have received blood products or globulin treatment (except hepatitis B immunoglobulin) in the past 3 months (<3 months); 11. Being or planning to participate in other drug clinical research during the study; 12. Any situation that the researcher believes may affect the evaluation of the clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum IgG antibody concentration of 13 pneumococcal serotypes; | — |
Countries
China
Contacts
Public ContactZhen Huang
Outcome results
None listed