Pneumococcal disease caused by Streptococcus pneumoniae
Conditions
Interventions
Experimental group:In the 0th, 1st, and 2nd months, simultaneously inoculate 1 dose of 13-valent pneumococcal polysaccharide conjugate vaccine and 1 dose of adsorbed acellular DTP combined vaccine
Control group:In the 0th, 1st, and 2nd months, 1 dose of 13-valent pneumococcal polysaccharide conjugate vaccine and 1 dose of adsorbed acellular DTP combined vaccine were administered at an interval
Sponsors
Disease Control and Prevention Center of Shanxi Provincial
Eligibility
Sex/Gender
All
Age
0.3 Years to 0.3 Years
Inclusion criteria
Inclusion criteria: 1. Healthy infants who meet the observation age of this clinical study (3 months old) and are determined according to medical history, physical examination and the judgment of the investigator; 2. The volunteer's legal guardian voluntarily agreed to his or her child's participation in the study and signed the informed consent form (if the legal guardian goes out, the client of the legal guardian can sign on behalf of him or her on the premise of written entrustment); 3. The volunteer and his or her legal guardians can comply with the relevant requirements of the clinical study protocol; 4. The volunteer has not been vaccinated with any pneumococcal vaccine, and have not been vaccinated with any pertussis, diphtheria and tetanus vaccines (including but not limited to the corresponding single vaccine, DTaP combined vaccine, DTaP-Hib-IPV combined vaccines, etc.); 5. The interval between the day of vaccination and other subunit vaccines and inactivated vaccines shall be more than 7 days, and the interval between vaccination and other live attenuated vaccines should be more than 14 days; 6. The volunteer's axillary body temperature is blow 37.3 ?.
Exclusion criteria
Exclusion criteria: 1. Premature infants (delivered before the 37th week of pregnancy), or low birth weight (birth weight: Girls < 2300 g, boys < 2500 g), or congenital malformations, developmental disorders, genetic defects, severe malnutrition, etc.; 2. Birth with abnormal labor process (dystocia, instrumental delivery) or history of asphyxia rescue and nerve organ damage; 3. The volunteer was diagnosed and confirmed to have pathological jaundice or had pathological jaundice (repeated for 2-4 weeks); 4. Previous medical history of invasive diseases caused by Streptococcus pneumoniae confirmed by culture; 5. Previous medical history of pertussis, diphtheria and tetanus; 6. It is known that the volunteer is allergic to some components of the vaccine used in this clinical study (including pneumococcal capsular polysaccharide, tetanus toxoid, effective component of pertussis bacilli, diphtheria toxoid, etc.); 7. Previous history of vaccination or drug allergy (including but not limited to: anaphylactic shock, allergic laryngeal edema, allergic purpura, thrombocytopenic purpura, local allergic necrosis reaction (Arthur reaction)); 8. History or family history of convulsion, epilepsy, encephalopathy and psychosis; 9. History of thrombocytopenia or other coagulation disorders with definite diagnosis; 10. The volunteer has suffered from acute disease or acute attack of chronic disease in the past 3 days; 11. The volunteer has taken prophylactic drugs within 3 days before vaccination (drugs to prevent AE that may occur during the solicitation period after vaccination); 12. The volunteer is determined to have or may have immunological defects, including being treated with immunosuppressants (such as radiotherapy, chemotherapy, corticosteroids, antimetabolics, cytotoxic drugs, etc.) and HIV infection; 13. The volunteer suffers from congenital malformations, developmental disorders or severe chronic diseases with clinical diagnosis (such as Down syndrome, diabetes, sickle cell anemia or thalassemia, neuropathy, Guillain-Barre syndrome, etc.) 14. The volunteer is determined to have or may have the following diseases, including: severe respiratory diseases, acute infection or active stage of chronic diseases, severe cardiovascular and cerebrovascular diseases, liver and kidney diseases, malignant tumors, severe skin diseases and active tuberculosis; 15. The volunteer has received blood products or globulin treatment (except HBV immunoglobulin); 16. The volunteer is or plan to participate in other clinical studies; 17. Any situation that the investigators believe may affect the evaluation of the clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum IgG antibody concentration of 13 pneumococcal serotypes;Anti-diphtheria toxoid (DT);Anti-tetanus toxoid (TT);Anti-pertussis toxin (PT);Anti-filament hemagglutinin (FHA) antibody titers; | — |
Countries
China
Contacts
Public ContactYunong Zhang
Shanxi Provincial Center for Disease Control and Prevention
Outcome results
None listed