Related diseases caused by 15 serotype pneumococcal infections contained in the vaccine
Conditions
Interventions
2-month-old experimental group:Vaccination of 3 doses of experimental vaccine (0,2,4,1 booster dose)
2-month-old control group:Vaccination of 3 doses of control vaccine (0,2,4,1 booster dose)
3-month-old group:Vaccination of 3 doses of experimental vaccine (0,1,2,1 booster dose)
Sponsors
Hebei Provincial Center for Disease Control and Prevention
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged above 2 months (minimum to 6 weeks), term (37-42 weeks gestation) and birth weight >=2.5 kg; 2. The guardian understands the vaccination and research procedures, volunteers to participate in the research and sign the informed consent; 3. The guardian can follow the clinical research program, will be able to follow up until 3 years after booster immunization and have the ability to use thermometers, scale and fill in diary and contact cards as required; 4. There was no history of other live vaccines in the past 14 days and no history of other inactivated vaccines in the seventh day; 5. Subaxillary body temperature <=37.0 C; 6. Determine health based on medical history, physical examination, and researcher's judgment.
Exclusion criteria
Exclusion criteria: 1. Have been vaccinated a listed or experimental pneumococcal vaccine; 2. With history of invasive diseases caused by Streptococcus pneumoniae confirmed by bacterial culture in the past; 3. Those who have any history of vaccination or drug allergy and who have been inoculated with biological products for prevention with fever above 39.5 degree C; 4. With history of convulsion, epilepsy, encephalopathy and psychiatry or family history; 5. Had abnormal labor (dystocia, device midwifery), history of asphyxia rescue and nerve organ damage; 6. With history of pathological jaundice confirmed by diagnosis; 7. With a history of thrombocytopenia or other coagulation disorders with definite diagnosis; 8. Human serum gamma globulin injection after birth; 9. There are known or suspected immunological abnormalities, including immunosuppressive therapy (radiotherapy, chemotherapy, corticosteroids, antimetabolites, cytotoxic drugs), HIV infection, etc; 10. Congenital malformations, severe malnutrition, developmental disorders, genetic defects (e.g. broad bean disease); 11. With severe chronic disease, infectious disease, active infection, liver disease, kidney disease, cardiovascular disease, malignant tumor; 12. With severe asthma; 13. Systemic rash, dermatophytes, skin pus or blister; 14. Participating in other drug clinical trials; 15. Anything that the researcher considers likely to affect the evaluation of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Immunogenicity;safety; | — |
Countries
China
Contacts
Public ContactZhao Yuliang
Hebei Provincial Center for Disease Control and Prevention
Outcome results
None listed