Related diseases caused by 15 serotype pneumococcal infections contained in the vaccine
Conditions
Interventions
Group 1:1 dose of experimental vaccine
Group 2:1 dose of experimental vaccine
Group 3:3 doses of experimental vaccine (0,1,2)
Group 3:3 doses of experimental vaccine (0,2,4)
Sponsors
Hebei Center for Disease Control and Prevention
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged above 2 months (minimum to 6 weeks); 2. The subject himself/herself or guardian understands the vaccination and research procedures, volunteers to participate in the research and sign the informed consent; 3. The subject himself/herself or guardian can follow the clinical research program and have the ability to use thermometers, scale and fill in diary and contact cards as required; 4. No 13-valent pneumococcal conjugate vaccine or 7-valent pneumococcal conjugate vaccine was inoculated; 5. There was no history of other live vaccines in the past 14 days and no history of other inactivated vaccines in the seventh day; 6. Subaxillary body temperature <=37.0 C.
Exclusion criteria
Exclusion criteria: 1. History of invasive diseases caused by Streptococcus pneumoniae confirmed by bacterial culture in the past; 2. In the past, there was any history of vaccination or serious allergy to drugs. In the past, fever of over 39.0 C related to vaccination occurred in biological products for vaccination and prophylaxis; 3. allergic to diphtheria toxoid; 4. Babies under 1 year old were born with a weight of less than 2.5 kg, or had abnormal labor (dystocia, device midwifery), history of asphyxia rescue, history of nerve organ damage, and history of pathological jaundice confirmed by diagnosis; 5. History of convulsion, epilepsy, encephalopathy and psychiatry or family history; 6. A history of thrombocytopenia or other coagulation disorders with definite diagnosis; 7. Severe congenital malformations and developmental disorders are known. Severe chronic diseases clinically diagnosed are Down's syndrome, diabetes mellitus, sickle cell anemia or neurological disorders, and Guillain-Barre syndrome; 8. Known or suspected to suffer from: severe cardiovascular diseases, liver and kidney diseases, malignant tumors, skin diseases, severe respiratory diseases, acute infections or chronic disease active period; 9. There are known or suspected immunological abnormalities, including immunosuppressive therapy (radiotherapy, chemotherapy, corticosteroids, antimetabolites, cytotoxic drugs), HIV infection, etc; 10. Receive blood products or immunoglobulins within 3 months before admission (HBIG is acceptable), or plan to use them during the trial (before blood sample collection after immunization); 11. Participating in other clinical trials (vaccines, drugs, medical devices, etc.); 12. Women in lactation or pregnant women (positive pregnancy test); 13. Researchers of laboratory recruitment indicators (blood, urine, biochemistry) in the age group (= 18 years old) judged those with abnormal clinical significance; 14. Anything that the researcher considers likely to affect the evaluation of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety; | — |
Secondary
| Measure | Time frame |
|---|---|
| Immunogenicity; | — |
Countries
China
Contacts
Public ContactZhao Yuliang
Hebei Center for Disease Control and Prevention
Outcome results
None listed