poliomyelitis
Conditions
Interventions
Experimental group:primary immunization at 2, 3, 4 months
the booster immunization at 18 months
positive control group:primary immunization at 2, 3, 4 months
Sponsors
Henan Provincial Center for Disease Control and Prevention
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy infants aged 2 months; 2. Guardians have got informed and consented and signed an informed consent form; 3. Guardians and their families are able to comply with the requirements of the clinical trial protocol; 4. Axillary temperature = 37.0 degree C.
Exclusion criteria
Exclusion criteria: 1. With allergy, convulsion, epilepsy, encephalopathy, psychosis or other medical or a family history; 2. Allergic to the known components in the trial vaccine, or those with a severe allergic history of vaccination in the past; 3. Suffering from immunodeficiency and receiving immunosuppressive therapy; 4. A history of poliomyelitis; 5. Suffering from acute febrile diseases and infectious diseases; 6. Suffering from congenital malformation, developmental disorder or serious chronic diseases (such as Down syndrome, diabetes, sickle cell anemia or neurological diseases, and Guillain–Barré syndrome); 7. A clearly diagnosed history of thrombocytopenia or other disturbance of blood coagulation that may lead to subcutaneous injection contraindication; 8. Once with high fever in the past 3 days (axillary temperature =38.0?); 9. A history of abnormal stage of labor, asphyxia rescue or premature delivery; 10. Known or concurrent diseases suspected by researchers, including those suffering from respiratory diseases, acute infection or chronic disease, cardiovascular diseases, liver and kidney diseases, skin diseases, and HIV infection of mothers (provision of test reports is advisable); 11. Have recently received any other investigated drug or have any conditions that the investigators determine might affect the assessment; 12. With history of immunization with poliomyelitis vaccines (including OPV and IPV) and contraindications to vaccination; 13. With history of vaccination with Gamma globulin after the infant is born. 14. With history of vaccination with live vaccine within 14 days.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the seroconversion rates and antibody levels to polioviruses;the incidence rates of adverse events, adverse reactions and serious adverse events; | — |
Countries
China
Contacts
Public ContactXu Bianli
Henan Provincial Center for Disease Control and Prevention
Outcome results
None listed