Poliomyelitis
Conditions
Interventions
4-years old:one dose of bOPV
IPV-bOPV-bOPV:Infants aged 2 months receive sequential IPV-bOPV-bOPV schedules according to the procedure of Month 0,1 and 2
IPV-IPV-bOPV:Infants aged 2 months receive sequential IPV-IPV-bOPV schedules according to the procedure of Month 0,1 and 2
IPV-tOPV-tOPV:Infants aged 2 months receive sequential IPV-tOPV-tOPV schedules according to the procedure of Month 0,1 and 2
IPV-IPV-tOPV:Infants aged 2 months receive sequential IPV-IPV-tOPV schedules according to the procedure of Month 0,1 and 2
IPV-IPV-IPV:Infants aged 2 months receive 3 doses of IPV according to the procedure of Month 0,1 and 2
tOPV-tOPV-tOPV:Infants aged 2 months receive 3 doses of tOPV
Sponsors
Center for Disease Prevention and Control of Guangxi Zhuang Autonomous Region
Eligibility
Sex/Gender
All
Age
No minimum to 4 Years
Inclusion criteria
Inclusion criteria: 1. Children aged 4 years who had completed 3 doses of OPV basic immunization within 1 year and had not completed booster immunization/without polio vaccine immunization history, and full term (37-42 gestational weeks) infants weight up to standard at birth (=2500 g) and aged over 60 days but less than 90 days; 2. The guardians had been informed and consented, and had signed the ICF; 3. The guardians and their families had agreed to abide by the requirements for the clinical trial protocol; 4. Children aged 4 years without a history of immunoglobulin vaccination in the past three months/infants aged 2 months without a history of immunoglobulin vaccination after birth, without a history of other live vaccine inoculation within 14 days and 7 days before vaccination; 5. Axillary temperature <37.1 degree C.
Exclusion criteria
Exclusion criteria: 1. With a history or a family medical history of allergies, convulsions, seizures, encephalopathy and psychosis; 2. Allergic to neomycin, streptomycin and polymyxin B; 3. Patients of immunodeficiency receiving immunosuppressant therapy; 4. With a history of polio; 5. With acute febrile diseases and infectious diseases; 6. Ever experiencing an abnormal birth process or choking rescue, congenital malformations, developmental disorders or serious chronic diseases; 7. With a severe allergic reaction in the course of vaccination; 8. Continuously taking oral steroids for 14 days in the previous month; 9. Ever suffering from a high fever (axillary temperature = 38.0?) in the past 3 days; 10. Ever suffering from a diarrhea in the past 1 week (a defecate frequency = 3 times per day); 11. Participating in any other drug clinical research; 12. With OPV immunization contraindications or any circumstances, which the investigators think might affect the trial assessment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse event/reaction rate;the positive conversion rates and antibody level; | — |
Countries
China
Contacts
Public ContactGong Jian
Center for Disease Prevention and Control of Guangxi Zhuang Autonomous Region
Outcome results
None listed