A Multi-center, Open-labelled, Randomized, Controlled, Extended Phase Ⅲ Clinical Trial of sIPV Vaccine
Poliomyelitis, Polio
About this trial
This is an interventional prevention trial for Poliomyelitis focused on measuring Polio vaccines, Poliomyelitis Vaccine, Inactivated polio vaccine, Sabin Inactivated Poliovirus Vaccine (sIPV)
Eligibility Criteria
Inclusion Criteria: 1) Infants of 6 weeks old (42-47 days); 2) For whom a parent/legal guardian has given written informed consent after the study has been explained; 3) Be able to provide the vaccination records after birth; 4) Negative results in SARS-CoV-2 rapid antigen testing, within 24 hours before enrollment; 5) The participant's mother was tested negative for HIV, Syphilis, Hepatitis A, Hepatitis B infection during or before (during pregnancy) her child's enrollment to this study (the test result should be provided, and that obtained during pregnancy is acceptable). - Exclusion Criteria: 1) History of polio vaccination (except the OPV at birth); 2) Prior vaccination with routine infant vaccines against Diphtheria, Tetanus, Pertussis, Haemophilus influenzae type b (Hib), Pneumococcal or rotavirus; 3) History of severe allergic reaction after previous vaccinations or hypersensitivity to any vaccine component; 4) Infants with premature labor (delivery before week 37 of gestation) and low body weight (birth body weight is <2500 g); 5) Infants with difficult labor at birth, asphyxiation rescue and history of nervous system injury; 6) Congenital malformation or development disorder, genetic defect, severe malnutrition, etc.; 7) Autoimmune disease or immunodeficiency/immunosuppression; 8) Patients with serious chronic diseases (such as Down's syndrome, diabetes, sickle cell anemia, or neurological disorders); 9) Abnormal coagulation functions (such as coagulation factor deficiency, blood coagulation disease and blood platelet disorders) or obvious bruise or blood coagulation disorders diagnosed by the doctors; 10) Those who have received immunosuppressant therapy, cytotoxic drug therapy and inhaled corticosteroid therapy (excluding the corticosteroid aerosol therapy for allergic rhinitis and surface corticosteroid therapy for acute non-complicated dermatitis); 11) The volunteer has received blood products before inoculation of the trial vaccine; 12) The volunteer has received other study drugs within 30 days before inoculation of the trial vaccine; 13) The volunteer has received live attenuated vaccines within 14 days before inoculation of the trial vaccine; 14) The volunteer has received subunit or inactivated vaccines within 7 days before inoculation of the trial vaccine; 15) Various acute diseases or acute exacerbation of chronic diseases within recent 7 days; 16) Significant acute disease or chronic infection within the previous 7 days or axillary temperature equal and more than 37.3℃ prior to vaccination in the present study; 17) The volunteer has any other factors which are unsuitable for participation in the clinical trial as judged by the investigators. -
Sites / Locations
- International Centre for Diarrhoeal Disease Research, BangladeshRecruiting
- Central HospitalRecruiting
- The Aga Khan UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Experimental
group C1
group C2
group S1
group S2
Co-administration of sIPV and routine infant vaccines at 6,10,14 weeks old (N=360)
Co-administration of sIPV and routine infant vaccines at 6, 10,14 weeks old
Administration of sIPV at 6,10,14 weeks old; Administration of routine infant vaccines at 8,12,16 weeks old
Administration of routine infant vaccines at 6,10,14 weeks old; Administration of sIPV at 8,12,16 weeks old