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โ† Trials
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Phase IV Clinical Study of Sequential Vaccination of Sabin Strain and Wild Strain Inactivated Poliovirus Vaccine

RecruitingPhase 4Ages 56 Days - 84 DaysAllSinovac Biotech Co., Ltd
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In plain words

What the trial is, and whether it could suit you

The goal of this study is to compare the immunogenicity and safety of sIPV administered via subcutaneous and intramuscular injection routes

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Infants of 2 months old (aged 56-84 days). 2. Have a parent/legal guardian who has provided written informed consent after being fully informed about the study. 3. Be able to provide the vaccination records since birth. 4. The infant's mother is tested negative for HIV, syphilis, hepatitis B, and hepatitis C during or before the infant's enrollment to this study (test results obtained during pregnancy are acceptable, if provided). Exclusion Criteria: 1. History of any polio vaccination. 2. History of severe allergic reaction to previous vaccinations or hypersensitivity to any vaccine component. 3. Premature infants (born before week 37 of gestation). 4. History of asphyxia rescue or nervous system injury. 5. Congenital malformations, developmental disorders, clinically significant genetic defects, severe malnutrition. 6. Autoimmune diseases or immunodeficiency/immunosuppression. 7. Serious chronic diseases such as Down's syndrome, diabetes, sickle cell anemia, or neurological disorders. 8. Abnormal coagulation functions (e.g., coagulation factor deficiency, blood coagulation diseases, platelet disorders). 9. Received immunosuppressant (excluding topical or inhaled corticosteroids), cytotoxic drug, or other immunomodulatory therapies. 10. Received blood products before trial vaccine inoculation. 11. Received other study drugs within 30 days before enrollment. 12. Received live attenuated vaccines within 14 days before enrollment. 13. Received subunit or inactivated vaccines within 7 days before enrollment. 14. Acute diseases or acute exacerbations of chronic diseases within 7 days before enrollment. 15. Significant acute diseases, chronic infections, or axillary temperature โ‰ฅ 37.5ยฐC before enrollment. 16. Any other factors deemed by the investigators as unsuitable for participation.
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What it tests

  • 2wIPV+1sIPV
  • 1wIPV+2sIPV
  • 3wIPV
  • 3sIPV
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Where

3 sites
Centennial Clindev Research and Development of Medical Sciences
Kawit, Philippines
Iloilo Doctors' Hospital
Iloilo City, Philippines
Health Index Multispecialty Clinic - Research and Development on Medical Sciences
Imus, Philippines
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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