Phase IV Clinical Study of Sequential Vaccination of Sabin Strain and Wild Strain Inactivated Poliovirus Vaccine
An Open-labelled, Randomized, Controlled, Clinical Trial to Evaluate the Immunogenicity and Tolerability of Sequential Vaccination of Sabin Strain and Wild Strain Inactivated Poliovirus Vaccine
Sinovac Biotech Co., Ltd
480 participants
Nov 27, 2025
INTERVENTIONAL
Conditions
Summary
The goal of this study is to compare the immunogenicity and safety of sIPV administered via subcutaneous and intramuscular injection routes
Eligibility
Inclusion Criteria4
- Infants of 2 months old (aged 56-84 days).
- Have a parent/legal guardian who has provided written informed consent after being fully informed about the study.
- Be able to provide the vaccination records since birth.
- 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 Criteria16
- History of any polio vaccination.
- History of severe allergic reaction to previous vaccinations or hypersensitivity to any vaccine component.
- Premature infants (born before week 37 of gestation).
- History of asphyxia rescue or nervous system injury.
- Congenital malformations, developmental disorders, clinically significant genetic defects, severe malnutrition.
- Autoimmune diseases or immunodeficiency/immunosuppression.
- Serious chronic diseases such as Down's syndrome, diabetes, sickle cell anemia, or neurological disorders.
- Abnormal coagulation functions (e.g., coagulation factor deficiency, blood coagulation diseases, platelet disorders).
- Received immunosuppressant (excluding topical or inhaled corticosteroids), cytotoxic drug, or other immunomodulatory therapies.
- Received blood products before trial vaccine inoculation.
- Received other study drugs within 30 days before enrollment.
- Received live attenuated vaccines within 14 days before enrollment.
- Received subunit or inactivated vaccines within 7 days before enrollment.
- Acute diseases or acute exacerbations of chronic diseases within 7 days before enrollment.
- Significant acute diseases, chronic infections, or axillary temperature ≥ 37.5°C before enrollment.
- Any other factors deemed by the investigators as unsuitable for participation.
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Interventions
First 2 doses: wIPV. 3rd dose: sIPV In each intervention group, two-thirds of the participants will receive the full-course vaccination via intramuscular injections, while the remaining one-third will receive it via subcutaneous injections.
1st dose: wIPV. 2nd \& 3rd doses: sIPV In each intervention group, two-thirds of the participants will receive the full-course vaccination via intramuscular injections, while the remaining one-third will receive it via subcutaneous injections.
three doses of wIPV with an interval of 28 days (+14 days) between doses; In each intervention group, two-thirds of the participants will receive the full-course vaccination via intramuscular injections, while the remaining one-third will receive it via subcutaneous injections.
Three doses of sIPV with an interval of 28 days (+14 days) between doses. In each intervention group, two-thirds of the participants will receive the full-course vaccination via intramuscular injections, while the remaining one-third will receive it via subcutaneous injections.
Locations(3)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07457060