RecruitingPhase 4

Phase IV Clinical Study of Sequential Vaccination of Sabin Strain and Wild Strain Inactivated Poliovirus Vaccine

Philippines480 participantsStarted 2025-11-27

Plain-language summary

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

Age range56 Days – 84 Days

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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).

✕. 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).

The SPR of nab against polioviruses of three types at day 28 after three doses of vaccination

Timeframe: day 28 after three doses of vaccination

The frequency of adverse reactions within 28 days after vaccination

Timeframe: day 0-28 after vaccination

NCT IDNCT07457060

SponsorSinovac Biotech Co., Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-09-08

Who can participate

Age range56 Days – 84 Days

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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).

✕. 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).