CompletedPhase 3

Phase III Clinical Trial of Sabin Strain Inactivated Poliovirus Vaccine (Vero Cell)

China1,200 participantsStarted 2017-08-21

Plain-language summary

The study aimed to evaluate the safety and immunogenicity of a Sabin strain-based inactivated polio vaccine in infants aged two months (60\~89 days).

Age range60 Days – 89 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.

✓. Healthy permanent residents aged 2 months (60\~89 days);
✓. Infant's legal guardians agree to sign the informed consent forms voluntarily;
✓. Infant's legal guardians are able to comply with the requirements of the clinical trial protocol;
✓. Armpit temperature ≤ 37.0 ℃

✕. preterm birth (gestational age \< 37 weeks);
✕. the presence of congenital malformations, developmental disorders, genetic defects, or severe malnutrition;
✕. had a history of poliomyelitis;
✕. had a personal or family history of allergy, convulsions, epilepsy, encephalopathy, or psychiatric disorders;
✕. had known hypersensitivity to any component of the study vaccine or a history of severe allergic reaction (e.g., anaphylaxis) to any previous vaccination;
✕. had immunodeficiency or receipt of immunosuppressive therapy;
✕. diagnosed coagulation disorders (including factor deficiencies, coagulopathies, platelet abnormalities) or evidence of significant bruising/bleeding diathesis;
✕. had known or investigator-suspected concurrent acute or active chronic diseases (including respiratory, cardiovascular, hepatic, renal, or dermatological conditions) or acute infection, or maternal HIV infection;

the seroconversion rates of poliovirus type I, type II and type III neutralizing antibodies

Timeframe: 30 days after the primary immunization

NCT IDNCT07297186

SponsorBeijing Minhai Biotechnology Co., Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-04-10

Who can participate

Age range60 Days – 89 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.

✓. Healthy permanent residents aged 2 months (60\~89 days);
✓. Infant's legal guardians agree to sign the informed consent forms voluntarily;
✓. Infant's legal guardians are able to comply with the requirements of the clinical trial protocol;
✓. Armpit temperature ≤ 37.0 ℃

✕. preterm birth (gestational age \< 37 weeks);
✕. the presence of congenital malformations, developmental disorders, genetic defects, or severe malnutrition;
✕. had a history of poliomyelitis;
✕. had a personal or family history of allergy, convulsions, epilepsy, encephalopathy, or psychiatric disorders;
✕. had known hypersensitivity to any component of the study vaccine or a history of severe allergic reaction (e.g., anaphylaxis) to any previous vaccination;
✕. had immunodeficiency or receipt of immunosuppressive therapy;
✕. diagnosed coagulation disorders (including factor deficiencies, coagulopathies, platelet abnormalities) or evidence of significant bruising/bleeding diathesis;
✕. had known or investigator-suspected concurrent acute or active chronic diseases (including respiratory, cardiovascular, hepatic, renal, or dermatological conditions) or acute infection, or maternal HIV infection;