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

Beijing Minhai Biotechnology

Status and phase

Completed

Phase 3

Conditions

Poliomyelitis

Treatments

Biological: wIPV

Biological: sIPV

Study type

Interventional

Funder types

Industry

Identifiers

NCT07297186

2017L00935

Details and patient eligibility

About

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).

Enrollment

1,200 patients

Sex

All

Ages

60 to 89 days old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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 ℃

Exclusion criteria

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;
occurrence of fever (axillary temperature ≥ 38.0 °C) within the 3 days preceding enrollment;
had acute illness requiring systemic antibiotic or antiviral treatment within the 7 days preceding enrollment;
administration of blood products within the 3 months preceding enrollment;
had receipt of any live attenuated vaccine within the 14 days preceding enrollment;
had receipt of any inactivated or subunit vaccine within the 7 days preceding enrollment;
had recent administration of any other experimental product and any other condition deemed by the investigator as potentially interfering with the assessment of trial outcomes.