Consistency Study for Three Commercial Lots of Inactivated Poliomyelitis Vaccine Made From Sabin Strain

20171217

A randomized and blind clinical consistency study for three commercial batches of Inactivated Poliomyelitis Vaccine Made From Sabin Strain (sIPV) for immunogenicity and safety evaluation.

2018-04-15

2019-02-25

2019-10-12

Completed

Early phase I

1200

Inclusion Criteria: * Healthy infants of 2 months of age * The legal identity certificate (birth/household register) and vaccination certificate of the participants can be provided, and the legal guardian can provide the legal identity certificate (identity card). * Guardians are able to understand the experimental vaccine, volunteer to participate in the study and sign informed consent for participation. * Guardians are capable of using thermometer, graduated scale, filling diary card and contact card. * Participants are not vaccinated with polio vaccine and immunoglobulin (except for Hepatitis b specific immunoglobulin) after birth, no vaccination of live vaccine within 28 days before enrollment and no vaccination of inactivated vaccine within 14 days before enrollment. * Participants or guardians are able to obey and follow all study instructions, complete all the monitoring, and cooperate to complete collection of blood sample. * Axillary temperature ≤37℃ Exclusion Criteria: * Allergic to any active substance, inactive substance or materials used during production such as kanamycin. * Patients with fever or acute disease. * Have thrombocytopenia or hemorrhagic diseases * Patients undergoing immunosuppressive therapy or immunodeficiency * Have uncontrolled epilepsy or other progressive neurological disorders * Other situations that the investigator consider as non-eligible

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 1200, 'type': 'ACTUAL'}}

2023-10-11