Randomized, Blind and Positive Control Design: a Phase III Clinical Trial to Evaluate the Consistency Between Batches of 5 Doses of Freeze-dried Rabies Vaccine (Vero Cell) and the Immunogenicity and Safety of 4 Doses of Vaccine (1-1-1-1)

ZY202106001

To evaluate the non inferiority of the immunogenicity of the test vaccine inoculated according to the four dose immunization program over the five dose immunization program and the batches consistency of immunogenicity according to five dose immunization procedures.

2022-06-18

2024-05-30

2024-12-30

Early phase I

2100

Inclusion Criteria: * People aged 10-60； * Body temperature on the day of enrollment\<37.3℃ (axillary temperature) Exclusion Criteria: * Have a history of rabies vaccine immunization or use of rabies virus passive immunization agents； * People with congenital or acquired immunodeficiency or other autoimmune diseases； * Female urine pregnancy test is positive, or during pregnancy and lactation, or she has a birth plan during the study period;

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 2100, 'type': 'ESTIMATED'}}

2024-03-13