Clinical trial
Randomized, Blind, Phase III Clinical Trial to Evaluate the Immunogenicity and Safety of Freeze-dried Human Rabies Vaccine (Vero Cell) Inoculated in 4-dose Program (2-1-1)
Name
ZY201905001
Description
A phase III clinical trial to evaluate the immunogenicity and safety of freeze-dried human rabies vaccine (Vero cell) developed by Changchun Zhuoyi Biological Co., Ltd. inoculated in a 4-dose procedure (2-1-1)
Trial arms
Trial start
2020-07-22
Estimated PCD
2021-10-31
Trial end
2023-04-20
Status
Completed
Phase
Early phase I
Treatment
rabies vaccine
The subjects were vaccinated with rabies vaccines with different immunization procedures, and the safety and immunogenicity were compared
Arms:
Experimental 4 doses, Experimental 5 doses, SPEEDA® 4 doses
Size
1800
Primary endpoint
Antibody positive conversion rate of experimental groups
3 months
Antibody positive conversion rate of 4 doses groups
3 months
Compare the GMT between two experimental groups
3 months
Geometric Mean Titer (GMT) of 4 doses groups
3 months
Safety within 30 minutes
3 months
Safety within 0-7 days
3 months
Safety within 6 months
9months
Eligibility criteria
Inclusion Criteria:
* The age is 10-60 years old;
* Underarm temperature ≤ 37.0 ℃.
Exclusion Criteria:
* Have a history of rabies vaccine immunization or use of rabies virus passive immunization agents；
* Has been diagnosed with congenital or acquired immunodeficiency disease；
* Pregnancy (including positive urine pregnancy test) or lactation, planned pregnancy preparation within 2 months.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 1800, 'type': 'ACTUAL'}}
Updated at
2024-03-13
1 organization
1 product
2 indications
Organization
Changchun Zhuoyi BiologicalProduct
Rabies VaccineIndication
Rabies HumanIndication
Antibody Titer