Single Arm, Single Center Phase IV Clinical Trial to Evaluate the Immune Persistence and Safety of Freeze-dried Human Rabies Vaccine (Vero Cell)
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Enrollment
- 149
- Locations
- 1
- Primary Endpoint
- positive conversion rate evaluation (6 months)
Study Overview
Brief Summary
Evaluation of immune persistence after rabies vaccination in 150 people.
Detailed Description
150 subjects aged 10-60 were recruited to inoculate the frozen human rabies vaccine (Vero cells) produced and marketed by Changchun Zhuoyi Biological Co., Ltd. in the whole process of 0, 3, 7, 14 and 28 day immunization. The immunogenicity persistence and safety of the test vaccine were evaluated 14 days, 6 months and 12 months after the whole process of vaccination.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 10 Years to 60 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •10-60 years old；
- •Temperature on the day of admission≤37.0 ° C (axillary temperature).
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.
Outcomes
Primary Outcomes
positive conversion rate evaluation (6 months)
Time Frame: 6 months
Evaluate the positive conversion rate 6 months after vaccination of rabies vaccine according to the 5-dose immunization program
antibody titer evaluation (6 months)
Time Frame: 6 months
Evaluate the antibody titer of serum neutralizing antibody 6 months after vaccination of rabies vaccine according to the 5-dose immunization program
positive conversion rate evaluation (12 months)
Time Frame: 12 months
Evaluate the positive conversion rate 12 months after vaccination of rabies vaccine according to the 5-dose immunization program
antibody titer evaluation (12 months)
Time Frame: 12 months
Evaluate the antibody titer of serum neutralizing antibody 12 months after vaccination of rabies vaccine according to the 5-dose immunization program
Secondary Outcomes
No secondary outcomes reported