Antibody Titer, Rabies Human
Conditions
Brief summary
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)
Detailed description
It is to prove that the freeze-dried human rabies vaccine (Vero cell) in the population aged 10-60 years, the four dose vaccination program is not inferior to the five dose vaccination program, and the safty、antibody positive conversion rate and geometric mean concentration of the four dose group of the test vaccine are not inferior to the five dose program group 14 days after the first dose vaccination. To compare the immunogenicity of people aged 10-60 years old who were vaccinated 6 and 12 months after the whole vaccination, so as to evaluate the antibody positive rate and GMT 6 and 12 months after the test vaccine was vaccinated.
Interventions
BIOLOGICALrabies vaccine
The subjects were vaccinated with rabies vaccines with different immunization procedures, and the safety and immunogenicity were compared
Sponsors
Changchun Zhuoyi Biological Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
10 Years to 60 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety within 6 months | 9months | \- Incidence rate of all serious adverse events (SAE) within 6 months from the first dose of inoculation to the full course of inoculation. |
| Geometric Mean Titer (GMT) of 4 doses groups | 3 months | \- Compare the GMT between the SPEEDA 4 doses group and the experimental 4 doses group 14 days after the first dose inoculation. |
| Safety within 30 minutes | 3 months | \- Incidence rate of any local and systemic adverse events (AE) within 30 minutes after each dose of inoculation; |
| Safety within 0-7 days | 3 months | \- Incidence rate of collected AE within 0-7 days after each dose of inoculation; |
| Antibody positive conversion rate of experimental groups | 3 months | \- Compare the Antibody positive conversion rate between two experimental groups 14 days after the first dose of inoculation. |
| Antibody positive conversion rate of 4 doses groups | 3 months | -Compare the Antibody positive conversion rate between the SPEEDA 4 doses group and experimental 4 doses group 14 days after the first dose of inoculation. |
| Compare the GMT between two experimental groups | 3 months | \- Compare the GMT between two experimental groups 14 days after the first dose of inoculation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Antibody test after whole vaccination. | 3 months | \- Antibody test 14days after the whole vaccination. |
| Persistent observation within 12 months | 16 months | \- Antibody test in different points within 12 months after the whole vaccination. |
| Antibody test of 7 days. | 3 months | \- Antibody test 7 days after the first dose of inoculation. |
Countries
China
Outcome results
None listed