Vaccine Prevention of Rabies Adopts 4-shot Immunization Method

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)

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)

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.

The subjects were vaccinated with rabies vaccines with different immunization procedures, and the safety and immunogenicity were compared

- Compare the Antibody positive conversion rate between two experimental groups 14 days after the first dose of inoculation.

-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 the SPEEDA 4 doses group and the experimental 4 doses group 14 days after the first dose inoculation.

- Incidence rate of any local and systemic adverse events (AE) within 30 minutes after each dose of inoculation;

- Incidence rate of all serious adverse events (SAE) within 6 months from the first dose of inoculation to the full course of inoculation.

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.