NCT05549908

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)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,800 (actual)
• Sponsor: Changchun Zhuoyi Biological Co., Ltd · Academic / Other
• Sex: All
• Age: 10 Years – 60 Years
• Healthy volunteers: Accepted

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.

Conditions

• Rabies Human
• Antibody Titer

Interventions

Type	Name	Description
BIOLOGICAL	rabies vaccine	The subjects were vaccinated with rabies vaccines with different immunization procedures, and the safety and immunogenicity were compared

Timeline

• Start date: 2020-07-22
• Primary completion: 2021-10-31
• Completion: 2023-04-20
• First posted: 2022-09-22
• Last updated: 2024-03-13

Locations

1 site across 1 country: China