NCT05545371

Prevention of Rabies With Four Doses of Rabies Vaccine

Randomized, Blind and Positive Control Design: a Phase III Clinical Trial to Evaluate the Consistency Between Batches of 5 Doses of Freeze-dried Rabies Vaccine (Vero Cell) and the Immunogenicity and Safety of 4 Doses of Vaccine (1-1-1-1)

• Status: Enrolling By Invitation
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,100 (estimated)
• Sponsor: Changchun Zhuoyi Biological Co., Ltd · Academic / Other
• Sex: All
• Age: 10 Years – 60 Years
• Healthy volunteers: Accepted

Summary

To evaluate the non inferiority of the immunogenicity of the test vaccine inoculated according to the four dose immunization program over the five dose immunization program and the batches consistency of immunogenicity according to five dose immunization procedures.

Detailed description

* In the population aged 10-60 years, evaluate the non inferiority of the immunogenicity of the test vaccine inoculated according to the four dose immunization program (0, 3, 7, 14/28 days) over the five dose immunization program (0, 3, 7, 14, 28 days)； * To evaluate the consistency of immunogenicity between batches of freeze-dried human rabies vaccine (Vero cell) inoculated according to five dose immunization procedures (0, 3, 7, 14, 28 days).

Conditions

• Rabies Human
• Antibody

Interventions

Type	Name	Description
BIOLOGICAL	immunization procedures	The subjects were vaccinated with rabies vaccine according to different immunization procedures

Timeline

• Start date: 2022-06-18
• Primary completion: 2024-11-30
• Completion: 2024-12-30
• First posted: 2022-09-19
• Last updated: 2024-07-10

Locations

1 site across 1 country: China