NCT05969626

Clinical Trial of Freeze-dried Human Rabies Vaccine (Without Serum Vero Cells)

A Randomized, Blinded, Parallel Controlled Phase 3 Clinical Trial to Evaluate the Immunogenicity and Safety of Freeze-dried Human Rabies Vaccine (Without Serum Vero Cells) Administered to People Aged 10-60 Years With Different Immunization Procedures

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,460 (estimated)
• Sponsor: Ningbo Rongan Biological Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 10 Years – 60 Years
• Healthy volunteers: Accepted

Summary

This study was intended to explore the safety and immunogenicity of the test vaccine compared to the control vaccine. The trial consisted of two phases. Phase I used an open-ended design. Phase II used a randomized, blinded, parallel-controlled non-inferiority design with the same type of active vaccine, in which the control vaccine 5-dose group and the test vaccine 5 group were kept blinded throughout, the test vaccine 4-dose B group was kept blinded from the other three groups until visit 4 （D14）, and the test vaccine 4-dose A group was kept blinded from the control vaccine 5-dose group and the test vaccine 5-dose group until visit 5 （D28）.

Conditions

• Rabies

Interventions

Type	Name	Description
BIOLOGICAL	5-dose group of test vaccine	Subjects will be vaccinated on days 0, 3, 7, 14, and 28
BIOLOGICAL	5-dose group of control vaccine	Subjects will be vaccinated on days 0, 3, 7, 14, and 28
BIOLOGICAL	4-dose A group of test vaccine	Subjects will be vaccinated on days 0, 3, 7, 14
BIOLOGICAL	4-dose B group of test vaccine	Subjects will be vaccinated on days 0, 3, 7, 28

Timeline

• Start date: 2023-08-01
• Primary completion: 2024-04-01
• Completion: 2024-12-01
• First posted: 2023-08-01
• Last updated: 2023-08-09

Locations

4 sites across 1 country: China