NCT05547815

Observation on the Immune Persistence of People Aged 10-60 Years Old Immunized With Five Doses of Rabies Vaccine

Single Arm, Single Center Phase IV Clinical Trial to Evaluate the Immune Persistence and Safety of Freeze-dried Human Rabies Vaccine (Vero Cell)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 149 (actual)
• Sponsor: Changchun Zhuoyi Biological Co., Ltd · Academic / Other
• Sex: All
• Age: 10 Years – 60 Years
• Healthy volunteers: Accepted

Summary

Evaluation of immune persistence after rabies vaccination in 150 people.

Detailed description

150 subjects aged 10-60 were recruited to inoculate the frozen human rabies vaccine (Vero cells) produced and marketed by Changchun Zhuoyi Biological Co., Ltd. in the whole process of 0, 3, 7, 14 and 28 day immunization. The immunogenicity persistence and safety of the test vaccine were evaluated 14 days, 6 months and 12 months after the whole process of vaccination.

Conditions

• Rabies
• Antibody

Interventions

Type	Name	Description
BIOLOGICAL	5 doses program	Inoculate 5 doses of rabies vaccine, and collect blood at fixed time points to detect neutralizing antibody

Timeline

• Start date: 2019-11-11
• Primary completion: 2020-12-17
• Completion: 2021-11-08
• First posted: 2022-09-21
• Last updated: 2022-09-21

Locations

1 site across 1 country: China