NCT02288286

Safety and Immunogenicity of Freeze-dried Rabies Vaccine（MRC-5 Cell) in Chinese Humans

Safety and Immunogenicity of Freeze-dried Rabies Vaccine（MRC-5 Cell) in Chinese Humans From 10-60 Years Old

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,200 (actual)
• Sponsor: Beijing Center for Disease Control and Prevention · Other Government
• Sex: All
• Age: 10 Years – 60 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the safety and immunogenicity of freeze-dried rabies vaccine (MRC-5 cells)in different age health human populations, according to the traditional Essen methods (1-1-1-1-1) vaccination.

Conditions

• Safety, Immunogenicity

Interventions

Type	Name	Description
BIOLOGICAL	2.5IU/ml rabies vaccine(MRC-5 cell) in humans aged 10-20 years old	freeze-dried rabies vaccine(MRC-5 cell) of 2.5IU/ml, 5 doses, 4 weeks interval
BIOLOGICAL	2.5IU/ml rabies vaccine(MRC-5 cell) in humans aged 21-50 years old	freeze-dried rabies vaccine(MRC-5 cell) of 2.5IU/ml, 5 doses, 4 weeks interval
BIOLOGICAL	2.5IU/ml rabies vaccine(MRC-5 cell) in humans aged 51-60 years old	freeze-dried rabies vaccine(MRC-5 cell) of 2.5IU/ml, 5 doses, 4 weeks interval
BIOLOGICAL	2.5IU/ml rabies vaccine(vero cell) in humans aged 10-20 years old	freeze-dried rabies vaccine(vero cell) of 2.5IU/ml, 5 doses, 4 weeks interval
BIOLOGICAL	2.5IU/ml rabies vaccine(vero cell) in humans aged 21-50 years old	freeze-dried rabies vaccine(vero cell) of 2.5IU/ml, 5 doses, 4 weeks interval
BIOLOGICAL	2.5IU/ml rabies vaccine(vero cell) in humans aged 51-60 years old	freeze-dried rabies vaccine(vero cell) of 2.5IU/ml, 5 doses, 4 weeks interval

Timeline

• Start date: 2014-11-01
• Primary completion: 2015-02-01
• Completion: 2015-04-01
• First posted: 2014-11-11
• Last updated: 2016-01-20