Safety and Immunogenicity of Freeze-dried Rabies Vaccine(MRC-5 Cell) in Chinese Humans
NCT02288286 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1200
Last updated 2016-01-20
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
- 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
Sponsors & Collaborators
-
Beijing Minhai Biotechnology Co., Ltd
collaborator INDUSTRY -
Beijing Center for Disease Control and Prevention
lead OTHER_GOV
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 10 Years
- Max Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2014-11-30
- Primary Completion
- 2015-02-28
- Completion
- 2015-04-30
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