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

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02288286 on ClinicalTrials.gov