Safety and Immunogenicity of Freeze-dried Rabies Vaccine（MRC-5 Cell) in Chinese Humans
1 other identifier
interventional
1,200
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Nov 2014
Shorter than P25 for phase_3
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2014
CompletedFirst Submitted
Initial submission to the registry
November 7, 2014
CompletedFirst Posted
Study publicly available on registry
November 11, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2015
CompletedJanuary 20, 2016
November 1, 2014
3 months
November 7, 2014
January 19, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Evaluate the safety of freeze-dried rabies vaccine(MRC-5 cell) in chinese humans
Adverse reactions associated with vaccine
within the first 4 weeks after the first vaccination
Secondary Outcomes (1)
Evaluate the immunogenicity of freeze-dried rabies vaccine(MRC-5 cell) in chinese humans
within the first 4 weeks after the first vaccination
Study Arms (6)
2.5IU/ml in humans aged 10-20 years old
EXPERIMENTALfreeze-dried rabies vaccines(MRC-5 cell) of 2.5IU/ml in 200 humans aged 10-20 years old on days 0,3,7,14,28
2.5IU/ml in humans aged 21-50
EXPERIMENTALfreeze-dried rabies vaccines(MRC-5 cell) of 2.5IU/ml in 200 humans aged 21-50 years old on days 0,3,7,14,28
2.5IU/ml in humans aged 51-60
EXPERIMENTALfreeze-dried rabies vaccines(MRC-5 cell) of 2.5IU/ml in 200 humans aged 51-60 years old on days 0,3,7,14,28
2.5IU/ml in humans(from 10-20 years old)
PLACEBO COMPARATORfreeze-dried rabies vaccines(vero cell) of 2.5IU/ml in 200 humans aged 10-20 years old on days 0,3,7,14,28
2.5IU/ml in humans(from 21-50 years old)
PLACEBO COMPARATORfreeze-dried rabies vaccines(vero cell) of 2.5IU/ml in 200 humans aged 21-50 years old on days 0,3,7,14,28
2.5IU/ml in humans(from 51-60 years old)
PLACEBO COMPARATORfreeze-dried rabies vaccines(vero cell) of 2.5IU/ml in 200 humans aged 51-60 years old on days 0,3,7,14,28
Interventions
freeze-dried rabies vaccine(MRC-5 cell) of 2.5IU/ml, 5 doses, 4 weeks interval
freeze-dried rabies vaccine(MRC-5 cell) of 2.5IU/ml, 5 doses, 4 weeks interval
freeze-dried rabies vaccine(MRC-5 cell) of 2.5IU/ml, 5 doses, 4 weeks interval
freeze-dried rabies vaccine(vero cell) of 2.5IU/ml, 5 doses, 4 weeks interval
freeze-dried rabies vaccine(vero cell) of 2.5IU/ml, 5 doses, 4 weeks interval
freeze-dried rabies vaccine(vero cell) of 2.5IU/ml, 5 doses, 4 weeks interval
Eligibility Criteria
You may qualify if:
- years old healthy people with normal intelligence
- Obtain informed consent from the participants or their guardians, and signed informed consent
- The participants or their guardians can comply with the requirements of clinical trial scheme
- The axillary temperature is 37.0 ℃ or less
You may not qualify if:
- participants who vaccinated with rabies vaccine before
- participants who used anti-rabies passive immunization agents
- participants who were Suspect or have a history of injury which is hurted by warm-blooded mammals
- Female who was pregnant, or in the lactation period, or have Pregnant plans in the clinical trial.
- participants who have allergy history, especially those who are allergic to neomycin,or had serious adverse reactions ever, Such as allergies, hives, difficulty breathing, angioneurotic edema, or abdominal pain and so on.
- participants who had been diagnosed or suspected to have immunodeficiency or Autoimmune diseases,or have Immune system disorders.
- participants who have Thyroidectomy History,or had been treated because of Thyroid disease in the past year.
- participants who had abnormal clotting which is diagnosed by doctor(such as clotting factor deficiency, coagulation disorders, platelet abnormalities),or who had coagulopathy.
- Participants who had history of epilepsy, seizures or convulsions ,or family history of mental illness.
- Participants who is asplenia, or functional asplenia, and asplenia or splenic resection under any circumstances.
- Participants who had immunosuppressive therapy, cytotoxic therapy, inhaled corticosteroids in the past six months. (It does not include Corticosteroid spray treatment Of allergic rhinitis, Surface treatment with corticosteroids because of acute uncomplicated dermatitis)
- Participants who had Received blood products in the past 3 months
- Participants who had Received other investigational drug in the past one month.
- Participants who had received Live attenuated vaccine 14 days before the clinical trial.
- Participants who had received Subunit vaccines and inactivated vaccines 7days before the clinical trial.
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 7, 2014
First Posted
November 11, 2014
Study Start
November 1, 2014
Primary Completion
February 1, 2015
Study Completion
April 1, 2015
Last Updated
January 20, 2016
Record last verified: 2014-11