- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02288286
Safety and Immunogenicity of Freeze-dried Rabies Vaccine(MRC-5 Cell) in Chinese Humans
January 19, 2016 updated by: Beijing Center for Disease Control and Prevention
Safety and Immunogenicity of Freeze-dried Rabies Vaccine(MRC-5 Cell) in Chinese Humans From 10-60 Years Old
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
- Biological: 2.5IU/ml rabies vaccine(MRC-5 cell) in humans aged 10-20 years old
- Biological: 2.5IU/ml rabies vaccine(MRC-5 cell) in humans aged 21-50 years old
- Biological: 2.5IU/ml rabies vaccine(MRC-5 cell) in humans aged 51-60 years old
- Biological: 2.5IU/ml rabies vaccine(vero cell) in humans aged 10-20 years old
- Biological: 2.5IU/ml rabies vaccine(vero cell) in humans aged 21-50 years old
- Biological: 2.5IU/ml rabies vaccine(vero cell) in humans aged 51-60 years old
Study Type
Interventional
Enrollment (Actual)
1200
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
8 years to 58 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 10-60 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
Exclusion Criteria:
- 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.
- Participants who was having the prevent or the treatment of Antituberculosis.
- Participants who had fever 3 days before receving the Vaccine.( Axillary temperature is above 38℃)
- Participants who was suffering from severe chronic.( Such as Down's syndrome, diabetes, sickle cell anemia or neurological disorder, Guillain-Barre syndrome);
- Participants who was diagnosed or suspected to be suffering from some disease, such as Respiratory diseases, acute infection, Chronic of active stage,Cardiovascular Disease, Severe hypertension, Skin disease ,or the mother or her children was HIV-infected, besides the participants were during the Treatment period of malignant tumors,.
- According to the researchers, there are other factors that are not suitable for Participants to join the clinical trial.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 2.5IU/ml in humans aged 10-20 years old
freeze-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
|
freeze-dried rabies vaccine(MRC-5 cell) of 2.5IU/ml, 5 doses, 4 weeks interval
|
Experimental: 2.5IU/ml in humans aged 21-50
freeze-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
|
freeze-dried rabies vaccine(MRC-5 cell) of 2.5IU/ml, 5 doses, 4 weeks interval
|
Experimental: 2.5IU/ml in humans aged 51-60
freeze-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
|
freeze-dried rabies vaccine(MRC-5 cell) of 2.5IU/ml, 5 doses, 4 weeks interval
|
Placebo Comparator: 2.5IU/ml in humans(from 10-20 years old)
freeze-dried rabies vaccines(vero cell) of 2.5IU/ml in 200 humans aged 10-20 years old on days 0,3,7,14,28
|
freeze-dried rabies vaccine(vero cell) of 2.5IU/ml, 5 doses, 4 weeks interval
|
Placebo Comparator: 2.5IU/ml in humans(from 21-50 years old)
freeze-dried rabies vaccines(vero cell) of 2.5IU/ml in 200 humans aged 21-50 years old on days 0,3,7,14,28
|
freeze-dried rabies vaccine(vero cell) of 2.5IU/ml, 5 doses, 4 weeks interval
|
Placebo Comparator: 2.5IU/ml in humans(from 51-60 years old)
freeze-dried rabies vaccines(vero cell) of 2.5IU/ml in 200 humans aged 51-60 years old on days 0,3,7,14,28
|
freeze-dried rabies vaccine(vero cell) of 2.5IU/ml, 5 doses, 4 weeks interval
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluate the safety of freeze-dried rabies vaccine(MRC-5 cell) in chinese humans
Time Frame: within the first 4 weeks after the first vaccination
|
Adverse reactions associated with vaccine
|
within the first 4 weeks after the first vaccination
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluate the immunogenicity of freeze-dried rabies vaccine(MRC-5 cell) in chinese humans
Time Frame: within the first 4 weeks after the first vaccination
|
Examination of the value of IgE antibody
|
within the first 4 weeks after the first vaccination
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2014
Primary Completion (Actual)
February 1, 2015
Study Completion (Actual)
April 1, 2015
Study Registration Dates
First Submitted
November 7, 2014
First Submitted That Met QC Criteria
November 10, 2014
First Posted (Estimate)
November 11, 2014
Study Record Updates
Last Update Posted (Estimate)
January 20, 2016
Last Update Submitted That Met QC Criteria
January 19, 2016
Last Verified
November 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BJCDCP-11
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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