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The Safety Research of Freeze-dried Rabies Vaccine(MRC-5 Cell) in Chinese Humans

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Disease Information

Descriptive Information
Brief Title † The Safety Research of Freeze-dried Rabies Vaccine(MRC-5 Cell) in Chinese Humans
Official Title † A Safety Study of Freeze-dried Rabies Vaccine(MRC-5 Cell)in Chinese Humans From 10-60 Years Old
Brief Summary The purpose of this study is to evaluate the safety of Freeze-dried Rabies Vaccine (MRC-5 Cell) in healthy humans aged from 10-60 years old, according to the traditional Essen methods (1-1-1-1-1) vaccination.
Detailed Description
Study Phase Phase 1
Study Type † Interventional
Study Design † Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Primary Outcome Measure † evaluate the safety of freeze-dried rabies vaccine (MRC-5 cell) in chinese humans Adverse reactions associated with vaccine
Secondary Outcome Measure †
Condition † Rabies Healthy
Intervention † Biological2.5IU/ml in rabies vaccine (MRC-5 Cell) humans aged 10-20 years old
Study Arms / Comparison Groups 2.5IU/ml in humans aged 10-20 years old freeze-dried rabies vaccine(MRC-5 cell) of 2.5IU/ml in 20 humans aged 10-20 years old on day 0,3,7,14,28 2.5IU/ml in humans aged 21-60 years old freeze-dried rabies vaccine(MRC-5 cell) of 2.5IU/ml in 20 humans aged 21-60 years old on day 0,3,7,14,28 2.5IU/ml in humans(from 10-20 years old) freeze-dried rabies vaccine(vero cell) of 2.5IU/ml in 20 humans aged 10-20 years old on day 0,3,7,14,28 2.5IU/ml in humans(from 21-60 years old) freeze-dried rabies vaccine(vero cell) of 2.5IU/ml in 20 humans aged 21-60 years old on day 0,3,7,14,28
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status † Biological
Estimated Enrollment † 40
Start Date † November 2014
Completion Date February 2015
Primary Completion Date December 2014
Eligibility Criteria † 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 receiving 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.
Gender Both
Ages 10 Years - 60 Years
Accepts Healthy Volunteers Accepts Healthy Volunteers
Contacts ††
Location Countries †
Administrative Information
NCT ID † NCT02281396
Organization ID BJCDCP-10
Secondary IDs ††
Responsible Party Sponsor
Study Sponsor † Beijing Center for Disease Control and Prevention
Collaborators †† Beijing Minhai Biotechnology Co., Ltd
Investigators † : ,
Information Provided By
Verification Date October 2014
First Received Date † October 30, 2014
Last Updated Date October 31, 2014
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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