Status:
COMPLETED
Safety and Immunogenicity of Freeze-dried Rabies Vaccine（MRC-5 Cell) in Chinese Humans
Lead Sponsor:
Beijing Center for Disease Control and Prevention
Collaborating Sponsors:
Beijing Minhai Biotechnology Co., Ltd
Conditions:
Safety, Immunogenicity
Eligibility:
All Genders
10-60 years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2015
Estimated Enrollment :
1200 Patients enrolled
Trial Details
Trial ID
NCT02288286
Start Date
November 1 2014
End Date
April 1 2015
Last Update
January 20 2016
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