Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Safety and Immunogenicity of Freeze-dried Rabies Vaccine(MRC-5 Cell) in Chinese Humans

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02288286
Recruitment Status : Completed
First Posted : November 11, 2014
Last Update Posted : January 20, 2016
Sponsor:
Collaborator:
Beijing Minhai Biotechnology Co., Ltd
Information provided by (Responsible Party):
Beijing Center for Disease Control and Prevention

Tracking Information
First Submitted Date  ICMJE November 7, 2014
First Posted Date  ICMJE November 11, 2014
Last Update Posted Date January 20, 2016
Study Start Date  ICMJE November 2014
Actual Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 10, 2014)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02288286 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 10, 2014)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Immunogenicity of Freeze-dried Rabies Vaccine(MRC-5 Cell) in Chinese Humans
Official Title  ICMJE Safety and Immunogenicity 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 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE Safety, Immunogenicity
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
    Intervention: Biological: 2.5IU/ml rabies vaccine(MRC-5 cell) in humans aged 10-20 years old
  • 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
    Intervention: Biological: 2.5IU/ml rabies vaccine(MRC-5 cell) in humans aged 21-50 years old
  • 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
    Intervention: Biological: 2.5IU/ml rabies vaccine(MRC-5 cell) in humans aged 51-60 years old
  • 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
    Intervention: Biological: 2.5IU/ml rabies vaccine(vero cell) in humans aged 10-20 years old
  • 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
    Intervention: Biological: 2.5IU/ml rabies vaccine(vero cell) in humans aged 21-50 years old
  • 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
    Intervention: Biological: 2.5IU/ml rabies vaccine(vero cell) in humans aged 51-60 years old
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 10, 2014)
1200
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2015
Actual Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 10 Years to 60 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02288286
Other Study ID Numbers  ICMJE BJCDCP-11
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Beijing Center for Disease Control and Prevention
Study Sponsor  ICMJE Beijing Center for Disease Control and Prevention
Collaborators  ICMJE Beijing Minhai Biotechnology Co., Ltd
Investigators  ICMJE Not Provided
PRS Account Beijing Center for Disease Control and Prevention
Verification Date November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP