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

Primary Purpose

Safety, Immunogenicity

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
2.5IU/ml rabies vaccine(MRC-5 cell) in humans aged 10-20 years old
2.5IU/ml rabies vaccine(MRC-5 cell) in humans aged 21-50 years old
2.5IU/ml rabies vaccine(MRC-5 cell) in humans aged 51-60 years old
2.5IU/ml rabies vaccine(vero cell) in humans aged 10-20 years old
2.5IU/ml rabies vaccine(vero cell) in humans aged 21-50 years old
2.5IU/ml rabies vaccine(vero cell) in humans aged 51-60 years old
Sponsored by
Beijing Center for Disease Control and Prevention
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Safety, Immunogenicity

Eligibility Criteria

10 Years - 60 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm 6

    Arm Type

    Experimental

    Experimental

    Experimental

    Placebo Comparator

    Placebo Comparator

    Placebo Comparator

    Arm Label

    2.5IU/ml in humans aged 10-20 years old

    2.5IU/ml in humans aged 21-50

    2.5IU/ml in humans aged 51-60

    2.5IU/ml in humans(from 10-20 years old)

    2.5IU/ml in humans(from 21-50 years old)

    2.5IU/ml in humans(from 51-60 years old)

    Arm Description

    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 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 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 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 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 vaccines(vero cell) of 2.5IU/ml in 200 humans aged 51-60 years old on days 0,3,7,14,28

    Outcomes

    Primary Outcome Measures

    Evaluate the safety of freeze-dried rabies vaccine(MRC-5 cell) in chinese humans
    Adverse reactions associated with vaccine

    Secondary Outcome Measures

    Evaluate the immunogenicity of freeze-dried rabies vaccine(MRC-5 cell) in chinese humans
    Examination of the value of IgE antibody

    Full Information

    First Posted
    November 7, 2014
    Last Updated
    January 19, 2016
    Sponsor
    Beijing Center for Disease Control and Prevention
    Collaborators
    Beijing Minhai Biotechnology Co., Ltd
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02288286
    Brief Title
    Safety and Immunogenicity of Freeze-dried Rabies Vaccine(MRC-5 Cell) in Chinese Humans
    Official Title
    Safety and Immunogenicity of Freeze-dried Rabies Vaccine(MRC-5 Cell) in Chinese Humans From 10-60 Years Old
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2014 (undefined)
    Primary Completion Date
    February 2015 (Actual)
    Study Completion Date
    April 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Beijing Center for Disease Control and Prevention
    Collaborators
    Beijing Minhai Biotechnology Co., Ltd

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Safety, Immunogenicity

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    1200 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    2.5IU/ml in humans aged 10-20 years old
    Arm Type
    Experimental
    Arm Description
    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
    Arm Title
    2.5IU/ml in humans aged 21-50
    Arm Type
    Experimental
    Arm Description
    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
    Arm Title
    2.5IU/ml in humans aged 51-60
    Arm Type
    Experimental
    Arm Description
    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
    Arm Title
    2.5IU/ml in humans(from 10-20 years old)
    Arm Type
    Placebo Comparator
    Arm Description
    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
    Arm Title
    2.5IU/ml in humans(from 21-50 years old)
    Arm Type
    Placebo Comparator
    Arm Description
    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
    Arm Title
    2.5IU/ml in humans(from 51-60 years old)
    Arm Type
    Placebo Comparator
    Arm Description
    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 Type
    Biological
    Intervention Name(s)
    2.5IU/ml rabies vaccine(MRC-5 cell) in humans aged 10-20 years old
    Intervention Description
    freeze-dried rabies vaccine(MRC-5 cell) of 2.5IU/ml, 5 doses, 4 weeks interval
    Intervention Type
    Biological
    Intervention Name(s)
    2.5IU/ml rabies vaccine(MRC-5 cell) in humans aged 21-50 years old
    Intervention Description
    freeze-dried rabies vaccine(MRC-5 cell) of 2.5IU/ml, 5 doses, 4 weeks interval
    Intervention Type
    Biological
    Intervention Name(s)
    2.5IU/ml rabies vaccine(MRC-5 cell) in humans aged 51-60 years old
    Intervention Description
    freeze-dried rabies vaccine(MRC-5 cell) of 2.5IU/ml, 5 doses, 4 weeks interval
    Intervention Type
    Biological
    Intervention Name(s)
    2.5IU/ml rabies vaccine(vero cell) in humans aged 10-20 years old
    Intervention Description
    freeze-dried rabies vaccine(vero cell) of 2.5IU/ml, 5 doses, 4 weeks interval
    Intervention Type
    Biological
    Intervention Name(s)
    2.5IU/ml rabies vaccine(vero cell) in humans aged 21-50 years old
    Intervention Description
    freeze-dried rabies vaccine(vero cell) of 2.5IU/ml, 5 doses, 4 weeks interval
    Intervention Type
    Biological
    Intervention Name(s)
    2.5IU/ml rabies vaccine(vero cell) in humans aged 51-60 years old
    Intervention Description
    freeze-dried rabies vaccine(vero cell) of 2.5IU/ml, 5 doses, 4 weeks interval
    Primary Outcome Measure Information:
    Title
    Evaluate the safety of freeze-dried rabies vaccine(MRC-5 cell) in chinese humans
    Description
    Adverse reactions associated with vaccine
    Time Frame
    within the first 4 weeks after the first vaccination
    Secondary Outcome Measure Information:
    Title
    Evaluate the immunogenicity of freeze-dried rabies vaccine(MRC-5 cell) in chinese humans
    Description
    Examination of the value of IgE antibody
    Time Frame
    within the first 4 weeks after the first vaccination

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    10 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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 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.

    12. IPD Sharing Statement

    Learn more about this trial

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

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