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

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ClinicalTrials.gov Identifier: NCT02281396
Recruitment Status : Completed
First Posted : November 3, 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

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.

Condition or disease Intervention/treatment Phase
Rabies Healthy Biological: 2.5IU/ml in rabies vaccine (MRC-5 Cell) humans aged 10-20 years old Biological: 2.5IU/ml rabies vaccine (MRC-5 Cell) in humans aged 21-60 years old Biological: 2.5IU/ml rabies vaccine (MRC-5 Cell) in humans(from 10-20 years old) Biological: 2.5IU/ml rabies vaccine (MRC-5 Cell) in humans(from 21-60 years old) Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Safety Study of Freeze-dried Rabies Vaccine(MRC-5 Cell)in Chinese Humans From 10-60 Years Old
Study Start Date : November 2014
Actual Primary Completion Date : January 2015
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rabies

Arm Intervention/treatment
Experimental: 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
Biological: 2.5IU/ml in rabies vaccine (MRC-5 Cell) humans aged 10-20 years old
Freeze-dried Rabies Vaccine(MRC-5 Cell) of 2.5IU/ml,5 doses,4 weeks interval

Experimental: 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
Biological: 2.5IU/ml rabies vaccine (MRC-5 Cell) in humans aged 21-60 years old
Freeze-dried Rabies Vaccine(MRC-5 Cell) of 2.5IU/ml,5 doses,4 weeks interval

Active Comparator: 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
Biological: 2.5IU/ml rabies vaccine (MRC-5 Cell) in humans(from 10-20 years old)
Freeze-dried Rabies Vaccine(vero Cell) of 2.5IU/ml,5 doses,4 weeks interval

Active Comparator: 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
Biological: 2.5IU/ml rabies vaccine (MRC-5 Cell) in humans(from 21-60 years old)
Freeze-dried Rabies Vaccine(vero Cell) of 2.5IU/ml,5 doses,4 weeks interval




Primary Outcome Measures :
  1. evaluate the safety of freeze-dried rabies vaccine (MRC-5 cell) in chinese humans Adverse reactions associated with vaccine [ Time Frame: within the first 4 weeks after the first vaccination ]
    Adverse reactions associated with vaccine



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Ages Eligible for Study:   10 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Responsible Party: Beijing Center for Disease Control and Prevention
ClinicalTrials.gov Identifier: NCT02281396     History of Changes
Other Study ID Numbers: BJCDCP-10
First Posted: November 3, 2014    Key Record Dates
Last Update Posted: January 20, 2016
Last Verified: October 2014

Keywords provided by Beijing Center for Disease Control and Prevention:
safety
rabies vaccine
MRC-5 cell

Additional relevant MeSH terms:
Rabies
Rhabdoviridae Infections
Mononegavirales Infections
RNA Virus Infections
Virus Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs