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

Healthy Clinical Trial

Official title:

A Safety Study of Freeze-dried Rabies Vaccine(MRC-5 Cell)in Chinese Humans From 10-60 Years Old

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02281396
• Other study ID #: BJCDCP-10
• Status: Completed
• Phase: Phase 1
• First received: October 30, 2014
• Last updated: January 19, 2016
• Start date: November 2014
• Est. completion date: May 2015

Study information

• Verified date: October 2014
• Source: Beijing Center for Disease Control and Prevention
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 10 Years to 60 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Healthy
• Rabies

Intervention

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
• 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
• 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
• 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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Beijing Center for Disease Control and Prevention	Beijing Minhai Biotechnology Co., Ltd

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	evaluate the safety of freeze-dried rabies vaccine (MRC-5 cell) in chinese humans Adverse reactions associated with vaccine	Adverse reactions associated with vaccine	within the first 4 weeks after the first vaccination	Yes