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

NCT ID: NCT02288286

Last Updated: 2016-01-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2015-04-30

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.

Conditions

Safety, Immunogenicity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: EXPERIMENTAL

2.5IU/ml rabies vaccine(MRC-5 cell) in humans aged 10-20 years old

Intervention Type: BIOLOGICAL

freeze-dried rabies vaccine(MRC-5 cell) of 2.5IU/ml, 5 doses, 4 weeks interval

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

Group Type: EXPERIMENTAL

2.5IU/ml rabies vaccine(MRC-5 cell) in humans aged 21-50 years old

Intervention Type: BIOLOGICAL

freeze-dried rabies vaccine(MRC-5 cell) of 2.5IU/ml, 5 doses, 4 weeks interval

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

Group Type: EXPERIMENTAL

2.5IU/ml rabies vaccine(MRC-5 cell) in humans aged 51-60 years old

Intervention Type: BIOLOGICAL

freeze-dried rabies vaccine(MRC-5 cell) of 2.5IU/ml, 5 doses, 4 weeks interval

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

Group Type: PLACEBO_COMPARATOR

2.5IU/ml rabies vaccine(vero cell) in humans aged 10-20 years old

Intervention Type: BIOLOGICAL

freeze-dried rabies vaccine(vero cell) of 2.5IU/ml, 5 doses, 4 weeks interval

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

Group Type: PLACEBO_COMPARATOR

2.5IU/ml rabies vaccine(vero cell) in humans aged 21-50 years old

Intervention Type: BIOLOGICAL

freeze-dried rabies vaccine(vero cell) of 2.5IU/ml, 5 doses, 4 weeks interval

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

Group Type: PLACEBO_COMPARATOR

2.5IU/ml rabies vaccine(vero cell) in humans aged 51-60 years old

Intervention Type: BIOLOGICAL

freeze-dried rabies vaccine(vero cell) of 2.5IU/ml, 5 doses, 4 weeks interval

Interventions

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

Intervention Type: 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

Intervention Type: 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

Intervention Type: 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

Intervention Type: 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

Intervention Type: 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

Intervention Type: BIOLOGICAL

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.

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Beijing Minhai Biotechnology Co., Ltd

INDUSTRY

Sponsor Role: collaborator

Beijing Center for Disease Control and Prevention

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

BJCDCP-11

Identifier Type: -

Identifier Source: org_study_id