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

NCT02281396 | Completed Phase 1

• 1 other identifier: BJCDCP-10
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Rabies; Healthy

Keywords

safety; rabies vaccine; MRC-5 cell

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

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

EXPERIMENTAL

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

2.5IU/ml in humans aged 21-60 years old

EXPERIMENTAL

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

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

ACTIVE COMPARATOR

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)

2.5IU/ml in humans(from 21-60 years old)

ACTIVE COMPARATOR

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)

Interventions

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

Freeze-dried Rabies Vaccine（MRC-5 Cell) of 2.5IU/ml,5 doses,4 weeks interval

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

2.5IU/ml rabies vaccine （MRC-5 Cell) in humans aged 21-60 years old BIOLOGICAL

Freeze-dried Rabies Vaccine（MRC-5 Cell) of 2.5IU/ml,5 doses,4 weeks interval

2.5IU/ml in humans aged 21-60 years old

2.5IU/ml rabies vaccine （MRC-5 Cell) in humans(from 10-20 years old) BIOLOGICAL

Freeze-dried Rabies Vaccine（vero Cell) of 2.5IU/ml,5 doses,4 weeks interval

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

2.5IU/ml rabies vaccine （MRC-5 Cell) in humans(from 21-60 years old) BIOLOGICAL

Freeze-dried Rabies Vaccine（vero Cell) of 2.5IU/ml,5 doses,4 weeks interval

2.5IU/ml in humans(from 21-60 years old)

Eligibility Criteria

• Age: 10 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Center for Disease Control and Prevention: lead
• Beijing Minhai Biotechnology Co., Ltd: collaborator

MeSH Terms

Conditions

Rabies

Condition Hierarchy (Ancestors)

Rhabdoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2014
• First Posted: November 3, 2014
• Study Start: November 1, 2014
• Primary Completion: January 1, 2015
• Study Completion: May 1, 2015
• Last Updated: January 20, 2016

Record last verified: 2014-10