RabiesPhase 1NCT02281396
The Safety Research of Freeze-dried Rabies Vaccine（MRC-5 Cell) in Chinese Humans
A Phase 1 study testing 2.5IU/ml in rabies vaccine （MRC-5 Cell) humans aged 10-20 years old, 2.5IU/ml rabies vaccine （MRC-5 Cell) in humans aged 21-60 years old and 2.5IU/ml rabies vaccine （MRC-5 Cell) in humans(from 10-20 years old) in people with Rabies and Healthy, run by Beijing Center for Disease Control and Prevention.
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. Read more about this study
- Who is it for?
- Ages 10 to 60 yearsHealthy volunteers can take part
- What is being tested?
- 2.5IU/ml in rabies vaccine （MRC-5 Cell) humans aged 10-20 years old, 2.5IU/ml rabies vaccine （MRC-5 Cell) in humans aged 21-60 years old and 2.5IU/ml rabies vaccine （MRC-5 Cell) in humans(from 10-20 years old)
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Nov 2014to May 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
About this study
Official title: A Safety Study of Freeze-dried Rabies Vaccine(MRC-5 Cell)in Chinese Humans From 10-60 Years Old
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.
- Being tested
- 2.5IU/ml in rabies vaccine （MRC-5 Cell) humans aged 10-20 years old, 2.5IU/ml rabies vaccine （MRC-5 Cell) in humans aged 21-60 years old, 2.5IU/ml rabies vaccine （MRC-5 Cell) in humans(from 10-20 years old), 2.5IU/ml rabies vaccine （MRC-5 Cell) in humans(from 21-60 years old)
- Keywords
- safety, rabies vaccine, MRC-5 cell
- Medical subject headings
- Rabies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2.5IU/ml in rabies vaccine （MRC-5 Cell) humans aged 10-20 years oldBiological
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 oldBiological
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)Biological
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)Biological
Freeze-dried Rabies Vaccine（vero Cell) of 2.5IU/ml,5 doses,4 weeks interval
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: 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 Receives: Biological: 2.5IU/ml rabies vaccine （MRC-5 Cell) in humans(from 21-60 years old) |
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluate the safety of freeze-dried rabies vaccine (MRC-5 cell) in chinese humans Adverse reactions associated with vaccine
Adverse reactions associated with vaccine
Measured: within the first 4 weeks after the first vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2014 (estimated)
- Study startNov 2014
- Primary completionJan 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RabiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Center for Disease Control and Prevention
- Sponsor type
- Other government
- Collaborators
- Beijing Minhai Biotechnology Co., Ltd
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02281396
- Sponsor's protocol ID
- BJCDCP-10
- Status last verified
- Oct 2014
- First submitted
- 30 Oct 2014
- Last updated
- 20 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Safety Study of Freeze-dried Rabies Vaccine(MRC-5 Cell)in Chinese Humans From 10-60 Years Old
- ClinicalTrials.gov ID
- NCT02281396
- Acronym / sponsor ID
- BJCDCP-10
- Keywords
- safety, rabies vaccine, MRC-5 cell
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Beijing Center for Disease Control and PreventionOther government
- Collaborators
- Beijing Minhai Biotechnology Co., Ltd
- Study start
- Nov 2014
- Primary completion
- Jan 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 3 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 2.5IU/ml in humans aged 10-20 years old | Experimental | Biological: 2.5IU/ml in rabies vaccine （MRC-5 Cell) humans aged 10-20 years oldfreeze-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 |
| 2.5IU/ml in humans aged 21-60 years old | Experimental | Biological: 2.5IU/ml rabies vaccine （MRC-5 Cell) in humans aged 21-60 years oldfreeze-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 |
| 2.5IU/ml in humans(from 10-20 years old) | Active comparator | 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 in 20 humans aged 10-20 years old on day 0,3,7,14,28 |
| 2.5IU/ml in humans(from 21-60 years old) | Active comparator | 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 in 20 humans aged 21-60 years old on day 0,3,7,14,28 |
Who may qualify
- Ages
- 10 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 2.5IU/ml in rabies vaccine （MRC-5 Cell) humans aged 10-20 years oldFreeze-dried Rabies Vaccine（MRC-5 Cell) of 2.5IU/ml,5 doses,4 weeks interval | Biological | 2.5IU/ml in humans aged 10-20 years old |
| 2.5IU/ml rabies vaccine （MRC-5 Cell) in humans aged 21-60 years oldFreeze-dried Rabies Vaccine（MRC-5 Cell) of 2.5IU/ml,5 doses,4 weeks interval | Biological | 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)Freeze-dried Rabies Vaccine（vero Cell) of 2.5IU/ml,5 doses,4 weeks interval | Biological | 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)Freeze-dried Rabies Vaccine（vero Cell) of 2.5IU/ml,5 doses,4 weeks interval | Biological | 2.5IU/ml in humans(from 21-60 years old) |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 2.5IU/ml in rabies vaccine （MRC-5 Cell) humans aged 10-20 years old, 2.5IU/ml rabies vaccine （MRC-5 Cell) in humans aged 21-60 years old and 2.5IU/ml rabies vaccine （MRC-5 Cell) in humans(from 10-20 years old) in people with Rabies and Healthy, run by Beijing Center for Disease Control and Prevention.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2016.