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AzTrials

Safety, ImmunogenicityPhase 3NCT02288286

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

A Phase 3 study testing 2.5IU/ml rabies vaccine(MRC-5 cell) in humans aged 10-20 years old, 2.5IU/ml rabies vaccine(MRC-5 cell) in humans aged 21-50 years old and 2.5IU/ml rabies vaccine(MRC-5 cell) in humans aged 51-60 years old in people with Safety, Immunogenicity, run by Beijing Center for Disease Control and Prevention.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 10 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Safety, Immunogenicity
What is being tested?
2.5IU/ml rabies vaccine(MRC-5 cell) in humans aged 10-20 years old, 2.5IU/ml rabies vaccine(MRC-5 cell) in humans aged 21-50 years old and 2.5IU/ml rabies vaccine(MRC-5 cell) in humans aged 51-60 years old
Type of treatment
Vaccines
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,200 participants
Where
No sites listed yet
Study dates
Nov 2014to Apr 2015
Phase
Phase 3
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 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.

About this study

Official title: Safety and Immunogenicity 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 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.

Being tested
2.5IU/ml rabies vaccine(MRC-5 cell) in humans aged 10-20 years old, 2.5IU/ml rabies vaccine(MRC-5 cell) in humans aged 21-50 years old, 2.5IU/ml rabies vaccine(MRC-5 cell) in humans aged 51-60 years old, 2.5IU/ml rabies vaccine(vero cell) in humans aged 10-20 years old, 2.5IU/ml rabies vaccine(vero cell) in humans aged 21-50 years old

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 2.5IU/ml rabies vaccine(MRC-5 cell) in 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 21-50 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 51-60 years oldBiological

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

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

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

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

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

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

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

Study groups in NCT02288286
Study groupRoleWhat they receive
2.5IU/ml in humans aged 10-20 years oldExperimentalfreeze-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
Receives: Biological: 2.5IU/ml rabies vaccine(MRC-5 cell) in humans aged 10-20 years old
2.5IU/ml in humans aged 21-50Experimentalfreeze-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
Receives: Biological: 2.5IU/ml rabies vaccine(MRC-5 cell) in humans aged 21-50 years old
2.5IU/ml in humans aged 51-60Experimentalfreeze-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
Receives: Biological: 2.5IU/ml rabies vaccine(MRC-5 cell) in humans aged 51-60 years old
2.5IU/ml in humans(from 10-20 years old)Placebo comparatorfreeze-dried rabies vaccines(vero cell) of 2.5IU/ml in 200 humans aged 10-20 years old on days 0,3,7,14,28
Receives: Biological: 2.5IU/ml rabies vaccine(vero cell) in humans aged 10-20 years old
2.5IU/ml in humans(from 21-50 years old)Placebo comparatorfreeze-dried rabies vaccines(vero cell) of 2.5IU/ml in 200 humans aged 21-50 years old on days 0,3,7,14,28
Receives: Biological: 2.5IU/ml rabies vaccine(vero cell) in humans aged 21-50 years old
2.5IU/ml in humans(from 51-60 years old)Placebo comparatorfreeze-dried rabies vaccines(vero cell) of 2.5IU/ml in 200 humans aged 51-60 years old on days 0,3,7,14,28
Receives: Biological: 2.5IU/ml rabies vaccine(vero cell) in humans aged 51-60 years old

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Evaluate the safety of freeze-dried rabies vaccine(MRC-5 cell) in chinese humans

    Adverse reactions associated with vaccine

    Measured: within the first 4 weeks after the first vaccination

Secondary outcomes (1)

  1. Evaluate the immunogenicity of freeze-dried rabies vaccine(MRC-5 cell) in chinese humans

    Examination of the value of IgE antibody

    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.

  1. First posted11 Nov 2014 (estimated)
  2. Study startNov 2014
  3. Primary completionFeb 2015
  4. Study completionApr 2015

Resources

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 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
1,200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02288286
Sponsor's protocol ID
BJCDCP-11
Status last verified
Nov 2014
First submitted
7 Nov 2014
Last updated
20 Jan 2016
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing 2.5IU/ml rabies vaccine(MRC-5 cell) in humans aged 10-20 years old, 2.5IU/ml rabies vaccine(MRC-5 cell) in humans aged 21-50 years old and 2.5IU/ml rabies vaccine(MRC-5 cell) in humans aged 51-60 years old in people with Safety, Immunogenicity, 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 (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?

On the ClinicalTrials.gov record for NCT02288286.

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.

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