RabiesPhase 3NCT02491541
A Phase 3 Clinical Trial for a Rabies Vaccine (Vero Cell) for Human Use in Healthy Chinese Subjects
A Phase 3 study testing Changchun Werersai and Jilin Maifeng in people with Rabies, run by Jiangsu Province Centers for Disease Control and Prevention at 1 site in China.
Trial summary
The purpose of this single-centre, randomized, double-blind, parallel control, phase 3 study is to evaluate the safety and immunogenicity of a rabies vaccine (Vero Cell) for human use in healthy Chinese subjects aged 10-60 years, according to the 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
- Rabies
- What is being tested?
- Changchun Werersai and Jilin Maifeng
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- 1 siteChina
- Study dates
- Aug 2012to Dec 2013
- 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
- Aged from 10 to 60 years old
- Subjects or legal guardians can and will comply with the requirements of the protocol
- Subjects or legal guardians are able to understand and sign the informed consent
- Healthy subjects judged from medical history after investigator's inquiry
- Subjects with temperature <=37.0°C on axillary setting
Who cannot join
- Female in lactation or pregnancy, or plan to be pregnant during the study period
- Subject who has allergic history to any vaccine or other medicines
- Subject who has injury history by dogs or other mammals and has been vaccinated with rabies vaccine
- Subject who has serious adverse reaction history after vaccination such as allergies, hives, difficulty in breathing, angioedema or abdominal pain
- Subject with congenital malformation, developmental disorder or serious chronic disease
- Subject with autoimmune diseases or immunodeficiency
Show all 24Show fewer
- Subject with asthma, unstable over the past two years requiring emergency treatment, hospitalization, intubation, oral or intravenous corticosteroids
- Subject with diabetes (Type I or II) excluding gestational diabetes
- Subject with thyroidectomy history, or require treatment in the past 12 months due to thyroid disease
- Subject with severe angioedema in the past 3 years or require treatment in the past 2 years
- Subject with hypertension and with a blood pressure exceeding 145/95 mmHg at enrollment time
- Subject with coagulation abnormalities diagnosed by doctors (such as clotting factor deficiency, coagulation disorders, platelet disorder) or obvious bruises or blood clotting disorder
- Subject with cancer, or has been treated in active cancer period or not clearly cured, or may recur during the study period
- Subject with epilepsy, excluding those alcohol epilepsy within three years before quitting drinking or those do not need treatment in the past 3 years
- Asplenia, functional asplenia, without a spleen or removal of the spleen caused by any situation
- Guillain-Barre syndrome
- Any prior administration of immunodepressant or corticosteroids in last 6 months
- Any prior administration of blood products in last 3 months
- Any prior administration of other research medicine/vaccine in last 30 days
- Any prior administration of any attenuated live vaccine in last 30 days
- Any prior administration of subunit or inactivated vaccines in last 14 days, such as pneumococcal vaccine
- Ongoing anti-tuberculosis prevention or treatment
- Subject who cannot comply with the trial requirements, or with mental illness/ dual-stage affective psychosis in the past or at present; or has not been controlled and needs to take psychiatric drugs the past 2 years; or with suicidal tendencies in the past 5 years
- Any medical, psychological, social or other condition judged by investigator, that may interfere subject's compliance with the protocol or signature on informed consent
Trial locations and contacts
1 site in 1 country.
China1 site
Xinyi Center for Disease Control and Prevention
Xuzhou, Jiangsu, 221400
About this study
Official title: A Single-centre, Randomized, Double-blind, Parallel Control, Phase 3 Study to Evaluate the Safety and Immunogenicity of a Rabies Vaccine (Vero Cell) for Human Use in Healthy Chinese Subjects Aged 10-60 Years
The purpose of this single-centre, randomized, double-blind, parallel control, phase 3 study is to evaluate the safety and immunogenicity of a rabies vaccine (Vero Cell) for human use in healthy Chinese subjects aged 10-60 years, according to the Essen methods (1-1-1-1-1) vaccination.
Read the detailed description
There will be two immunization arms. 1200 healthy subjects will be randomly assigned (1:1) to receive an experimental vaccine or a parallel comparator vaccine. All of them will be received five doses of rabies vaccine at day 0,3,7,14,28 according to the traditional Essen methods (1-1-1-1-1) vaccination.
- Conditions
- Rabies
- Being tested
- Changchun Werersai, Jilin Maifeng
- Medical subject headings
- Rabies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Changchun WerersaiBiological
A rabies vaccine (Vero Cell) for human use produced by Changchun Werersai Biotech Pharmaceutical Co., Ltd.
1.0 ml experimental vaccine on day 0,3,7,14,28
Jilin MaifengBiological
A rabies vaccine (Vero Cell) for human use produced by Jilin Maifeng Biotech Pharmaceutical Co., Ltd.
1.0 ml comparator vaccine on day 0,3,7,14,28
| Study group | Role | What they receive |
|---|---|---|
| Changchun Werersai | Experimental | A rabies vaccine (Vero Cell) for human use produced by Changchun Werersai Biotech Pharmaceutical Co., Ltd. Receives: Biological: Changchun Werersai |
| Jilin Maifeng | Active comparator | A rabies vaccine (Vero Cell) for human use produced by Jilin Maifeng Biotech Pharmaceutical Co., Ltd. Receives: Biological: Jilin Maifeng |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive seroconversion rate of serum rabies virus neutralizing antibody 42 days after full vaccination
Measured: 42 days after full vaccination
Secondary outcomes (4)
Geometric mean concentration (GMC) of serum rabies virus neutralizing antibody 42 days after full vaccination
Measured: 42 days after full vaccination
Positive seroconversion rate of serum rabies virus neutralizing antibody 14 days after full vaccination
Measured: 14 days after full vaccination
Geometric mean concentration (GMC) of serum rabies virus neutralizing antibody 14 days after full vaccination
Measured: 14 days after full vaccination
Incidence of local and systemic adverse reactions during safety observation period after each vaccination
Measured: 0-7 days after each vaccination and 8-28 days after the fifth vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2015 (estimated)
- Study startAug 2012
- Primary completionDec 2012
- Study completionDec 2013
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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu Province Centers for Disease Control and Prevention
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Yuemei Hu, Principal investigator, Jiangsu Provincial Center for Diseases Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02491541
- Sponsor's protocol ID
- 20120002
- Status last verified
- Jul 2015
- First submitted
- 3 Jul 2015
- Last updated
- 9 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-centre, Randomized, Double-blind, Parallel Control, Phase 3 Study to Evaluate the Safety and Immunogenicity of a Rabies Vaccine (Vero Cell) for Human Use in Healthy Chinese Subjects Aged 10-60 Years
- ClinicalTrials.gov ID
- NCT02491541
- Acronym / sponsor ID
- 20120002
- Conditions
- Rabies
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,200 participants (actual)
- Lead sponsor
- Jiangsu Province Centers for Disease Control and PreventionResearch network
- Study start
- Aug 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 8 Jul 2015 (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 single-centre, randomized, double-blind, parallel control, phase 3 study is to evaluate the safety and immunogenicity of a rabies vaccine (Vero Cell) for human use in healthy Chinese subjects aged 10-60 years, according to the Essen methods (1-1-1-1-1) vaccination.
Detailed description
There will be two immunization arms. 1200 healthy subjects will be randomly assigned (1:1) to receive an experimental vaccine or a parallel comparator vaccine. All of them will be received five doses of rabies vaccine at day 0,3,7,14,28 according to the traditional Essen methods (1-1-1-1-1) vaccination.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Changchun Werersai | Experimental | Biological: Changchun WerersaiA rabies vaccine (Vero Cell) for human use produced by Changchun Werersai Biotech Pharmaceutical Co., Ltd. |
| Jilin Maifeng | Active comparator | Biological: Jilin MaifengA rabies vaccine (Vero Cell) for human use produced by Jilin Maifeng Biotech Pharmaceutical Co., Ltd. |
Who may qualify
- Ages
- 10 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Aged from 10 to 60 years old
- Subjects or legal guardians can and will comply with the requirements of the protocol
- Subjects or legal guardians are able to understand and sign the informed consent
- Healthy subjects judged from medical history after investigator's inquiry
- Subjects with temperature <=37.0°C on axillary setting
Key exclusion criteria (24 listed)
- Female in lactation or pregnancy, or plan to be pregnant during the study period
- Subject who has allergic history to any vaccine or other medicines
- Subject who has injury history by dogs or other mammals and has been vaccinated with rabies vaccine
- Subject who has serious adverse reaction history after vaccination such as allergies, hives, difficulty in breathing, angioedema or abdominal pain
- Subject with congenital malformation, developmental disorder or serious chronic disease
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 |
|---|---|---|
| Changchun WerersaiA rabies vaccine (Vero Cell) for human use produced by Changchun Werersai Biotech Pharmaceutical Co., Ltd. 1.0 ml experimental vaccine on day 0,3,7,14,28 | Biological | Changchun Werersai |
| Jilin MaifengA rabies vaccine (Vero Cell) for human use produced by Jilin Maifeng Biotech Pharmaceutical Co., Ltd. 1.0 ml comparator vaccine on day 0,3,7,14,28 | Biological | Jilin Maifeng |
Primary outcome
Positive seroconversion rate of serum rabies virus neutralizing antibody 42 days after full vaccination
Time frame: 42 days after full vaccination
4 secondary outcomes
Geometric mean concentration (GMC) of serum rabies virus neutralizing antibody 42 days after full vaccination
Time frame: 42 days after full vaccination
Positive seroconversion rate of serum rabies virus neutralizing antibody 14 days after full vaccination
Time frame: 14 days after full vaccination
Geometric mean concentration (GMC) of serum rabies virus neutralizing antibody 14 days after full vaccination
Time frame: 14 days after full vaccination
Incidence of local and systemic adverse reactions during safety observation period after each vaccination
Time frame: 0-7 days after each vaccination and 8-28 days after the fifth vaccination
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 9 Jul 2015.
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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.
Yuemei Hu principal investigator
Jiangsu Provincial Center for Diseases Control and Prevention
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Changchun Werersai and Jilin Maifeng in people with Rabies, run by Jiangsu Province Centers for Disease Control and Prevention at 1 site in China.
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 5 inclusion and 24 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 9 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 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?
Positive seroconversion rate of serum rabies virus neutralizing antibody 42 days after full vaccination (time frame: 42 days after full 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 9 Jul 2015.