Rabies Vaccine AllergyPhase 4NCT01821911
The Post-Marketing Safety and Immunogenicity Research of Speeda® Rabies Vaccine for Human Use
A Phase 4 study testing Zagreb2-1-1 and Essen in people with Rabies Vaccine Allergy and Vaccination Adverse Event, run by Beijing Center for Disease Control and Prevention at 3 sites in China.
Trial summary
The objective of this study was to achieve the post-marketing safety and immunogenicity research of Speeda® rabies vaccine for human use from Chengda Bio Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Rabies Vaccine Allergy, Vaccination Adverse Event, Anti-D Antibodies
- What is being tested?
- Zagreb2-1-1 and Essen
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10,500 participants
- Where
- 3 sitesChina
- Study dates
- Jul 2012to Dec 2014
- Phase
- Phase 4
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Parent/legal acceptable representatives of children or the adult participants are willing and able to understand the protocol requirements and provide informed consent signed
- Participant is considered to be in good health including the body and mental status on the basis of reported medical history and limited physical examination and live in local ≥ 12 months
- Participant body temperature ≤ 37.0℃
- Participant without preventive inoculation of rabies vaccine(only limited in immunogenicity subgroup)
Who cannot join
- Three-level exposure
- Known allergy to any constituent of the vaccine
- Reported the history of allergies, convulsions, epilepsy, mental illness and brain disease and clear serious systemic reaction
- Known bleeding disorder or suspected impairment of immunologic function, or receipt of immunosuppressive therapy or immunoglobulin since birth
- Participation in any other interventional clinical trial
- An acute illness with or without fever (temperature > 37.0℃) in the latest week preceding enrollment in the trial
Show all 9Show fewer
- Inoculated other vaccines, immunoglobulin or investigational drugs within 4 weeks prior to participation in the study
- Reported clearly the infection of the upper respiratory tract with 6 months Clinical Manifestation of Metabolic, blood system, lungs, heart, the gastrointestinal tract, nervous system, kidneys, urinary system, endocrine, liver disease or malignant tumor
- Any condition which, in the opinion of the investigator, would pose a health risk to the subject or interfere with the vaccine
Trial locations and contacts
3 sites in 1 country.
China3 sites
Beijing Chaoyang District Centers for Disease Control and Prevention
Beijing
Wuhan Centers for Disease Control and Prevention
Wuhan, Hubei
Guangdong Centers for Disease Control and Prevention
Zhaoqing, Guangdong
About this study
Official title: Phase 4 Study of Speeda® Rabies Vaccine for Human Use
The objective of this study was to achieve the post-marketing safety and immunogenicity research of Speeda® rabies vaccine for human use from Chengda Bio
Read the detailed description
The aim of the research is to compare the two immune procedures. The investigators plan to enroll 10500 participants signed the informed consent who separately inject by Zagreb or Essen procedure.
- Being tested
- Zagreb2-1-1, Essen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zagreb2-1-1Biological
Injection on day 0、7、21
EssenBiological
Injection on day 0、3、7、14、28
| Study group | Role | What they receive |
|---|---|---|
| Zagreb2-1-1 | Experimental | Injection on day 0、7、21 Receives: Biological: Zagreb2-1-1; Biological: Essen |
| Essen | Active comparator | Injection on day 0、3、7、14、28 Receives: Biological: Zagreb2-1-1; Biological: Essen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence Rate of Adverse Events of the rabies vaccine each injection
Measured: 2 years
Secondary outcomes (1)
Antibody titre of the subject on 0、7、14、42、180、365
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2013 (estimated)
- Study startJul 2012
- Primary completionDec 2013
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Rabies Vaccine AllergyStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Center for Disease Control and Prevention
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Nianmin Shi, Principal investigator, Beijing Chaoyang District Centers for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01821911
- Sponsor's protocol ID
- BJCDPC-5
- Status last verified
- Apr 2013
- First submitted
- 27 Mar 2013
- Last updated
- 20 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Li L, Xu J, Zhang J, Wang F, Cai J, Yang L, Zhu Z, Bai Y, Jia B, Ma J, Shi N, Li S. Immunogenicity and immune persistence of Zagreb 2-1-1 regimen of rabies vaccine in Chinese healthy individuals: A randomized, parallel-controlled of homologous vaccine with different immune procedure study. Hum Vaccin Immunother. 2024 Dec 31;20(1):2403177. doi: 10.1080/21645515.2024.2403177. Epub 2024 Oct 2.
PubMed 39358206Shi N, Zhang Y, Zheng H, Zhu Z, Wang D, Li S, Li Y, Yang L, Zhang J, Bai Y, Lu Q, Zhang Z, Luo F, Yu C, Li L. Immunogenicity, safety and antibody persistence of a purified vero cell cultured rabies vaccine (Speeda) administered by the Zagreb regimen or Essen regimen in post-exposure subjects. Hum Vaccin Immunother. 2017 Jun 3;13(6):1-8. doi: 10.1080/21645515.2017.1279770. Epub 2017 Jan 25.
PubMed 28121231
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
- Phase 4 Study of Speeda® Rabies Vaccine for Human Use
- ClinicalTrials.gov ID
- NCT01821911
- Acronym / sponsor ID
- BJCDPC-5
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10,500 participants (actual)
- Lead sponsor
- Beijing Center for Disease Control and PreventionOther government
- Study start
- Jul 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 1 Apr 2013 (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 objective of this study was to achieve the post-marketing safety and immunogenicity research of Speeda® rabies vaccine for human use from Chengda Bio
Detailed description
The aim of the research is to compare the two immune procedures. The investigators plan to enroll 10500 participants signed the informed consent who separately inject by Zagreb or Essen procedure.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Zagreb2-1-1 | Experimental | Biological: Zagreb2-1-1, Biological: EssenInjection on day 0、7、21 |
| Essen | Active comparator | Biological: Zagreb2-1-1, Biological: EssenInjection on day 0、3、7、14、28 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Parent/legal acceptable representatives of children or the adult participants are willing and able to understand the protocol requirements and provide informed consent signed
- Participant is considered to be in good health including the body and mental status on the basis of reported medical history and limited physical examination and live in local ≥ 12 months
- Participant body temperature ≤ 37.0℃
- Participant without preventive inoculation of rabies vaccine(only limited in immunogenicity subgroup)
Key exclusion criteria (9 listed)
- Three-level exposure
- Known allergy to any constituent of the vaccine
- Reported the history of allergies, convulsions, epilepsy, mental illness and brain disease and clear serious systemic reaction
- Known bleeding disorder or suspected impairment of immunologic function, or receipt of immunosuppressive therapy or immunoglobulin since birth
- Participation in any other interventional clinical trial
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 |
|---|---|---|
| Zagreb2-1-1Injection on day 0、7、21 | Biological | Essen, Zagreb2-1-1 |
| EssenInjection on day 0、3、7、14、28 | Biological | Essen, Zagreb2-1-1 |
Primary outcome
Incidence Rate of Adverse Events of the rabies vaccine each injection
Time frame: 2 years
1 secondary outcome
Antibody titre of the subject on 0、7、14、42、180、365
Time frame: 3 years
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.
- Derived from this study: PubMed 39358206Li L, Xu J, Zhang J, Wang F, Cai J, Yang L, Zhu Z, Bai Y, Jia B, Ma J, Shi N, Li S. Immunogenicity and immune persistence of Zagreb 2-1-1 regimen of rabies vaccine in Chinese healthy individuals: A randomized, parallel-controlled of homologous vaccine with different immune procedure study. Hum Vaccin Immunother. 2024 Dec 31;20(1):2403177. doi: 10.1080/21645515.2024.2403177. Epub 2024 Oct 2.
- Derived from this study: PubMed 28121231Shi N, Zhang Y, Zheng H, Zhu Z, Wang D, Li S, Li Y, Yang L, Zhang J, Bai Y, Lu Q, Zhang Z, Luo F, Yu C, Li L. Immunogenicity, safety and antibody persistence of a purified vero cell cultured rabies vaccine (Speeda) administered by the Zagreb regimen or Essen regimen in post-exposure subjects. Hum Vaccin Immunother. 2017 Jun 3;13(6):1-8. doi: 10.1080/21645515.2017.1279770. Epub 2017 Jan 25.
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.
Nianmin Shi principal investigator
Beijing Chaoyang District Centers for Disease Control and Prevention
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Zagreb2-1-1 and Essen in people with Rabies Vaccine Allergy and Vaccination Adverse Event, run by Beijing Center for Disease Control and Prevention at 3 sites 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 4 inclusion and 9 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.
Where is the study taking place?
The record lists 3 sites 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Incidence Rate of Adverse Events of the rabies vaccine each injection (time frame: 2 years). 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 NCT01821911, which also lists 2 linked publications.
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.