Rabies HumanPhase 3NCT05545371
Prevention of Rabies With Four Doses of Rabies Vaccine
A Phase 3 study testing immunization procedures in people with Rabies Human and Antibody, run by Changchun Zhuoyi Biological Co., Ltd at 1 site in China.
Trial summary
To evaluate the non inferiority of the immunogenicity of the test vaccine inoculated according to the four dose immunization program over the five dose immunization program and the batches consistency of immunogenicity according to five dose immunization procedures. Read more about this study
- Who is it for?
- Ages 10 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Rabies Human, Antibody
- What is being tested?
- immunization procedures
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,100 participants
- Where
- 1 siteChina
- Study dates
- 18 Jun 2022to 14 Aug 2023
- 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
- People aged 10-60；
- Body temperature on the day of enrollment<37.3℃ (axillary temperature)
Who cannot join
- Have a history of rabies vaccine immunization or use of rabies virus passive immunization agents；
- People with congenital or acquired immunodeficiency or other autoimmune diseases；
- Female urine pregnancy test is positive, or during pregnancy and lactation, or she has a birth plan during the study period;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Blind and Positive Control Design: a Phase III Clinical Trial to Evaluate the Consistency Between Batches of 5 Doses of Freeze-dried Rabies Vaccine (Vero Cell) and the Immunogenicity and Safety of 4 Doses of Vaccine (1-1-1-1)
To evaluate the non inferiority of the immunogenicity of the test vaccine inoculated according to the four dose immunization program over the five dose immunization program and the batches consistency of immunogenicity according to five dose immunization procedures.
Read the detailed description
- In the population aged 10-60 years, evaluate the non inferiority of the immunogenicity of the test vaccine inoculated according to the four dose immunization program (0, 3, 7, 14/28 days) over the five dose immunization program (0, 3, 7, 14, 28 days)；
- To evaluate the consistency of immunogenicity between batches of freeze-dried human rabies vaccine (Vero cell) inoculated according to five dose immunization procedures (0, 3, 7, 14, 28 days).
- Conditions
- Rabies Human, Antibody
- Being tested
- immunization procedures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
immunization proceduresBiological
The subjects were vaccinated with rabies vaccine according to different immunization procedures
| Study group | Role | What they receive |
|---|---|---|
| 4 doses | Experimental | Inoculate rabies vaccine according to 1-1-1-1 immunization procedure Receives: Biological: immunization procedures |
| 5 doses | Experimental | Inoculate rabies vaccine according to 1-1-1-1-1 immunization procedure Receives: Biological: immunization procedures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive conversion rate of 14 days
- 14 days after the first dose of inoculation, the positive conversion rate of serum neutralizing antibody.
Measured: 6 months
Antibody Geometric Mean Titer (GMT) of 14 days
- 14 days after the first dose of inoculation, the Geometric Mean Titer (GMT) of serum neutralizing antibody .
Measured: 6 months
Positive conversion rate of 42 days
- The seroconversion rate of serum neutralizing antibody that 42 days after the first dose of inoculation.
Measured: 6 months
Advertise Events (AE) incidence within 1 month
- The distribution of AE incidence in different time periods (including all, within 30 minutes, 0-3 days, 0-7 days, 8-30 days) after each dose of inoculation;
Measured: 6 months
Serious Adverse Events (SAE) incidence within 6 months
- Incidence rate of SAE within 6 months from the first dose of inoculation to the full course of inoculation.
Measured: 12 months
Secondary outcomes (3)
Antibody test of 28 days
Detection of serum neutralizing antibody 28 days after the first dose of inoculation
Measured: 6 months
Antibody GMT of 42 days
The serum neutralized antibody GMT 42 days after the first dose of inoculation;
Measured: 6 months
Antibody test within 12 months
The serum neutralizing antibody was detected in 3 timepoints within 12 months after the whole vaccination.
Measured: 18months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2022
- Study start18 Jun 2022
- Primary completion27 Nov 2022
- Study completion14 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rabies HumanStudies 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
- 2,100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changchun Zhuoyi Biological Co., Ltd
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Li Miao, Study director, Changchun Zhuoyi Biological Co., Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05545371
- Sponsor's protocol ID
- ZY202106001
- Status last verified
- Sep 2026
- First submitted
- 14 Sep 2022
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: safety and antibody results.
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Blind and Positive Control Design: a Phase III Clinical Trial to Evaluate the Consistency Between Batches of 5 Doses of Freeze-dried Rabies Vaccine (Vero Cell) and the Immunogenicity and Safety of 4 Doses of Vaccine (1-1-1-1)
- ClinicalTrials.gov ID
- NCT05545371
- Acronym / sponsor ID
- ZY202106001
- Conditions
- Rabies Human, Antibody
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,100 participants (actual)
- Lead sponsor
- Changchun Zhuoyi Biological Co., LtdUniversity, hospital or other
- Study start
- 18 Jun 2022 (actual)
- Primary completion
- 27 Nov 2022 (actual)
- Study completion
- 14 Aug 2023 (actual)
- First posted
- 19 Sep 2022 (actual)
- 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.
To evaluate the non inferiority of the immunogenicity of the test vaccine inoculated according to the four dose immunization program over the five dose immunization program and the batches consistency of immunogenicity according to five dose immunization procedures.
Detailed description
- In the population aged 10-60 years, evaluate the non inferiority of the immunogenicity of the test vaccine inoculated according to the four dose immunization program (0, 3, 7, 14/28 days) over the five dose immunization program (0, 3, 7, 14, 28 days)；
- To evaluate the consistency of immunogenicity between batches of freeze-dried human rabies vaccine (Vero cell) inoculated according to five dose immunization procedures (0, 3, 7, 14, 28 days).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 4 doses | Experimental | Biological: immunization proceduresInoculate rabies vaccine according to 1-1-1-1 immunization procedure |
| 5 doses | Experimental | Biological: immunization proceduresInoculate rabies vaccine according to 1-1-1-1-1 immunization procedure |
Who may qualify
- Ages
- 10 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- People aged 10-60；
- Body temperature on the day of enrollment<37.3℃ (axillary temperature)
Key exclusion criteria (3 listed)
- Have a history of rabies vaccine immunization or use of rabies virus passive immunization agents；
- People with congenital or acquired immunodeficiency or other autoimmune diseases；
- Female urine pregnancy test is positive, or during pregnancy and lactation, or she has a birth plan during the study period;
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 |
|---|---|---|
| immunization proceduresThe subjects were vaccinated with rabies vaccine according to different immunization procedures | Biological | 4 doses, 5 doses |
Primary outcome
Positive conversion rate of 14 days
Time frame: 6 months
- 14 days after the first dose of inoculation, the positive conversion rate of serum neutralizing antibody.
Antibody Geometric Mean Titer (GMT) of 14 days
Time frame: 6 months
- 14 days after the first dose of inoculation, the Geometric Mean Titer (GMT) of serum neutralizing antibody .
Positive conversion rate of 42 days
Time frame: 6 months
- The seroconversion rate of serum neutralizing antibody that 42 days after the first dose of inoculation.
Advertise Events (AE) incidence within 1 month
Time frame: 6 months
- The distribution of AE incidence in different time periods (including all, within 30 minutes, 0-3 days, 0-7 days, 8-30 days) after each dose of inoculation;
Serious Adverse Events (SAE) incidence within 6 months
Time frame: 12 months
- Incidence rate of SAE within 6 months from the first dose of inoculation to the full course of inoculation.
3 secondary outcomes
Antibody test of 28 days
Time frame: 6 months
Antibody GMT of 42 days
Time frame: 6 months
Antibody test within 12 months
Time frame: 18months
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 30 Sep 2026.
- Individual participant dataSharing planned: Yes. safety and antibody results.
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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.
Li Miao study director
Changchun Zhuoyi Biological Co., Ltd
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 immunization procedures in people with Rabies Human and Antibody, run by Changchun Zhuoyi Biological Co., Ltd 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 2 inclusion and 3 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 30 Sep 2026. 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 conversion rate of 14 days (time frame: 6 months). The study lists 5 primary outcomes in all. 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 30 Sep 2026.