Rabies Post-exposure ProphylaxisNCT07327307
Real World Evidence Study of SYN023 in Children Exposed to Rabies
An observational study of Rabies Post-exposure Prophylaxis, run by Synermore Biologics (Suzhou) Co., Ltd. at 6 sites in China.
Trial summary
This observational study is an open-label, prospective, multi-center design. The goal is to evaluate the long-term clinical survival outcomes at 3 months and 1 year in individuals under 18 years of age with WHO Category III rabies exposure who have received real-world Post-Exposure Prophylaxis (PEP) with Zamerovimab… Read more about this study
- Who is it for?
- Ages 0 to 17 years
- Conditions the study is for
- Rabies Post-exposure Prophylaxis
- How many people
- 232 participants
- Where
- 6 sitesChina
- Study dates
- 2 Aug 2025to 31 Dec 2026
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 0 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Individuals under 18 years of age with category III rabies exposure who have received post-exposure prophylaxis (PEP) with Zamerovimab and Mazorelvimab Injection /other passive immunization products combined rabies vaccine in the real world
Who may be able to join
- Age under 18 years on the day of enrollment, regardless of gender, and able to provide legal proof of identity;
- Individuals with WHO Category III rabies exposure, and the time from exposure to the initiation of Post-Exposure Prophylaxis (PEP) is <7 days;
- Have completed standardized wound management, injection of Zamerovimab and Mazorelvimab Injection /other passive immunization products, and the first dose of rabies vaccination within 24 hours prior to screening;
- The volunteer's guardian voluntarily agrees to their participation in the study and signs the informed consent form. Specifically: for volunteers under 8 years old, the guardian signs the informed consent form with the child's assent fully respected; for volunteers aged 8-17, the guardian signs the informed consent form, and the minor volunteer signs the minor assent form;
- Willing and able to comply with all study procedures, and is expected to be able to complete the full course of rabies vaccination and the 1-year follow-up as required (with no plans for long-term absence or relocation from the study area).
Who cannot join
- Based on inquiry, besides the current Category III rabies exposure, there is a history of bites by dogs, cats, mongooses, foxes, ferrets, skunks, bats, or raccoons within the past year;
- Other conditions considered by the investigator as unsuitable for participation in this study.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
China6 sites, 6 recruiting
- Recruiting
Peking University First Hospital
Beijing, Beijing Municipality
Si Liu, +86 13501220344, DocLeo@vip.sina.com
Si Liu
- Recruiting
Hunan Provincial People's Hospital
Changsha, Hunan
Xiaotong Han
Xiaotong Han
- Recruiting
Affiliated Nanhua Hospital, University of South China
Hengyang, Hunan
Wenkai Bin
Wenkai Bin
- Recruiting
Jiangxi Provincial Chest Hospital
Nanchang, Jiangxi
Qilong Zhang
- Recruiting
Shenzhen second people's hospital
Shenzhen, Guangdong
Zhe Deng, +86 0755 83366388
Zhe Deng
- Recruiting
The University of Hong Kong - Shenzhen Hospital
Shenzhen, Guangdong
Haibing Xiao
Haibing Xiao
About this study
Official title: A Real-World Registry Study to Evaluate Clinical Protection Outcomes Following Post-Exposure Prophylaxis With Zamerovimab and Mazorelvimab Injection in Combination With Rabies Vaccine in Pediatric With Category III Rabies Exposure
This observational study is an open-label, prospective, multi-center design. The goal is to evaluate the long-term clinical survival outcomes at 3 months and 1 year in individuals under 18 years of age with WHO Category III rabies exposure who have received real-world Post-Exposure Prophylaxis (PEP) with Zamerovimab and Mazorelvimab Injection / other passive immunization products combined with the rabies vaccine.
Participants will: (1) Have their clinical protection outcomes (rabies-free survival status) registered and evaluated on Day 90 and Day 365. (2) Have the option to provide a blood sample on Day 7 for Rabies Virus Neutralizing Antibody (RVNA) testing. (3) Have all adverse events (within 42 days) and all serious adverse events (within 126 days) after PEP administration collected and recorded.
- Conditions
- Rabies Post-exposure Prophylaxis
- Keywords
- rabies, SYN023, pediatric
- Medical subject headings
- Rabies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| SYN023 combined with rabies vaccine | Not described | |
| Other rabies passive immunization products combined with rabies vaccine | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rabies-free survival rate
WHO's Classification of Rabies Cases:
Suspected case: refers to a case that satisfies the definition of clinical case; Probable case: refers to a suspected case with a reliable medical history of contact with any suspected animal infected with the rabies virus; Confirmed case: refers to a suspected or probable case that is proved to be infected based on the lab test result.
Measured: 3 months and 1 year
Secondary outcomes (4)
Incidence of adverse reactions and adverse events
Measured: 42 days
Incidence of serious adverse reactions and serious adverse events
Measured: 126 days
Rabies Virus Neutralizing Activity (RVNA) of Geometric Mean Concentration (GMC)
Measured: Day 7
Percentage of Participants With Rabies Virus Neutralizing Activity (RVNA) ≥0.5 IU/mL
Measured: Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2026
- Study start2 Aug 2025
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rabies Post-exposure ProphylaxisStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 232 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Synermore Biologics (Suzhou) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Peking University First Hospital, Shenzhen Second People's Hospital, Hunan Provincial People's Hospital, The University of Hong Kong-Shenzhen Hospital, University of South China Affiliated Nanhua Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07327307
- Sponsor's protocol ID
- SYN023-008
- Status last verified
- Apr 2026
- First submitted
- 24 Dec 2025
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real-World Registry Study to Evaluate Clinical Protection Outcomes Following Post-Exposure Prophylaxis With Zamerovimab and Mazorelvimab Injection in Combination With Rabies Vaccine in Pediatric With Category III Rabies Exposure
- ClinicalTrials.gov ID
- NCT07327307
- Acronym / sponsor ID
- SYN023-008
- Conditions
- Rabies Post-exposure Prophylaxis
- Keywords
- rabies, SYN023, pediatric
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 232 participants (estimated)
- Lead sponsor
- Synermore Biologics (Suzhou) Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Peking University First Hospital, Shenzhen Second People's Hospital, Hunan Provincial People's Hospital, The University of Hong Kong-Shenzhen Hospital, University of South China Affiliated Nanhua Hospital
- Study start
- 2 Aug 2025 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 8 Jan 2026 (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.
This observational study is an open-label, prospective, multi-center design. The goal is to evaluate the long-term clinical survival outcomes at 3 months and 1 year in individuals under 18 years of age with WHO Category III rabies exposure who have received real-world Post-Exposure Prophylaxis (PEP) with Zamerovimab and Mazorelvimab Injection / other passive immunization products combined with the rabies vaccine.
Participants will: (1) Have their clinical protection outcomes (rabies-free survival status) registered and evaluated on Day 90 and Day 365. (2) Have the option to provide a blood sample on Day 7 for Rabies Virus Neutralizing Antibody (RVNA) testing. (3) Have all adverse events (within 42 days) and all serious adverse events (within 126 days) after PEP administration collected and recorded.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SYN023 combined with rabies vaccine | – | – |
| Other rabies passive immunization products combined with rabies vaccine | – | – |
Who may qualify
- Ages
- 0 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Individuals under 18 years of age with category III rabies exposure who have received post-exposure prophylaxis (PEP) with Zamerovimab and Mazorelvimab Injection /other passive immunization products combined rabies vaccine in the real world
Key inclusion criteria (5 listed)
- Age under 18 years on the day of enrollment, regardless of gender, and able to provide legal proof of identity;
- Individuals with WHO Category III rabies exposure, and the time from exposure to the initiation of Post-Exposure Prophylaxis (PEP) is <7 days;
- Have completed standardized wound management, injection of Zamerovimab and Mazorelvimab Injection /other passive immunization products, and the first dose of rabies vaccination within 24 hours prior to screening;
- The volunteer's guardian voluntarily agrees to their participation in the study and signs the informed consent form. Specifically: for volunteers under 8 years old, the guardian signs the informed consent form with the child's assent fully respected; for volunteers aged 8-17, the guardian signs the informed consent form, and the minor volunteer signs the minor assent form;
- Willing and able to comply with all study procedures, and is expected to be able to complete the full course of rabies vaccination and the 1-year follow-up as required (with no plans for long-term absence or relocation from the study area).
Key exclusion criteria (2 listed)
- Based on inquiry, besides the current Category III rabies exposure, there is a history of bites by dogs, cats, mongooses, foxes, ferrets, skunks, bats, or raccoons within the past year;
- Other conditions considered by the investigator as unsuitable for participation in this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Rabies-free survival rate
Time frame: 3 months and 1 year
WHO's Classification of Rabies Cases: Suspected case: refers to a case that satisfies the definition of clinical case; Probable case: refers to a suspected case with a reliable medical history of contact with any suspected animal infected with the rabies virus; Confirmed case: refers to a suspected or probable case that is proved to be infected based on the lab test result.
4 secondary outcomes
Incidence of adverse reactions and adverse events
Time frame: 42 days
Incidence of serious adverse reactions and serious adverse events
Time frame: 126 days
Rabies Virus Neutralizing Activity (RVNA) of Geometric Mean Concentration (GMC)
Time frame: Day 7
Percentage of Participants With Rabies Virus Neutralizing Activity (RVNA) ≥0.5 IU/mL
Time frame: Day 7
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
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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.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rabies Post-exposure Prophylaxis, run by Synermore Biologics (Suzhou) Co., Ltd. at 6 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 5 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiangjun Li (+86 0512-8765807, xjli@synermore.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rabies-free survival rate (time frame: 3 months and 1 year). 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 23 Apr 2026.