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RecruitingNCT07327307Updated Apr 23, 2026

Real World Evidence Study of SYN023 in Children Exposed to Rabies

An observational study in Rabies Post-exposure Prophylaxis, sponsored by Synermore Biologics (Suzhou) Co., Ltd.. Recruiting at 6 sites in China. Open to participants aged 0 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-04-23.

Sponsored by Synermore Biologics (Suzhou) Co., Ltd. · Observational

From the registry’s dates

  • Started Aug 2025; still recruiting 1 year 3 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
232
Ages
0 Years to 17 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Rabies Post-exposure Prophylaxis

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Keywords

  • rabies
  • SYN023
  • pediatric
03

In context

Rabies

114 studies on the registry are indexed under Rabies; 15 are open to participants now.

Browse Rabies studies →

Lead sponsor

Synermore Biologics (Suzhou) Co., Ltd. is the lead sponsor of 6 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
0 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Age under 18 years on the day of enrollment, regardless of gender, and able to provide legal proof of identity;
  2. Individuals with WHO Category III rabies exposure, and the time from exposure to the initiation of Post-Exposure Prophylaxis (PEP) is \<7 days;
  3. 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;
  4. The volunteer's guardian voluntarily agrees to their participation in the study and signs the 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;
  5. 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).

Exclusion criteria

Exclusion Criteria:

  1. 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;
  2. Other conditions considered by the investigator as unsuitable for participation in this study.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
232 participants (estimated)
Target follow-up
1 Year
Patient registry
Yes

Groups and cohorts

  • SYN023 combined with rabies vaccine
  • Other rabies passive immunization products combined with rabies vaccine
06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 3 months and 1 year

Secondary outcomes

  1. Incidence of adverse reactions and adverse events

    Time frame: 42 days

  2. Incidence of serious adverse reactions and serious adverse events

    Time frame: 126 days

  3. Rabies Virus Neutralizing Activity (RVNA) of Geometric Mean Concentration (GMC)

    Time frame: Day 7

  4. Percentage of Participants With Rabies Virus Neutralizing Activity (RVNA) ≥0.5 IU/mL

    Time frame: Day 7

07

Study locations

6 of 6 sites recruiting
  • Peking University First Hospital
    Beijing, Beijing Municipality, China
    Recruiting
  • Shenzhen second people's hospital
    Shenzhen, Guangdong, China
    Recruiting
    • Zhe Deng · Contact+86 0755 83366388
    • Zhe Deng · Principal investigator
  • The University of Hong Kong - Shenzhen Hospital
    Shenzhen, Guangdong, China
    Recruiting
    • Haibing Xiao · Contact
    • Haibing Xiao · Principal investigator
  • Hunan Provincial People's Hospital
    Changsha, Hunan, China
    Recruiting
    • Xiaotong Han · Contact
    • Xiaotong Han · Principal investigator
  • Affiliated Nanhua Hospital, University of South China
    Hengyang, Hunan, China
    Recruiting
    • Wenkai Bin · Contact
    • Wenkai Bin · Principal investigator
  • Jiangxi Provincial Chest Hospital
    Nanchang, Jiangxi, China
    Recruiting
    • Qilong Zhang · Principal investigator
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07327307
Lead sponsor
Synermore Biologics (Suzhou) Co., Ltd.
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
First posted
Jan 8, 2026
Start date
Aug 2, 2025
Primary completion
Oct 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Apr 23, 2026

Study contacts

Xiangjun Li
Contact
xjli@synermore.cn
+86 0512-8765807

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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