Real World Evidence Study of SYN023 in Children Exposed to Rabies
NCT07327307 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 232
Last updated 2026-04-23
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.
Conditions
- Rabies Post-exposure Prophylaxis
Sponsors & Collaborators
-
Peking University First Hospital
collaborator OTHER -
Shenzhen Second People's Hospital
collaborator OTHER -
Hunan Provincial People's Hospital
collaborator OTHER -
The University of Hong Kong-Shenzhen Hospital
collaborator OTHER -
University of South China Affiliated Nanhua Hospital
collaborator UNKNOWN -
Synermore Biologics (Suzhou) Co., Ltd.
lead INDUSTRY
Eligibility
- Min Age
- 0 Years
- Max Age
- 17 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-08-02
- Primary Completion
- 2026-10-31
- Completion
- 2026-12-31
Countries
- China
Study Locations
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