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Real World Evidence Study of SYN023 in Children Exposed to Rabies
Sponsor: Synermore Biologics (Suzhou) Co., Ltd.
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.
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
Key Details
Gender
All
Age Range
0 Years - 17 Years
Study Type
OBSERVATIONAL
Enrollment
232
Start Date
2025-08-02
Completion Date
2026-12-31
Last Updated
2026-01-08
Healthy Volunteers
No
Conditions
Locations (6)
Peking University First Hospital
Beijing, Beijing Municipality, China
Shenzhen second people's hospital
Shenzhen, Guangdong, China
The University of Hong Kong - Shenzhen Hospital
Shenzhen, Guangdong, China
Hunan Provincial People's Hospital
Changsha, Hunan, China
Affiliated Nanhua Hospital, University of South China
Hengyang, Hunan, China
Jiangxi Provincial Chest Hospital
Nanchang, Jiangxi, China