Real World Evidence Study of SYN023 in Children Exposed to Rabies

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.

NCT Number	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
Conditions	Rabies Post-exposure Prophylaxis
Enrollment	232 participants
Start Date	2025-08-02
Primary Completion	2026-10-31 (estimated)
Study Completion	2026-12-31 (estimated)
Updated on ClinicalTrials.gov	2026-04-23