NCT07327307

Real World Evidence Study of SYN023 in Children Exposed to Rabies

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 232 (estimated)
• Sponsor: Synermore Biologics (Suzhou) Co., Ltd. · Industry
• Sex: All
• Age: 0 Years – 17 Years
• Healthy volunteers: Not accepted

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

Timeline

• Start date: 2025-08-02
• Primary completion: 2026-01-31
• Completion: 2026-12-31
• First posted: 2026-01-08
• Last updated: 2026-01-08

Locations

6 sites across 1 country: China