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RECRUITING
NCT07327307

Real World Evidence Study of SYN023 in Children Exposed to Rabies

Sponsor: Synermore Biologics (Suzhou) Co., Ltd.

View on ClinicalTrials.gov

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

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