Real World Evidence Study of SYN023 in Children Exposed to Rabies

NCT07327307 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 232

Last updated 2026-04-23

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07327307 on ClinicalTrials.gov