Actively Recruiting
Real World Evidence Study of SYN023 in Children Exposed to Rabies
Led by Synermore Biologics (Suzhou) Co., Ltd. · Updated on 2026-04-23
232
Participants Needed
6
Research Sites
73 weeks
Total Duration
On this page
Sponsors
S
Synermore Biologics (Suzhou) Co., Ltd.
Lead Sponsor
P
Peking University First Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Real World Evidence Study of SYN023 in Children Exposed to Rabies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Under 18 years old on enrollment day and able to provide legal proof of identity
- Experienced WHO Category III rabies exposure with PEP started within 7 days after exposure
- Completed wound management, received Zamerovimab and Mazorelvimab Injection or other passive immunization, and first rabies vaccine dose within 24 hours before screening
- Guardian consents to participation; assent obtained from children aged 8-17
- Willing and able to follow all study procedures and complete vaccination and one-year follow-up without plans to relocate
You will not qualify if you...
- History of bites by dogs, cats, mongooses, foxes, ferrets, skunks, bats, or raccoons within the past year besides the current exposure
- Any conditions the investigator considers unsuitable for participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
Peking University First Hospital
Beijing, Beijing Municipality, China
Actively Recruiting
2
Shenzhen second people's hospital
Shenzhen, Guangdong, China
Actively Recruiting
3
The University of Hong Kong - Shenzhen Hospital
Shenzhen, Guangdong, China
Actively Recruiting
4
Hunan Provincial People's Hospital
Changsha, Hunan, China
Actively Recruiting
5
Affiliated Nanhua Hospital, University of South China
Hengyang, Hunan, China
Actively Recruiting
6
Jiangxi Provincial Chest Hospital
Nanchang, Jiangxi, China
Actively Recruiting
Research Team
X
Xiangjun Li
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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