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Clinical Trials in China / NCT07327307
Recruiting Observational

Real World Evidence Study of SYN023 in Children Exposed to Rabies

NCT07327307 · tracked via the Priya Life Science China tracker
Sponsor
Synermore Biologics (Suzhou) Co., Ltd
Phase
Observational
Started
2025-08-02
Last updated
2026-04-23

Condition(s) studied

Rabies Post-exposure Prophylaxis

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.

Eligibility

Sex
ALL
Min age
0 Years
Max age
17 Years
Healthy volunteers
No
Inclusion Criteria: 1. Age under 18 years on the day of enrollment, regardless of gender, and able to provide legal proof of identity; 2. Individuals with WHO Category III rabies exposure, and the time from exposure to the initiation of Post-Exposure Prophylaxis (PEP) is \<7 days; 3. Have completed standardized wound management, injection of Zamerovimab and Mazorelvimab Injection /other passive immunization products, and the first dose of rabies vaccination within 24 hours prior to screening; 4. The volunteer's guardian voluntarily agrees to their participation in the study and signs the informed consent form. Specifically: for volunteers under 8 years old, the guardian signs the informed consent form with the child's assent fully respected; for volunteers aged 8-17, the guardian signs the informed consent form, and the minor volunteer signs the minor assent form; 5. Willing and able to comply with all study procedures, and is expected to be able to complete the full course of rabies vaccination and the 1-year follow-up as required (with no plans for long-term absence or relocation from the study area). Exclusion Criteria: 1. Based on inquiry, besides the current Category III rabies exposure, there is a history of bites by dogs, cats, mongooses, foxes, ferrets, skunks, bats, or raccoons within the past year; 2. Other conditions considered by the investigator as unsuitable for participation in this study.

Primary outcome measure(s)

  • Rabies-free survival rate — 3 months and 1 year
    WHO's Classification of Rabies Cases: Suspected case: refers to a case that satisfies the definition of clinical case; Probable case: refers to a suspected case with a reliable medical history of contact with any suspected animal infected with the rabies virus; Confirmed case: refers to a suspected or probable case that is proved to be infected based on the lab test result.

Trial sites (6)

FacilityCityRegionStatus
Peking University First Hospital Beijing Beijing Municipality Recruiting
Shenzhen second people's hospital Shenzhen Guangdong Recruiting
The University of Hong Kong - Shenzhen Hospital Shenzhen Guangdong Recruiting
Hunan Provincial People's Hospital Changsha Hunan Recruiting
Affiliated Nanhua Hospital, University of South China Hengyang Hunan Recruiting
Jiangxi Provincial Chest Hospital Nanchang Jiangxi Recruiting

More Synermore Biologics (Suzhou) Co., Ltd. trials in China

Real-World Effectiveness of Zamerovimab and Mazorelvimab and Vaccine for Rabies Grade III Exposure in Nanyang Active, not recruiting

Other trials for the same condition

Real-World Effectiveness of Zamerovimab and Mazorelvimab and Vaccine for Rabies Grade III Exposure in Nanyang Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07327307 on ClinicalTrials.gov ↗ ← All trials in China