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.
Study Type
OBSERVATIONAL
Enrollment
232
Peking University First Hospital
Beijing, Beijing Municipality, China
RECRUITINGShenzhen second people's hospital
Shenzhen, Guangdong, China
RECRUITINGThe University of Hong Kong - Shenzhen Hospital
Shenzhen, Guangdong, China
RECRUITINGHunan Provincial People's Hospital
Changsha, Hunan, China
RECRUITINGAffiliated Nanhua Hospital, University of South China
Hengyang, Hunan, China
RECRUITINGJiangxi Provincial Chest Hospital
Nanchang, Jiangxi, China
RECRUITINGRabies-free survival rate
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.
Time frame: 3 months and 1 year
Incidence of adverse reactions and adverse events
Time frame: 42 days
Incidence of serious adverse reactions and serious adverse events
Time frame: 126 days
Rabies Virus Neutralizing Activity (RVNA) of Geometric Mean Concentration (GMC)
Time frame: Day 7
Percentage of Participants With Rabies Virus Neutralizing Activity (RVNA) ≥0.5 IU/mL
Time frame: Day 7
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