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NCT Number: NCT07327307

Real World Evidence Study of SYN023 in Children Exposed to Rabies

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.

Recruiting

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Key information

Age range

0 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Peking University First Hospital, Beijing, Beijing Municipality, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age under 18 years on the day of enrollment, regardless of gender, and able to provide legal proof of identity;
  • Individuals with WHO Category III rabies exposure, and the time from exposure to the initiation of Post-Exposure Prophylaxis (PEP) is <7 days;
  • 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;
  • 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;
  • 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

  • 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;
  • Other conditions considered by the investigator as unsuitable for participation in this study.

Treatment and study plan

Primary outcomes

  1. Rabies-free survival rate

    Time frame: 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.

Secondary outcomes

  1. Incidence of adverse reactions and adverse events

    Time frame: 42 days

  2. Incidence of serious adverse reactions and serious adverse events

    Time frame: 126 days

  3. Rabies Virus Neutralizing Activity (RVNA) of Geometric Mean Concentration (GMC)

    Time frame: Day 7

  4. Percentage of Participants With Rabies Virus Neutralizing Activity (RVNA) ≥0.5 IU/mL

    Time frame: Day 7

Study contacts

Contact information is provided by the study sponsor or research team.

Xiangjun Li

CONTACT

[email protected]

+86 0512-8765807

Sponsors and collaborators

Lead sponsor

Synermore Biologics (Suzhou) Co., Ltd.

Industry

Collaborators

  • Hunan Provincial People's Hospital
  • Peking University First Hospital
  • Shenzhen Second People's Hospital
  • The University of Hong Kong-Shenzhen Hospital
  • University of South China Affiliated Nanhua Hospital

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 8, 2026
Registry last updated
Apr 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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