RecruitingNot Applicable

Real World Evidence Study of SYN023 in Children Exposed to Rabies

China232 participantsStarted 2025-08-02

Plain-language 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.

Who can participate

Age range

0 Years – 17 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Rabies-free survival rate

Timeframe: 3 months and 1 year

Trial details

NCT IDNCT07327307

SponsorSynermore Biologics (Suzhou) Co., Ltd.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2026-10-31

Contact for this trial

Xiangjun Li

+86 0512-8765807 xjli@synermore.cn

View on ClinicalTrials.gov More Rabies Post-exposure Prophylaxis trials

Plain-language summary

Who can participate

Age range

0 Years – 17 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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).

Real World Evidence Study of SYN023 in Children Exposed to Rabies

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Contact for this trial

Real World Evidence Study of SYN023 in Children Exposed to Rabies

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Contact for this trial

Exclusion criteria