Not Yet RecruitingPhase 3

Clinical Trial of Freeze-dried Human Rabies Vaccine (Human Diploid Cells)

China3,000 participantsStarted 2025-07-31

Plain-language summary

The Phase 3 clinical trial of freeze-dried human rabies vaccine (human diploid cells) adopted a randomized, blinded, parallel control,non-inferiority design,and administered vaccines to participants aged 10 to 60 years with different immunization schedules (5-dose schedule group, two simple 4-dose schedule groups, and 2-1-1 schedule group) to evaluate the immunogenicity and safety of the vaccine.

Who can participate

Age range

10 Years – 60 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.

Exclusion criteria

. After inquiry, it is found that there is a history of rabies vaccination or the use of passive immunization preparations for rabies virus.
. There was a history of injury from rabies virus-susceptible animals (such as cats and dogs) before the first dose of vaccination;
. The axillary body temperature of the participants on the day of enrollment was ≥37.3℃\*;
. Women who have a positive urine pregnancy trial before vaccination (on the day of vaccination), or who, after assessment, cannot rule out the possibility of pregnancy or are breastfeeding;
. Hypertension that cannot be controlled by medication, such as systolic blood pressure ≥160mmHg and/or diastolic blood pressure ≥100mmHg for participants aged 18 years and above before enrollment;
. Allergy to any component of the vaccine used in the trial, such as human albumin, sucrose, or maltose;

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

Antibody SCR for the 5-dose schedule group of the trial vaccine and the 5-dose schedule group of the control vaccine

Timeframe: 14 days after the first dose

Antibody GMC for the 5-dose schedule group of the trial vaccine and the 5-dose schedule group of the control vaccine

Timeframe: 14 days after the first dose

Antibody SCR for the simple 4-dose schedule group 1 of the trial vaccine and the 5-dose schedule group of the control vaccine

Timeframe: 14 days after the first dose

Antibody GMC for the simple 4-dose schedule group 1 of the trial vaccine and the 5-dose schedule of the control vaccine

Timeframe: 14 days after the first dose

Antibody SCR for the simple 4-dose schedule group 2 of the trial vaccine and the 5-dose schedule group of the control vaccine

Timeframe: 14 days after the first dose

Antibody GMC for the simple 4-dose schedule group 2 of the trial vaccine and the 5-dose schedule group of the control vaccine

Timeframe: 14 days after the first dose

Trial details

NCT IDNCT07028801

SponsorNingbo Rongan Biological Pharmaceutical Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-09-30

Contact for this trial

Zhiqiang Xie

+8613526534586 xiezqshang@163.com

View on ClinicalTrials.gov More Rabies trials

Plain-language summary

Who can participate

Age range

10 Years – 60 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.

Exclusion criteria

. After inquiry, it is found that there is a history of rabies vaccination or the use of passive immunization preparations for rabies virus.
. There was a history of injury from rabies virus-susceptible animals (such as cats and dogs) before the first dose of vaccination;
. The axillary body temperature of the participants on the day of enrollment was ≥37.3℃\*;
. Women who have a positive urine pregnancy trial before vaccination (on the day of vaccination), or who, after assessment, cannot rule out the possibility of pregnancy or are breastfeeding;
. Hypertension that cannot be controlled by medication, such as systolic blood pressure ≥160mmHg and/or diastolic blood pressure ≥100mmHg for participants aged 18 years and above before enrollment;
. Allergy to any component of the vaccine used in the trial, such as human albumin, sucrose, or maltose;

What they're measuring

Antibody SCR for the 5-dose schedule group of the trial vaccine and the 5-dose schedule group of the control vaccine

Timeframe: 14 days after the first dose

Antibody GMC for the 5-dose schedule group of the trial vaccine and the 5-dose schedule group of the control vaccine

Timeframe: 14 days after the first dose

Antibody SCR for the simple 4-dose schedule group 1 of the trial vaccine and the 5-dose schedule group of the control vaccine

Timeframe: 14 days after the first dose

Antibody GMC for the simple 4-dose schedule group 1 of the trial vaccine and the 5-dose schedule of the control vaccine

Timeframe: 14 days after the first dose

Antibody SCR for the simple 4-dose schedule group 2 of the trial vaccine and the 5-dose schedule group of the control vaccine

Timeframe: 14 days after the first dose

Antibody GMC for the simple 4-dose schedule group 2 of the trial vaccine and the 5-dose schedule group of the control vaccine

Timeframe: 14 days after the first dose