CompletedPhase 3

To Evaluate the Immunogenicity and Safety of Two Different Immunization Schedules of Rabies Vaccine (Vero Cell)

China1,956 participantsStarted 2015-03-15

Plain-language summary

To evaluate the safety and immunogenicity of lyophilized human rabies vaccine (Vero cell) developed by Hualan Biological in healthy people aged 9 to 65 years with two different immunization schedules.

Who can participate

Age range

9 Years – 65 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: * 9 to 65 years old healthy residents; * volunteered for the experiment and signed informed consent; * the subjects or their guardians can comply with the requirements of the clinical trial protocol; * have not received rabies vaccination at any time; * nearly six months has not been mammals bite, scratch; * not participating in clinical trials of other drugs; * No use of human immunoglobulin or other products in the past six months. Exclusion Criteria: First needle exclusion: * have allergies, convulsions, seizures, mental and nervous system, such as history, or family history of epilepsy; * Allergic to the main ingredient of the investigational vaccine; * known to people with poor immune function damage or the tumor, spleen; * Axillary temperature \>38.0℃ within 7 days due to acute febrile illness; * Patients with axillary body temperature \> 37.0℃; * Severe chronic diseases such as congenital malformation, developmental disorder or severe cardiovascular disease, diabetes mellitus, hypertension that cannot be stabilized by drugs, liver and kidney diseases, and malignant tumors; * patients with acute and chronic infectious diseases, active infections, severe asthma, infectious skin diseases; * pregnant and lactating women; Any circumstances that the investigator believes may affect the assessment of the trial. Subsequent needle exclusions: * any serious adverse event causally related to vaccination; * new findings that meet the "first dose exclusion…

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

1956 subjects accept the observation of local adverse reaction according to Guidelines for grading standard of adverse reaction of clinical trial of vaccine used for prevention

Timeframe: Every needle 30 days after vaccination

1956 subjects accept the observation of local adverse reaction according to Guidelines for grading standard of adverse reaction of clinical trial of vaccine used for prevention

Timeframe: Vaccinations 31 days to 180 days

1956 subjects accept the observation of systemic adverse reactions according to Guidelines for grading standard of adverse reaction of clinical trial of vaccine used for prevention.

Timeframe: Every needle 30 days after vaccination

1956 subjects accept the observation of systemic adverse reactions according to Guidelines for grading standard of adverse reaction of clinical trial of vaccine used for prevention.

Timeframe: Vaccinations 31 days to 180 days

Trial details

NCT IDNCT06177249

SponsorHualan Biological Bacterin Co. Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2015-12-16

View on ClinicalTrials.gov More Rabies Human trials

Who can participate

Age range

9 Years – 65 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.

What they're measuring

1956 subjects accept the observation of local adverse reaction according to Guidelines for grading standard of adverse reaction of clinical trial of vaccine used for prevention

Timeframe: Every needle 30 days after vaccination

1956 subjects accept the observation of local adverse reaction according to Guidelines for grading standard of adverse reaction of clinical trial of vaccine used for prevention

Timeframe: Vaccinations 31 days to 180 days

1956 subjects accept the observation of systemic adverse reactions according to Guidelines for grading standard of adverse reaction of clinical trial of vaccine used for prevention.

Timeframe: Every needle 30 days after vaccination

1956 subjects accept the observation of systemic adverse reactions according to Guidelines for grading standard of adverse reaction of clinical trial of vaccine used for prevention.

Timeframe: Vaccinations 31 days to 180 days