Actively Recruiting
A Clinical Trial of Rabies Vaccine（Human Diploid Cell）for Human Use,Freeze-dried
Led by Ningbo Rongan Biological Pharmaceutical Co., Ltd. · Updated on 2025-06-15
60
Participants Needed
1
Research Sites
31 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The Phase 1 clinical trial of the freeze-dried human rabies vaccine (human diploid cells) will be conducted on participants aged 10 to 60. This study will design a single-arm, randomized, open-access trial with different immunization schedules (5-dose schedule and 2-1-1 schedule) to evaluate the safety and tolerability of the vaccine in participants aged 10 to 60
CONDITIONS
Official Title
A Clinical Trial of Rabies Vaccine（Human Diploid Cell）for Human Use,Freeze-dried
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants aged 10 to 60 years old (10 years and older but younger than 61 years)
- Participants aged 10 to 17 and their guardians can provide valid identification
- Participants aged 18 to 60 can provide valid identification
- Participants aged 10 to 17 and their guardians, and participants aged 18 to 60, voluntarily sign informed consent and understand the trial procedures and risks
- Participants possess basic reading and writing skills and can complete diary and contact cards
- Female participants with fertility have taken effective contraception within 2 weeks before the trial
- Female participants have no plans to conceive for 6 months from the start of the trial until full vaccination
- Female participants agree to use effective contraception during the trial period, including condoms, intrauterine devices, oral contraceptives, sterilization, abstention, injections, implants, hormone patches, diaphragms, or cervical caps
You will not qualify if you...
- History of rabies vaccination or use of rabies passive immunization
- History of injury from rabies-susceptible animals before first vaccination dose
- Axillary body temperature of 37.3°C or higher on enrollment day
- Abnormal screening exam results deemed clinically significant by clinicians
- Positive urine pregnancy test on vaccination day, possible pregnancy, or breastfeeding
- Uncontrolled hypertension with systolic ≥140 mmHg or diastolic ≥90 mmHg in participants 18 and older
- Allergy to any vaccine components such as human albumin, sucrose, or maltose
- History of severe allergic reactions like anaphylactic shock, allergic laryngeal edema, allergic purpura, severe urticaria, or acquired angioedema
- Diagnosed congenital or acquired immune diseases affecting trial evaluation
- Serious diseases including severe respiratory, liver, kidney, cardiovascular, cerebrovascular diseases, malignant tumors, or poorly controlled chronic diseases
- Abnormal coagulation function or diagnosed coagulation disorders
- Splenectomy or asplenia conditions
- Diagnosed neurological or mental disorders unsuitable for trial participation
- Planned long-term systemic glucocorticoid therapy within 30 days after first vaccination dose
- Use of immunoenhancers, immunoglobulins, or blood products within 3 months before enrollment
- Attenuated live vaccines within 14 days or inactivated/subunit vaccines within 7 days before enrollment
- Acute diseases or acute phase of chronic diseases within 3 days before enrollment
- Use of antipyretic, analgesic, or antihistamine drugs within 3 days before enrollment
- Currently or planning to participate in other clinical trials during this trial
- Medical, psychological, social, or other conditions preventing compliance with trial protocol or deemed unsuitable by researchers
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Henan Provincial Center for Disease Control and Prevention
Zhengzhou, Henan, China, 450000
Actively Recruiting
Research Team
Z
Zhiqiang Q Xie
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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