Status:
UNKNOWN
A Clinical Trial of Freeze-dried Human Rabies Vaccine (Vero Cells)
Lead Sponsor:
Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
Conditions:
Rabies Vaccine Adverse Reaction
Safety and Efficacy
Eligibility:
All Genders
10-60 years
Phase:
PHASE3
Brief Summary
This clinical trial is carried out in two phases. The first phase adopts an open design, and the second phase adopts a randomized, blinded, and similar vaccine-controlled non-inferiority trial design....
Eligibility Criteria
Inclusion
- Age 10-60 on the day of enrollment, able to provide legal identification
- Subjects and/or their guardians voluntarily agree to participate in the study and sign an adult informed consent form or a minor's informed consent form
- Subjects and/or their legal guardians have the ability to understand (non-illiterate) research procedures and participate in all planned follow-ups
- On the day of enrollment, the axillary body temperature of people aged 14 and under was \<37.5℃, and the axillary body temperature of people over 14 years of age was \<37.3℃
- Female subjects of childbearing age were not breast-feeding at the time of enrollment, were not pregnant (the urine pregnancy test was negative before vaccination (on the day)), had no pregnancy plan within 2 months after enrollment, and agreed to take effective measures within 2 months after enrolling in the study Contraceptive measures
Exclusion
- Have a history of rabies vaccination or use of rabies virus passive immunization preparations
- A history of bites by mammals (such as dogs, cats, etc.) within 1 year before the first dose of vaccination (wound skin damage)
- Previous vaccination has a history of severe allergies to any vaccine component that requires medical intervention: such as anaphylactic shock, allergic laryngeal edema, allergic purpura, thrombocytopenic purpura, local allergic necrosis, severe urticaria, etc.
- Within 3 days before vaccination, acute febrile disease (body temperature under armpit\>38.5℃) or in the acute onset of chronic disease, or taking antipyretic, analgesic, and anti-allergic drugs
- Have received blood/blood-related products or immunoglobulins within 3 months before the first dose of vaccination; or plan to use such products within 1 month after the last dose of vaccination
- Get any vaccine within 14 days before the first dose of vaccination
- Any condition (such as splenectomy) caused asplenia or functional asplenia
- Has been diagnosed with congenital or acquired immunodeficiency (HIV), or received immunosuppressive therapy within 3 months
- Severe congenital malformations or autoimmune (hereditary) diseases, serious chronic diseases (including but not limited to: heart disease, kidney disease, diabetes with comorbidities, allergic constitution, Guillain-Barre syndrome, etc.), evaluated by the investigator that it may affect research evaluation
- People with a history or family history of convulsions, epilepsy, encephalopathy, and psychosis (including but not limited to: congenital brain hypoplasia, brain trauma, brain tumor, cerebral hemorrhage, cerebral obstruction, brain nerve tissue damage caused by infection, chemical drug poisoning, etc.)
- There are contraindications for intramuscular injection (diagnosed as any coagulation disorder or receiving anticoagulant treatment)
- Are participating in other research or unregistered products (drugs, vaccines or devices, etc.) clinical research, or plan to participate in other clinical research before the end of this clinical research
- The researcher believes that the subject has any conditions that may interfere with the evaluation of the research purpose
Key Trial Info
Start Date :
April 10 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 30 2024
Estimated Enrollment :
2480 Patients enrolled
Trial Details
Trial ID
NCT04852068
Start Date
April 10 2021
End Date
October 30 2024
Last Update
November 24 2023
Active Locations (1)
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1
Hunan Provincial Center for Disease Control and Prevention
Changsha, Hunan, China, 410005