Status:
COMPLETED
A Clinical Trial of Freeze-dried Human Rabies Vaccine (MRC-5 Cells)
Lead Sponsor:
Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
Collaborating Sponsors:
Sponsor GmbH
Conditions:
Rabies Vaccine Adverse Reaction
Eligibility:
All Genders
10-60 years
Phase:
PHASE3
Brief Summary
This trial is a randomized, blind, similar vaccine controlled, single center, non-inferiority design phase III clinical trial, with a study population of 10 to 60 years old, conducted in two stages.Ph...
Detailed Description
This trial is a randomized, blind, similar vaccine controlled, single center, non-inferiority design phase III clinical trial, with a study population of 10 to 60 years old, conducted in two stages. ...
Eligibility Criteria
Inclusion
- Age range from 10 to 60 years old;
- Willing to participate in this experiment and sign an informed consent or notification form;
- The subjects themselves or/and their guardians promise to comply with the requirements of the clinical research protocol;
- Under the age of 14 (including 14 years old), the axillary body temperature is less than 37.5 ℃, and above the age of 14, the axillary body temperature is less than 37.3 ℃
Exclusion
- Have a history of rabies vaccine immunization or use of rabies virus passive immunity preparations;
- Have a history of injury to dogs or other mammals within 12 months prior to the first vaccination;
- Have used blood products within 4 months before the first vaccination;
- Inoculate any vaccine within 14 days before the first vaccination;
- Have used other research or unregistered products (drugs or vaccines) within one month before the first vaccination, or have planned to participate in other clinical studies after enrollment in this clinical study;
- Suffering from congenital or acquired immune deficiency. Receiving immunosuppressive therapy, such as long-term (oral) systemic glucocorticoid therapy (continuous (oral) systemic glucocorticoid therapy for more than 2 weeks, such as prednisone or similar drugs);
- Have a history of convulsion, epilepsy, encephalopathy, psychosis or family history;
- Allergic to any component in the study vaccine (such as human albumin, disodium hydrogen phosphate, sodium dihydrogen phosphate, sodium chloride, sucrose, maltose, etc.); Have a history of severe allergies, such as allergic shock, allergic laryngeal edema, allergic purpura, thrombocytopenic purpura, and local allergic necrosis reaction (Arthur reaction);
- Have any previous history of serious side effects from vaccines or drugs, such as urticaria, skin eczema, respiratory difficulties, vascular and neurological edema, etc;
- Individuals with acute febrile diseases (body temperature ≥ 38.5 ℃) and infectious diseases within 3 days before vaccination;
- Having congenital heart disease, developmental disorder or chronic disease, such as asthma, diabetes, thyroid disease;
- Suffering from urticaria within one year before receiving the experimental vaccine;
- Blood pressure: systolic blood pressure ≥ 160mmHg or diastolic blood pressure ≥ 100mmHg (regardless of medication);
- Suffering from thrombocytopenia or other coagulation disorders (which may cause contraindications for intramuscular injection);
- Women of childbearing age who have a positive urine pregnancy test, or have a fertility plan during pregnancy, lactation, or within 2 months;
- Any situation that the researcher believes may affect the evaluation of the experiment
Key Trial Info
Start Date :
October 19 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 26 2022
Estimated Enrollment :
1880 Patients enrolled
Trial Details
Trial ID
NCT06078423
Start Date
October 19 2019
End Date
September 26 2022
Last Update
October 11 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Hunan Provincial Center for Disease Control and Prevention
Changsha, Hunan, China, 410005