Clinical trial
Randomized, Blind, Phase III Clinical Trial Comparing the Immunogenicity and Safety of Freeze-dried Human Rabies Vaccine (MRC-5 Cells) With a 5-dose Program and a 4-dose (2-dose First-dose) Program
Name
2018-Rab01
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.Phase 1 and Phase 2
Trial arms
Trial start
2019-10-19
Estimated PCD
2021-07-21
Trial end
2022-09-26
Status
Completed
Phase
Early phase I
Treatment
Freeze-dried human rabies vaccine (MRC-5 cells) Zhifeilongkoma - 5-dose program
Inoculate 1 dose of Investigational vaccine each on 0, 3, 7, 14, 28 days, by intramuscular injection of deltoid muscle of upper arm
Arms:
Investigational Vaccine - 5-dose program
Freeze-dried human rabies vaccine (MRC-5 cells) Zhifeilongkoma - 4-dose program
Inoculate 1 dose of Investigational vaccine each on both arms on day 0, and 1 dose each on day 7 and 21, by intramuscular injection of deltoid muscle of upper arm
Arms:
Investigational Vaccine - 4-dose program
Freeze-dried human rabies vaccine (MRC-5 cells) Kanghua - 5-dose program
Inoculate 1 dose of Investigational vaccine each on 0, 3, 7, 14, 28 days, by intramuscular injection of deltoid muscle of upper arm
Arms:
Control vaccine - 5-dose program
Freeze-dried human rabies vaccine (MRC-5 cells) Kanghua - 4-dose program
Inoculate 1 dose of Investigational vaccine each on both arms on day 0, and 1 dose each on day 7 and 21, by intramuscular injection of deltoid muscle of upper arm
Arms:
Control vaccine - 4-dose program
Size
1880
Primary endpoint
Antibody positive conversion rate - Immunogenicity endpoint
up to 14 days after the first/full dose of vaccination
Geometric mean concentration - Immunogenicity endpoint
14 days after the first/full dose of vaccination
Incidence of Adverse Events [Safety and Tolerability]
within 30 minutes after each dose of vaccination
Incidence of Adverse Events [Safety and Tolerability]
within 0-7 days after each dose of vaccination
Incidence of Adverse Events [Safety and Tolerability]
within 30 days after the first dose of vaccination to the full course of vaccination
Incidence of Adverse Events [Safety and Tolerability]
within 6 months after the first dose administration and the entire vaccination process
Eligibility criteria
Inclusion Criteria:
* 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 Criteria:
* 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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Similar vaccine control', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 1880, 'type': 'ACTUAL'}}
Updated at
2023-10-11
1 organization
2 products
1 indication
Indication
Rabies Vaccine Adverse ReactionOrganization
Anhui Zhifei Longcom Biologic Pharmacy