The Post-Marketing Safety and Immunogenicity Research of Speeda® Rabies Vaccine for Human Use

Study Overview
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Brief Summary
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The objective of this study was to achieve the post-marketing safety and immunogenicity research of Speeda® rabies vaccine for human use from Chengda Bio

Detailed Description
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The aim of the research is to compare the two immune procedures. The investigators plan to enroll 10500 participants signed the informed consent who separately inject by Zagreb or Essen procedure.

Official Title
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Phase 4 Study of Speeda® Rabies Vaccine for Human Use

Conditions
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Rabies Vaccine Allergy, Vaccination Adverse Event, Anti-D Antibodies

Intervention / Treatment
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* Biological: Zagreb2-1-1
* Biological: Essen


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Parent/legal acceptable representatives of children or the adult participants are willing and able to understand the protocol requirements and provide informed consent signed Participant is considered to be in good health including the body and mental status on the basis of reported medical history and limited physical examination and live in local ≥ 12 months Participant body temperature ≤ 37.0℃ Participant without preventive inoculation of rabies vaccine(only limited in immunogenicity subgroup) Exclusion Criteria: Three-level exposure Known allergy to any constituent of the vaccine Reported the history of allergies, convulsions, epilepsy, mental illness and brain disease and clear serious systemic reaction Known bleeding disorder or suspected impairment of immunologic function, or receipt of immunosuppressive therapy or immunoglobulin since birth Participation in any other interventional clinical trial An acute illness with or without fever (temperature > 37.0℃) in the latest week preceding enrollment in the trial Inoculated other vaccines, immunoglobulin or investigational drugs within 4 weeks prior to participation in the study Reported clearly the infection of the upper respiratory tract with 6 months Clinical Manifestation of Metabolic, blood system, lungs, heart, the gastrointestinal tract, nervous system, kidneys, urinary system, endocrine, liver disease or malignant tumor Any condition which, in the opinion of the investigator, would pose a health risk to the subject or interfere with the vaccine
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Zagreb2-1-1<br>Injection on day 0、7、21 | Biological: Zagreb2-1-1<br>* Injection on day 0、7、21<br>Biological: Essen<br>* Injection on day 0、3、7、14、28<br>|
| Active Comparator: Essen<br>Injection on day 0、3、7、14、28 | Biological: Zagreb2-1-1<br>* Injection on day 0、7、21<br>Biological: Essen<br>* Injection on day 0、3、7、14、28<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence Rate of Adverse Events of the rabies vaccine each injection |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antibody titre of the subject on 0、7、14、42、180、365 |  | 3 years |