Prevention of Rabies With Four Doses of Rabies Vaccine

Study Overview
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Brief Summary
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To evaluate the non inferiority of the immunogenicity of the test vaccine inoculated according to the four dose immunization program over the five dose immunization program and the batches consistency of immunogenicity according to five dose immunization procedures.

Detailed Description
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In the population aged 10-60 years, evaluate the non inferiority of the immunogenicity of the test vaccine inoculated according to the four dose immunization program (0, 3, 7, 14/28 days) over the five dose immunization program (0, 3, 7, 14, 28 days)； To evaluate the consistency of immunogenicity between batches of freeze-dried human rabies vaccine (Vero cell) inoculated according to five dose immunization procedures (0, 3, 7, 14, 28 days).

Official Title
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Randomized, Blind and Positive Control Design: a Phase III Clinical Trial to Evaluate the Consistency Between Batches of 5 Doses of Freeze-dried Rabies Vaccine (Vero Cell) and the Immunogenicity and Safety of 4 Doses of Vaccine (1-1-1-1)

Conditions
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Rabies Human, Antibody

Intervention / Treatment
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* Biological: immunization procedures


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: People aged 10-60； Body temperature on the day of enrollment<37.3℃ (axillary temperature) Exclusion Criteria: Have a history of rabies vaccine immunization or use of rabies virus passive immunization agents； People with congenital or acquired immunodeficiency or other autoimmune diseases； Female urine pregnancy test is positive, or during pregnancy and lactation, or she has a birth plan during the study period;

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 60 Years

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 4 doses<br>Inoculate rabies vaccine according to 1-1-1-1 immunization procedure | Biological: immunization procedures<br>* The subjects were vaccinated with rabies vaccine according to different immunization procedures<br>|
| Experimental: 5 doses<br>Inoculate rabies vaccine according to 1-1-1-1-1 immunization procedure | Biological: immunization procedures<br>* The subjects were vaccinated with rabies vaccine according to different immunization procedures<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive conversion rate of 14 days | - 14 days after the first dose of inoculation, the positive conversion rate of serum neutralizing antibody. | 6 months | 
| Antibody Geometric Mean Titer (GMT) of 14 days | - 14 days after the first dose of inoculation, the Geometric Mean Titer (GMT) of serum neutralizing antibody . | 6 months | 
| Positive conversion rate of 42 days | - The seroconversion rate of serum neutralizing antibody that 42 days after the first dose of inoculation. | 6 months | 
| Advertise Events (AE) incidence within 1 month | - The distribution of AE incidence in different time periods (including all, within 30 minutes, 0-3 days, 0-7 days, 8-30 days) after each dose of inoculation; | 6 months | 
| Serious Adverse Events (SAE) incidence within 6 months | - Incidence rate of SAE within 6 months from the first dose of inoculation to the full course of inoculation. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antibody test of 28 days | Detection of serum neutralizing antibody 28 days after the first dose of inoculation | 6 months | 
| Antibody GMT of 42 days | The serum neutralized antibody GMT 42 days after the first dose of inoculation; | 6 months | 
| Antibody test within 12 months | The serum neutralizing antibody was detected in 3 timepoints within 12 months after the whole vaccination. | 18months |