A Phase 3 Clinical Trial for a Rabies Vaccine (Vero Cell) for Human Use in Healthy Chinese Subjects

Study Overview
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Brief Summary
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The purpose of this single-centre, randomized, double-blind, parallel control, phase 3 study is to evaluate the safety and immunogenicity of a rabies vaccine (Vero Cell) for human use in healthy Chinese subjects aged 10-60 years, according to the Essen methods (1-1-1-1-1) vaccination.

Detailed Description
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There will be two immunization arms. 1200 healthy subjects will be randomly assigned (1:1) to receive an experimental vaccine or a parallel comparator vaccine. All of them will be received five doses of rabies vaccine at day 0,3,7,14,28 according to the traditional Essen methods (1-1-1-1-1) vaccination.

Official Title
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A Single-centre, Randomized, Double-blind, Parallel Control, Phase 3 Study to Evaluate the Safety and Immunogenicity of a Rabies Vaccine (Vero Cell) for Human Use in Healthy Chinese Subjects Aged 10-60 Years

Conditions
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Rabies

Intervention / Treatment
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* Biological: Changchun Werersai
* Biological: Jilin Maifeng


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged from 10 to 60 years old Subjects or legal guardians can and will comply with the requirements of the protocol Subjects or legal guardians are able to understand and sign the informed consent Healthy subjects judged from medical history after investigator's inquiry Subjects with temperature <=37.0°C on axillary setting Exclusion Criteria: Female in lactation or pregnancy, or plan to be pregnant during the study period Subject who has allergic history to any vaccine or other medicines Subject who has injury history by dogs or other mammals and has been vaccinated with rabies vaccine Subject who has serious adverse reaction history after vaccination such as allergies, hives, difficulty in breathing, angioedema or abdominal pain Subject with congenital malformation, developmental disorder or serious chronic disease Subject with autoimmune diseases or immunodeficiency Subject with asthma, unstable over the past two years requiring emergency treatment, hospitalization, intubation, oral or intravenous corticosteroids Subject with diabetes (Type I or II) excluding gestational diabetes Subject with thyroidectomy history, or require treatment in the past 12 months due to thyroid disease Subject with severe angioedema in the past 3 years or require treatment in the past 2 years Subject with hypertension and with a blood pressure exceeding 145/95 mmHg at enrollment time Subject with coagulation abnormalities diagnosed by doctors (such as clotting factor deficiency, coagulation disorders, platelet disorder) or obvious bruises or blood clotting disorder Subject with cancer, or has been treated in active cancer period or not clearly cured, or may recur during the study period Subject with epilepsy, excluding those alcohol epilepsy within three years before quitting drinking or those do not need treatment in the past 3 years Asplenia, functional asplenia, without a spleen or removal of the spleen caused by any situation Guillain-Barre syndrome Any prior administration of immunodepressant or corticosteroids in last 6 months Any prior administration of blood products in last 3 months Any prior administration of other research medicine/vaccine in last 30 days Any prior administration of any attenuated live vaccine in last 30 days Any prior administration of subunit or inactivated vaccines in last 14 days, such as pneumococcal vaccine Ongoing anti-tuberculosis prevention or treatment Subject who cannot comply with the trial requirements, or with mental illness/ dual-stage affective psychosis in the past or at present; or has not been controlled and needs to take psychiatric drugs the past 2 years; or with suicidal tendencies in the past 5 years Any medical, psychological, social or other condition judged by investigator, that may interfere subject's compliance with the protocol or signature on informed consent

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: Changchun Werersai<br>A rabies vaccine (Vero Cell) for human use produced by Changchun Werersai Biotech Pharmaceutical Co., Ltd. | Biological: Changchun Werersai<br>* A rabies vaccine (Vero Cell) for human use produced by Changchun Werersai Biotech Pharmaceutical Co., Ltd. 1.0 ml experimental vaccine on day 0,3,7,14,28<br>|
| Active Comparator: Jilin Maifeng<br>A rabies vaccine (Vero Cell) for human use produced by Jilin Maifeng Biotech Pharmaceutical Co., Ltd. | Biological: Jilin Maifeng<br>* A rabies vaccine (Vero Cell) for human use produced by Jilin Maifeng Biotech Pharmaceutical Co., Ltd. 1.0 ml comparator vaccine 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 |
| --- | --- | --- |
| Positive seroconversion rate of serum rabies virus neutralizing antibody 42 days after full vaccination |  | 42 days after full vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Geometric mean concentration (GMC) of serum rabies virus neutralizing antibody 42 days after full vaccination |  | 42 days after full vaccination | 
| Positive seroconversion rate of serum rabies virus neutralizing antibody 14 days after full vaccination |  | 14 days after full vaccination | 
| Geometric mean concentration (GMC) of serum rabies virus neutralizing antibody 14 days after full vaccination |  | 14 days after full vaccination | 
| Incidence of local and systemic adverse reactions during safety observation period after each vaccination |  | 0-7 days after each vaccination and 8-28 days after the fifth vaccination |