Observation Study an Immunogenicity Modified TRC-ID Regimen With CPRV With or Without Rabies Immunoglobulin in Children

Study Overview
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Brief Summary
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To determine Immunogenicity and Safety Study of Modified TRC-ID Regimen with A New Chromatographically Purified Vero Cell Rabies Vaccine (SPEEDA®) as post exposure rabies intradermal regimen with or without Rabies Immunoglobulin in Children

Detailed Description
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post exposure rabies vaccination with modified Thai red cross intrademal regimen has been proven to be immunogenic and effection when using purified vero cell vaccine (PVRV) In present, new chromatographically purified vero cell rabies vaccine (SPEEDA), chromatography purifed vero cell derived rabies vaccine, is manufactured by the Liaoning Chengda Biotechnology is available This study has a goal to determine the immunogenicity of speeda when using with post exposure rabies intradermal vaccination with or without rabies immune globulin in children

Official Title
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Observation an Immunogenicity and Safety Study of Modified TRC-ID Regimen With A New Chromatographically Purified Vero Cell Rabies Vaccine (SPEEDA®) With or Without Rabies Immunoglobulin in Children

Conditions
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Dog Bite

Intervention / Treatment
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* Biological: rabies vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: they are 1-15 years healthy children give signed informed consent from their parents willing to participate in this study and be able to receive the vaccination and collect blood sample as the study plan. Exclusion Criteria: they have prior history of rabies vaccination or any equine/human serum administration such as snake antivenom and tetanus antiserum or vaccine allergy Persons who have immunosuppressive conditions such as known HIV infection, transplantation, chronic renal failure, receiving of steroid or immunosuppressive drugs person received anti-malarial drugs within the previous two months or any blood products within previous three months were excluded Urine pregnancy test must be done in all female adolescents to exclude the pregnancy in first visit

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 15 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| WHO category 2<br>Children patient who have experienced WHO category II exposure will receive rabies vaccine (SPEEDA) 0.1 ml intradermal two site for 4 times | Biological: rabies vaccine<br>* rabies vaccine 0.1 ml intradermal two site for 4 times<br>|
| WHO category 3<br>Children patient who have experienced WHO category II exposure will receive rabies vaccine (SPEEDA) 0.1 ml intradermal two site for 4 times with ERIG | Biological: rabies vaccine<br>* rabies vaccine 0.1 ml intradermal two site for 4 times<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| determine the level of rabies neutralizing antibodies after using SPEEDA® with modified TRC-ID rabies with or without RIG and the safety of using SPEEDA® with modified TRC-ID rabies with or without RIG in children |  | 1 year 6 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rabies, modified TRC intradermal rabies vaccine, SPEEDA