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

Queen Saovabha Memorial Institute45 enrolled

Overview

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

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

Study Type

OBSERVATIONAL

Enrollment

Conditions

Dog Bite

Interventions

rabies vaccineBIOLOGICAL

rabies vaccine 0.1 ml intradermal two site for 4 times

Eligibility

Sex: ALLMin age: 1 YearMax age: 15 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: 1 year 6 month

Data from ClinicalTrials.gov

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