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

• Conditions: Dog Bite

• Registration Number: NCT02339896
• Lead Sponsor: Queen Saovabha Memorial Institute

Brief Summary

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

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 Timeline

• Study Start: 2014-02
• Status Verified: 2015-01
• Study First Submitted: 2015-01-07
• Study First Submitted QC: 2015-01-15
• Last Update Submitted: 2015-01-15
• Study First Posted: 2015-01-16
• Last Update Posted: 2015-01-16
• Primary Completion: 2015-03
• Study Completion: 2016-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 45

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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