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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

45 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-02-28

Study Completion Date

2016-01-31

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

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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

Conditions

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Dog Bite

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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WHO category 2

Children patient who have experienced WHO category II exposure will receive rabies vaccine (SPEEDA) 0.1 ml intradermal two site for 4 times

rabies vaccine

Intervention Type BIOLOGICAL

rabies vaccine 0.1 ml intradermal two site for 4 times

WHO category 3

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

rabies vaccine

Intervention Type BIOLOGICAL

rabies vaccine 0.1 ml intradermal two site for 4 times

Interventions

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rabies vaccine

rabies vaccine 0.1 ml intradermal two site for 4 times

Intervention Type BIOLOGICAL

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

Minimum Eligible Age

1 Year

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes