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

January 15, 2015 updated by: Piyada Angsuwatcharakon, Queen Saovabha Memorial Institute

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

45

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 15 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

recruit the patients from Rabies clinic of Queen Saovabha Memorial Institute, Thammasat Hospital, Charoen Krung Pracha Rak Hospital and HRM Princess Maha Chakri Sirindhorn Medical Center and all had experienced WHO category II or III exposure to suspected rabid animal. In patients with WHO category III have to receive a heterologous biological (ERIG or HRIG)

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Biological: rabies vaccine
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
Biological: rabies vaccine
rabies vaccine 0.1 ml intradermal two site for 4 times

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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
Time Frame: 1 year 6 month
1 year 6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Queen Saovabha Memorial Institute

Investigators

  • Principal Investigator: Piyada Angsuwatcharakon, MD, QSMI TRC society

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (Anticipated)

March 1, 2015

Study Completion (Anticipated)

January 1, 2016

Study Registration Dates

First Submitted

January 7, 2015

First Submitted That Met QC Criteria

January 15, 2015

First Posted (Estimate)

January 16, 2015

Study Record Updates

Last Update Posted (Estimate)

January 16, 2015

Last Update Submitted That Met QC Criteria

January 15, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC5704

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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