- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02339896
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
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
|
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 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.
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
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.
Clinical Trials on Dog Bite
-
University of Alabama at BirminghamCompleted
-
Duke UniversityRecruiting
-
National Jewish HealthALK-Abelló A/SCompleted
-
Assistance Publique - Hôpitaux de ParisFondation MUTACUnknownElderly | Loneliness | Companion Dog | Home Based
-
Damascus UniversityCompleted
-
Alexandria UniversityCompletedAnterior Open Bite MalocclusionEgypt
-
State University of MaringáCompleted
-
Cairo UniversityRecruitingPosterior Cross BiteEgypt
-
University of WashingtonCompleted
-
National Taiwan University HospitalRecruiting
Clinical Trials on rabies vaccine
-
CureVacCompleted
-
Sanofi Pasteur, a Sanofi CompanyActive, not recruiting
-
Sanofi Pasteur, a Sanofi CompanyCompleted
-
Sanofi Pasteur, a Sanofi CompanyCompleted
-
Sanofi Pasteur, a Sanofi CompanyCompleted
-
Yisheng Biopharma (Singapore) Pte. Ltd.Duke-NUS Graduate Medical SchoolCompleted
-
NovartisNovartis VaccinesCompletedJapanese Encephalitis | Rabies | Pre-Exposure ProphylaxisThailand
-
Leiden University Medical CenterUnknownRabies Pre-exposure ProphylaxisNetherlands
-
Queen Saovabha Memorial InstituteChulalongkorn UniversityRecruiting
-
Changchun Zhuoyi Biological Co., LtdCompleted