Clinical trial NCT02339896: Observation Study an Immunogenicity Modified TRC-ID Regimen With CPRV With or Without Rabies Immunoglobulin in Children
Official title: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Dog Bite
Keywords: rabies
modified TRC intradermal rabies vaccine
SPEEDA
Lead sponsor: Queen Saovabha Memorial Institute
Sponsor class: OTHER
First posted: 2015-01-16
Enrollment: 45
Sex: ALL
Minimum age (years): 1
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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)

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

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: 1 year 6 month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: QSMI TRC society
name: Piyada Angsuwatcharakon, MD
role: PRINCIPAL_INVESTIGATOR
References: