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

Dog Bite Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02339896
• Other study ID #: RC5704
• Status: Enrolling by invitation
• Phase: N/A
• First received: January 7, 2015
• Last updated: January 15, 2015
• Start date: February 2014
• Est. completion date: January 2016

Study information

• Verified date: January 2015
• Source: Queen Saovabha Memorial Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Observational [Patient Registry]

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 45
• Est. completion date: January 2016
• Est. primary completion date: March 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 1 Year to 15 Years

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Dog Bite
• Rabies

Intervention

Biological:
• rabies vaccine
rabies vaccine 0.1 ml intradermal two site for 4 times

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Queen Saovabha Memorial Institute

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes