Status:
COMPLETED
Immunogenicity and Safety Study of A New Chromatographically Purified Vero Cell Rabies Vaccine With ID Regimen and ERIG
Lead Sponsor:
Queen Saovabha Memorial Institute
Conditions:
Rabies
Eligibility:
All Genders
15-60 years
Phase:
PHASE4
Brief Summary
A comparative,randomized (1:1)study to evaluate the safety and immunogenicity of a new chromatographically purified vero cell rabies vaccine (SPEEDA) and chromatographically purified vero cell rabies ...
Detailed Description
Rabies is an important world health problem especially in developing countries.Although the case-fatality ratio of human rabies is 100%,the disease is preventable by the modern cell-culture vaccine an...
Eligibility Criteria
Inclusion
- subjects are healthy population older than 15 years.
- subjects are willing to give signed informed consents.
- subjects are willing to give blood samples on recommended days.
- subjects are available for follow up according to the table of administration
Exclusion
- subjects who had received any type of rabies vaccination in the past
- subjects who had received rabies immunoglobulin in the past
- subjects who had known as immunocompromised hosts
- subjects on steroids or any other immunosuppressant
- subjects on concomitant antimalarials
- subjects who have received of any blood products within the previous 3 months
- subjects with history of allergy to any ingredient of the vaccine
- subjects who had known as pregnancy in first recruitment
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2018
Estimated Enrollment :
210 Patients enrolled
Trial Details
Trial ID
NCT01137045
Start Date
June 1 2010
End Date
April 1 2018
Last Update
April 6 2018
Active Locations (2)
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1
Suda Sibunruang
Bangkok, Thailand, 10130
2
Queen Saovabha Memorial Institute
Bangkok, Thailand, 10330