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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Page 1 of 1 (2 locations)

1

Suda Sibunruang

Bangkok, Thailand, 10130

2

Queen Saovabha Memorial Institute

Bangkok, Thailand, 10330