Status:
COMPLETED
Regulatory Post-Marketing Surveillance Study for TETRAXIM™
Lead Sponsor:
Sanofi Pasteur, a Sanofi Company
Conditions:
Diphtheria
Tetanus
Eligibility:
All Genders
2-6 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to assess the safety of TETRAXIM™ administered in routine clinical practice according to Korea Food and Drug Administration Notification No. 2009-46 "Basic standard for re...
Detailed Description
Primary vaccination will be administered from 2 months and booster vaccination from age 4 to 6 years.
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Subjects who are 2 months or more of age (as indicated in the currently approved local product labeling) and who are given the study vaccine at least one dose or more, during a routine health-care visit, as primary immunization or booster immunization for the prevention of diphtheria, tetanus, pertussis, poliomyelitis.
- Written informed consent obtained from the subject's parents/legal representative.
Exclusion
Key Trial Info
Start Date :
June 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2015
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT01437423
Start Date
June 1 2011
End Date
November 1 2015
Last Update
March 28 2022
Active Locations (1)
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1
Seoul, South Korea