Status:
COMPLETED
Post Marketing Surveillance for ADACEL™ in South Korea
Lead Sponsor:
Sanofi Pasteur, a Sanofi Company
Conditions:
Diphtheria
Tetanus
Eligibility:
All Genders
11-64 years
Phase:
PHASE4
Brief Summary
This safety surveillance study is being conducted in accordance with Korea Food and Drug Administration (KFDA) Notification No. 2009-46 "Basic standard for reexamination of new drug". The study objec...
Eligibility Criteria
Inclusion
- Inclusion Criteria :
- Subjects who are 11 through 64 years of age (as indicated in the currently approved local product labeling) , who are given a single dose of the study vaccine, during a routine health-care visit, as active booster immunization for the prevention of tetanus, diphtheria and pertussis.
- Written informed consent obtained from the subject. For subjects below the legal age of consent, written informed consent must be obtained from the parent or legal guardian (legally acceptable representative -LAR) of the subject.
- Exclusion Criteria :
- None
Exclusion
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2016
Estimated Enrollment :
659 Patients enrolled
Trial Details
Trial ID
NCT01137435
Start Date
June 1 2010
End Date
September 1 2016
Last Update
April 28 2022
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Jung-gu, Incheon, South Korea
2
Seoul, South Korea