Status:
COMPLETED
Post Market Surveillance to Observe Safety of Prevenar13™ in Adults
Lead Sponsor:
Pfizer
Conditions:
Pneumococcal Disease
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this study is to assess safety profile of Prevenar 13™ when used among Korean adults in the routine clinical setting, as required for any new drug approved by Korea Food and Drug Admini...
Detailed Description
non-randomization, non-probability sampling
Eligibility Criteria
Inclusion
- Korean adults aged 18 years and older; provided the conditions pertaining to contraindications, warnings, precautions, and interactions stated in the local product document do not apply.
- Evidence of a personally signed and dated informed consent document indicating that the subject(or a legally acceptable representative) has been informed of all pertinent aspects of the study.
Exclusion
- Subjects who are not indicated and/or contraindicated for the Prevenar13 usage will not be included.
Key Trial Info
Start Date :
December 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 1 2016
Estimated Enrollment :
659 Patients enrolled
Trial Details
Trial ID
NCT01834222
Start Date
December 1 2013
End Date
March 1 2016
Last Update
April 18 2017
Active Locations (27)
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1
Chungnam National University Hospital (CNUH)
Jung-gu, Daejeon, South Korea, 35015
2
Bundang 21st Clinic
Seongnam-si, Gyeonggi-do, South Korea, 463-823
3
Lee soo yang Internal Medical Clinic
Guro-gu, Seoul, South Korea, 152-893
4
Hansarang Internal Medicine Hospital
Busan, South Korea, South Korea, 616-820