Status:
COMPLETED
Prevenar13 Post Market Surveillance
Lead Sponsor:
Pfizer
Conditions:
Healthy
Eligibility:
All Genders
6-17 years
Brief Summary
It is an observational multi-center study to assess the safety profile of Prevenar13 used among Korean children in the routine clinical setting following a licensure and introduction of the vaccine. T...
Detailed Description
non-randomization, non-probability sampling
Eligibility Criteria
Inclusion
- Infants and children aged 6 weeks to 5 years, whose legally authorized representatives of patients agree to provide written informed consent form (data privacy statement).
Exclusion
- Infants and children who are not indicated and/or contraindicated for the Prevenar13 usage will not be included.
Key Trial Info
Start Date :
September 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 1 2016
Estimated Enrollment :
649 Patients enrolled
Trial Details
Trial ID
NCT01509105
Start Date
September 1 2011
End Date
January 1 2016
Last Update
February 13 2017
Active Locations (18)
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1
Choi's Pediatric Clinic
Wŏnju, Gangwon-do, South Korea, 220-956
2
Seoul Children's Hospital
Osan, Gyeonggi-do, South Korea, 447-804
3
Bundang Pediatric Clinic
Seongnam-si, Gyeonggi-do, South Korea, 463-821
4
Teun Teun Pediatric clinic
Suwon, Gyeonggi-do, South Korea, 443-471