At a glance
ClinicalIndex Comparison RecordN/ACompleted· 649 enrolled
Drug / intervention
13-valent pneumococcal vaccinebiological
Likely dose
13-valent pneumococcal vaccine 0.5mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Post Marketing Surveillance To Observe Safety Of Prevenar 13
In Brief
An observational study evaluating 13-valent pneumococcal vaccine for Healthy. Completed, enrolled 649 participants across 18 sites.
Detailed 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. This study is designed to fulfill regulatory requirement for any new drug authorized by KFDA.
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesSouth Korea
Collaborators--
Timeline
N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
Enrollment StartSep 2011
First PostedJan 2012
Primary CompletionJan 2016
TodayJul 2026
First PostedJan 12, 2012
Enrollment StartSep 1, 2011
Primary CompletionJan 1, 2016
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 14.5 years ago
Interventions
13-valent pneumococcal vaccinebiological
0.5mL IM (Intramuscular administration) as per recommended schedule