At a glance
ClinicalIndex Comparison RecordN/ACompleted· 682 enrolled
Drug / intervention
Boostrix +1 morebiological
Likely dose
Not stated in 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.
Assessment of Safety of GlaxoSmithKline (GSK) Biologicals' Combined Reduced Antigen Content Diphtheria-tetanus Toxoids and Acellular Pertussis Vaccine (dTPa), Boostrix When Administered According to the Approved Prescribing Information in Korea
In Brief
An observational study evaluating Boostrix and Safety data collection for Diphtheria-Tetanus-acellular Pertussis Vaccines. Completed, enrolled 682 participants across 1 site.
Detailed Summary
The purpose of this study is to collect safety information from pre-adolescents, adolescents and adults after Boostrix vaccination is administered according to the approved prescribing information in Korea.
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesSouth Korea
Collaborators--
Timeline
N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedAug 2013
Enrollment StartSep 2013
Primary CompletionJan 2016
TodayJul 2026
First PostedAug 27, 2013
Enrollment StartSep 23, 2013
Primary CompletionJan 11, 2016
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 12.8 years ago
Interventions
Boostrixbiological
Single intramuscular injection
Safety data collectionother
Safety monitoring: recording of adverse events using diary cards and recording of serious adverse events using the latest version of Korea's Post-Marketing Surveillance Serious Adverse Event Reporting Form