At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 600 enrolled
Drug / intervention
TETRAXIM™: Combined adsorbed diphtheria, tetanus, acellular pertussis and enhanced inactivated poliobiological
Likely dose
TETRAXIM™: Combined adsorbed diphtheria, tetanus, acellular pertussis and enhanced inactivated polio 0.5 mLfrom 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.
Regulatory Post-Marketing Surveillance (PMS) Study for TETRAXIM™(Combined Vaccine of Adsorbed Diphtheria, Tetanus, Acellular Pertussis and Enhanced Inactivated Poliomyelitis)
In Brief
A Phase 4 clinical trial evaluating TETRAXIM™: Combined adsorbed diphtheria, tetanus, acellular pertussis and enhanced inactivated polio for Diphtheria and 3 related conditions. Completed, enrolled 600 participants across 1 site.
Detailed Summary
The purpose of this study is to assess the safety of TETRAXIM™ administered in routine clinical practice according to Korea Food and Drug Administration Notification No. 2009-46 "Basic standard for reexamination of new drug" based on the pharmaceutical law in Korea.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiphtheria, Tetanus, Pertussis, Poliomyelitis
CountriesSouth Korea
Collaborators--
Timeline
Phase 4CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartJun 2011
First PostedSep 2011
Primary CompletionNov 2015
TodayJul 2026
First PostedSep 20, 2011
Enrollment StartJun 1, 2011
Primary CompletionNov 1, 2015
TodayJul 2, 2026
Enrollment to primary: 4.4 yearsPosted 14.8 years ago
Interventions
TETRAXIM™: Combined adsorbed diphtheria, tetanus, acellular pertussis and enhanced inactivated poliobiological
0.5 mL, Intramuscular at 2, 4, 6 months (Primary) or at 4 to 6 years (Booster) vaccination