CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 659 enrolled
Drug / intervention
ADACEL™:Adsorbed Diphtheria, Tetanus Toxoids and Component Pertussis Combinedbiological
Likely dose
ADACEL™:Adsorbed Diphtheria, Tetanus Toxoids and Component Pertussis Combined 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.

Search/NCT01137435
NCT01137435Phase 4Completed
CompareCT.gov

Regulatory Post-Marketing Surveillance (PMS) Study for ADACEL™ (Adsorbed Diphtheria, Tetanus Toxoids and Component Pertussis Combined Vaccine for Adult)

Sanofi Pasteur, a Sanofi Company·interventional·Posted Jun 4, 2010·Updated Apr 28, 2022

In Brief

A Phase 4 clinical trial evaluating ADACEL™:Adsorbed Diphtheria, Tetanus Toxoids and Component Pertussis Combined for Diphtheria and 2 related conditions. Completed, enrolled 659 participants across 2 sites.

Detailed Summary

This safety surveillance study is being conducted in accordance with Korea Food and Drug Administration (KFDA) Notification No. 2009-46 "Basic standard for reexamination of new drug". The study objective is to assess within 30 days post-administration, the safety of ADACEL™ administered under the real clinical practice.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiphtheria, Tetanus, Pertussis
CountriesSouth Korea
Collaborators--

Timeline

Phase 4CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJun 4, 2010
Enrollment StartJun 1, 2010
Primary CompletionMar 1, 2016
Study CompletionSep 1, 2016
TodayJul 2, 2026
Enrollment to primary: 5.8 yearsPosted 16.1 years ago

Interventions

ADACEL™:Adsorbed Diphtheria, Tetanus Toxoids and Component Pertussis Combinedbiological

0.5 mL, intramuscular (IM)