CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 327,293 enrolled
Drug / intervention
Tetanus Toxoid, acellular pertussis, diphtheria toxoidbiological
Likely dose
0.5 mL intramuscularlyAI-extracted
Key inclusion· 1
  • ✓Receipt of Adacel vaccine during the study period
Key exclusion· 0

None specified.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00258882
NCT00258882N/ACompleted
CompareCT.gov

Post-licensure Safety Surveillance Study of Routine Use of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Adacel®)

Sanofi Pasteur, a Sanofi Company·observational·Posted Nov 28, 2005·Updated Jul 17, 2018

In Brief

An observational study evaluating Tetanus Toxoid, acellular pertussis, diphtheria toxoid for Pertussis. Completed, enrolled 327,293 participants across 3 sites.

Detailed Summary

To further characterize the vaccine safety profile and to identify any signals of potentially vaccine-related adverse events (AEs) not detected during pre-licensure studies.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsPertussis
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 28, 2005
Enrollment StartJan 1, 2006
Primary CompletionJul 1, 2011
Study CompletionDec 1, 2012
TodayJul 2, 2026
Enrollment to primary: 5.5 yearsPosted 20.6 years ago

Interventions

Tetanus Toxoid, acellular pertussis, diphtheria toxoidbiological

0.5 mL, Intramuscular