CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 1,564 enrolled
Drug / intervention
ADACEL®: Tetanus, Reduced Diphtheria and Acellular Pertussis Adsorbed +1 morebiological
Likely dose
ADACEL®: Tetanus, Reduced Diphtheria and Acellular Pertussis Adsorbed 0.5 mLfrom record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00457249
NCT00457249Phase 4Completed

Safety and Immunogenicity of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (ADACEL®) in Persons ≥65 Years of Age

Sanofi·interventional·Posted Apr 6, 2007·Updated Oct 19, 2012

In Brief

A Phase 4 clinical trial evaluating ADACEL®: Tetanus, Reduced Diphtheria and Acellular Pertussis Adsorbed and DECAVAC®: Tetanus and Diphtheria Toxoids Adsorbed for Pertussis and 2 related conditions. Completed, enrolled 1,564 participants across 19 sites.

Detailed Summary

It is well recognized that older adults can contract pertussis, suffer its complications, and unwittingly transmit it to close contacts, which may well include infants too young to have received their primary series of DTaP vaccinations. ADACEL® vaccine is currently licensed in the US for persons 11 - 64 years of age, but no pertussis vaccine is yet approved for administration to older adults. The most widely used Td vaccine in the US, DECAVAC®, has no upper limit on its age indication. The purpose of this trial is to describe the safety and immunogenicity of ADACEL® vaccine among individuals ≥ 65 years of age.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 6, 2007
Enrollment StartMar 1, 2007
Primary CompletionSep 1, 2008
Study CompletionNov 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 19.2 years ago

Interventions

ADACEL®: Tetanus, Reduced Diphtheria and Acellular Pertussis Adsorbedbiological

0.5 mL, IM

DECAVAC®: Tetanus and Diphtheria Toxoids Adsorbedbiological

0.5 mL, IM