CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 1,302 enrolled
Drug / intervention
Adacel®: Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Adsorbed +1 morebiological
Likely dose
Adacel®: Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Adsorbed 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/NCT01311557
NCT01311557Phase 4Completed
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Safety and Immunogenicity of Adacel® Vaccine Administered to Persons 10 Years of Age

Sanofi·interventional·Posted Mar 9, 2011·Updated Apr 8, 2016

In Brief

A Phase 4 clinical trial evaluating Adacel®: Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Adsorbed for Tetanus and 2 related conditions. Completed, enrolled 1,302 participants across 34 sites.

Detailed Summary

The purpose of study Td519 is to demonstrate that Adacel® vaccine (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Adsorbed) is safe and immunogenic in persons 10 years of age. Primary Objectives: * To compare pertussis antibody responses induced by Adacel® in persons 10 to \<11 years of age to those induced by Adacel in persons 11 to \<12 years of age. * To compare the booster responses against pertussis antigens induced by Adacel in persons 10 to \<11 years of age to those induced by Adacel in persons 11 to \<12 years of age. * To compare booster responses against tetanus and diphtheria induced by Adacel in persons 10 to \<11 years of age to those induced by Adacel in persons 11 to \<12 years of age. Secondary Objective: * To compare seroprotection rates against tetanus and diphtheria induced by Adacel in persons 10 to \<11 years of age to those induced by Adacel in persons 11 to \<12 years of age.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTetanus, Diphtheria, Pertussis
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMar 9, 2011
Enrollment StartMar 1, 2011
Primary CompletionNov 1, 2011
Study CompletionJan 1, 2012
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 15.3 years ago

Interventions

Adacel®: Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Adsorbedbiological

0.5 mL, Intramuscular

Adacel®: Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Adsorbedbiological

0.5 mL, Intramuscular