At a glance

ClinicalIndex Comparison Record

Phase 4Completed· 989 enrolled

Drug / intervention

Diphtheria and Tetanus Toxoids and Acellular Pertussis (DAPTACEL®)biological

Likely dose

Diphtheria and Tetanus Toxoids and Acellular Pertussis (DAPTACEL®) 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/NCT00802867

NCT00802867Phase 4Completed

Compare CT.gov

Safety and Immunogenicity of DAPTACEL® (CP10/5/5/3DT Aventis Pasteur 5-component Pertussis Vaccine in Combination With Tetanus and Diphtheria Toxoids Adsorbed) Administered as a 5th Dose in 4 to 6-Year-Old Children Previously Immunized With PENTACEL™ (HCP20/20/5/3DT-mIPV//PRP-T)

Sanofi Pasteur, a Sanofi Company·interventional·Posted Dec 5, 2008·Updated Apr 14, 2016

In Brief

A Phase 4 clinical trial evaluating Diphtheria and Tetanus Toxoids and Acellular Pertussis (DAPTACEL®) for Diphtheria and 4 related conditions. Completed, enrolled 989 participants across 19 sites.

Detailed Summary

Objectives: * To present the rates of adverse reactions after a dose of DAPTACEL® vaccine administered to children 4 to 6 years of age who have previously received four doses of PENTACEL™ vaccine. * To present immunogenicity before and after a single dose of DAPTACEL® vaccine administered to children 4 to 6 years of age who have previously received four doses of PENTACEL™ vaccine.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsDiphtheria, Tetanus, Pertussis, Polio, Haemophilus Infection

CountriesUnited States

Collaborators--

Timeline

Phase 4CompletedFinished

200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartFeb 2004

Primary CompletionJun 2005

Study CompletionSep 2005

First PostedDec 2008

TodayJul 2026

First PostedDec 5, 2008

Enrollment StartFeb 1, 2004

Primary CompletionJun 1, 2005

Study CompletionSep 1, 2005

TodayJul 2, 2026

Enrollment to primary: 1.3 yearsPosted 17.6 years ago

Interventions

Diphtheria and Tetanus Toxoids and Acellular Pertussis (DAPTACEL®)biological

0.5 mL, Intramuscular