CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 2,167 enrolled
Drug / intervention
DAPTACEL®. (DTaP), IPOL®., and ActHIB®. +3 morebiological
Likely dose
DAPTACEL®. (DTaP), IPOL®., and ActHIB®. 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/NCT00255047
NCT00255047Phase 3Completed
CompareCT.gov

Comparative Immunogenicity of Different Multivalent Component Pertussis Vaccine Formulations Based on a 5 Component Acellular Pertussis Vaccine in Infants and Toddlers

Sanofi Pasteur, a Sanofi Company·interventional·Posted Nov 17, 2005·Updated Feb 14, 2014

In Brief

A Phase 3 clinical trial evaluating DAPTACEL®. (DTaP), IPOL®., and ActHIB®., Pentacel®: DTaP-IPV/Hib combined, and 1 other intervention for Diphtheria and 2 related conditions. Completed, enrolled 2,167 participants across 36 sites.

Detailed Summary

The overall aim of the study is to corroborate that a schedule consisting of 3 doses of Pentacel™ and a 4th dose of DAPTACEL® and ActHIB® or 4 doses of Pentacel™ or 4 doses of Quadracel and ActHIB® is as safe and immunogenic as a standard of care schedule based on 3 doses of the licensed-equivalent vaccines DAPTACEL®, Vero cell derived Inactivated Poliovirus vaccine (IPOL®), and ActHIB® and a 4th dose of DAPTACEL® and ActHIB®.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiphtheria, Polio, Pertussis
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 17, 2005
Enrollment StartNov 1, 2005
Primary CompletionJul 1, 2008
Study CompletionFeb 1, 2009
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 20.6 years ago

Interventions

DAPTACEL®. (DTaP), IPOL®., and ActHIB®.biological

0.5 mL, Intramuscular

Pentacel®: DTaP-IPV/Hib combinedbiological

0.5 mL, Intramuscular

DTaP-IPV and ActHIB®biological

0.5 mL, Intramuscular

Pentacel®: DTaP-IPV/Hib combinedbiological

0.5 mL, Intramuscular