CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 624 enrolled
Drug / intervention
DTaP-IPV-HB-PRP~T +1 morebiological
Likely dose
DTaP-IPV-HB-PRP~T 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/NCT00831311
NCT00831311Phase 2Completed
CompareCT.gov

Phase-II Immunogenicity Study of a DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared With PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age in Healthy Argentinean Infants

Sanofi Pasteur, a Sanofi Company·interventional·Posted Jan 28, 2009·Updated Dec 17, 2013

In Brief

A Phase 2 clinical trial evaluating DTaP-IPV-HB-PRP~T and DTaP-IPV//PRP~T combined vaccine & Recombinant hep B vaccine for Diphtheria and 4 related conditions. Completed, enrolled 624 participants across 1 site.

Detailed Summary

Primary Objective: * To demonstrate that the immune response of the DTaP-IPV-Hep B-PRP\~T is non-inferior for all valences to those of the association of PENTAXIM™ and ENGERIX B® PEDIATRICO one month after a three-dose primary series. Secondary Objectives: * To describe in each group the immunogenicity parameters one month after the three-dose primary series. * To describe safety profile after each vaccination in both groups.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiphtheria, Tetanus, Pertussis, Haemophilus Influenzae Type b, Poliomyelitis
CountriesArgentina
Collaborators--

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 28, 2009
Enrollment StartOct 1, 2004
Primary CompletionNov 1, 2005
Study CompletionMar 1, 2007
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 17.4 years ago

Interventions

DTaP-IPV-HB-PRP~Tbiological

0.5 mL, Intramuscular

DTaP-IPV//PRP~T combined vaccine & Recombinant hep B vaccinebiological

0.5 mL, Intramuscular (right and left thighs, respectively)