CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,167 enrolled
Drug / intervention
Pentacel™: HCPDT-IPV//PRP-T Vaccine and Prevnar® +1 morebiological
Likely dose
Pentacel™: HCPDT-IPV//PRP-T Vaccine and Prevnar® 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/NCT00772928
NCT00772928Phase 3Completed
CompareCT.gov

Immunogenicity Assessment of Pentacel™ (Hybrid CP20/20/5/3DT-mIPV//PRP-T) When Given at Different Times From or Concurrently With a Pneumococcal Conjugate Vaccine

Sanofi·interventional·Posted Oct 15, 2008·Updated Feb 1, 2012

In Brief

A Phase 3 clinical trial evaluating Pentacel™: HCPDT-IPV//PRP-T Vaccine and Prevnar® for Diphtheria and 4 related conditions. Completed, enrolled 1,167 participants across 23 sites.

Detailed Summary

This study is designed to evaluate in a controlled manner the effect of Prevnar® on the immune responses of Pentacel™ Primary Objective - Stage I: To compare the immune responses elicited by an infant series of Pentacel™ when given at different times from or concurrently with a Pneumococcal conjugate vaccine (Prevnar®). Primary Objective - Stage II: To compare the immune responses elicited by a 4th dose of Pentacel™ when given at different times from or concurrently with Prevnar®.

Study Details

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

Timeline

Phase 3CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 15, 2008
Enrollment StartOct 1, 2003
Primary CompletionMay 1, 2006
Study CompletionNov 1, 2006
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 17.7 years ago

Interventions

Pentacel™: HCPDT-IPV//PRP-T Vaccine and Prevnar®biological

0.5 mL, Intramuscular

Pentacel™: HCPDT-IPV//PRP-T Vaccine and Prevnar®biological

0.5 mL, Intramuscular