CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 254 enrolled
Drug / intervention
DTaP-IPV-HB-PRP~T vaccinebiological
Likely dose
DTaP-IPV-HB-PRP~T vaccine 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/NCT00619502
NCT00619502Phase 3Completed
CompareCT.gov

Immunogenicity and Safety Study of a Booster Dose of DTaP-IPV-Hep B-PRP~T Combined Vaccine at 15 to 18 Months of Age Following a Primary Series at 2, 3 and 4 Months of Age in Healthy Turkish Infants

Sanofi Pasteur, a Sanofi Company·interventional·Posted Feb 21, 2008·Updated May 13, 2016

In Brief

A Phase 3 clinical trial evaluating DTaP-IPV-HB-PRP~T vaccine for Diphtheria and 3 related conditions. Completed, enrolled 254 participants across 1 site.

Detailed Summary

This is a follow-up of Study A3L10 (NCT00315055) Immunogenicity * To describe the antibody persistence following a primary series vaccination of either DTaP-IPV-HB-PRP\~T or PENTAXIM™ and ENGERIX B®. * To describe the immunogenicity of a booster dose of DTaP-IPV-HB-PRP\~T. Safety \- To describe the safety profile after a booster dose of DTaP-IPV-HB-PRP\~T.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiphtheria, Polio, Pertussis, Hepatitis B
CountriesTurkey (Türkiye)
Collaborators--

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 21, 2008
Enrollment StartDec 1, 2007
Primary CompletionJul 1, 2008
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 18.4 years ago

Interventions

DTaP-IPV-HB-PRP~T vaccinebiological

0.5 mL, intramuscular (IM)