CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 881 enrolled
Drug / intervention
DTaP-IPV-Hep B-PRP~T vaccine (Batch 1) +3 morebiological
Likely dose
DTaP-IPV-Hep B-PRP~T vaccine (Batch 1) 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/NCT00654901
NCT00654901Phase 3Completed
CompareCT.gov

Immunogenicity Study of the Antibody Persistence and Booster Effect of the DTaP-IPV-Hep B-PRP~T Combined Vaccine at 15 to 18 Months of Age Following a Primary Series of DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Administered at 2, 4, and 6 Months of Age in Healthy Mexican Infants

Sanofi Pasteur, a Sanofi Company·interventional·Posted Apr 9, 2008·Updated May 13, 2016

In Brief

A Phase 3 clinical trial evaluating DTaP-IPV-Hep B-PRP~T vaccine (Batch 1), DTaP-IPV-Hep B-PRP~T vaccine (Batch 2), and 2 other interventions for Diphtheria and 5 related conditions. Completed, enrolled 881 participants across 4 sites.

Detailed Summary

This is a follow-up of Study A3L11 (NCT00404651). Immunogenicity * To describe the antibody persistence following a primary series vaccination of either DTaP-IPV-Hep B-PRP\~T or Infanrix hexa™. * To describe the immunogenicity of a booster dose of DTaP-IPV-HepB-PRP\~T in a subset of subjects. Safety \- To describe the safety profile after a booster dose of DTacP-IPV-HepB-PRP\~T.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiphtheria, Tetanus, Pertussis, Hepatitis B, Poliomyelitis, Haemophilus Influenzae Type B Infection
CountriesMexico
Collaborators--

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 9, 2008
Enrollment StartMar 1, 2008
Primary CompletionMay 1, 2009
Study CompletionJul 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 18.2 years ago

Interventions

DTaP-IPV-Hep B-PRP~T vaccine (Batch 1)biological

0.5 mL, Intramuscular

DTaP-IPV-Hep B-PRP~T vaccine (Batch 2)biological

0.5 mL, Intramuscular

DTaP-IPV-Hep B-PRP~T vaccine (Batch 3)biological

0.5 mL, Intramuscular

Infanrix Hexa™biological

0.5 mL, Intramuscular