CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 362 enrolled
Drug / intervention
DTaP-HB-PRP~T vaccine +2 morebiological
Likely dose
DTaP-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/NCT00534833
NCT00534833Phase 3Completed
CompareCT.gov

Immunogenicity Study of the Antibody Persistence and Booster Effect of DTaP-Hep B-PRP-T Combined Vaccine or Tritanrix HepB/Hib™ at 15 to 18 Months of Age Following a Primary Series at 6, 10 and 14 Weeks of Age in Healthy Filipino Infants

Sanofi Pasteur, a Sanofi Company·interventional·Posted Sep 26, 2007·Updated Nov 21, 2013

In Brief

A Phase 3 clinical trial evaluating DTaP-HB-PRP~T vaccine, Tritanrix-HepB/Hib™, and 1 other intervention for Diphtheria and 4 related conditions. Completed, enrolled 362 participants across 2 sites.

Detailed Summary

The present trial is a follow-up of AL203 study (NCT00343889). Primary Objectives: To describe the antibody persistence at 15 to 18 months of age and the booster effect of a dose of DTaP-HB-PRP\~T or Tritanrix-HepB/Hib™ (given concomitantly with Oral Polio Vaccine \[OPV\]). Secondary Objective: To describe the safety profile of a booster dose of DTaP-HB-PRP\~T or Tritanrix-HepB/Hib™ when administered concomitantly with OPV in each vaccine group.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiphtheria, Tetanus, Pertussis, Hepatitis B, Haemophilus Influenzae Type b
CountriesPhilippines
Collaborators--

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 26, 2007
Enrollment StartSep 1, 2007
Primary CompletionSep 1, 2008
Study CompletionMar 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 18.8 years ago

Interventions

DTaP-HB-PRP~T vaccinebiological

0.5 mL, Intramuscular

Tritanrix-HepB/Hib™biological

0.5 mL, Intramuscular

Oral Polio Vaccinebiological

0.5 mL, Oral