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Study of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared With PENTAXIM™ and ENGERIX B® PEDIATRICO in Argentinean Infants

NCT00831311 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 624

Last updated 2013-12-17

Study results available
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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.

Conditions

  • Diphtheria
  • Tetanus
  • Pertussis
  • Haemophilus Influenzae Type b
  • Poliomyelitis

Interventions

BIOLOGICAL

DTaP-IPV-HB-PRP~T

0.5 mL, Intramuscular

BIOLOGICAL

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

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

Sponsors & Collaborators

  • Sanofi Pasteur, a Sanofi Company

    lead INDUSTRY

Principal Investigators

  • Medical Monitor · Sanofi Pasteur Inc.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Days
Max Age
70 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2004-10-31
Primary Completion
2005-11-30
Completion
2007-03-31

Countries

  • Argentina

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00831311 on ClinicalTrials.gov