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Comparison of Safety and Immunogenicity of Pediacel™ and Infanrix™ IPV+Hib (Penta) Given in a 3 Dose Schedule in Infants

NCT00287092 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 807

Last updated 2015-01-07

No results posted yet for this study

Summary

Pediacel™ is currently licensed in the UK for use as a 3 dose regimen for the active immunisation of infants against Diphtheria, Tetanus, Pertussis, Poliomyelitis and invasive infections caused by Haemophilus influenzae type b. However there are currently no clinical data supporting the use of Pediacel™ using a 3, 5, and 12 months of age vaccination schedule. This study is designed to provide safety and immunogenicity data to support the use of Pediacel™ according to a 3, 5, and 12 months schedule.

Conditions

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

Interventions

BIOLOGICAL

DT5aP-IPV-Hib 5-component Pertussis vaccine

0.5 mL, IM

BIOLOGICAL

Infanrix® -IPV+Hib

0.5 mL, IM

Sponsors & Collaborators

  • Sanofi Pasteur, a Sanofi Company

    lead INDUSTRY

Principal Investigators

  • Medical Director · Sanofi Pasteur Inc.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
80 Days
Max Age
120 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-02-28
Primary Completion
2007-05-31
Completion
2008-09-30

Countries

  • Finland
  • Sweden

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 NCT00287092 on ClinicalTrials.gov