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Study to Compare Pediacel® to Infanrix®-IPV+Hib When Both Are Co-Administered With Prevenar® in Infants and Toddlers

NCT00343421 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 588

Last updated 2016-06-03

No results posted yet for this study

Summary

The purpose of this study is to evaluate safety and immunogenicity of Pediacel® in infants and toddlers when given at 2,3,4 and 12-18 months of age.

Primary Objectives:

* To compare the post-dose 3 immunogenicity of Pediacel® to Infanrix®-IPV+Hib when both are co-administered with Prevenar®.
* To describe the post-dose 3 pertussis antibody responses.

Secondary Objectives:

* To compare the post-dose 4 immunogenicity of Pediacel® to Infanrix®-IPV+Hib when both are co-administered with Prevenar®.
* To describe the safety after each vaccination following co-administration with Prevenar®.

Conditions

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

Interventions

BIOLOGICAL

PEDIACEL® and Prevenar®

0.5 mL each, IM (opposite thigh)

BIOLOGICAL

Infanrix®-IPV+Hib and Prevenar®

0.5 mL each, IM (opposite thigh)

Sponsors & Collaborators

  • Sanofi Pasteur, a Sanofi Company

    lead INDUSTRY

Principal Investigators

  • Medical Director · Sanofi Pasteur Inc.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
55 Days
Max Age
75 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-07-31
Primary Completion
2008-06-30
Completion
2009-06-30

Countries

  • France
  • Poland

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 NCT00343421 on ClinicalTrials.gov