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Interchangeability of Infanrix™ IPV/Hib and Pediacel® at 2,4 & 6 Months of Age

NCT00990080 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 253

Last updated 2011-06-15

No results posted yet for this study

Summary

To demonstrate the safety and immunogenicity of two mixed primary immunization schedules: Pediacel® at 2 and 4 months of age followed by one dose of Infanrix™ IPV/Hib at 6 months of age; and, Infanrix™ IPV/Hib at 2 months of age, followed by Pediacel® at 4 and 6 months of age.

Conditions

  • Infant Immunizations

Interventions

BIOLOGICAL

Pediacel® and Infanrix™-IPV/Hib

0.5 mL IM at 2,4 and 6 months of age

Sponsors & Collaborators

  • IWK Health Centre

    collaborator OTHER

  • MCM Vaccines B.V.

    collaborator INDUSTRY

  • Dalhousie University

    lead OTHER

Principal Investigators

  • Joanne Langley, MD · Dalhousie University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
42 Days
Max Age
3 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2010-07-31
Completion
2011-01-31

Countries

  • Canada

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 NCT00990080 on ClinicalTrials.gov