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Study to Compare Booster Vaccination With Pediacel® to Infanrix® Hexa When Both Are Co-Administered With Prevenar®

NCT00355654 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 847

Last updated 2015-01-07

No results posted yet for this study

Summary

The purpose of the study is to provide data on the safety and immunogenicity of Pediacel® to allow its use as a fourth dose administered to 11-18 months old toddlers at the same time as Prevenar®.

Primary Objective:

To evaluate the safety of Pediacel® booster dose co-administered with Prevenar® to toddlers at 11-18 months of age.

Secondary Objectives:

* To describe the incidence rate of severe fever within four days post-vaccination
* To describe the antibody responses to all antigens in a subgroup of subjects at baseline and post-vaccination.

Conditions

  • Infant
  • Healthy

Interventions

BIOLOGICAL

DT5aP-IPV-Hib 5-component Pertussis vaccine

0.5 mL, IM

BIOLOGICAL

DT3aP-HBs-IPV

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
11 Months
Max Age
18 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-09-30
Primary Completion
2007-09-30
Completion
2008-07-31

Countries

  • Germany

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 NCT00355654 on ClinicalTrials.gov