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Study of the Effect of Pneumococcal Conjugate Vaccine (PCV) on Immunogenicity of Pentacel™

NCT00772928 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1167

Last updated 2012-02-01

Study results available
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Summary

This study is designed to evaluate in a controlled manner the effect of Prevnar® on the immune responses of Pentacel™

Primary Objective - Stage I:

To compare the immune responses elicited by an infant series of Pentacel™ when given at different times from or concurrently with a Pneumococcal conjugate vaccine (Prevnar®).

Primary Objective - Stage II:

To compare the immune responses elicited by a 4th dose of Pentacel™ when given at different times from or concurrently with Prevnar®.

Conditions

  • Diphtheria
  • Tetanus
  • Haemophilus Infection
  • Pertussis
  • Polio

Interventions

BIOLOGICAL

Pentacel™: HCPDT-IPV//PRP-T Vaccine and Prevnar®

0.5 mL, Intramuscular

BIOLOGICAL

Pentacel™: HCPDT-IPV//PRP-T Vaccine and Prevnar®

0.5 mL, Intramuscular

Sponsors & Collaborators

Principal Investigators

  • Medical Monitor · Sanofi Pasteur Inc.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
42 Days
Max Age
89 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2003-10-31
Primary Completion
2006-05-31
Completion
2006-11-30

Countries

  • United States

Study Locations

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Diseases
Companies

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 NCT00772928 on ClinicalTrials.gov