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Study of DAPTACEL® Administered as a 5th Dose in 4 to 6-Year-Old Children Previously Immunized With PENTACEL™

NCT00802867 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 989

Last updated 2016-04-14

Study results available
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Summary

Objectives:

* To present the rates of adverse reactions after a dose of DAPTACEL® vaccine administered to children 4 to 6 years of age who have previously received four doses of PENTACEL™ vaccine.
* To present immunogenicity before and after a single dose of DAPTACEL® vaccine administered to children 4 to 6 years of age who have previously received four doses of PENTACEL™ vaccine.

Conditions

  • Diphtheria
  • Tetanus
  • Pertussis
  • Polio
  • Haemophilus Infection

Interventions

BIOLOGICAL

Diphtheria and Tetanus Toxoids and Acellular Pertussis (DAPTACEL®)

0.5 mL, Intramuscular

Sponsors & Collaborators

  • Sanofi Pasteur, a Sanofi Company

    lead INDUSTRY

Principal Investigators

  • Medical Monitor · Sanofi Pasteur Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
4 Years
Max Age
6 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2004-02-29
Primary Completion
2005-06-30
Completion
2005-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT00802867 on ClinicalTrials.gov