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Descriptive, Open-label, Multicenter Study of the Safety of Redosing With ADACEL® Vaccine

NCT00347958 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 545

Last updated 2013-12-04

Study results available
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Summary

Objectives:

To provide safety data on revaccination with ADACEL® vaccine.

To describe the immune response to tetanus, diphtheria, and pertussis antigens following revaccination with ADACEL® vaccine 4-5 years after first vaccination.

Conditions

  • Tetanus
  • Diphtheria
  • Pertussis

Interventions

BIOLOGICAL

Tetanus-diphtheria-acellular pertussis (Tdap) vaccine

0.5mL, Intramuscular (IM)

Sponsors & Collaborators

  • Sanofi Pasteur, a Sanofi Company

    lead INDUSTRY

Principal Investigators

  • Clinical Trials · Sanofi Pasteur, a Sanofi Company

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
15 Years
Max Age
69 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-08-31
Primary Completion
2008-02-29
Completion
2008-10-31

Countries

  • United States
  • 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 NCT00347958 on ClinicalTrials.gov