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Immune Responses in Adults to Revaccination With ADACEL® 10 Years After a Previous Dose

NCT00712959 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 769

Last updated 2014-04-30

Study results available
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Summary

The purpose of this study is to collect additional immunogenicity and safety data on re-dosing with Tdap vaccine (ADACEL®) in a continuing effort to address the public health need to establish broader population immunity against pertussis, as well as diphtheria and tetanus.

Primary Objective:

* To assess immune response to Tdap vaccine (ADACEL®) one month after booster vaccination.

Conditions

  • Pertussis
  • Tetanus
  • Diphtheria

Interventions

BIOLOGICAL

Tetanus, Reduced Diphtheria Toxoid and Acellular Pertussis (ADACEL®)

0.5 ml, IM

BIOLOGICAL

Tetanus, Reduced Diphtheria Toxoid and Acellular Pertussis (ADACEL®)

0.5 mL, IM

Sponsors & Collaborators

  • Sanofi Pasteur, a Sanofi Company

    lead INDUSTRY

Principal Investigators

  • Medical Director · Sanofi Pasteur Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-06-30
Primary Completion
2009-09-30
Completion
2009-12-31

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 NCT00712959 on ClinicalTrials.gov