Post-licensure, Modified Double-blind, Multi-center Study Evaluating Safety and Immunogenicity of ADACEL® and BOOSTRIX®

September 28, 2012 updated by: Sanofi

Comparison in US Adolescents of the Safety and Immunogenicity of Two Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis (Tdap) Vaccines: ADACEL™ and BOOSTRIX®

This is a descriptive study to evaluate the safety and immunogenicity of ADACEL® and BOOSTRIX® vaccines among US adolescents.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

647

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Annapolis, Maryland, United States, 21401
      • Baltimore, Maryland, United States, 21201
      • Frederick, Maryland, United States, 21702
    • North Carolina
      • Durham, North Carolina, United States, 27705
      • Durham, North Carolina, United States, 27704
    • Tennessee
      • Franklin, Tennessee, United States, 37067
    • Washington
      • Bellevue, Washington, United States, 98005
      • Mercer Island, Washington, United States, 98040-2758
      • Sammamish, Washington, United States, 98075
      • Seattle, Washington, United States, 98105

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

11 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Aged 11 - 18 years of age at the time of vaccination in this trial
  • Signed Institutional Review Board (IRB)-approved informed assent / consent form.
  • Able to attend all scheduled visits and to comply with all trial procedures.
  • For a female, negative serum/urine pregnancy test.

Exclusion Criteria:

  • Any condition which, in the opinion of the investigator, would pose a health risk to the participant or interfere with the evaluation of the vaccine.

  • Serious chronic disease (i.e. cardiac, renal, neurologic, metabolic, rheumatologic, psychiatric etc) that is unstable or that might:

    • interfere with the ability to participate fully in the study; or
    • interfere with evaluation of the vaccine.
  • Known or suspected impairment of immunologic function.
  • Febrile illness within the last 72 hours or an oral temperature ≥ 100.4°F (≥ 38°C) at the time of inclusion.
  • History of documented tetanus, diphtheria or pertussis disease within the preceding 5 years.
  • Known or suspected receipt of a tetanus or diphtheria-containing vaccine within the preceding 2 years.
  • Known or suspected receipt of a pertussis-containing vaccine within the preceding 5 years.
  • Administration of immune globulin or other blood products within the last three months, or injected or oral corticosteroids or other therapy expected to materially alter immune function within six weeks of the study vaccine. Individuals on a tapering dose schedule of oral steroids lasting less than 7 days may be included in the trial as long as they have not received more than one course within the last two weeks prior to enrollment.
  • Received any vaccine in the 21-day period prior to enrollment or scheduled to receive any vaccination after enrollment and prior to visit 2.
  • Suspected or known hypersensitivity to any of the vaccine components or to latex.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Adacel® Vaccine Group
Biological: ADACEL®:Tetanus, Reduced Diphtheria and Acellular Pertussis Adsorbed
0.5 mL, IM
Other Names:
  • ADACEL®
Active Comparator: BOOSTRIX® Vaccine Group
Biological: BOOSTRIX®: Tetanus, Reduced Diphtheria and Acellular Pertussis Adsorbed
0.5 mL, IM
Other Names:
  • BOOSTRIX®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Reporting A Solicited Injection Site or Systemic Reactions Within 7 Days Following Vaccination With Adacel® or Boostrix®
Time Frame: Day 0 to 7 post-vaccination

Solicited injection site reactions: Pain, Erythema, and swelling. Solicited systemic reactions: Fever (temperature), Headache, Malaise, and Myalgia.

Grade 3 reaction definitions: Pain = Incapacitating, unable to perform usual activities; Erythema and swelling = ≥ 5 cm; Fever = temperature ≥ 39.1°C or ≥ 102.3°F; Headache, Malaise, and Myalgia = Prevents daily activities.
Day 0 to 7 post-vaccination
Percentage of Participants With Tetanus Antitoxin Concentrations ≥ 0.1 IU/mL Pre- and Post-Vaccination With Adacel® or Boostrix®.
Time Frame: Day 0 and 28 days post-vaccination
Day 0 and 28 days post-vaccination
Percentage of Participants With Diphtheria Antitoxin Concentrations ≥ 0.1 IU/mL Pre- and Post-Vaccination With Adacel® or Boostrix®.
Time Frame: Day 0 and 28 days post-vaccination
Day 0 and 28 days post-vaccination
Geometric Mean Concentration of Antibody to Pertussis Antigens Pre- and Post-Vaccination With Adacel® or Boostrix®.
Time Frame: Day 0 and 28 days post-vaccination
Day 0 and 28 days post-vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2006

Primary Completion (Actual)

October 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

April 28, 2006

First Submitted That Met QC Criteria

April 28, 2006

First Posted (Estimate)

April 27, 2006

Study Record Updates

Last Update Posted (Estimate)

October 5, 2012

Last Update Submitted That Met QC Criteria

September 28, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Td516

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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