A Trial to Evaluate the Safety and Immunogenicity of ADACEL® Vaccine in Persons 65 Years of Age and Older

September 17, 2012 updated by: Sanofi

Safety and Immunogenicity of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (ADACEL®) in Persons ≥65 Years of Age

It is well recognized that older adults can contract pertussis, suffer its complications, and unwittingly transmit it to close contacts, which may well include infants too young to have received their primary series of DTaP vaccinations. ADACEL® vaccine is currently licensed in the US for persons 11 - 64 years of age, but no pertussis vaccine is yet approved for administration to older adults. The most widely used Td vaccine in the US, DECAVAC®, has no upper limit on its age indication.

The purpose of this trial is to describe the safety and immunogenicity of ADACEL® vaccine among individuals ≥ 65 years of age.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1564

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
    • Arizona
      • Chandler, Arizona, United States, 85224
      • Phoenix, Arizona, United States, 85014
    • California
      • Cypress, California, United States, 90630
      • San Luis Obispo, California, United States, 93405
    • Georgia
      • Atlanta, Georgia, United States, 30322
    • Illinois
      • Chicago, Illinois, United States, 60610
    • Louisiana
      • New Orleans, Louisiana, United States, 70119
    • Maryland
      • Rockville, Maryland, United States, 20854
    • Minnesota
      • Minneapolis, Minnesota, United States, 55417
    • Missouri
      • St. Louis, Missouri, United States, 63141
    • Ohio
      • Akron, Ohio, United States, 44308
      • Cincinnati, Ohio, United States, 45249
      • Mogadore, Ohio, United States, 44260
    • Tennessee
      • Knoxville, Tennessee, United States, 37920
    • Utah
      • Salt Lake City, Utah, United States, 84121
      • Salt Lake City, Utah, United States, 84109
      • West Jordan, Utah, United States, 84084
    • Virginia
      • Annandale, Virginia, United States, 22003
      • Williamsburg, Virginia, United States, 23187

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

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria :

  • Ambulatory and not institutionalized.
  • At least 65 years of age at the time of vaccination.
  • Signed Institutional Review Board (IRB)-approved informed consent form.
  • Able to attend all scheduled visits and to comply with all trial procedures.

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 (eg, cardiac, renal, neurologic, metabolic, rheumatologic, psychiatric) that is unstable or that, in the opinion of the investigator, 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, including use of immune suppressive medications (eg, rheumatoid arthritis drugs such as methotrexate; cancer chemotherapy agents such as vincristine).
  • Febrile illness within the last 72 hours or an oral temperature ≥ 100.4°F (≥ 38°C) at the time of inclusion.
  • Any history of documented tetanus, diphtheria or pertussis disease.
  • Known or suspected receipt of a tetanus, diphtheria or acellular pertussis containing vaccine within the preceding 5 years.
  • Administration of immune globulin or other blood products within the last three months, or systemic corticosteroid therapy (prednisone or equivalent) for more than 2 consecutive weeks within the past 6 months.
  • Systemic antibiotic therapy within the 72 hours prior to enrollment.
  • Received any vaccine, other than influenza vaccine, in the 30-day period prior to enrollment or scheduled to receive any vaccine, other than influenza vaccine, in the 35-day period after enrollment. For influenza vaccine only, defer if received in the 14-day period prior to enrollment or scheduled to receive in the 14-day period after enrollment.
  • Suspected or known hypersensitivity to any of the vaccine components.
  • Participation in another interventional clinical trial in the 4 weeks preceding enrollment or planning to participate in another interventional clinical trial during the planned period of this study.
  • Use of alcohol or drugs in a manner that may, in the opinion of the investigator, interfere with the subject's ability to comply with trial visits or procedures.
  • Thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination.
  • Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent, or requires a legally authorized representative.

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: DECAVAC Vaccine Group
Biological: DECAVAC®: Tetanus and Diphtheria Toxoids Adsorbed
0.5 mL, IM
Other Names:
  • DECAVAC®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Geometric Mean Titers (GMTs) of Tetanus, Diphtheria, and Pertussis Antibodies Pre- and Post-Vaccination With ADACEL® or DECAVAC® Vaccine
Time Frame: Day 35 post-vaccination
Day 35 post-vaccination
Percentage of Participants With Post-vaccination Tetanus and Diphtheria Concentrations ≥0.10 IU/mL (Seroprotection) ADACEL® or DECAVAC®.
Time Frame: Day 35 post-vaccination
Seroprotection was defined as a post-vaccination Concentrations of ≥0.10 IU/mL.
Day 35 post-vaccination
Percentage of Participants With Booster Response to Tetanus and Diphtheria Post-vaccination With ADACEL® or DECAVAC® Vaccine.
Time Frame: Day 35 post-vaccination
Booster response was defined as a minimum rise in antibody concentration from pre- to post-vaccination. The minimum rise is at least 2 times, if pre-vaccination concentration is above the the cutoff value (Tetanus 5.47 IU/mL; Diphtheria 1.28 IU/mL) or at least 4 times it it is at or below the cutoff value.
Day 35 post-vaccination

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Either ADACEL® or DECAVAC® Vaccine.
Time Frame: Day 0 up to 14 days post-vaccination
Solicited injection site reactions: Pain, Erythema, and Swelling; Solicited systemic reactions; Fever (Temperature), Headache, Myalgia, and Malaise.
Day 0 up to 14 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

March 1, 2007

Primary Completion (Actual)

September 1, 2008

Study Completion (Actual)

November 1, 2008

Study Registration Dates

First Submitted

April 5, 2007

First Submitted That Met QC Criteria

April 5, 2007

First Posted (Estimate)

April 6, 2007

Study Record Updates

Last Update Posted (Estimate)

October 19, 2012

Last Update Submitted That Met QC Criteria

September 17, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TD515

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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