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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00457249
First received: April 5, 2007
Last updated: September 17, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention Phase
Pertussis
Tetanus
Diphtheria
Biological: ADACEL®: Tetanus, Reduced Diphtheria and Acellular Pertussis Adsorbed
Biological: DECAVAC®: Tetanus and Diphtheria Toxoids Adsorbed
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Safety and Immunogenicity of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (ADACEL®) in Persons ≥65 Years of Age

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Percentage of Participants With Post-vaccination Tetanus and Diphtheria Concentrations ≥0.10 IU/mL (Seroprotection) ADACEL® or DECAVAC®. [ Time Frame: Day 35 post-vaccination ] [ Designated as safety issue: No ]
    Seroprotection was defined as a post-vaccination Concentrations of ≥0.10 IU/mL.

  • Percentage of Participants With Booster Response to Tetanus and Diphtheria Post-vaccination With ADACEL® or DECAVAC® Vaccine. [ Time Frame: Day 35 post-vaccination ] [ Designated as safety issue: No ]
    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.


Other Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Solicited injection site reactions: Pain, Erythema, and Swelling; Solicited systemic reactions; Fever (Temperature), Headache, Myalgia, and Malaise.


Enrollment: 1564
Study Start Date: March 2007
Study Completion Date: November 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Adacel Vaccine Group Biological: ADACEL®: Tetanus, Reduced Diphtheria and Acellular Pertussis Adsorbed
0.5 mL, IM
Other Name: ADACEL®
Active Comparator: DECAVAC Vaccine Group Biological: DECAVAC®: Tetanus and Diphtheria Toxoids Adsorbed
0.5 mL, IM
Other Name: DECAVAC®

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00457249

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

Additional Information:
No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00457249     History of Changes
Other Study ID Numbers: TD515
Study First Received: April 5, 2007
Results First Received: September 17, 2012
Last Updated: September 17, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Sanofi:
Pertussis
Tetanus
Diphtheria
Tdap

Additional relevant MeSH terms:
Tetanus
Diphtheria
Whooping Cough
Tetany
Corynebacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Bordetella Infections
Gram-Negative Bacterial Infections
Respiratory Tract Infections
Infection
Respiratory Tract Diseases
Clostridium Infections
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Hypocalcemia
Calcium Metabolism Disorders
Metabolic Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on April 17, 2014