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

April 5, 2007
September 17, 2012
March 2007
September 2008   (final data collection date for primary outcome measure)
  • 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.
Not Provided
Complete list of historical versions of study NCT00457249 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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.
Not Provided
 
A Trial to Evaluate the Safety and Immunogenicity of ADACEL® Vaccine in Persons 65 Years of Age and Older
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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Pertussis
  • Tetanus
  • Diphtheria
  • Biological: ADACEL®: Tetanus, Reduced Diphtheria and Acellular Pertussis Adsorbed
    0.5 mL, IM
    Other Name: ADACEL®
  • Biological: DECAVAC®: Tetanus and Diphtheria Toxoids Adsorbed
    0.5 mL, IM
    Other Name: DECAVAC®
  • Experimental: Adacel Vaccine Group
    Intervention: Biological: ADACEL®: Tetanus, Reduced Diphtheria and Acellular Pertussis Adsorbed
  • Active Comparator: DECAVAC Vaccine Group
    Intervention: Biological: DECAVAC®: Tetanus and Diphtheria Toxoids Adsorbed
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1564
November 2008
September 2008   (final data collection date for primary outcome measure)

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.
Both
65 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00457249
TD515
No
Sanofi
Sanofi
Not Provided
Study Director: Medical Director Sanofi Pasteur Inc.
Sanofi
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP