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
1 other identifier
interventional
1,564
1 country
19
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Mar 2007
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2007
CompletedFirst Submitted
Initial submission to the registry
April 5, 2007
CompletedFirst Posted
Study publicly available on registry
April 6, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2008
CompletedResults Posted
Study results publicly available
October 19, 2012
CompletedOctober 19, 2012
September 1, 2012
1.5 years
April 5, 2007
September 17, 2012
September 17, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Geometric Mean Titers (GMTs) of Tetanus, Diphtheria, and Pertussis Antibodies Pre- and Post-Vaccination With ADACEL® or DECAVAC® Vaccine
Day 35 post-vaccination
Percentage of Participants With Post-vaccination Tetanus and Diphtheria Concentrations ≥0.10 IU/mL (Seroprotection) ADACEL® or DECAVAC®.
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.
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 Outcomes (1)
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Either ADACEL® or DECAVAC® Vaccine.
Day 0 up to 14 days post-vaccination
Study Arms (2)
Adacel Vaccine Group
EXPERIMENTALDECAVAC Vaccine Group
ACTIVE COMPARATORInterventions
0.5 mL, IM
0.5 mL, IM
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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).
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sanofilead
Study Sites (19)
Unknown Facility
Chandler, Arizona, 85224, United States
Unknown Facility
Phoenix, Arizona, 85014, United States
Unknown Facility
Cypress, California, 90630, United States
Unknown Facility
San Luis Obispo, California, 93405, United States
Unknown Facility
Atlanta, Georgia, 30322, United States
Unknown Facility
Chicago, Illinois, 60610, United States
Unknown Facility
New Orleans, Louisiana, 70119, United States
Unknown Facility
Rockville, Maryland, 20854, United States
Unknown Facility
Minneapolis, Minnesota, 55417, United States
Unknown Facility
St Louis, Missouri, 63141, United States
Unknown Facility
Akron, Ohio, 44308, United States
Unknown Facility
Cincinnati, Ohio, 45249, United States
Unknown Facility
Mogadore, Ohio, 44260, United States
Unknown Facility
Knoxville, Tennessee, 37920, United States
Unknown Facility
Salt Lake City, Utah, 84109, United States
Unknown Facility
Salt Lake City, Utah, 84121, United States
Unknown Facility
West Jordan, Utah, 84084, United States
Unknown Facility
Annandale, Virginia, 22003, United States
Unknown Facility
Williamsburg, Virginia, 23187, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Director
- Organization
- Sanofi Pasteur Inc.
Study Officials
- STUDY DIRECTOR
Medical Director
Sanofi Pasteur Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 5, 2007
First Posted
April 6, 2007
Study Start
March 1, 2007
Primary Completion
September 1, 2008
Study Completion
November 1, 2008
Last Updated
October 19, 2012
Results First Posted
October 19, 2012
Record last verified: 2012-09