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

• ClinicalTrials.gov Identifier: NCT00457249
• Recruitment Status: Completed
• First Posted: April 6, 2007
• Results First Posted: October 19, 2012
• Last Update Posted: October 19, 2012
• Sponsor: Sanofi
• Information provided by (Responsible Party): Sanofi

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Pertussis; Tetanus; Diphtheria	Biological: ADACEL®: Tetanus, Reduced Diphtheria and Acellular Pertussis Adsorbed; Biological: DECAVAC®: Tetanus and Diphtheria Toxoids Adsorbed	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 1564 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, 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
• Study Start Date: March 2007
• Actual Primary Completion Date: September 2008
• Actual Study Completion Date: November 2008

Arms and Interventions

Arm	Intervention/treatment
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®

Outcome Measures

Primary Outcome Measures :

1. 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 ]
2. 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.
3. 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.

Other Outcome Measures:

1. 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.

Eligibility Criteria

• Ages Eligible for Study: 65 Years and older (Older Adult)
• Sexes Eligible for Study: All
• 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

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, 84109

Salt Lake City, Utah, United States, 84121

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:

Related Info 

• Responsible Party: Sanofi
• ClinicalTrials.gov Identifier: NCT00457249
• Other Study ID Numbers: TD515
• First Posted: April 6, 2007
• Results First Posted: October 19, 2012
• Last Update Posted: October 19, 2012
• Last Verified: September 2012

Keywords provided by Sanofi:

Pertussis; Tetanus; Diphtheria; Tdap

Additional relevant MeSH terms:

Whooping Cough; Tetanus; Diphtheria; Tetany; Bordetella Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Respiratory Tract Infections; Infection; Respiratory Tract Diseases; Clostridium Infections; Gram-Positive Bacterial Infections; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Hypocalcemia; Calcium Metabolism Disorders; Metabolic Diseases; Corynebacterium Infections; Actinomycetales Infections