Safety and Immunogenicity in Adults of Revaccination With Adacel® Vaccine 10 Years After a Previous Dose

NCT ID: NCT01439165

Last Updated: 2022-04-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 1330 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2017-02-28

Brief Summary

The purpose of this study is to describe the safety and immunogenicity of repeat administration of Adacel vaccine approximately 10 years following initial administration of the vaccine. Antibody levels prior to revaccination will also be used to characterize antibody persistence following initial vaccination 10 years earlier.

Primary Objectives:

• To compare seroprotection rates against tetanus and diphtheria induced by Adacel vaccine to those induced by Td Adsorbed vaccine.
• To compare booster response rates against tetanus and diphtheria induced by Adacel vaccine to those induced by Td Adsorbed vaccine.
• To compare anti-pertussis geometric mean antibody concentrations (GMCs) induced by Adacel vaccine to the GMCs induced by Daptacel® vaccine given to infants.

Secondary Objectives:

• To describe the rates of immediate reactions, solicited reactions, unsolicited adverse events (AEs), and serious adverse events (SAEs) following vaccination with Adacel or Td Adsorbed vaccine.
• To describe booster response rates for pertussis antigens following revaccination with Adacel vaccine.

Detailed Description

Healthy adults < 65 years of age who received Adacel vaccine 10 years previously will be randomized to receive either Adacel or TENIVAC (Td Adsorbed) vaccine. They will be assessed for immunogenicity at baseline and post-vaccination. Safety data will be collected for 6 months following vaccination.

Conditions

Tetanus; Diphtheria; Pertussis; Whooping Cough

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Adacel® Vaccine Group

Participants randomized to receive a repeat dose of Tetanus Toxoid, Diphtheria Toxoid and Pertussis Vaccine (Adacel®)

Group Type: EXPERIMENTAL

Tetanus Toxoid, Diphtheria Toxoid and Pertussis Vaccine

Intervention Type: BIOLOGICAL

0.5 mL, Intramuscular

Td Adsorbed Vaccine Group

Participants randomized to receive Subjects randomized to receive a Tetanus and Diphtheria Toxoids Adsorbed For Adult Use (TENIVAC) vaccine.

Group Type: ACTIVE_COMPARATOR

Tetanus and Diphtheria Toxoids Adsorbed For Adult Use

Intervention Type: BIOLOGICAL

0.5 mL, Intramuscular

Interventions

Tetanus Toxoid, Diphtheria Toxoid and Pertussis Vaccine

0.5 mL, Intramuscular

Intervention Type: BIOLOGICAL

Tetanus and Diphtheria Toxoids Adsorbed For Adult Use

0.5 mL, Intramuscular

Intervention Type: BIOLOGICAL

Other Intervention Names

Adacel®; TENIVAC

Eligibility Criteria

Inclusion Criteria

• Subject is ≥ 18 to < 65 years of age at the time of vaccination.
• Received Adacel vaccine no less than 9 and no more than 11 years previously.
• Informed consent form has been signed and dated.
• Subject is able to attend all scheduled visits and to comply with all trial procedures.

Exclusion Criteria

• Subject is pregnant, or lactating, or of child bearing potential without using an effective method of contraception or not practicing abstinence for at least 4 weeks prior to vaccination and until at least 4 weeks after vaccination. Females who are pre-menarche or post-menopausal for at least one year, or surgically sterile will not be excluded.
• Any condition that, in the opinion of the Investigator, would pose a health risk to the participant or interfere with the evaluation of the vaccine.
• Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with trial conduct or completion.
• Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months).
• Known or suspected receipt of tetanus toxoid (T), tetanus and diphtheria toxoids (Td), or tetanus and diphtheria toxoids and acellular pertussis (Tdap) vaccine since receipt of the qualifying dose of Adacel vaccine described in Inclusion Criterion #2.
• A personal history of physician-diagnosed or laboratory-confirmed pertussis disease within the last 10 years.
• A previous severe reaction to pertussis, diphtheria or tetanus vaccine including immediate anaphylaxis, encephalopathy within 7 days or seizure within 3 days of receiving the vaccine.
• Receipt of immune globulins, blood or blood-derived products in the past 3 months.
• Suspected or known hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine used in the trial or to a vaccine containing any of the same substances.
• Receipt of any vaccine within 30 days before receiving study vaccine, or plans to receive another vaccine before the 2nd visit; except that influenza vaccine may have been received between 30 and 15 days (but no less than 15 days) before receiving study vaccine.
• Participation in another interventional clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 30 days preceding the first study vaccination or during the course of the study, at the discretion of the Sponsor.
• Seropositivity for Human Immunodeficiency Virus (HIV), Hepatitis B, or Hepatitis C, as reported by the subject.
• Laboratory-confirmed thrombocytopenia, which may be a contraindication for IM vaccination, at the discretion of the Investigator.
• Bleeding disorder or receipt of anticoagulants in the 3 weeks preceding inclusion, which may be a contraindication for intramuscular (IM) vaccination, at the discretion of the Investigator.
• Personal history of Guillain-Barré syndrome.
• Moderate or severe acute illness/infection (according to Investigator judgment) or febrile illness (temperature ≥ 38.0°C [≥ 100.4°F]) on the day of vaccination. A prospective subject should not be enrolled in the study until the condition has resolved or the febrile event has subsided.
• Identified as an Investigator or employee of the Investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (i.e., parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study.
• Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily.
• Current alcohol or drug use that, in the opinion of the Investigator, might interfere with the ability to comply with trial procedures.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sanofi Pasteur, a Sanofi Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Sanofi Pasteur Inc.

Locations

Huntsville, Alabama, United States

Jonesboro, Arkansas, United States

Little Rock, Arkansas, United States

San Diego, California, United States

Boulder, Colorado, United States

Marietta, Georgia, United States

Woodstock, Georgia, United States

Peoria, Illinois, United States

Mishawaka, Indiana, United States

Louisville, Kentucky, United States

Rockville, Maryland, United States

Woburn, Massachusetts, United States

Columbia, Missouri, United States

St Louis, Missouri, United States

Albuquerque, New Mexico, United States

Brooklyn, New York, United States

Ithaca, New York, United States

Rochester, New York, United States

Raleigh, North Carolina, United States

Winston-Salem, North Carolina, United States

Cincinnati, Ohio, United States

Cleveland, Ohio, United States

Clairton, Pennsylvania, United States

Hershey, Pennsylvania, United States

Latrobe, Pennsylvania, United States

Pittsburgh, Pennsylvania, United States

Syracuse, Utah, United States

Virginia Beach, Virginia, United States

Vancouver, Washington, United States

Chippewa Falls, Wisconsin, United States

Marshfield, Wisconsin, United States

Harbour Grace, Newfoundland and Labrador, Canada

St. John's, Newfoundland and Labrador, Canada

Countries

United States; Canada

References

Halperin SA, Donovan C, Marshall GS, Pool V, Decker MD, Johnson DR, Greenberg DP; Tdap Booster Investigators. Randomized Controlled Trial of the Safety and Immunogenicity of Revaccination With Tetanus-Diphtheria-Acellular Pertussis Vaccine (Tdap) in Adults 10 Years After a Previous Dose. J Pediatric Infect Dis Soc. 2019 May 11;8(2):105-114. doi: 10.1093/jpids/pix113.

Reference Type: RESULT

PMID: 29438562 (View on PubMed)

Pool V, Tomovici A, Johnson DR, Greenberg DP, Decker MD. Humoral immunity 10 years after booster immunization with an adolescent and adult formulation combined tetanus, diphtheria, and 5-component acellular pertussis vaccine in the USA. Vaccine. 2018 Apr 19;36(17):2282-2287. doi: 10.1016/j.vaccine.2018.03.029. Epub 2018 Mar 21.

Reference Type: DERIVED

PMID: 29573876 (View on PubMed)

Other Identifiers

U1111-1117-7012

Identifier Type: OTHER

Identifier Source: secondary_id

Td537

Identifier Type: -

Identifier Source: org_study_id