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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT01439165
First received: September 20, 2011
Last updated: August 19, 2014
Last verified: August 2014
  Purpose

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.

Condition Intervention Phase
Tetanus
Diphtheria
Pertussis
Whooping Cough
Biological: Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed
Biological: Tetanus and Diphtheria Toxoids Adsorbed For Adult Use
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Safety and Immunogenicity in Adults of Revaccination With Adacel® Vaccine 10 Years After a Previous Dose

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Frequencies and proportions of study participants with tetanus and diphtheria antibody concentrations ≥ 0.1 IU/mL [ Time Frame: 28 days post-vaccination ] [ Designated as safety issue: No ]
  • Information on the booster response against tetanus and diphtheria based on antibody rises between pre- and post-vaccination specimens. [ Time Frame: 28 days post-vaccination ] [ Designated as safety issue: No ]
    A booster response is defined as a 4 fold increase in pre- to post-vaccination antibody concentrations for participants with a pre-vaccination concentration ≤ 2.56 IU/mL for diphtheria and ≤ 2.7 IU/mL for tetanus, and defined as a 2-fold increase for participants with a pre-vaccination concentration > 2.56 IU/mL for diphtheria and > 2.7 IU/mL for tetanus.


Secondary Outcome Measures:
  • Information concerning the safety in terms of solicited injection site and systemic reactions, unsolicited adverse events, and serious adverse events post vaccination with Adacel® vaccine. [ Time Frame: Day 0 to up to 6 months post-vaccination ] [ Designated as safety issue: No ]
    Solicited injection site reactions: Pain, Erythema, and Swelling; Solicited Systemic Reactions: Fever (Temperature), Headache, Malaise, and Myalgia.


Estimated Enrollment: 1333
Study Start Date: November 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Adacel® Vaccine Group
Participants randomized to receive a repeat dose of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Adacel®)
Biological: Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed
0.5 mL, Intramuscular
Other Name: Adacel®
Active Comparator: Td Adsorbed Vaccine Group
Participants randomized to receive Subjects randomized to receive a Tetanus and Diphtheria Toxoids Adsorbed For Adult Use (TENIVAC) vaccine.
Biological: Tetanus and Diphtheria Toxoids Adsorbed For Adult Use
0.5 mL, Intramuscular
Other Name: TENIVAC

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.

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01439165

  Show 33 Study Locations
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
Study Director: Medical Director Sanofi Pasteur Inc.
  More Information

Additional Information:
No publications provided

Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT01439165     History of Changes
Other Study ID Numbers: Td537, U1111-1117-7012
Study First Received: September 20, 2011
Last Updated: August 19, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Sanofi:
Adacel vaccine
Tetanus
Diphtheria
whooping cough

Additional relevant MeSH terms:
Diphtheria
Whooping Cough
Corynebacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Bordetella Infections
Gram-Negative Bacterial Infections
Respiratory Tract Infections
Infection
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 18, 2014