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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01439165
First Posted: September 23, 2011
Last Update Posted: October 9, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
  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, Diphtheria Toxoid and Pertussis Vaccine Biological: Tetanus and Diphtheria Toxoids Adsorbed For Adult Use Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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 ( Sanofi Pasteur, a Sanofi Company ):

Primary Outcome Measures:
  • Percentage of Participants With Diphtheria and Tetanus Seroprotection [ Time Frame: 1 month post-booster vaccination ]
    Anti-Diphtheria antibodies were assessed by a toxin neutralization test. Anti-Tetanus antibodies were assessed using an enzyme-linked immunosorbent assay. Seroprotection was defined as the following: Anti-Diphtheria and Anti-Tetanus ≥ 0.1 IU/mL.

  • Percentage of Participants With Diphtheria and Tetanus Booster Response [ Time Frame: 1 month post-booster vaccination ]
    Anti-Diphtheria antibodies were assessed by a toxin neutralization test. Anti-Tetanus antibodies were assessed using an enzyme-linked immunosorbent assay. A booster response was defined as a 4-fold increase in pre- to post-vaccination antibody concentrations for subjects with pre-vaccination antibody concentrations ≤2.56 IU/mL for diphtheria and ≤ 2.7 IU/mL for tetanus. If the pre vaccination antibody concentrations were > 2.56 IU/mL for diphtheria and > 2.7 IU/mL for tetanus, then a 2-fold increase in response rate was defined as a booster response.

  • Geometric Mean Concentrations (GMC) of Anti Pertussis Antibodies [ Time Frame: 1 month post-booster vaccination ]
    Anti-Pertussis antibodies (Pertussis toxoid, Filamentous Hemagglutinin (FHA), Pertactin, Fimbriae types 2 and 3) were assessed using an enzyme-linked immunosorbent assay. Anti-pertussis GMCs further to Adacel vaccination was compared to an historical control group with Daptacel (NCT00255047 for pertussis toxoid and PMID 8538705 for FHA, Pertactin and Fimbriae) since Td Adsorbed Vaccine does not contain any pertussis antigens.

  • Percentage of Subjects With Pertussis Antigen Booster Response [ Time Frame: 1 month post-booster vaccination ]

    Anti-Pertussis antibodies (Pertussis toxoid, Filamentous Hemagglutinin [FHA], Pertactin, Fimbriae (types 2 and 3) were assessed using an enzyme-linked immunosorbent assay. Booster response is defined as a minimum rise in antibody concentration from pre- to post-vaccination. The minimum rise is at least 2 times if the pre-vaccination concentration is above the cutoff value, or at least 4 times if it is at or below the cutoff value.

    Anti-pertussis toxoid booster response rates further to Adacel vaccination was compared to an expected booster rates based on study Td506 (PMID 15933223) since Td Adsorbed Vaccine does not contain any pertussis antigens.



Secondary Outcome Measures:
  • Percentage of Participants Reporting a Solicited Injection Site or Systemic Reactions [ Time Frame: Day 0 up to Day 7 post-vaccination ]
    Injection site reactions: Pain, Erythema, and Swelling. Systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia. Grade 3 Injection site reactions: Pain, Significant, prevents daily activity. Erythema and Swelling, >100 mm. Grade 3 Systemic reactions: Fever, ≥39°C or ≥102.1 F; Headache, Malaise, and Myalgia, Significant; prevents daily activity.


Enrollment: 1330
Study Start Date: November 2011
Study Completion Date: February 2017
Primary Completion Date: December 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, Diphtheria Toxoid and Pertussis Vaccine (Adacel®)
Biological: Tetanus Toxoid, Diphtheria Toxoid and Pertussis Vaccine
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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Responsible Party: Sanofi Pasteur, a Sanofi Company
ClinicalTrials.gov Identifier: NCT01439165     History of Changes
Other Study ID Numbers: Td537
U1111-1117-7012 ( Other Identifier: WHO )
First Submitted: September 20, 2011
First Posted: September 23, 2011
Results First Submitted: July 28, 2017
Results First Posted: October 9, 2017
Last Update Posted: October 9, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data (IPD) and supporting clinical documents are available for request at clinicalstudydatarequest.com. While making information available at Sanofi continues to protect the privacy of the participants in clinical trials and to remove commercially confidential information (CCI). Details on Data Sharing criteria and process for requesting access can be found at this web address: clinicalstudydatarequest.com

Keywords provided by Sanofi ( Sanofi Pasteur, a Sanofi Company ):
Adacel vaccine
Tetanus
Diphtheria
whooping cough

Additional relevant MeSH terms:
Whooping Cough
Tetanus
Diphtheria
Clostridium Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Corynebacterium Infections
Actinomycetales Infections
Bordetella Infections
Gram-Negative Bacterial Infections
Respiratory Tract Infections
Infection
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs