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

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ClinicalTrials.gov Identifier: NCT01439165
Recruitment Status : Completed
First Posted : September 23, 2011
Results First Posted : October 9, 2017
Last Update Posted : July 24, 2018
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Tracking Information
First Submitted Date  ICMJE September 20, 2011
First Posted Date  ICMJE September 23, 2011
Results First Submitted Date  ICMJE July 28, 2017
Results First Posted Date  ICMJE October 9, 2017
Last Update Posted Date July 24, 2018
Study Start Date  ICMJE November 2011
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 8, 2017)
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 21, 2011)
  • Frequencies and proportions of study participants with tetanus and diphtheria antibody concentrations ≥ 0.1 IU/mL [ Time Frame: 28 days post-vaccination ]
  • 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 ]
    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.
Change History Complete list of historical versions of study NCT01439165 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 8, 2017)
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 21, 2011)
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 ]
Solicited injection site reactions: Pain, Erythema, and Swelling; Solicited Systemic Reactions: Fever (Temperature), Headache, Malaise, and Myalgia.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Immunogenicity in Adults of Revaccination With Adacel® Vaccine 10 Years After a Previous Dose
Official Title  ICMJE Safety and Immunogenicity in Adults of Revaccination With Adacel® Vaccine 10 Years After a Previous Dose
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Tetanus
  • Diphtheria
  • Pertussis
  • Whooping Cough
Intervention  ICMJE
  • Biological: Tetanus Toxoid, Diphtheria Toxoid and Pertussis Vaccine
    0.5 mL, Intramuscular
    Other Name: Adacel®
  • Biological: Tetanus and Diphtheria Toxoids Adsorbed For Adult Use
    0.5 mL, Intramuscular
    Other Name: TENIVAC
Study Arms  ICMJE
  • Experimental: Adacel® Vaccine Group
    Participants randomized to receive a repeat dose of Tetanus Toxoid, Diphtheria Toxoid and Pertussis Vaccine (Adacel®)
    Intervention: Biological: Tetanus Toxoid, Diphtheria Toxoid and Pertussis Vaccine
  • 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.
    Intervention: Biological: Tetanus and Diphtheria Toxoids Adsorbed For Adult Use
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 8, 2017)
1330
Original Estimated Enrollment  ICMJE
 (submitted: September 21, 2011)
1333
Actual Study Completion Date  ICMJE February 2017
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 64 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01439165
Other Study ID Numbers  ICMJE Td537
U1111-1117-7012 ( Other Identifier: WHO )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
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
Responsible Party Sanofi ( Sanofi Pasteur, a Sanofi Company )
Study Sponsor  ICMJE Sanofi Pasteur, a Sanofi Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Sanofi Pasteur Inc.
PRS Account Sanofi
Verification Date June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP