AzTrials
AzTrials

PertussisPhase 4NCT00712959

Immune Responses in Adults to Revaccination With ADACEL® 10 Years After a Previous Dose

A Phase 4 study testing Tetanus, Reduced Diphtheria Toxoid and Acellular Pertussis (ADACEL®) in people with Pertussis and Tetanus, run by Sanofi Pasteur, a Sanofi Company at 7 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study is to collect additional immunogenicity and safety data on re-dosing with Tdap vaccine (ADACEL®) in a continuing effort to address the public health need to establish broader population immunity against pertussis, as well as diphtheria and tetanus. Read more about this study

Who is it for?
Ages 20 years and olderHealthy volunteers can take part
Conditions the study is for
Pertussis, Tetanus, Diphtheria
What is being tested?
Tetanus, Reduced Diphtheria Toxoid and Acellular Pertussis (ADACEL®)
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
769 participants
Where
7 sitesCanada
Study dates
Jun 2008to Dec 2009
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Received Tdap or Tdap-IPV vaccine in study TD9707 or TD9805.
  • Never previously received Tdap vaccine and has not received any tetanus-, diphtheria , or pertussis-containing vaccine in the past 10 years.
  • Participated in TD9707 or TD9805 but does not meet inclusion/ exclusion criteria or willing to undergo phlebotomy but not willing to receive Tdap (ADACEL®) vaccine.
  • Signed Institutional Review Board (IRB)-approved informed consent form
  • Able to attend all scheduled visits and to comply with all trial procedures
  • For a woman, a negative urine pregnancy test and the use of effective method(s) of contraception, or the inability to become pregnant

Who cannot join

  • Any condition listed as a contraindication in the ADACEL® Canadian product monograph
  • Any condition which, in the opinion of the investigator, would pose a health risk to the subject or interfere with the evaluation of the vaccine
  • Chronic illness, at a stage that could interfere with trial conduct or completion, in the opinion of the investigator
  • Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic (injected or oral) corticosteroid therapy. Individuals on a tapering dose schedule of oral steroids lasting less than 7 days may be included in the trial as long as they have not received more than 1 course within the last 2 weeks prior to enrollment
  • Febrile illness (temperature ≥ 37.5°C [99.5°F]) at the time of inclusion
  • History of documented diphtheria, pertussis, or tetanus disease since participation in studies TD9707 or TD9805. Or history of documented diphtheria, pertussis, or tetanus disease in the last 10 years.
Show all 20Show fewer
  • Known or suspected receipt of a diphtheria-, pertussis-, or tetanus-containing vaccine since participation in study TD9707 or TD9805. For Group 2, known or suspected receipt of a diphtheria-, pertussis-, or tetanus-containing vaccine in the last 10 years.
  • Receipt of any vaccine, other than influenza vaccine, in the 28-day period prior to Visit 1 or scheduled to receive any vaccine, other than influenza vaccine, in the period between Visit 1 and Visit 2. For influenza vaccine only, defer if received in the 14 days prior to enrollment or scheduled to receive prior to Visit 2.
  • Receipt of blood or blood-derived products in the past 3 months
  • Suspected or known hypersensitivity to any of the vaccine components, or a life-threatening reaction after previous administration of the vaccine or a vaccine containing the same substances
  • Unable to attend the scheduled visits or to comply with the study procedures
  • In females of childbearing potential, known pregnancy or positive serum/urine pregnancy test
  • Breast-feeding woman
  • Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding enrollment. Planned participation in another clinical trial during the present trial period
  • Current alcohol or recreational drug use that may interfere with the subject's ability to comply with trial procedures
  • Thrombocytopenia, bleeding disorder, anticoagulation therapy contraindicating intramuscular (IM) vaccination
  • Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent.
  • Other events which in the judgment of the investigator would preclude vaccination at the time of Visit 1 For Group 3
  • History of documented diphtheria, pertussis, or tetanus disease since participation in study TD9707 or TD9805
  • Known or suspected receipt of a diphtheria-, pertussis-, or tetanus-containing vaccine since participation in study TD9707 or TD9805.

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

Canada7 sites

  • Study site

    Coquitlam, British Columbia, V3C 4J2

  • Study site

    Halifax, Nova Scotia, B3K 6R8

  • Study site

    Pierrefonds, Quebec, H9H 4Y6

  • Study site

    Québec, Quebec, G1E 7G9

  • Study site

    Sherbrooke, Quebec, J1H 4J6

  • Study site

    Surrey, British Columbia, V3R 8P8

  • Study site

    Vancouver, British Columbia, V6H 3V4

Other trials in Canada

About this study

Official title: Immune Responses in Adults to Revaccination With Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (ADACEL®) 10 Years After a Previous Dose

The purpose of this study is to collect additional immunogenicity and safety data on re-dosing with Tdap vaccine (ADACEL®) in a continuing effort to address the public health need to establish broader population immunity against pertussis, as well as diphtheria and tetanus.

Primary Objective:

  • To assess immune response to Tdap vaccine (ADACEL®) one month after booster vaccination.
Read the detailed description

This is an open-label, multicenter study to describe the immunological response and safety of repeat administration of an adolescent/adult-formulation tetanus-diphtheria-acellular pertussis Tdap vaccine (ADACEL®), 10 years following initial administration of Tdap vaccine.

Being tested
Tetanus, Reduced Diphtheria Toxoid and Acellular Pertussis (ADACEL®)
Keywords
Pertussis, Tetanus, Diphtheria, Acellular pertussis, ADACEL®,, Tdap vaccine
Medical subject headings
Whooping Cough, Tetanus, Diphtheria

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tetanus, Reduced Diphtheria Toxoid and Acellular Pertussis (ADACEL®)Biological

    Also called Tdap, ADACEL®

    0.5 ml, IM

  • Tetanus, Reduced Diphtheria Toxoid and Acellular Pertussis (ADACEL®)Biological

    Also called Tdap, Adacel®

    0.5 mL, IM

Study groups in NCT00712959
Study groupRoleWhat they receive
Group 1: Previous Tdap or Tdap-IPV RecipientsExperimentalParticipants received Tdap or Tdap-Inactivated Poliomyelitis Vaccine (IPV) in a previous study (TD9707 or TD9805)
Receives: Biological: Tetanus, Reduced Diphtheria Toxoid and Acellular Pertussis (ADACEL®)
Group 2: Tdap vaccine-naïveActive comparatorParticipants are age-balanced Tdap vaccine-naïve and will receive Tdap vaccine in the study at least 10 years after a previous tetanus, diphtheria and/or pertussis dose.
Receives: Biological: Tetanus, Reduced Diphtheria Toxoid and Acellular Pertussis (ADACEL®)
Group 3No interventionPast participants in Study TD9707 and TD9805 did not qualify for Tdap re-administration in this study or were unwilling to receive a second dose of Tdap. They were not included in the analysis for the study

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants With Seroprotection Against Tetanus and Diphtheria Before and After Revaccination With ADACEL® 10 Years After a Previous Dose

    Diphtheria concentrations were determined by neutralization assay; tetanus concentrations were determined by enzyme-linked immunosorbent assay (ELISA).

    Seroprotection was defined as anti-tetanus or anti-diphtheria concentrations ≥ 0.1 IU/mL.

    Measured: Day 0 (pre-vaccination) and 30 post-vaccination

  2. Anti-Pertussis Geometric Mean Concentrations Post-vaccination With ADACEL® 10 Years After a Previous Dose

    Post-vaccination geometric mean concentrations (GMCs) for pertussis toxoid (PT), filamentous hemagglutinin (FHA), pertactin (PRN), and fimbriae types 2 and 3 (FIM), were determined by enzyme-linked immunosorbent assay (ELISA).

    Measured: Day 30 post-vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jul 2008 (estimated)
  2. Study startJun 2008
  3. Primary completionSep 2009
  4. Study completionDec 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
769 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00712959
Sponsor's protocol ID
TD526
Status last verified
Apr 2014
First submitted
7 Jul 2008
Last updated
30 Apr 2014
Data monitoring committee
No

Publications

  • Halperin SA, Scheifele D, De Serres G, Noya F, Meekison W, Zickler P, Larrivee L, Langley JM, McNeil SA, Dobson S, Jordanov E, Thakur M, Decker MD, Johnson DR. Immune responses in adults to revaccination with a tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine 10 years after a previous dose. Vaccine. 2012 Jan 20;30(5):974-82. doi: 10.1016/j.vaccine.2011.11.035. Epub 2011 Nov 21.

    PubMed 22115634

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Tetanus, Reduced Diphtheria Toxoid and Acellular Pertussis (ADACEL®) in people with Pertussis and Tetanus, run by Sanofi Pasteur, a Sanofi Company at 7 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Apr 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Seroprotection Against Tetanus and Diphtheria Before and After Revaccination With ADACEL® 10 Years After a Previous Dose (time frame: Day 0 (pre-vaccination) and 30 post-vaccination). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00712959, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2014.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in