Clinical trial NCT00347958: Descriptive, Open-label, Multicenter Study of the Safety of Redosing With ADACEL® Vaccine
Official title: Safety Among Adolescents and Adults of Revaccination With Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Adacel®) 4 to 5 Years After a Previous Dose
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Tetanus
Diphtheria
Pertussis
Keywords: Tetanus,
Diphtheria,
Pertussis
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2006-07-04
Enrollment: 545
Sex: ALL
Minimum age (years): 15
Maximum age (years): 69
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Objectives:

To provide safety data on revaccination with ADACEL® vaccine.

To describe the immune response to tetanus, diphtheria, and pertussis antigens following revaccination with ADACEL® vaccine 4-5 years after first vaccination.


Eligibility criteria: Inclusion Criteria:

* Previously received ADACEL vaccine as part of Aventis Pasteur studies Td501, Td502, or Td505.
* At least 15 but no greater than 69 years of age at the time of vaccination in this trial.
* Signed Institutional Review Board (IRB)-approved informed assent / consent form.
* Able to attend all scheduled visits and to comply with all trial procedures.
* For a woman, inability to become pregnant or negative serum/urine pregnancy test.

Exclusion Criteria:

* Any condition which, in the opinion of the investigator, would pose a health risk to the participant or interfere with the evaluation of the vaccine.
* Serious chronic disease (ie, cardiac, renal, neurologic, metabolic, rheumatologic, psychiatric) that is unstable or that might:

  * interfere with the ability to participate fully in the study; or
  * interfere with evaluation of the vaccine.
* Known or suspected impairment of immunologic function.
* Febrile illness within the last 72 hours or an oral temperature ≥100.4°F (≥38°C) at the time of inclusion.
* History of documented tetanus, diphtheria or pertussis disease within the preceding 5 years.
* Known or suspected receipt of a tetanus-, diphtheria- or pertussis-containing vaccine since participation in Study Td501, Td502, or Td505. (Receipt of Menactra vaccine at any time prior to the present study is permitted, subject to the next exclusion criterion).
* Received any vaccine, other than influenza vaccine, in the 28-day period prior to enrollment or scheduled to receive any vaccine, other than influenza vaccine, in the 28-day period after enrollment. For influenza vaccine only, defer if received in the 14-day period prior to enrollment or scheduled to receive in the 14-day period after enrollment
* Administration of immune globulin or other blood products within the last three months, or injected or oral corticosteroids or other immunomodulator therapy within six weeks of the study vaccine. 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 one course within the last two weeks prior to enrollment.
* Suspected or known hypersensitivity to any of the vaccine components or to latex.
* Unable to attend the scheduled visits or to comply with the study procedures.
* In females of childbearing potential, a positive or equivocal urine pregnancy test at enrollment.
* Nursing mother.
* Participation in another interventional clinical trial in the 4 weeks preceding enrollment or planning to participate in another interventional clinical trial during the planned period of this study.
* Current abuse of alcohol or drug addiction that may interfere with the subject's ability to comply with trial visits or procedures.
* Thrombocytopenia or bleeding disorder contraindicating intramuscular (IM) vaccination.
* Subject deprived of freedom by an administrative or court order, or under the stress of an emergency setting, or hospitalized without his/her consent.

Primary outcomes:
measure: Percentage of Participants With at Least 1 Solicited Injection Site and Systemic Reactions Post-Vaccination
timeFrame: 0-14 days post-vaccination
Secondary outcomes:
Other outcomes:
measure: Geometric Mean Titers (GMTs) of Tetanus and Diphtheria Antibodies Pre- and Post-Vaccination.
timeFrame: Day 28 post-vaccination
measure: Geometric Mean Titers (GMTs) of Pertussis Antibodies Pre- and Post-Vaccination.
timeFrame: Day 28 post-vaccination
measure: Percentage of Participants With Tetanus and Diptheria Antibody Titers ≥ 0.1 Pre- and Post-Vaccination With Adacel®
timeFrame: Day 28 post-vaccination
Locations:
city: Jonesboro
country: United States
state: Arkansas
city: Bossier City
country: United States
state: Louisiana
city: University Heights
country: United States
state: Ohio
city: Pittsburgh
country: United States
state: Pennsylvania
city: Coquitlam
country: Canada
state: British Columbia
city: Surrey
country: Canada
state: British Columbia
city: Winnipeg
country: Canada
state: Manitoba
city: Halifax
country: Canada
state: Nova Scotia
city: Beauport
country: Canada
state: Quebec
city: Montreal
country: Canada
state: Quebec
Study officials:
affiliation: Sanofi Pasteur, a Sanofi Company
name: Clinical Trials
role: STUDY_DIRECTOR
References: