Clinical trial NCT00319553: Post-licensure, Modified Double-blind, Multi-center Study Evaluating Safety and Immunogenicity of ADACEL® and BOOSTRIX®
Official title: Comparison in US Adolescents of the Safety and Immunogenicity of Two Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis (Tdap) Vaccines: ADACEL™ and BOOSTRIX®
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pertussis
Tetanus
Diphtheria
Keywords: Tetanus
diphtheria
acellular pertussis
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2006-04-27
Enrollment: 647
Sex: ALL
Minimum age (years): 11
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a descriptive study to evaluate the safety and immunogenicity of ADACEL® and BOOSTRIX® vaccines among US adolescents.


Eligibility criteria: Inclusion Criteria:

* Aged 11 - 18 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 female, 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 (i.e. cardiac, renal, neurologic, metabolic, rheumatologic, psychiatric etc) 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 or diphtheria-containing vaccine within the preceding 2 years.
* Known or suspected receipt of a pertussis-containing vaccine within the preceding 5 years.
* Administration of immune globulin or other blood products within the last three months, or injected or oral corticosteroids or other therapy expected to materially alter immune function 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.
* Received any vaccine in the 21-day period prior to enrollment or scheduled to receive any vaccination after enrollment and prior to visit 2.
* Suspected or known hypersensitivity to any of the vaccine components or to latex.

Primary outcomes:
measure: Number of Participants Reporting A Solicited Injection Site or Systemic Reactions Within 7 Days Following Vaccination With Adacel® or Boostrix®
timeFrame: Day 0 to 7 post-vaccination
measure: Percentage of Participants With Tetanus Antitoxin Concentrations ≥ 0.1 IU/mL Pre- and Post-Vaccination With Adacel® or Boostrix®.
timeFrame: Day 0 and 28 days post-vaccination
measure: Percentage of Participants With Diphtheria Antitoxin Concentrations ≥ 0.1 IU/mL Pre- and Post-Vaccination With Adacel® or Boostrix®.
timeFrame: Day 0 and 28 days post-vaccination
measure: Geometric Mean Concentration of Antibody to Pertussis Antigens Pre- and Post-Vaccination With Adacel® or Boostrix®.
timeFrame: Day 0 and 28 days post-vaccination
Secondary outcomes:
Other outcomes:
Locations:
city: Annapolis
country: United States
state: Maryland
city: Baltimore
country: United States
state: Maryland
city: Frederick
country: United States
state: Maryland
city: Durham
country: United States
state: North Carolina
city: Durham
country: United States
state: North Carolina
city: Franklin
country: United States
state: Tennessee
city: Bellevue
country: United States
state: Washington
city: Mercer Island
country: United States
state: Washington
city: Sammamish
country: United States
state: Washington
city: Seattle
country: United States
state: Washington
Study officials:
affiliation: Sanofi Pasteur Inc.
name: Medical Director
role: STUDY_DIRECTOR
References: