Post-licensure, Modified Double-blind, Multi-center Study Evaluating Safety and Immunogenicity of ADACEL® and BOOSTRIX®
Comparison in US Adolescents of the Safety and Immunogenicity of Two Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis (Tdap) Vaccines: ADACEL™ and BOOSTRIX®
1 other identifier
interventional
647
1 country
10
Brief Summary
This is a descriptive study to evaluate the safety and immunogenicity of ADACEL® and BOOSTRIX® vaccines among US adolescents.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started May 2006
Typical duration for phase_4
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Posted
Study publicly available on registry
April 27, 2006
CompletedFirst Submitted
Initial submission to the registry
April 28, 2006
CompletedStudy Start
First participant enrolled
May 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2008
CompletedResults Posted
Study results publicly available
October 21, 2010
CompletedOctober 5, 2012
September 1, 2012
2.4 years
April 28, 2006
September 28, 2010
September 28, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Number of Participants Reporting A Solicited Injection Site or Systemic Reactions Within 7 Days Following Vaccination With Adacel® or Boostrix®
Solicited injection site reactions: Pain, Erythema, and swelling. Solicited systemic reactions: Fever (temperature), Headache, Malaise, and Myalgia. Grade 3 reaction definitions: Pain = Incapacitating, unable to perform usual activities; Erythema and swelling = ≥ 5 cm; Fever = temperature ≥ 39.1°C or ≥ 102.3°F; Headache, Malaise, and Myalgia = Prevents daily activities.
Day 0 to 7 post-vaccination
Percentage of Participants With Tetanus Antitoxin Concentrations ≥ 0.1 IU/mL Pre- and Post-Vaccination With Adacel® or Boostrix®.
Day 0 and 28 days post-vaccination
Percentage of Participants With Diphtheria Antitoxin Concentrations ≥ 0.1 IU/mL Pre- and Post-Vaccination With Adacel® or Boostrix®.
Day 0 and 28 days post-vaccination
Geometric Mean Concentration of Antibody to Pertussis Antigens Pre- and Post-Vaccination With Adacel® or Boostrix®.
Day 0 and 28 days post-vaccination
Study Arms (2)
Adacel® Vaccine Group
EXPERIMENTALBOOSTRIX® Vaccine Group
ACTIVE COMPARATORInterventions
0.5 mL, IM
0.5 mL, IM
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sanofilead
Study Sites (10)
Unknown Facility
Annapolis, Maryland, 21401, United States
Unknown Facility
Baltimore, Maryland, 21201, United States
Unknown Facility
Frederick, Maryland, 21702, United States
Unknown Facility
Durham, North Carolina, 27704, United States
Unknown Facility
Durham, North Carolina, 27705, United States
Unknown Facility
Franklin, Tennessee, 37067, United States
Unknown Facility
Bellevue, Washington, 98005, United States
Unknown Facility
Mercer Island, Washington, 98040-2758, United States
Unknown Facility
Sammamish, Washington, 98075, United States
Unknown Facility
Seattle, Washington, 98105, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Director
- Organization
- Sanofi Pasteur Inc.
Study Officials
- STUDY DIRECTOR
Medical Director
Sanofi Pasteur Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 28, 2006
First Posted
April 27, 2006
Study Start
May 1, 2006
Primary Completion
October 1, 2008
Study Completion
December 1, 2008
Last Updated
October 5, 2012
Results First Posted
October 21, 2010
Record last verified: 2012-09