Post-licensure, Modified Double-blind, Multi-center Study Evaluating Safety and Immunogenicity of ADACEL® and BOOSTRIX®
NCT ID: NCT00319553
Last Updated: 2012-10-05
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
647 participants
INTERVENTIONAL
2006-05-31
2008-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Adacel® Vaccine Group
ADACEL®:Tetanus, Reduced Diphtheria and Acellular Pertussis Adsorbed
0.5 mL, IM
BOOSTRIX® Vaccine Group
BOOSTRIX®: Tetanus, Reduced Diphtheria and Acellular Pertussis Adsorbed
0.5 mL, IM
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
ADACEL®:Tetanus, Reduced Diphtheria and Acellular Pertussis Adsorbed
0.5 mL, IM
BOOSTRIX®: Tetanus, Reduced Diphtheria and Acellular Pertussis Adsorbed
0.5 mL, IM
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
11 Years
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Sanofi
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Medical Director
Role: STUDY_DIRECTOR
Sanofi Pasteur Inc.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Annapolis, Maryland, United States
Baltimore, Maryland, United States
Frederick, Maryland, United States
Durham, North Carolina, United States
Durham, North Carolina, United States
Franklin, Tennessee, United States
Bellevue, Washington, United States
Mercer Island, Washington, United States
Sammamish, Washington, United States
Seattle, Washington, United States
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
Related Info
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Td516
Identifier Type: -
Identifier Source: org_study_id