Brief Title
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®
Brief Summary
This is a descriptive study to evaluate the safety and immunogenicity of ADACEL® and
BOOSTRIX® vaccines among US adolescents.
Study Phase
Phase 4
Study Type
Interventional
Primary Outcome
Number of Participants Reporting A Solicited Injection Site or Systemic Reactions Within 7 Days Following Vaccination With Adacel® or Boostrix®
Condition
Pertussis
Intervention
ADACEL®:Tetanus, Reduced Diphtheria and Acellular Pertussis Adsorbed
Study Arms / Comparison Groups
Adacel® Vaccine Group
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Biological
Estimated Enrollment
647
Start Date
May 2006
Completion Date
December 2008
Primary Completion Date
October 2008
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.
Gender
All
Ages
11 Years - 18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Medical Director, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00319553
Organization ID
Td516
Responsible Party
Sponsor
Study Sponsor
Sanofi
Study Sponsor
Medical Director, Study Director, Sanofi Pasteur Inc.
Verification Date
September 2012