Post-licensure, Modified Double-blind, Multi-center Study Evaluating Safety and Immunogenicity of ADACEL® and BOOSTRIX®

Tetanus Clinical Trial

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®

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00319553
• Other study ID #: Td516
• Status: Completed
• Phase: Phase 4
• First received: April 28, 2006
• Last updated: September 28, 2012
• Start date: May 2006
• Est. completion date: December 2008

Study information

• Verified date: September 2012
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 647
• Est. completion date: December 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 11 Years to 18 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diphtheria
• Pertussis
• Tetanus
• Whooping Cough

Intervention

Biological:
• ADACEL®:Tetanus, Reduced Diphtheria and Acellular Pertussis Adsorbed
0.5 mL, IM
• BOOSTRIX®: Tetanus, Reduced Diphtheria and Acellular Pertussis Adsorbed
0.5 mL, IM

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Primary	Geometric Mean Concentration of Antibody to Pertussis Antigens Pre- and Post-Vaccination With Adacel® or Boostrix®.		Day 0 and 28 days post-vaccination	No

External Links

•   Link
•   Link