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

Primary Purpose

Pertussis, Tetanus, Diphtheria

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
ADACEL®:Tetanus, Reduced Diphtheria and Acellular Pertussis Adsorbed
BOOSTRIX®: Tetanus, Reduced Diphtheria and Acellular Pertussis Adsorbed
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pertussis focused on measuring Tetanus, diphtheria, acellular pertussis

Eligibility Criteria

11 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Adacel® Vaccine Group

BOOSTRIX® Vaccine Group

Arm Description

Outcomes

Primary Outcome Measures

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.
Percentage of Participants With Tetanus Antitoxin Concentrations ≥ 0.1 IU/mL Pre- and Post-Vaccination With Adacel® or Boostrix®.
Percentage of Participants With Diphtheria Antitoxin Concentrations ≥ 0.1 IU/mL Pre- and Post-Vaccination With Adacel® or Boostrix®.
Geometric Mean Concentration of Antibody to Pertussis Antigens Pre- and Post-Vaccination With Adacel® or Boostrix®.

Secondary Outcome Measures

Full Information

First Posted
April 28, 2006
Last Updated
September 28, 2012
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT00319553
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®
Study Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pertussis, Tetanus, Diphtheria
Keywords
Tetanus, diphtheria, acellular pertussis

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
647 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Adacel® Vaccine Group
Arm Type
Experimental
Arm Title
BOOSTRIX® Vaccine Group
Arm Type
Active Comparator
Intervention Type
Biological
Intervention Name(s)
ADACEL®:Tetanus, Reduced Diphtheria and Acellular Pertussis Adsorbed
Other Intervention Name(s)
ADACEL®
Intervention Description
0.5 mL, IM
Intervention Type
Biological
Intervention Name(s)
BOOSTRIX®: Tetanus, Reduced Diphtheria and Acellular Pertussis Adsorbed
Other Intervention Name(s)
BOOSTRIX®
Intervention Description
0.5 mL, IM
Primary Outcome Measure Information:
Title
Number of Participants Reporting A Solicited Injection Site or Systemic Reactions Within 7 Days Following Vaccination With Adacel® or Boostrix®
Description
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.
Time Frame
Day 0 to 7 post-vaccination
Title
Percentage of Participants With Tetanus Antitoxin Concentrations ≥ 0.1 IU/mL Pre- and Post-Vaccination With Adacel® or Boostrix®.
Time Frame
Day 0 and 28 days post-vaccination
Title
Percentage of Participants With Diphtheria Antitoxin Concentrations ≥ 0.1 IU/mL Pre- and Post-Vaccination With Adacel® or Boostrix®.
Time Frame
Day 0 and 28 days post-vaccination
Title
Geometric Mean Concentration of Antibody to Pertussis Antigens Pre- and Post-Vaccination With Adacel® or Boostrix®.
Time Frame
Day 0 and 28 days post-vaccination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Sanofi Pasteur Inc.
Official's Role
Study Director
Facility Information:
City
Annapolis
State/Province
Maryland
ZIP/Postal Code
21401
Country
United States
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
City
Frederick
State/Province
Maryland
ZIP/Postal Code
21702
Country
United States
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27704
Country
United States
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
City
Franklin
State/Province
Tennessee
ZIP/Postal Code
37067
Country
United States
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98005
Country
United States
City
Mercer Island
State/Province
Washington
ZIP/Postal Code
98040-2758
Country
United States
City
Sammamish
State/Province
Washington
ZIP/Postal Code
98075
Country
United States
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.sanofipasteur.com
Description
Related Info

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

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