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Descriptive, Open-label, Multicenter Study of the Safety of Redosing With ADACEL® Vaccine

Primary Purpose

Tetanus, Diphtheria, Pertussis

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Tetanus-diphtheria-acellular pertussis (Tdap) vaccine
Sponsored by
Sanofi Pasteur, a Sanofi Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Tetanus focused on measuring Tetanus,, Diphtheria,, Pertussis

Eligibility Criteria

15 Years - 69 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Previously received ADACEL vaccine as part of Aventis Pasteur studies Td501, Td502, or Td505. At least 15 but no greater than 69 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 woman, inability to become pregnant or 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 (ie, cardiac, renal, neurologic, metabolic, rheumatologic, psychiatric) 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-, diphtheria- or pertussis-containing vaccine since participation in Study Td501, Td502, or Td505. (Receipt of Menactra vaccine at any time prior to the present study is permitted, subject to the next exclusion criterion). Received any vaccine, other than influenza vaccine, in the 28-day period prior to enrollment or scheduled to receive any vaccine, other than influenza vaccine, in the 28-day period after enrollment. For influenza vaccine only, defer if received in the 14-day period prior to enrollment or scheduled to receive in the 14-day period after enrollment Administration of immune globulin or other blood products within the last three months, or injected or oral corticosteroids or other immunomodulator therapy 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. Suspected or known hypersensitivity to any of the vaccine components or to latex. Unable to attend the scheduled visits or to comply with the study procedures. In females of childbearing potential, a positive or equivocal urine pregnancy test at enrollment. Nursing mother. Participation in another interventional clinical trial in the 4 weeks preceding enrollment or planning to participate in another interventional clinical trial during the planned period of this study. Current abuse of alcohol or drug addiction that may interfere with the subject's ability to comply with trial visits or procedures. Thrombocytopenia or bleeding disorder contraindicating intramuscular (IM) vaccination. Subject deprived of freedom by an administrative or court order, or under the stress of an emergency setting, or hospitalized without his/her consent.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Adacel vaccine group

Arm Description

Participants 15 to 69 years of age who received a dose of Adacel vaccine in one of three previous studies (Td501, or Td502, or Td505), revaccinated in Study Td518.

Outcomes

Primary Outcome Measures

Percentage of Participants With at Least 1 Solicited Injection Site and Systemic Reactions Post-Vaccination
Solicited Injection Site Reactions: Pain, Erythema/Redness, Swelling. Solicited Systemic Reactions: Fever (Temperature), Headache, Myalgia, Malaise.

Secondary Outcome Measures

Full Information

First Posted
July 3, 2006
Last Updated
November 11, 2013
Sponsor
Sanofi Pasteur, a Sanofi Company
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1. Study Identification

Unique Protocol Identification Number
NCT00347958
Brief Title
Descriptive, Open-label, Multicenter Study of the Safety of Redosing With ADACEL® Vaccine
Official Title
Safety Among Adolescents and Adults of Revaccination With Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Adacel®) 4 to 5 Years After a Previous Dose
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
August 2006 (undefined)
Primary Completion Date
February 2008 (Actual)
Study Completion Date
October 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi Pasteur, a Sanofi Company

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Objectives: To provide safety data on revaccination with ADACEL® vaccine. To describe the immune response to tetanus, diphtheria, and pertussis antigens following revaccination with ADACEL® vaccine 4-5 years after first vaccination.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
545 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Adacel vaccine group
Arm Type
Experimental
Arm Description
Participants 15 to 69 years of age who received a dose of Adacel vaccine in one of three previous studies (Td501, or Td502, or Td505), revaccinated in Study Td518.
Intervention Type
Biological
Intervention Name(s)
Tetanus-diphtheria-acellular pertussis (Tdap) vaccine
Other Intervention Name(s)
Adacel®
Intervention Description
0.5mL, Intramuscular (IM)
Primary Outcome Measure Information:
Title
Percentage of Participants With at Least 1 Solicited Injection Site and Systemic Reactions Post-Vaccination
Description
Solicited Injection Site Reactions: Pain, Erythema/Redness, Swelling. Solicited Systemic Reactions: Fever (Temperature), Headache, Myalgia, Malaise.
Time Frame
0-14 days post-vaccination
Other Pre-specified Outcome Measures:
Title
Geometric Mean Titers (GMTs) of Tetanus and Diphtheria Antibodies Pre- and Post-Vaccination.
Description
Pre- and post-vaccination GMTs and their 95% confidence intervals for diphtheria were determined by toxin neutralization testing; the other antibody levels were determined by enzyme-linked immunosorbent assay testing.
Time Frame
Day 28 post-vaccination
Title
Geometric Mean Titers (GMTs) of Pertussis Antibodies Pre- and Post-Vaccination.
Description
Pre- and post-vaccination GMTs and their 95% confidence intervals for Pertussis were determined by enzyme-linked immunosorbent assay testing.
Time Frame
Day 28 post-vaccination
Title
Percentage of Participants With Tetanus and Diptheria Antibody Titers ≥ 0.1 Pre- and Post-Vaccination With Adacel®
Description
Seroprotection: Tetanus or diphtheria titer ≥ 0.1 after Adacel® vaccination. Tetanus titers determined by enzyme-linked immunosorbent assay; diphtheria titers determined by toxin neutralization assay.
Time Frame
Day 28 post-vaccination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Previously received ADACEL vaccine as part of Aventis Pasteur studies Td501, Td502, or Td505. At least 15 but no greater than 69 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 woman, inability to become pregnant or 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 (ie, cardiac, renal, neurologic, metabolic, rheumatologic, psychiatric) 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-, diphtheria- or pertussis-containing vaccine since participation in Study Td501, Td502, or Td505. (Receipt of Menactra vaccine at any time prior to the present study is permitted, subject to the next exclusion criterion). Received any vaccine, other than influenza vaccine, in the 28-day period prior to enrollment or scheduled to receive any vaccine, other than influenza vaccine, in the 28-day period after enrollment. For influenza vaccine only, defer if received in the 14-day period prior to enrollment or scheduled to receive in the 14-day period after enrollment Administration of immune globulin or other blood products within the last three months, or injected or oral corticosteroids or other immunomodulator therapy 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. Suspected or known hypersensitivity to any of the vaccine components or to latex. Unable to attend the scheduled visits or to comply with the study procedures. In females of childbearing potential, a positive or equivocal urine pregnancy test at enrollment. Nursing mother. Participation in another interventional clinical trial in the 4 weeks preceding enrollment or planning to participate in another interventional clinical trial during the planned period of this study. Current abuse of alcohol or drug addiction that may interfere with the subject's ability to comply with trial visits or procedures. Thrombocytopenia or bleeding disorder contraindicating intramuscular (IM) vaccination. Subject deprived of freedom by an administrative or court order, or under the stress of an emergency setting, or hospitalized without his/her consent.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Sanofi Pasteur, a Sanofi Company
Official's Role
Study Director
Facility Information:
City
Jonesboro
State/Province
Arkansas
ZIP/Postal Code
72401
Country
United States
City
Bossier City
State/Province
Louisiana
ZIP/Postal Code
71111
Country
United States
City
University Heights
State/Province
Ohio
ZIP/Postal Code
44118
Country
United States
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15241
Country
United States
City
Coquitlam
State/Province
British Columbia
ZIP/Postal Code
V3C 4J2
Country
Canada
City
Surrey
State/Province
British Columbia
ZIP/Postal Code
V3R-8P8
Country
Canada
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E 3P4
Country
Canada
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3K-6R8
Country
Canada
City
Beauport
State/Province
Quebec
ZIP/Postal Code
G1E 7G9
Country
Canada
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3H LP3
Country
Canada

12. IPD Sharing Statement

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

Learn more about this trial

Descriptive, Open-label, Multicenter Study of the Safety of Redosing With ADACEL® Vaccine

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