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

Tetanus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00347958
• Other study ID #: TD518
• Status: Completed
• Phase: Phase 4
• First received: July 3, 2006
• Last updated: November 11, 2013
• Start date: August 2006
• Est. completion date: October 2008

Study information

• Verified date: November 2013
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 545
• Est. completion date: October 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 15 Years to 69 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diphtheria
• Pertussis
• Tetanus
• Whooping Cough

Intervention

Biological:
• Tetanus-diphtheria-acellular pertussis (Tdap) vaccine
0.5mL, Intramuscular (IM)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi Pasteur, a Sanofi Company

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Geometric Mean Titers (GMTs) of Tetanus and Diphtheria Antibodies Pre- and Post-Vaccination.	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.	Day 28 post-vaccination	No
Other	Geometric Mean Titers (GMTs) of Pertussis Antibodies Pre- and Post-Vaccination.	Pre- and post-vaccination GMTs and their 95% confidence intervals for Pertussis were determined by enzyme-linked immunosorbent assay testing.	Day 28 post-vaccination	No
Other	Percentage of Participants With Tetanus and Diptheria Antibody Titers = 0.1 Pre- and Post-Vaccination With Adacel®	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.	Day 28 post-vaccination	No
Primary	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.	0-14 days post-vaccination	No

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