Descriptive, Open-label, Multicenter Study of the Safety of Redosing With ADACEL® Vaccine
This study has been completed.
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
First received: July 3, 2006
Last updated: November 11, 2013
Last verified: November 2013
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.
Biological: Tetanus-diphtheria-acellular pertussis (Tdap) vaccine
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
||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
Primary Outcome Measures:
- Percentage of Participants With at Least 1 Solicited Injection Site and Systemic Reactions Post-Vaccination [ Time Frame: 0-14 days post-vaccination ] [ Designated as safety issue: No ]
Solicited Injection Site Reactions: Pain, Erythema/Redness, Swelling. Solicited Systemic Reactions: Fever (Temperature), Headache, Myalgia, Malaise.
Other Outcome Measures:
- Geometric Mean Titers (GMTs) of Tetanus and Diphtheria Antibodies Pre- and Post-Vaccination. [ Time Frame: Day 28 post-vaccination ] [ Designated as safety issue: No ]
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.
- Geometric Mean Titers (GMTs) of Pertussis Antibodies Pre- and Post-Vaccination. [ Time Frame: Day 28 post-vaccination ] [ Designated as safety issue: No ]
Pre- and post-vaccination GMTs and their 95% confidence intervals for Pertussis were determined by enzyme-linked immunosorbent assay testing.
- Percentage of Participants With Tetanus and Diptheria Antibody Titers ≥ 0.1 Pre- and Post-Vaccination With Adacel® [ Time Frame: Day 28 post-vaccination ] [ Designated as safety issue: No ]
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.
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||February 2008 (Final data collection date for primary outcome measure)
Experimental: Adacel vaccine group
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.
Biological: Tetanus-diphtheria-acellular pertussis (Tdap) vaccine
0.5mL, Intramuscular (IM)
Other Name: Adacel®
|Ages Eligible for Study:
||15 Years to 69 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00347958
|Jonesboro, Arkansas, United States, 72401 |
|Bossier City, Louisiana, United States, 71111 |
|University Heights, Ohio, United States, 44118 |
|Pittsburgh, Pennsylvania, United States, 15241 |
|Coquitlam, British Columbia, Canada, V3C 4J2 |
|Surrey, British Columbia, Canada, V3R-8P8 |
|Winnipeg, Manitoba, Canada, R3E 3P4 |
|Halifax, Nova Scotia, Canada, B3K-6R8 |
|Beauport, Quebec, Canada, G1E 7G9 |
|Montreal, Quebec, Canada, H3H LP3 |
Sanofi Pasteur, a Sanofi Company
||Sanofi Pasteur, a Sanofi Company
No publications provided
||Sanofi ( Sanofi Pasteur, a Sanofi Company )
History of Changes
|Other Study ID Numbers:
|Study First Received:
||July 3, 2006
|Results First Received:
||May 14, 2010
||November 11, 2013
||United States: Food and Drug Administration
Canada: Health Canada
Keywords provided by Sanofi:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on December 11, 2013
Gram-Positive Bacterial Infections
Gram-Negative Bacterial Infections
Respiratory Tract Infections
Respiratory Tract Diseases
Nervous System Diseases
Calcium Metabolism Disorders
Signs and Symptoms