Descriptive, Open-label, Multicenter Study of the Safety of Redosing With ADACEL® Vaccine
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00347958|
Recruitment Status : Completed
First Posted : July 4, 2006
Results First Posted : July 22, 2010
Last Update Posted : December 4, 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.
|Condition or disease||Intervention/treatment||Phase|
|Tetanus Diphtheria Pertussis||Biological: Tetanus-diphtheria-acellular pertussis (Tdap) vaccine||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||545 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||August 2006|
|Actual Primary Completion Date :||February 2008|
|Actual Study Completion Date :||October 2008|
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®
- Percentage of Participants With at Least 1 Solicited Injection Site and Systemic Reactions Post-Vaccination [ Time Frame: 0-14 days post-vaccination ]Solicited Injection Site Reactions: Pain, Erythema/Redness, Swelling. Solicited Systemic Reactions: Fever (Temperature), Headache, Myalgia, Malaise.
- Geometric Mean Titers (GMTs) of Tetanus and Diphtheria Antibodies Pre- and Post-Vaccination. [ Time Frame: Day 28 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.
- Geometric Mean Titers (GMTs) of Pertussis Antibodies Pre- and Post-Vaccination. [ Time Frame: Day 28 post-vaccination ]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 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00347958
|United States, Arkansas|
|Jonesboro, Arkansas, United States, 72401|
|United States, Louisiana|
|Bossier City, Louisiana, United States, 71111|
|United States, Ohio|
|University Heights, Ohio, United States, 44118|
|United States, Pennsylvania|
|Pittsburgh, Pennsylvania, United States, 15241|
|Canada, British Columbia|
|Coquitlam, British Columbia, Canada, V3C 4J2|
|Surrey, British Columbia, Canada, V3R-8P8|
|Winnipeg, Manitoba, Canada, R3E 3P4|
|Canada, Nova Scotia|
|Halifax, Nova Scotia, Canada, B3K-6R8|
|Beauport, Quebec, Canada, G1E 7G9|
|Montreal, Quebec, Canada, H3H LP3|
|Study Director:||Clinical Trials||Sanofi Pasteur, a Sanofi Company|