The purpose of this study is to collect additional immunogenicity and safety data on re-dosing with Tdap vaccine (ADACEL®) in a continuing effort to address the public health need to establish broader population immunity against pertussis, as well as diphtheria and tetanus. Primary Objective: * To assess immune response to Tdap vaccine (ADACEL®) one month after booster vaccination.
This is an open-label, multicenter study to describe the immunological response and safety of repeat administration of an adolescent/adult-formulation tetanus-diphtheria-acellular pertussis Tdap vaccine (ADACEL®), 10 years following initial administration of Tdap vaccine.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
769
0.5 ml, IM
0.5 mL, IM
Unnamed facility
Coquitlam, British Columbia, Canada
Unnamed facility
Surrey, British Columbia, Canada
Unnamed facility
Vancouver, British Columbia, Canada
Unnamed facility
Halifax, Nova Scotia, Canada
Percentage of Participants With Seroprotection Against Tetanus and Diphtheria Before and After Revaccination With ADACEL® 10 Years After a Previous Dose
Diphtheria concentrations were determined by neutralization assay; tetanus concentrations were determined by enzyme-linked immunosorbent assay (ELISA). Seroprotection was defined as anti-tetanus or anti-diphtheria concentrations ≥ 0.1 IU/mL.
Time frame: Day 0 (pre-vaccination) and 30 post-vaccination
Anti-Pertussis Geometric Mean Concentrations Post-vaccination With ADACEL® 10 Years After a Previous Dose
Post-vaccination geometric mean concentrations (GMCs) for pertussis toxoid (PT), filamentous hemagglutinin (FHA), pertactin (PRN), and fimbriae types 2 and 3 (FIM), were determined by enzyme-linked immunosorbent assay (ELISA).
Time frame: Day 30 post-vaccination
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Unnamed facility
Pierrefonds, Quebec, Canada
Unnamed facility
Québec, Quebec, Canada
Unnamed facility
Sherbrooke, Quebec, Canada