At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Safety and Immunogenicity in Adults of Revaccination With Adacel® Vaccine 10 Years After a Previous Dose
In Brief
A Phase 4 clinical trial evaluating Tetanus Toxoid, Diphtheria Toxoid and Pertussis Vaccine and Tetanus and Diphtheria Toxoids Adsorbed For Adult Use for Tetanus and 3 related conditions. Completed, enrolled 1,330 participants across 33 sites in 2 countries.
Detailed Summary
The purpose of this study is to describe the safety and immunogenicity of repeat administration of Adacel vaccine approximately 10 years following initial administration of the vaccine. Antibody levels prior to revaccination will also be used to characterize antibody persistence following initial vaccination 10 years earlier. Primary Objectives: * To compare seroprotection rates against tetanus and diphtheria induced by Adacel vaccine to those induced by Td Adsorbed vaccine. * To compare booster response rates against tetanus and diphtheria induced by Adacel vaccine to those induced by Td Adsorbed vaccine. * To compare anti-pertussis geometric mean antibody concentrations (GMCs) induced by Adacel vaccine to the GMCs induced by Daptacel® vaccine given to infants. Secondary Objectives: * To describe the rates of immediate reactions, solicited reactions, unsolicited adverse events (AEs), and serious adverse events (SAEs) following vaccination with Adacel or Td Adsorbed vaccine. * To describe booster response rates for pertussis antigens following revaccination with Adacel vaccine.
Study Details
Timeline
Interventions
0.5 mL, Intramuscular
0.5 mL, Intramuscular