NCT01439165

Safety and Immunogenicity in Adults of Revaccination With Adacel® Vaccine 10 Years After a Previous Dose

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,330 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Accepted

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.

Detailed description

Healthy adults \< 65 years of age who received Adacel vaccine 10 years previously will be randomized to receive either Adacel or TENIVAC (Td Adsorbed) vaccine. They will be assessed for immunogenicity at baseline and post-vaccination. Safety data will be collected for 6 months following vaccination.

Conditions

• Tetanus
• Diphtheria
• Pertussis
• Whooping Cough

Interventions

Type	Name	Description
BIOLOGICAL	Tetanus Toxoid, Diphtheria Toxoid and Pertussis Vaccine	0.5 mL, Intramuscular
BIOLOGICAL	Tetanus and Diphtheria Toxoids Adsorbed For Adult Use	0.5 mL, Intramuscular

Timeline

• Start date: 2011-11-01
• Primary completion: 2015-12-01
• Completion: 2017-02-01
• First posted: 2011-09-23
• Last updated: 2022-04-28
• Results posted: 2017-10-09

Locations

33 sites across 2 countries: United States, Canada