Immune Responses in Adults to Revaccination With ADACEL® 10 Years After a Previous Dose

Phase 4

Completed

• Conditions: Pertussis; Tetanus; Diphtheria
• Interventions: Biological: Tetanus, Reduced Diphtheria Toxoid and Acellular Pertussis (ADACEL®)

• Registration Number: NCT00712959
• Lead Sponsor: Sanofi Pasteur, a Sanofi Company

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2008-06
• Study First Submitted: 2008-07-07
• Study First Submitted QC: 2008-07-09
• Study First Posted: 2008-07-10
• Primary Completion: 2009-09
• Study Completion: 2009-12
• Disposition First Submitted: 2011-03-01
• Disposition First Submitted QC: 2011-03-01
• Disposition First Posted: 2011-03-16
• Results First Submitted: 2014-02-18
• Status Verified: 2014-04
• Results First Submitted QC: 2014-04-01
• Last Update Submitted: 2014-04-01
• Results First Posted: 2014-04-30
• Last Update Posted: 2014-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 769

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1: Previous Tdap or Tdap-IPV Recipients	Tetanus, Reduced Diphtheria Toxoid and Acellular Pertussis (ADACEL®)	Participants received Tdap or Tdap-Inactivated Poliomyelitis Vaccine (IPV) in a previous study (TD9707 or TD9805)
Group 2: Tdap vaccine-naïve	Tetanus, Reduced Diphtheria Toxoid and Acellular Pertussis (ADACEL®)	Participants are age-balanced Tdap vaccine-naïve and will receive Tdap vaccine in the study at least 10 years after a previous tetanus, diphtheria and/or pertussis dose.

Primary Outcome Measures

Name	Time	Method
Anti-Pertussis Geometric Mean Concentrations Post-vaccination With ADACEL® 10 Years After a Previous Dose	Day 30 post-vaccination	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).
Percentage of Participants With Seroprotection Against Tetanus and Diphtheria Before and After Revaccination With ADACEL® 10 Years After a Previous Dose	Day 0 (pre-vaccination) and 30 post-vaccination	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.