Safety and Immunogenicity of GSK's Tdap Vaccine (Boostrix) in Adults Aged 19 to 64 Years

A Study to Evaluate Immunogenicity and Safety of Boostrix Compared to Adacel When Administered as a Booster Vaccination in Adults Aged 19 to 64 Years of Age

GSK Biologicals' dTpa vaccine has recently been approved by the US Food and Drug Administration (FDA) for booster vaccination of adolescents aged 10 to 18 years. The ACIP has recently issued provisional recommendations for universal adult Tdap vaccination. The current study will provide pivotal data in support of extending the age range for Boostrix vaccine to include adults 19-64 years of age.

Study Overview

• Status: Completed
• Conditions: Tetanus; Diphtheria; Acellular Pertussis
• Intervention / Treatment: Biological: Boostrix™; Biological: ADACEL®

• Study Type: Interventional
• Enrollment (Actual): 2337
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Huntsville, Alabama, United States, 35802
      • GSK Investigational Site
  • Arizona
    • Chandler, Arizona, United States, 85224
      • GSK Investigational Site
    • Mesa, Arizona, United States, 85213
      • GSK Investigational Site
    • Mesa, Arizona, United States, 85203
      • GSK Investigational Site
    • Peoria, Arizona, United States, 85381 - 4828
      • GSK Investigational Site
    • Phoenix, Arizona, United States, 85014
      • GSK Investigational Site
    • Tempe, Arizona, United States, 85283
      • GSK Investigational Site
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • GSK Investigational Site
  • California
    • San Diego, California, United States, 92103-6204
      • GSK Investigational Site
    • San Diego, California, United States, 92108
      • GSK Investigational Site
  • Colorado
    • Colorado Springs, Colorado, United States, 80909
      • GSK Investigational Site
    • Pueblo, Colorado, United States, 81001
      • GSK Investigational Site
  • District of Columbia
    • Washington, District of Columbia, United States, 20036
      • GSK Investigational Site
  • Florida
    • Melbourne, Florida, United States, 32901
      • GSK Investigational Site
    • Miami, Florida, United States, 33143
      • GSK Investigational Site
    • Pembroke Pines, Florida, United States, 33024
      • GSK Investigational Site
    • Tampa, Florida, United States, 33603
      • GSK Investigational Site
  • Idaho
    • Boise, Idaho, United States, 83713
      • GSK Investigational Site
  • Illinois
    • Peoria, Illinois, United States, 61602
      • GSK Investigational Site
  • Indiana
    • South Bend, Indiana, United States, 46601
      • GSK Investigational Site
  • Kentucky
    • Bardstown, Kentucky, United States, 40004
      • GSK Investigational Site
  • Michigan
    • Richland, Michigan, United States, 49083
      • GSK Investigational Site
  • Missouri
    • Kansas City, Missouri, United States, 64114
      • GSK Investigational Site
    • Saint Louis, Missouri, United States, 63141
      • GSK Investigational Site
  • Nebraska
    • Alliance, Nebraska, United States, 69301
      • GSK Investigational Site
    • North Platte, Nebraska, United States, 69101
      • GSK Investigational Site
  • Nevada
    • Las Vegas, Nevada, United States, 89104
      • GSK Investigational Site
  • New Mexico
    • Albuquerque, New Mexico, United States, 87108
      • GSK Investigational Site
  • North Carolina
    • Hickory, North Carolina, United States, 28601
      • GSK Investigational Site
    • Raleigh, North Carolina, United States, 27609
      • GSK Investigational Site
    • Winston-Salem, North Carolina, United States, 27103
      • GSK Investigational Site
  • North Dakota
    • Bismarck, North Dakota, United States, 58501
      • GSK Investigational Site
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73112
      • GSK Investigational Site
  • Pennsylvania
    • Grove City, Pennsylvania, United States, 16127
      • GSK Investigational Site
    • Pittsburgh, Pennsylvania, United States, 15241
      • GSK Investigational Site
  • Tennessee
    • Bristol, Tennessee, United States, 37620
      • GSK Investigational Site
    • Knoxville, Tennessee, United States, 37920
      • GSK Investigational Site
  • Texas
    • Houston, Texas, United States, 77024
      • GSK Investigational Site
  • Utah
    • Salt Lake City, Utah, United States, 84109
      • GSK Investigational Site
    • Salt Lake City, Utah, United States, 84121
      • GSK Investigational Site
    • West Jordan, Utah, United States, 84088
      • GSK Investigational Site
  • Virginia
    • Norfolk, Virginia, United States, 23507
      • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 64 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• A healthy male or female, 19 to 64 years of age (not having reached the 65th birthday) at the time of study vaccination.

Exclusion Criteria:

• Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding administration of study vaccine, or planned use during the active phase of the study.
• Chronic administration of immunosuppressants or within six months prior to administration of study vaccine.
• Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days of administration of study vaccine (with the exception of an influenza vaccine).
• Administration of a diphtheria-tetanus (Td) booster within previous five years.
• Administration of Tdap vaccine at any time prior to study entry. History of serious allergic reaction (e.g. anaphylaxis) following any other tetanus toxoid, diphtheria toxoid or pertussis-containing vaccine or any component of the study vaccines.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Boostrix Group; Subjects, male or female, between, and including, 19 and 64 years of age received a single dose of Boostrix® vaccine administered intramuscularly in the deltoid region of the non-dominant upper arm at Day 0.	Biological: Boostrix™; Combined Reduced Antigen Content Diphtheria, Tetanus, Acellular Pertussis Vaccine
EXPERIMENTAL: Adacel Group; Subjects, male or female, between, and including, 19 and 64 years of age received a single dose of Adacel™ vaccine administered intramuscularly in the deltoid region of the non-dominant upper arm at Day 0.	Biological: ADACEL®; Sanofi Pasteur

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Seroprotected Subjects With Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibodies	A seroprotected subject is defined as a vaccinated subject with anti-D and anti-T antibody concentration greater than or equal to ( ≥) 0.1 international units per milliliter (IU/mL).	At Month 1
Number of Seropositive Subjects With Anti-tetanus (Anti-T) Antibodies	A seropositive subject was a subject whose antibody concentration was greater than or equal to the cut-off value. Cut-off values assessed were greater than or equal to 1.0 international units per milliliter (IU/mL).	At Month 1
Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations	Concentrations are presented as geometric mean concentrations (GMCs) and expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).	At Month 1
Number of Subjects With Booster Responses for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibodies	Booster responses for anti-PT, anti-FHA and anti-PRN antibodies were defined as: for initially seronegative subjects (pre-vaccination concentration below cut-off: smaller than (<) 5 EU/mL): antibody concentrations at least four times the cut-off (post-vaccination concentration greater than or equal to (≥) 20 EU/mL), one month after vaccination; for initially seropositive subjects with pre-vaccination concentration ≥ 5 EU/mL and < 20 EU/mL: an increase in antibody concentrations of at least four times the pre-vaccination concentration one month after vaccination; and for initially seropositive subjects with pre-vaccination concentration ≥ 20 EU/mL: an increase in antibody concentrations of at least two times the pre-vaccination concentration, one month after vaccination.	At Month 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Seropositive Subjects With Anti-diphteria (Anti-D) Antibodies	A seropositive subject was a subject whose antibody concentration was greater than or equal to the cut-off value. Cut-off values assessed were greater than or equal to (≥) 1.0 international units per milliliter (IU/mL).	At Month 1
Number of Subjects With Booster Responses for Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T)	Booster responses for anti-D and anti-T antibodies were defined as: for initially seronegative subjects (pre-vaccination concentration below cut-off: smaller than (<) 0.1 IU/mL): antibody concentrations at least four times the cut-off (post-vaccination concentration greater than or equal to (≥ 0.4 IU/mL), one month after vaccination; and for initially seropositive subjects (pre-vaccination concentration ≥ 0.1 IU/mL): an increase in antibody concentrations of at least four times the pre-vaccination concentration one month after vaccination.	At Month 1
Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations	Concentrations are presented as geometric mean concentrations (GMCs), expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).	At Month 1
Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site.	During the 15-day period (Day 0-14) following vaccination
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Assessed solicited general symptoms were fatigue, fever [defined as temperature measured orally, greater than or equal to (≥) 37.5 degrees Celsius (°C)], gastrointestinal symptoms [gastro sympt.] and headache. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.	During the 15-day period (Day 0-14) following vaccination
Number of Subjects With Any Unsolicited Adverse Events (AEs)	An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.	During the 31-day period (Days 0-30) following vaccination
Number of Subjects With Serious Adverse Events (SAEs).	Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.	During the active phase of the study (Day 0 - Day 30)
Number of Subjects With Serious Adverse Events (SAEs)	Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.	During the extended safety follow-up (ESFU) phase (Day 31 - Month 6)
Number of Subjects Reporting Hospitalizations	Hospitalization signified that the subject had been detained (usually involving at least an overnight stay) at the hospital or emergency ward for observation and/or treatment that would not have been appropriate in the physician's office or out patient setting.	During the extended safety follow-up (ESFU) period (from Day 31 to Month 6)
Number of Subjects Reporting Emergency Room Visits	Emergency room visits refer to AEs requiring immediate medical attention.	During the extended safety follow-up (ESFU) period (from Day 31 to Month 6)
Number of Subjects Reporting the Onset of New Chronic Illnesses	New onset chronic illnesses include diabetes, asthma, allergies, autoimmune diseases.	During the extended safety follow-up (ESFU) period (from Day 31 to Month 6)

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Publications and helpful links

General Publications

• Blatter M, Friedland LR, Weston WM, Li P, Howe B. Immunogenicity and safety of a tetanus toxoid, reduced diphtheria toxoid and three-component acellular pertussis vaccine in adults 19-64 years of age. Vaccine. 2009 Jan 29;27(5):765-72. doi: 10.1016/j.vaccine.2008.11.028. Epub 2008 Nov 27.

Helpful Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 13, 2006
• Primary Completion (ACTUAL): March 1, 2007
• Study Completion (ACTUAL): March 7, 2007

Study Registration Dates

• First Submitted: June 28, 2006
• First Submitted That Met QC Criteria: June 28, 2006
• First Posted (ESTIMATE): June 29, 2006

Study Record Updates

• Last Update Posted (ACTUAL): August 7, 2018
• Last Update Submitted That Met QC Criteria: February 2, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: Prophylaxis for diphtheria, tetanus, pertussis; Immunogenicity, booster, dTpa
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Bordetella Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Actinomycetales Infections; Clostridium Infections; Corynebacterium Infections; Whooping Cough; Tetanus; Diphtheria
• Other Study ID Numbers: 106316

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Study Data/Documents

1. Study Protocol
   Information identifier: 106316
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
2. Statistical Analysis Plan
   Information identifier: 106316
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
3. Individual Participant Data Set
   Information identifier: 106316
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
4. Dataset Specification
   Information identifier: 106316
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
5. Clinical Study Report
   Information identifier: 106316
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
6. Informed Consent Form
   Information identifier: 106316
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register