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
1 other identifier
interventional
2,337
1 country
42
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jul 2006
Shorter than P25 for phase_3
42 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 28, 2006
CompletedFirst Posted
Study publicly available on registry
June 29, 2006
CompletedStudy Start
First participant enrolled
July 13, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
March 7, 2007
CompletedResults Posted
Study results publicly available
August 7, 2018
CompletedAugust 7, 2018
February 1, 2018
8 months
June 28, 2006
January 30, 2017
February 2, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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 Outcomes (11)
Number of Seropositive Subjects With Anti-diphteria (Anti-D) Antibodies
At Month 1
Number of Subjects With Booster Responses for Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T)
At Month 1
Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations
At Month 1
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
During the 15-day period (Day 0-14) following vaccination
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
During the 15-day period (Day 0-14) following vaccination
- +6 more secondary outcomes
Study Arms (2)
Boostrix Group
EXPERIMENTALSubjects, 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.
Adacel Group
EXPERIMENTALSubjects, 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.
Interventions
Eligibility Criteria
You may qualify if:
- A healthy male or female, 19 to 64 years of age (not having reached the 65th birthday) at the time of study vaccination.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (42)
GSK Investigational Site
Huntsville, Alabama, 35802, United States
GSK Investigational Site
Chandler, Arizona, 85224, United States
GSK Investigational Site
Mesa, Arizona, 85203, United States
GSK Investigational Site
Mesa, Arizona, 85213, United States
GSK Investigational Site
Peoria, Arizona, 85381 - 4828, United States
GSK Investigational Site
Phoenix, Arizona, 85014, United States
GSK Investigational Site
Tempe, Arizona, 85283, United States
GSK Investigational Site
Little Rock, Arkansas, 72205, United States
GSK Investigational Site
San Diego, California, 92103-6204, United States
GSK Investigational Site
San Diego, California, 92108, United States
GSK Investigational Site
Colorado Springs, Colorado, 80909, United States
GSK Investigational Site
Pueblo, Colorado, 81001, United States
GSK Investigational Site
Washington D.C., District of Columbia, 20036, United States
GSK Investigational Site
Melbourne, Florida, 32901, United States
GSK Investigational Site
Miami, Florida, 33143, United States
GSK Investigational Site
Pembroke Pines, Florida, 33024, United States
GSK Investigational Site
Tampa, Florida, 33603, United States
GSK Investigational Site
Boise, Idaho, 83713, United States
GSK Investigational Site
Peoria, Illinois, 61602, United States
GSK Investigational Site
South Bend, Indiana, 46601, United States
GSK Investigational Site
Bardstown, Kentucky, 40004, United States
GSK Investigational Site
Richland, Michigan, 49083, United States
GSK Investigational Site
Kansas City, Missouri, 64114, United States
GSK Investigational Site
St Louis, Missouri, 63141, United States
GSK Investigational Site
Alliance, Nebraska, 69301, United States
GSK Investigational Site
North Platte, Nebraska, 69101, United States
GSK Investigational Site
Las Vegas, Nevada, 89104, United States
GSK Investigational Site
Albuquerque, New Mexico, 87108, United States
GSK Investigational Site
Hickory, North Carolina, 28601, United States
GSK Investigational Site
Raleigh, North Carolina, 27609, United States
GSK Investigational Site
Winston-Salem, North Carolina, 27103, United States
GSK Investigational Site
Bismarck, North Dakota, 58501, United States
GSK Investigational Site
Oklahoma City, Oklahoma, 73112, United States
GSK Investigational Site
Grove City, Pennsylvania, 16127, United States
GSK Investigational Site
Pittsburgh, Pennsylvania, 15241, United States
GSK Investigational Site
Bristol, Tennessee, 37620, United States
GSK Investigational Site
Knoxville, Tennessee, 37920, United States
GSK Investigational Site
Houston, Texas, 77024, United States
GSK Investigational Site
Salt Lake City, Utah, 84109, United States
GSK Investigational Site
Salt Lake City, Utah, 84121, United States
GSK Investigational Site
West Jordan, Utah, 84088, United States
GSK Investigational Site
Norfolk, Virginia, 23507, United States
Related Publications (1)
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.
PMID: 19041352BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 28, 2006
First Posted
June 29, 2006
Study Start
July 13, 2006
Primary Completion
March 1, 2007
Study Completion
March 7, 2007
Last Updated
August 7, 2018
Results First Posted
August 7, 2018
Record last verified: 2018-02
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.