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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00346073
Recruitment Status : Completed
First Posted : June 29, 2006
Results First Posted : August 7, 2018
Last Update Posted : August 7, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

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.

Condition or disease Intervention/treatment Phase
Acellular Pertussis Diphtheria Tetanus Biological: Boostrix™ Biological: ADACEL® Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2337 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: 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
Actual Study Start Date : July 13, 2006
Actual Primary Completion Date : March 1, 2007
Actual Study Completion Date : March 7, 2007


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




Primary Outcome Measures :
  1. Number of Seroprotected Subjects With Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibodies [ Time Frame: At Month 1 ]
    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).

  2. Number of Seropositive Subjects With Anti-tetanus (Anti-T) Antibodies [ Time Frame: At Month 1 ]
    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).

  3. Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations [ Time Frame: At Month 1 ]
    Concentrations are presented as geometric mean concentrations (GMCs) and expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).

  4. Number of Subjects With Booster Responses for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibodies [ Time Frame: At Month 1 ]
    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.


Secondary Outcome Measures :
  1. Number of Seropositive Subjects With Anti-diphteria (Anti-D) Antibodies [ Time Frame: At Month 1 ]
    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).

  2. Number of Subjects With Booster Responses for Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) [ Time Frame: At Month 1 ]
    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.

  3. Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations [ Time Frame: At Month 1 ]
    Concentrations are presented as geometric mean concentrations (GMCs), expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).

  4. Number of Subjects With Any and Grade 3 Solicited Local Symptoms [ Time Frame: During the 15-day period (Day 0-14) following vaccination ]
    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.

  5. Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms [ Time Frame: During the 15-day period (Day 0-14) following vaccination ]
    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.

  6. Number of Subjects With Any Unsolicited Adverse Events (AEs) [ Time Frame: During the 31-day period (Days 0-30) following vaccination ]
    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.

  7. Number of Subjects With Serious Adverse Events (SAEs). [ Time Frame: During the active phase of the study (Day 0 - Day 30) ]
    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.

  8. Number of Subjects With Serious Adverse Events (SAEs) [ Time Frame: During the extended safety follow-up (ESFU) phase (Day 31 - Month 6) ]
    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.

  9. Number of Subjects Reporting Hospitalizations [ Time Frame: During the extended safety follow-up (ESFU) period (from Day 31 to Month 6) ]
    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.

  10. Number of Subjects Reporting Emergency Room Visits [ Time Frame: During the extended safety follow-up (ESFU) period (from Day 31 to Month 6) ]
    Emergency room visits refer to AEs requiring immediate medical attention.

  11. Number of Subjects Reporting the Onset of New Chronic Illnesses [ Time Frame: During the extended safety follow-up (ESFU) period (from Day 31 to Month 6) ]
    New onset chronic illnesses include diabetes, asthma, allergies, autoimmune diseases.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   19 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00346073


Locations
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United States, Alabama
GSK Investigational Site
Huntsville, Alabama, United States, 35802
United States, Arizona
GSK Investigational Site
Chandler, Arizona, United States, 85224
GSK Investigational Site
Mesa, Arizona, United States, 85203
GSK Investigational Site
Mesa, Arizona, United States, 85213
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
United States, Arkansas
GSK Investigational Site
Little Rock, Arkansas, United States, 72205
United States, California
GSK Investigational Site
San Diego, California, United States, 92103-6204
GSK Investigational Site
San Diego, California, United States, 92108
United States, Colorado
GSK Investigational Site
Colorado Springs, Colorado, United States, 80909
GSK Investigational Site
Pueblo, Colorado, United States, 81001
United States, District of Columbia
GSK Investigational Site
Washington, District of Columbia, United States, 20036
United States, Florida
GSK Investigational Site
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
United States, Idaho
GSK Investigational Site
Boise, Idaho, United States, 83713
United States, Illinois
GSK Investigational Site
Peoria, Illinois, United States, 61602
United States, Indiana
GSK Investigational Site
South Bend, Indiana, United States, 46601
United States, Kentucky
GSK Investigational Site
Bardstown, Kentucky, United States, 40004
United States, Michigan
GSK Investigational Site
Richland, Michigan, United States, 49083
United States, Missouri
GSK Investigational Site
Kansas City, Missouri, United States, 64114
GSK Investigational Site
Saint Louis, Missouri, United States, 63141
United States, Nebraska
GSK Investigational Site
Alliance, Nebraska, United States, 69301
GSK Investigational Site
North Platte, Nebraska, United States, 69101
United States, Nevada
GSK Investigational Site
Las Vegas, Nevada, United States, 89104
United States, New Mexico
GSK Investigational Site
Albuquerque, New Mexico, United States, 87108
United States, North Carolina
GSK Investigational Site
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
United States, North Dakota
GSK Investigational Site
Bismarck, North Dakota, United States, 58501
United States, Oklahoma
GSK Investigational Site
Oklahoma City, Oklahoma, United States, 73112
United States, Pennsylvania
GSK Investigational Site
Grove City, Pennsylvania, United States, 16127
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15241
United States, Tennessee
GSK Investigational Site
Bristol, Tennessee, United States, 37620
GSK Investigational Site
Knoxville, Tennessee, United States, 37920
United States, Texas
GSK Investigational Site
Houston, Texas, United States, 77024
United States, Utah
GSK Investigational Site
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
United States, Virginia
GSK Investigational Site
Norfolk, Virginia, United States, 23507
Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline
Additional Information:
Study Data/Documents: Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 106316
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: 106316
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: 106316
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 106316
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: 106316
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: 106316
For additional information about this study please refer to the GSK Clinical Study Register

Publications:
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00346073    
Other Study ID Numbers: 106316
First Posted: June 29, 2006    Key Record Dates
Results First Posted: August 7, 2018
Last Update Posted: August 7, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Keywords provided by GlaxoSmithKline:
Prophylaxis for diphtheria, tetanus, pertussis
Immunogenicity, booster, dTpa
Additional relevant MeSH terms:
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Whooping Cough
Tetanus
Diphtheria
Bordetella Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Respiratory Tract Infections
Infection
Respiratory Tract Diseases
Clostridium Infections
Gram-Positive Bacterial Infections
Corynebacterium Infections
Actinomycetales Infections