Safety and Immunogenicity of GSK's Tdap Vaccine (Boostrix) in Adults Aged 19 to 64 Years
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ClinicalTrials.gov Identifier: NCT00346073 |
Recruitment Status :
Completed
First Posted : June 29, 2006
Results First Posted : August 7, 2018
Last Update Posted : August 7, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Acellular Pertussis Diphtheria Tetanus | Biological: Boostrix™ Biological: ADACEL® | Phase 3 |
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.
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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.
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Biological: ADACEL®
Sanofi Pasteur |
- 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).
- 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).
- 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).
- 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.
- 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).
- 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.
- 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).
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.

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

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
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 |
Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Study Data/Documents: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

For additional information about this study please refer to the GSK Clinical Study Register

For additional information about this study please refer to the GSK Clinical Study Register

For additional information about this study please refer to the GSK Clinical Study Register

For additional information about this study please refer to the GSK Clinical Study Register

For additional information about this study please refer to the GSK Clinical Study Register
Publications:
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. |
Prophylaxis for diphtheria, tetanus, pertussis Immunogenicity, booster, dTpa |
Whooping Cough Tetanus Diphtheria Bordetella Infections Gram-Negative Bacterial Infections Bacterial Infections Bacterial Infections and Mycoses |
Infections Respiratory Tract Infections Respiratory Tract Diseases Clostridium Infections Gram-Positive Bacterial Infections Corynebacterium Infections Actinomycetales Infections |