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

Browse trials for

• Whooping Cough 238
• Tetanus 198
• Diphtheria 265

Keywords

• Prophylaxis for diphtheria, tetanus, pertussis
• Immunogenicity, booster, dTpa

Whooping Cough

238 studies on the registry are indexed under Whooping Cough; 15 are open to participants now.

This study's enrollment of 2,337 is above the median of 375 across 180 interventional studies indexed under Whooping Cough.

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.

Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.

Study arms

• 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™

• 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®

Interventions

• BiologicalBoostrix™

  Combined Reduced Antigen Content Diphtheria, Tetanus, Acellular Pertussis Vaccine

• BiologicalADACEL®

  Sanofi Pasteur

Primary outcomes

1. 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).

   Time frame: At Month 1

2. 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).

   Time frame: At Month 1

3. 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).

   Time frame: At Month 1

4. 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.

   Time frame: At Month 1

Secondary outcomes

1. 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).

   Time frame: At Month 1

2. 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.

   Time frame: At Month 1

3. 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).

   Time frame: At Month 1

4. 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.

   Time frame: During the 15-day period (Day 0-14) following vaccination

5. 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.

   Time frame: During the 15-day period (Day 0-14) following vaccination

6. 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.

   Time frame: During the 31-day period (Days 0-30) following vaccination

7. 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.

   Time frame: During the active phase of the study (Day 0 - Day 30)

8. 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.

   Time frame: During the extended safety follow-up (ESFU) phase (Day 31 - Month 6)

9. 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.

   Time frame: During the extended safety follow-up (ESFU) period (from Day 31 to Month 6)

10. Number of Subjects Reporting Emergency Room Visits

    Emergency room visits refer to AEs requiring immediate medical attention.

    Time frame: During the extended safety follow-up (ESFU) period (from Day 31 to Month 6)

11. Number of Subjects Reporting the Onset of New Chronic Illnesses

    New onset chronic illnesses include diabetes, asthma, allergies, autoimmune diseases.

    Time frame: During the extended safety follow-up (ESFU) period (from Day 31 to Month 6)

Baseline characteristics

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. PubMed 19041352 ↗

Related 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. ↗

Individual participant data

Plan to share: Yes — Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.