Clinical Trial: Evaluation of Boostrix™10 Years After Previous Booster Vaccination

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Evaluation of GSK Biologicals' Boostrix™ in Healthy Adults, 10 Years After Previous Booster Vaccination

Brief Summary: The purpose of the study is to evaluate the immunogenicity, safety and reactogenicity of a dTpa (Boostrix™ vaccine) booster dose given 10 years after the previous vaccination with dTpa in GSK 263855/029 study. Only subjects who were part of the primary study will be invited to participate in this study.This protocol posting deals with objectives & outcome measures of the booster phase. The objectives & outcome measures of the primary phase are presented in a separate study (see reference).

Detailed Summary: All subjects will receive a booster dose of the vaccine that they received in their primary study. Subjects who received the investigational vaccine formulation, will receive Boostrix™ in the present study.
Sponsor: GlaxoSmithKline

Current Primary Outcome:

  • Number of Seroprotected Subjects Against Diphtheria and Tetanus [ Time Frame: At Year 8.5 ]
    A subject seroprotected against diphtheria/tetanus was defined as a vaccinated subject who had an anti-diphtheria (anti-D)/anti-tetanus (anti-T) antibody concentration greater than or above (≥) 0.1 international units per milliliter (IU/mL).
  • Concentrations for Anti-D and Anti-T Antibodies. [ Time Frame: At Year 8.5 ]
    Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was 0.1 IU/mL for all antibodies assessed.
  • Number of Seroprotected Subjects Against Diphtheria and Tetanus. [ Time Frame: At Year 10 ]
    A subject seroprotected against diphtheria/tetanus was defined as a vaccinated subject who had an anti-D/anti-T antibody concentration greater than or above (≥) 0.1 international units per milliliter (IU/mL).
  • Concentrations for Anti-D and Anti-T Antibodies. [ Time Frame: At Year 10 ]
    Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was 0.1 IU/mL.
  • Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-pertactin (Anti-PRN) and Anti-filamentous Haemagglutinin (Anti-FHA) Antibodies. [ Time Frame: At Year 8.5 ]
    A seropositive subject for anti-PT/anti-PRN/anti-FHA antibodies was defined as a vaccinated subject who had anti-PT/anti-PRN/anti-FHA antibody concentrations greater than or equal to (

    Original Primary Outcome:

    • Immunogenicity with respect to components of the study vaccines. [ Time Frame: One month after booster vaccination ]
    • Immune persistence with respect to components of the study vaccines [ Time Frame: Year 8.5 after the previous booster dose ]
    • Immune persistence with respect to components of the study vaccines [ Time Frame: Year 10 after the previous booster dose ]


    Current Secondary Outcome:

    • Number of Subjects With Any Solicited Local Symptoms. [ Time Frame: During the 4-day (Days 0-3) follow-up period after booster vaccination ]
      Assessed solicited local symptoms were pain, redness and swelling at the injection site. Any = incidence of a particular symptom regardless of intensity grade.
    • Number of Subjects With Any Solicited General Symptoms. [ Time Frame: During the 4-day (Days 0-3) follow-up period after booster vaccination ]
      Assessed solicited general symptoms were fatigue, gastrointestinal, headache and fever [defined as axillary temperature ≥ 37.5 degrees Celsius (°C)]. Any = incidence of a particular symptom regardless of intensity grade and relationship to vaccination.
    • Number of Subjects With Any Unsolicited Adverse Events (AEs). [ Time Frame: During the 31-day (Days 0-30) follow-up period after booster vaccination ]
      An unsolicited AE is any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) 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 unsolicited AE = any unsolicited AE regardless of intensity or relationship to vaccination.
    • Number of Subjects With Any Serious Adverse Events (SAEs). [ Time Frame: At Year 8.5 ]
      Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject..
    • Number of Subjects With Any Serious Adverse Events (SAEs). [ Time Frame: From Year 8.5 up to study end (one month post Year 10 booster vaccination) ]
      Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.


    Original Secondary Outcome:

    • Solicited local and general symptoms [ Time Frame: During the 4-day follow-up period after booster vaccination ]
    • Occurrence of Unsolicited adverse events [ Time Frame: During the 31-day follow-up period after booster vaccination ]
    • Occurrence of serious adverse events [ Time Frame: During the entire study period (From Day 0 up to Month 19) ]


    Information By: GlaxoSmithKline

    Dates:
    Date Received: May 20, 2010
    Date Started: June 2010
    Date Completion:
    Last Updated: September 29, 2016
    Last Verified: September 2016