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).
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
180
Intramuscular, single dose
Intramuscular, single dose
GSK Investigational Site
Brussels, Belgium
GSK Investigational Site
Leuven, Belgium
GSK Investigational Site
Wilrijk, Belgium
Number of Seroprotected Subjects Against Diphtheria and Tetanus
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).
Time frame: At Year 8.5
Concentrations for Anti-D and Anti-T Antibodies.
Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was 0.1 IU/mL for all antibodies assessed.
Time frame: At Year 8.5
Number of Seroprotected Subjects Against Diphtheria and Tetanus.
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).
Time frame: At Year 10
Concentrations for Anti-D and Anti-T Antibodies.
Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was 0.1 IU/mL.
Time frame: At Year 10
Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-pertactin (Anti-PRN) and Anti-filamentous Haemagglutinin (Anti-FHA) Antibodies.
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 (≥) 5 Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).
Time frame: At Year 8.5
Concentrations for Anti-PT, Anti-PRN and Anti-FHA Antibodies.
Concentrations were expressed as geometric mean concentrations (GMCs). The seropositivity cut-off of the assay was 5 EL.U/mL for all antibodies assessed.
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Time frame: At Year 8.5
Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN Antibodies.
A seropositive subject for anti-PT/anti-FHA/anti-PRN antibodies was defined as a vaccinated subject who had anti-PT/anti-FHA/anti-PRN antibody concentrations greater than or equal to (≥) 5 Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).
Time frame: At Year 10
Concentrations for Anti-PT, Anti-FHA and Anti-PRN Antibodies.
Concentrations were expressed as geometric mean concentrations (GMCs). The seropositivity cut-off of the assay was 5 EL.U/mL.
Time frame: At Year 10
Number of Seroprotected Subjects Against Diphtheria and Tetanus
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).
Time frame: At Year 10 pre booster vaccination (PRE) and at 1 month post Year 10 booster vaccination (POST)
Concentrations for Anti-D and Anti-T Antibodies.
Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was 0.1 IU/mL for all antibodies assessed.
Time frame: At Year 10 pre booster vaccination (PRE) and at 1 month post Year 10 booster vaccination (POST)
Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN Antibodies.
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 (≥) 5 ELISA units per milliliter (EL.U/mL).
Time frame: At Year 10 pre booster vaccination (PRE) and at 1 month post Year 10 booster vaccination (POST)
Concentrations for Anti-PT, Anti-FHA and Anti-PRN Antibodies.
Concentrations were expressed as geometric mean concentrations (GMCs). The seropositivity cut-off of the assay was 5 EL.U/mL.
Time frame: At Year 10 pre booster vaccination (PRE) and at 1 month post Year 10 booster vaccination (POST)
Number of Booster Responders to Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antigens.
A booster responder to PT/PRN antigens was defined as either a vaccinated subject seronegative at analysis baseline (Year 10) with anti-PT/anti-PRN antibody concentration greater than or equal to (≥) 5 EL.U/mL at one month post Year 10 booster vaccination, or as a vaccinated subject seropositive at analysis baseline (Year 10) and with anti-PT/anti-PRN antibody concentration with at least a 2-fold increase at one month post Year 10 booster vaccination. A seronegative/seropositive subject was defined as a vaccinated subject with anti-PT/anti-PRN antibody concentration ≥/\< 5 EL.U/mL.
Time frame: At 1 month post Year 10 booster vaccination
Number of Subjects With Any Solicited Local Symptoms.
Assessed solicited local symptoms were pain, redness and swelling at the injection site. Any = incidence of a particular symptom regardless of intensity grade.
Time frame: During the 4-day (Days 0-3) follow-up period after booster vaccination
Number of Subjects With Any Solicited General Symptoms.
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.
Time frame: During the 4-day (Days 0-3) follow-up period after booster vaccination
Number of Subjects With Any Unsolicited Adverse Events (AEs).
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.
Time frame: During the 31-day (Days 0-30) follow-up period after booster vaccination
Number of Subjects With Any 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, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject..
Time frame: At Year 8.5
Number of Subjects With Any 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, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
Time frame: From Year 8.5 up to study end (one month post Year 10 booster vaccination)