Evaluation of Boostrix™10 Years After Previous Booster Vaccination

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)

Population: Analysis was done on the According-to-Protocol for immunogenicity at Year 10, which included all evaluable subjects who had received the booster dose of Boostrix™ vaccine, any formulation (at least 9.5 years after the dose administered in GSK263855/029 study) and for whom data concerning immunogenicity outcome measures were available.

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

Population: The analysis was performed on the According To Protocol cohort for persistence at Year 10, which included all subjects who had received no additional dose of diphtheria, tetanus or pertussis vaccine other than the Boostrix™ booster dose received in the GSK263855/029 study, and for whom serological results were available at Year 10.

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

Population: The analysis was performed on the According To Protocol cohort for persistence at Year 8.5 , which included all subjects who had received no additional dose of diphtheria, tetanus or pertussis vaccine other than the Boostrix™ booster dose received in the GSK263855/029 study, and for whom serological results were available at Year 8.5.

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

Population: The analysis was performed on the According To Protocol cohort for persistence at Year 10, which included all subjects who had received no additional dose of diphtheria, tetanus or pertussis vaccine other than the Boostrix™ booster dose received in the GSK263855/029 study, and for whom serological results were available at Year 10.

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)

Population: Analysis was done on the According-to-Protocol for immunogenicity at Year 10, which included all evaluable subjects who had received the booster dose of Boostrix™ vaccine, any formulation (at least 9.5 years after the dose administered in GSK263855/029 study) and for whom data concerning immunogenicity outcome measures were available.

Concentrations were expressed as geometric mean concentrations (GMCs). The seropositivity cut-off of the assay was 5 EL.U/mL for all antibodies assessed.

Time frame: At Year 8.5

Population: The analysis was performed on the According To Protocol cohort for persistence at Year 8.5 , which included all subjects who had received no additional dose of diphtheria, tetanus or pertussis vaccine other than the Boostrix™ booster dose received in the GSK263855/029 study, and for whom serological results were available at Year 8.5.

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

Population: Analysis was done on the According-to-Protocol for immunogenicity at Year 10, which included all evaluable subjects who had received the booster dose of Boostrix™ vaccine, any formulation (at least 9.5 years after the dose administered in GSK263855/029 study) and for whom data concerning immunogenicity outcome measures were available.

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

Population: The analysis was performed on the According To Protocol cohort for persistence at Year 8.5 , which included all subjects who had received no additional dose of diphtheria, tetanus or pertussis vaccine other than the Boostrix™ booster dose received in the GSK263855/029 study, and for whom serological results were available at Year 8.5.

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

Population: The analysis was performed on the According To Protocol cohort for persistence at Year 10, which included all subjects who had received no additional dose of diphtheria, tetanus or pertussis vaccine other than the Boostrix™ booster dose received in the GSK263855/029 study, and for whom serological results were available at Year 10.

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)

Population: Analysis was done on the According-to-Protocol for immunogenicity at Year 10, which included all evaluable subjects who had received the booster dose of Boostrix™ vaccine, any formulation (at least 9.5 years after the dose administered in GSK263855/029 study) and for whom data concerning immunogenicity outcome measures were available.

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

Population: The analysis was performed on the According To Protocol cohort for persistence at Year 8.5, which included all subjects who had received no additional dose of diphtheria, tetanus or pertussis vaccine other than the Boostrix™ booster dose received in the GSK263855/029 study, and for whom serological results were available at Year 8.5.

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)

Population: Analysis was done on the According-to-Protocol for immunogenicity at Year 10, which included all evaluable subjects who had received the booster dose of Boostrix™ vaccine, any formulation (at least 9.5 years after the dose administered in GSK263855/029 study) and for whom data concerning immunogenicity outcome measures were available.

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

Population: The analysis was performed on the According To Protocol cohort for persistence at Year 10, which included all subjects who had received no additional dose of diphtheria, tetanus or pertussis vaccine other than the Boostrix™ booster dose received in the GSK263855/029 study, and for whom serological results were available at Year 10.

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

Population: Analysis was performed on the Total Vaccinated cohort, which included all subjects with documented administration of Boostrix™ vaccine, any formulation, for whom data were available.

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)

Population: Analysis was performed on the Total Vaccinated cohort, which included all subjects with documented administration of Boostrix™ vaccine, any formulation, for whom data were available.

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

Population: Analysis was performed on the Total Vaccinated cohort, which included all subjects with documented administration of Boostrix™ vaccine, any formulation, for whom data were available.

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

Population: Analysis was performed on the Total Vaccinated cohort, which included all subjects with documented administration of Boostrix™ vaccine, any formulation, for whom data were available.

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

Population: Analysis was performed on the Total Vaccinated cohort, which included all subjects with documented administration of Boostrix™ vaccine, any formulation, for whom data were available.