| Primary | Number of Subjects With Anti-diphtheria (Anti-D) Antibody Concentrations Greater Than or Equal to (≥) Protocol Specified Cut-off | Anti-D cut-off was defined as ≥ 0.1 International Units per milliliter (IU/mL) determined with Enzyme-linked Immunosorbent Assay (ELISA) | The analysis was performed on the Adapted ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and for whom data concerning immunogenicity endpoint measures obtained from the ATP cohort for immunogenicity corresponding to each time point were available. | Posted | | Count of Participants | | Participants | | At year 1 after the vaccination in primary study (NCT00346073) | | | | ID | Title | Description |
|---|
| OG000 | Boostrix Group | Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine [Tdap](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a second dose of Boostrix vaccine [Tdap](GSK776423). | | OG001 | Adacel Group | Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a dose of Boostrix vaccine [Tdap](GSK776423). |
| | | Title | Denominators | Categories |
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| Primary | Number of Subjects With Anti-D Antibody Concentrations ≥ Protocol Specified Cut-off | Anti-D cut-off was defined as ≥ 0.1 IU/mL as assessed by ELISA | The analysis was performed on the Adapted ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and for whom data concerning immunogenicity endpoint measures obtained from the ATP cohort for immunogenicity corresponding to each time point were available. | Posted | | Count of Participants | | Participants | | At year 3 after the vaccination in primary study (NCT00346073) | | | | ID | Title | Description |
|---|
| OG000 | Boostrix Group | Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine [Tdap](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a second dose of Boostrix vaccine [Tdap](GSK776423). | | OG001 | Adacel Group | Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a dose of Boostrix vaccine [Tdap](GSK776423). |
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| Primary | Number of Subjects With Anti-D Antibody Concentrations ≥ Protocol Specified Cut-off | Anti-D cut-off was defined as ≥ 0.1IU/mL as assessed by ELISA. | The analysis was performed on the Adapted ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and for whom data concerning immunogenicity endpoint measures obtained from the ATP cohort for immunogenicity corresponding to each time point were available. | Posted | | Count of Participants | | Participants | | At year 5 after the vaccination in primary study (NCT00346073) | | | | ID | Title | Description |
|---|
| OG000 | Boostrix Group | Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine [Tdap](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a second dose of Boostrix vaccine [Tdap](GSK776423). | | OG001 | Adacel Group | Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a dose of Boostrix vaccine [Tdap](GSK776423). |
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| Primary | Number of Subjects With Anti-D Antibody Concentrations ≥ Protocol Specified Cut-off | Anti-D cut-off was defined as ≥ to 0.1IU/mL as assessed by ELISA. | The analysis was performed on the Adapted ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and for whom data concerning immunogenicity endpoint measures obtained from the ATP cohort for immunogenicity corresponding to each time point were available. | Posted | | Count of Participants | | Participants | | At Year 9, one month before the booster vaccination. | | | | ID | Title | Description |
|---|
| OG000 | Boostrix Group | Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine [Tdap](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a second dose of Boostrix vaccine [Tdap](GSK776423). | | OG001 | Adacel Group | Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a dose of Boostrix vaccine [Tdap](GSK776423). |
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| Primary | Number of Subjects With Anti-tetanus (Anti-T) Antibody Concentrations ≥ Protocol Specified Cut-off | Anti-T cut-off was defined as ≥ 0.1 IU/mL as assessed by ELISA. | The analysis was performed on the Adapted ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and for whom data concerning immunogenicity endpoint measures obtained from the ATP cohort for immunogenicity corresponding to each time point were available. | Posted | | Count of Participants | | Participants | | At year 1 after the vaccination in primary study (NCT00346073) | | | | ID | Title | Description |
|---|
| OG000 | Boostrix Group | Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine [Tdap](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a second dose of Boostrix vaccine [Tdap](GSK776423). | | OG001 | Adacel Group | Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a dose of Boostrix vaccine [Tdap](GSK776423). |
| |
| Primary | Number of Subjects With Anti-T Antibody Concentrations ≥ Protocol Specified Cut-off | Anti-T cut-off was defined as ≥ 0.1 IU/mL as assessed by ELISA. | The analysis was performed on the Adapted ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and for whom data concerning immunogenicity endpoint measures obtained from the ATP cohort for immunogenicity corresponding to each time point were available. | Posted | | Count of Participants | | Participants | | At year 3 after the vaccination in primary study (NCT00346073) | | | | ID | Title | Description |
|---|
| OG000 | Boostrix Group | Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine [Tdap](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a second dose of Boostrix vaccine [Tdap](GSK776423). | | OG001 | Adacel Group | Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a dose of Boostrix vaccine [Tdap](GSK776423). |
| |
| Primary | Number of Subjects With Anti-T Antibody Concentrations ≥ Protocol Specified Cut-off | Anti-T cut-off was defined as ≥ 0.1 IU/mL as assessed by ELISA. | The analysis was performed on the Adapted ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and for whom data concerning immunogenicity endpoint measures obtained from the ATP cohort for immunogenicity corresponding to each time point were available. | Posted | | Count of Participants | | Participants | | At year 5 after the vaccination in primary study (NCT00346073) | | | | ID | Title | Description |
|---|
| OG000 | Boostrix Group | Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine [Tdap](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a second dose of Boostrix vaccine [Tdap](GSK776423). | | OG001 | Adacel Group | Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a dose of Boostrix vaccine [Tdap](GSK776423). |
| |
| Primary | Number of Subjects With Anti-T Antibody Concentrations ≥ Protocol Specified Cut-off | Anti-T cut-off was defined as ≥ 0.1 IU/mL as assessed by ELISA. | The analysis was performed on the Adapted ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and for whom data concerning immunogenicity endpoint measures obtained from the ATP cohort for immunogenicity corresponding to each time point were available. | Posted | | Count of Participants | | Participants | | At Year 9, one month before the booster vaccination. | | | | ID | Title | Description |
|---|
| OG000 | Boostrix Group | Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine [Tdap](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a second dose of Boostrix vaccine [Tdap](GSK776423). | | OG001 | Adacel Group | Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a dose of Boostrix vaccine [Tdap](GSK776423). |
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| Primary | Number of Subjects With Anti-D and Anti-T Concentrations ≥ 0.1 IU/mL and 1 IU/mL | Number of subjects with anti-D and anti-T concentrations ≥ 0.1 IU/mL and 1 IU/mL were tabulated | Analysis was performed on the According-to-Protocol (ATP) Cohort for analysis of immunogenicity at Year 9, which included all subjects who received the dose of study vaccine and for whom assay results were available for antibodies against at least one study vaccine antigen component after Year 9 vaccination. | Posted | | Count of Participants | | Participants | | At Year 9, one month after the booster vaccination. | | | | ID | Title | Description |
|---|
| OG000 | Boostrix Group | Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine [Tdap](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a second dose of Boostrix vaccine [Tdap](GSK776423). | | OG001 | Adacel Group | Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a dose of Boostrix vaccine [Tdap](GSK776423). | | OG002 | Control Group | Subjects received the first dose of Boostrix vaccine [Tdap](GSK776423) in this study at Year 9. |
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| Primary | Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations | Anti-PT, anti-FHA and anti-PRN antibody concentrations were measured by ELISA, tabulated as GMCs and expressed in IU/mL. | The analysis was performed on the Adapted ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and for whom data concerning immunogenicity endpoint measures obtained from the ATP cohort for immunogenicity corresponding to each time point were available. | Posted | | Geometric Mean | 95% Confidence Interval | IU/mL | | At Year 9, one month before booster vaccination | | | | ID | Title | Description |
|---|
| OG000 | Boostrix Group | Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine [Tdap](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a second dose of Boostrix vaccine [Tdap](GSK776423). | | OG001 | Adacel Group | Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a dose of Boostrix vaccine [Tdap](GSK776423). | | OG002 | Control Group | |
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| Primary | Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations | Anti-PT, anti-FHA and anti-PRN antibody concentrations were measured by ELISA, tabulated as GMCs and expressed in IU/mL. | Analysis was performed on the Total Vaccinated Cohort (TVC) at Year 9 which included all subjects with a study vaccine administration dose documented: a safety analysis based on the TVC included all vaccinated subjects, an immunogenicity analysis based on the TVC included all vaccinated subjects for whom immunogenicity results were available. | Posted | | Geometric Mean | 95% Confidence Interval | IU/mL | | At Year 9, one month after the booster vaccination | | | | ID | Title | Description |
|---|
| OG000 | Boostrix Group | Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine [Tdap](GSK776423) intramuscularly in the deltoid region of the nondominant upper arm and in this study at Year 9 received a second dose of Boostrix vaccine [Tdap] (GSK776423). | | OG001 | Adacel Group | Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a dose of Boostrix vaccine [Tdap](GSK776423) divided by Infanrix Group in APV-039 who included subjects who received 3 consecutive doses of Infanrix. |
| |
| Primary | Booster Response to D and T Antigens | A booster response was defined as: for initially seronegative subjects (S-) (pre-vaccination concentration below cut-off: < 0.1 IU/mL) antibody concentrations at least four times the cut-off (post vaccination concentration ≥ 0.4 IU/mL); for initially seropositive subjects (S+) (pre-vaccination concentration ≥ 0.1 IU/mL): an increase in antibody concentrations of at least four times the pre-vaccination concentration; Total = subjects either seropositive or seronegative. | Analysis was performed on the According-to-Protocol (ATP) Cohort for analysis of immunogenicity at Year 9, which included all subjects who received the dose of study vaccine and for whom assay results were available for antibodies against at least one study vaccine antigen component after Year 9 vaccination. | Posted | | Count of Participants | | Participants | | At Year 9, one month after the booster vaccination. | | | | ID | Title | Description |
|---|
| OG000 | Boostrix Group | Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine [Tdap](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a second dose of Boostrix vaccine [Tdap](GSK776423). | | OG001 | Adacel Group | Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a dose of Boostrix vaccine [Tdap](GSK776423). |
|
| Primary | Booster Response to PT, FHA and PRN Antigens | Booster response was defined as: for subjects with pre-vaccination antibody concentration < 5 EL.U/mL (S-): antibody concentration ≥ 20 EL.U/mL; for subjects with pre-vaccination antibody concentration ≥ 5 EL.U/mL and < 20 EL.U/mL (S+, <4*cut-off): antibody concentration at least four times the pre-vaccination concentration; for subjects with pre-vaccination antibody concentration ≥ 20 EL.U/mL (S+, ≥4*cut-off): antibody concentration at least two times the pre-vaccination concentration; Total = subjects either seropositive or seronegative | Analysis was performed on the According-to-Protocol (ATP) Cohort for analysis of immunogenicity at Year 9, which included all subjects who received the dose of study vaccine and for whom assay results were available for antibodies against at least one study vaccine antigen component after Year 9 vaccination. | Posted | | Count of Participants | | Participants | | At Year 9, one month after the booster vaccination. | | | | ID | Title | Description |
|---|
| OG000 | Boostrix Group | Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine [Tdap](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a second dose of Boostrix vaccine [Tdap](GSK776423). | | OG001 | Adacel Group | Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a dose of Boostrix vaccine [Tdap](GSK776423). |
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| Secondary | Number of Subjects With Anti-pertussis Toxoid (PT) Antibody Concentrations Equal to or Above Protocol Specified Cut-off | The cut-off for anti-PT concentrations was defined as ≥ 5 ELISA units per mililiter (EL.U/mL). | The analysis was performed on the Adapted ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and for whom data concerning immunogenicity endpoint measures obtained from the ATP cohort for immunogenicity corresponding to each time point were available. | Posted | | Count of Participants | | Participants | | At 1, 3, and 5 years after the vaccination in primary study (NCT00346073) | | | | ID | Title | Description |
|---|
| OG000 | Boostrix Group | Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine [Tdap](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a second dose of Boostrix vaccine [Tdap](GSK776423). | | OG001 | Adacel Group | Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a dose of Boostrix vaccine [Tdap](GSK776423). |
| |
| Secondary | Number of Subjects With Anti-PT Antibody Concentrations Equal to or Above Protocol Specified Cut-off | The cut-off for anti-PT concentrations was defined as equal to or greater than 2.693 IU/mL. | Analysis was performed on the According-to-Protocol (ATP) Cohort for analysis of immunogenicity at Year 9, which included all subjects who received the dose of study vaccine and for whom assay results were available for antibodies against at least one study vaccine antigen component after Year 9 vaccination. | Posted | | Count of Participants | | Participants | | At Year 9, one month before(pre booster) and after the booster vaccination(post booster) | | | | ID | Title | Description |
|---|
| OG000 | Boostrix Group | Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine [Tdap](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a second dose of Boostrix vaccine [Tdap](GSK776423). | | OG001 | Adacel Group | Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a dose of Boostrix vaccine [Tdap](GSK776423). | | OG002 | Control Group | |
|
| Secondary | Number of Subjects With Anti-FHA Antibody Concentrations Equal to or Above Protocol Specified Cut-off | The cut-off for anti-FHA concentrations was defined as equal to or greater than 5 EL.U/mL. | The analysis was performed on the Adapted ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and for whom data concerning immunogenicity endpoint measures obtained from the ATP cohort for immunogenicity corresponding to each time point were available. | Posted | | Count of Participants | | Participants | | At 1, 3, and 5 years after the vaccination in primary study (NCT00346073) | | | | ID | Title | Description |
|---|
| OG000 | Boostrix Group | Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine [Tdap](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a second dose of Boostrix vaccine [Tdap](GSK776423). | | OG001 | Adacel Group | Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a dose of Boostrix vaccine [Tdap](GSK776423). |
| |
| Secondary | Number of Subjects With Anti-FHA Antibody Concentrations Equal to or Above Protocol Specified Cut-off | The cut-off for anti-FHA concentrations was defined as equal to or greater than 2.046 IU/mL | Analysis was performed on the According-to-Protocol (ATP) Cohort for analysis of immunogenicity at Year 9, which included all subjects who received the dose of study vaccine and for whom assay results were available for antibodies against at least one study vaccine antigen component after Year 9 vaccination. | Posted | | Count of Participants | | Participants | | At Year 9, one month before(pre booster) and after the booster vaccination(post booster) | | | | ID | Title | Description |
|---|
| OG000 | Boostrix Group | Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine [Tdap](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a second dose of Boostrix vaccine [Tdap](GSK776423). | | OG001 | Adacel Group | Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a dose of Boostrix vaccine [Tdap](GSK776423). | | OG002 | Control Group | |
|
| Secondary | Number of Subjects With Anti-PRN Antibody Concentrations Equal to or Above Protocol Specified Cut-off | The cut-off for anti-PRN concentrations was defined as equal to or greater than 5 EL.U/mL. | The analysis was performed on the Adapted ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and for whom data concerning immunogenicity endpoint measures obtained from the ATP cohort for immunogenicity corresponding to each time point were available. | Posted | | Count of Participants | | Participants | | At 1, 3, and 5 years after the vaccination in primary study (NCT00346073) | | | | ID | Title | Description |
|---|
| OG000 | Boostrix Group | Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine [Tdap](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a second dose of Boostrix vaccine [Tdap](GSK776423). | | OG001 | Adacel Group | Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a dose of Boostrix vaccine [Tdap](GSK776423). |
| |
| Secondary | Number of Subjects With Anti-PRN Antibody Concentrations Equal to or Above Protocol Specified Cut-off | The cut-off for anti-PRN concentrations was defined as equal to or greater than 2.187 IU/mL. | Analysis was performed on the According-to-Protocol (ATP) Cohort for analysis of immunogenicity at Year 9, which included all subjects who received the dose of study vaccine and for whom assay results were available for antibodies against at least one study vaccine antigen component after Year 9 vaccination. | Posted | | Count of Participants | | Participants | | At Year 9, one month before(pre booster) and after the booster vaccination(post booster) | | | | ID | Title | Description |
|---|
| OG000 | Boostrix Group | Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine [Tdap](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a second dose of Boostrix vaccine [Tdap](GSK776423). | | OG001 | Adacel Group | Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a dose of Boostrix vaccine [Tdap](GSK776423). | | OG002 | Control Group | |
|
| Secondary | Anti-D Antibody Concentration | Anti-D antibody concentration is expressed as geometric mean concentration (GMC) in IU/mL. | The analysis was performed on the Adapted ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and for whom data concerning immunogenicity endpoint measures obtained from the ATP cohort for immunogenicity corresponding to each time point were available. | Posted | | Geometric Mean | 95% Confidence Interval | IU/mL | | At 1, 3, and 5 years after the vaccination in primary study (NCT00346073) | | | | ID | Title | Description |
|---|
| OG000 | Boostrix Group | Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine [Tdap](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a second dose of Boostrix vaccine [Tdap](GSK776423). | | OG001 | Adacel Group | Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a dose of Boostrix vaccine [Tdap](GSK776423). |
| |
| Secondary | Anti-D Antibody Concentration | Anti-D antibody concentration is expressed as GMC in IU/mL. | Analysis was performed on the According-to-Protocol (ATP) Cohort for analysis of immunogenicity at Year 9, which included all subjects who received the dose of study vaccine and for whom assay results were available for antibodies against at least one study vaccine antigen component after Year 9 vaccination. | Posted | | Geometric Mean | 95% Confidence Interval | IU/mL | | At Year 9, one month before(pre booster) and after the booster vaccination(post booster) | | | | ID | Title | Description |
|---|
| OG000 | Boostrix Group | Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine [Tdap](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a second dose of Boostrix vaccine [Tdap](GSK776423). | | OG001 | Adacel Group | Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a dose of Boostrix vaccine [Tdap](GSK776423). | | OG002 | Control Group | Subjects received the first dose of Boostrix vaccine [Tdap](GSK776423) in this study at Year 9. |
|
| Secondary | Anti-T Antibody Concentration | Anti-T antibody concentration is expressed as GMC in IU/mL. | The analysis was performed on the Adapted ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and for whom data concerning immunogenicity endpoint measures obtained from the ATP cohort for immunogenicity corresponding to each time point were available. | Posted | | Geometric Mean | 95% Confidence Interval | IU/mL | | At 1, 3, and 5 years after the vaccination in primary study (NCT00346073) | | | | ID | Title | Description |
|---|
| OG000 | Boostrix Group | Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine [Tdap](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a second dose of Boostrix vaccine [Tdap](GSK776423). | | OG001 | Adacel Group | Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a dose of Boostrix vaccine [Tdap](GSK776423). |
| |
| Secondary | Anti-T Antibody Concentration | Anti-T antibody concentration is expressed as GMC in IU/mL. | Analysis was performed on the According-to-Protocol (ATP) Cohort for analysis of immunogenicity at Year 9, which included all subjects who received the dose of study vaccine and for whom assay results were available for antibodies against at least one study vaccine antigen component after Year 9 vaccination. | Posted | | Geometric Mean | 95% Confidence Interval | IU/mL | | At Year 9, one month before(pre booster) and after the booster vaccination(post booster) | | | | ID | Title | Description |
|---|
| OG000 | Boostrix Group | Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine [Tdap](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a second dose of Boostrix vaccine [Tdap](GSK776423). | | OG001 | Adacel Group | Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a dose of Boostrix vaccine [Tdap](GSK776423). | | OG002 | Control Group | Subjects received the first dose of Boostrix vaccine [Tdap](GSK776423) in this study at Year 9. |
|
| Secondary | Anti-PT Antibody Concentration | Anti-PT antibody concentration is expressed as GMC in EL.U/mL. | The analysis was performed on the Adapted ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and for whom data concerning immunogenicity endpoint measures obtained from the ATP cohort for immunogenicity corresponding to each time point were available. | Posted | | Geometric Mean | 95% Confidence Interval | IU/mL | | At 1, 3, and 5 years after the vaccination in primary study (NCT00346073) | | | | ID | Title | Description |
|---|
| OG000 | Boostrix Group | Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine [Tdap](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a second dose of Boostrix vaccine [Tdap](GSK776423). | | OG001 | Adacel Group | Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a dose of Boostrix vaccine [Tdap](GSK776423). |
| |
| Secondary | Anti-PT Antibody Concentration | Anti-PT antibody concentration was expressed as GMC in IU/mL. | Analysis was performed on the According-to-Protocol (ATP) Cohort for analysis of immunogenicity at Year 9, which included all subjects who received the dose of study vaccine and for whom assay results were available for antibodies against at least one study vaccine antigen component after Year 9 vaccination. | Posted | | Geometric Mean | 95% Confidence Interval | IU/mL | | At Year 9, one month before(pre booster) and after the booster vaccination(post booster) | | | | ID | Title | Description |
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| OG000 | Boostrix Group | Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine [Tdap](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a second dose of Boostrix vaccine [Tdap](GSK776423). | | OG001 | Adacel Group | Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a dose of Boostrix vaccine [Tdap](GSK776423). | | OG002 | Control Group | Subjects received the first dose of Boostrix vaccine [Tdap](GSK776423) in this study at Year 9. |
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| Secondary | Anti-FHA Antibody Concentration | Anti-FHA antibody concentration is expressed as GMC in IU/mL | The analysis was performed on the Adapted ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and for whom data concerning immunogenicity endpoint measures obtained from the ATP cohort for immunogenicity corresponding to each time point were available. | Posted | | Geometric Mean | 95% Confidence Interval | IU/mL | | At 1, 3, and 5 years after the vaccination in primary study (NCT00346073) | | | | ID | Title | Description |
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| OG000 | Boostrix Group | Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine [Tdap](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a second dose of Boostrix vaccine [Tdap](GSK776423). | | OG001 | Adacel Group | Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a dose of Boostrix vaccine [Tdap](GSK776423). |
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| Secondary | Anti-FHA Antibody Concentration | Anti-FHA antibody concentration was expressed as GMC in IU/mL. | Analysis was performed on the According-to-Protocol (ATP) Cohort for analysis of immunogenicity at Year 9, which included all subjects who received the dose of study vaccine and for whom assay results were available for antibodies against at least one study vaccine antigen component after Year 9 vaccination. | Posted | | Geometric Mean | 95% Confidence Interval | IU/mL | | At Year 9, one month before(pre booster) and after the booster vaccination(post booster) | | | | ID | Title | Description |
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| OG000 | Boostrix Group | Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine [Tdap](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a second dose of Boostrix vaccine [Tdap](GSK776423). | | OG001 | Adacel Group | Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a dose of Boostrix vaccine [Tdap](GSK776423). | | OG002 | Control Group | Subjects received the first dose of Boostrix vaccine [Tdap](GSK776423) in this study at Year 9. |
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| Secondary | Anti-PRN Antibody Concentration | Anti-PRN antibody concentration is expressed as GMC in IU/mL | The analysis was performed on the Adapted ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and for whom data concerning immunogenicity endpoint measures obtained from the ATP cohort for immunogenicity corresponding to each time point were available. | Posted | | Geometric Mean | 95% Confidence Interval | IU/mL | | At 1, 3, and 5 years after the vaccination in primary study (NCT00346073) | | | | ID | Title | Description |
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| OG000 | Boostrix Group | Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine [Tdap](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a second dose of Boostrix vaccine [Tdap](GSK776423). | | OG001 | Adacel Group | Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a dose of Boostrix vaccine [Tdap](GSK776423). |
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| Secondary | Anti-PRN Antibody Concentration | Anti-PRN antibody concentration is expressed as GMC in IU/mL. | Analysis was performed on the According-to-Protocol (ATP) Cohort for analysis of immunogenicity at Year 9, which included all subjects who received the dose of study vaccine and for whom assay results were available for antibodies against at least one study vaccine antigen component after Year 9 vaccination. | Posted | | Geometric Mean | 95% Confidence Interval | IU/mL | | At Year 9, one month before(pre booster) and after the booster vaccination(post booster) | | | | ID | Title | Description |
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| OG000 | Boostrix Group | Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine [Tdap](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a second dose of Boostrix vaccine [Tdap](GSK776423). | | OG001 | Adacel Group | Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a dose of Boostrix vaccine [Tdap](GSK776423). | | OG002 | Control Group | Subjects received the first dose of Boostrix vaccine [Tdap](GSK776423) in this study at Year 9. |
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| Secondary | Alternative Booster Response to Anti-D and Anti-T Antigens | Alternative Booster response to D and T antigens is defined as: - For subjects with pre-booster antibody concentration below 0.1 IU/mL: antibody concentrations at least four times the 0.1IU/ML, one month after vaccination, and - For subjects with pre-booster antibody concentration ≥0.1 IU/mL and <1.0 IU/mL: antibody concentrations of at least four times the pre-booster antibody concentration, one month after vaccination. - For subjects with pre-booster antibody concentration ≥1.0 IU/mL and <6.0 IU/mL: antibody concentrations of at least two times the pre-booster antibody concentration, one month after vaccination. - Subjects with pre-booster antibody concentration ≥6.0 IU/mL are not evaluable for booster response. S- = Antibody concentration < 0.1 IU/mL S+ = Antibody concentration ≥ 0.1 IU/mL Total = subjects either seropositive or seronegative | Analysis was performed on the According-to-Protocol (ATP) Cohort for analysis of immunogenicity at Year 9, which included all subjects who received the dose of study vaccine and for whom assay results were available for antibodies against at least one study vaccine antigen component after Year 9 vaccination. | Posted | | Count of Participants | | Participants | | At Year 9, one month after booster vaccination | | | | ID | Title | Description |
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| OG000 | Boostrix Group | Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine [Tdap](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a second dose of Boostrix vaccine [Tdap](GSK776423). | |
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| Secondary | Alternative Booster Responses to Anti-PT, Anti-FHA and Anti-PRN Antigens | Alternative Booster response to PT, FHA and PRN antigens is defined as: - For subjects with pre-booster antibody concentration below the assay cut off: antibody concentrations at least four times the assay cut off one month after vaccination, and - For subjects with pre-booster antibody concentration ≥ assay cut off and < 60 IU/mL: antibody concentration increase of at least 30 IU/mL from the pre-booster antibody concentration, one month after vaccination. - For subjects with pre-booster antibody concentration ≥ 60 IU/mL : at least 1.5 fold increase of antibody concentration from the pre-booster antibody concentration, one month after vaccination. S- = seronegative subjects (antibody concentration below assay cut off for anti-PT, anti-FHA, anti-PRN) S+ = seropositive subjects (antibody concentration below assay cut off for anti-PT, anti-FHA, anti-PRN) Total = subjects either seropositive or seronegative | Analysis was performed on the According-to-Protocol (ATP) Cohort for analysis of immunogenicity at Year 9, which included all subjects who received the dose of study vaccine and for whom assay results were available for antibodies against at least one study vaccine antigen component after Year 9 vaccination. | Posted | | Count of Participants | | Participants | | At Year 9, one month after booster vaccination | | | | ID | Title | Description |
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| OG000 | Boostrix Group | Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine [Tdap](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a second dose of Boostrix vaccine [Tdap](GSK776423). |
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| Secondary | Seroprotection Status for Anti-D Antibody Concentration | Seroprotection status for anti-D antibody concentration < 0.1 IU/mL were tested for neutralizing antibodies using a VERO-cell neutralization assay. Seroprotection rate is defined as the percentage of subjects with antibody concentrations greater than or equal (≥) the seroprotection cut-off value defined for that antibody. | Analysis was performed on the According-to-Protocol (ATP) Cohort for analysis of immunogenicity at Year 9, which included all subjects who received the dose of study vaccine and for whom assay results were available for antibodies against at least one study vaccine antigen component after Year 9 vaccination. | Posted | | Number | | Percentage of subjects | | At Year 9, one month before(pre booster) and after the booster vaccination(post booster) | | | | ID | Title | Description |
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| OG000 | Boostrix Group | Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine [Tdap](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a second dose of Boostrix vaccine [Tdap](GSK776423). | | OG001 | Adacel Group | Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a dose of Boostrix vaccine [Tdap](GSK776423). |
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| Secondary | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Year 9 | Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity. Grade 3 pain was defined as significant pain at rest that prevented normal everyday activities. Grade 3 redness and swelling was greater than 50 millimeters (mm) | The analysis was performed on the Total Vaccinated cohort at Year 9, which included all subjects with study vaccine administration dose documented, who returned at Year 9 and had their diary cards completed. | Posted | | Count of Participants | | Participants | | During the 4-day (Days 0-3) post vaccination period. | | | | ID | Title | Description |
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| OG000 | Boostrix Group | Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine [Tdap](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a second dose of Boostrix vaccine [Tdap](GSK776423). | | OG001 | Adacel Group | Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a dose of Boostrix vaccine [Tdap](GSK776423). | | OG002 | Control Group |
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| Secondary | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Year 9 | The solicited general symptoms assessed were Fatigue, Gastrointestinal symptoms (including nausea, vomiting, diarrhea and abdominal pain), Headache and Fever [defined as temperature of ≥100.4 degrees Fahrenheit (F) by any route]. Any = Occurrence of any general symptom regardless of its intensity grade or relationship to vaccination; Grade 3 Symptom = Symptom that prevented normal activity; Grade 3 Fever > 104.0 degrees F. | The analysis was performed on the Total Vaccinated cohort at Year 9, which included all subjects with study vaccine administration dose documented, who returned at Year 9 and had their diary cards completed. | Posted | | Count of Participants | | Participants | | During the 4-day (Days 0-3) post vaccination period. | | | | ID | Title | Description |
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| OG000 | Boostrix Group | Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine [Tdap](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a second dose of Boostrix vaccine [Tdap](GSK776423). | | OG001 | Adacel Group | Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a dose of Boostrix vaccine [Tdap](GSK776423). |
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| Secondary | Number of Subjects With Any Large Injection Site Reaction - Year 9 | Large injection site reaction = a swelling with a diameter > 100 mm, noticeable diffuse swelling or noticeable increase in limb circumference. | The analysis was performed on the Total Vaccinated cohort at Year 9, which included all subjects with study vaccine administration dose documented, who returned at Year 9. | Posted | | Count of Participants | | Participants | | During the 4-day (Days 0-3) follow-up period after vaccination. | | | | ID | Title | Description |
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| OG000 | Boostrix Group | Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine [Tdap](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a second dose of Boostrix vaccine [Tdap](GSK776423). | | OG001 | Adacel Group | Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a dose of Boostrix vaccine [Tdap](GSK776423). | | OG002 | Control Group | Subjects received the first dose of Boostrix vaccine [Tdap](GSK776423) in this study at Year 9. |
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| Secondary | Number of Subjects With Any Unsolicited Adverse Events (AEs) - Year 9 | An unsolicited AE covers any untoward medical oc-currence 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. | The analysis was performed on the Total Vaccinated cohort at Year 9, which included all subjects with study vaccine administration dose documented, who returned at Year 9. | Posted | | Count of Participants | | Participants | | During the 31-day (Days 0-30) post-vaccination period. | | | | ID | Title | Description |
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| OG000 | Boostrix Group | Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine [Tdap](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a second dose of Boostrix vaccine [Tdap](GSK776423). | | OG001 | Adacel Group | Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm. | | OG002 | Control Group | |
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| Secondary | Number of Subjects With Serious Adverse Events (SAEs) - Year 9 | SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. | The analysis was performed on the Total Vaccinated cohort at Year 9, which included all subjects with study vaccine administration dose documented, who returned at Year 9. | Posted | | Count of Participants | | Participants | | During the 31-day (Days 0-30) post-vaccination period | | | | ID | Title | Description |
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| OG000 | Boostrix Group | Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine [Tdap](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a second dose of Boostrix vaccine [Tdap](GSK776423). | | OG001 | Adacel Group | Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a dose of Boostrix vaccine [Tdap](GSK776423). | | OG002 | Control Group | Subjects received the first dose of Boostrix vaccine [Tdap](GSK776423) in this study at Year 9. |
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