| Primary | Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Antigens | 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 millilitre (IU/mL). | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included subjects who met all eligibility criteria, complied with the procedures defined in the protocol, who received the booster dose of Boostrix™ Polio vaccine and for whom data concerning immunogenicity outcome measures were available. | Posted | | Number | | Subjects | | At Month 1 | | | | ID | Title | Description |
|---|
| OG000 | Boostrix Polio Group | Healthy subjects who had received one booster dose Boostrix™ Polio vaccine in the NCT01277705 study received one additional booster dose of Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm. | | OG001 | Boostrix+Poliorix Group | Healthy subjects who had received one booster dose of the co-administered Boostrix™ and Poliorix™ vaccines in the NCT01277705 study received one booster dose Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm. | | OG002 | Revaxis Group | Healthy subjects who had received one booster dose of Revaxis® vaccine in the NCT01277705 study received one booster dose of Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm. |
| | | Title | Denominators | Categories |
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| Anti-D | | | | Anti-T | | |
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| The objective of the analysis was to demonstrate that a booster dose of Boostrix™ Polio vaccine, administered to adults 10 years after a dose of Boostrix™ Polio vaccine or co-administered Boostrix™ + Poliorix™ vaccines, elicited seroprotective antibody concentrations, 1 month after the booster dose, in at least 80% of the subjects against diphtheria. Samples were analysed both with ELISA (enzyme-linked immunosorbent assay), and VERO-cell (African green monkey kidney cell) neutralisation testing. | | | | | Percentage of subjects seroprotected | 96.8 | | | 2-Sided | 95 | 89 | 99.6 | | | The pre-specified lower limit (LL) of the 95% confidence interval (CI) for the percentage of seroprotected (Anti-D concentrations ≥ 0.1 IU/mL by ELISA or ≥ 0.01 IU/mL by VERO-cell when subjects with ELISA result <0.1 IU/mL) subjects was above 80%. |
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| Primary | Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3 | A seroprotected subject is defined as a vaccinated subject with anti-poliovirus types 1, 2 and 3 antibody concentration greater than or equal to (≥) 8 Effective Dose 50 (ED50) | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included subjects who met all eligibility criteria, complied with the procedures defined in the protocol, who received the booster dose of Boostrix™ Polio vaccine and for whom data concerning immunogenicity outcome measures were available. | Posted | | Number | | Subjects | | At Month 1 | | | | ID | Title | Description |
|---|
| OG000 | Boostrix Polio Group | Healthy subjects who had received one booster dose Boostrix™ Polio vaccine in the NCT01277705 study received one additional booster dose of Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm. | | OG001 | Boostrix+Poliorix Group | Healthy subjects who had received one booster dose of the co-administered Boostrix™ and Poliorix™ vaccines in the NCT01277705 study received one booster dose Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm. | | OG002 | Revaxis Group |
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| Primary | Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Antigens | 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 millilitre (IU/mL) | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included subjects who met all eligibility criteria, complied with the procedures defined in the protocol, who received the booster dose of Boostrix™ Polio vaccine and for whom data concerning immunogenicity outcome measures were available. | Posted | | Number | | Subjects | | At Day 0 | | | | ID | Title | Description |
|---|
| OG000 | Boostrix Polio Group | Healthy subjects who had received one booster dose Boostrix™ Polio vaccine in the NCT01277705 study received one additional booster dose of Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm. | | OG001 | Boostrix+Poliorix Group | Healthy subjects who had received one booster dose of the co-administered Boostrix™ and Poliorix™ vaccines in the NCT01277705 study received one booster dose Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm. | | OG002 | Revaxis Group |
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| Primary | Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3 | A seroprotected subject is defined as a vaccinated subject with anti-poliovirus types 1, 2 and 3 antibody concentration greater than or equal to (≥) 8 Effective Dose 50 (ED50) | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included subjects who met all eligibility criteria, complied with the procedures defined in the protocol, who received the booster dose of Boostrix™ Polio vaccine and for whom data concerning immunogenicity outcome measures were available. | Posted | | Number | | Subjects | | At Day 0 | | | | ID | Title | Description |
|---|
| OG000 | Boostrix Polio Group | Healthy subjects who had received one booster dose Boostrix™ Polio vaccine in the NCT01277705 study received one additional booster dose of Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm. | | OG001 | Boostrix+Poliorix Group | Healthy subjects who had received one booster dose of the co-administered Boostrix™ and Poliorix™ vaccines in the NCT01277705 study received one booster dose Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm. | | OG002 | Revaxis Group |
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| Primary | Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN) Antibodies | Cut-off values assessed were greater than or equal to ≥ 5 Enzyme Linked Immunosorbent Assay (ELISA) units per millilitre (EL.U/ml) | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included subjects who met all eligibility criteria, complied with the procedures defined in the protocol, who received the booster dose of Boostrix™ Polio vaccine and for whom data concerning immunogenicity outcome measures were available. | Posted | | Number | | Subjects | | At Day 0 | | | | ID | Title | Description |
|---|
| OG000 | Boostrix Polio Group | Healthy subjects who had received one booster dose Boostrix™ Polio vaccine in the NCT01277705 study received one additional booster dose of Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm. | | OG001 | Boostrix+Poliorix Group | Healthy subjects who had received one booster dose of the co-administered Boostrix™ and Poliorix™ vaccines in the NCT01277705 study received one booster dose Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm. | | OG002 | Revaxis Group |
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| Primary | Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations | Concentrations are presented as geometric mean concentrations (GMCs), expressed in international units per millilitre (IU/mL) | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included subjects who met all eligibility criteria, complied with the procedures defined in the protocol, who received the booster dose of Boostrix™ Polio vaccine and for whom data concerning immunogenicity outcome measures were available. | Posted | | Geometric Mean | 95% Confidence Interval | IU/mL | | At Day 0 | | | | ID | Title | Description |
|---|
| OG000 | Boostrix Polio Group | Healthy subjects who had received one booster dose Boostrix™ Polio vaccine in the NCT01277705 study received one additional booster dose of Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm. | | OG001 | Boostrix+Poliorix Group | Healthy subjects who had received one booster dose of the co-administered Boostrix™ and Poliorix™ vaccines in the NCT01277705 study received one booster dose Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm. | | OG002 | Revaxis Group | |
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| Primary | Anti-polio 1, Anti-polio 2 and Anti-polio 3 Antibody Titers | Titers are presented as geometric mean titers (GMTs). | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included subjects who met all eligibility criteria, complied with the procedures defined in the protocol, who received the booster dose of Boostrix™ Polio vaccine and for whom data concerning immunogenicity outcome measures were available. | Posted | | Geometric Mean | 95% Confidence Interval | Titers | | At Day 0 | | | | ID | Title | Description |
|---|
| OG000 | Boostrix Polio Group | Healthy subjects who had received one booster dose Boostrix™ Polio vaccine in the NCT01277705 study received one additional booster dose of Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm. | | OG001 | Boostrix+Poliorix Group | Healthy subjects who had received one booster dose of the co-administered Boostrix™ and Poliorix™ vaccines in the NCT01277705 study received one booster dose Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm. | | OG002 | Revaxis Group | Healthy subjects who had received one booster dose of Revaxis® vaccine in the NCT01277705 study received one booster dose of Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm. |
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| Primary | Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN) Antibodies Antibody Concentrations | Concentrations are presented as geometric mean concentrations (GMCs), expressed in expressed in ELISA units per millilitre (EL.U/mL) | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included subjects who met all eligibility criteria, complied with the procedures defined in the protocol, who received the booster dose of Boostrix™ Polio vaccine and for whom data concerning immunogenicity outcome measures were available. | Posted | | Geometric Mean | 95% Confidence Interval | EL.U/mL | | At Day 0 | | | | ID | Title | Description |
|---|
| OG000 | Boostrix Polio Group | Healthy subjects who had received one booster dose Boostrix™ Polio vaccine in the NCT01277705 study received one additional booster dose of Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm. | | OG001 | Boostrix+Poliorix Group | Healthy subjects who had received one booster dose of the co-administered Boostrix™ and Poliorix™ vaccines in the NCT01277705 study received one booster dose Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm. | | OG002 | Revaxis Group |
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| Secondary | Number of Subjects With Booster Response to Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA), Pertactin (PRN) | Booster response was defined as: for initially seronegative subjects: antibody concentration ≥ 20 EL.U/mL at post booster vaccination; for initially seropositive subjects with pre-vaccination antibody concentration < 20 EL.U/mL: antibody concentration at post booster ≥ 4 fold the pre-vaccination antibody concentration; and for initially seropositive subjects with pre-vaccination antibody concentration ≥ 20 EL.U/mL: antibody concentration at post booster ≥ 2 fold the pre-vaccination antibody concentration. | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included subjects who met all eligibility criteria, complied with the procedures defined in the protocol, who received the booster dose of Boostrix™ Polio vaccine and for whom data concerning immunogenicity outcome measures were available. | Posted | | Number | | Subjects | | At Month 1 | | | | ID | Title | Description |
|---|
| OG000 | Boostrix Polio Group | Healthy subjects who had received one booster dose Boostrix™ Polio vaccine in the NCT01277705 study received one additional booster dose of Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm. | | OG001 | Boostrix+Poliorix Group | Healthy subjects who had received one booster dose of the co-administered Boostrix™ and Poliorix™ vaccines in the NCT01277705 study received one booster dose Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm. |
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| Secondary | Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN) Antibodies Above the Cut-off | Cut-off values assessed were greater than or equal to ≥ 5 Enzyme Linked Immunosorbent Assay (ELISA) units per millilitre (EL.U/ml) | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included subjects who met all eligibility criteria, complied with the procedures defined in the protocol, who received the booster dose of Boostrix™ Polio vaccine and for whom data concerning immunogenicity outcome measures were available. | Posted | | Number | | Subjects | | At Month 1 | | | | ID | Title | Description |
|---|
| OG000 | Boostrix Polio Group | Healthy subjects who had received one booster dose Boostrix™ Polio vaccine in the NCT01277705 study received one additional booster dose of Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm. | | OG001 | Boostrix+Poliorix Group | Healthy subjects who had received one booster dose of the co-administered Boostrix™ and Poliorix™ vaccines in the NCT01277705 study received one booster dose Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm. | | OG002 | Revaxis Group |
|
| Secondary | Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations | Concentrations are presented as geometric mean concentrations (GMCs), expressed in international units per millilitre (IU/mL) | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included subjects who met all eligibility criteria, complied with the procedures defined in the protocol, who received the booster dose of Boostrix™ Polio vaccine and for whom data concerning immunogenicity outcome measures were available. | Posted | | Geometric Mean | 95% Confidence Interval | IU/mL | | At Month 1 | | | | ID | Title | Description |
|---|
| OG000 | Boostrix Polio Group | Healthy subjects who had received one booster dose Boostrix™ Polio vaccine in the NCT01277705 study received one additional booster dose of Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm. | | OG001 | Boostrix+Poliorix Group | Healthy subjects who had received one booster dose of the co-administered Boostrix™ and Poliorix™ vaccines in the NCT01277705 study received one booster dose Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm. | | OG002 | Revaxis Group | |
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| Secondary | Anti-polio 1, Anti-polio 2 and Anti-polio 3 Antibody Titers | Titers are presented as geometric mean titers (GMTs). | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included subjects who met all eligibility criteria, complied with the procedures defined in the protocol, who received the booster dose of Boostrix™ Polio vaccine and for whom data concerning immunogenicity outcome measures were available. | Posted | | Geometric Mean | 95% Confidence Interval | Titers | | At Month 1 | | | | ID | Title | Description |
|---|
| OG000 | Boostrix Polio Group | Healthy subjects who had received one booster dose Boostrix™ Polio vaccine in the NCT01277705 study received one additional booster dose of Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm. | | OG001 | Boostrix+Poliorix Group | Healthy subjects who had received one booster dose of the co-administered Boostrix™ and Poliorix™ vaccines in the NCT01277705 study received one booster dose Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm. | | OG002 | Revaxis Group | Healthy subjects who had received one booster dose of Revaxis® vaccine in the NCT01277705 study received one booster dose of Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm. |
|
| Secondary | Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN) Antibodies Antibody Concentrations | Concentrations are presented as geometric mean concentrations (GMCs), expressed in expressed in ELISA units per millilitre (EL.U/mL) | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included subjects who met all eligibility criteria, complied with the procedures defined in the protocol, who received the booster dose of Boostrix™ Polio vaccine and for whom data concerning immunogenicity outcome measures were available. | Posted | | Geometric Mean | 95% Confidence Interval | EL.U/mL | | At Month 1 | | | | ID | Title | Description |
|---|
| OG000 | Boostrix Polio Group | Healthy subjects who had received one booster dose Boostrix™ Polio vaccine in the NCT01277705 study received one additional booster dose of Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm. | | OG001 | Boostrix+Poliorix Group | Healthy subjects who had received one booster dose of the co-administered Boostrix™ and Poliorix™ vaccines in the NCT01277705 study received one booster dose Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm. | | OG002 |
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| Secondary | 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. | The analysis was performed on the Total Vaccinated cohort, which included all subjects with documented administration of the study booster vaccine, for whom data was available. | Posted | | Number | | Subjects | | During the 4-day (Day 0-Day 3) follow-up period after vaccination | | | | ID | Title | Description |
|---|
| OG000 | Boostrix Polio Group | Healthy subjects who had received one booster dose Boostrix™ Polio vaccine in the NCT01277705 study received one additional booster dose of Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm. | | OG001 | Boostrix+Poliorix Group | Healthy subjects who had received one booster dose of the co-administered Boostrix™ and Poliorix™ vaccines in the NCT01277705 study received one booster dose Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm. | | OG002 | Revaxis Group |
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| Secondary | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Assessed solicited general symptoms were fatigue, fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)], headache and gastrointestinal symptoms. 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. | The analysis was performed on the Total Vaccinated cohort, which included all subjects with documented administration of the study booster vaccine, for whom data was available and the symptom sheet filled in. | Posted | | Number | | Subjects | | During the 4-day (Day 0-Day 3) follow-up period after vaccination | | | | ID | Title | Description |
|---|
| OG000 | Boostrix Polio Group | Healthy subjects who had received one booster dose Boostrix™ Polio vaccine in the NCT01277705 study received one additional booster dose of Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm. | | OG001 | Boostrix+Poliorix Group | Healthy subjects who had received one booster dose of the co-administered Boostrix™ and Poliorix™ vaccines in the NCT01277705 study received one booster dose Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm. |
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| Secondary | 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. | The analysis was performed on the Total Vaccinated cohort, which included all subjects with documented administration of the study booster vaccine, for whom data was available and the symptom sheet filled in. | Posted | | Number | | Subjects | | During the 31-day (Day 0-Day 30) follow-up period after vaccination | | | | ID | Title | Description |
|---|
| OG000 | Boostrix Polio Group | Healthy subjects who had received one booster dose Boostrix™ Polio vaccine in the NCT01277705 study received one additional booster dose of Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm. | | OG001 | Boostrix+Poliorix Group | Healthy subjects who had received one booster dose of the co-administered Boostrix™ and Poliorix™ vaccines in the NCT01277705 study received one booster dose Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm. |
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| Secondary | 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. | The analysis was performed on the Total Vaccinated cohort, which included all subjects with documented administration of the study booster vaccine, for whom data was available. | Posted | | Number | | Subjects | | Month 0 - Month 1 | | | | ID | Title | Description |
|---|
| OG000 | Boostrix Polio Group | Healthy subjects who had received one booster dose Boostrix™ Polio vaccine in the NCT01277705 study received one additional booster dose of Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm. | | OG001 | Boostrix+Poliorix Group | Healthy subjects who had received one booster dose of the co-administered Boostrix™ and Poliorix™ vaccines in the NCT01277705 study received one booster dose Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm. | | OG002 | Revaxis Group | Healthy subjects who had received one booster dose of Revaxis® vaccine in the NCT01277705 study received one booster dose of Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm. |
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