| Primary | Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Toxoid Antigens | A seroprotected subject was defined as a vaccinated subject with anti-D and anti-T antibody concentrations equal to or above (≥) 0.1 International Units per milliliter (IU/mL), respectively. | The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available. | Posted | | Count of Participants | | Participants | | At Month 1 post-Boostrix® vaccination | | | | ID | Title | Description |
|---|
| OG000 | Boostrix+Fluarix 19-64 YOA Group | Healthy male or female adults, between 19 to 64 years of age (YOA) inclusive, who received Boostrix® vaccine co-administered with Fluarix® vaccine at Day 0, injected intramuscularly in the left and right upper deltoid regions, respectively. | | OG001 | Fluarix Boostrix 19-64 YOA Group | Healthy male or female adults, between 19 to 64 years of age (YOA) inclusive, who received Fluarix® vaccine at Day 0 and Boostrix® vaccine at Month 1, both injected intramuscularly in the upper left deltoid region. | | OG002 | Boostrix+Fluarix ≥ 65 YOA Group | Healthy male or female adults, aged 65 years or older, who received Boostrix® vaccine co-administered with Fluarix® vaccine at Day 0, injected intramuscularly in the left and right upper deltoid regions, respectively. | | OG003 | Fluarix Boostrix ≥ 65 YOA Group | Healthy male or female adults, aged 65 years or older, who received Fluarix® vaccine at Day 0 and Boostrix® vaccine at Month 1, both injected intramuscularly in the upper left deltoid region. |
| | Units | Counts |
|---|
| Participants | - OG000713
- OG001654
- OG002108
- OG003
|
| | Title | Denominators | Categories |
|---|
| Anti-D | - ParticipantsOG000712
- ParticipantsOG001653
- ParticipantsOG002106
- ParticipantsOG003
|
| | 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 |
|---|
| Difference in seroprotection rates against diphteria toxoid: To demonstrate that the immunogenicity of Boostrix® vaccine co-administered with Fluarix® vaccine (Boostrix+Fluarix 19-64 YOA Group) at Day 0, was non-inferior to that of Boostrix® vaccine administered alone at Month 1 (Fluarix Boostrix 19-64 YOA Group), in terms of seroprotection rates for anti-D antibody, one month post-Boostrix® vaccination. | | | | | Difference in percentage | 1.06 | | | 2-Sided | 95 | -1.36 | 3.56 | | | | | Non-Inferiority | Non-inferiority was defined as the lower limit of the 95% confidence interval (CI) for the difference between the two groups (Boostrix+Fluarix 19-64 YOA Group minus Fluarix Boostrix 19-64 YOA Group), in terms of percentages of subjects with anti-D antibody concentrations ≥ 0.1 IU/mL, being ≥ - 10%. |
|
| Primary | Number of Subjects With Anti-T Antibody Concentrations ≥ the Assay Cut-off Value | The assay cut-off value was ≥ 1.0 IU/mL, as assessed by enzyme-linked immunosorbent assay (ELISA). | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available. | Posted | | Count of Participants | | Participants | | At Month 1 post-Boostrix® vaccination | | | | ID | Title | Description |
|---|
| OG000 | Boostrix+Fluarix 19-64 YOA Group | Healthy male or female adults, aged between 19 to 64 years inclusive, who received Boostrix® vaccine co-administered with Fluarix® vaccine at Day 0, injected intramuscularly in the left and right upper deltoid regions, respectively. | | OG001 | Fluarix Boostrix 19-64 YOA Group | Healthy male or female adults, aged between 19 to 64 years inclusive, who received Fluarix® vaccine at Day 0 and Boostrix® vaccine at Month 1, both injected intramuscularly in the upper left deltoid region. | | OG002 | Boostrix+Fluarix ≥ 65 YOA Group | Healthy male or female adults, aged 65 years or older, who received Boostrix® vaccine co-administered with Fluarix® vaccine at Day 0, injected intramuscularly in the left and right upper deltoid regions, respectively. |
|
| Primary | Antibody Concentrations Against Pertussis Toxoid (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) Antigens | Anti-PT, anti-FHA and anti-PRN antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per milliliter (EL.U/mL). | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available. | Posted | | Geometric Mean | 95% Confidence Interval | EL.U/mL | | At Month 1 post-Boostrix® vaccination | | | | ID | Title | Description |
|---|
| OG000 | Boostrix+Fluarix 19-64 YOA Group | Healthy male or female adults, aged between 19 to 64 years inclusive, who received Boostrix® vaccine co-administered with Fluarix® vaccine at Day 0, injected intramuscularly in the left and right upper deltoid regions, respectively. | | OG001 | Fluarix Boostrix 19-64 YOA Group | Healthy male or female adults, aged between 19 to 64 years inclusive, who received Fluarix® vaccine at Day 0 and Boostrix® vaccine at Month 1, both injected intramuscularly in the upper left deltoid region. | | OG002 | Boostrix+Fluarix ≥ 65 YOA Group | Healthy male or female adults, aged 65 years or older, who received Boostrix® vaccine co-administered with Fluarix® vaccine at Day 0, injected intramuscularly in the left and right upper deltoid regions, respectively. |
|
| Primary | Number of Subjects With Serum Haemagglutinin Inhibition (HI) Titers Against 3 Strains of Influenza | The antibody titer cut-off value for the 3 influenza strains assessed (H1N1, H3N2 and B) was ≥ 1:40. | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available. | Posted | | Count of Participants | | Participants | | At Month 1 post-Fluarix® vaccination | | | | ID | Title | Description |
|---|
| OG000 | Boostrix+Fluarix 19-64 YOA Group | Healthy male or female adults, aged between 19 to 64 years inclusive, who received Boostrix® vaccine co-administered with Fluarix® vaccine at Day 0, injected intramuscularly in the left and right upper deltoid regions, respectively. | | OG001 | Fluarix Boostrix 19-64 YOA Group | Healthy male or female adults, aged between 19 to 64 years inclusive, who received Fluarix® vaccine at Day 0 and Boostrix® vaccine at Month 1, both injected intramuscularly in the upper left deltoid region. | | OG002 | Boostrix+Fluarix ≥ 65 YOA Group | Healthy male or female adults, aged 65 years or older, who received Boostrix® vaccine co-administered with Fluarix® vaccine at Day 0, injected intramuscularly in the left and right upper deltoid regions, respectively. |
|
| Primary | Number of Seroconverted Subjects Against Influenza Antigens H1N1, H3N2, and B | Seroconversion for HI antibodies is defined as: For initially seronegative subjects: post-vaccination antibody titer ≥ 1:40 at Month 1 post-Boostrix® vaccination; For initially seropositive subjects: antibody titer at Month 1≥ 4 fold the pre-vaccination antibody titer. | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available. | Posted | | Count of Participants | | Participants | | At Month 1 post-Fluarix® vaccination | | | | ID | Title | Description |
|---|
| OG000 | Boostrix+Fluarix 19-64 YOA Group | Healthy male or female adults, aged between 19 to 64 years inclusive, who received Boostrix® vaccine co-administered with Fluarix® vaccine at Day 0, injected intramuscularly in the left and right upper deltoid regions, respectively. | | OG001 | Fluarix Boostrix 19-64 YOA Group | Healthy male or female adults, aged between 19 to 64 years inclusive, who received Fluarix® vaccine at Day 0 and Boostrix® vaccine at Month 1, both injected intramuscularly in the upper left deltoid region. | | OG002 | Boostrix+Fluarix ≥ 65 YOA Group | Healthy male or female adults, aged 65 years or older, who received Boostrix® vaccine co-administered with Fluarix® vaccine at Day 0, injected intramuscularly in the left and right upper deltoid regions, respectively. |
|
| Secondary | Number of Seropositive Subjects With Anti-D Antibody Concentrations Above the Cut-off Value | A seropositive subject was a subject whose antibody concentration was greater than or equal (≥) to the cut-off value of 1.0 IU/mL. | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available. | Posted | | Count of Participants | | Participants | | At Month 1 post-Boostrix® vaccination | | | | ID | Title | Description |
|---|
| OG000 | Boostrix+Fluarix 19-64 YOA Group | Healthy male or female adults, aged between 19 to 64 years inclusive, who received Boostrix® vaccine co-administered with Fluarix® vaccine at Day 0, injected intramuscularly in the left and right upper deltoid regions, respectively. | | OG001 | Fluarix Boostrix 19-64 YOA Group | Healthy male or female adults, aged between 19 to 64 years inclusive, who received Fluarix® vaccine at Day 0 and Boostrix® vaccine at Month 1, both injected intramuscularly in the upper left deltoid region. | | OG002 | Boostrix+Fluarix ≥ 65 YOA Group | Healthy male or female adults, aged 65 years or older, who received Boostrix® vaccine co-administered with Fluarix® vaccine at Day 0, injected intramuscularly in the left and right upper deltoid regions, respectively. |
|
| Secondary | Antibody Concentrations for Diphteria Toxoid (D) and Tetanus Toxoid (T) | Anti-D and anti-T antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in International Units per milliliter (IU/mL). | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available. | Posted | | Geometric Mean | 95% Confidence Interval | IU/mL | | At Day 0 and Month 1 post-Boostrix® vaccination | | | | ID | Title | Description |
|---|
| OG000 | Boostrix+Fluarix 19-64 YOA Group | Healthy male or female adults, aged between 19 to 64 years inclusive, who received Boostrix® vaccine co-administered with Fluarix® vaccine at Day 0, injected intramuscularly in the left and right upper deltoid regions, respectively. | | OG001 | Fluarix Boostrix 19-64 YOA Group | Healthy male or female adults, aged between 19 to 64 years inclusive, who received Fluarix® vaccine at Day 0 and Boostrix® vaccine at Month 1, both injected intramuscularly in the upper left deltoid region. | | OG002 | Boostrix+Fluarix ≥ 65 YOA Group | Healthy male or female adults, aged 65 years or older, who received Boostrix® vaccine co-administered with Fluarix® vaccine at Day 0, injected intramuscularly in the left and right upper deltoid regions, respectively. |
|
| Secondary | Antibody Concentrations for Pertussis Toxoid (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) | Anti-PT, anti-FHA and anti-PRN antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per milliliter (EL.U/mL). | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available. | Posted | | Geometric Mean | 95% Confidence Interval | EL.U/mL | | At Day 0 and Month 1 post-Boostrix® vaccination | | | | ID | Title | Description |
|---|
| OG000 | Boostrix+Fluarix 19-64 YOA Group | Healthy male or female adults, aged between 19 to 64 years inclusive, who received Boostrix® vaccine co-administered with Fluarix® vaccine at Day 0, injected intramuscularly in the left and right upper deltoid regions, respectively. | | OG001 | Fluarix Boostrix 19-64 YOA Group | Healthy male or female adults, aged between 19 to 64 years inclusive, who received Fluarix® vaccine at Day 0 and Boostrix® vaccine at Month 1, both injected intramuscularly in the upper left deltoid region. | | OG002 | Boostrix+Fluarix ≥ 65 YOA Group | Healthy male or female adults, aged 65 years or older, who received Boostrix® vaccine co-administered with Fluarix® vaccine at Day 0, injected intramuscularly in the left and right upper deltoid regions, respectively. |
|
| Secondary | Number of Subjects With Booster Response Against Diphteria Toxoid (D) and Tetanus Toxoid (T) Antigens | Booster responses for anti-D and anti-T antibodies are defined as: For initially seronegative subjects [pre-vaccination concentration below (<) cut-off 0.1 IU/mL]: antibody concentrations at least four times the assay cut-off (post-vaccination concentration ≥ 0.4 IU/mL), one month after vaccination with Boostrix®; For initially seropositive subjects (pre-vaccination concentration ≥ 0.1 IU/mL): an increase in antibody concentrations of at least four times the pre-vaccination concentration, one month after vaccination with Boostrix®. | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available. | Posted | | Count of Participants | | Participants | | At Month 1 post-Boostrix® vaccination | | | | ID | Title | Description |
|---|
| OG000 | Boostrix+Fluarix 19-64 YOA Group | Healthy male or female adults, aged between 19 to 64 years inclusive, who received Boostrix® vaccine co-administered with Fluarix® vaccine at Day 0, injected intramuscularly in the left and right upper deltoid regions, respectively. | | OG001 | Fluarix Boostrix 19-64 YOA Group | Healthy male or female adults, aged between 19 to 64 years inclusive, who received Fluarix® vaccine at Day 0 and Boostrix® vaccine at Month 1, both injected intramuscularly in the upper left deltoid region. |
|
| Secondary | Number of Subjects With Booster Response Against Pertussis Toxoid (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) Antigens | Booster responses for anti-PT, anti-FHA and anti-PRN are defined as: For initially seronegative subjects (pre-vaccination concentration < cut-off of 5 EL.U/mL): antibody concentrations at least four times the cut-off (post-vaccination concentration ≥ 20 EL.U/mL), one month after vaccination with Boostrix®; For initially seropositive subjects with pre-vaccination concentration ≥ 5 EL.U/mL and < 20 EL.U/mL: an increase in antibody concentrations of at least four times the pre-vaccination concentration one month after vaccination with Boostrix®; For initially seropositive subjects with pre-vaccination concentration ≥ 20 EL.U/mL: an increase in antibody concentrations of at least two times the pre-vaccination concentration one month after vaccination with Boostrix®. | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available. | Posted | | Count of Participants | | Participants | | At Month 1 post-Boostrix® vaccination | | | | ID | Title | Description |
|---|
| OG000 | Boostrix+Fluarix 19-64 YOA Group | Healthy male or female adults, aged between 19 to 64 years inclusive, who received Boostrix® vaccine co-administered with Fluarix® vaccine at Day 0, injected intramuscularly in the left and right upper deltoid regions, respectively. | | OG001 | Fluarix Boostrix 19-64 YOA Group | |
|
| Secondary | Anti-H1N1, Anti-H3N2 and Anti-B Antibody Titers | Anti-H1N1, anti-H3N2 and anti-B antibody titers are presented as geometric mean titers (GMTs). | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available. | Posted | | Geometric Mean | 95% Confidence Interval | Titers | | At Month 1 post-Fluarix® vaccination | | | | ID | Title | Description |
|---|
| OG000 | Boostrix+Fluarix 19-64 YOA Group | Healthy male or female adults, aged between 19 to 64 years inclusive, who received Boostrix® vaccine co-administered with Fluarix® vaccine at Day 0, injected intramuscularly in the left and right upper deltoid regions, respectively. | | OG001 | Fluarix Boostrix 19-64 YOA Group | Healthy male or female adults, aged between 19 to 64 years inclusive, who received Fluarix® vaccine at Day 0 and Boostrix® vaccine at Month 1, both injected intramuscularly in the upper left deltoid region. | | OG002 | Boostrix+Fluarix ≥ 65 YOA Group | Healthy male or female adults, aged 65 years or older, who received Boostrix® vaccine co-administered with Fluarix® vaccine at Day 0, injected intramuscularly in the left and right upper deltoid regions, respectively. |
|
| 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. Subjects from Boostrix+Fluarix Groups (19-64 YOA and ≥ 65 YOA) received only one vaccination dose (Boostrix® vaccine co-administered with Fluarix® vaccine), at Day 0. | The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with the symptom sheet filled in. | Posted | | Count of Participants | | Participants | | During the 15-day (Day 0-14) period following each dose and across doses, up to 2 months | | | | ID | Title | Description |
|---|
| OG000 | Boostrix+Fluarix 19-64 YOA Group | Healthy male or female adults, aged between 19 to 64 years inclusive, who received Boostrix® vaccine co-administered with Fluarix® vaccine at Day 0, injected intramuscularly in the left and right upper deltoid regions, respectively. | | OG001 | Fluarix Boostrix 19-64 YOA Group | Healthy male or female adults, aged between 19 to 64 years inclusive, who received Fluarix® vaccine at Day 0 and Boostrix® vaccine at Month 1, both injected intramuscularly in the upper left deltoid region. | |
|
| Secondary | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Assessed solicited general symptoms were fatigue, fever [defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)], gastrointestinal (nausea, vomiting, diarrhoea and/or abdominal pain), headache, joint pain, muscle aches and shivering. Any = occurrence of the symptom regardless of intensity grade or relationship to the study vaccination. 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. Subjects from Boostrix+Fluarix Groups (19-64 YOA and ≥ 65 YOA) received only one vaccination dose (Boostrix® vaccine co-administered with Fluarix® vaccine), at Day 0. | The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with the symptom sheet filled in. | Posted | | Count of Participants | | Participants | | During the 15-day (Day 0-14) period following each dose and across doses, up to 2 months | | | | ID | Title | Description |
|---|
| OG000 | Boostrix+Fluarix 19-64 YOA Group | Healthy male or female adults, aged between 19 to 64 years inclusive, who received Boostrix® vaccine co-administered with Fluarix® vaccine at Day 0, injected intramuscularly in the left and right upper deltoid regions, respectively. | | OG001 | Fluarix Boostrix 19-64 YOA Group | Healthy male or female adults, aged between 19 to 64 years inclusive, who received Fluarix® vaccine at Day 0 and Boostrix® vaccine at Month 1, both injected intramuscularly in the upper left deltoid region. |
|
| 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 at least one vaccine administration documented. | Posted | | Count of Participants | | Participants | | During the 31-day period (Day 0-30) following each vaccination, up to 2 months | | | | ID | Title | Description |
|---|
| OG000 | Boostrix+Fluarix 19-64 YOA Group | Healthy male or female adults, aged between 19 to 64 years inclusive, who received Boostrix® vaccine co-administered with Fluarix® vaccine at Day 0, injected intramuscularly in the left and right upper deltoid regions, respectively. | | OG001 | Fluarix Boostrix 19-64 YOA Group | Healthy male or female adults, aged between 19 to 64 years inclusive, who received Fluarix® vaccine at Day 0 and Boostrix® vaccine at Month 1, both injected intramuscularly in the upper left deltoid region. | |
|
| Secondary | Number of Subjects With Serious Adverse Events (SAEs) | 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 at least one vaccine administration documented. | Posted | | Count of Participants | | Participants | | Throughout the whole study period (from Day 0 to Month 2) | | | | ID | Title | Description |
|---|
| OG000 | Boostrix+Fluarix 19-64 YOA Group | Healthy male or female adults, aged between 19 to 64 years inclusive, who received Boostrix® vaccine co-administered with Fluarix® vaccine at Day 0, injected intramuscularly in the left and right upper deltoid regions, respectively. | | OG001 | Fluarix Boostrix 19-64 YOA Group | Healthy male or female adults, aged between 19 to 64 years inclusive, who received Fluarix® vaccine at Day 0 and Boostrix® vaccine at Month 1, both injected intramuscularly in the upper left deltoid region. | | OG002 | Boostrix+Fluarix ≥ 65 YOA Group | Healthy male or female adults, aged 65 years or older, who received Boostrix® vaccine co-administered with Fluarix® vaccine at Day 0, injected intramuscularly in the left and right upper deltoid regions, respectively. |
|