Acellular Pertussis, Diphtheria, Tetanus
Conditions
Keywords
Immunogenicity,, Influenza, Co-administration,, Tdap,
Brief summary
The current study will provide information for the use of Boostrix concomitantly with influenza vaccine in adults aged 19-64 years. This study will also provide safety and immunogenicity data in a cohort of adults aged greater than or equal to 65 years.
Interventions
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Healthy male or female adults aged between 19 to 64 years, inclusive for the primary cohort), or aged 65 years or older (for the exploratory cohort), at the time of vaccination.
Exclusion criteria
* Administration of an influenza vaccine within six months prior to study entry * Administration of a diphtheria-tetanus (Td) booster within the previous 5 years. * Administration of a Tdap vaccine at any time prior to study entry. * Administration of any investigational or non-registered drug or vaccine other than the study vaccines within 30 days preceding vaccination, or planned use during the entire study period. * History of diphtheria and/or tetanus and/or pertussis disease. * History of serious allergic reaction (e.g. anaphylaxis) following any other tetanus toxoid, diphtheria toxoid or pertussis-containing vaccine or influenza vaccine or any component of the study vaccines.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Toxoid Antigens | At Month 1 post-Boostrix® vaccination | 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. |
| Number of Subjects With Anti-T Antibody Concentrations ≥ the Assay Cut-off Value | At Month 1 post-Boostrix® vaccination | The assay cut-off value was ≥ 1.0 IU/mL, as assessed by enzyme-linked immunosorbent assay (ELISA). |
| Antibody Concentrations Against Pertussis Toxoid (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) Antigens | At Month 1 post-Boostrix® vaccination | 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). |
| Number of Subjects With Serum Haemagglutinin Inhibition (HI) Titers Against 3 Strains of Influenza | At Month 1 post-Fluarix® vaccination | The antibody titer cut-off value for the 3 influenza strains assessed (H1N1, H3N2 and B) was ≥ 1:40. |
| Number of Seroconverted Subjects Against Influenza Antigens H1N1, H3N2, and B | At Month 1 post-Fluarix® vaccination | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anti-H1N1, Anti-H3N2 and Anti-B Antibody Titers | At Month 1 post-Fluarix® vaccination | Anti-H1N1, anti-H3N2 and anti-B antibody titers are presented as geometric mean titers (GMTs). |
| Number of Subjects With Any and Grade 3 Solicited Local Symptoms | During the 15-day (Day 0-14) period following each dose and across doses, up to 2 months | 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. |
| Number of Seropositive Subjects With Anti-D Antibody Concentrations Above the Cut-off Value | At Month 1 post-Boostrix® vaccination | A seropositive subject was a subject whose antibody concentration was greater than or equal (≥) to the cut-off value of 1.0 IU/mL. |
| Number of Subjects With Any Unsolicited Adverse Events (AEs) | During the 31-day period (Day 0-30) following each vaccination, up to 2 months | 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. |
| Number of Subjects With Serious Adverse Events (SAEs) | Throughout the whole study period (from Day 0 to Month 2) | SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. |
| Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | During the 15-day (Day 0-14) period following each dose and across doses, up to 2 months | 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. |
| Antibody Concentrations for Diphteria Toxoid (D) and Tetanus Toxoid (T) | At Day 0 and Month 1 post-Boostrix® vaccination | Anti-D and anti-T antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in International Units per milliliter (IU/mL). |
| Antibody Concentrations for Pertussis Toxoid (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) | At Day 0 and Month 1 post-Boostrix® vaccination | 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). |
| Number of Subjects With Booster Response Against Diphteria Toxoid (D) and Tetanus Toxoid (T) Antigens | At Month 1 post-Boostrix® vaccination | 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®. |
| Number of Subjects With Booster Response Against Pertussis Toxoid (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) Antigens | At Month 1 post-Boostrix® vaccination | 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®. |
Countries
United States
Participant flow
Pre-assignment details
Out of the 1726 subjects originally enrolled in this study, 8 subjects (7 subjects from the 19-64 years of age cohort and 1 subject from the 65 years of age cohort) did not receive the study vaccine and hence were not included in the Total Vaccinated Cohort.
Participants by arm
| Arm | Count |
|---|---|
| Boostrix+Fluarix Group Healthy male or female adults, aged between 19 to 64 years inclusive and 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. | 860 |
| Fluarix Boostrix Group Healthy male or female adults, aged between 19 to 64 years inclusive and 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. | 858 |
| Total | 1,718 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 20 | 58 |
| Overall Study | Migrated/moved from study area | 0 | 1 |
| Overall Study | Protocol Violation | 0 | 4 |
| Overall Study | Serious Adverse Event | 1 | 2 |
| Overall Study | Withdrawal by Subject | 0 | 8 |
Baseline characteristics
| Characteristic | Fluarix Boostrix Group | Total | Boostrix+Fluarix Group |
|---|---|---|---|
| Age, Continuous | 49.29 Years STANDARD_DEVIATION 14.58 | 49.12 Years STANDARD_DEVIATION 14.66 | 48.95 Years STANDARD_DEVIATION 14.74 |
| Race/Ethnicity, Customized Geographic ancestry African heritage/African American | 82 Participants | 151 Participants | 69 Participants |
| Race/Ethnicity, Customized Geographic ancestry American Indian or Alaskan native | 0 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized Geographic ancestry Asian-Central/South Asian heritage | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Geographic ancestry Asian-East Asian heritage | 2 Participants | 3 Participants | 1 Participants |
| Race/Ethnicity, Customized Geographic ancestry Asian-Japanese heritage | 2 Participants | 3 Participants | 1 Participants |
| Race/Ethnicity, Customized Geographic ancestry Asian-South East Asian heritage | 4 Participants | 7 Participants | 3 Participants |
| Race/Ethnicity, Customized Geographic ancestry Native Hawaiian or other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Geographic ancestry Not specified | 16 Participants | 33 Participants | 17 Participants |
| Race/Ethnicity, Customized Geographic ancestry White-Arabic/North African heritage | 4 Participants | 11 Participants | 7 Participants |
| Race/Ethnicity, Customized Geographic ancestry White-Caucasian/European heritage | 747 Participants | 1506 Participants | 759 Participants |
| Sex: Female, Male Female | 481 Participants | 1008 Participants | 527 Participants |
| Sex: Female, Male Male | 377 Participants | 710 Participants | 333 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 860 | 0 / 858 |
| other Total, other adverse events | 640 / 860 | 619 / 858 |
| serious Total, serious adverse events | 3 / 860 | 7 / 858 |
Outcome results
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).
Time frame: At Month 1 post-Boostrix® vaccination
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Boostrix+Fluarix 19-64 YOA Group | Antibody Concentrations Against Pertussis Toxoid (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) Antigens | Anti-PT | 57.5 EL.U/mL |
| Boostrix+Fluarix 19-64 YOA Group | Antibody Concentrations Against Pertussis Toxoid (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) Antigens | Anti-FHA | 467.6 EL.U/mL |
| Boostrix+Fluarix 19-64 YOA Group | Antibody Concentrations Against Pertussis Toxoid (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) Antigens | Anti-PRN | 234.9 EL.U/mL |
| Fluarix Boostrix 19-64 YOA Group | Antibody Concentrations Against Pertussis Toxoid (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) Antigens | Anti-PRN | 343.6 EL.U/mL |
| Fluarix Boostrix 19-64 YOA Group | Antibody Concentrations Against Pertussis Toxoid (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) Antigens | Anti-FHA | 663.3 EL.U/mL |
| Fluarix Boostrix 19-64 YOA Group | Antibody Concentrations Against Pertussis Toxoid (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) Antigens | Anti-PT | 76.9 EL.U/mL |
| Boostrix+Fluarix ≥ 65 YOA Group | Antibody Concentrations Against Pertussis Toxoid (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) Antigens | Anti-PT | 51.2 EL.U/mL |
| Boostrix+Fluarix ≥ 65 YOA Group | Antibody Concentrations Against Pertussis Toxoid (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) Antigens | Anti-FHA | 502.5 EL.U/mL |
| Boostrix+Fluarix ≥ 65 YOA Group | Antibody Concentrations Against Pertussis Toxoid (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) Antigens | Anti-PRN | 87.9 EL.U/mL |
| Fluarix Boostrix ≥ 65 YOA Group | Antibody Concentrations Against Pertussis Toxoid (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) Antigens | Anti-PT | 59.3 EL.U/mL |
| Fluarix Boostrix ≥ 65 YOA Group | Antibody Concentrations Against Pertussis Toxoid (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) Antigens | Anti-FHA | 669.6 EL.U/mL |
| Fluarix Boostrix ≥ 65 YOA Group | Antibody Concentrations Against Pertussis Toxoid (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) Antigens | Anti-PRN | 97.0 EL.U/mL |
Comparison: Difference in adjusted GMC ratios for anti-PT antibody: 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 geometric mean concentrations (GMCs) for anti-PT antibody, one month post-Boostrix® vaccination.95% CI: [0.67, 0.82]ANCOVA
Comparison: Difference in adjusted GMC ratio for anti-FHA antibody: 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 geometric mean concentrations (GMCs) for anti-FHA antibody, one month post-Boostrix® vaccination.95% CI: [0.64, 0.79]ANCOVA
Comparison: Difference in adjusted GMC ratio for anti-PRN antibody: 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 geometric mean concentrations (GMCs) for anti-PRN antibody, one month post-Boostrix® vaccination.95% CI: [0.6, 0.81]ANCOVA
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.
Time frame: At Month 1 post-Fluarix® vaccination
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Boostrix+Fluarix 19-64 YOA Group | Number of Seroconverted Subjects Against Influenza Antigens H1N1, H3N2, and B | Anti-B | 463 Participants |
| Boostrix+Fluarix 19-64 YOA Group | Number of Seroconverted Subjects Against Influenza Antigens H1N1, H3N2, and B | Anti-H1N1 | 414 Participants |
| Boostrix+Fluarix 19-64 YOA Group | Number of Seroconverted Subjects Against Influenza Antigens H1N1, H3N2, and B | Anti-H3N2 | 560 Participants |
| Fluarix Boostrix 19-64 YOA Group | Number of Seroconverted Subjects Against Influenza Antigens H1N1, H3N2, and B | Anti-H1N1 | 377 Participants |
| Fluarix Boostrix 19-64 YOA Group | Number of Seroconverted Subjects Against Influenza Antigens H1N1, H3N2, and B | Anti-B | 425 Participants |
| Fluarix Boostrix 19-64 YOA Group | Number of Seroconverted Subjects Against Influenza Antigens H1N1, H3N2, and B | Anti-H3N2 | 494 Participants |
| Boostrix+Fluarix ≥ 65 YOA Group | Number of Seroconverted Subjects Against Influenza Antigens H1N1, H3N2, and B | Anti-H3N2 | 72 Participants |
| Boostrix+Fluarix ≥ 65 YOA Group | Number of Seroconverted Subjects Against Influenza Antigens H1N1, H3N2, and B | Anti-H1N1 | 37 Participants |
| Boostrix+Fluarix ≥ 65 YOA Group | Number of Seroconverted Subjects Against Influenza Antigens H1N1, H3N2, and B | Anti-B | 41 Participants |
| Fluarix Boostrix ≥ 65 YOA Group | Number of Seroconverted Subjects Against Influenza Antigens H1N1, H3N2, and B | Anti-H1N1 | 32 Participants |
| Fluarix Boostrix ≥ 65 YOA Group | Number of Seroconverted Subjects Against Influenza Antigens H1N1, H3N2, and B | Anti-B | 43 Participants |
| Fluarix Boostrix ≥ 65 YOA Group | Number of Seroconverted Subjects Against Influenza Antigens H1N1, H3N2, and B | Anti-H3N2 | 64 Participants |
Comparison: Difference in seroconversion rates for anti-H1N1 antibody: 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 Fluarix® vaccine administered alone at Day 0 (Fluarix Boostrix 19-64 YOA Group), in terms of seroconversion rates for anti-H1N1 antibody, one month post-Fluarix® vaccination.95% CI: [-2.84, 7.58]
Comparison: Difference in seroconversion rates for anti-H3N2 antibody: 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 Fluarix® vaccine administered alone at Day 0 (Fluarix Boostrix 19-64 YOA Group), in terms of seroconversion rates for anti-H3N2 antibody, one month post-Fluarix® vaccination.95% CI: [1.1, 10.07]
Comparison: Difference in seroconversion rates for anti-B antibody: 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 Fluarix® vaccine administered alone at Day 0 (Fluarix Boostrix 19-64 YOA Group), in terms of seroconversion rates for anti-B antibody, one month post-Fluarix® vaccination.95% CI: [-2.9, 7.2]
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.
Time frame: At Month 1 post-Boostrix® vaccination
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Boostrix+Fluarix 19-64 YOA Group | Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Toxoid Antigens | Anti-D | 677 Participants |
| Boostrix+Fluarix 19-64 YOA Group | Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Toxoid Antigens | Anti-T | 700 Participants |
| Fluarix Boostrix 19-64 YOA Group | Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Toxoid Antigens | Anti-T | 653 Participants |
| Fluarix Boostrix 19-64 YOA Group | Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Toxoid Antigens | Anti-D | 614 Participants |
| Boostrix+Fluarix ≥ 65 YOA Group | Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Toxoid Antigens | Anti-T | 105 Participants |
| Boostrix+Fluarix ≥ 65 YOA Group | Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Toxoid Antigens | Anti-D | 93 Participants |
| Fluarix Boostrix ≥ 65 YOA Group | Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Toxoid Antigens | Anti-D | 79 Participants |
| Fluarix Boostrix ≥ 65 YOA Group | Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Toxoid Antigens | Anti-T | 95 Participants |
Comparison: 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.95% CI: [-1.36, 3.56]
Comparison: Difference in seroprotection rates against tetanus 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-T antibody, one month post-Boostrix® vaccination.95% CI: [-2.96, -0.74]
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).
Time frame: At Month 1 post-Boostrix® vaccination
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Boostrix+Fluarix 19-64 YOA Group | Number of Subjects With Anti-T Antibody Concentrations ≥ the Assay Cut-off Value | 687 Participants |
| Fluarix Boostrix 19-64 YOA Group | Number of Subjects With Anti-T Antibody Concentrations ≥ the Assay Cut-off Value | 621 Participants |
| Boostrix+Fluarix ≥ 65 YOA Group | Number of Subjects With Anti-T Antibody Concentrations ≥ the Assay Cut-off Value | 94 Participants |
| Fluarix Boostrix ≥ 65 YOA Group | Number of Subjects With Anti-T Antibody Concentrations ≥ the Assay Cut-off Value | 84 Participants |
Comparison: Difference in seropositivity rates against tetanus 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 seropositivity rates for anti-T antibody, one month post-Boostrix® vaccination.95% CI: [-0.77, 3.68]
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.
Time frame: At Month 1 post-Fluarix® vaccination
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Boostrix+Fluarix 19-64 YOA Group | Number of Subjects With Serum Haemagglutinin Inhibition (HI) Titers Against 3 Strains of Influenza | Anti-H3N2 | 694 Participants |
| Boostrix+Fluarix 19-64 YOA Group | Number of Subjects With Serum Haemagglutinin Inhibition (HI) Titers Against 3 Strains of Influenza | Anti-B | 685 Participants |
| Boostrix+Fluarix 19-64 YOA Group | Number of Subjects With Serum Haemagglutinin Inhibition (HI) Titers Against 3 Strains of Influenza | Anti-H1N1 | 669 Participants |
| Fluarix Boostrix 19-64 YOA Group | Number of Subjects With Serum Haemagglutinin Inhibition (HI) Titers Against 3 Strains of Influenza | Anti-H3N2 | 663 Participants |
| Fluarix Boostrix 19-64 YOA Group | Number of Subjects With Serum Haemagglutinin Inhibition (HI) Titers Against 3 Strains of Influenza | Anti-B | 654 Participants |
| Fluarix Boostrix 19-64 YOA Group | Number of Subjects With Serum Haemagglutinin Inhibition (HI) Titers Against 3 Strains of Influenza | Anti-H1N1 | 643 Participants |
| Boostrix+Fluarix ≥ 65 YOA Group | Number of Subjects With Serum Haemagglutinin Inhibition (HI) Titers Against 3 Strains of Influenza | Anti-B | 107 Participants |
| Boostrix+Fluarix ≥ 65 YOA Group | Number of Subjects With Serum Haemagglutinin Inhibition (HI) Titers Against 3 Strains of Influenza | Anti-H1N1 | 92 Participants |
| Boostrix+Fluarix ≥ 65 YOA Group | Number of Subjects With Serum Haemagglutinin Inhibition (HI) Titers Against 3 Strains of Influenza | Anti-H3N2 | 104 Participants |
| Fluarix Boostrix ≥ 65 YOA Group | Number of Subjects With Serum Haemagglutinin Inhibition (HI) Titers Against 3 Strains of Influenza | Anti-H3N2 | 95 Participants |
| Fluarix Boostrix ≥ 65 YOA Group | Number of Subjects With Serum Haemagglutinin Inhibition (HI) Titers Against 3 Strains of Influenza | Anti-B | 101 Participants |
| Fluarix Boostrix ≥ 65 YOA Group | Number of Subjects With Serum Haemagglutinin Inhibition (HI) Titers Against 3 Strains of Influenza | Anti-H1N1 | 88 Participants |
Comparison: Difference in percentage of subjects with anti-H1N1 antibody titers ≥ 1:40: 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 Fluarix® vaccine administered alone at Day 0 (Fluarix Boostrix 19-64 YOA Group), in terms of percentage of subjects with anti-H1N1 antibody titers ≥ 1:40, one month post-Fluarix® vaccination.95% CI: [-3.58, 1.23]
Comparison: Difference in percentage of subjects with anti-H3N2 antibody titers ≥ 1:40: 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 Fluarix® vaccine administered alone at Day 0 (Fluarix Boostrix 19-64 YOA Group), in terms of percentage of subjects with anti-H3N2 antibody titers ≥ 1:40, one month post-Fluarix® vaccination.95% CI: [-2.22, 0.96]
Comparison: Difference in percentage of subjects with anti-B antibody titers ≥ 1:40: 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 Fluarix® vaccine administered alone at Day 0 (Fluarix Boostrix 19-64 YOA Group), in terms of percentage of subjects with anti-B antibody titers ≥ 1:40, one month post-Fluarix® vaccination.95% CI: [-2.52, 1.42]
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).
Time frame: At Day 0 and Month 1 post-Boostrix® vaccination
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Boostrix+Fluarix 19-64 YOA Group | Antibody Concentrations for Diphteria Toxoid (D) and Tetanus Toxoid (T) | Anti-T, Day 0 | 1.5 IU/mL |
| Boostrix+Fluarix 19-64 YOA Group | Antibody Concentrations for Diphteria Toxoid (D) and Tetanus Toxoid (T) | Anti-D, Month 1 | 3.1 IU/mL |
| Boostrix+Fluarix 19-64 YOA Group | Antibody Concentrations for Diphteria Toxoid (D) and Tetanus Toxoid (T) | Anti-D, Day 0 | 0.4 IU/mL |
| Boostrix+Fluarix 19-64 YOA Group | Antibody Concentrations for Diphteria Toxoid (D) and Tetanus Toxoid (T) | Anti-T, Month 1 | 6.5 IU/mL |
| Fluarix Boostrix 19-64 YOA Group | Antibody Concentrations for Diphteria Toxoid (D) and Tetanus Toxoid (T) | Anti-D, Month 1 | 3.4 IU/mL |
| Fluarix Boostrix 19-64 YOA Group | Antibody Concentrations for Diphteria Toxoid (D) and Tetanus Toxoid (T) | Anti-D, Day 0 | 0.4 IU/mL |
| Fluarix Boostrix 19-64 YOA Group | Antibody Concentrations for Diphteria Toxoid (D) and Tetanus Toxoid (T) | Anti-T, Day 0 | 1.5 IU/mL |
| Fluarix Boostrix 19-64 YOA Group | Antibody Concentrations for Diphteria Toxoid (D) and Tetanus Toxoid (T) | Anti-T, Month 1 | 7.6 IU/mL |
| Boostrix+Fluarix ≥ 65 YOA Group | Antibody Concentrations for Diphteria Toxoid (D) and Tetanus Toxoid (T) | Anti-D, Day 0 | 0.2 IU/mL |
| Boostrix+Fluarix ≥ 65 YOA Group | Antibody Concentrations for Diphteria Toxoid (D) and Tetanus Toxoid (T) | Anti-T, Month 1 | 3.4 IU/mL |
| Boostrix+Fluarix ≥ 65 YOA Group | Antibody Concentrations for Diphteria Toxoid (D) and Tetanus Toxoid (T) | Anti-T, Day 0 | 0.5 IU/mL |
| Boostrix+Fluarix ≥ 65 YOA Group | Antibody Concentrations for Diphteria Toxoid (D) and Tetanus Toxoid (T) | Anti-D, Month 1 | 1.0 IU/mL |
| Fluarix Boostrix ≥ 65 YOA Group | Antibody Concentrations for Diphteria Toxoid (D) and Tetanus Toxoid (T) | Anti-D, Month 1 | 1.0 IU/mL |
| Fluarix Boostrix ≥ 65 YOA Group | Antibody Concentrations for Diphteria Toxoid (D) and Tetanus Toxoid (T) | Anti-T, Month 1 | 3.6 IU/mL |
| Fluarix Boostrix ≥ 65 YOA Group | Antibody Concentrations for Diphteria Toxoid (D) and Tetanus Toxoid (T) | Anti-D, Day 0 | 0.2 IU/mL |
| Fluarix Boostrix ≥ 65 YOA Group | Antibody Concentrations for Diphteria Toxoid (D) and Tetanus Toxoid (T) | Anti-T, Day 0 | 0.6 IU/mL |
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).
Time frame: At Day 0 and Month 1 post-Boostrix® vaccination
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Boostrix+Fluarix 19-64 YOA Group | Antibody Concentrations for Pertussis Toxoid (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) | Anti-PT, Day 0 | 6.4 EL.U/mL |
| Boostrix+Fluarix 19-64 YOA Group | Antibody Concentrations for Pertussis Toxoid (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) | Anti-PT, Month 1 | 57.5 EL.U/mL |
| Boostrix+Fluarix 19-64 YOA Group | Antibody Concentrations for Pertussis Toxoid (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) | Anti-FHA, Day 0 | 36.6 EL.U/mL |
| Boostrix+Fluarix 19-64 YOA Group | Antibody Concentrations for Pertussis Toxoid (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) | Anti-FHA, Month 1 | 467.6 EL.U/mL |
| Boostrix+Fluarix 19-64 YOA Group | Antibody Concentrations for Pertussis Toxoid (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) | Anti-PRN, Day 0 | 12.6 EL.U/mL |
| Boostrix+Fluarix 19-64 YOA Group | Antibody Concentrations for Pertussis Toxoid (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) | Anti-PRN, Month 1 | 234.9 EL.U/mL |
| Fluarix Boostrix 19-64 YOA Group | Antibody Concentrations for Pertussis Toxoid (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) | Anti-PRN, Month 1 | 343.6 EL.U/mL |
| Fluarix Boostrix 19-64 YOA Group | Antibody Concentrations for Pertussis Toxoid (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) | Anti-FHA, Month 1 | 663.3 EL.U/mL |
| Fluarix Boostrix 19-64 YOA Group | Antibody Concentrations for Pertussis Toxoid (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) | Anti-PT, Day 0 | 6.5 EL.U/mL |
| Fluarix Boostrix 19-64 YOA Group | Antibody Concentrations for Pertussis Toxoid (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) | Anti-FHA, Day 0 | 36.2 EL.U/mL |
| Fluarix Boostrix 19-64 YOA Group | Antibody Concentrations for Pertussis Toxoid (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) | Anti-PT, Month 1 | 76.9 EL.U/mL |
| Fluarix Boostrix 19-64 YOA Group | Antibody Concentrations for Pertussis Toxoid (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) | Anti-PRN, Day 0 | 12.9 EL.U/mL |
| Boostrix+Fluarix ≥ 65 YOA Group | Antibody Concentrations for Pertussis Toxoid (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) | Anti-PT, Month 1 | 51.2 EL.U/mL |
| Boostrix+Fluarix ≥ 65 YOA Group | Antibody Concentrations for Pertussis Toxoid (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) | Anti-FHA, Day 0 | 54.5 EL.U/mL |
| Boostrix+Fluarix ≥ 65 YOA Group | Antibody Concentrations for Pertussis Toxoid (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) | Anti-FHA, Month 1 | 502.5 EL.U/mL |
| Boostrix+Fluarix ≥ 65 YOA Group | Antibody Concentrations for Pertussis Toxoid (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) | Anti-PRN, Month 1 | 87.9 EL.U/mL |
| Boostrix+Fluarix ≥ 65 YOA Group | Antibody Concentrations for Pertussis Toxoid (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) | Anti-PRN, Day 0 | 7.5 EL.U/mL |
| Boostrix+Fluarix ≥ 65 YOA Group | Antibody Concentrations for Pertussis Toxoid (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) | Anti-PT, Day 0 | 8.0 EL.U/mL |
| Fluarix Boostrix ≥ 65 YOA Group | Antibody Concentrations for Pertussis Toxoid (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) | Anti-PRN, Day 0 | 6.4 EL.U/mL |
| Fluarix Boostrix ≥ 65 YOA Group | Antibody Concentrations for Pertussis Toxoid (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) | Anti-PRN, Month 1 | 97.0 EL.U/mL |
| Fluarix Boostrix ≥ 65 YOA Group | Antibody Concentrations for Pertussis Toxoid (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) | Anti-PT, Month 1 | 59.3 EL.U/mL |
| Fluarix Boostrix ≥ 65 YOA Group | Antibody Concentrations for Pertussis Toxoid (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) | Anti-FHA, Month 1 | 669.6 EL.U/mL |
| Fluarix Boostrix ≥ 65 YOA Group | Antibody Concentrations for Pertussis Toxoid (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) | Anti-PT, Day 0 | 8.0 EL.U/mL |
| Fluarix Boostrix ≥ 65 YOA Group | Antibody Concentrations for Pertussis Toxoid (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) | Anti-FHA, Day 0 | 59.0 EL.U/mL |
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).
Time frame: At Month 1 post-Fluarix® vaccination
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Boostrix+Fluarix 19-64 YOA Group | Anti-H1N1, Anti-H3N2 and Anti-B Antibody Titers | Anti-H1N1 | 189.1 Titers |
| Boostrix+Fluarix 19-64 YOA Group | Anti-H1N1, Anti-H3N2 and Anti-B Antibody Titers | Anti-B | 210.1 Titers |
| Boostrix+Fluarix 19-64 YOA Group | Anti-H1N1, Anti-H3N2 and Anti-B Antibody Titers | Anti-H3N2 | 368.7 Titers |
| Fluarix Boostrix 19-64 YOA Group | Anti-H1N1, Anti-H3N2 and Anti-B Antibody Titers | Anti-H1N1 | 181.6 Titers |
| Fluarix Boostrix 19-64 YOA Group | Anti-H1N1, Anti-H3N2 and Anti-B Antibody Titers | Anti-B | 222.8 Titers |
| Fluarix Boostrix 19-64 YOA Group | Anti-H1N1, Anti-H3N2 and Anti-B Antibody Titers | Anti-H3N2 | 337.3 Titers |
| Boostrix+Fluarix ≥ 65 YOA Group | Anti-H1N1, Anti-H3N2 and Anti-B Antibody Titers | Anti-H3N2 | 333.6 Titers |
| Boostrix+Fluarix ≥ 65 YOA Group | Anti-H1N1, Anti-H3N2 and Anti-B Antibody Titers | Anti-H1N1 | 79.9 Titers |
| Boostrix+Fluarix ≥ 65 YOA Group | Anti-H1N1, Anti-H3N2 and Anti-B Antibody Titers | Anti-B | 221.2 Titers |
| Fluarix Boostrix ≥ 65 YOA Group | Anti-H1N1, Anti-H3N2 and Anti-B Antibody Titers | Anti-H1N1 | 89.3 Titers |
| Fluarix Boostrix ≥ 65 YOA Group | Anti-H1N1, Anti-H3N2 and Anti-B Antibody Titers | Anti-B | 214.3 Titers |
| Fluarix Boostrix ≥ 65 YOA Group | Anti-H1N1, Anti-H3N2 and Anti-B Antibody Titers | Anti-H3N2 | 276.8 Titers |
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.
Time frame: At Month 1 post-Boostrix® vaccination
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Boostrix+Fluarix 19-64 YOA Group | Number of Seropositive Subjects With Anti-D Antibody Concentrations Above the Cut-off Value | 579 Participants |
| Fluarix Boostrix 19-64 YOA Group | Number of Seropositive Subjects With Anti-D Antibody Concentrations Above the Cut-off Value | 528 Participants |
| Boostrix+Fluarix ≥ 65 YOA Group | Number of Seropositive Subjects With Anti-D Antibody Concentrations Above the Cut-off Value | 55 Participants |
| Fluarix Boostrix ≥ 65 YOA Group | Number of Seropositive Subjects With Anti-D Antibody Concentrations Above the Cut-off Value | 49 Participants |
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.
Time frame: During the 15-day (Day 0-14) period following each dose and across doses, up to 2 months
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Boostrix+Fluarix 19-64 YOA Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 1 | 28 Participants |
| Boostrix+Fluarix 19-64 YOA Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Across doses | 179 Participants |
| Boostrix+Fluarix 19-64 YOA Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 1 | 179 Participants |
| Boostrix+Fluarix 19-64 YOA Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 1 | 4 Participants |
| Boostrix+Fluarix 19-64 YOA Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Across doses | 12 Participants |
| Boostrix+Fluarix 19-64 YOA Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 2 | 0 Participants |
| Boostrix+Fluarix 19-64 YOA Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 2 | 0 Participants |
| Boostrix+Fluarix 19-64 YOA Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 1 | 180 Participants |
| Boostrix+Fluarix 19-64 YOA Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Across doses | 4 Participants |
| Boostrix+Fluarix 19-64 YOA Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Across doses | 180 Participants |
| Boostrix+Fluarix 19-64 YOA Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Across doses | 467 Participants |
| Boostrix+Fluarix 19-64 YOA Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Across doses | 28 Participants |
| Boostrix+Fluarix 19-64 YOA Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 2 | 0 Participants |
| Boostrix+Fluarix 19-64 YOA Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 2 | 0 Participants |
| Boostrix+Fluarix 19-64 YOA Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 2 | 0 Participants |
| Boostrix+Fluarix 19-64 YOA Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 2 | 0 Participants |
| Boostrix+Fluarix 19-64 YOA Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 1 | 467 Participants |
| Boostrix+Fluarix 19-64 YOA Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 1 | 12 Participants |
| Fluarix Boostrix 19-64 YOA Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 1 | 315 Participants |
| Fluarix Boostrix 19-64 YOA Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 1 | 7 Participants |
| Fluarix Boostrix 19-64 YOA Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 2 | 106 Participants |
| Fluarix Boostrix 19-64 YOA Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 1 | 7 Participants |
| Fluarix Boostrix 19-64 YOA Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 1 | 148 Participants |
| Fluarix Boostrix 19-64 YOA Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 1 | 5 Participants |
| Fluarix Boostrix 19-64 YOA Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 1 | 93 Participants |
| Fluarix Boostrix 19-64 YOA Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 2 | 327 Participants |
| Fluarix Boostrix 19-64 YOA Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 2 | 3 Participants |
| Fluarix Boostrix 19-64 YOA Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 2 | 9 Participants |
| Fluarix Boostrix 19-64 YOA Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 2 | 124 Participants |
| Fluarix Boostrix 19-64 YOA Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 2 | 6 Participants |
| Fluarix Boostrix 19-64 YOA Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Across doses | 429 Participants |
| Fluarix Boostrix 19-64 YOA Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Across doses | 15 Participants |
| Fluarix Boostrix 19-64 YOA Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Across doses | 207 Participants |
| Fluarix Boostrix 19-64 YOA Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Across doses | 8 Participants |
| Fluarix Boostrix 19-64 YOA Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Across doses | 160 Participants |
| Fluarix Boostrix 19-64 YOA Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Across doses | 12 Participants |
| Boostrix+Fluarix ≥ 65 YOA Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Across doses | 18 Participants |
| Boostrix+Fluarix ≥ 65 YOA Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 2 | 0 Participants |
| Boostrix+Fluarix ≥ 65 YOA Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Across doses | 23 Participants |
| Boostrix+Fluarix ≥ 65 YOA Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 2 | 0 Participants |
| Boostrix+Fluarix ≥ 65 YOA Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 2 | 0 Participants |
| Boostrix+Fluarix ≥ 65 YOA Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 2 | 0 Participants |
| Boostrix+Fluarix ≥ 65 YOA Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 2 | 0 Participants |
| Boostrix+Fluarix ≥ 65 YOA Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 2 | 0 Participants |
| Boostrix+Fluarix ≥ 65 YOA Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Across doses | 3 Participants |
| Boostrix+Fluarix ≥ 65 YOA Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 1 | 41 Participants |
| Boostrix+Fluarix ≥ 65 YOA Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 1 | 3 Participants |
| Boostrix+Fluarix ≥ 65 YOA Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Across doses | 41 Participants |
| Boostrix+Fluarix ≥ 65 YOA Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Across doses | 3 Participants |
| Boostrix+Fluarix ≥ 65 YOA Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Across doses | 0 Participants |
| Boostrix+Fluarix ≥ 65 YOA Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 1 | 23 Participants |
| Boostrix+Fluarix ≥ 65 YOA Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 1 | 0 Participants |
| Boostrix+Fluarix ≥ 65 YOA Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 1 | 18 Participants |
| Boostrix+Fluarix ≥ 65 YOA Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 1 | 3 Participants |
| Fluarix Boostrix ≥ 65 YOA Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 1 | 2 Participants |
| Fluarix Boostrix ≥ 65 YOA Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Across doses | 1 Participants |
| Fluarix Boostrix ≥ 65 YOA Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 2 | 30 Participants |
| Fluarix Boostrix ≥ 65 YOA Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Across doses | 17 Participants |
| Fluarix Boostrix ≥ 65 YOA Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Across doses | 44 Participants |
| Fluarix Boostrix ≥ 65 YOA Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Across doses | 20 Participants |
| Fluarix Boostrix ≥ 65 YOA Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 1 | 1 Participants |
| Fluarix Boostrix ≥ 65 YOA Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 2 | 3 Participants |
| Fluarix Boostrix ≥ 65 YOA Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Across doses | 4 Participants |
| Fluarix Boostrix ≥ 65 YOA Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 1 | 11 Participants |
| Fluarix Boostrix ≥ 65 YOA Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 1 | 25 Participants |
| Fluarix Boostrix ≥ 65 YOA Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 2 | 16 Participants |
| Fluarix Boostrix ≥ 65 YOA Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 1 | 15 Participants |
| Fluarix Boostrix ≥ 65 YOA Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 2 | 2 Participants |
| Fluarix Boostrix ≥ 65 YOA Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 1 | 1 Participants |
| Fluarix Boostrix ≥ 65 YOA Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 2 | 9 Participants |
| Fluarix Boostrix ≥ 65 YOA Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Across doses | 4 Participants |
| Fluarix Boostrix ≥ 65 YOA Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 2 | 0 Participants |
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.
Time frame: During the 15-day (Day 0-14) period following each dose and across doses, up to 2 months
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Boostrix+Fluarix 19-64 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Shivering, Dose 1 | 8 Participants |
| Boostrix+Fluarix 19-64 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Shivering, Dose 1 | 42 Participants |
| Boostrix+Fluarix 19-64 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Dose 1 | 24 Participants |
| Boostrix+Fluarix 19-64 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Dose 2 | 0 Participants |
| Boostrix+Fluarix 19-64 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Across doses | 220 Participants |
| Boostrix+Fluarix 19-64 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Dose 2 | 0 Participants |
| Boostrix+Fluarix 19-64 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Muscle aches, Dose 2 | 0 Participants |
| Boostrix+Fluarix 19-64 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Joint pain, Dose 2 | 0 Participants |
| Boostrix+Fluarix 19-64 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Across doses | 24 Participants |
| Boostrix+Fluarix 19-64 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Dose 2 | 0 Participants |
| Boostrix+Fluarix 19-64 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Dose 2 | 0 Participants |
| Boostrix+Fluarix 19-64 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Across doses | 144 Participants |
| Boostrix+Fluarix 19-64 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Shivering, Dose 2 | 0 Participants |
| Boostrix+Fluarix 19-64 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Dose 2 | 0 Participants |
| Boostrix+Fluarix 19-64 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Joint pain, Dose 2 | 0 Participants |
| Boostrix+Fluarix 19-64 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal, Dose 1 | 121 Participants |
| Boostrix+Fluarix 19-64 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Across doses | 225 Participants |
| Boostrix+Fluarix 19-64 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Dose 2 | 0 Participants |
| Boostrix+Fluarix 19-64 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Joint pain, Dose 1 | 137 Participants |
| Boostrix+Fluarix 19-64 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Shivering, Dose 2 | 0 Participants |
| Boostrix+Fluarix 19-64 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Shivering, Dose 2 | 0 Participants |
| Boostrix+Fluarix 19-64 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal, Dose 2 | 0 Participants |
| Boostrix+Fluarix 19-64 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Across doses | 1 Participants |
| Boostrix+Fluarix 19-64 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Muscle aches, Across doses | 266 Participants |
| Boostrix+Fluarix 19-64 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Muscle aches, Across doses | 194 Participants |
| Boostrix+Fluarix 19-64 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Dose 1 | 54 Participants |
| Boostrix+Fluarix 19-64 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal, Across doses | 68 Participants |
| Boostrix+Fluarix 19-64 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Across doses | 54 Participants |
| Boostrix+Fluarix 19-64 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal, Dose 1 | 16 Participants |
| Boostrix+Fluarix 19-64 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Joint pain, Dose 2 | 0 Participants |
| Boostrix+Fluarix 19-64 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Shivering, Across doses | 70 Participants |
| Boostrix+Fluarix 19-64 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Dose 1 | 22 Participants |
| Boostrix+Fluarix 19-64 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Dose 2 | 0 Participants |
| Boostrix+Fluarix 19-64 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Joint pain, Across doses | 10 Participants |
| Boostrix+Fluarix 19-64 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal, Dose 1 | 68 Participants |
| Boostrix+Fluarix 19-64 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal, Across doses | 16 Participants |
| Boostrix+Fluarix 19-64 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Dose 1 | 144 Participants |
| Boostrix+Fluarix 19-64 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Muscle aches, Dose 1 | 266 Participants |
| Boostrix+Fluarix 19-64 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Joint pain, Dose 1 | 10 Participants |
| Boostrix+Fluarix 19-64 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Joint pain, Across doses | 97 Participants |
| Boostrix+Fluarix 19-64 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Joint pain, Dose 1 | 97 Participants |
| Boostrix+Fluarix 19-64 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Shivering, Across doses | 42 Participants |
| Boostrix+Fluarix 19-64 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Across doses | 22 Participants |
| Boostrix+Fluarix 19-64 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Muscle aches, Dose 1 | 27 Participants |
| Boostrix+Fluarix 19-64 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Muscle aches, Dose 2 | 0 Participants |
| Boostrix+Fluarix 19-64 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Muscle aches, Across doses | 27 Participants |
| Boostrix+Fluarix 19-64 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Dose 1 | 1 Participants |
| Boostrix+Fluarix 19-64 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Dose 2 | 0 Participants |
| Boostrix+Fluarix 19-64 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Joint pain, Across doses | 137 Participants |
| Boostrix+Fluarix 19-64 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Muscle aches, Dose 1 | 194 Participants |
| Boostrix+Fluarix 19-64 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal, Across doses | 121 Participants |
| Boostrix+Fluarix 19-64 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Dose 1 | 143 Participants |
| Boostrix+Fluarix 19-64 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Dose 2 | 0 Participants |
| Boostrix+Fluarix 19-64 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Shivering, Across doses | 8 Participants |
| Boostrix+Fluarix 19-64 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Dose 1 | 220 Participants |
| Boostrix+Fluarix 19-64 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal, Dose 2 | 0 Participants |
| Boostrix+Fluarix 19-64 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Shivering, Dose 1 | 70 Participants |
| Boostrix+Fluarix 19-64 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Muscle aches, Dose 2 | 0 Participants |
| Boostrix+Fluarix 19-64 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Across doses | 28 Participants |
| Boostrix+Fluarix 19-64 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal, Dose 2 | 0 Participants |
| Boostrix+Fluarix 19-64 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Dose 1 | 28 Participants |
| Boostrix+Fluarix 19-64 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Dose 1 | 225 Participants |
| Boostrix+Fluarix 19-64 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Across doses | 143 Participants |
| Fluarix Boostrix 19-64 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Across doses | 1 Participants |
| Fluarix Boostrix 19-64 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Dose 1 | 197 Participants |
| Fluarix Boostrix 19-64 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Dose 2 | 132 Participants |
| Fluarix Boostrix 19-64 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Across doses | 80 Participants |
| Fluarix Boostrix 19-64 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Dose 2 | 12 Participants |
| Fluarix Boostrix 19-64 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Dose 2 | 87 Participants |
| Fluarix Boostrix 19-64 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Across doses | 149 Participants |
| Fluarix Boostrix 19-64 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Joint pain, Dose 2 | 75 Participants |
| Fluarix Boostrix 19-64 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Joint pain, Dose 2 | 14 Participants |
| Fluarix Boostrix 19-64 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Dose 1 | 25 Participants |
| Fluarix Boostrix 19-64 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Across doses | 30 Participants |
| Fluarix Boostrix 19-64 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Joint pain, Dose 2 | 52 Participants |
| Fluarix Boostrix 19-64 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Across doses | 218 Participants |
| Fluarix Boostrix 19-64 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Muscle aches, Dose 2 | 21 Participants |
| Fluarix Boostrix 19-64 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Dose 1 | 118 Participants |
| Fluarix Boostrix 19-64 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Muscle aches, Dose 2 | 150 Participants |
| Fluarix Boostrix 19-64 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Joint pain, Across doses | 23 Participants |
| Fluarix Boostrix 19-64 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Shivering, Dose 2 | 34 Participants |
| Fluarix Boostrix 19-64 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Shivering, Dose 2 | 48 Participants |
| Fluarix Boostrix 19-64 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Shivering, Dose 2 | 7 Participants |
| Fluarix Boostrix 19-64 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Joint pain, Dose 1 | 87 Participants |
| Fluarix Boostrix 19-64 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Joint pain, Dose 1 | 10 Participants |
| Fluarix Boostrix 19-64 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Dose 1 | 52 Participants |
| Fluarix Boostrix 19-64 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Dose 1 | 15 Participants |
| Fluarix Boostrix 19-64 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Shivering, Across doses | 10 Participants |
| Fluarix Boostrix 19-64 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Joint pain, Across doses | 135 Participants |
| Fluarix Boostrix 19-64 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Muscle aches, Dose 1 | 15 Participants |
| Fluarix Boostrix 19-64 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Muscle aches, Dose 1 | 131 Participants |
| Fluarix Boostrix 19-64 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Across doses | 163 Participants |
| Fluarix Boostrix 19-64 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Shivering, Dose 1 | 44 Participants |
| Fluarix Boostrix 19-64 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Shivering, Dose 1 | 30 Participants |
| Fluarix Boostrix 19-64 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Dose 1 | 28 Participants |
| Fluarix Boostrix 19-64 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Across doses | 33 Participants |
| Fluarix Boostrix 19-64 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Dose 2 | 18 Participants |
| Fluarix Boostrix 19-64 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Dose 1 | 165 Participants |
| Fluarix Boostrix 19-64 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Dose 2 | 83 Participants |
| Fluarix Boostrix 19-64 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Shivering, Across doses | 80 Participants |
| Fluarix Boostrix 19-64 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Across doses | 251 Participants |
| Fluarix Boostrix 19-64 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Dose 2 | 38 Participants |
| Fluarix Boostrix 19-64 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Dose 2 | 1 Participants |
| Fluarix Boostrix 19-64 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal, Dose 1 | 101 Participants |
| Fluarix Boostrix 19-64 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal, Across doses | 73 Participants |
| Fluarix Boostrix 19-64 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Shivering, Across doses | 56 Participants |
| Fluarix Boostrix 19-64 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Muscle aches, Dose 2 | 183 Participants |
| Fluarix Boostrix 19-64 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Muscle aches, Across doses | 34 Participants |
| Fluarix Boostrix 19-64 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Muscle aches, Across doses | 224 Participants |
| Fluarix Boostrix 19-64 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal, Across doses | 16 Participants |
| Fluarix Boostrix 19-64 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Dose 1 | 0 Participants |
| Fluarix Boostrix 19-64 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal, Dose 1 | 11 Participants |
| Fluarix Boostrix 19-64 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Joint pain, Across doses | 89 Participants |
| Fluarix Boostrix 19-64 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Joint pain, Dose 1 | 56 Participants |
| Fluarix Boostrix 19-64 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Muscle aches, Dose 1 | 193 Participants |
| Fluarix Boostrix 19-64 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Shivering, Dose 1 | 5 Participants |
| Fluarix Boostrix 19-64 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal, Across doses | 132 Participants |
| Fluarix Boostrix 19-64 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Dose 2 | 115 Participants |
| Fluarix Boostrix 19-64 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal, Dose 1 | 55 Participants |
| Fluarix Boostrix 19-64 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Across doses | 47 Participants |
| Fluarix Boostrix 19-64 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Dose 2 | 23 Participants |
| Fluarix Boostrix 19-64 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Dose 1 | 103 Participants |
| Fluarix Boostrix 19-64 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal, Dose 2 | 55 Participants |
| Fluarix Boostrix 19-64 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Muscle aches, Across doses | 287 Participants |
| Fluarix Boostrix 19-64 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal, Dose 2 | 6 Participants |
| Fluarix Boostrix 19-64 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal, Dose 2 | 29 Participants |
| Boostrix+Fluarix ≥ 65 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Shivering, Across doses | 4 Participants |
| Boostrix+Fluarix ≥ 65 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Dose 1 | 20 Participants |
| Boostrix+Fluarix ≥ 65 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Dose 1 | 0 Participants |
| Boostrix+Fluarix ≥ 65 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Dose 1 | 15 Participants |
| Boostrix+Fluarix ≥ 65 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Dose 1 | 4 Participants |
| Boostrix+Fluarix ≥ 65 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Dose 1 | 3 Participants |
| Boostrix+Fluarix ≥ 65 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal, Dose 1 | 18 Participants |
| Boostrix+Fluarix ≥ 65 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal, Dose 1 | 2 Participants |
| Boostrix+Fluarix ≥ 65 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal, Dose 1 | 12 Participants |
| Boostrix+Fluarix ≥ 65 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Dose 1 | 17 Participants |
| Boostrix+Fluarix ≥ 65 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Dose 1 | 2 Participants |
| Boostrix+Fluarix ≥ 65 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Joint pain, Dose 1 | 14 Participants |
| Boostrix+Fluarix ≥ 65 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Joint pain, Dose 1 | 0 Participants |
| Boostrix+Fluarix ≥ 65 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Joint pain, Dose 1 | 8 Participants |
| Boostrix+Fluarix ≥ 65 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Muscle aches, Dose 1 | 26 Participants |
| Boostrix+Fluarix ≥ 65 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Muscle aches, Dose 1 | 2 Participants |
| Boostrix+Fluarix ≥ 65 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Muscle aches, Dose 1 | 16 Participants |
| Boostrix+Fluarix ≥ 65 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Shivering, Dose 1 | 5 Participants |
| Boostrix+Fluarix ≥ 65 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Shivering, Dose 1 | 4 Participants |
| Boostrix+Fluarix ≥ 65 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Dose 2 | 0 Participants |
| Boostrix+Fluarix ≥ 65 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Dose 2 | 0 Participants |
| Boostrix+Fluarix ≥ 65 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Dose 2 | 0 Participants |
| Boostrix+Fluarix ≥ 65 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Dose 2 | 0 Participants |
| Boostrix+Fluarix ≥ 65 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Joint pain, Dose 2 | 0 Participants |
| Boostrix+Fluarix ≥ 65 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Muscle aches, Across doses | 26 Participants |
| Boostrix+Fluarix ≥ 65 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Muscle aches, Across doses | 16 Participants |
| Boostrix+Fluarix ≥ 65 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Dose 1 | 0 Participants |
| Boostrix+Fluarix ≥ 65 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Dose 1 | 12 Participants |
| Boostrix+Fluarix ≥ 65 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Shivering, Dose 1 | 0 Participants |
| Boostrix+Fluarix ≥ 65 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Dose 2 | 0 Participants |
| Boostrix+Fluarix ≥ 65 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Dose 2 | 0 Participants |
| Boostrix+Fluarix ≥ 65 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal, Dose 2 | 0 Participants |
| Boostrix+Fluarix ≥ 65 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal, Dose 2 | 0 Participants |
| Boostrix+Fluarix ≥ 65 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal, Dose 2 | 0 Participants |
| Boostrix+Fluarix ≥ 65 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Dose 2 | 0 Participants |
| Boostrix+Fluarix ≥ 65 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Dose 2 | 0 Participants |
| Boostrix+Fluarix ≥ 65 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Dose 2 | 0 Participants |
| Boostrix+Fluarix ≥ 65 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Joint pain, Dose 2 | 0 Participants |
| Boostrix+Fluarix ≥ 65 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Joint pain, Dose 2 | 0 Participants |
| Boostrix+Fluarix ≥ 65 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Muscle aches, Dose 2 | 0 Participants |
| Boostrix+Fluarix ≥ 65 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Muscle aches, Dose 2 | 0 Participants |
| Boostrix+Fluarix ≥ 65 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Muscle aches, Dose 2 | 0 Participants |
| Boostrix+Fluarix ≥ 65 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Shivering, Dose 2 | 0 Participants |
| Boostrix+Fluarix ≥ 65 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Shivering, Dose 2 | 0 Participants |
| Boostrix+Fluarix ≥ 65 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Shivering, Dose 2 | 0 Participants |
| Boostrix+Fluarix ≥ 65 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Across doses | 20 Participants |
| Boostrix+Fluarix ≥ 65 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Across doses | 0 Participants |
| Boostrix+Fluarix ≥ 65 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Across doses | 15 Participants |
| Boostrix+Fluarix ≥ 65 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Across doses | 4 Participants |
| Boostrix+Fluarix ≥ 65 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Across doses | 0 Participants |
| Boostrix+Fluarix ≥ 65 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Across doses | 3 Participants |
| Boostrix+Fluarix ≥ 65 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal, Across doses | 18 Participants |
| Boostrix+Fluarix ≥ 65 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Joint pain, Across doses | 8 Participants |
| Boostrix+Fluarix ≥ 65 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal, Across doses | 2 Participants |
| Boostrix+Fluarix ≥ 65 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal, Across doses | 12 Participants |
| Boostrix+Fluarix ≥ 65 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Across doses | 17 Participants |
| Boostrix+Fluarix ≥ 65 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Across doses | 2 Participants |
| Boostrix+Fluarix ≥ 65 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Across doses | 12 Participants |
| Boostrix+Fluarix ≥ 65 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Joint pain, Across doses | 14 Participants |
| Boostrix+Fluarix ≥ 65 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Joint pain, Across doses | 0 Participants |
| Boostrix+Fluarix ≥ 65 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Muscle aches, Across doses | 2 Participants |
| Boostrix+Fluarix ≥ 65 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Shivering, Across doses | 5 Participants |
| Boostrix+Fluarix ≥ 65 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Shivering, Across doses | 0 Participants |
| Fluarix Boostrix ≥ 65 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal, Dose 1 | 6 Participants |
| Fluarix Boostrix ≥ 65 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Across doses | 7 Participants |
| Fluarix Boostrix ≥ 65 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal, Dose 2 | 1 Participants |
| Fluarix Boostrix ≥ 65 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal, Dose 2 | 1 Participants |
| Fluarix Boostrix ≥ 65 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Muscle aches, Across doses | 26 Participants |
| Fluarix Boostrix ≥ 65 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Across doses | 0 Participants |
| Fluarix Boostrix ≥ 65 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal, Dose 2 | 3 Participants |
| Fluarix Boostrix ≥ 65 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Dose 2 | 0 Participants |
| Fluarix Boostrix ≥ 65 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal, Dose 1 | 1 Participants |
| Fluarix Boostrix ≥ 65 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Across doses | 4 Participants |
| Fluarix Boostrix ≥ 65 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Dose 2 | 6 Participants |
| Fluarix Boostrix ≥ 65 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Shivering, Dose 1 | 0 Participants |
| Fluarix Boostrix ≥ 65 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Dose 1 | 12 Participants |
| Fluarix Boostrix ≥ 65 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Joint pain, Dose 1 | 0 Participants |
| Fluarix Boostrix ≥ 65 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Joint pain, Dose 1 | 13 Participants |
| Fluarix Boostrix ≥ 65 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal, Dose 1 | 12 Participants |
| Fluarix Boostrix ≥ 65 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Joint pain, Across doses | 17 Participants |
| Fluarix Boostrix ≥ 65 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal, Across doses | 13 Participants |
| Fluarix Boostrix ≥ 65 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Dose 1 | 1 Participants |
| Fluarix Boostrix ≥ 65 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Muscle aches, Across doses | 25 Participants |
| Fluarix Boostrix ≥ 65 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Dose 1 | 2 Participants |
| Fluarix Boostrix ≥ 65 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal, Across doses | 2 Participants |
| Fluarix Boostrix ≥ 65 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Muscle aches, Across doses | 0 Participants |
| Fluarix Boostrix ≥ 65 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Dose 2 | 2 Participants |
| Fluarix Boostrix ≥ 65 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Dose 1 | 1 Participants |
| Fluarix Boostrix ≥ 65 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal, Across doses | 7 Participants |
| Fluarix Boostrix ≥ 65 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Dose 2 | 4 Participants |
| Fluarix Boostrix ≥ 65 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Dose 2 | 5 Participants |
| Fluarix Boostrix ≥ 65 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Shivering, Across doses | 5 Participants |
| Fluarix Boostrix ≥ 65 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Across doses | 22 Participants |
| Fluarix Boostrix ≥ 65 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Dose 2 | 0 Participants |
| Fluarix Boostrix ≥ 65 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Shivering, Dose 1 | 3 Participants |
| Fluarix Boostrix ≥ 65 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Dose 1 | 0 Participants |
| Fluarix Boostrix ≥ 65 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Across doses | 1 Participants |
| Fluarix Boostrix ≥ 65 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Shivering, Dose 1 | 4 Participants |
| Fluarix Boostrix ≥ 65 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Muscle aches, Dose 1 | 17 Participants |
| Fluarix Boostrix ≥ 65 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Dose 1 | 3 Participants |
| Fluarix Boostrix ≥ 65 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Across doses | 19 Participants |
| Fluarix Boostrix ≥ 65 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Muscle aches, Dose 1 | 0 Participants |
| Fluarix Boostrix ≥ 65 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Muscle aches, Dose 1 | 18 Participants |
| Fluarix Boostrix ≥ 65 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Dose 1 | 18 Participants |
| Fluarix Boostrix ≥ 65 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Joint pain, Across doses | 18 Participants |
| Fluarix Boostrix ≥ 65 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Joint pain, Dose 1 | 12 Participants |
| Fluarix Boostrix ≥ 65 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Dose 1 | 13 Participants |
| Fluarix Boostrix ≥ 65 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Shivering, Dose 2 | 0 Participants |
| Fluarix Boostrix ≥ 65 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Shivering, Dose 2 | 2 Participants |
| Fluarix Boostrix ≥ 65 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Muscle aches, Dose 2 | 13 Participants |
| Fluarix Boostrix ≥ 65 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Shivering, Across doses | 0 Participants |
| Fluarix Boostrix ≥ 65 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Shivering, Dose 2 | 2 Participants |
| Fluarix Boostrix ≥ 65 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Muscle aches, Dose 2 | 0 Participants |
| Fluarix Boostrix ≥ 65 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Muscle aches, Dose 2 | 14 Participants |
| Fluarix Boostrix ≥ 65 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Joint pain, Across doses | 0 Participants |
| Fluarix Boostrix ≥ 65 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Across doses | 22 Participants |
| Fluarix Boostrix ≥ 65 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Joint pain, Dose 2 | 7 Participants |
| Fluarix Boostrix ≥ 65 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Joint pain, Dose 2 | 0 Participants |
| Fluarix Boostrix ≥ 65 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Shivering, Across doses | 4 Participants |
| Fluarix Boostrix ≥ 65 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Across doses | 1 Participants |
| Fluarix Boostrix ≥ 65 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Joint pain, Dose 2 | 7 Participants |
| Fluarix Boostrix ≥ 65 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Dose 2 | 7 Participants |
| Fluarix Boostrix ≥ 65 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Dose 1 | 17 Participants |
| Fluarix Boostrix ≥ 65 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Across doses | 16 Participants |
| Fluarix Boostrix ≥ 65 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Dose 2 | 0 Participants |
| Fluarix Boostrix ≥ 65 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Dose 2 | 8 Participants |
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.
Time frame: During the 31-day period (Day 0-30) following each vaccination, up to 2 months
Population: The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Boostrix+Fluarix 19-64 YOA Group | Number of Subjects With Any Unsolicited Adverse Events (AEs) | 161 Participants |
| Fluarix Boostrix 19-64 YOA Group | Number of Subjects With Any Unsolicited Adverse Events (AEs) | 205 Participants |
| Boostrix+Fluarix ≥ 65 YOA Group | Number of Subjects With Any Unsolicited Adverse Events (AEs) | 22 Participants |
| Fluarix Boostrix ≥ 65 YOA Group | Number of Subjects With Any Unsolicited Adverse Events (AEs) | 21 Participants |
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®.
Time frame: At Month 1 post-Boostrix® vaccination
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Boostrix+Fluarix 19-64 YOA Group | Number of Subjects With Booster Response Against Diphteria Toxoid (D) and Tetanus Toxoid (T) Antigens | Anti-D | 487 Participants |
| Boostrix+Fluarix 19-64 YOA Group | Number of Subjects With Booster Response Against Diphteria Toxoid (D) and Tetanus Toxoid (T) Antigens | Anti-T | 293 Participants |
| Fluarix Boostrix 19-64 YOA Group | Number of Subjects With Booster Response Against Diphteria Toxoid (D) and Tetanus Toxoid (T) Antigens | Anti-T | 320 Participants |
| Fluarix Boostrix 19-64 YOA Group | Number of Subjects With Booster Response Against Diphteria Toxoid (D) and Tetanus Toxoid (T) Antigens | Anti-D | 459 Participants |
| Boostrix+Fluarix ≥ 65 YOA Group | Number of Subjects With Booster Response Against Diphteria Toxoid (D) and Tetanus Toxoid (T) Antigens | Anti-D | 61 Participants |
| Boostrix+Fluarix ≥ 65 YOA Group | Number of Subjects With Booster Response Against Diphteria Toxoid (D) and Tetanus Toxoid (T) Antigens | Anti-T | 62 Participants |
| Fluarix Boostrix ≥ 65 YOA Group | Number of Subjects With Booster Response Against Diphteria Toxoid (D) and Tetanus Toxoid (T) Antigens | Anti-D | 48 Participants |
| Fluarix Boostrix ≥ 65 YOA Group | Number of Subjects With Booster Response Against Diphteria Toxoid (D) and Tetanus Toxoid (T) Antigens | Anti-T | 63 Participants |
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®.
Time frame: At Month 1 post-Boostrix® vaccination
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Boostrix+Fluarix 19-64 YOA Group | Number of Subjects With Booster Response Against Pertussis Toxoid (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) Antigens | Anti-PT | 514 Participants |
| Boostrix+Fluarix 19-64 YOA Group | Number of Subjects With Booster Response Against Pertussis Toxoid (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) Antigens | Anti-PRN | 630 Participants |
| Boostrix+Fluarix 19-64 YOA Group | Number of Subjects With Booster Response Against Pertussis Toxoid (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) Antigens | Anti-FHA | 651 Participants |
| Fluarix Boostrix 19-64 YOA Group | Number of Subjects With Booster Response Against Pertussis Toxoid (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) Antigens | Anti-PT | 530 Participants |
| Fluarix Boostrix 19-64 YOA Group | Number of Subjects With Booster Response Against Pertussis Toxoid (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) Antigens | Anti-PRN | 589 Participants |
| Fluarix Boostrix 19-64 YOA Group | Number of Subjects With Booster Response Against Pertussis Toxoid (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) Antigens | Anti-FHA | 621 Participants |
| Boostrix+Fluarix ≥ 65 YOA Group | Number of Subjects With Booster Response Against Pertussis Toxoid (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) Antigens | Anti-FHA | 94 Participants |
| Boostrix+Fluarix ≥ 65 YOA Group | Number of Subjects With Booster Response Against Pertussis Toxoid (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) Antigens | Anti-PT | 71 Participants |
| Boostrix+Fluarix ≥ 65 YOA Group | Number of Subjects With Booster Response Against Pertussis Toxoid (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) Antigens | Anti-PRN | 79 Participants |
| Fluarix Boostrix ≥ 65 YOA Group | Number of Subjects With Booster Response Against Pertussis Toxoid (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) Antigens | Anti-PT | 68 Participants |
| Fluarix Boostrix ≥ 65 YOA Group | Number of Subjects With Booster Response Against Pertussis Toxoid (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) Antigens | Anti-PRN | 77 Participants |
| Fluarix Boostrix ≥ 65 YOA Group | Number of Subjects With Booster Response Against Pertussis Toxoid (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) Antigens | Anti-FHA | 91 Participants |
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.
Time frame: Throughout the whole study period (from Day 0 to Month 2)
Population: The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Boostrix+Fluarix 19-64 YOA Group | Number of Subjects With Serious Adverse Events (SAEs) | 2 Participants |
| Fluarix Boostrix 19-64 YOA Group | Number of Subjects With Serious Adverse Events (SAEs) | 7 Participants |
| Boostrix+Fluarix ≥ 65 YOA Group | Number of Subjects With Serious Adverse Events (SAEs) | 1 Participants |
| Fluarix Boostrix ≥ 65 YOA Group | Number of Subjects With Serious Adverse Events (SAEs) | 0 Participants |