Trial Outcomes & Findings for Immunogenicity, Safety of GSKs Tdap Vaccine Boostrix When Coadministered With GSKs Influenza Vaccine Fluarix in Adults (NCT NCT00385255)

NCT ID: NCT00385255

Last Updated: 2019-06-10

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 1726 participants
• Primary outcome timeframe: At Month 1 post-Boostrix® vaccination
• Results posted on: 2019-06-10

Participant Flow

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.

Participant milestones

Measure	Boostrix+Fluarix Group Healthy male or female adults, aged between 19 to 64 years of age 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.	Fluarix Boostrix Group Healthy male or female adults, aged between 19 to 64 years of age 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.
Overall Study STARTED	860	858
Overall Study ≥ 65 Years of Age (YOA) Cohort	112	109
Overall Study 19-64 Years of Age (YOA) Cohort	748	749
Overall Study COMPLETED	839	785
Overall Study NOT COMPLETED	21	73

Reasons for withdrawal

Measure	Boostrix+Fluarix Group Healthy male or female adults, aged between 19 to 64 years of age 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.	Fluarix Boostrix Group Healthy male or female adults, aged between 19 to 64 years of age 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.
Overall Study Serious Adverse Event	1	2
Overall Study Protocol Violation	0	4
Overall Study Withdrawal by Subject	0	8
Overall Study Migrated/moved from study area	0	1
Overall Study Lost to Follow-up	20	58

Baseline Characteristics

Immunogenicity, Safety of GSKs Tdap Vaccine Boostrix When Coadministered With GSKs Influenza Vaccine Fluarix in Adults

Baseline characteristics by cohort

Measure	Boostrix+Fluarix Group n=860 Participants 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.	Fluarix Boostrix Group n=858 Participants 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.	Total n=1718 Participants Total of all reporting groups
Age, Continuous	48.95 Years STANDARD_DEVIATION 14.74 • n=93 Participants	49.29 Years STANDARD_DEVIATION 14.58 • n=4 Participants	49.12 Years STANDARD_DEVIATION 14.66 • n=27 Participants
Sex: Female, Male Female	527 Participants n=93 Participants	481 Participants n=4 Participants	1008 Participants n=27 Participants
Sex: Female, Male Male	333 Participants n=93 Participants	377 Participants n=4 Participants	710 Participants n=27 Participants
Race/Ethnicity, Customized Geographic ancestry · African heritage/African American	69 Participants n=93 Participants	82 Participants n=4 Participants	151 Participants n=27 Participants
Race/Ethnicity, Customized Geographic ancestry · American Indian or Alaskan native	2 Participants n=93 Participants	0 Participants n=4 Participants	2 Participants n=27 Participants
Race/Ethnicity, Customized Geographic ancestry · Asian-Central/South Asian heritage	0 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants
Race/Ethnicity, Customized Geographic ancestry · Asian-East Asian heritage	1 Participants n=93 Participants	2 Participants n=4 Participants	3 Participants n=27 Participants
Race/Ethnicity, Customized Geographic ancestry · Asian-Japanese heritage	1 Participants n=93 Participants	2 Participants n=4 Participants	3 Participants n=27 Participants
Race/Ethnicity, Customized Geographic ancestry · Asian-South East Asian heritage	3 Participants n=93 Participants	4 Participants n=4 Participants	7 Participants n=27 Participants
Race/Ethnicity, Customized Geographic ancestry · Native Hawaiian or other Pacific Islander	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Race/Ethnicity, Customized Geographic ancestry · White-Arabic/North African heritage	7 Participants n=93 Participants	4 Participants n=4 Participants	11 Participants n=27 Participants
Race/Ethnicity, Customized Geographic ancestry · White-Caucasian/European heritage	759 Participants n=93 Participants	747 Participants n=4 Participants	1506 Participants n=27 Participants
Race/Ethnicity, Customized Geographic ancestry · Not specified	17 Participants n=93 Participants	16 Participants n=4 Participants	33 Participants n=27 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Boostrix+Fluarix 19-64 YOA Group n=713 Participants Healthy male or female adults, between 19 to 64 years of age (YOA) inclusive, who received Boostrix® vaccine co-administered with Fluarix® vaccine at Day 0, injected intramuscularly in the left and right upper deltoid regions, respectively.	Fluarix Boostrix 19-64 YOA Group n=654 Participants Healthy male or female adults, between 19 to 64 years of age (YOA) inclusive, who received Fluarix® vaccine at Day 0 and Boostrix® vaccine at Month 1, both injected intramuscularly in the upper left deltoid region.	Boostrix+Fluarix ≥ 65 YOA Group n=108 Participants Healthy male or female adults, aged 65 years or older, who received Boostrix® vaccine co-administered with Fluarix® vaccine at Day 0, injected intramuscularly in the left and right upper deltoid regions, respectively.	Fluarix Boostrix ≥ 65 YOA Group n=102 Participants Healthy male or female adults, aged 65 years or older, who received Fluarix® vaccine at Day 0 and Boostrix® vaccine at Month 1, both injected intramuscularly in the upper left deltoid region.
Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Toxoid Antigens Anti-D	677 Participants	614 Participants	93 Participants	79 Participants
Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Toxoid Antigens Anti-T	700 Participants	653 Participants	105 Participants	95 Participants

PRIMARY outcome

Timeframe: 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.

The assay cut-off value was ≥ 1.0 IU/mL, as assessed by enzyme-linked immunosorbent assay (ELISA).

Outcome measures

Measure	Boostrix+Fluarix 19-64 YOA Group n=713 Participants Healthy male or female adults, between 19 to 64 years of age (YOA) inclusive, who received Boostrix® vaccine co-administered with Fluarix® vaccine at Day 0, injected intramuscularly in the left and right upper deltoid regions, respectively.	Fluarix Boostrix 19-64 YOA Group n=654 Participants Healthy male or female adults, between 19 to 64 years of age (YOA) inclusive, who received Fluarix® vaccine at Day 0 and Boostrix® vaccine at Month 1, both injected intramuscularly in the upper left deltoid region.	Boostrix+Fluarix ≥ 65 YOA Group n=108 Participants Healthy male or female adults, aged 65 years or older, who received Boostrix® vaccine co-administered with Fluarix® vaccine at Day 0, injected intramuscularly in the left and right upper deltoid regions, respectively.	Fluarix Boostrix ≥ 65 YOA Group n=102 Participants Healthy male or female adults, aged 65 years or older, who received Fluarix® vaccine at Day 0 and Boostrix® vaccine at Month 1, both injected intramuscularly in the upper left deltoid region.
Number of Subjects With Anti-T Antibody Concentrations ≥ the Assay Cut-off Value	687 Participants	621 Participants	94 Participants	84 Participants

PRIMARY outcome

Timeframe: 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.

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).

Outcome measures

Measure	Boostrix+Fluarix 19-64 YOA Group n=713 Participants Healthy male or female adults, between 19 to 64 years of age (YOA) inclusive, who received Boostrix® vaccine co-administered with Fluarix® vaccine at Day 0, injected intramuscularly in the left and right upper deltoid regions, respectively.	Fluarix Boostrix 19-64 YOA Group n=655 Participants Healthy male or female adults, between 19 to 64 years of age (YOA) inclusive, who received Fluarix® vaccine at Day 0 and Boostrix® vaccine at Month 1, both injected intramuscularly in the upper left deltoid region.	Boostrix+Fluarix ≥ 65 YOA Group n=108 Participants Healthy male or female adults, aged 65 years or older, who received Boostrix® vaccine co-administered with Fluarix® vaccine at Day 0, injected intramuscularly in the left and right upper deltoid regions, respectively.	Fluarix Boostrix ≥ 65 YOA Group n=101 Participants Healthy male or female adults, aged 65 years or older, who received Fluarix® vaccine at Day 0 and Boostrix® vaccine at Month 1, both injected intramuscularly in the upper left deltoid region.
Antibody Concentrations Against Pertussis Toxoid (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) Antigens Anti-PT	57.5 EL.U/mL Interval 53.1 to 62.3	76.9 EL.U/mL Interval 71.1 to 83.2	51.2 EL.U/mL Interval 40.8 to 64.2	59.3 EL.U/mL Interval 47.0 to 74.8
Antibody Concentrations Against Pertussis Toxoid (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) Antigens Anti-FHA	467.6 EL.U/mL Interval 434.9 to 502.8	663.3 EL.U/mL Interval 613.3 to 717.4	502.5 EL.U/mL Interval 409.5 to 616.7	669.6 EL.U/mL Interval 539.1 to 831.8
Antibody Concentrations Against Pertussis Toxoid (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) Antigens Anti-PRN	234.9 EL.U/mL Interval 208.7 to 264.3	343.6 EL.U/mL Interval 302.5 to 390.1	87.9 EL.U/mL Interval 60.1 to 128.5	97.0 EL.U/mL Interval 68.1 to 138.4

PRIMARY outcome

Timeframe: 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.

The antibody titer cut-off value for the 3 influenza strains assessed (H1N1, H3N2 and B) was ≥ 1:40.

Outcome measures

Measure	Boostrix+Fluarix 19-64 YOA Group n=711 Participants Healthy male or female adults, between 19 to 64 years of age (YOA) inclusive, who received Boostrix® vaccine co-administered with Fluarix® vaccine at Day 0, injected intramuscularly in the left and right upper deltoid regions, respectively.	Fluarix Boostrix 19-64 YOA Group n=675 Participants Healthy male or female adults, between 19 to 64 years of age (YOA) inclusive, who received Fluarix® vaccine at Day 0 and Boostrix® vaccine at Month 1, both injected intramuscularly in the upper left deltoid region.	Boostrix+Fluarix ≥ 65 YOA Group n=108 Participants Healthy male or female adults, aged 65 years or older, who received Boostrix® vaccine co-administered with Fluarix® vaccine at Day 0, injected intramuscularly in the left and right upper deltoid regions, respectively.	Fluarix Boostrix ≥ 65 YOA Group n=103 Participants Healthy male or female adults, aged 65 years or older, who received Fluarix® vaccine at Day 0 and Boostrix® vaccine at Month 1, both injected intramuscularly in the upper left deltoid region.
Number of Subjects With Serum Haemagglutinin Inhibition (HI) Titers Against 3 Strains of Influenza Anti-H1N1	669 Participants	643 Participants	92 Participants	88 Participants
Number of Subjects With Serum Haemagglutinin Inhibition (HI) Titers Against 3 Strains of Influenza Anti-H3N2	694 Participants	663 Participants	104 Participants	95 Participants
Number of Subjects With Serum Haemagglutinin Inhibition (HI) Titers Against 3 Strains of Influenza Anti-B	685 Participants	654 Participants	107 Participants	101 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Boostrix+Fluarix 19-64 YOA Group n=708 Participants Healthy male or female adults, between 19 to 64 years of age (YOA) inclusive, who received Boostrix® vaccine co-administered with Fluarix® vaccine at Day 0, injected intramuscularly in the left and right upper deltoid regions, respectively.	Fluarix Boostrix 19-64 YOA Group n=672 Participants Healthy male or female adults, between 19 to 64 years of age (YOA) inclusive, who received Fluarix® vaccine at Day 0 and Boostrix® vaccine at Month 1, both injected intramuscularly in the upper left deltoid region.	Boostrix+Fluarix ≥ 65 YOA Group n=108 Participants Healthy male or female adults, aged 65 years or older, who received Boostrix® vaccine co-administered with Fluarix® vaccine at Day 0, injected intramuscularly in the left and right upper deltoid regions, respectively.	Fluarix Boostrix ≥ 65 YOA Group n=102 Participants Healthy male or female adults, aged 65 years or older, who received Fluarix® vaccine at Day 0 and Boostrix® vaccine at Month 1, both injected intramuscularly in the upper left deltoid region.
Number of Seroconverted Subjects Against Influenza Antigens H1N1, H3N2, and B Anti-H1N1	414 Participants	377 Participants	37 Participants	32 Participants
Number of Seroconverted Subjects Against Influenza Antigens H1N1, H3N2, and B Anti-H3N2	560 Participants	494 Participants	72 Participants	64 Participants
Number of Seroconverted Subjects Against Influenza Antigens H1N1, H3N2, and B Anti-B	463 Participants	425 Participants	41 Participants	43 Participants

SECONDARY outcome

Timeframe: 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.

A seropositive subject was a subject whose antibody concentration was greater than or equal (≥) to the cut-off value of 1.0 IU/mL.

Outcome measures

Measure	Boostrix+Fluarix 19-64 YOA Group n=712 Participants Healthy male or female adults, between 19 to 64 years of age (YOA) inclusive, who received Boostrix® vaccine co-administered with Fluarix® vaccine at Day 0, injected intramuscularly in the left and right upper deltoid regions, respectively.	Fluarix Boostrix 19-64 YOA Group n=653 Participants Healthy male or female adults, between 19 to 64 years of age (YOA) inclusive, who received Fluarix® vaccine at Day 0 and Boostrix® vaccine at Month 1, both injected intramuscularly in the upper left deltoid region.	Boostrix+Fluarix ≥ 65 YOA Group n=106 Participants Healthy male or female adults, aged 65 years or older, who received Boostrix® vaccine co-administered with Fluarix® vaccine at Day 0, injected intramuscularly in the left and right upper deltoid regions, respectively.	Fluarix Boostrix ≥ 65 YOA Group n=98 Participants Healthy male or female adults, aged 65 years or older, who received Fluarix® vaccine at Day 0 and Boostrix® vaccine at Month 1, both injected intramuscularly in the upper left deltoid region.
Number of Seropositive Subjects With Anti-D Antibody Concentrations Above the Cut-off Value	579 Participants	528 Participants	55 Participants	49 Participants

SECONDARY outcome

Timeframe: 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.

Anti-D and anti-T antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in International Units per milliliter (IU/mL).

Outcome measures

Measure	Boostrix+Fluarix 19-64 YOA Group n=713 Participants Healthy male or female adults, between 19 to 64 years of age (YOA) inclusive, who received Boostrix® vaccine co-administered with Fluarix® vaccine at Day 0, injected intramuscularly in the left and right upper deltoid regions, respectively.	Fluarix Boostrix 19-64 YOA Group n=675 Participants Healthy male or female adults, between 19 to 64 years of age (YOA) inclusive, who received Fluarix® vaccine at Day 0 and Boostrix® vaccine at Month 1, both injected intramuscularly in the upper left deltoid region.	Boostrix+Fluarix ≥ 65 YOA Group n=108 Participants Healthy male or female adults, aged 65 years or older, who received Boostrix® vaccine co-administered with Fluarix® vaccine at Day 0, injected intramuscularly in the left and right upper deltoid regions, respectively.	Fluarix Boostrix ≥ 65 YOA Group n=104 Participants Healthy male or female adults, aged 65 years or older, who received Fluarix® vaccine at Day 0 and Boostrix® vaccine at Month 1, both injected intramuscularly in the upper left deltoid region.
Antibody Concentrations for Diphteria Toxoid (D) and Tetanus Toxoid (T) Anti-D, Day 0	0.4 IU/mL Interval 0.4 to 0.4	0.4 IU/mL Interval 0.3 to 0.4	0.2 IU/mL Interval 0.1 to 0.2	0.2 IU/mL Interval 0.2 to 0.3
Antibody Concentrations for Diphteria Toxoid (D) and Tetanus Toxoid (T) Anti-D, Month 1	3.1 IU/mL Interval 2.8 to 3.5	3.4 IU/mL Interval 3.0 to 3.8	1.0 IU/mL Interval 0.7 to 1.4	1.0 IU/mL Interval 0.6 to 1.4
Antibody Concentrations for Diphteria Toxoid (D) and Tetanus Toxoid (T) Anti-T, Day 0	1.5 IU/mL Interval 1.4 to 1.7	1.5 IU/mL Interval 1.3 to 1.6	0.5 IU/mL Interval 0.4 to 0.7	0.6 IU/mL Interval 0.4 to 0.8
Antibody Concentrations for Diphteria Toxoid (D) and Tetanus Toxoid (T) Anti-T, Month 1	6.5 IU/mL Interval 6.0 to 7.0	7.6 IU/mL Interval 7.0 to 8.2	3.4 IU/mL Interval 2.7 to 4.3	3.6 IU/mL Interval 2.6 to 5.0

SECONDARY outcome

Timeframe: 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.

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).

Outcome measures

Measure	Boostrix+Fluarix 19-64 YOA Group n=713 Participants Healthy male or female adults, between 19 to 64 years of age (YOA) inclusive, who received Boostrix® vaccine co-administered with Fluarix® vaccine at Day 0, injected intramuscularly in the left and right upper deltoid regions, respectively.	Fluarix Boostrix 19-64 YOA Group n=676 Participants Healthy male or female adults, between 19 to 64 years of age (YOA) inclusive, who received Fluarix® vaccine at Day 0 and Boostrix® vaccine at Month 1, both injected intramuscularly in the upper left deltoid region.	Boostrix+Fluarix ≥ 65 YOA Group n=108 Participants Healthy male or female adults, aged 65 years or older, who received Boostrix® vaccine co-administered with Fluarix® vaccine at Day 0, injected intramuscularly in the left and right upper deltoid regions, respectively.	Fluarix Boostrix ≥ 65 YOA Group n=104 Participants Healthy male or female adults, aged 65 years or older, who received Fluarix® vaccine at Day 0 and Boostrix® vaccine at Month 1, both injected intramuscularly in the upper left deltoid region.
Antibody Concentrations for Pertussis Toxoid (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) Anti-PT, Day 0	6.4 EL.U/mL Interval 5.9 to 6.9	6.5 EL.U/mL Interval 6.0 to 7.1	8.0 EL.U/mL Interval 6.4 to 10.0	8.0 EL.U/mL Interval 6.4 to 9.9
Antibody Concentrations for Pertussis Toxoid (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) Anti-PT, Month 1	57.5 EL.U/mL Interval 53.1 to 62.3	76.9 EL.U/mL Interval 71.1 to 83.2	51.2 EL.U/mL Interval 40.8 to 64.2	59.3 EL.U/mL Interval 47.0 to 74.8
Antibody Concentrations for Pertussis Toxoid (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) Anti-FHA, Day 0	36.6 EL.U/mL Interval 33.7 to 39.9	36.2 EL.U/mL Interval 33.2 to 39.5	54.5 EL.U/mL Interval 43.2 to 68.7	59.0 EL.U/mL Interval 46.5 to 75.0
Antibody Concentrations for Pertussis Toxoid (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) Anti-FHA, Month 1	467.6 EL.U/mL Interval 434.9 to 502.8	663.3 EL.U/mL Interval 613.3 to 717.4	502.5 EL.U/mL Interval 409.5 to 616.7	669.6 EL.U/mL Interval 539.1 to 831.8
Antibody Concentrations for Pertussis Toxoid (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) Anti-PRN, Day 0	12.6 EL.U/mL Interval 11.4 to 13.9	12.9 EL.U/mL Interval 11.7 to 14.3	7.5 EL.U/mL Interval 5.9 to 9.4	6.4 EL.U/mL Interval 5.0 to 8.2
Antibody Concentrations for Pertussis Toxoid (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) Anti-PRN, Month 1	234.9 EL.U/mL Interval 208.7 to 264.3	343.6 EL.U/mL Interval 302.5 to 390.1	87.9 EL.U/mL Interval 60.1 to 128.5	97.0 EL.U/mL Interval 68.1 to 138.4

SECONDARY outcome

Timeframe: 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.

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®.

Outcome measures

Measure	Boostrix+Fluarix 19-64 YOA Group n=710 Participants Healthy male or female adults, between 19 to 64 years of age (YOA) inclusive, who received Boostrix® vaccine co-administered with Fluarix® vaccine at Day 0, injected intramuscularly in the left and right upper deltoid regions, respectively.	Fluarix Boostrix 19-64 YOA Group n=650 Participants Healthy male or female adults, between 19 to 64 years of age (YOA) inclusive, who received Fluarix® vaccine at Day 0 and Boostrix® vaccine at Month 1, both injected intramuscularly in the upper left deltoid region.	Boostrix+Fluarix ≥ 65 YOA Group n=106 Participants Healthy male or female adults, aged 65 years or older, who received Boostrix® vaccine co-administered with Fluarix® vaccine at Day 0, injected intramuscularly in the left and right upper deltoid regions, respectively.	Fluarix Boostrix ≥ 65 YOA Group n=102 Participants Healthy male or female adults, aged 65 years or older, who received Fluarix® vaccine at Day 0 and Boostrix® vaccine at Month 1, both injected intramuscularly in the upper left deltoid region.
Number of Subjects With Booster Response Against Diphteria Toxoid (D) and Tetanus Toxoid (T) Antigens Anti-T	293 Participants	320 Participants	62 Participants	63 Participants
Number of Subjects With Booster Response Against Diphteria Toxoid (D) and Tetanus Toxoid (T) Antigens Anti-D	487 Participants	459 Participants	61 Participants	48 Participants

SECONDARY outcome

Timeframe: 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.

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®.

Outcome measures

Measure	Boostrix+Fluarix 19-64 YOA Group n=712 Participants Healthy male or female adults, between 19 to 64 years of age (YOA) inclusive, who received Boostrix® vaccine co-administered with Fluarix® vaccine at Day 0, injected intramuscularly in the left and right upper deltoid regions, respectively.	Fluarix Boostrix 19-64 YOA Group n=652 Participants Healthy male or female adults, between 19 to 64 years of age (YOA) inclusive, who received Fluarix® vaccine at Day 0 and Boostrix® vaccine at Month 1, both injected intramuscularly in the upper left deltoid region.	Boostrix+Fluarix ≥ 65 YOA Group n=108 Participants Healthy male or female adults, aged 65 years or older, who received Boostrix® vaccine co-administered with Fluarix® vaccine at Day 0, injected intramuscularly in the left and right upper deltoid regions, respectively.	Fluarix Boostrix ≥ 65 YOA Group n=100 Participants Healthy male or female adults, aged 65 years or older, who received Fluarix® vaccine at Day 0 and Boostrix® vaccine at Month 1, both injected intramuscularly in the upper left deltoid region.
Number of Subjects With Booster Response Against Pertussis Toxoid (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) Antigens Anti-PT	514 Participants	530 Participants	71 Participants	68 Participants
Number of Subjects With Booster Response Against Pertussis Toxoid (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) Antigens Anti-FHA	651 Participants	621 Participants	94 Participants	91 Participants
Number of Subjects With Booster Response Against Pertussis Toxoid (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) Antigens Anti-PRN	630 Participants	589 Participants	79 Participants	77 Participants

SECONDARY outcome

Timeframe: 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.

Anti-H1N1, anti-H3N2 and anti-B antibody titers are presented as geometric mean titers (GMTs).

Outcome measures

Measure	Boostrix+Fluarix 19-64 YOA Group n=711 Participants Healthy male or female adults, between 19 to 64 years of age (YOA) inclusive, who received Boostrix® vaccine co-administered with Fluarix® vaccine at Day 0, injected intramuscularly in the left and right upper deltoid regions, respectively.	Fluarix Boostrix 19-64 YOA Group n=675 Participants Healthy male or female adults, between 19 to 64 years of age (YOA) inclusive, who received Fluarix® vaccine at Day 0 and Boostrix® vaccine at Month 1, both injected intramuscularly in the upper left deltoid region.	Boostrix+Fluarix ≥ 65 YOA Group n=108 Participants Healthy male or female adults, aged 65 years or older, who received Boostrix® vaccine co-administered with Fluarix® vaccine at Day 0, injected intramuscularly in the left and right upper deltoid regions, respectively.	Fluarix Boostrix ≥ 65 YOA Group n=103 Participants Healthy male or female adults, aged 65 years or older, who received Fluarix® vaccine at Day 0 and Boostrix® vaccine at Month 1, both injected intramuscularly in the upper left deltoid region.
Anti-H1N1, Anti-H3N2 and Anti-B Antibody Titers Anti-H1N1	189.1 Titers Interval 171.7 to 208.3	181.6 Titers Interval 165.5 to 199.3	79.9 Titers Interval 65.0 to 98.3	89.3 Titers Interval 72.8 to 109.5
Anti-H1N1, Anti-H3N2 and Anti-B Antibody Titers Anti-H3N2	368.7 Titers Interval 337.9 to 402.3	337.3 Titers Interval 309.2 to 367.9	333.6 Titers Interval 267.8 to 415.5	276.8 Titers Interval 212.4 to 360.8
Anti-H1N1, Anti-H3N2 and Anti-B Antibody Titers Anti-B	210.1 Titers Interval 194.4 to 227.0	222.8 Titers Interval 205.9 to 241.1	221.2 Titers Interval 184.3 to 265.4	214.3 Titers Interval 175.4 to 261.8

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Boostrix+Fluarix 19-64 YOA Group n=725 Participants Healthy male or female adults, between 19 to 64 years of age (YOA) inclusive, who received Boostrix® vaccine co-administered with Fluarix® vaccine at Day 0, injected intramuscularly in the left and right upper deltoid regions, respectively.	Fluarix Boostrix 19-64 YOA Group n=710 Participants Healthy male or female adults, between 19 to 64 years of age (YOA) inclusive, who received Fluarix® vaccine at Day 0 and Boostrix® vaccine at Month 1, both injected intramuscularly in the upper left deltoid region.	Boostrix+Fluarix ≥ 65 YOA Group n=110 Participants Healthy male or female adults, aged 65 years or older, who received Boostrix® vaccine co-administered with Fluarix® vaccine at Day 0, injected intramuscularly in the left and right upper deltoid regions, respectively.	Fluarix Boostrix ≥ 65 YOA Group n=108 Participants Healthy male or female adults, aged 65 years or older, who received Fluarix® vaccine at Day 0 and Boostrix® vaccine at Month 1, both injected intramuscularly in the upper left deltoid region.
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Swelling, Across doses	179 Participants	160 Participants	18 Participants	17 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Pain, Dose 1	467 Participants	315 Participants	41 Participants	25 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Pain, Dose 1	28 Participants	7 Participants	0 Participants	1 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Redness, Dose 1	180 Participants	148 Participants	23 Participants	15 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Redness, Dose 1	4 Participants	5 Participants	3 Participants	2 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Swelling, Dose 1	179 Participants	93 Participants	18 Participants	11 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Swelling, Dose 1	12 Participants	7 Participants	3 Participants	1 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Pain, Dose 2	0 Participants	327 Participants	0 Participants	30 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Pain, Dose 2	0 Participants	9 Participants	0 Participants	3 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Redness, Dose 2	0 Participants	124 Participants	0 Participants	16 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Redness, Dose 2	0 Participants	3 Participants	0 Participants	2 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Swelling, Dose 2	0 Participants	106 Participants	0 Participants	9 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Swelling, Dose 2	0 Participants	6 Participants	0 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Pain, Across doses	467 Participants	429 Participants	41 Participants	44 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Pain, Across doses	28 Participants	15 Participants	0 Participants	4 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Redness, Across doses	180 Participants	207 Participants	23 Participants	20 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Redness, Across doses	4 Participants	8 Participants	3 Participants	4 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Swelling, Across doses	12 Participants	12 Participants	3 Participants	1 Participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Boostrix+Fluarix 19-64 YOA Group n=726 Participants Healthy male or female adults, between 19 to 64 years of age (YOA) inclusive, who received Boostrix® vaccine co-administered with Fluarix® vaccine at Day 0, injected intramuscularly in the left and right upper deltoid regions, respectively.	Fluarix Boostrix 19-64 YOA Group n=710 Participants Healthy male or female adults, between 19 to 64 years of age (YOA) inclusive, who received Fluarix® vaccine at Day 0 and Boostrix® vaccine at Month 1, both injected intramuscularly in the upper left deltoid region.	Boostrix+Fluarix ≥ 65 YOA Group n=110 Participants Healthy male or female adults, aged 65 years or older, who received Boostrix® vaccine co-administered with Fluarix® vaccine at Day 0, injected intramuscularly in the left and right upper deltoid regions, respectively.	Fluarix Boostrix ≥ 65 YOA Group n=108 Participants Healthy male or female adults, aged 65 years or older, who received Fluarix® vaccine at Day 0 and Boostrix® vaccine at Month 1, both injected intramuscularly in the upper left deltoid region.
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fever, Dose 1	28 Participants	28 Participants	3 Participants	2 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fatigue, Dose 1	220 Participants	165 Participants	20 Participants	18 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fatigue, Dose 1	22 Participants	15 Participants	0 Participants	1 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fatigue, Dose 1	144 Participants	103 Participants	15 Participants	12 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fever, Dose 1	54 Participants	52 Participants	4 Participants	3 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fever, Dose 1	1 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Gastrointestinal, Dose 1	121 Participants	101 Participants	18 Participants	12 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Gastrointestinal, Dose 1	16 Participants	11 Participants	2 Participants	1 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Gastrointestinal, Dose 1	68 Participants	55 Participants	12 Participants	6 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Headache, Dose 1	225 Participants	197 Participants	17 Participants	17 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Headache, Dose 1	24 Participants	25 Participants	2 Participants	1 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Headache, Dose 1	143 Participants	118 Participants	12 Participants	13 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Joint pain, Dose 1	137 Participants	87 Participants	14 Participants	13 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Joint pain, Dose 1	10 Participants	10 Participants	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Joint pain, Dose 1	97 Participants	56 Participants	8 Participants	12 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Muscle aches, Dose 1	266 Participants	193 Participants	26 Participants	18 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Muscle aches, Dose 1	27 Participants	15 Participants	2 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Muscle aches, Dose 1	194 Participants	131 Participants	16 Participants	17 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Shivering, Dose 1	70 Participants	44 Participants	5 Participants	4 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Shivering, Dose 1	8 Participants	5 Participants	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Shivering, Dose 1	42 Participants	30 Participants	4 Participants	3 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fatigue, Dose 2	0 Participants	115 Participants	0 Participants	6 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fever, Across doses	54 Participants	80 Participants	4 Participants	7 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fatigue, Dose 2	0 Participants	18 Participants	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Gastrointestinal, Dose 2	0 Participants	6 Participants	0 Participants	1 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Gastrointestinal, Dose 2	0 Participants	29 Participants	0 Participants	1 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Headache, Dose 2	0 Participants	132 Participants	0 Participants	8 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Headache, Dose 2	0 Participants	12 Participants	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Headache, Dose 2	0 Participants	87 Participants	0 Participants	7 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Joint pain, Dose 2	0 Participants	75 Participants	0 Participants	7 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Joint pain, Dose 2	0 Participants	14 Participants	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Joint pain, Dose 2	0 Participants	52 Participants	0 Participants	7 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Muscle aches, Dose 2	0 Participants	183 Participants	0 Participants	14 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Muscle aches, Dose 2	0 Participants	21 Participants	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Muscle aches, Dose 2	0 Participants	150 Participants	0 Participants	13 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Shivering, Dose 2	0 Participants	48 Participants	0 Participants	2 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Shivering, Dose 2	0 Participants	7 Participants	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Shivering, Dose 2	0 Participants	34 Participants	0 Participants	2 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fatigue, Across doses	220 Participants	218 Participants	20 Participants	22 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fatigue, Across doses	22 Participants	30 Participants	0 Participants	1 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fatigue, Across doses	144 Participants	149 Participants	15 Participants	16 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fever, Across doses	1 Participants	1 Participants	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fever, Across doses	28 Participants	47 Participants	3 Participants	4 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Gastrointestinal, Across doses	121 Participants	132 Participants	18 Participants	13 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Gastrointestinal, Across doses	16 Participants	16 Participants	2 Participants	2 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Gastrointestinal, Across doses	68 Participants	73 Participants	12 Participants	7 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Headache, Across doses	225 Participants	251 Participants	17 Participants	22 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Headache, Across doses	24 Participants	33 Participants	2 Participants	1 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Headache, Across doses	143 Participants	163 Participants	12 Participants	19 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Joint pain, Across doses	137 Participants	135 Participants	14 Participants	18 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Joint pain, Across doses	10 Participants	23 Participants	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Joint pain, Across doses	97 Participants	89 Participants	8 Participants	17 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Muscle aches, Across doses	266 Participants	287 Participants	26 Participants	26 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Muscle aches, Across doses	27 Participants	34 Participants	2 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Muscle aches, Across doses	194 Participants	224 Participants	16 Participants	25 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Shivering, Across doses	70 Participants	80 Participants	5 Participants	5 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Shivering, Across doses	8 Participants	10 Participants	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fatigue, Dose 2	0 Participants	83 Participants	0 Participants	5 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fever, Dose 2	0 Participants	38 Participants	0 Participants	4 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fever, Dose 2	0 Participants	1 Participants	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fever, Dose 2	0 Participants	23 Participants	0 Participants	2 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Gastrointestinal, Dose 2	0 Participants	55 Participants	0 Participants	3 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Shivering, Across doses	42 Participants	56 Participants	4 Participants	4 Participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Boostrix+Fluarix 19-64 YOA Group n=748 Participants Healthy male or female adults, between 19 to 64 years of age (YOA) inclusive, who received Boostrix® vaccine co-administered with Fluarix® vaccine at Day 0, injected intramuscularly in the left and right upper deltoid regions, respectively.	Fluarix Boostrix 19-64 YOA Group n=749 Participants Healthy male or female adults, between 19 to 64 years of age (YOA) inclusive, who received Fluarix® vaccine at Day 0 and Boostrix® vaccine at Month 1, both injected intramuscularly in the upper left deltoid region.	Boostrix+Fluarix ≥ 65 YOA Group n=112 Participants Healthy male or female adults, aged 65 years or older, who received Boostrix® vaccine co-administered with Fluarix® vaccine at Day 0, injected intramuscularly in the left and right upper deltoid regions, respectively.	Fluarix Boostrix ≥ 65 YOA Group n=109 Participants Healthy male or female adults, aged 65 years or older, who received Fluarix® vaccine at Day 0 and Boostrix® vaccine at Month 1, both injected intramuscularly in the upper left deltoid region.
Number of Subjects With Any Unsolicited Adverse Events (AEs)	161 Participants	205 Participants	22 Participants	21 Participants

SECONDARY outcome

Timeframe: 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.

SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

Outcome measures

Measure	Boostrix+Fluarix 19-64 YOA Group n=748 Participants Healthy male or female adults, between 19 to 64 years of age (YOA) inclusive, who received Boostrix® vaccine co-administered with Fluarix® vaccine at Day 0, injected intramuscularly in the left and right upper deltoid regions, respectively.	Fluarix Boostrix 19-64 YOA Group n=749 Participants Healthy male or female adults, between 19 to 64 years of age (YOA) inclusive, who received Fluarix® vaccine at Day 0 and Boostrix® vaccine at Month 1, both injected intramuscularly in the upper left deltoid region.	Boostrix+Fluarix ≥ 65 YOA Group n=112 Participants Healthy male or female adults, aged 65 years or older, who received Boostrix® vaccine co-administered with Fluarix® vaccine at Day 0, injected intramuscularly in the left and right upper deltoid regions, respectively.	Fluarix Boostrix ≥ 65 YOA Group n=109 Participants Healthy male or female adults, aged 65 years or older, who received Fluarix® vaccine at Day 0 and Boostrix® vaccine at Month 1, both injected intramuscularly in the upper left deltoid region.
Number of Subjects With Serious Adverse Events (SAEs)	2 Participants	7 Participants	1 Participants	0 Participants

Adverse Events

Boostrix+Fluarix Group

Serious events: 3 serious events

Other events: 640 other events

Deaths: 0 deaths

Fluarix Boostrix Group

Serious events: 7 serious events

Other events: 619 other events

Deaths: 0 deaths

Serious adverse events

Measure	Boostrix+Fluarix Group n=860 participants at risk 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.	Fluarix Boostrix Group n=858 participants at risk 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.
Blood and lymphatic system disorders Anaemia	0.00% 0/860 • Solicited local and general symptoms: during the 15-day (Day 0-14) period following each vaccination; Unsolicited AEs: during the 31-day period (Day 0-30) following each vaccination; SAEs: throughout the whole study period (from Day 0 to Month 2).	0.12% 1/858 • Number of events 1 • Solicited local and general symptoms: during the 15-day (Day 0-14) period following each vaccination; Unsolicited AEs: during the 31-day period (Day 0-30) following each vaccination; SAEs: throughout the whole study period (from Day 0 to Month 2).
Gastrointestinal disorders Gastric ulcer	0.00% 0/860 • Solicited local and general symptoms: during the 15-day (Day 0-14) period following each vaccination; Unsolicited AEs: during the 31-day period (Day 0-30) following each vaccination; SAEs: throughout the whole study period (from Day 0 to Month 2).	0.12% 1/858 • Number of events 1 • Solicited local and general symptoms: during the 15-day (Day 0-14) period following each vaccination; Unsolicited AEs: during the 31-day period (Day 0-30) following each vaccination; SAEs: throughout the whole study period (from Day 0 to Month 2).
Gastrointestinal disorders Vomiting	0.00% 0/860 • Solicited local and general symptoms: during the 15-day (Day 0-14) period following each vaccination; Unsolicited AEs: during the 31-day period (Day 0-30) following each vaccination; SAEs: throughout the whole study period (from Day 0 to Month 2).	0.12% 1/858 • Number of events 1 • Solicited local and general symptoms: during the 15-day (Day 0-14) period following each vaccination; Unsolicited AEs: during the 31-day period (Day 0-30) following each vaccination; SAEs: throughout the whole study period (from Day 0 to Month 2).
General disorders Chest pain	0.00% 0/860 • Solicited local and general symptoms: during the 15-day (Day 0-14) period following each vaccination; Unsolicited AEs: during the 31-day period (Day 0-30) following each vaccination; SAEs: throughout the whole study period (from Day 0 to Month 2).	0.23% 2/858 • Number of events 2 • Solicited local and general symptoms: during the 15-day (Day 0-14) period following each vaccination; Unsolicited AEs: during the 31-day period (Day 0-30) following each vaccination; SAEs: throughout the whole study period (from Day 0 to Month 2).
Infections and infestations Pneumonia	0.00% 0/860 • Solicited local and general symptoms: during the 15-day (Day 0-14) period following each vaccination; Unsolicited AEs: during the 31-day period (Day 0-30) following each vaccination; SAEs: throughout the whole study period (from Day 0 to Month 2).	0.12% 1/858 • Number of events 1 • Solicited local and general symptoms: during the 15-day (Day 0-14) period following each vaccination; Unsolicited AEs: during the 31-day period (Day 0-30) following each vaccination; SAEs: throughout the whole study period (from Day 0 to Month 2).
Infections and infestations Urosepsis	0.12% 1/860 • Number of events 1 • Solicited local and general symptoms: during the 15-day (Day 0-14) period following each vaccination; Unsolicited AEs: during the 31-day period (Day 0-30) following each vaccination; SAEs: throughout the whole study period (from Day 0 to Month 2).	0.00% 0/858 • Solicited local and general symptoms: during the 15-day (Day 0-14) period following each vaccination; Unsolicited AEs: during the 31-day period (Day 0-30) following each vaccination; SAEs: throughout the whole study period (from Day 0 to Month 2).
Metabolism and nutrition disorders Diabetic ketoacidosis	0.00% 0/860 • Solicited local and general symptoms: during the 15-day (Day 0-14) period following each vaccination; Unsolicited AEs: during the 31-day period (Day 0-30) following each vaccination; SAEs: throughout the whole study period (from Day 0 to Month 2).	0.12% 1/858 • Number of events 1 • Solicited local and general symptoms: during the 15-day (Day 0-14) period following each vaccination; Unsolicited AEs: during the 31-day period (Day 0-30) following each vaccination; SAEs: throughout the whole study period (from Day 0 to Month 2).
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.00% 0/860 • Solicited local and general symptoms: during the 15-day (Day 0-14) period following each vaccination; Unsolicited AEs: during the 31-day period (Day 0-30) following each vaccination; SAEs: throughout the whole study period (from Day 0 to Month 2).	0.12% 1/858 • Number of events 1 • Solicited local and general symptoms: during the 15-day (Day 0-14) period following each vaccination; Unsolicited AEs: during the 31-day period (Day 0-30) following each vaccination; SAEs: throughout the whole study period (from Day 0 to Month 2).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Leukaemia	0.12% 1/860 • Number of events 1 • Solicited local and general symptoms: during the 15-day (Day 0-14) period following each vaccination; Unsolicited AEs: during the 31-day period (Day 0-30) following each vaccination; SAEs: throughout the whole study period (from Day 0 to Month 2).	0.00% 0/858 • Solicited local and general symptoms: during the 15-day (Day 0-14) period following each vaccination; Unsolicited AEs: during the 31-day period (Day 0-30) following each vaccination; SAEs: throughout the whole study period (from Day 0 to Month 2).
Nervous system disorders Headache	0.00% 0/860 • Solicited local and general symptoms: during the 15-day (Day 0-14) period following each vaccination; Unsolicited AEs: during the 31-day period (Day 0-30) following each vaccination; SAEs: throughout the whole study period (from Day 0 to Month 2).	0.23% 2/858 • Number of events 2 • Solicited local and general symptoms: during the 15-day (Day 0-14) period following each vaccination; Unsolicited AEs: during the 31-day period (Day 0-30) following each vaccination; SAEs: throughout the whole study period (from Day 0 to Month 2).
Renal and urinary disorders Renal failure	0.12% 1/860 • Number of events 1 • Solicited local and general symptoms: during the 15-day (Day 0-14) period following each vaccination; Unsolicited AEs: during the 31-day period (Day 0-30) following each vaccination; SAEs: throughout the whole study period (from Day 0 to Month 2).	0.00% 0/858 • Solicited local and general symptoms: during the 15-day (Day 0-14) period following each vaccination; Unsolicited AEs: during the 31-day period (Day 0-30) following each vaccination; SAEs: throughout the whole study period (from Day 0 to Month 2).
Reproductive system and breast disorders Prostatitis	0.12% 1/860 • Number of events 1 • Solicited local and general symptoms: during the 15-day (Day 0-14) period following each vaccination; Unsolicited AEs: during the 31-day period (Day 0-30) following each vaccination; SAEs: throughout the whole study period (from Day 0 to Month 2).	0.00% 0/858 • Solicited local and general symptoms: during the 15-day (Day 0-14) period following each vaccination; Unsolicited AEs: during the 31-day period (Day 0-30) following each vaccination; SAEs: throughout the whole study period (from Day 0 to Month 2).
Reproductive system and breast disorders Testicular pain	0.12% 1/860 • Number of events 1 • Solicited local and general symptoms: during the 15-day (Day 0-14) period following each vaccination; Unsolicited AEs: during the 31-day period (Day 0-30) following each vaccination; SAEs: throughout the whole study period (from Day 0 to Month 2).	0.00% 0/858 • Solicited local and general symptoms: during the 15-day (Day 0-14) period following each vaccination; Unsolicited AEs: during the 31-day period (Day 0-30) following each vaccination; SAEs: throughout the whole study period (from Day 0 to Month 2).
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/860 • Solicited local and general symptoms: during the 15-day (Day 0-14) period following each vaccination; Unsolicited AEs: during the 31-day period (Day 0-30) following each vaccination; SAEs: throughout the whole study period (from Day 0 to Month 2).	0.12% 1/858 • Number of events 1 • Solicited local and general symptoms: during the 15-day (Day 0-14) period following each vaccination; Unsolicited AEs: during the 31-day period (Day 0-30) following each vaccination; SAEs: throughout the whole study period (from Day 0 to Month 2).

Other adverse events

Measure	Boostrix+Fluarix Group n=860 participants at risk 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.	Fluarix Boostrix Group n=858 participants at risk 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.
Musculoskeletal and connective tissue disorders Arthralgia	17.6% 151/860 • Number of events 152 • Solicited local and general symptoms: during the 15-day (Day 0-14) period following each vaccination; Unsolicited AEs: during the 31-day period (Day 0-30) following each vaccination; SAEs: throughout the whole study period (from Day 0 to Month 2).	18.2% 156/858 • Number of events 186 • Solicited local and general symptoms: during the 15-day (Day 0-14) period following each vaccination; Unsolicited AEs: during the 31-day period (Day 0-30) following each vaccination; SAEs: throughout the whole study period (from Day 0 to Month 2).
General disorders Chills	8.8% 76/860 • Number of events 76 • Solicited local and general symptoms: during the 15-day (Day 0-14) period following each vaccination; Unsolicited AEs: during the 31-day period (Day 0-30) following each vaccination; SAEs: throughout the whole study period (from Day 0 to Month 2).	10.0% 86/858 • Number of events 99 • Solicited local and general symptoms: during the 15-day (Day 0-14) period following each vaccination; Unsolicited AEs: during the 31-day period (Day 0-30) following each vaccination; SAEs: throughout the whole study period (from Day 0 to Month 2).
Skin and subcutaneous tissue disorders Erythema	23.6% 203/860 • Number of events 203 • Solicited local and general symptoms: during the 15-day (Day 0-14) period following each vaccination; Unsolicited AEs: during the 31-day period (Day 0-30) following each vaccination; SAEs: throughout the whole study period (from Day 0 to Month 2).	26.5% 227/858 • Number of events 303 • Solicited local and general symptoms: during the 15-day (Day 0-14) period following each vaccination; Unsolicited AEs: during the 31-day period (Day 0-30) following each vaccination; SAEs: throughout the whole study period (from Day 0 to Month 2).
General disorders Fatigue	27.9% 240/860 • Number of events 240 • Solicited local and general symptoms: during the 15-day (Day 0-14) period following each vaccination; Unsolicited AEs: during the 31-day period (Day 0-30) following each vaccination; SAEs: throughout the whole study period (from Day 0 to Month 2).	28.0% 240/858 • Number of events 306 • Solicited local and general symptoms: during the 15-day (Day 0-14) period following each vaccination; Unsolicited AEs: during the 31-day period (Day 0-30) following each vaccination; SAEs: throughout the whole study period (from Day 0 to Month 2).
Gastrointestinal disorders Gastrointestinal disorder	16.2% 139/860 • Number of events 139 • Solicited local and general symptoms: during the 15-day (Day 0-14) period following each vaccination; Unsolicited AEs: during the 31-day period (Day 0-30) following each vaccination; SAEs: throughout the whole study period (from Day 0 to Month 2).	16.9% 145/858 • Number of events 171 • Solicited local and general symptoms: during the 15-day (Day 0-14) period following each vaccination; Unsolicited AEs: during the 31-day period (Day 0-30) following each vaccination; SAEs: throughout the whole study period (from Day 0 to Month 2).
Nervous system disorders Headache	28.4% 244/860 • Number of events 244 • Solicited local and general symptoms: during the 15-day (Day 0-14) period following each vaccination; Unsolicited AEs: during the 31-day period (Day 0-30) following each vaccination; SAEs: throughout the whole study period (from Day 0 to Month 2).	32.2% 276/858 • Number of events 361 • Solicited local and general symptoms: during the 15-day (Day 0-14) period following each vaccination; Unsolicited AEs: during the 31-day period (Day 0-30) following each vaccination; SAEs: throughout the whole study period (from Day 0 to Month 2).
Musculoskeletal and connective tissue disorders Myalgia	34.2% 294/860 • Number of events 294 • Solicited local and general symptoms: during the 15-day (Day 0-14) period following each vaccination; Unsolicited AEs: during the 31-day period (Day 0-30) following each vaccination; SAEs: throughout the whole study period (from Day 0 to Month 2).	36.5% 313/858 • Number of events 411 • Solicited local and general symptoms: during the 15-day (Day 0-14) period following each vaccination; Unsolicited AEs: during the 31-day period (Day 0-30) following each vaccination; SAEs: throughout the whole study period (from Day 0 to Month 2).
General disorders Pain	59.2% 509/860 • Number of events 513 • Solicited local and general symptoms: during the 15-day (Day 0-14) period following each vaccination; Unsolicited AEs: during the 31-day period (Day 0-30) following each vaccination; SAEs: throughout the whole study period (from Day 0 to Month 2).	55.1% 473/858 • Number of events 698 • Solicited local and general symptoms: during the 15-day (Day 0-14) period following each vaccination; Unsolicited AEs: during the 31-day period (Day 0-30) following each vaccination; SAEs: throughout the whole study period (from Day 0 to Month 2).
General disorders Pyrexia	6.9% 59/860 • Number of events 59 • Solicited local and general symptoms: during the 15-day (Day 0-14) period following each vaccination; Unsolicited AEs: during the 31-day period (Day 0-30) following each vaccination; SAEs: throughout the whole study period (from Day 0 to Month 2).	10.3% 88/858 • Number of events 98 • Solicited local and general symptoms: during the 15-day (Day 0-14) period following each vaccination; Unsolicited AEs: during the 31-day period (Day 0-30) following each vaccination; SAEs: throughout the whole study period (from Day 0 to Month 2).
General disorders Swelling	23.0% 198/860 • Number of events 198 • Solicited local and general symptoms: during the 15-day (Day 0-14) period following each vaccination; Unsolicited AEs: during the 31-day period (Day 0-30) following each vaccination; SAEs: throughout the whole study period (from Day 0 to Month 2).	20.6% 177/858 • Number of events 219 • Solicited local and general symptoms: during the 15-day (Day 0-14) period following each vaccination; Unsolicited AEs: during the 31-day period (Day 0-30) following each vaccination; SAEs: throughout the whole study period (from Day 0 to Month 2).

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

• Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
• Publication restrictions are in place

Restriction type: OTHER