Trial Outcomes & Findings for Immunogenicity & Reactogenicity of Boostrix 10 Years After Previous Booster Vaccination in Study NCT01267058 (NCT NCT00548171)

NCT ID: NCT00548171

Last Updated: 2020-01-13

Results Overview

Cut-off values defining seroprotected subjects against anti-DT/anti-TT were greater than or equal to (≥) 0.1 IU/mL as assessed by the Enzyme-Linked Immunosorbent Assay (ELISA). The analysis was performed and presents results only for subjects who in the previous study NCT01267058, had received the Boostrix™ vaccine as first booster.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 203 participants
• Primary outcome timeframe: One month after the booster vaccination [PI(M1)]
• Results posted on: 2020-01-13

Participant Flow

Participant milestones

Measure	Boostrix I Group Subjects who had received the Boostrix™ vaccine in the primary study 263855/002 (NCT01267058), were boosted in the current study with one dose of the same vaccine, intramuscularly in the deltoid region of the non-dominant arm.	Boostrix II Group Subjects who had received the Td vaccines in the primary study 263855/002 (NCT01267058), were boosted in the current study with one dose of the Boostrix™ vaccine intramuscularly in the deltoid region of the non-dominant arm.
Overall Study STARTED	164	39
Overall Study COMPLETED	164	39
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Boostrix I Group n=164 Participants Subjects who had received the Boostrix™ vaccine in the primary study 263855/002 (NCT01267058), were boosted in the current study with one dose of the same vaccine, intramuscularly in the deltoid region of the non-dominant arm.	Boostrix II Group n=39 Participants Subjects who had received the Td vaccines in the primary study 263855/002 (NCT01267058), were boosted in the current study with one dose of the Boostrix™ vaccine intramuscularly in the deltoid region of the non-dominant arm.	Total n=203 Participants Total of all reporting groups
Age, Continuous	50.1 Years STANDARD_DEVIATION 9.98 • n=164 Participants	51.0 Years STANDARD_DEVIATION 8.70 • n=39 Participants	50.27 Years STANDARD_DEVIATION 9.73 • n=203 Participants
Sex: Female, Male Female	107 Participants n=164 Participants	33 Participants n=39 Participants	140 Participants n=203 Participants
Sex: Female, Male Male	57 Participants n=164 Participants	6 Participants n=39 Participants	63 Participants n=203 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: One month after the booster vaccination [PI(M1)]

Population: The ATP cohort for immunogenicity included all evaluable subjects who had received the booster dose of Boostrix™ vaccine and for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component at the post-vaccination blood-sampling time point.

Cut-off values defining seroprotected subjects against anti-DT/anti-TT were greater than or equal to (≥) 0.1 IU/mL as assessed by the Enzyme-Linked Immunosorbent Assay (ELISA).

The analysis was performed and presents results only for subjects who in the previous study NCT01267058, had received the Boostrix™ vaccine as first booster.

Outcome measures

Measure	Boostrix I Group n=153 Participants Subjects who had received the Boostrix™ vaccine in the primary study 263855/002 (NCT01267058), were boosted in the current study with one dose of the same vaccine, intramuscularly in the deltoid region of the non-dominant arm.	Boostrix II Group n=35 Participants Subjects who had received the Td vaccines in the primary study 263855/002 (NCT01267058), were boosted in the current study with one dose of the Boostrix™ vaccine intramuscularly in the deltoid region of the non-dominant arm.
Number of Subjects With Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoid (Anti-TT) Antibody Concentrations Equal to or Above (≥) 0.1 International Units Per Milliliter (IU/mL) Anti-DT ≥ 0.1 PI(M1)	151 Participants	35 Participants
Number of Subjects With Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoid (Anti-TT) Antibody Concentrations Equal to or Above (≥) 0.1 International Units Per Milliliter (IU/mL) Anti-TT ≥ 0.1 PI(M1)	153 Participants	35 Participants

SECONDARY outcome

Timeframe: Prior to (PRE) and one month after [PI(M1)] the booster vaccination

Population: The ATP cohort for immunogenicity included all evaluable subjects who had received the booster dose of Boostrix™ vaccine and for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component at the post-vaccination blood-sampling time point.

Cut-off values, as assessed by ELISA, were greater than or equal to (≥) 0.1 IU/mL and (≥) 1 IU/mL.

Outcome measures

Measure	Boostrix I Group n=153 Participants Subjects who had received the Boostrix™ vaccine in the primary study 263855/002 (NCT01267058), were boosted in the current study with one dose of the same vaccine, intramuscularly in the deltoid region of the non-dominant arm.	Boostrix II Group n=35 Participants Subjects who had received the Td vaccines in the primary study 263855/002 (NCT01267058), were boosted in the current study with one dose of the Boostrix™ vaccine intramuscularly in the deltoid region of the non-dominant arm.
Number of Subjects With Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations Equal to or Above Cut-off Values Anti-DT ≥ 0.1 IU/mL, PI(M1)	151 Participants	35 Participants
Number of Subjects With Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations Equal to or Above Cut-off Values Anti-DT ≥ 0.1 IU/mL, PRE	95 Participants	20 Participants
Number of Subjects With Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations Equal to or Above Cut-off Values Anti-DT ≥ 1 IU/mL, PRE	24 Participants	7 Participants
Number of Subjects With Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations Equal to or Above Cut-off Values Anti-DT ≥ 1 IU/mL, PI(M1)	106 Participants	23 Participants
Number of Subjects With Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations Equal to or Above Cut-off Values Anti-TT ≥ 0.1 IU/mL, PRE	145 Participants	30 Participants
Number of Subjects With Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations Equal to or Above Cut-off Values Anti-TT ≥ 0.1 IU/mL, PI(M1)	153 Participants	35 Participants
Number of Subjects With Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations Equal to or Above Cut-off Values Anti-TT ≥ 1 IU/mL, PRE	90 Participants	23 Participants
Number of Subjects With Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations Equal to or Above Cut-off Values Anti-TT ≥ 1 IU/mL, PI(M1)	153 Participants	35 Participants

SECONDARY outcome

Timeframe: Prior to (PRE) and one month after [PI(M1)] the booster vaccination

Population: The ATP cohort for immunogenicity included all evaluable subjects who had received the booster dose of Boostrix™ vaccine and for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component at the post-vaccination blood-sampling time point.

Concentrations were presented as geometric mean concentrations (GMCs), expressed in international units per milliliter (IU/mL).

Outcome measures

Measure	Boostrix I Group n=153 Participants Subjects who had received the Boostrix™ vaccine in the primary study 263855/002 (NCT01267058), were boosted in the current study with one dose of the same vaccine, intramuscularly in the deltoid region of the non-dominant arm.	Boostrix II Group n=35 Participants Subjects who had received the Td vaccines in the primary study 263855/002 (NCT01267058), were boosted in the current study with one dose of the Boostrix™ vaccine intramuscularly in the deltoid region of the non-dominant arm.
Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations Anti-DT, PRE	0.200 IU/mL Interval 0.161 to 0.249	0.233 IU/mL Interval 0.138 to 0.392
Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations Anti-DT, PI(M1)	1.889 IU/mL Interval 1.547 to 2.306	1.605 IU/mL Interval 1.111 to 2.319
Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations Anti-TT, PRE	1.026 IU/mL Interval 0.859 to 1.224	0.845 IU/mL Interval 0.538 to 1.327
Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations Anti-TT, PI(M1)	6.927 IU/mL Interval 6.204 to 7.735	5.933 IU/mL Interval 4.768 to 7.384

SECONDARY outcome

Timeframe: Prior (PRE) to booster vaccination

Population: The ATP cohort for antibody persistence included all subjects who had not received any additional dose of DTP vaccine after the booster dose received in study 263855/002 (dTpa-002), with no evidence of diphtheria, tetanus, or pertussis infection or disease, and for whom serological results were available at the pre-booster blood sampling time point

Cut-off values, as assessed by ELISA, were greater than or equal to (≥) 0.1 IU/mL and ≥ 1 IU/mL.

This endpoint presents results for subjects included in the ATP cohort for antibody persistence.

Outcome measures

Measure	Boostrix I Group n=160 Participants Subjects who had received the Boostrix™ vaccine in the primary study 263855/002 (NCT01267058), were boosted in the current study with one dose of the same vaccine, intramuscularly in the deltoid region of the non-dominant arm.	Boostrix II Group n=37 Participants Subjects who had received the Td vaccines in the primary study 263855/002 (NCT01267058), were boosted in the current study with one dose of the Boostrix™ vaccine intramuscularly in the deltoid region of the non-dominant arm.
Number of Subjects With Anti-DT and Anti-TT Antibody Concentrations Equal to or Above Cut-off Values Anti-DT ≥ 1 IU/mL, PRE	25 Participants	7 Participants
Number of Subjects With Anti-DT and Anti-TT Antibody Concentrations Equal to or Above Cut-off Values Anti-DT ≥ 0.1 IU/mL, PRE	102 Participants	22 Participants
Number of Subjects With Anti-DT and Anti-TT Antibody Concentrations Equal to or Above Cut-off Values Anti-TT ≥ 0.1 IU/mL, PRE	152 Participants	32 Participants
Number of Subjects With Anti-DT and Anti-TT Antibody Concentrations Equal to or Above Cut-off Values Anti-TT ≥ 1 IU/mL, PRE	95 Participants	25 Participants

SECONDARY outcome

Timeframe: Prior to the booster vaccination

Population: The ATP cohort for antibody persistence included all subjects who had not received any additional dose of DTP vaccine after the booster dose received in study 263855/002 (dTpa-002), with no evidence of diphtheria, tetanus, or pertussis infection or disease, and for whom serological results were available at the pre-booster blood sampling time point

Concentrations are presented as geometric mean concentrations (GMCs), expressed in international units per milliliter (IU/mL).

Outcome measures

Measure	Boostrix I Group n=160 Participants Subjects who had received the Boostrix™ vaccine in the primary study 263855/002 (NCT01267058), were boosted in the current study with one dose of the same vaccine, intramuscularly in the deltoid region of the non-dominant arm.	Boostrix II Group n=37 Participants Subjects who had received the Td vaccines in the primary study 263855/002 (NCT01267058), were boosted in the current study with one dose of the Boostrix™ vaccine intramuscularly in the deltoid region of the non-dominant arm.
Anti-DT and Anti-TT Antibody Concentrations Anti-TT, PRE	1.031 IU/mL Interval 0.868 to 1.225	0.898 IU/mL Interval 0.581 to 1.386
Anti-DT and Anti-TT Antibody Concentrations Anti-DT, PRE	0.208 IU/mL Interval 0.168 to 0.257	0.235 IU/mL Interval 0.144 to 0.384

SECONDARY outcome

Timeframe: Prior the booster vaccination

Population: The ATP cohort for antibody persistence included all subjects who had not received any additional dose of DTP vaccine after the booster dose received in study 263855/002 (dTpa-002), with no evidence of diphtheria, tetanus, or pertussis infection or disease, and for whom serological results were available at the pre-booster blood sampling time point

Seronegative subjects were defined as subjects with anti-DT antibody concentrations < 0.1 IU/mL prior to vaccination, as assessed by ELISA.

Outcome measures

Measure	Boostrix I Group n=158 Participants Subjects who had received the Boostrix™ vaccine in the primary study 263855/002 (NCT01267058), were boosted in the current study with one dose of the same vaccine, intramuscularly in the deltoid region of the non-dominant arm.	Boostrix II Group n=36 Participants Subjects who had received the Td vaccines in the primary study 263855/002 (NCT01267058), were boosted in the current study with one dose of the Boostrix™ vaccine intramuscularly in the deltoid region of the non-dominant arm.
Number of Seronegative Subjects for Anti-DT Antibodies - ELISA	56 Participants	14 Participants

SECONDARY outcome

Timeframe: Prior the booster vaccination

Population: This analysis was performed on those participants from the According to Protocol (ATP) cohort for antibody persistence who were found to be seronegative for anti-diphtheria antibodies as tested by ELISA.

Sera with ELISA concentrations <0.1 IU/mL before vaccination were tested for neutralising antibodies using a Vero-cell neutralisation assay. Concentrations ≥0.016 IU/mL by Vero-cell indicated detectable anti-diphteria neutralising antibodies.

Outcome measures

Measure	Boostrix I Group n=56 Participants Subjects who had received the Boostrix™ vaccine in the primary study 263855/002 (NCT01267058), were boosted in the current study with one dose of the same vaccine, intramuscularly in the deltoid region of the non-dominant arm.	Boostrix II Group n=14 Participants Subjects who had received the Td vaccines in the primary study 263855/002 (NCT01267058), were boosted in the current study with one dose of the Boostrix™ vaccine intramuscularly in the deltoid region of the non-dominant arm.
Number of Seronegative Subjects for Anti-DT Antibodies - Neutralisation Test	16 Participants	4 Participants

SECONDARY outcome

Timeframe: Prior the booster vaccination

Population: The ATP cohort for antibody persistence included all subjects who had not received any additional dose of DTP vaccine after the booster dose received in study 263855/002 (dTpa-002), with no evidence of diphtheria, tetanus, or pertussis infection or disease, and for whom serological results were available at the pre-booster blood sampling time point

Cut-off values, as assessed by ELISA, were greater than or equal to ≥ 5 ELISA Units per millilitre (EL.U/mL) defining seropositive subjects post-vaccination.

Outcome measures

Measure	Boostrix I Group n=160 Participants Subjects who had received the Boostrix™ vaccine in the primary study 263855/002 (NCT01267058), were boosted in the current study with one dose of the same vaccine, intramuscularly in the deltoid region of the non-dominant arm.	Boostrix II Group n=37 Participants Subjects who had received the Td vaccines in the primary study 263855/002 (NCT01267058), were boosted in the current study with one dose of the Boostrix™ vaccine intramuscularly in the deltoid region of the non-dominant arm.
Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibodies Anti-PT	137 Participants	23 Participants
Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibodies Anti-FHA	159 Participants	37 Participants
Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibodies Anti-PRN	151 Participants	33 Participants

SECONDARY outcome

Timeframe: Prior the booster vaccination

Population: The ATP cohort for antibody persistence included all subjects who had not received any additional dose of DTP vaccine after the booster dose received in study 263855/002 (dTpa-002), with no evidence of diphtheria, tetanus, or pertussis infection or disease, and for whom serological results were available at the pre-booster blood sampling time point

Concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per millilitre (EL.U/mL)

Outcome measures

Measure	Boostrix I Group n=160 Participants Subjects who had received the Boostrix™ vaccine in the primary study 263855/002 (NCT01267058), were boosted in the current study with one dose of the same vaccine, intramuscularly in the deltoid region of the non-dominant arm.	Boostrix II Group n=37 Participants Subjects who had received the Td vaccines in the primary study 263855/002 (NCT01267058), were boosted in the current study with one dose of the Boostrix™ vaccine intramuscularly in the deltoid region of the non-dominant arm.
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations Anti-PT	13.9 EL.U/mL Interval 11.9 to 16.2	8.3 EL.U/mL Interval 5.9 to 11.7
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations Anti-FHA	137.2 EL.U/mL Interval 116.7 to 161.3	115.6 EL.U/mL Interval 80.2 to 166.5
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations Anti-PRN	56.6 EL.U/mL Interval 44.2 to 72.4	50.2 EL.U/mL Interval 27.9 to 90.4

SECONDARY outcome

Timeframe: Prior to the booster vaccination

Population: The ATP cohort for immunogenicity included all evaluable subjects who had received the booster dose of Boostrix™ vaccine and for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component at the post-vaccination blood-sampling time point.

Seronegative subjects were defined as subjects with anti-DT antibody concentrations < 0.1 IU/mL prior to vaccination, as assessed by ELISA.

Outcome measures

Measure	Boostrix I Group n=151 Participants Subjects who had received the Boostrix™ vaccine in the primary study 263855/002 (NCT01267058), were boosted in the current study with one dose of the same vaccine, intramuscularly in the deltoid region of the non-dominant arm.	Boostrix II Group n=34 Participants Subjects who had received the Td vaccines in the primary study 263855/002 (NCT01267058), were boosted in the current study with one dose of the Boostrix™ vaccine intramuscularly in the deltoid region of the non-dominant arm.
Number of Seronegative Subjects for Anti-DT Antibodies - ELISA.	56 Participants	14 Participants

SECONDARY outcome

Timeframe: Prior to the booster vaccination

Population: This analysis was performed on those participants from the According to Protocol (ATP) cohort for immunogenicity who were found to be seronegative for anti-diphtheria antibodies as assessed by ELISA.

Sera with ELISA concentrations <0.1 IU/mL before vaccination were tested for neutralising antibodies using a Vero-cell neutralisation assay. Concentrations ≥0.016 IU/mL by Vero-cell indicated detectable anti-diphteria neutralising antibodies.

Outcome measures

Measure	Boostrix I Group n=56 Participants Subjects who had received the Boostrix™ vaccine in the primary study 263855/002 (NCT01267058), were boosted in the current study with one dose of the same vaccine, intramuscularly in the deltoid region of the non-dominant arm.	Boostrix II Group n=14 Participants Subjects who had received the Td vaccines in the primary study 263855/002 (NCT01267058), were boosted in the current study with one dose of the Boostrix™ vaccine intramuscularly in the deltoid region of the non-dominant arm.
Number of Seronegative Subjects for Anti-DT Antibodies - Neutralisation Test.	16 Participants	4 Participants

SECONDARY outcome

Timeframe: One month after the booster vaccination

Population: The ATP cohort for immunogenicity included all evaluable subjects who had received the booster dose of Boostrix™ vaccine and for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component at the post-vaccination blood-sampling time point.

Seronegative subjects were defined as subjects with anti-DT antibody concentrations < 0.1 IU/mL prior to vaccination, as assessed by ELISA.

Outcome measures

Measure	Boostrix I Group n=152 Participants Subjects who had received the Boostrix™ vaccine in the primary study 263855/002 (NCT01267058), were boosted in the current study with one dose of the same vaccine, intramuscularly in the deltoid region of the non-dominant arm.	Boostrix II Group n=35 Participants Subjects who had received the Td vaccines in the primary study 263855/002 (NCT01267058), were boosted in the current study with one dose of the Boostrix™ vaccine intramuscularly in the deltoid region of the non-dominant arm.
Number of Seronegative Subjects for Anti-DT Antibodies - ELISA	1 Participants	0 Participants

SECONDARY outcome

Timeframe: One month after the booster vaccination

Population: This analysis was performed on those participants from the According to Protocol (ATP) cohort for immunogenicity who were found to be seronegative for anti-diphtheria antibodies as assessed by ELISA.

Sera with ELISA concentrations <0.1 IU/mL before vaccination were tested for neutralising antibodies using a Vero-cell neutralisation assay. Concentrations ≥ 0.016 IU/mL by Vero-cell indicated detectable anti-diphteria neutralising antibodies.

Outcome measures

Measure	Boostrix I Group n=1 Participants Subjects who had received the Boostrix™ vaccine in the primary study 263855/002 (NCT01267058), were boosted in the current study with one dose of the same vaccine, intramuscularly in the deltoid region of the non-dominant arm.	Boostrix II Group Subjects who had received the Td vaccines in the primary study 263855/002 (NCT01267058), were boosted in the current study with one dose of the Boostrix™ vaccine intramuscularly in the deltoid region of the non-dominant arm.
Number of Seronegative Subjects for Anti-DT Antibodies - Neutralisation Test	0 Participants	—

SECONDARY outcome

Timeframe: Prior to (PRE) and one month after [PI(M1)] the booster vaccination

Population: The ATP cohort for immunogenicity included all evaluable subjects who had received the booster dose of Boostrix™ vaccine and for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component at the post-vaccination blood-sampling time point.

Cut-off values, as assessed by ELISA, were greater than or equal to ≥ 5 ELISA Units per millilitre (EL.U/mL) defining seropositive subjects post-vaccination.

Outcome measures

Measure	Boostrix I Group n=153 Participants Subjects who had received the Boostrix™ vaccine in the primary study 263855/002 (NCT01267058), were boosted in the current study with one dose of the same vaccine, intramuscularly in the deltoid region of the non-dominant arm.	Boostrix II Group n=35 Participants Subjects who had received the Td vaccines in the primary study 263855/002 (NCT01267058), were boosted in the current study with one dose of the Boostrix™ vaccine intramuscularly in the deltoid region of the non-dominant arm.
Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN Antibodies Anti-PT, PRE	131 Participants	22 Participants
Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN Antibodies Anti-FHA, PI(M1)	152 Participants	35 Participants
Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN Antibodies Anti-PRN, PRE	144 Participants	31 Participants
Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN Antibodies Anti-PT, PI(M1)	152 Participants	35 Participants
Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN Antibodies Anti-FHA, PRE	152 Participants	35 Participants
Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN Antibodies Anti-PRN, PI(M1)	153 Participants	34 Participants

SECONDARY outcome

Timeframe: Prior to (PRE) and one month after [PI(M1)] the booster vaccination

Population: The ATP cohort for immunogenicity included all evaluable subjects who had received the booster dose of Boostrix™ vaccine and for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component at the post-vaccination blood-sampling time point.

Concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per millilitre (EL.U/mL).

Outcome measures

Measure	Boostrix I Group n=153 Participants Subjects who had received the Boostrix™ vaccine in the primary study 263855/002 (NCT01267058), were boosted in the current study with one dose of the same vaccine, intramuscularly in the deltoid region of the non-dominant arm.	Boostrix II Group n=35 Participants Subjects who had received the Td vaccines in the primary study 263855/002 (NCT01267058), were boosted in the current study with one dose of the Boostrix™ vaccine intramuscularly in the deltoid region of the non-dominant arm.
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations Anti-PT, PRE	13.9 EL.U/mL Interval 11.9 to 16.2	8.4 EL.U/mL Interval 5.9 to 11.8
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations Anti-PT, PI(M1)	126.5 EL.U/mL Interval 109.9 to 145.6	120.8 EL.U/mL Interval 88.9 to 164.2
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations Anti-FHA, PRE	140.2 EL.U/mL Interval 118.9 to 165.4	119.3 EL.U/mL Interval 81.3 to 175.1
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations Anti-FHA, PI(M1)	615.3 EL.U/mL Interval 543.8 to 696.2	677.4 EL.U/mL Interval 513.7 to 893.2
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations Anti-PRN, PRE	56.2 EL.U/mL Interval 43.6 to 72.5	45.7 EL.U/mL Interval 24.9 to 83.7
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations Anti-PRN, PI(M1)	303.6 EL.U/mL Interval 259.6 to 355.0	370.7 EL.U/mL Interval 280.5 to 489.9

SECONDARY outcome

Timeframe: One month after the booster vaccination

Population: The ATP cohort for immunogenicity included all evaluable subjects who had received the booster dose of Boostrix™ vaccine and for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component at the post-vaccination blood-sampling time point.

Booster response was defined as appearance of antibodies in subjects who were seronegative at the pre-vaccination time point (i.e. with concentrations < 5 El.U/mL) or at least 2-fold increase of pre-vaccination antibody concentrations in subjects who were seropositive at the pre-vaccination time point (i.e. with concentrations ≥5 El.U/mL).

Outcome measures

Measure	Boostrix I Group n=152 Participants Subjects who had received the Boostrix™ vaccine in the primary study 263855/002 (NCT01267058), were boosted in the current study with one dose of the same vaccine, intramuscularly in the deltoid region of the non-dominant arm.	Boostrix II Group n=35 Participants Subjects who had received the Td vaccines in the primary study 263855/002 (NCT01267058), were boosted in the current study with one dose of the Boostrix™ vaccine intramuscularly in the deltoid region of the non-dominant arm.
Number of Subjects With Booster Response to Anti-PT, Anti-FHA and Anti-PRN Anti-PT	148 Participants	33 Participants
Number of Subjects With Booster Response to Anti-PT, Anti-FHA and Anti-PRN Anti-FHA	119 Participants	31 Participants
Number of Subjects With Booster Response to Anti-PT, Anti-FHA and Anti-PRN Anti-PRN	106 Participants	26 Participants

SECONDARY outcome

Timeframe: During the 4-day (Day 0-3) follow-up period after booster vaccination

Population: The Total Vaccinated Cohort (TVC) included all vaccinated subjects for whom data were available.

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. Relationship analysis was not performed.

For safety assessment Boostrix I Group and Boostrix II Group were pooled into Booster Pooled Group.

Outcome measures

Measure	Boostrix I Group n=203 Participants Subjects who had received the Boostrix™ vaccine in the primary study 263855/002 (NCT01267058), were boosted in the current study with one dose of the same vaccine, intramuscularly in the deltoid region of the non-dominant arm.	Boostrix II Group Subjects who had received the Td vaccines in the primary study 263855/002 (NCT01267058), were boosted in the current study with one dose of the Boostrix™ vaccine intramuscularly in the deltoid region of the non-dominant arm.
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Swelling	66 Participants	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Pain	142 Participants	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Pain	2 Participants	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Redness	72 Participants	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Redness	14 Participants	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Swelling	20 Participants	—

SECONDARY outcome

Timeframe: During the 4-day (Day 0-3) follow-up period after booster vaccination

Population: The Total Vaccinated Cohort (TVC) included all vaccinated subjects for whom data were available.

Assessed solicited general symptoms were fatigue, fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], headache, gastrointestinal symptoms [nausea, vomiting, diarrhoea and/or abdominal pain]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.

For safety assessment Boostrix I Group and Boostrix II Group were pooled into Booster Pooled Group.

Outcome measures

Measure	Boostrix I Group n=203 Participants Subjects who had received the Boostrix™ vaccine in the primary study 263855/002 (NCT01267058), were boosted in the current study with one dose of the same vaccine, intramuscularly in the deltoid region of the non-dominant arm.	Boostrix II Group Subjects who had received the Td vaccines in the primary study 263855/002 (NCT01267058), were boosted in the current study with one dose of the Boostrix™ vaccine intramuscularly in the deltoid region of the non-dominant arm.
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fever	6 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fatigue	47 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fatigue	0 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fatigue	25 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fever	0 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fever	5 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Gastrointestinal symptom	15 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Gastrointestinal symptom	1 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Gastrointestinal symptom	7 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Headache	39 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Headache	2 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Headache	18 Participants	—

SECONDARY outcome

Timeframe: During the 31-day (Day 0-30) follow-up period after booster vaccination

Population: The Total Vaccinated Cohort (TVC) included all vaccinated subjects for whom data were available.

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.

For safety assessment Boostrix I Group and Boostrix II Group were pooled into Booster Pooled Group.

Outcome measures

Measure	Boostrix I Group n=203 Participants Subjects who had received the Boostrix™ vaccine in the primary study 263855/002 (NCT01267058), were boosted in the current study with one dose of the same vaccine, intramuscularly in the deltoid region of the non-dominant arm.	Boostrix II Group Subjects who had received the Td vaccines in the primary study 263855/002 (NCT01267058), were boosted in the current study with one dose of the Boostrix™ vaccine intramuscularly in the deltoid region of the non-dominant arm.
Number of Subjects With Any Unsolicited Adverse Events (AEs)	35 Participants	—

SECONDARY outcome

Timeframe: Following the booster vaccination

Population: The Total Vaccinated Cohort (TVC) included all vaccinated subjects for whom data were available.

Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

For safety assessment Boostrix I Group and Boostrix II Group were pooled into Booster Pooled Group.

Outcome measures

Measure	Boostrix I Group n=203 Participants Subjects who had received the Boostrix™ vaccine in the primary study 263855/002 (NCT01267058), were boosted in the current study with one dose of the same vaccine, intramuscularly in the deltoid region of the non-dominant arm.	Boostrix II Group Subjects who had received the Td vaccines in the primary study 263855/002 (NCT01267058), were boosted in the current study with one dose of the Boostrix™ vaccine intramuscularly in the deltoid region of the non-dominant arm.
Number of Subjects With Serious Adverse Events (SAEs)	0 Participants	—

Adverse Events

Boostrix Pooled Group

Serious events: 0 serious events

Other events: 163 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Boostrix Pooled Group n=203 participants at risk Subjects who had received the Boostrix™ and the Td vaccines in the primary study 263855/002 (NCT01267058) administrated intramuscularly in the deltoid region of the non-dominant arm were boosted in the current study with one dose of Boostrix™ vaccine, intramuscularly in the deltoid region of the non-dominant arm.
General disorders Fatigue	23.2% 47/203 • Number of events 47 • Solicited symptoms: during the 4-day (Days 0-3) follow-up period post booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) follow-up period post booster vaccination; SAEs: during the entire study period (following booster vaccination). For safety assessment Boostrix I Group and Boostrix II Group were pooled into Booster Pooled Group.
Gastrointestinal disorders Gastrointestinal disorder	7.4% 15/203 • Number of events 15 • Solicited symptoms: during the 4-day (Days 0-3) follow-up period post booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) follow-up period post booster vaccination; SAEs: during the entire study period (following booster vaccination). For safety assessment Boostrix I Group and Boostrix II Group were pooled into Booster Pooled Group.
Nervous system disorders Headache	19.7% 40/203 • Number of events 40 • Solicited symptoms: during the 4-day (Days 0-3) follow-up period post booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) follow-up period post booster vaccination; SAEs: during the entire study period (following booster vaccination). For safety assessment Boostrix I Group and Boostrix II Group were pooled into Booster Pooled Group.
General disorders Pain	70.0% 142/203 • Number of events 142 • Solicited symptoms: during the 4-day (Days 0-3) follow-up period post booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) follow-up period post booster vaccination; SAEs: during the entire study period (following booster vaccination). For safety assessment Boostrix I Group and Boostrix II Group were pooled into Booster Pooled Group.
Skin and subcutaneous tissue disorders Erythema	35.5% 72/203 • Number of events 72 • Solicited symptoms: during the 4-day (Days 0-3) follow-up period post booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) follow-up period post booster vaccination; SAEs: during the entire study period (following booster vaccination). For safety assessment Boostrix I Group and Boostrix II Group were pooled into Booster Pooled Group.
General disorders Swelling	32.5% 66/203 • Number of events 66 • Solicited symptoms: during the 4-day (Days 0-3) follow-up period post booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) follow-up period post booster vaccination; SAEs: during the entire study period (following booster vaccination). For safety assessment Boostrix I Group and Boostrix II Group were pooled into Booster Pooled Group.
General disorders Injection site pruritus	4.4% 9/203 • Number of events 9 • Solicited symptoms: during the 4-day (Days 0-3) follow-up period post booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) follow-up period post booster vaccination; SAEs: during the entire study period (following booster vaccination). For safety assessment Boostrix I Group and Boostrix II Group were pooled into Booster Pooled Group.
General disorders Pyrexia	3.0% 6/203 • Number of events 6 • Solicited symptoms: during the 4-day (Days 0-3) follow-up period post booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) follow-up period post booster vaccination; SAEs: during the entire study period (following booster vaccination). For safety assessment Boostrix I Group and Boostrix II Group were pooled into Booster Pooled Group.

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