Trial Outcomes & Findings for Persistence Study of GSK Biologicals' Tdap Vaccine 1, 3, 5 and 9 Years Following Administration as an Initial Single Dose in Healthy Young Adults and to Evaluate the Immunogenicity and Safety of Boostrix as a Second Dose of Tdap, When Administered at Year 9 (NCT NCT00489970)
NCT ID: NCT00489970
Last Updated: 2020-05-01
Results Overview
Anti-D cut-off was defined as ≥ 0.1 International Units per milliliter (IU/mL) determined with Enzyme-linked Immunosorbent Assay (ELISA)
COMPLETED
PHASE3
1954 participants
At year 1 after the vaccination in primary study (NCT00346073)
2020-05-01
Participant Flow
A total of 1592 participants were enrolled in the study at Year 1 (in the Boostrix and Adacel groups). As per advice from the Centre for Biologics and Research Evaluation (CBER), an additional treatment group acting as control was also added at Year 9, therefore the total number of subjects analyzed was 1592 (Year 1) + 362 (Year 9) = 1954.
Subjects who received a single dose of Boostrix or Adacel vaccines, in the primary study (NCT00346073) were included in this study.
Participant milestones
| Measure |
Boostrix Group
Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine \[Tdap\](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a second dose of Boostrix vaccine \[Tdap\](GSK776423).
|
Adacel Group
Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a dose of Boostrix vaccine \[Tdap\](GSK776423).
|
Control Group
Subjects received the first dose of Boostrix vaccine \[Tdap\](GSK776423) in this study at Year 9.
|
|---|---|---|---|
|
Persistence Year 1
STARTED
|
1069
|
523
|
0
|
|
Persistence Year 1
COMPLETED
|
1069
|
523
|
0
|
|
Persistence Year 1
NOT COMPLETED
|
0
|
0
|
0
|
|
Persistence Year 3
STARTED
|
1019
|
486
|
0
|
|
Persistence Year 3
COMPLETED
|
1019
|
486
|
0
|
|
Persistence Year 3
NOT COMPLETED
|
0
|
0
|
0
|
|
Persistence Year 5
STARTED
|
856
|
401
|
0
|
|
Persistence Year 5
COMPLETED
|
856
|
401
|
0
|
|
Persistence Year 5
NOT COMPLETED
|
0
|
0
|
0
|
|
Persistence Year 9
STARTED
|
309
|
138
|
362
|
|
Persistence Year 9
COMPLETED
|
306
|
136
|
357
|
|
Persistence Year 9
NOT COMPLETED
|
3
|
2
|
5
|
Reasons for withdrawal
| Measure |
Boostrix Group
Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine \[Tdap\](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a second dose of Boostrix vaccine \[Tdap\](GSK776423).
|
Adacel Group
Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a dose of Boostrix vaccine \[Tdap\](GSK776423).
|
Control Group
Subjects received the first dose of Boostrix vaccine \[Tdap\](GSK776423) in this study at Year 9.
|
|---|---|---|---|
|
Persistence Year 9
Lost to Follow-up
|
2
|
2
|
3
|
|
Persistence Year 9
Other
|
1
|
0
|
2
|
Baseline Characteristics
Persistence Study of GSK Biologicals' Tdap Vaccine 1, 3, 5 and 9 Years Following Administration as an Initial Single Dose in Healthy Young Adults and to Evaluate the Immunogenicity and Safety of Boostrix as a Second Dose of Tdap, When Administered at Year 9
Baseline characteristics by cohort
| Measure |
Boostrix Group
n=1069 Participants
Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine \[Tdap\](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a second dose of Boostrix vaccine \[Tdap\](GSK776423).
|
Adacel Group
n=523 Participants
Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a dose of Boostrix vaccine \[Tdap\](GSK776423).
|
Control Group
n=362 Participants
Subjects received the first dose of Boostrix vaccine \[Tdap\](GSK776423) in this study at Year 9.
|
Total
n=1954 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
41.7 years
STANDARD_DEVIATION 13.39 • n=5 Participants
|
42.5 years
STANDARD_DEVIATION 13.27 • n=7 Participants
|
52.0 years
STANDARD_DEVIATION 13.6 • n=5 Participants
|
42.0 years
STANDARD_DEVIATION 13.35 • n=4 Participants
|
|
Sex: Female, Male
Female
|
680 Participants
n=5 Participants
|
357 Participants
n=7 Participants
|
196 Participants
n=5 Participants
|
1233 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
389 Participants
n=5 Participants
|
166 Participants
n=7 Participants
|
166 Participants
n=5 Participants
|
721 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: At year 1 after the vaccination in primary study (NCT00346073)Population: The analysis was performed on the Adapted ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and for whom data concerning immunogenicity endpoint measures obtained from the ATP cohort for immunogenicity corresponding to each time point were available.
Anti-D cut-off was defined as ≥ 0.1 International Units per milliliter (IU/mL) determined with Enzyme-linked Immunosorbent Assay (ELISA)
Outcome measures
| Measure |
Boostrix Group
n=1010 Participants
Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine \[Tdap\](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a second dose of Boostrix vaccine \[Tdap\](GSK776423).
|
Adacel Group
n=504 Participants
Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a dose of Boostrix vaccine \[Tdap\](GSK776423).
|
Control Group
Subjects received the first dose of Boostrix vaccine \[Tdap\](GSK776423) in this study at Year 9.
|
|---|---|---|---|
|
Number of Subjects With Anti-diphtheria (Anti-D) Antibody Concentrations Greater Than or Equal to (≥) Protocol Specified Cut-off
|
967 Participants
|
489 Participants
|
—
|
PRIMARY outcome
Timeframe: At year 3 after the vaccination in primary study (NCT00346073)Population: The analysis was performed on the Adapted ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and for whom data concerning immunogenicity endpoint measures obtained from the ATP cohort for immunogenicity corresponding to each time point were available.
Anti-D cut-off was defined as ≥ 0.1 IU/mL as assessed by ELISA
Outcome measures
| Measure |
Boostrix Group
n=934 Participants
Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine \[Tdap\](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a second dose of Boostrix vaccine \[Tdap\](GSK776423).
|
Adacel Group
n=449 Participants
Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a dose of Boostrix vaccine \[Tdap\](GSK776423).
|
Control Group
Subjects received the first dose of Boostrix vaccine \[Tdap\](GSK776423) in this study at Year 9.
|
|---|---|---|---|
|
Number of Subjects With Anti-D Antibody Concentrations ≥ Protocol Specified Cut-off
|
857 Participants
|
425 Participants
|
—
|
PRIMARY outcome
Timeframe: At year 5 after the vaccination in primary study (NCT00346073)Population: The analysis was performed on the Adapted ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and for whom data concerning immunogenicity endpoint measures obtained from the ATP cohort for immunogenicity corresponding to each time point were available.
Anti-D cut-off was defined as ≥ 0.1IU/mL as assessed by ELISA.
Outcome measures
| Measure |
Boostrix Group
n=789 Participants
Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine \[Tdap\](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a second dose of Boostrix vaccine \[Tdap\](GSK776423).
|
Adacel Group
n=372 Participants
Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a dose of Boostrix vaccine \[Tdap\](GSK776423).
|
Control Group
Subjects received the first dose of Boostrix vaccine \[Tdap\](GSK776423) in this study at Year 9.
|
|---|---|---|---|
|
Number of Subjects With Anti-D Antibody Concentrations ≥ Protocol Specified Cut-off
|
735 Participants
|
359 Participants
|
—
|
PRIMARY outcome
Timeframe: At Year 9, one month before the booster vaccination.Population: The analysis was performed on the Adapted ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and for whom data concerning immunogenicity endpoint measures obtained from the ATP cohort for immunogenicity corresponding to each time point were available.
Anti-D cut-off was defined as ≥ to 0.1IU/mL as assessed by ELISA.
Outcome measures
| Measure |
Boostrix Group
n=269 Participants
Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine \[Tdap\](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a second dose of Boostrix vaccine \[Tdap\](GSK776423).
|
Adacel Group
n=118 Participants
Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a dose of Boostrix vaccine \[Tdap\](GSK776423).
|
Control Group
Subjects received the first dose of Boostrix vaccine \[Tdap\](GSK776423) in this study at Year 9.
|
|---|---|---|---|
|
Number of Subjects With Anti-D Antibody Concentrations ≥ Protocol Specified Cut-off
|
245 Participants
|
113 Participants
|
—
|
PRIMARY outcome
Timeframe: At year 1 after the vaccination in primary study (NCT00346073)Population: The analysis was performed on the Adapted ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and for whom data concerning immunogenicity endpoint measures obtained from the ATP cohort for immunogenicity corresponding to each time point were available.
Anti-T cut-off was defined as ≥ 0.1 IU/mL as assessed by ELISA.
Outcome measures
| Measure |
Boostrix Group
n=1014 Participants
Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine \[Tdap\](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a second dose of Boostrix vaccine \[Tdap\](GSK776423).
|
Adacel Group
n=506 Participants
Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a dose of Boostrix vaccine \[Tdap\](GSK776423).
|
Control Group
Subjects received the first dose of Boostrix vaccine \[Tdap\](GSK776423) in this study at Year 9.
|
|---|---|---|---|
|
Number of Subjects With Anti-tetanus (Anti-T) Antibody Concentrations ≥ Protocol Specified Cut-off
|
1000 Participants
|
504 Participants
|
—
|
PRIMARY outcome
Timeframe: At year 3 after the vaccination in primary study (NCT00346073)Population: The analysis was performed on the Adapted ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and for whom data concerning immunogenicity endpoint measures obtained from the ATP cohort for immunogenicity corresponding to each time point were available.
Anti-T cut-off was defined as ≥ 0.1 IU/mL as assessed by ELISA.
Outcome measures
| Measure |
Boostrix Group
n=937 Participants
Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine \[Tdap\](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a second dose of Boostrix vaccine \[Tdap\](GSK776423).
|
Adacel Group
n=442 Participants
Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a dose of Boostrix vaccine \[Tdap\](GSK776423).
|
Control Group
Subjects received the first dose of Boostrix vaccine \[Tdap\](GSK776423) in this study at Year 9.
|
|---|---|---|---|
|
Number of Subjects With Anti-T Antibody Concentrations ≥ Protocol Specified Cut-off
|
899 Participants
|
440 Participants
|
—
|
PRIMARY outcome
Timeframe: At year 5 after the vaccination in primary study (NCT00346073)Population: The analysis was performed on the Adapted ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and for whom data concerning immunogenicity endpoint measures obtained from the ATP cohort for immunogenicity corresponding to each time point were available.
Anti-T cut-off was defined as ≥ 0.1 IU/mL as assessed by ELISA.
Outcome measures
| Measure |
Boostrix Group
n=788 Participants
Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine \[Tdap\](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a second dose of Boostrix vaccine \[Tdap\](GSK776423).
|
Adacel Group
n=372 Participants
Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a dose of Boostrix vaccine \[Tdap\](GSK776423).
|
Control Group
Subjects received the first dose of Boostrix vaccine \[Tdap\](GSK776423) in this study at Year 9.
|
|---|---|---|---|
|
Number of Subjects With Anti-T Antibody Concentrations ≥ Protocol Specified Cut-off
|
772 Participants
|
370 Participants
|
—
|
PRIMARY outcome
Timeframe: At Year 9, one month before the booster vaccination.Population: The analysis was performed on the Adapted ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and for whom data concerning immunogenicity endpoint measures obtained from the ATP cohort for immunogenicity corresponding to each time point were available.
Anti-T cut-off was defined as ≥ 0.1 IU/mL as assessed by ELISA.
Outcome measures
| Measure |
Boostrix Group
n=268 Participants
Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine \[Tdap\](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a second dose of Boostrix vaccine \[Tdap\](GSK776423).
|
Adacel Group
n=120 Participants
Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a dose of Boostrix vaccine \[Tdap\](GSK776423).
|
Control Group
Subjects received the first dose of Boostrix vaccine \[Tdap\](GSK776423) in this study at Year 9.
|
|---|---|---|---|
|
Number of Subjects With Anti-T Antibody Concentrations ≥ Protocol Specified Cut-off
|
263 Participants
|
120 Participants
|
—
|
PRIMARY outcome
Timeframe: At Year 9, one month after the booster vaccination.Population: Analysis was performed on the According-to-Protocol (ATP) Cohort for analysis of immunogenicity at Year 9, which included all subjects who received the dose of study vaccine and for whom assay results were available for antibodies against at least one study vaccine antigen component after Year 9 vaccination.
Number of subjects with anti-D and anti-T concentrations ≥ 0.1 IU/mL and 1 IU/mL were tabulated
Outcome measures
| Measure |
Boostrix Group
n=269 Participants
Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine \[Tdap\](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a second dose of Boostrix vaccine \[Tdap\](GSK776423).
|
Adacel Group
n=120 Participants
Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a dose of Boostrix vaccine \[Tdap\](GSK776423).
|
Control Group
n=363 Participants
Subjects received the first dose of Boostrix vaccine \[Tdap\](GSK776423) in this study at Year 9.
|
|---|---|---|---|
|
Number of Subjects With Anti-D and Anti-T Concentrations ≥ 0.1 IU/mL and 1 IU/mL
Anti-D, ≥ 0.1 IU/ML
|
245 Participants
|
113 Participants
|
265 Participants
|
|
Number of Subjects With Anti-D and Anti-T Concentrations ≥ 0.1 IU/mL and 1 IU/mL
Anti-T, ≥ 0.1 IU/ML
|
263 Participants
|
120 Participants
|
304 Participants
|
|
Number of Subjects With Anti-D and Anti-T Concentrations ≥ 0.1 IU/mL and 1 IU/mL
Anti-D, ≥ 1 IU/ML
|
114 Participants
|
54 Participants
|
92 Participants
|
|
Number of Subjects With Anti-D and Anti-T Concentrations ≥ 0.1 IU/mL and 1 IU/mL
Anti-T, ≥ 1 IU/ML
|
211 Participants
|
101 Participants
|
231 Participants
|
PRIMARY outcome
Timeframe: At Year 9, one month before booster vaccinationPopulation: The analysis was performed on the Adapted ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and for whom data concerning immunogenicity endpoint measures obtained from the ATP cohort for immunogenicity corresponding to each time point were available.
Anti-PT, anti-FHA and anti-PRN antibody concentrations were measured by ELISA, tabulated as GMCs and expressed in IU/mL.
Outcome measures
| Measure |
Boostrix Group
n=271 Participants
Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine \[Tdap\](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a second dose of Boostrix vaccine \[Tdap\](GSK776423).
|
Adacel Group
n=120 Participants
Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a dose of Boostrix vaccine \[Tdap\](GSK776423).
|
Control Group
n=327 Participants
Subjects received the first dose of Boostrix vaccine \[Tdap\](GSK776423) in this study at Year 9.
|
|---|---|---|---|
|
Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations
Anti-PRN
|
63.8 IU/mL
Interval 53.1 to 76.7
|
64.7 IU/mL
Interval 50.3 to 83.3
|
17.8 IU/mL
Interval 14.7 to 21.6
|
|
Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations
Anti-PT
|
8.2 IU/mL
Interval 7.2 to 9.3
|
7.8 IU/mL
Interval 6.5 to 9.4
|
5.4 IU/mL
Interval 4.7 to 6.2
|
|
Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations
Anti-FHA
|
42.2 IU/mL
Interval 37.6 to 47.5
|
28.4 IU/mL
Interval 24.0 to 33.4
|
23.6 IU/mL
Interval 20.6 to 27.1
|
PRIMARY outcome
Timeframe: At Year 9, one month after the booster vaccinationPopulation: Analysis was performed on the Total Vaccinated Cohort (TVC) at Year 9 which included all subjects with a study vaccine administration dose documented: a safety analysis based on the TVC included all vaccinated subjects, an immunogenicity analysis based on the TVC included all vaccinated subjects for whom immunogenicity results were available.
Anti-PT, anti-FHA and anti-PRN antibody concentrations were measured by ELISA, tabulated as GMCs and expressed in IU/mL.
Outcome measures
| Measure |
Boostrix Group
n=271 Participants
Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine \[Tdap\](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a second dose of Boostrix vaccine \[Tdap\](GSK776423).
|
Adacel Group
n=121 Participants
Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a dose of Boostrix vaccine \[Tdap\](GSK776423).
|
Control Group
Subjects received the first dose of Boostrix vaccine \[Tdap\](GSK776423) in this study at Year 9.
|
|---|---|---|---|
|
Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations
ANTI-PT
|
64.1 IU/mL
Interval 56.8 to 72.3
|
70.4 IU/mL
Interval 58.6 to 84.5
|
—
|
|
Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations
ANTI-FHA
|
247.9 IU/mL
Interval 227.3 to 270.3
|
254.6 IU/mL
Interval 218.9 to 296.1
|
—
|
|
Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations
ANTI-PRN
|
405.4 IU/mL
Interval 359.3 to 457.5
|
511.8 IU/mL
Interval 427.8 to 612.2
|
—
|
PRIMARY outcome
Timeframe: At Year 9, one month after the booster vaccination.Population: Analysis was performed on the According-to-Protocol (ATP) Cohort for analysis of immunogenicity at Year 9, which included all subjects who received the dose of study vaccine and for whom assay results were available for antibodies against at least one study vaccine antigen component after Year 9 vaccination.
A booster response was defined as: for initially seronegative subjects (S-) (pre-vaccination concentration below cut-off: \< 0.1 IU/mL) antibody concentrations at least four times the cut-off (post vaccination concentration ≥ 0.4 IU/mL); for initially seropositive subjects (S+) (pre-vaccination concentration ≥ 0.1 IU/mL): an increase in antibody concentrations of at least four times the pre-vaccination concentration; Total = subjects either seropositive or seronegative.
Outcome measures
| Measure |
Boostrix Group
n=269 Participants
Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine \[Tdap\](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a second dose of Boostrix vaccine \[Tdap\](GSK776423).
|
Adacel Group
n=120 Participants
Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a dose of Boostrix vaccine \[Tdap\](GSK776423).
|
Control Group
n=324 Participants
Subjects received the first dose of Boostrix vaccine \[Tdap\](GSK776423) in this study at Year 9.
|
|---|---|---|---|
|
Booster Response to D and T Antigens
Anti-D, S-
|
16 Participants
|
3 Participants
|
35 Participants
|
|
Booster Response to D and T Antigens
Anti-D, S+
|
153 Participants
|
68 Participants
|
187 Participants
|
|
Booster Response to D and T Antigens
Anti-D, Total
|
169 Participants
|
71 Participants
|
222 Participants
|
|
Booster Response to D and T Antigens
Anti-T, S-
|
5 Participants
|
—
|
18 Participants
|
|
Booster Response to D and T Antigens
Anti-T, S+
|
121 Participants
|
44 Participants
|
139 Participants
|
|
Booster Response to D and T Antigens
Anti-T, Total
|
126 Participants
|
44 Participants
|
157 Participants
|
PRIMARY outcome
Timeframe: At Year 9, one month after the booster vaccination.Population: Analysis was performed on the According-to-Protocol (ATP) Cohort for analysis of immunogenicity at Year 9, which included all subjects who received the dose of study vaccine and for whom assay results were available for antibodies against at least one study vaccine antigen component after Year 9 vaccination.
Booster response was defined as: for subjects with pre-vaccination antibody concentration \< 5 EL.U/mL (S-): antibody concentration ≥ 20 EL.U/mL; for subjects with pre-vaccination antibody concentration ≥ 5 EL.U/mL and \< 20 EL.U/mL (S+, \<4\*cut-off): antibody concentration at least four times the pre-vaccination concentration; for subjects with pre-vaccination antibody concentration ≥ 20 EL.U/mL (S+, ≥4\*cut-off): antibody concentration at least two times the pre-vaccination concentration; Total = subjects either seropositive or seronegative
Outcome measures
| Measure |
Boostrix Group
n=271 Participants
Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine \[Tdap\](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a second dose of Boostrix vaccine \[Tdap\](GSK776423).
|
Adacel Group
n=120 Participants
Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a dose of Boostrix vaccine \[Tdap\](GSK776423).
|
Control Group
n=327 Participants
Subjects received the first dose of Boostrix vaccine \[Tdap\](GSK776423) in this study at Year 9.
|
|---|---|---|---|
|
Booster Response to PT, FHA and PRN Antigens
Anti-PT, S-
|
34 Participants
|
10 Participants
|
101 Participants
|
|
Booster Response to PT, FHA and PRN Antigens
Anti-PT, S+, < 4*cut-off
|
106 Participants
|
53 Participants
|
94 Participants
|
|
Booster Response to PT, FHA and PRN Antigens
Anti-PT, S+, ≥ 4*cut-off
|
95 Participants
|
43 Participants
|
97 Participants
|
|
Booster Response to PT, FHA and PRN Antigens
Anti-PT, Total
|
235 Participants
|
106 Participants
|
292 Participants
|
|
Booster Response to PT, FHA and PRN Antigens
Anti-FHA, S-
|
—
|
1 Participants
|
5 Participants
|
|
Booster Response to PT, FHA and PRN Antigens
Anti-FHA, S+, < 4*cut-off
|
16 Participants
|
9 Participants
|
70 Participants
|
|
Booster Response to PT, FHA and PRN Antigens
Anti-FHA, S+, ≥ 4*cut-off
|
216 Participants
|
106 Participants
|
228 Participants
|
|
Booster Response to PT, FHA and PRN Antigens
Anti-FHA, Total
|
232 Participants
|
116 Participants
|
303 Participants
|
|
Booster Response to PT, FHA and PRN Antigens
Anti-PRN, S-
|
4 Participants
|
1 Participants
|
31 Participants
|
|
Booster Response to PT, FHA and PRN Antigens
Anti-PRN, S+, < 4*cut-off
|
27 Participants
|
10 Participants
|
75 Participants
|
|
Booster Response to PT, FHA and PRN Antigens
Anti-PRN, S+, ≥ 4*cut-off
|
179 Participants
|
87 Participants
|
175 Participants
|
|
Booster Response to PT, FHA and PRN Antigens
Anti-PRN, Total
|
210 Participants
|
98 Participants
|
281 Participants
|
SECONDARY outcome
Timeframe: At 1, 3, and 5 years after the vaccination in primary study (NCT00346073)Population: The analysis was performed on the Adapted ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and for whom data concerning immunogenicity endpoint measures obtained from the ATP cohort for immunogenicity corresponding to each time point were available.
The cut-off for anti-PT concentrations was defined as ≥ 5 ELISA units per mililiter (EL.U/mL).
Outcome measures
| Measure |
Boostrix Group
n=1013 Participants
Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine \[Tdap\](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a second dose of Boostrix vaccine \[Tdap\](GSK776423).
|
Adacel Group
n=506 Participants
Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a dose of Boostrix vaccine \[Tdap\](GSK776423).
|
Control Group
Subjects received the first dose of Boostrix vaccine \[Tdap\](GSK776423) in this study at Year 9.
|
|---|---|---|---|
|
Number of Subjects With Anti-pertussis Toxoid (PT) Antibody Concentrations Equal to or Above Protocol Specified Cut-off
Year 1
|
917 Participants
|
435 Participants
|
—
|
|
Number of Subjects With Anti-pertussis Toxoid (PT) Antibody Concentrations Equal to or Above Protocol Specified Cut-off
Year 3
|
751 Participants
|
316 Participants
|
—
|
|
Number of Subjects With Anti-pertussis Toxoid (PT) Antibody Concentrations Equal to or Above Protocol Specified Cut-off
Year 5
|
670 Participants
|
285 Participants
|
—
|
SECONDARY outcome
Timeframe: At Year 9, one month before(pre booster) and after the booster vaccination(post booster)Population: Analysis was performed on the According-to-Protocol (ATP) Cohort for analysis of immunogenicity at Year 9, which included all subjects who received the dose of study vaccine and for whom assay results were available for antibodies against at least one study vaccine antigen component after Year 9 vaccination.
The cut-off for anti-PT concentrations was defined as equal to or greater than 2.693 IU/mL.
Outcome measures
| Measure |
Boostrix Group
n=271 Participants
Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine \[Tdap\](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a second dose of Boostrix vaccine \[Tdap\](GSK776423).
|
Adacel Group
n=121 Participants
Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a dose of Boostrix vaccine \[Tdap\](GSK776423).
|
Control Group
n=327 Participants
Subjects received the first dose of Boostrix vaccine \[Tdap\](GSK776423) in this study at Year 9.
|
|---|---|---|---|
|
Number of Subjects With Anti-PT Antibody Concentrations Equal to or Above Protocol Specified Cut-off
Pre-booster
|
230 Participants
|
106 Participants
|
209 Participants
|
|
Number of Subjects With Anti-PT Antibody Concentrations Equal to or Above Protocol Specified Cut-off
Post-booster
|
268 Participants
|
120 Participants
|
322 Participants
|
SECONDARY outcome
Timeframe: At 1, 3, and 5 years after the vaccination in primary study (NCT00346073)Population: The analysis was performed on the Adapted ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and for whom data concerning immunogenicity endpoint measures obtained from the ATP cohort for immunogenicity corresponding to each time point were available.
The cut-off for anti-FHA concentrations was defined as equal to or greater than 5 EL.U/mL.
Outcome measures
| Measure |
Boostrix Group
n=1014 Participants
Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine \[Tdap\](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a second dose of Boostrix vaccine \[Tdap\](GSK776423).
|
Adacel Group
n=502 Participants
Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a dose of Boostrix vaccine \[Tdap\](GSK776423).
|
Control Group
Subjects received the first dose of Boostrix vaccine \[Tdap\](GSK776423) in this study at Year 9.
|
|---|---|---|---|
|
Number of Subjects With Anti-FHA Antibody Concentrations Equal to or Above Protocol Specified Cut-off
Year 1
|
1012 Participants
|
501 Participants
|
—
|
|
Number of Subjects With Anti-FHA Antibody Concentrations Equal to or Above Protocol Specified Cut-off
Year 3
|
913 Participants
|
437 Participants
|
—
|
|
Number of Subjects With Anti-FHA Antibody Concentrations Equal to or Above Protocol Specified Cut-off
Year 5
|
788 Participants
|
368 Participants
|
—
|
SECONDARY outcome
Timeframe: At Year 9, one month before(pre booster) and after the booster vaccination(post booster)Population: Analysis was performed on the According-to-Protocol (ATP) Cohort for analysis of immunogenicity at Year 9, which included all subjects who received the dose of study vaccine and for whom assay results were available for antibodies against at least one study vaccine antigen component after Year 9 vaccination.
The cut-off for anti-FHA concentrations was defined as equal to or greater than 2.046 IU/mL
Outcome measures
| Measure |
Boostrix Group
n=271 Participants
Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine \[Tdap\](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a second dose of Boostrix vaccine \[Tdap\](GSK776423).
|
Adacel Group
n=121 Participants
Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a dose of Boostrix vaccine \[Tdap\](GSK776423).
|
Control Group
n=327 Participants
Subjects received the first dose of Boostrix vaccine \[Tdap\](GSK776423) in this study at Year 9.
|
|---|---|---|---|
|
Number of Subjects With Anti-FHA Antibody Concentrations Equal to or Above Protocol Specified Cut-off
Pre-booster
|
271 Participants
|
119 Participants
|
322 Participants
|
|
Number of Subjects With Anti-FHA Antibody Concentrations Equal to or Above Protocol Specified Cut-off
Post-booster
|
271 Participants
|
121 Participants
|
327 Participants
|
SECONDARY outcome
Timeframe: At 1, 3, and 5 years after the vaccination in primary study (NCT00346073)Population: The analysis was performed on the Adapted ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and for whom data concerning immunogenicity endpoint measures obtained from the ATP cohort for immunogenicity corresponding to each time point were available.
The cut-off for anti-PRN concentrations was defined as equal to or greater than 5 EL.U/mL.
Outcome measures
| Measure |
Boostrix Group
n=1011 Participants
Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine \[Tdap\](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a second dose of Boostrix vaccine \[Tdap\](GSK776423).
|
Adacel Group
n=501 Participants
Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a dose of Boostrix vaccine \[Tdap\](GSK776423).
|
Control Group
Subjects received the first dose of Boostrix vaccine \[Tdap\](GSK776423) in this study at Year 9.
|
|---|---|---|---|
|
Number of Subjects With Anti-PRN Antibody Concentrations Equal to or Above Protocol Specified Cut-off
Year 1
|
971 Participants
|
489 Participants
|
—
|
|
Number of Subjects With Anti-PRN Antibody Concentrations Equal to or Above Protocol Specified Cut-off
Year 3
|
862 Participants
|
426 Participants
|
—
|
|
Number of Subjects With Anti-PRN Antibody Concentrations Equal to or Above Protocol Specified Cut-off
Year 5
|
755 Participants
|
362 Participants
|
—
|
SECONDARY outcome
Timeframe: At Year 9, one month before(pre booster) and after the booster vaccination(post booster)Population: Analysis was performed on the According-to-Protocol (ATP) Cohort for analysis of immunogenicity at Year 9, which included all subjects who received the dose of study vaccine and for whom assay results were available for antibodies against at least one study vaccine antigen component after Year 9 vaccination.
The cut-off for anti-PRN concentrations was defined as equal to or greater than 2.187 IU/mL.
Outcome measures
| Measure |
Boostrix Group
n=271 Participants
Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine \[Tdap\](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a second dose of Boostrix vaccine \[Tdap\](GSK776423).
|
Adacel Group
n=121 Participants
Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a dose of Boostrix vaccine \[Tdap\](GSK776423).
|
Control Group
n=326 Participants
Subjects received the first dose of Boostrix vaccine \[Tdap\](GSK776423) in this study at Year 9.
|
|---|---|---|---|
|
Number of Subjects With Anti-PRN Antibody Concentrations Equal to or Above Protocol Specified Cut-off
Pre-booster
|
267 Participants
|
117 Participants
|
284 Participants
|
|
Number of Subjects With Anti-PRN Antibody Concentrations Equal to or Above Protocol Specified Cut-off
Post-booster
|
271 Participants
|
121 Participants
|
326 Participants
|
SECONDARY outcome
Timeframe: At 1, 3, and 5 years after the vaccination in primary study (NCT00346073)Population: The analysis was performed on the Adapted ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and for whom data concerning immunogenicity endpoint measures obtained from the ATP cohort for immunogenicity corresponding to each time point were available.
Anti-D antibody concentration is expressed as geometric mean concentration (GMC) in IU/mL.
Outcome measures
| Measure |
Boostrix Group
n=1010 Participants
Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine \[Tdap\](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a second dose of Boostrix vaccine \[Tdap\](GSK776423).
|
Adacel Group
n=504 Participants
Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a dose of Boostrix vaccine \[Tdap\](GSK776423).
|
Control Group
Subjects received the first dose of Boostrix vaccine \[Tdap\](GSK776423) in this study at Year 9.
|
|---|---|---|---|
|
Anti-D Antibody Concentration
Year 1
|
1.4 IU/mL
Interval 1.3 to 1.6
|
1.4 IU/mL
Interval 1.3 to 1.6
|
—
|
|
Anti-D Antibody Concentration
Year 3
|
0.9 IU/mL
Interval 0.8 to 1.0
|
1.0 IU/mL
Interval 0.9 to 1.1
|
—
|
|
Anti-D Antibody Concentration
Year 5
|
0.8 IU/mL
Interval 0.7 to 0.9
|
0.9 IU/mL
Interval 0.8 to 1.0
|
—
|
SECONDARY outcome
Timeframe: At Year 9, one month before(pre booster) and after the booster vaccination(post booster)Population: Analysis was performed on the According-to-Protocol (ATP) Cohort for analysis of immunogenicity at Year 9, which included all subjects who received the dose of study vaccine and for whom assay results were available for antibodies against at least one study vaccine antigen component after Year 9 vaccination.
Anti-D antibody concentration is expressed as GMC in IU/mL.
Outcome measures
| Measure |
Boostrix Group
n=271 Participants
Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine \[Tdap\](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a second dose of Boostrix vaccine \[Tdap\](GSK776423).
|
Adacel Group
n=121 Participants
Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a dose of Boostrix vaccine \[Tdap\](GSK776423).
|
Control Group
n=326 Participants
Subjects received the first dose of Boostrix vaccine \[Tdap\](GSK776423) in this study at Year 9.
|
|---|---|---|---|
|
Anti-D Antibody Concentration
Pre-booster
|
0.7 IU/mL
Interval 0.6 to 0.8
|
0.8 IU/mL
Interval 0.6 to 0.9
|
0.4 IU/mL
Interval 0.4 to 0.5
|
|
Anti-D Antibody Concentration
Post-booster
|
4.1 IU/mL
Interval 3.6 to 4.7
|
4.7 IU/mL
Interval 3.9 to 5.7
|
4.0 IU/mL
Interval 3.4 to 4.6
|
SECONDARY outcome
Timeframe: At 1, 3, and 5 years after the vaccination in primary study (NCT00346073)Population: The analysis was performed on the Adapted ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and for whom data concerning immunogenicity endpoint measures obtained from the ATP cohort for immunogenicity corresponding to each time point were available.
Anti-T antibody concentration is expressed as GMC in IU/mL.
Outcome measures
| Measure |
Boostrix Group
n=1014 Participants
Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine \[Tdap\](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a second dose of Boostrix vaccine \[Tdap\](GSK776423).
|
Adacel Group
n=506 Participants
Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a dose of Boostrix vaccine \[Tdap\](GSK776423).
|
Control Group
Subjects received the first dose of Boostrix vaccine \[Tdap\](GSK776423) in this study at Year 9.
|
|---|---|---|---|
|
Anti-T Antibody Concentration
Year 1
|
3.4 IU/mL
Interval 3.2 to 3.6
|
4.4 IU/mL
Interval 4.1 to 4.7
|
—
|
|
Anti-T Antibody Concentration
Year 3
|
2.2 IU/mL
Interval 2.1 to 2.3
|
2.9 IU/mL
Interval 2.7 to 3.1
|
—
|
|
Anti-T Antibody Concentration
Year 5
|
2.0 IU/mL
Interval 1.9 to 2.1
|
2.5 IU/mL
Interval 2.3 to 2.7
|
—
|
SECONDARY outcome
Timeframe: At Year 9, one month before(pre booster) and after the booster vaccination(post booster)Population: Analysis was performed on the According-to-Protocol (ATP) Cohort for analysis of immunogenicity at Year 9, which included all subjects who received the dose of study vaccine and for whom assay results were available for antibodies against at least one study vaccine antigen component after Year 9 vaccination.
Anti-T antibody concentration is expressed as GMC in IU/mL.
Outcome measures
| Measure |
Boostrix Group
n=271 Participants
Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine \[Tdap\](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a second dose of Boostrix vaccine \[Tdap\](GSK776423).
|
Adacel Group
n=121 Participants
Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a dose of Boostrix vaccine \[Tdap\](GSK776423).
|
Control Group
n=327 Participants
Subjects received the first dose of Boostrix vaccine \[Tdap\](GSK776423) in this study at Year 9.
|
|---|---|---|---|
|
Anti-T Antibody Concentration
Pre-booster
|
1.8 IU/mL
Interval 1.6 to 2.0
|
2.3 IU/mL
Interval 2.0 to 2.7
|
1.5 IU/mL
Interval 1.3 to 1.7
|
|
Anti-T Antibody Concentration
Post-booster
|
8.4 IU/mL
Interval 7.7 to 9.3
|
8.6 IU/mL
Interval 7.6 to 9.8
|
8.8 IU/mL
Interval 8.0 to 9.7
|
SECONDARY outcome
Timeframe: At 1, 3, and 5 years after the vaccination in primary study (NCT00346073)Population: The analysis was performed on the Adapted ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and for whom data concerning immunogenicity endpoint measures obtained from the ATP cohort for immunogenicity corresponding to each time point were available.
Anti-PT antibody concentration is expressed as GMC in EL.U/mL.
Outcome measures
| Measure |
Boostrix Group
n=1013 Participants
Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine \[Tdap\](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a second dose of Boostrix vaccine \[Tdap\](GSK776423).
|
Adacel Group
n=506 Participants
Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a dose of Boostrix vaccine \[Tdap\](GSK776423).
|
Control Group
Subjects received the first dose of Boostrix vaccine \[Tdap\](GSK776423) in this study at Year 9.
|
|---|---|---|---|
|
Anti-PT Antibody Concentration
Year 1
|
22.4 IU/mL
Interval 21.0 to 24.0
|
15.6 IU/mL
Interval 14.2 to 17.2
|
—
|
|
Anti-PT Antibody Concentration
Year 3
|
14.1 IU/mL
Interval 13.0 to 15.0
|
10.0 IU/mL
Interval 9.0 to 11.1
|
—
|
|
Anti-PT Antibody Concentration
Year 5
|
14.6 IU/mL
Interval 13.5 to 15.8
|
11.6 IU/mL
Interval 10.3 to 13.0
|
—
|
SECONDARY outcome
Timeframe: At Year 9, one month before(pre booster) and after the booster vaccination(post booster)Population: Analysis was performed on the According-to-Protocol (ATP) Cohort for analysis of immunogenicity at Year 9, which included all subjects who received the dose of study vaccine and for whom assay results were available for antibodies against at least one study vaccine antigen component after Year 9 vaccination.
Anti-PT antibody concentration was expressed as GMC in IU/mL.
Outcome measures
| Measure |
Boostrix Group
n=271 Participants
Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine \[Tdap\](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a second dose of Boostrix vaccine \[Tdap\](GSK776423).
|
Adacel Group
n=121 Participants
Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a dose of Boostrix vaccine \[Tdap\](GSK776423).
|
Control Group
n=327 Participants
Subjects received the first dose of Boostrix vaccine \[Tdap\](GSK776423) in this study at Year 9.
|
|---|---|---|---|
|
Anti-PT Antibody Concentration
Pre-booster
|
8.2 IU/mL
Interval 7.2 to 9.3
|
7.8 IU/mL
Interval 6.5 to 9.4
|
5.4 IU/mL
Interval 4.7 to 6.2
|
|
Anti-PT Antibody Concentration
Post-booster
|
64.1 IU/mL
Interval 56.8 to 72.3
|
70.4 IU/mL
Interval 58.6 to 84.5
|
66.2 IU/mL
Interval 58.5 to 74.8
|
SECONDARY outcome
Timeframe: At 1, 3, and 5 years after the vaccination in primary study (NCT00346073)Population: The analysis was performed on the Adapted ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and for whom data concerning immunogenicity endpoint measures obtained from the ATP cohort for immunogenicity corresponding to each time point were available.
Anti-FHA antibody concentration is expressed as GMC in IU/mL
Outcome measures
| Measure |
Boostrix Group
n=1014 Participants
Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine \[Tdap\](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a second dose of Boostrix vaccine \[Tdap\](GSK776423).
|
Adacel Group
n=502 Participants
Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a dose of Boostrix vaccine \[Tdap\](GSK776423).
|
Control Group
Subjects received the first dose of Boostrix vaccine \[Tdap\](GSK776423) in this study at Year 9.
|
|---|---|---|---|
|
Anti-FHA Antibody Concentration
Year 1
|
190.1 IU/mL
Interval 178.5 to 202.6
|
118.8 IU/mL
Interval 108.7 to 129.9
|
—
|
|
Anti-FHA Antibody Concentration
Year 3
|
114.1 IU/mL
Interval 107.1 to 121.5
|
81.8 IU/mL
Interval 74.7 to 89.4
|
—
|
|
Anti-FHA Antibody Concentration
Year 5
|
110.0 IU/mL
Interval 103.0 to 117.4
|
80.8 IU/mL
Interval 73.1 to 89.4
|
—
|
SECONDARY outcome
Timeframe: At Year 9, one month before(pre booster) and after the booster vaccination(post booster)Population: Analysis was performed on the According-to-Protocol (ATP) Cohort for analysis of immunogenicity at Year 9, which included all subjects who received the dose of study vaccine and for whom assay results were available for antibodies against at least one study vaccine antigen component after Year 9 vaccination.
Anti-FHA antibody concentration was expressed as GMC in IU/mL.
Outcome measures
| Measure |
Boostrix Group
n=271 Participants
Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine \[Tdap\](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a second dose of Boostrix vaccine \[Tdap\](GSK776423).
|
Adacel Group
n=121 Participants
Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a dose of Boostrix vaccine \[Tdap\](GSK776423).
|
Control Group
n=327 Participants
Subjects received the first dose of Boostrix vaccine \[Tdap\](GSK776423) in this study at Year 9.
|
|---|---|---|---|
|
Anti-FHA Antibody Concentration
Pre-booster
|
42.2 IU/mL
Interval 37.6 to 47.5
|
28.4 IU/mL
Interval 24.0 to 33.4
|
23.6 IU/mL
Interval 20.6 to 27.1
|
|
Anti-FHA Antibody Concentration
Post-booster
|
247.9 IU/mL
Interval 227.3 to 270.3
|
254.6 IU/mL
Interval 218.9 to 296.1
|
373.6 IU/mL
Interval 336.5 to 414.8
|
SECONDARY outcome
Timeframe: At 1, 3, and 5 years after the vaccination in primary study (NCT00346073)Population: The analysis was performed on the Adapted ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and for whom data concerning immunogenicity endpoint measures obtained from the ATP cohort for immunogenicity corresponding to each time point were available.
Anti-PRN antibody concentration is expressed as GMC in IU/mL
Outcome measures
| Measure |
Boostrix Group
n=1011 Participants
Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine \[Tdap\](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a second dose of Boostrix vaccine \[Tdap\](GSK776423).
|
Adacel Group
n=501 Participants
Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a dose of Boostrix vaccine \[Tdap\](GSK776423).
|
Control Group
Subjects received the first dose of Boostrix vaccine \[Tdap\](GSK776423) in this study at Year 9.
|
|---|---|---|---|
|
Anti-PRN Antibody Concentration
Year 1
|
152.2 IU/mL
Interval 137.2 to 168.8
|
132.5 IU/mL
Interval 115.6 to 151.8
|
—
|
|
Anti-PRN Antibody Concentration
Year 3
|
82.5 IU/mL
Interval 74.4 to 91.5
|
70.6 IU/mL
Interval 61.6 to 81.0
|
—
|
|
Anti-PRN Antibody Concentration
Year 5
|
85.3 IU/mL
Interval 76.7 to 94.9
|
77.4 IU/mL
Interval 66.9 to 89.6
|
—
|
SECONDARY outcome
Timeframe: At Year 9, one month before(pre booster) and after the booster vaccination(post booster)Population: Analysis was performed on the According-to-Protocol (ATP) Cohort for analysis of immunogenicity at Year 9, which included all subjects who received the dose of study vaccine and for whom assay results were available for antibodies against at least one study vaccine antigen component after Year 9 vaccination.
Anti-PRN antibody concentration is expressed as GMC in IU/mL.
Outcome measures
| Measure |
Boostrix Group
n=271 Participants
Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine \[Tdap\](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a second dose of Boostrix vaccine \[Tdap\](GSK776423).
|
Adacel Group
n=121 Participants
Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a dose of Boostrix vaccine \[Tdap\](GSK776423).
|
Control Group
n=326 Participants
Subjects received the first dose of Boostrix vaccine \[Tdap\](GSK776423) in this study at Year 9.
|
|---|---|---|---|
|
Anti-PRN Antibody Concentration
Pre-booster
|
63.8 IU/mL
Interval 53.1 to 76.7
|
64.7 IU/mL
Interval 50.3 to 83.3
|
17.8 IU/mL
Interval 14.7 to 21.6
|
|
Anti-PRN Antibody Concentration
Post-booster
|
405.4 IU/mL
Interval 359.3 to 457.5
|
511.8 IU/mL
Interval 427.8 to 612.2
|
336.4 IU/mL
Interval 283.3 to 399.4
|
SECONDARY outcome
Timeframe: At Year 9, one month after booster vaccinationPopulation: Analysis was performed on the According-to-Protocol (ATP) Cohort for analysis of immunogenicity at Year 9, which included all subjects who received the dose of study vaccine and for whom assay results were available for antibodies against at least one study vaccine antigen component after Year 9 vaccination.
Alternative Booster response to D and T antigens is defined as: - For subjects with pre-booster antibody concentration below 0.1 IU/mL: antibody concentrations at least four times the 0.1IU/ML, one month after vaccination, and - For subjects with pre-booster antibody concentration ≥0.1 IU/mL and \<1.0 IU/mL: antibody concentrations of at least four times the pre-booster antibody concentration, one month after vaccination. - For subjects with pre-booster antibody concentration ≥1.0 IU/mL and \<6.0 IU/mL: antibody concentrations of at least two times the pre-booster antibody concentration, one month after vaccination. - Subjects with pre-booster antibody concentration ≥6.0 IU/mL are not evaluable for booster response. S- = Antibody concentration \< 0.1 IU/mL S+ = Antibody concentration ≥ 0.1 IU/mL Total = subjects either seropositive or seronegative
Outcome measures
| Measure |
Boostrix Group
n=259 Participants
Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine \[Tdap\](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a second dose of Boostrix vaccine \[Tdap\](GSK776423).
|
Adacel Group
n=115 Participants
Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a dose of Boostrix vaccine \[Tdap\](GSK776423).
|
Control Group
n=311 Participants
Subjects received the first dose of Boostrix vaccine \[Tdap\](GSK776423) in this study at Year 9.
|
|---|---|---|---|
|
Alternative Booster Response to Anti-D and Anti-T Antigens
ANTI-D, S-
|
16 Participants
|
3 Participants
|
35 Participants
|
|
Alternative Booster Response to Anti-D and Anti-T Antigens
ANTI-D, S+ (<1 IU/ML)
|
103 Participants
|
45 Participants
|
148 Participants
|
|
Alternative Booster Response to Anti-D and Anti-T Antigens
ANTI-D, S+ (≥1 IU/ML)
|
84 Participants
|
40 Participants
|
65 Participants
|
|
Alternative Booster Response to Anti-D and Anti-T Antigens
ANTI-D, Total
|
203 Participants
|
88 Participants
|
248 Participants
|
|
Alternative Booster Response to Anti-D and Anti-T Antigens
ANTI-T, S-
|
5 Participants
|
—
|
18 Participants
|
|
Alternative Booster Response to Anti-D and Anti-T Antigens
ANTI-T, S+ (<1 IU/ML)
|
46 Participants
|
14 Participants
|
65 Participants
|
|
Alternative Booster Response to Anti-D and Anti-T Antigens
ANTI-T, S+ (≥1 IU/ML)
|
151 Participants
|
74 Participants
|
159 Participants
|
|
Alternative Booster Response to Anti-D and Anti-T Antigens
ANTI-T, Total
|
202 Participants
|
88 Participants
|
242 Participants
|
SECONDARY outcome
Timeframe: At Year 9, one month after booster vaccinationPopulation: Analysis was performed on the According-to-Protocol (ATP) Cohort for analysis of immunogenicity at Year 9, which included all subjects who received the dose of study vaccine and for whom assay results were available for antibodies against at least one study vaccine antigen component after Year 9 vaccination.
Alternative Booster response to PT, FHA and PRN antigens is defined as: - For subjects with pre-booster antibody concentration below the assay cut off: antibody concentrations at least four times the assay cut off one month after vaccination, and - For subjects with pre-booster antibody concentration ≥ assay cut off and \< 60 IU/mL: antibody concentration increase of at least 30 IU/mL from the pre-booster antibody concentration, one month after vaccination. - For subjects with pre-booster antibody concentration ≥ 60 IU/mL : at least 1.5 fold increase of antibody concentration from the pre-booster antibody concentration, one month after vaccination. S- = seronegative subjects (antibody concentration below assay cut off for anti-PT, anti-FHA, anti-PRN) S+ = seropositive subjects (antibody concentration below assay cut off for anti-PT, anti-FHA, anti-PRN) Total = subjects either seropositive or seronegative
Outcome measures
| Measure |
Boostrix Group
n=271 Participants
Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine \[Tdap\](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a second dose of Boostrix vaccine \[Tdap\](GSK776423).
|
Adacel Group
n=120 Participants
Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a dose of Boostrix vaccine \[Tdap\](GSK776423).
|
Control Group
n=327 Participants
Subjects received the first dose of Boostrix vaccine \[Tdap\](GSK776423) in this study at Year 9.
|
|---|---|---|---|
|
Alternative Booster Responses to Anti-PT, Anti-FHA and Anti-PRN Antigens
ANTI-FHA, S-
|
—
|
1 Participants
|
5 Participants
|
|
Alternative Booster Responses to Anti-PT, Anti-FHA and Anti-PRN Antigens
ANTI-FHA, ≥ assay Cut-off and < 60 IU/mL
|
171 Participants
|
91 Participants
|
241 Participants
|
|
Alternative Booster Responses to Anti-PT, Anti-FHA and Anti-PRN Antigens
ANTI-FHA, ≥ 60 IU/mL
|
82 Participants
|
27 Participants
|
64 Participants
|
|
Alternative Booster Responses to Anti-PT, Anti-FHA and Anti-PRN Antigens
ANTI-FHA, Total
|
253 Participants
|
119 Participants
|
310 Participants
|
|
Alternative Booster Responses to Anti-PT, Anti-FHA and Anti-PRN Antigens
ANTI-PRN, S-
|
4 Participants
|
1 Participants
|
31 Participants
|
|
Alternative Booster Responses to Anti-PT, Anti-FHA and Anti-PRN Antigens
ANTI-PRN, ≥ assay Cut-off and < 60 IU/mL
|
115 Participants
|
52 Participants
|
185 Participants
|
|
Alternative Booster Responses to Anti-PT, Anti-FHA and Anti-PRN Antigens
ANTI-PRN, ≥ 60 IU/mL
|
111 Participants
|
53 Participants
|
62 Participants
|
|
Alternative Booster Responses to Anti-PT, Anti-FHA and Anti-PRN Antigens
ANTI-PRN, Total
|
230 Participants
|
106 Participants
|
278 Participants
|
|
Alternative Booster Responses to Anti-PT, Anti-FHA and Anti-PRN Antigens
ANTI-PT, S-
|
34 Participants
|
10 Participants
|
101 Participants
|
|
Alternative Booster Responses to Anti-PT, Anti-FHA and Anti-PRN Antigens
ANTI-PT, ≥ assay Cut-off and < 60 IU/mL
|
169 Participants
|
83 Participants
|
166 Participants
|
|
Alternative Booster Responses to Anti-PT, Anti-FHA and Anti-PRN Antigens
ANTI-PT, ≥ 60 IU/mL
|
7 Participants
|
3 Participants
|
10 Participants
|
|
Alternative Booster Responses to Anti-PT, Anti-FHA and Anti-PRN Antigens
ANTI-PT, Total
|
210 Participants
|
96 Participants
|
277 Participants
|
SECONDARY outcome
Timeframe: At Year 9, one month before(pre booster) and after the booster vaccination(post booster)Population: Analysis was performed on the According-to-Protocol (ATP) Cohort for analysis of immunogenicity at Year 9, which included all subjects who received the dose of study vaccine and for whom assay results were available for antibodies against at least one study vaccine antigen component after Year 9 vaccination.
Seroprotection status for anti-D antibody concentration \< 0.1 IU/mL were tested for neutralizing antibodies using a VERO-cell neutralization assay. Seroprotection rate is defined as the percentage of subjects with antibody concentrations greater than or equal (≥) the seroprotection cut-off value defined for that antibody.
Outcome measures
| Measure |
Boostrix Group
n=271 Participants
Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine \[Tdap\](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a second dose of Boostrix vaccine \[Tdap\](GSK776423).
|
Adacel Group
n=121 Participants
Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a dose of Boostrix vaccine \[Tdap\](GSK776423).
|
Control Group
n=326 Participants
Subjects received the first dose of Boostrix vaccine \[Tdap\](GSK776423) in this study at Year 9.
|
|---|---|---|---|
|
Seroprotection Status for Anti-D Antibody Concentration
Pre-booster
|
8.3 Percentage of subjects
|
40.0 Percentage of subjects
|
27.6 Percentage of subjects
|
|
Seroprotection Status for Anti-D Antibody Concentration
Post-booster
|
50.0 Percentage of subjects
|
0.0 Percentage of subjects
|
14.3 Percentage of subjects
|
SECONDARY outcome
Timeframe: During the 4-day (Days 0-3) post vaccination period.Population: The analysis was performed on the Total Vaccinated cohort at Year 9, which included all subjects with study vaccine administration dose documented, who returned at Year 9 and had their diary cards completed.
Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity. Grade 3 pain was defined as significant pain at rest that prevented normal everyday activities. Grade 3 redness and swelling was greater than 50 millimeters (mm)
Outcome measures
| Measure |
Boostrix Group
n=306 Participants
Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine \[Tdap\](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a second dose of Boostrix vaccine \[Tdap\](GSK776423).
|
Adacel Group
n=137 Participants
Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a dose of Boostrix vaccine \[Tdap\](GSK776423).
|
Control Group
n=358 Participants
Subjects received the first dose of Boostrix vaccine \[Tdap\](GSK776423) in this study at Year 9.
|
|---|---|---|---|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Year 9
Any Pain
|
180 Participants
|
84 Participants
|
132 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Year 9
Grade 3 Pain
|
3 Participants
|
1 Participants
|
4 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Year 9
Any Redness
|
74 Participants
|
32 Participants
|
53 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Year 9
Grade 3 Redness
|
5 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Year 9
Any Swelling
|
57 Participants
|
26 Participants
|
41 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Year 9
Grade 3 Swelling
|
4 Participants
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: During the 4-day (Days 0-3) post vaccination period.Population: The analysis was performed on the Total Vaccinated cohort at Year 9, which included all subjects with study vaccine administration dose documented, who returned at Year 9 and had their diary cards completed.
The solicited general symptoms assessed were Fatigue, Gastrointestinal symptoms (including nausea, vomiting, diarrhea and abdominal pain), Headache and Fever \[defined as temperature of ≥100.4 degrees Fahrenheit (F) by any route\]. Any = Occurrence of any general symptom regardless of its intensity grade or relationship to vaccination; Grade 3 Symptom = Symptom that prevented normal activity; Grade 3 Fever \> 104.0 degrees F.
Outcome measures
| Measure |
Boostrix Group
n=306 Participants
Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine \[Tdap\](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a second dose of Boostrix vaccine \[Tdap\](GSK776423).
|
Adacel Group
n=137 Participants
Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a dose of Boostrix vaccine \[Tdap\](GSK776423).
|
Control Group
n=358 Participants
Subjects received the first dose of Boostrix vaccine \[Tdap\](GSK776423) in this study at Year 9.
|
|---|---|---|---|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Year 9
Any Fatigue
|
71 Participants
|
23 Participants
|
51 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Year 9
Grade 3 Fatigue
|
3 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Year 9
Any Gastrointestinal symptoms
|
27 Participants
|
4 Participants
|
29 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Year 9
Grade 3 Gastrointestinal symptoms
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Year 9
Any Headache
|
52 Participants
|
25 Participants
|
53 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Year 9
Grade 3 Headache
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Year 9
Any Fever
|
2 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Year 9
Grade 3 Fever
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: During the 4-day (Days 0-3) follow-up period after vaccination.Population: The analysis was performed on the Total Vaccinated cohort at Year 9, which included all subjects with study vaccine administration dose documented, who returned at Year 9.
Large injection site reaction = a swelling with a diameter \> 100 mm, noticeable diffuse swelling or noticeable increase in limb circumference.
Outcome measures
| Measure |
Boostrix Group
n=309 Participants
Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine \[Tdap\](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a second dose of Boostrix vaccine \[Tdap\](GSK776423).
|
Adacel Group
n=138 Participants
Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a dose of Boostrix vaccine \[Tdap\](GSK776423).
|
Control Group
n=362 Participants
Subjects received the first dose of Boostrix vaccine \[Tdap\](GSK776423) in this study at Year 9.
|
|---|---|---|---|
|
Number of Subjects With Any Large Injection Site Reaction - Year 9
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: During the 31-day (Days 0-30) post-vaccination period.Population: The analysis was performed on the Total Vaccinated cohort at Year 9, which included all subjects with study vaccine administration dose documented, who returned at Year 9.
An unsolicited AE covers any untoward medical oc-currence 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.
Outcome measures
| Measure |
Boostrix Group
n=309 Participants
Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine \[Tdap\](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a second dose of Boostrix vaccine \[Tdap\](GSK776423).
|
Adacel Group
n=138 Participants
Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a dose of Boostrix vaccine \[Tdap\](GSK776423).
|
Control Group
n=362 Participants
Subjects received the first dose of Boostrix vaccine \[Tdap\](GSK776423) in this study at Year 9.
|
|---|---|---|---|
|
Number of Subjects With Any Unsolicited Adverse Events (AEs) - Year 9
|
42 Participants
|
23 Participants
|
37 Participants
|
SECONDARY outcome
Timeframe: During the 31-day (Days 0-30) post-vaccination periodPopulation: The analysis was performed on the Total Vaccinated cohort at Year 9, which included all subjects with study vaccine administration dose documented, who returned at Year 9.
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 Group
n=309 Participants
Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine \[Tdap\](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a second dose of Boostrix vaccine \[Tdap\](GSK776423).
|
Adacel Group
n=138 Participants
Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a dose of Boostrix vaccine \[Tdap\](GSK776423).
|
Control Group
n=362 Participants
Subjects received the first dose of Boostrix vaccine \[Tdap\](GSK776423) in this study at Year 9.
|
|---|---|---|---|
|
Number of Subjects With Serious Adverse Events (SAEs) - Year 9
|
0 Participants
|
0 Participants
|
1 Participants
|
Adverse Events
Boostrix Group
Adacel Group
Control Group
Serious adverse events
| Measure |
Boostrix Group
n=309 participants at risk
Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine \[Tdap\](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a second dose of Boostrix vaccine \[Tdap\](GSK776423).
|
Adacel Group
n=138 participants at risk
Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a dose of Boostrix vaccine \[Tdap\](GSK776423).
|
Control Group
n=362 participants at risk
Subjects received the first dose of Boostrix vaccine \[Tdap\](GSK776423) in this study at Year 9.
|
|---|---|---|---|
|
Nervous system disorders
Seizure
|
0.00%
0/309 • Solicited local/general symptoms: during the 4-day post-vaccination period; Unsolicited AE(s): during the 31-day (Day 0-30) post vaccination period; SAE(s): during the 31-day (Day 0-30) post vaccination period
Safety data is presented for subjects who received the study vaccine (at year 9) in this study.
|
0.00%
0/138 • Solicited local/general symptoms: during the 4-day post-vaccination period; Unsolicited AE(s): during the 31-day (Day 0-30) post vaccination period; SAE(s): during the 31-day (Day 0-30) post vaccination period
Safety data is presented for subjects who received the study vaccine (at year 9) in this study.
|
0.28%
1/362 • Solicited local/general symptoms: during the 4-day post-vaccination period; Unsolicited AE(s): during the 31-day (Day 0-30) post vaccination period; SAE(s): during the 31-day (Day 0-30) post vaccination period
Safety data is presented for subjects who received the study vaccine (at year 9) in this study.
|
Other adverse events
| Measure |
Boostrix Group
n=309 participants at risk
Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine \[Tdap\](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a second dose of Boostrix vaccine \[Tdap\](GSK776423).
|
Adacel Group
n=138 participants at risk
Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a dose of Boostrix vaccine \[Tdap\](GSK776423).
|
Control Group
n=362 participants at risk
Subjects received the first dose of Boostrix vaccine \[Tdap\](GSK776423) in this study at Year 9.
|
|---|---|---|---|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
9.1%
28/309 • Number of events 28 • Solicited local/general symptoms: during the 4-day post-vaccination period; Unsolicited AE(s): during the 31-day (Day 0-30) post vaccination period; SAE(s): during the 31-day (Day 0-30) post vaccination period
Safety data is presented for subjects who received the study vaccine (at year 9) in this study.
|
2.9%
4/138 • Number of events 4 • Solicited local/general symptoms: during the 4-day post-vaccination period; Unsolicited AE(s): during the 31-day (Day 0-30) post vaccination period; SAE(s): during the 31-day (Day 0-30) post vaccination period
Safety data is presented for subjects who received the study vaccine (at year 9) in this study.
|
8.0%
29/362 • Number of events 29 • Solicited local/general symptoms: during the 4-day post-vaccination period; Unsolicited AE(s): during the 31-day (Day 0-30) post vaccination period; SAE(s): during the 31-day (Day 0-30) post vaccination period
Safety data is presented for subjects who received the study vaccine (at year 9) in this study.
|
|
General disorders
Fatigue
|
23.0%
71/309 • Number of events 72 • Solicited local/general symptoms: during the 4-day post-vaccination period; Unsolicited AE(s): during the 31-day (Day 0-30) post vaccination period; SAE(s): during the 31-day (Day 0-30) post vaccination period
Safety data is presented for subjects who received the study vaccine (at year 9) in this study.
|
16.7%
23/138 • Number of events 23 • Solicited local/general symptoms: during the 4-day post-vaccination period; Unsolicited AE(s): during the 31-day (Day 0-30) post vaccination period; SAE(s): during the 31-day (Day 0-30) post vaccination period
Safety data is presented for subjects who received the study vaccine (at year 9) in this study.
|
14.1%
51/362 • Number of events 51 • Solicited local/general symptoms: during the 4-day post-vaccination period; Unsolicited AE(s): during the 31-day (Day 0-30) post vaccination period; SAE(s): during the 31-day (Day 0-30) post vaccination period
Safety data is presented for subjects who received the study vaccine (at year 9) in this study.
|
|
General disorders
Pain
|
58.6%
181/309 • Number of events 183 • Solicited local/general symptoms: during the 4-day post-vaccination period; Unsolicited AE(s): during the 31-day (Day 0-30) post vaccination period; SAE(s): during the 31-day (Day 0-30) post vaccination period
Safety data is presented for subjects who received the study vaccine (at year 9) in this study.
|
60.9%
84/138 • Number of events 84 • Solicited local/general symptoms: during the 4-day post-vaccination period; Unsolicited AE(s): during the 31-day (Day 0-30) post vaccination period; SAE(s): during the 31-day (Day 0-30) post vaccination period
Safety data is presented for subjects who received the study vaccine (at year 9) in this study.
|
36.5%
132/362 • Number of events 132 • Solicited local/general symptoms: during the 4-day post-vaccination period; Unsolicited AE(s): during the 31-day (Day 0-30) post vaccination period; SAE(s): during the 31-day (Day 0-30) post vaccination period
Safety data is presented for subjects who received the study vaccine (at year 9) in this study.
|
|
General disorders
Swelling
|
18.4%
57/309 • Number of events 57 • Solicited local/general symptoms: during the 4-day post-vaccination period; Unsolicited AE(s): during the 31-day (Day 0-30) post vaccination period; SAE(s): during the 31-day (Day 0-30) post vaccination period
Safety data is presented for subjects who received the study vaccine (at year 9) in this study.
|
18.8%
26/138 • Number of events 26 • Solicited local/general symptoms: during the 4-day post-vaccination period; Unsolicited AE(s): during the 31-day (Day 0-30) post vaccination period; SAE(s): during the 31-day (Day 0-30) post vaccination period
Safety data is presented for subjects who received the study vaccine (at year 9) in this study.
|
11.3%
41/362 • Number of events 41 • Solicited local/general symptoms: during the 4-day post-vaccination period; Unsolicited AE(s): during the 31-day (Day 0-30) post vaccination period; SAE(s): during the 31-day (Day 0-30) post vaccination period
Safety data is presented for subjects who received the study vaccine (at year 9) in this study.
|
|
Nervous system disorders
Headache
|
17.2%
53/309 • Number of events 54 • Solicited local/general symptoms: during the 4-day post-vaccination period; Unsolicited AE(s): during the 31-day (Day 0-30) post vaccination period; SAE(s): during the 31-day (Day 0-30) post vaccination period
Safety data is presented for subjects who received the study vaccine (at year 9) in this study.
|
20.3%
28/138 • Number of events 29 • Solicited local/general symptoms: during the 4-day post-vaccination period; Unsolicited AE(s): during the 31-day (Day 0-30) post vaccination period; SAE(s): during the 31-day (Day 0-30) post vaccination period
Safety data is presented for subjects who received the study vaccine (at year 9) in this study.
|
15.7%
57/362 • Number of events 58 • Solicited local/general symptoms: during the 4-day post-vaccination period; Unsolicited AE(s): during the 31-day (Day 0-30) post vaccination period; SAE(s): during the 31-day (Day 0-30) post vaccination period
Safety data is presented for subjects who received the study vaccine (at year 9) in this study.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
23.9%
74/309 • Number of events 74 • Solicited local/general symptoms: during the 4-day post-vaccination period; Unsolicited AE(s): during the 31-day (Day 0-30) post vaccination period; SAE(s): during the 31-day (Day 0-30) post vaccination period
Safety data is presented for subjects who received the study vaccine (at year 9) in this study.
|
23.2%
32/138 • Number of events 32 • Solicited local/general symptoms: during the 4-day post-vaccination period; Unsolicited AE(s): during the 31-day (Day 0-30) post vaccination period; SAE(s): during the 31-day (Day 0-30) post vaccination period
Safety data is presented for subjects who received the study vaccine (at year 9) in this study.
|
14.6%
53/362 • Number of events 53 • Solicited local/general symptoms: during the 4-day post-vaccination period; Unsolicited AE(s): during the 31-day (Day 0-30) post vaccination period; SAE(s): during the 31-day (Day 0-30) post vaccination period
Safety data is presented for subjects who received the study vaccine (at year 9) in this study.
|
Additional Information
GSK Response Center
GlaxoSmithKline
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