Trial Outcomes & Findings for Evaluation of Boostrix™10 Years After Previous Booster Vaccination (NCT NCT01147900)
NCT ID: NCT01147900
Last Updated: 2018-08-20
Results Overview
A subject seroprotected against diphtheria/tetanus was defined as a vaccinated subject who had an anti-diphtheria (anti-D)/anti-tetanus (anti-T) antibody concentration greater than or above (≥) 0.1 international units per milliliter (IU/mL).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
180 participants
Primary outcome timeframe
At Year 8.5
Results posted on
2018-08-20
Participant Flow
Subjects consisted of those previously vaccinated \& boosted in GSK263855/029 study and contacted for participation in this booster (BST) study. Duration of this study was about 19 months, from Year 8.5 (8.5 years post BST in GSK263855/029 study) to one month post BST in this study (Year 10 \[10 years post BST in GSK263855/029 study\] + one month).
At Year 8.5, a total of 180 subjects (out of the 478 planned) were enrolled: 54, 60 and 66 subjects in the Boostrix-REF, Boostrix-US, and Boostrix-INV groups, respectively. At Year 10, a total of 177 subjects (out of the 180 planned) were enrolled: 55, 60 and 62 in the Boostrix-REF, Boostrix-US, and Boostrix-INV groups, respectively.
Participant milestones
| Measure |
Boostrix-US Group
Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, United States(US)-marketed formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, US-marketed formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
|
Boostrix-INV Group
Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, investigational formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
|
Boostrix-REF Group
Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, reference formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
|
|---|---|---|---|
|
At Year 8.5
STARTED
|
54
|
60
|
66
|
|
At Year 8.5
COMPLETED
|
54
|
60
|
66
|
|
At Year 8.5
NOT COMPLETED
|
0
|
0
|
0
|
|
At Year 10
STARTED
|
55
|
60
|
62
|
|
At Year 10
COMPLETED
|
55
|
59
|
62
|
|
At Year 10
NOT COMPLETED
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
Boostrix-US Group
Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, United States(US)-marketed formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, US-marketed formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
|
Boostrix-INV Group
Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, investigational formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
|
Boostrix-REF Group
Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, reference formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
|
|---|---|---|---|
|
At Year 10
Lost to Follow-up
|
0
|
1
|
0
|
Baseline Characteristics
The baseline measure data correspond to Year 8.5.
Baseline characteristics by cohort
| Measure |
Boostrix-US Group
n=55 Participants
Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, United States(US)-marketed formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, US-marketed formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
|
Boostrix-INV Group
n=60 Participants
Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, investigational formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
|
Boostrix-REF Group
n=66 Participants
Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, reference formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
|
Total
n=181 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
23.5 Years
STANDARD_DEVIATION 1.44 • n=55 Participants • The baseline measure data correspond to Year 10.
|
23.4 Years
STANDARD_DEVIATION 1.21 • n=60 Participants • The baseline measure data correspond to Year 10.
|
23.3 Years
STANDARD_DEVIATION 1.17 • n=62 Participants • The baseline measure data correspond to Year 10.
|
23.4 Years
STANDARD_DEVIATION 1.19 • n=177 Participants • The baseline measure data correspond to Year 10.
|
|
Sex: Female, Male
Female
|
29 Participants
n=55 Participants • The baseline measure data correspond to Year 10.
|
31 Participants
n=60 Participants • The baseline measure data correspond to Year 10.
|
36 Participants
n=62 Participants • The baseline measure data correspond to Year 10.
|
96 Participants
n=177 Participants • The baseline measure data correspond to Year 10.
|
|
Sex: Female, Male
Male
|
26 Participants
n=55 Participants • The baseline measure data correspond to Year 10.
|
29 Participants
n=60 Participants • The baseline measure data correspond to Year 10.
|
26 Participants
n=62 Participants • The baseline measure data correspond to Year 10.
|
81 Participants
n=177 Participants • The baseline measure data correspond to Year 10.
|
PRIMARY outcome
Timeframe: At Year 8.5Population: The analysis was performed on the According To Protocol cohort for persistence at Year 8.5, which included all subjects who had received no additional dose of diphtheria, tetanus or pertussis vaccine other than the Boostrix™ booster dose received in the GSK263855/029 study, and for whom serological results were available at Year 8.5.
A subject seroprotected against diphtheria/tetanus was defined as a vaccinated subject who had an anti-diphtheria (anti-D)/anti-tetanus (anti-T) antibody concentration greater than or above (≥) 0.1 international units per milliliter (IU/mL).
Outcome measures
| Measure |
Boostrix-REF Group
n=65 Participants
Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, reference formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
|
Boostrix-US Group
n=54 Participants
Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, United States(US)-marketed formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, US-marketed formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
|
Boostrix-INV Group
n=59 Participants
Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, investigational formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
|
|---|---|---|---|
|
Number of Seroprotected Subjects Against Diphtheria and Tetanus
Anti-D
|
65 Participants
|
53 Participants
|
59 Participants
|
|
Number of Seroprotected Subjects Against Diphtheria and Tetanus
Anti-T
|
65 Participants
|
54 Participants
|
59 Participants
|
PRIMARY outcome
Timeframe: At Year 8.5Population: The analysis was performed on the According To Protocol cohort for persistence at Year 8.5 , which included all subjects who had received no additional dose of diphtheria, tetanus or pertussis vaccine other than the Boostrix™ booster dose received in the GSK263855/029 study, and for whom serological results were available at Year 8.5.
Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was 0.1 IU/mL for all antibodies assessed.
Outcome measures
| Measure |
Boostrix-REF Group
n=65 Participants
Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, reference formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
|
Boostrix-US Group
n=54 Participants
Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, United States(US)-marketed formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, US-marketed formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
|
Boostrix-INV Group
n=59 Participants
Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, investigational formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
|
|---|---|---|---|
|
Concentrations for Anti-D and Anti-T Antibodies.
Anti-D
|
0.872 IU/mL
Interval 0.711 to 1.068
|
0.912 IU/mL
Interval 0.728 to 1.141
|
1.205 IU/mL
Interval 0.984 to 1.474
|
|
Concentrations for Anti-D and Anti-T Antibodies.
Anti-T
|
1.846 IU/mL
Interval 1.604 to 2.123
|
1.889 IU/mL
Interval 1.585 to 2.251
|
1.991 IU/mL
Interval 1.674 to 2.368
|
PRIMARY outcome
Timeframe: At Year 10Population: The analysis was performed on the According To Protocol cohort for persistence at Year 10, which included all subjects who had received no additional dose of diphtheria, tetanus or pertussis vaccine other than the Boostrix™ booster dose received in the GSK263855/029 study, and for whom serological results were available at Year 10.
A subject seroprotected against diphtheria/tetanus was defined as a vaccinated subject who had an anti-D/anti-T antibody concentration greater than or above (≥) 0.1 international units per milliliter (IU/mL).
Outcome measures
| Measure |
Boostrix-REF Group
n=61 Participants
Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, reference formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
|
Boostrix-US Group
n=54 Participants
Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, United States(US)-marketed formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, US-marketed formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
|
Boostrix-INV Group
n=60 Participants
Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, investigational formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
|
|---|---|---|---|
|
Number of Seroprotected Subjects Against Diphtheria and Tetanus.
Anti-D
|
61 Participants
|
53 Participants
|
60 Participants
|
|
Number of Seroprotected Subjects Against Diphtheria and Tetanus.
Anti-T
|
61 Participants
|
54 Participants
|
60 Participants
|
PRIMARY outcome
Timeframe: At Year 10Population: The analysis was performed on the According To Protocol cohort for persistence at Year 10, which included all subjects who had received no additional dose of diphtheria, tetanus or pertussis vaccine other than the Boostrix™ booster dose received in the GSK263855/029 study, and for whom serological results were available at Year 10.
Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was 0.1 IU/mL.
Outcome measures
| Measure |
Boostrix-REF Group
n=61 Participants
Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, reference formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
|
Boostrix-US Group
n=54 Participants
Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, United States(US)-marketed formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, US-marketed formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
|
Boostrix-INV Group
n=60 Participants
Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, investigational formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
|
|---|---|---|---|
|
Concentrations for Anti-D and Anti-T Antibodies.
Anti-D
|
0.681 IU/mL
Interval 0.55 to 0.844
|
0.767 IU/mL
Interval 0.6 to 0.982
|
1.099 IU/mL
Interval 0.882 to 1.37
|
|
Concentrations for Anti-D and Anti-T Antibodies.
Anti-T
|
1.760 IU/mL
Interval 1.518 to 2.041
|
2.008 IU/mL
Interval 1.65 to 2.444
|
2.009 IU/mL
Interval 1.701 to 2.372
|
PRIMARY outcome
Timeframe: At Year 8.5Population: The analysis was performed on the According To Protocol cohort for persistence at Year 8.5 , which included all subjects who had received no additional dose of diphtheria, tetanus or pertussis vaccine other than the Boostrix™ booster dose received in the GSK263855/029 study, and for whom serological results were available at Year 8.5.
A seropositive subject for anti-PT/anti-PRN/anti-FHA antibodies was defined as a vaccinated subject who had anti-PT/anti-PRN/anti-FHA antibody concentrations greater than or equal to (≥) 5 Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).
Outcome measures
| Measure |
Boostrix-REF Group
n=65 Participants
Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, reference formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
|
Boostrix-US Group
n=54 Participants
Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, United States(US)-marketed formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, US-marketed formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
|
Boostrix-INV Group
n=59 Participants
Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, investigational formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
|
|---|---|---|---|
|
Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-pertactin (Anti-PRN) and Anti-filamentous Haemagglutinin (Anti-FHA) Antibodies.
Anti-PT [N=54;59;65]
|
60 Participants
|
42 Participants
|
48 Participants
|
|
Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-pertactin (Anti-PRN) and Anti-filamentous Haemagglutinin (Anti-FHA) Antibodies.
Anti-FHA [N=54;59;62]
|
62 Participants
|
54 Participants
|
59 Participants
|
|
Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-pertactin (Anti-PRN) and Anti-filamentous Haemagglutinin (Anti-FHA) Antibodies.
Anti-PRN [N=54;59;65]
|
65 Participants
|
54 Participants
|
59 Participants
|
PRIMARY outcome
Timeframe: At Year 8.5Population: The analysis was performed on the According To Protocol cohort for persistence at Year 8.5 , which included all subjects who had received no additional dose of diphtheria, tetanus or pertussis vaccine other than the Boostrix™ booster dose received in the GSK263855/029 study, and for whom serological results were available at Year 8.5.
Concentrations were expressed as geometric mean concentrations (GMCs). The seropositivity cut-off of the assay was 5 EL.U/mL for all antibodies assessed.
Outcome measures
| Measure |
Boostrix-REF Group
n=65 Participants
Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, reference formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
|
Boostrix-US Group
n=54 Participants
Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, United States(US)-marketed formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, US-marketed formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
|
Boostrix-INV Group
n=59 Participants
Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, investigational formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
|
|---|---|---|---|
|
Concentrations for Anti-PT, Anti-PRN and Anti-FHA Antibodies.
Anti-PT [N=54;59;65]
|
18.034 EL.U/mL
Interval 13.812 to 23.545
|
10.933 EL.U/mL
Interval 7.979 to 14.98
|
13.372 EL.U/mL
Interval 10.139 to 17.634
|
|
Concentrations for Anti-PT, Anti-PRN and Anti-FHA Antibodies.
Anti-FHA [N=54;59;62]
|
102.604 EL.U/mL
Interval 85.687 to 122.861
|
72.653 EL.U/mL
Interval 57.904 to 91.158
|
96.144 EL.U/mL
Interval 75.613 to 122.25
|
|
Concentrations for Anti-PT, Anti-PRN and Anti-FHA Antibodies.
Anti-PRN [N=54;59;65]
|
134.616 EL.U/mL
Interval 106.266 to 170.528
|
161.349 EL.U/mL
Interval 121.75 to 213.827
|
179.027 EL.U/mL
Interval 136.303 to 235.144
|
PRIMARY outcome
Timeframe: At Year 10Population: The analysis was performed on the According To Protocol cohort for persistence at Year 10, which included all subjects who had received no additional dose of diphtheria, tetanus or pertussis vaccine other than the Boostrix™ booster dose received in the GSK263855/029 study, and for whom serological results were available at Year 10.
A seropositive subject for anti-PT/anti-FHA/anti-PRN antibodies was defined as a vaccinated subject who had anti-PT/anti-FHA/anti-PRN antibody concentrations greater than or equal to (≥) 5 Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).
Outcome measures
| Measure |
Boostrix-REF Group
n=60 Participants
Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, reference formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
|
Boostrix-US Group
n=54 Participants
Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, United States(US)-marketed formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, US-marketed formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
|
Boostrix-INV Group
n=60 Participants
Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, investigational formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
|
|---|---|---|---|
|
Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN Antibodies.
Anti-PT [N=52;59;59]
|
51 Participants
|
44 Participants
|
49 Participants
|
|
Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN Antibodies.
Anti-PRN [N=54;60;60]
|
60 Participants
|
54 Participants
|
60 Participants
|
|
Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN Antibodies.
Anti-FHA [N=54;60;60]
|
60 Participants
|
54 Participants
|
60 Participants
|
PRIMARY outcome
Timeframe: At Year 10Population: The analysis was performed on the According To Protocol cohort for persistence at Year 10, which included all subjects who had received no additional dose of diphtheria, tetanus or pertussis vaccine other than the Boostrix™ booster dose received in the GSK263855/029 study, and for whom serological results were available at Year 10.
Concentrations were expressed as geometric mean concentrations (GMCs). The seropositivity cut-off of the assay was 5 EL.U/mL.
Outcome measures
| Measure |
Boostrix-REF Group
n=60 Participants
Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, reference formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
|
Boostrix-US Group
n=54 Participants
Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, United States(US)-marketed formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, US-marketed formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
|
Boostrix-INV Group
n=60 Participants
Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, investigational formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
|
|---|---|---|---|
|
Concentrations for Anti-PT, Anti-FHA and Anti-PRN Antibodies.
Anti-PT [N=52;59;59]
|
15.728 EL.U/mL
Interval 11.76 to 21.034
|
11.627 EL.U/mL
Interval 8.863 to 15.252
|
13.987 EL.U/mL
Interval 10.874 to 17.991
|
|
Concentrations for Anti-PT, Anti-FHA and Anti-PRN Antibodies.
Anti-PRN [N=54;60;60]
|
115.209 EL.U/mL
Interval 91.288 to 145.398
|
131.814 EL.U/mL
Interval 98.531 to 176.34
|
158.239 EL.U/mL
Interval 120.864 to 207.171
|
|
Concentrations for Anti-PT, Anti-FHA and Anti-PRN Antibodies.
Anti-FHA [N=54;60;60]
|
98.441 EL.U/mL
Interval 82.71 to 117.165
|
75.574 EL.U/mL
Interval 61.018 to 93.603
|
98.182 EL.U/mL
Interval 77.166 to 124.921
|
PRIMARY outcome
Timeframe: At Year 10 pre booster vaccination (PRE) and at 1 month post Year 10 booster vaccination (POST)Population: Analysis was done on the According-to-Protocol for immunogenicity at Year 10, which included all evaluable subjects who had received the booster dose of Boostrix™ vaccine, any formulation (at least 9.5 years after the dose administered in GSK263855/029 study) and for whom data concerning immunogenicity outcome measures were available.
A subject seroprotected against diphtheria/tetanus was defined as a vaccinated subject who had an anti-D/anti-T antibody concentration greater than or above (≥) 0.1 international units per milliliter (IU/mL).
Outcome measures
| Measure |
Boostrix-REF Group
n=60 Participants
Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, reference formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
|
Boostrix-US Group
n=54 Participants
Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, United States(US)-marketed formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, US-marketed formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
|
Boostrix-INV Group
n=59 Participants
Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, investigational formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
|
|---|---|---|---|
|
Number of Seroprotected Subjects Against Diphtheria and Tetanus
Anti-D, PRE
|
60 Participants
|
53 Participants
|
59 Participants
|
|
Number of Seroprotected Subjects Against Diphtheria and Tetanus
Anti-D, POST
|
60 Participants
|
54 Participants
|
59 Participants
|
|
Number of Seroprotected Subjects Against Diphtheria and Tetanus
Anti-T, PRE
|
60 Participants
|
54 Participants
|
59 Participants
|
|
Number of Seroprotected Subjects Against Diphtheria and Tetanus
Anti-T, POST
|
60 Participants
|
54 Participants
|
59 Participants
|
PRIMARY outcome
Timeframe: At Year 10 pre booster vaccination (PRE) and at 1 month post Year 10 booster vaccination (POST)Population: Analysis was done on the According-to-Protocol for immunogenicity at Year 10, which included all evaluable subjects who had received the booster dose of Boostrix™ vaccine, any formulation (at least 9.5 years after the dose administered in GSK263855/029 study) and for whom data concerning immunogenicity outcome measures were available.
Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was 0.1 IU/mL for all antibodies assessed.
Outcome measures
| Measure |
Boostrix-REF Group
n=60 Participants
Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, reference formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
|
Boostrix-US Group
n=54 Participants
Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, United States(US)-marketed formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, US-marketed formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
|
Boostrix-INV Group
n=59 Participants
Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, investigational formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
|
|---|---|---|---|
|
Concentrations for Anti-D and Anti-T Antibodies.
Anti-D, PRE
|
0.686 IU/mL
Interval 0.552 to 0.853
|
0.767 IU/mL
Interval 0.6 to 0.982
|
1.094 IU/mL
Interval 0.874 to 1.368
|
|
Concentrations for Anti-D and Anti-T Antibodies.
Anti-D, POST
|
4.150 IU/mL
Interval 3.543 to 4.862
|
4.251 IU/mL
Interval 3.646 to 4.957
|
5.226 IU/mL
Interval 4.353 to 6.275
|
|
Concentrations for Anti-D and Anti-T Antibodies.
Anti-T, PRE
|
1.752 IU/mL
Interval 1.508 to 2.037
|
2.008 IU/mL
Interval 1.65 to 2.444
|
1.987 IU/mL
Interval 1.68 to 2.35
|
|
Concentrations for Anti-D and Anti-T Antibodies.
Anti-T, POST
|
8.792 IU/mL
Interval 7.582 to 10.195
|
7.581 IU/mL
Interval 6.523 to 8.809
|
8.456 IU/mL
Interval 7.294 to 9.802
|
PRIMARY outcome
Timeframe: At Year 10 pre booster vaccination (PRE) and at 1 month post Year 10 booster vaccination (POST)Population: Analysis was done on the According-to-Protocol for immunogenicity at Year 10, which included all evaluable subjects who had received the booster dose of Boostrix™ vaccine, any formulation (at least 9.5 years after the dose administered in GSK263855/029 study) and for whom data concerning immunogenicity outcome measures were available.
A seropositive subject for anti-PT/anti-PRN/anti-FHA antibodies was defined as a vaccinated subject who had anti-PT/anti-PRN/anti-FHA antibody concentrations greater than or equal to (≥) 5 ELISA units per milliliter (EL.U/mL).
Outcome measures
| Measure |
Boostrix-REF Group
n=60 Participants
Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, reference formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
|
Boostrix-US Group
n=54 Participants
Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, United States(US)-marketed formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, US-marketed formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
|
Boostrix-INV Group
n=59 Participants
Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, investigational formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
|
|---|---|---|---|
|
Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN Antibodies.
Anti-PT, PRE [N=52;58;58]
|
50 Participants
|
44 Participants
|
48 Participants
|
|
Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN Antibodies.
Anti-PT, POST [N=54;59;60]
|
60 Participants
|
54 Participants
|
59 Participants
|
|
Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN Antibodies.
Anti-PRN, PRE [N=54;59;59]
|
59 Participants
|
54 Participants
|
59 Participants
|
|
Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN Antibodies.
Anti-PRN, POST [N=53;59;60]
|
60 Participants
|
53 Participants
|
59 Participants
|
|
Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN Antibodies.
Anti-FHA, PRE [N=54;59;59]
|
59 Participants
|
54 Participants
|
59 Participants
|
|
Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN Antibodies.
Anti-FHA, POST [N=53;59;60]
|
60 Participants
|
53 Participants
|
59 Participants
|
PRIMARY outcome
Timeframe: At Year 10 pre booster vaccination (PRE) and at 1 month post Year 10 booster vaccination (POST)Population: Analysis was done on the According-to-Protocol for immunogenicity at Year 10, which included all evaluable subjects who had received the booster dose of Boostrix™ vaccine, any formulation (at least 9.5 years after the dose administered in GSK263855/029 study) and for whom data concerning immunogenicity outcome measures were available.
Concentrations were expressed as geometric mean concentrations (GMCs). The seropositivity cut-off of the assay was 5 EL.U/mL.
Outcome measures
| Measure |
Boostrix-REF Group
n=60 Participants
Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, reference formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
|
Boostrix-US Group
n=54 Participants
Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, United States(US)-marketed formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, US-marketed formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
|
Boostrix-INV Group
n=59 Participants
Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, investigational formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
|
|---|---|---|---|
|
Concentrations for Anti-PT, Anti-FHA and Anti-PRN Antibodies.
Anti-PRN, POST [N=53;59;60]
|
448.839 EL.U/mL
Interval 379.488 to 530.863
|
445.751 EL.U/mL
Interval 372.77 to 533.02
|
448.475 EL.U/mL
Interval 383.748 to 524.12
|
|
Concentrations for Anti-PT, Anti-FHA and Anti-PRN Antibodies.
Anti-PT, PRE [N=52;58;58]
|
15.650 EL.U/mL
Interval 11.643 to 21.035
|
11.627 EL.U/mL
Interval 8.863 to 15.252
|
14.193 EL.U/mL
Interval 11.003 to 18.306
|
|
Concentrations for Anti-PT, Anti-FHA and Anti-PRN Antibodies.
Anti-PT, POST [N=54;59;60]
|
123.964 EL.U/mL
Interval 103.458 to 148.533
|
82.478 EL.U/mL
Interval 66.951 to 101.606
|
108.094 EL.U/mL
Interval 87.703 to 133.227
|
|
Concentrations for Anti-PT, Anti-FHA and Anti-PRN Antibodies.
Anti-PRN, PRE [N=54;59;59]
|
114.226 EL.U/mL
Interval 90.201 to 144.652
|
131.814 EL.U/mL
Interval 98.531 to 176.34
|
161.903 EL.U/mL
Interval 123.574 to 212.12
|
|
Concentrations for Anti-PT, Anti-FHA and Anti-PRN Antibodies.
Anti-FHA, PRE [N=54;59;59]
|
97.698 EL.U/mL
Interval 81.891 to 116.555
|
75.574 EL.U/mL
Interval 61.018 to 93.603
|
96.098 EL.U/mL
Interval 75.507 to 122.305
|
|
Concentrations for Anti-PT, Anti-FHA and Anti-PRN Antibodies.
Anti-FHA, POST [N=53;59;60]
|
558.648 EL.U/mL
Interval 489.266 to 637.869
|
503.532 EL.U/mL
Interval 426.524 to 594.444
|
592.177 EL.U/mL
Interval 516.831 to 678.507
|
PRIMARY outcome
Timeframe: At 1 month post Year 10 booster vaccinationPopulation: Analysis was done on the According-to-Protocol for immunogenicity at Year 10, which included all evaluable subjects who had received the booster dose of Boostrix™ vaccine, any formulation (at least 9.5 years after the dose administered in GSK263855/029 study) and for whom data concerning immunogenicity outcome measures were available.
A booster responder to PT/PRN antigens was defined as either a vaccinated subject seronegative at analysis baseline (Year 10) with anti-PT/anti-PRN antibody concentration greater than or equal to (≥) 5 EL.U/mL at one month post Year 10 booster vaccination, or as a vaccinated subject seropositive at analysis baseline (Year 10) and with anti-PT/anti-PRN antibody concentration with at least a 2-fold increase at one month post Year 10 booster vaccination. A seronegative/seropositive subject was defined as a vaccinated subject with anti-PT/anti-PRN antibody concentration ≥/\< 5 EL.U/mL.
Outcome measures
| Measure |
Boostrix-REF Group
n=52 Participants
Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, reference formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
|
Boostrix-US Group
n=46 Participants
Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, United States(US)-marketed formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, US-marketed formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
|
Boostrix-INV Group
n=52 Participants
Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, investigational formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
|
|---|---|---|---|
|
Number of Booster Responders to Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antigens.
Booster responses to anti-PT [N=44;51;51]
|
48 Participants
|
44 Participants
|
51 Participants
|
|
Number of Booster Responders to Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antigens.
Booster responses to anti-PRN [N=45;52;52]
|
35 Participants
|
23 Participants
|
29 Participants
|
|
Number of Booster Responders to Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antigens.
Booster responses to anti-FHA [N=46;52;50]
|
48 Participants
|
43 Participants
|
47 Participants
|
SECONDARY outcome
Timeframe: During the 4-day (Days 0-3) follow-up period after booster vaccinationPopulation: Analysis was performed on the Total Vaccinated cohort, which included all subjects with documented administration of Boostrix™ vaccine, any formulation, for whom data were available.
Assessed solicited local symptoms were pain, redness and swelling at the injection site. Any = incidence of a particular symptom regardless of intensity grade.
Outcome measures
| Measure |
Boostrix-REF Group
n=62 Participants
Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, reference formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
|
Boostrix-US Group
n=55 Participants
Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, United States(US)-marketed formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, US-marketed formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
|
Boostrix-INV Group
n=59 Participants
Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, investigational formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
|
|---|---|---|---|
|
Number of Subjects With Any Solicited Local Symptoms.
Any Pain
|
54 Participants
|
50 Participants
|
55 Participants
|
|
Number of Subjects With Any Solicited Local Symptoms.
Any Redness
|
21 Participants
|
23 Participants
|
23 Participants
|
|
Number of Subjects With Any Solicited Local Symptoms.
Any Swelling
|
19 Participants
|
21 Participants
|
20 Participants
|
SECONDARY outcome
Timeframe: During the 4-day (Days 0-3) follow-up period after booster vaccinationPopulation: Analysis was performed on the Total Vaccinated cohort, which included all subjects with documented administration of Boostrix™ vaccine, any formulation, for whom data were available.
Assessed solicited general symptoms were fatigue, gastrointestinal, headache and fever \[defined as axillary temperature ≥ 37.5 degrees Celsius (°C)\]. Any = incidence of a particular symptom regardless of intensity grade and relationship to vaccination.
Outcome measures
| Measure |
Boostrix-REF Group
n=62 Participants
Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, reference formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
|
Boostrix-US Group
n=54 Participants
Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, United States(US)-marketed formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, US-marketed formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
|
Boostrix-INV Group
n=59 Participants
Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, investigational formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
|
|---|---|---|---|
|
Number of Subjects With Any Solicited General Symptoms.
Any Fatigue
|
22 subjects
|
17 subjects
|
20 subjects
|
|
Number of Subjects With Any Solicited General Symptoms.
Any Gastrointestinal Symptoms
|
13 subjects
|
10 subjects
|
9 subjects
|
|
Number of Subjects With Any Solicited General Symptoms.
Any Headache
|
13 subjects
|
13 subjects
|
19 subjects
|
|
Number of Subjects With Any Solicited General Symptoms.
Any Fever
|
1 subjects
|
1 subjects
|
1 subjects
|
SECONDARY outcome
Timeframe: During the 31-day (Days 0-30) follow-up period after booster vaccinationPopulation: Analysis was performed on the Total Vaccinated cohort, which included all subjects with documented administration of Boostrix™ vaccine, any formulation, for whom data were available.
An unsolicited AE is any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) 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 unsolicited AE = any unsolicited AE regardless of intensity or relationship to vaccination.
Outcome measures
| Measure |
Boostrix-REF Group
n=62 Participants
Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, reference formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
|
Boostrix-US Group
n=55 Participants
Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, United States(US)-marketed formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, US-marketed formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
|
Boostrix-INV Group
n=60 Participants
Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, investigational formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
|
|---|---|---|---|
|
Number of Subjects With Any Unsolicited Adverse Events (AEs).
|
21 Participants
|
22 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: At Year 8.5Population: Analysis was performed on the Total Vaccinated cohort, which included all subjects with documented administration of Boostrix™ vaccine, any formulation, 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, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject..
Outcome measures
| Measure |
Boostrix-REF Group
n=66 Participants
Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, reference formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
|
Boostrix-US Group
n=54 Participants
Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, United States(US)-marketed formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, US-marketed formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
|
Boostrix-INV Group
n=60 Participants
Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, investigational formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
|
|---|---|---|---|
|
Number of Subjects With Any Serious Adverse Events (SAEs).
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From Year 8.5 up to study end (one month post Year 10 booster vaccination)Population: Analysis was performed on the Total Vaccinated cohort, which included all subjects with documented administration of Boostrix™ vaccine, any formulation, 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, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
Outcome measures
| Measure |
Boostrix-REF Group
n=62 Participants
Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, reference formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
|
Boostrix-US Group
n=55 Participants
Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, United States(US)-marketed formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, US-marketed formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
|
Boostrix-INV Group
n=60 Participants
Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, investigational formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
|
|---|---|---|---|
|
Number of Subjects With Any Serious Adverse Events (SAEs).
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Boostrix-US Group
Serious events: 0 serious events
Other events: 53 other events
Deaths: 0 deaths
Boostrix-INV Group
Serious events: 0 serious events
Other events: 58 other events
Deaths: 0 deaths
Boostrix-REF Group
Serious events: 0 serious events
Other events: 58 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Boostrix-US Group
n=55 participants at risk
Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, United States(US)-marketed formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, US-marketed formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
|
Boostrix-INV Group
n=60 participants at risk
Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, investigational formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
|
Boostrix-REF Group
n=62 participants at risk；n=66 participants at risk
Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, reference formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
|
|---|---|---|---|
|
General disorders
Redness
|
41.8%
23/55 • Serious adverse events (SAEs): Entire study period (From Year 8.5 to one month post Year 10) ; Unsolicited adverse events (AEs): During the 31 days (Day 0 - Day 30) post Year 10 booster vaccination; Solicited symptoms: During the 4 days (Day 0 - Day 3) post Year 10 booster vaccination.
Total numbers of subjects at risk for SAEs are those at time points with highest numbers of subjects enrolled. For unsolicited and solicited AEs they correspond to the numbers of subjects with available results. Numbers at risk are the highest ones, at Year 8.5 for Boostrix-US Group, \& Year 10 for the other groups.
|
39.0%
23/59 • Serious adverse events (SAEs): Entire study period (From Year 8.5 to one month post Year 10) ; Unsolicited adverse events (AEs): During the 31 days (Day 0 - Day 30) post Year 10 booster vaccination; Solicited symptoms: During the 4 days (Day 0 - Day 3) post Year 10 booster vaccination.
Total numbers of subjects at risk for SAEs are those at time points with highest numbers of subjects enrolled. For unsolicited and solicited AEs they correspond to the numbers of subjects with available results. Numbers at risk are the highest ones, at Year 8.5 for Boostrix-US Group, \& Year 10 for the other groups.
|
33.9%
21/62 • Serious adverse events (SAEs): Entire study period (From Year 8.5 to one month post Year 10) ; Unsolicited adverse events (AEs): During the 31 days (Day 0 - Day 30) post Year 10 booster vaccination; Solicited symptoms: During the 4 days (Day 0 - Day 3) post Year 10 booster vaccination.
Total numbers of subjects at risk for SAEs are those at time points with highest numbers of subjects enrolled. For unsolicited and solicited AEs they correspond to the numbers of subjects with available results. Numbers at risk are the highest ones, at Year 8.5 for Boostrix-US Group, \& Year 10 for the other groups.
|
|
General disorders
Swelling
|
38.2%
21/55 • Serious adverse events (SAEs): Entire study period (From Year 8.5 to one month post Year 10) ; Unsolicited adverse events (AEs): During the 31 days (Day 0 - Day 30) post Year 10 booster vaccination; Solicited symptoms: During the 4 days (Day 0 - Day 3) post Year 10 booster vaccination.
Total numbers of subjects at risk for SAEs are those at time points with highest numbers of subjects enrolled. For unsolicited and solicited AEs they correspond to the numbers of subjects with available results. Numbers at risk are the highest ones, at Year 8.5 for Boostrix-US Group, \& Year 10 for the other groups.
|
33.9%
20/59 • Serious adverse events (SAEs): Entire study period (From Year 8.5 to one month post Year 10) ; Unsolicited adverse events (AEs): During the 31 days (Day 0 - Day 30) post Year 10 booster vaccination; Solicited symptoms: During the 4 days (Day 0 - Day 3) post Year 10 booster vaccination.
Total numbers of subjects at risk for SAEs are those at time points with highest numbers of subjects enrolled. For unsolicited and solicited AEs they correspond to the numbers of subjects with available results. Numbers at risk are the highest ones, at Year 8.5 for Boostrix-US Group, \& Year 10 for the other groups.
|
30.6%
19/62 • Serious adverse events (SAEs): Entire study period (From Year 8.5 to one month post Year 10) ; Unsolicited adverse events (AEs): During the 31 days (Day 0 - Day 30) post Year 10 booster vaccination; Solicited symptoms: During the 4 days (Day 0 - Day 3) post Year 10 booster vaccination.
Total numbers of subjects at risk for SAEs are those at time points with highest numbers of subjects enrolled. For unsolicited and solicited AEs they correspond to the numbers of subjects with available results. Numbers at risk are the highest ones, at Year 8.5 for Boostrix-US Group, \& Year 10 for the other groups.
|
|
General disorders
Fatigue
|
31.5%
17/54 • Serious adverse events (SAEs): Entire study period (From Year 8.5 to one month post Year 10) ; Unsolicited adverse events (AEs): During the 31 days (Day 0 - Day 30) post Year 10 booster vaccination; Solicited symptoms: During the 4 days (Day 0 - Day 3) post Year 10 booster vaccination.
Total numbers of subjects at risk for SAEs are those at time points with highest numbers of subjects enrolled. For unsolicited and solicited AEs they correspond to the numbers of subjects with available results. Numbers at risk are the highest ones, at Year 8.5 for Boostrix-US Group, \& Year 10 for the other groups.
|
33.9%
20/59 • Serious adverse events (SAEs): Entire study period (From Year 8.5 to one month post Year 10) ; Unsolicited adverse events (AEs): During the 31 days (Day 0 - Day 30) post Year 10 booster vaccination; Solicited symptoms: During the 4 days (Day 0 - Day 3) post Year 10 booster vaccination.
Total numbers of subjects at risk for SAEs are those at time points with highest numbers of subjects enrolled. For unsolicited and solicited AEs they correspond to the numbers of subjects with available results. Numbers at risk are the highest ones, at Year 8.5 for Boostrix-US Group, \& Year 10 for the other groups.
|
35.5%
22/62 • Serious adverse events (SAEs): Entire study period (From Year 8.5 to one month post Year 10) ; Unsolicited adverse events (AEs): During the 31 days (Day 0 - Day 30) post Year 10 booster vaccination; Solicited symptoms: During the 4 days (Day 0 - Day 3) post Year 10 booster vaccination.
Total numbers of subjects at risk for SAEs are those at time points with highest numbers of subjects enrolled. For unsolicited and solicited AEs they correspond to the numbers of subjects with available results. Numbers at risk are the highest ones, at Year 8.5 for Boostrix-US Group, \& Year 10 for the other groups.
|
|
General disorders
Gastrointestinal symptoms
|
18.5%
10/54 • Serious adverse events (SAEs): Entire study period (From Year 8.5 to one month post Year 10) ; Unsolicited adverse events (AEs): During the 31 days (Day 0 - Day 30) post Year 10 booster vaccination; Solicited symptoms: During the 4 days (Day 0 - Day 3) post Year 10 booster vaccination.
Total numbers of subjects at risk for SAEs are those at time points with highest numbers of subjects enrolled. For unsolicited and solicited AEs they correspond to the numbers of subjects with available results. Numbers at risk are the highest ones, at Year 8.5 for Boostrix-US Group, \& Year 10 for the other groups.
|
15.3%
9/59 • Serious adverse events (SAEs): Entire study period (From Year 8.5 to one month post Year 10) ; Unsolicited adverse events (AEs): During the 31 days (Day 0 - Day 30) post Year 10 booster vaccination; Solicited symptoms: During the 4 days (Day 0 - Day 3) post Year 10 booster vaccination.
Total numbers of subjects at risk for SAEs are those at time points with highest numbers of subjects enrolled. For unsolicited and solicited AEs they correspond to the numbers of subjects with available results. Numbers at risk are the highest ones, at Year 8.5 for Boostrix-US Group, \& Year 10 for the other groups.
|
21.0%
13/62 • Serious adverse events (SAEs): Entire study period (From Year 8.5 to one month post Year 10) ; Unsolicited adverse events (AEs): During the 31 days (Day 0 - Day 30) post Year 10 booster vaccination; Solicited symptoms: During the 4 days (Day 0 - Day 3) post Year 10 booster vaccination.
Total numbers of subjects at risk for SAEs are those at time points with highest numbers of subjects enrolled. For unsolicited and solicited AEs they correspond to the numbers of subjects with available results. Numbers at risk are the highest ones, at Year 8.5 for Boostrix-US Group, \& Year 10 for the other groups.
|
|
General disorders
Headache
|
24.1%
13/54 • Serious adverse events (SAEs): Entire study period (From Year 8.5 to one month post Year 10) ; Unsolicited adverse events (AEs): During the 31 days (Day 0 - Day 30) post Year 10 booster vaccination; Solicited symptoms: During the 4 days (Day 0 - Day 3) post Year 10 booster vaccination.
Total numbers of subjects at risk for SAEs are those at time points with highest numbers of subjects enrolled. For unsolicited and solicited AEs they correspond to the numbers of subjects with available results. Numbers at risk are the highest ones, at Year 8.5 for Boostrix-US Group, \& Year 10 for the other groups.
|
32.2%
19/59 • Serious adverse events (SAEs): Entire study period (From Year 8.5 to one month post Year 10) ; Unsolicited adverse events (AEs): During the 31 days (Day 0 - Day 30) post Year 10 booster vaccination; Solicited symptoms: During the 4 days (Day 0 - Day 3) post Year 10 booster vaccination.
Total numbers of subjects at risk for SAEs are those at time points with highest numbers of subjects enrolled. For unsolicited and solicited AEs they correspond to the numbers of subjects with available results. Numbers at risk are the highest ones, at Year 8.5 for Boostrix-US Group, \& Year 10 for the other groups.
|
21.0%
13/62 • Serious adverse events (SAEs): Entire study period (From Year 8.5 to one month post Year 10) ; Unsolicited adverse events (AEs): During the 31 days (Day 0 - Day 30) post Year 10 booster vaccination; Solicited symptoms: During the 4 days (Day 0 - Day 3) post Year 10 booster vaccination.
Total numbers of subjects at risk for SAEs are those at time points with highest numbers of subjects enrolled. For unsolicited and solicited AEs they correspond to the numbers of subjects with available results. Numbers at risk are the highest ones, at Year 8.5 for Boostrix-US Group, \& Year 10 for the other groups.
|
|
Infections and infestations
Nasopharyngitis
|
10.9%
6/55 • Serious adverse events (SAEs): Entire study period (From Year 8.5 to one month post Year 10) ; Unsolicited adverse events (AEs): During the 31 days (Day 0 - Day 30) post Year 10 booster vaccination; Solicited symptoms: During the 4 days (Day 0 - Day 3) post Year 10 booster vaccination.
Total numbers of subjects at risk for SAEs are those at time points with highest numbers of subjects enrolled. For unsolicited and solicited AEs they correspond to the numbers of subjects with available results. Numbers at risk are the highest ones, at Year 8.5 for Boostrix-US Group, \& Year 10 for the other groups.
|
1.7%
1/60 • Serious adverse events (SAEs): Entire study period (From Year 8.5 to one month post Year 10) ; Unsolicited adverse events (AEs): During the 31 days (Day 0 - Day 30) post Year 10 booster vaccination; Solicited symptoms: During the 4 days (Day 0 - Day 3) post Year 10 booster vaccination.
Total numbers of subjects at risk for SAEs are those at time points with highest numbers of subjects enrolled. For unsolicited and solicited AEs they correspond to the numbers of subjects with available results. Numbers at risk are the highest ones, at Year 8.5 for Boostrix-US Group, \& Year 10 for the other groups.
|
6.5%
4/62 • Serious adverse events (SAEs): Entire study period (From Year 8.5 to one month post Year 10) ; Unsolicited adverse events (AEs): During the 31 days (Day 0 - Day 30) post Year 10 booster vaccination; Solicited symptoms: During the 4 days (Day 0 - Day 3) post Year 10 booster vaccination.
Total numbers of subjects at risk for SAEs are those at time points with highest numbers of subjects enrolled. For unsolicited and solicited AEs they correspond to the numbers of subjects with available results. Numbers at risk are the highest ones, at Year 8.5 for Boostrix-US Group, \& Year 10 for the other groups.
|
|
Nervous system disorders
Headache
|
9.1%
5/55 • Serious adverse events (SAEs): Entire study period (From Year 8.5 to one month post Year 10) ; Unsolicited adverse events (AEs): During the 31 days (Day 0 - Day 30) post Year 10 booster vaccination; Solicited symptoms: During the 4 days (Day 0 - Day 3) post Year 10 booster vaccination.
Total numbers of subjects at risk for SAEs are those at time points with highest numbers of subjects enrolled. For unsolicited and solicited AEs they correspond to the numbers of subjects with available results. Numbers at risk are the highest ones, at Year 8.5 for Boostrix-US Group, \& Year 10 for the other groups.
|
1.7%
1/60 • Serious adverse events (SAEs): Entire study period (From Year 8.5 to one month post Year 10) ; Unsolicited adverse events (AEs): During the 31 days (Day 0 - Day 30) post Year 10 booster vaccination; Solicited symptoms: During the 4 days (Day 0 - Day 3) post Year 10 booster vaccination.
Total numbers of subjects at risk for SAEs are those at time points with highest numbers of subjects enrolled. For unsolicited and solicited AEs they correspond to the numbers of subjects with available results. Numbers at risk are the highest ones, at Year 8.5 for Boostrix-US Group, \& Year 10 for the other groups.
|
4.8%
3/62 • Serious adverse events (SAEs): Entire study period (From Year 8.5 to one month post Year 10) ; Unsolicited adverse events (AEs): During the 31 days (Day 0 - Day 30) post Year 10 booster vaccination; Solicited symptoms: During the 4 days (Day 0 - Day 3) post Year 10 booster vaccination.
Total numbers of subjects at risk for SAEs are those at time points with highest numbers of subjects enrolled. For unsolicited and solicited AEs they correspond to the numbers of subjects with available results. Numbers at risk are the highest ones, at Year 8.5 for Boostrix-US Group, \& Year 10 for the other groups.
|
|
General disorders
Pain
|
90.9%
50/55 • Serious adverse events (SAEs): Entire study period (From Year 8.5 to one month post Year 10) ; Unsolicited adverse events (AEs): During the 31 days (Day 0 - Day 30) post Year 10 booster vaccination; Solicited symptoms: During the 4 days (Day 0 - Day 3) post Year 10 booster vaccination.
Total numbers of subjects at risk for SAEs are those at time points with highest numbers of subjects enrolled. For unsolicited and solicited AEs they correspond to the numbers of subjects with available results. Numbers at risk are the highest ones, at Year 8.5 for Boostrix-US Group, \& Year 10 for the other groups.
|
93.2%
55/59 • Serious adverse events (SAEs): Entire study period (From Year 8.5 to one month post Year 10) ; Unsolicited adverse events (AEs): During the 31 days (Day 0 - Day 30) post Year 10 booster vaccination; Solicited symptoms: During the 4 days (Day 0 - Day 3) post Year 10 booster vaccination.
Total numbers of subjects at risk for SAEs are those at time points with highest numbers of subjects enrolled. For unsolicited and solicited AEs they correspond to the numbers of subjects with available results. Numbers at risk are the highest ones, at Year 8.5 for Boostrix-US Group, \& Year 10 for the other groups.
|
87.1%
54/62 • Serious adverse events (SAEs): Entire study period (From Year 8.5 to one month post Year 10) ; Unsolicited adverse events (AEs): During the 31 days (Day 0 - Day 30) post Year 10 booster vaccination; Solicited symptoms: During the 4 days (Day 0 - Day 3) post Year 10 booster vaccination.
Total numbers of subjects at risk for SAEs are those at time points with highest numbers of subjects enrolled. For unsolicited and solicited AEs they correspond to the numbers of subjects with available results. Numbers at risk are the highest ones, at Year 8.5 for Boostrix-US Group, \& Year 10 for the other groups.
|
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