Trial Outcomes & Findings for Immunogenicity and Safety of Booster Dose of BoostrixTM Polio Vaccine in Previously Boosted Adults (NCT NCT01323959)
NCT ID: NCT01323959
Last Updated: 2018-06-06
Results Overview
A seroprotected subject is defined as a vaccinated subject with anti-D and anti-T antibody concentration greater than or equal to (≥) 0.1 international units per millilitre (IU/mL).
COMPLETED
PHASE4
212 participants
At Month 1
2018-06-06
Participant Flow
Out of the 212 subjects enrolled, 1 subject number was allocated without the study vaccine being administered to that subject, therefore the total number of subjects was 211.
Participant milestones
| Measure |
Boostrix Polio Group
Healthy subjects who had received one booster dose Boostrix™ Polio vaccine in the NCT01277705 study received one additional booster dose of Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
|
Boostrix+Poliorix Group
Healthy subjects who had received one booster dose of the co-administered Boostrix™ and Poliorix™ vaccines in the NCT01277705 study received one booster dose Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
|
Revaxis Group
Healthy subjects who had received one booster dose of Revaxis® vaccine in the NCT01277705 study received one booster dose of Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
|
|---|---|---|---|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
|
Overall Study
STARTED
|
67
|
72
|
72
|
|
Overall Study
COMPLETED
|
67
|
72
|
72
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Immunogenicity and Safety of Booster Dose of BoostrixTM Polio Vaccine in Previously Boosted Adults
Baseline characteristics by cohort
| Measure |
Boostrix Polio Group
n=67 Participants
Healthy subjects who had received one booster dose Boostrix™ Polio vaccine in the NCT01277705 study received one additional booster dose of Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
|
Boostrix+Poliorix Group
n=72 Participants
Healthy subjects who had received one booster dose of the co-administered Boostrix™ and Poliorix™ vaccines in the NCT01277705 study received one booster dose Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
|
Revaxis Group
n=72 Participants
Healthy subjects who had received one booster dose of Revaxis® vaccine in the NCT01277705 study received one booster dose of Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
|
Total
n=211 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
50.4 Years
STANDARD_DEVIATION 12.82 • n=5 Participants
|
49.2 Years
STANDARD_DEVIATION 12.53 • n=7 Participants
|
51.4 Years
STANDARD_DEVIATION 13.06 • n=5 Participants
|
50.33 Years
STANDARD_DEVIATION 12.78 • n=4 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
121 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
90 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: At Month 1Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included subjects who met all eligibility criteria, complied with the procedures defined in the protocol, who received the booster dose of Boostrix™ Polio vaccine and for whom data concerning immunogenicity outcome measures were available.
A seroprotected subject is defined as a vaccinated subject with anti-D and anti-T antibody concentration greater than or equal to (≥) 0.1 international units per millilitre (IU/mL).
Outcome measures
| Measure |
Boostrix Polio Group
n=63 Participants
Healthy subjects who had received one booster dose Boostrix™ Polio vaccine in the NCT01277705 study received one additional booster dose of Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
|
Boostrix+Poliorix Group
n=69 Participants
Healthy subjects who had received one booster dose of the co-administered Boostrix™ and Poliorix™ vaccines in the NCT01277705 study received one booster dose Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
|
Revaxis Group
n=69 Participants
Healthy subjects who had received one booster dose of Revaxis® vaccine in the NCT01277705 study received one booster dose of Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
|
|---|---|---|---|
|
Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Antigens
Anti-D
|
61 Subjects
|
66 Subjects
|
68 Subjects
|
|
Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Antigens
Anti-T
|
63 Subjects
|
69 Subjects
|
69 Subjects
|
PRIMARY outcome
Timeframe: At Month 1Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included subjects who met all eligibility criteria, complied with the procedures defined in the protocol, who received the booster dose of Boostrix™ Polio vaccine and for whom data concerning immunogenicity outcome measures were available.
A seroprotected subject is defined as a vaccinated subject with anti-poliovirus types 1, 2 and 3 antibody concentration greater than or equal to (≥) 8 Effective Dose 50 (ED50)
Outcome measures
| Measure |
Boostrix Polio Group
n=58 Participants
Healthy subjects who had received one booster dose Boostrix™ Polio vaccine in the NCT01277705 study received one additional booster dose of Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
|
Boostrix+Poliorix Group
n=62 Participants
Healthy subjects who had received one booster dose of the co-administered Boostrix™ and Poliorix™ vaccines in the NCT01277705 study received one booster dose Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
|
Revaxis Group
n=60 Participants
Healthy subjects who had received one booster dose of Revaxis® vaccine in the NCT01277705 study received one booster dose of Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
|
|---|---|---|---|
|
Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3
Anti-polio 1
|
58 Subjects
|
62 Subjects
|
58 Subjects
|
|
Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3
Anti-polio 2
|
46 Subjects
|
58 Subjects
|
56 Subjects
|
|
Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3
Anti-polio 3
|
58 Subjects
|
60 Subjects
|
60 Subjects
|
PRIMARY outcome
Timeframe: At Day 0Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included subjects who met all eligibility criteria, complied with the procedures defined in the protocol, who received the booster dose of Boostrix™ Polio vaccine and for whom data concerning immunogenicity outcome measures were available.
A seroprotected subject is defined as a vaccinated subject with anti-D and anti-T antibody concentration greater than or equal to (≥) 0.1 international units per millilitre (IU/mL)
Outcome measures
| Measure |
Boostrix Polio Group
n=63 Participants
Healthy subjects who had received one booster dose Boostrix™ Polio vaccine in the NCT01277705 study received one additional booster dose of Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
|
Boostrix+Poliorix Group
n=69 Participants
Healthy subjects who had received one booster dose of the co-administered Boostrix™ and Poliorix™ vaccines in the NCT01277705 study received one booster dose Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
|
Revaxis Group
n=69 Participants
Healthy subjects who had received one booster dose of Revaxis® vaccine in the NCT01277705 study received one booster dose of Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
|
|---|---|---|---|
|
Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Antigens
Anti-D
|
51 Subjects
|
50 Subjects
|
55 Subjects
|
|
Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Antigens
Anti-T
|
62 Subjects
|
68 Subjects
|
65 Subjects
|
PRIMARY outcome
Timeframe: At Day 0Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included subjects who met all eligibility criteria, complied with the procedures defined in the protocol, who received the booster dose of Boostrix™ Polio vaccine and for whom data concerning immunogenicity outcome measures were available.
A seroprotected subject is defined as a vaccinated subject with anti-poliovirus types 1, 2 and 3 antibody concentration greater than or equal to (≥) 8 Effective Dose 50 (ED50)
Outcome measures
| Measure |
Boostrix Polio Group
n=58 Participants
Healthy subjects who had received one booster dose Boostrix™ Polio vaccine in the NCT01277705 study received one additional booster dose of Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
|
Boostrix+Poliorix Group
n=66 Participants
Healthy subjects who had received one booster dose of the co-administered Boostrix™ and Poliorix™ vaccines in the NCT01277705 study received one booster dose Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
|
Revaxis Group
n=67 Participants
Healthy subjects who had received one booster dose of Revaxis® vaccine in the NCT01277705 study received one booster dose of Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
|
|---|---|---|---|
|
Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3
Anti-polio 1
|
52 Subjects
|
58 Subjects
|
59 Subjects
|
|
Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3
Anti-polio 2
|
56 Subjects
|
60 Subjects
|
62 Subjects
|
|
Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3
Anti-polio 3
|
57 Subjects
|
65 Subjects
|
67 Subjects
|
PRIMARY outcome
Timeframe: At Day 0Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included subjects who met all eligibility criteria, complied with the procedures defined in the protocol, who received the booster dose of Boostrix™ Polio vaccine and for whom data concerning immunogenicity outcome measures were available.
Cut-off values assessed were greater than or equal to ≥ 5 Enzyme Linked Immunosorbent Assay (ELISA) units per millilitre (EL.U/ml)
Outcome measures
| Measure |
Boostrix Polio Group
n=62 Participants
Healthy subjects who had received one booster dose Boostrix™ Polio vaccine in the NCT01277705 study received one additional booster dose of Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
|
Boostrix+Poliorix Group
n=69 Participants
Healthy subjects who had received one booster dose of the co-administered Boostrix™ and Poliorix™ vaccines in the NCT01277705 study received one booster dose Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
|
Revaxis Group
n=69 Participants
Healthy subjects who had received one booster dose of Revaxis® vaccine in the NCT01277705 study received one booster dose of Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
|
|---|---|---|---|
|
Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN) Antibodies
Anti-PT
|
48 Subjects
|
58 Subjects
|
49 Subjects
|
|
Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN) Antibodies
Anti-FHA
|
62 Subjects
|
69 Subjects
|
66 Subjects
|
|
Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN) Antibodies
Anti-PRN
|
55 Subjects
|
64 Subjects
|
59 Subjects
|
PRIMARY outcome
Timeframe: At Day 0Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included subjects who met all eligibility criteria, complied with the procedures defined in the protocol, who received the booster dose of Boostrix™ Polio vaccine and for whom data concerning immunogenicity outcome measures were available.
Concentrations are presented as geometric mean concentrations (GMCs), expressed in international units per millilitre (IU/mL)
Outcome measures
| Measure |
Boostrix Polio Group
n=63 Participants
Healthy subjects who had received one booster dose Boostrix™ Polio vaccine in the NCT01277705 study received one additional booster dose of Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
|
Boostrix+Poliorix Group
n=69 Participants
Healthy subjects who had received one booster dose of the co-administered Boostrix™ and Poliorix™ vaccines in the NCT01277705 study received one booster dose Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
|
Revaxis Group
n=69 Participants
Healthy subjects who had received one booster dose of Revaxis® vaccine in the NCT01277705 study received one booster dose of Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
|
|---|---|---|---|
|
Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations
Anti-D
|
0.416 IU/mL
Interval 0.293 to 0.592
|
0.360 IU/mL
Interval 0.249 to 0.519
|
0.501 IU/mL
Interval 0.348 to 0.721
|
|
Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations
Anti-T
|
1.371 IU/mL
Interval 1.019 to 1.844
|
1.578 IU/mL
Interval 1.227 to 2.028
|
1.491 IU/mL
Interval 1.096 to 2.028
|
PRIMARY outcome
Timeframe: At Day 0Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included subjects who met all eligibility criteria, complied with the procedures defined in the protocol, who received the booster dose of Boostrix™ Polio vaccine and for whom data concerning immunogenicity outcome measures were available.
Titers are presented as geometric mean titers (GMTs).
Outcome measures
| Measure |
Boostrix Polio Group
n=58 Participants
Healthy subjects who had received one booster dose Boostrix™ Polio vaccine in the NCT01277705 study received one additional booster dose of Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
|
Boostrix+Poliorix Group
n=66 Participants
Healthy subjects who had received one booster dose of the co-administered Boostrix™ and Poliorix™ vaccines in the NCT01277705 study received one booster dose Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
|
Revaxis Group
n=67 Participants
Healthy subjects who had received one booster dose of Revaxis® vaccine in the NCT01277705 study received one booster dose of Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
|
|---|---|---|---|
|
Anti-polio 1, Anti-polio 2 and Anti-polio 3 Antibody Titers
Anti-polio 1
|
341.0 Titers
Interval 233.5 to 497.9
|
567.0 Titers
Interval 392.3 to 819.4
|
332.0 Titers
Interval 239.0 to 461.2
|
|
Anti-polio 1, Anti-polio 2 and Anti-polio 3 Antibody Titers
Anti-polio 2
|
308.3 Titers
Interval 218.9 to 434.3
|
322.6 Titers
Interval 234.3 to 444.2
|
331.5 Titers
Interval 246.3 to 446.0
|
|
Anti-polio 1, Anti-polio 2 and Anti-polio 3 Antibody Titers
Anti-polio 3
|
388.9 Titers
Interval 271.2 to 557.7
|
648.5 Titers
Interval 476.7 to 882.2
|
542.1 Titers
Interval 397.1 to 740.1
|
PRIMARY outcome
Timeframe: At Day 0Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included subjects who met all eligibility criteria, complied with the procedures defined in the protocol, who received the booster dose of Boostrix™ Polio vaccine and for whom data concerning immunogenicity outcome measures were available.
Concentrations are presented as geometric mean concentrations (GMCs), expressed in expressed in ELISA units per millilitre (EL.U/mL)
Outcome measures
| Measure |
Boostrix Polio Group
n=62 Participants
Healthy subjects who had received one booster dose Boostrix™ Polio vaccine in the NCT01277705 study received one additional booster dose of Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
|
Boostrix+Poliorix Group
n=69 Participants
Healthy subjects who had received one booster dose of the co-administered Boostrix™ and Poliorix™ vaccines in the NCT01277705 study received one booster dose Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
|
Revaxis Group
n=69 Participants
Healthy subjects who had received one booster dose of Revaxis® vaccine in the NCT01277705 study received one booster dose of Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
|
|---|---|---|---|
|
Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN) Antibodies Antibody Concentrations
Anti-FHA
|
93.7 EL.U/mL
Interval 72.9 to 120.6
|
124.0 EL.U/mL
Interval 102.5 to 150.1
|
68.6 EL.U/mL
Interval 49.2 to 95.9
|
|
Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN) Antibodies Antibody Concentrations
Anti-PRN
|
66.1 EL.U/mL
Interval 41.9 to 104.1
|
93.9 EL.U/mL
Interval 62.7 to 140.7
|
19.4 EL.U/mL
Interval 14.2 to 26.5
|
|
Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN) Antibodies Antibody Concentrations
Anti-PT
|
10.3 EL.U/mL
Interval 8.2 to 13.0
|
13.4 EL.U/mL
Interval 10.4 to 17.2
|
14.7 EL.U/mL
Interval 10.1 to 21.5
|
SECONDARY outcome
Timeframe: At Month 1Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included subjects who met all eligibility criteria, complied with the procedures defined in the protocol, who received the booster dose of Boostrix™ Polio vaccine and for whom data concerning immunogenicity outcome measures were available.
Booster response was defined as: for initially seronegative subjects: antibody concentration ≥ 20 EL.U/mL at post booster vaccination; for initially seropositive subjects with pre-vaccination antibody concentration \< 20 EL.U/mL: antibody concentration at post booster ≥ 4 fold the pre-vaccination antibody concentration; and for initially seropositive subjects with pre-vaccination antibody concentration ≥ 20 EL.U/mL: antibody concentration at post booster ≥ 2 fold the pre-vaccination antibody concentration.
Outcome measures
| Measure |
Boostrix Polio Group
n=62 Participants
Healthy subjects who had received one booster dose Boostrix™ Polio vaccine in the NCT01277705 study received one additional booster dose of Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
|
Boostrix+Poliorix Group
n=69 Participants
Healthy subjects who had received one booster dose of the co-administered Boostrix™ and Poliorix™ vaccines in the NCT01277705 study received one booster dose Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
|
Revaxis Group
n=69 Participants
Healthy subjects who had received one booster dose of Revaxis® vaccine in the NCT01277705 study received one booster dose of Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
|
|---|---|---|---|
|
Number of Subjects With Booster Response to Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA), Pertactin (PRN)
Anti-PT
|
60 Subjects
|
60 Subjects
|
52 Subjects
|
|
Number of Subjects With Booster Response to Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA), Pertactin (PRN)
Anti-FHA
|
53 Subjects
|
62 Subjects
|
57 Subjects
|
|
Number of Subjects With Booster Response to Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA), Pertactin (PRN)
Anti-PRN
|
46 Subjects
|
43 Subjects
|
63 Subjects
|
SECONDARY outcome
Timeframe: At Month 1Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included subjects who met all eligibility criteria, complied with the procedures defined in the protocol, who received the booster dose of Boostrix™ Polio vaccine and for whom data concerning immunogenicity outcome measures were available.
Cut-off values assessed were greater than or equal to ≥ 5 Enzyme Linked Immunosorbent Assay (ELISA) units per millilitre (EL.U/ml)
Outcome measures
| Measure |
Boostrix Polio Group
n=63 Participants
Healthy subjects who had received one booster dose Boostrix™ Polio vaccine in the NCT01277705 study received one additional booster dose of Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
|
Boostrix+Poliorix Group
n=69 Participants
Healthy subjects who had received one booster dose of the co-administered Boostrix™ and Poliorix™ vaccines in the NCT01277705 study received one booster dose Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
|
Revaxis Group
n=69 Participants
Healthy subjects who had received one booster dose of Revaxis® vaccine in the NCT01277705 study received one booster dose of Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
|
|---|---|---|---|
|
Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN) Antibodies Above the Cut-off
Anti-PT
|
63 Subjects
|
69 Subjects
|
67 Subjects
|
|
Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN) Antibodies Above the Cut-off
Anti-FHA
|
63 Subjects
|
69 Subjects
|
69 Subjects
|
|
Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN) Antibodies Above the Cut-off
Anti-PRN
|
63 Subjects
|
69 Subjects
|
69 Subjects
|
SECONDARY outcome
Timeframe: At Month 1Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included subjects who met all eligibility criteria, complied with the procedures defined in the protocol, who received the booster dose of Boostrix™ Polio vaccine and for whom data concerning immunogenicity outcome measures were available.
Concentrations are presented as geometric mean concentrations (GMCs), expressed in international units per millilitre (IU/mL)
Outcome measures
| Measure |
Boostrix Polio Group
n=63 Participants
Healthy subjects who had received one booster dose Boostrix™ Polio vaccine in the NCT01277705 study received one additional booster dose of Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
|
Boostrix+Poliorix Group
n=69 Participants
Healthy subjects who had received one booster dose of the co-administered Boostrix™ and Poliorix™ vaccines in the NCT01277705 study received one booster dose Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
|
Revaxis Group
n=69 Participants
Healthy subjects who had received one booster dose of Revaxis® vaccine in the NCT01277705 study received one booster dose of Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
|
|---|---|---|---|
|
Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations
Anti-D
|
2.159 IU/mL
Interval 1.579 to 2.952
|
1.821 IU/mL
Interval 1.312 to 2.528
|
2.649 IU/mL
Interval 1.948 to 3.603
|
|
Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations
Anti-T
|
8.568 IU/mL
Interval 7.361 to 9.972
|
9.692 IU/mL
Interval 8.217 to 11.431
|
9.390 IU/mL
Interval 7.946 to 11.096
|
SECONDARY outcome
Timeframe: At Month 1Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included subjects who met all eligibility criteria, complied with the procedures defined in the protocol, who received the booster dose of Boostrix™ Polio vaccine and for whom data concerning immunogenicity outcome measures were available.
Titers are presented as geometric mean titers (GMTs).
Outcome measures
| Measure |
Boostrix Polio Group
n=58 Participants
Healthy subjects who had received one booster dose Boostrix™ Polio vaccine in the NCT01277705 study received one additional booster dose of Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
|
Boostrix+Poliorix Group
n=62 Participants
Healthy subjects who had received one booster dose of the co-administered Boostrix™ and Poliorix™ vaccines in the NCT01277705 study received one booster dose Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
|
Revaxis Group
n=60 Participants
Healthy subjects who had received one booster dose of Revaxis® vaccine in the NCT01277705 study received one booster dose of Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
|
|---|---|---|---|
|
Anti-polio 1, Anti-polio 2 and Anti-polio 3 Antibody Titers
Anti-polio 1
|
1519.0 Titers
Interval 1156.9 to 1994.4
|
1665.4 Titers
Interval 1263.5 to 2195.2
|
1526.7 Titers
Interval 1106.8 to 2105.9
|
|
Anti-polio 1, Anti-polio 2 and Anti-polio 3 Antibody Titers
Anti-polio 2
|
1071.3 Titers
Interval 806.2 to 1423.5
|
1269.8 Titers
Interval 954.5 to 1689.4
|
1550.1 Titers
Interval 1202.8 to 1997.7
|
|
Anti-polio 1, Anti-polio 2 and Anti-polio 3 Antibody Titers
Anti-polio 3
|
2035.7 Titers
Interval 1653.4 to 2506.4
|
2047.9 Titers
Interval 1604.6 to 2613.7
|
2024.6 Titers
Interval 1513.3 to 2708.6
|
SECONDARY outcome
Timeframe: At Month 1Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included subjects who met all eligibility criteria, complied with the procedures defined in the protocol, who received the booster dose of Boostrix™ Polio vaccine and for whom data concerning immunogenicity outcome measures were available.
Concentrations are presented as geometric mean concentrations (GMCs), expressed in expressed in ELISA units per millilitre (EL.U/mL)
Outcome measures
| Measure |
Boostrix Polio Group
n=63 Participants
Healthy subjects who had received one booster dose Boostrix™ Polio vaccine in the NCT01277705 study received one additional booster dose of Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
|
Boostrix+Poliorix Group
n=69 Participants
Healthy subjects who had received one booster dose of the co-administered Boostrix™ and Poliorix™ vaccines in the NCT01277705 study received one booster dose Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
|
Revaxis Group
n=69 Participants
Healthy subjects who had received one booster dose of Revaxis® vaccine in the NCT01277705 study received one booster dose of Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
|
|---|---|---|---|
|
Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN) Antibodies Antibody Concentrations
Anti-FHA
|
485.8 EL.U/mL
Interval 413.8 to 570.4
|
553.5 EL.U/mL
Interval 465.9 to 657.6
|
854.9 EL.U/mL
Interval 714.9 to 1022.3
|
|
Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN) Antibodies Antibody Concentrations
Anti-PT
|
97.5 EL.U/mL
Interval 81.4 to 116.9
|
100.1 EL.U/mL
Interval 80.3 to 124.8
|
92.9 EL.U/mL
Interval 68.7 to 125.6
|
|
Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN) Antibodies Antibody Concentrations
Anti-PRN
|
365.9 EL.U/mL
Interval 281.5 to 475.6
|
404.2 EL.U/mL
Interval 324.2 to 504.0
|
581.0 EL.U/mL
Interval 401.6 to 840.7
|
SECONDARY outcome
Timeframe: During the 4-day (Day 0-Day 3) follow-up period after vaccinationPopulation: The analysis was performed on the Total Vaccinated cohort, which included all subjects with documented administration of the study booster vaccine, for whom data was available.
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site.
Outcome measures
| Measure |
Boostrix Polio Group
n=67 Participants
Healthy subjects who had received one booster dose Boostrix™ Polio vaccine in the NCT01277705 study received one additional booster dose of Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
|
Boostrix+Poliorix Group
n=72 Participants
Healthy subjects who had received one booster dose of the co-administered Boostrix™ and Poliorix™ vaccines in the NCT01277705 study received one booster dose Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
|
Revaxis Group
n=72 Participants
Healthy subjects who had received one booster dose of Revaxis® vaccine in the NCT01277705 study received one booster dose of Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
|
|---|---|---|---|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Pain, Any
|
42 Subjects
|
49 Subjects
|
46 Subjects
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Pain, Grade 3
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Rednes, Any
|
22 Subjects
|
26 Subjects
|
32 Subjects
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Redness, >50 mm
|
1 Subjects
|
4 Subjects
|
3 Subjects
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Swelling, Any
|
18 Subjects
|
21 Subjects
|
19 Subjects
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Swelling, >50 mm
|
0 Subjects
|
3 Subjects
|
1 Subjects
|
SECONDARY outcome
Timeframe: During the 4-day (Day 0-Day 3) follow-up period after vaccinationPopulation: The analysis was performed on the Total Vaccinated cohort, which included all subjects with documented administration of the study booster vaccine, for whom data was available and the symptom sheet filled in.
Assessed solicited general symptoms were fatigue, fever \[defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)\], headache and gastrointestinal symptoms. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever \> 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
Outcome measures
| Measure |
Boostrix Polio Group
n=65 Participants
Healthy subjects who had received one booster dose Boostrix™ Polio vaccine in the NCT01277705 study received one additional booster dose of Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
|
Boostrix+Poliorix Group
n=71 Participants
Healthy subjects who had received one booster dose of the co-administered Boostrix™ and Poliorix™ vaccines in the NCT01277705 study received one booster dose Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
|
Revaxis Group
n=71 Participants
Healthy subjects who had received one booster dose of Revaxis® vaccine in the NCT01277705 study received one booster dose of Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
|
|---|---|---|---|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Fever (axillary), ≥ 37.5 °C
|
3 Subjects
|
2 Subjects
|
1 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Fatigue, Any
|
12 Subjects
|
16 Subjects
|
15 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Fatigue, Grade 3
|
1 Subjects
|
1 Subjects
|
0 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Fatigue, Related
|
9 Subjects
|
11 Subjects
|
9 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Gastrointestinal symptoms, Any
|
7 Subjects
|
9 Subjects
|
4 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Gastrointestinal symptoms, Grade 3
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Gastrointestinal symptoms, Related
|
3 Subjects
|
4 Subjects
|
3 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Headache, Any
|
7 Subjects
|
11 Subjects
|
11 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Headache, Grade 3
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Headache, Related
|
6 Subjects
|
6 Subjects
|
9 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Fever (axillary), > 39 °C
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Fever (axillary), Related
|
1 Subjects
|
2 Subjects
|
1 Subjects
|
SECONDARY outcome
Timeframe: During the 31-day (Day 0-Day 30) follow-up period after vaccinationPopulation: The analysis was performed on the Total Vaccinated cohort, which included all subjects with documented administration of the study booster vaccine, for whom data was available and the symptom sheet filled in.
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Outcome measures
| Measure |
Boostrix Polio Group
n=67 Participants
Healthy subjects who had received one booster dose Boostrix™ Polio vaccine in the NCT01277705 study received one additional booster dose of Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
|
Boostrix+Poliorix Group
n=72 Participants
Healthy subjects who had received one booster dose of the co-administered Boostrix™ and Poliorix™ vaccines in the NCT01277705 study received one booster dose Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
|
Revaxis Group
n=72 Participants
Healthy subjects who had received one booster dose of Revaxis® vaccine in the NCT01277705 study received one booster dose of Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
|
|---|---|---|---|
|
Number of Subjects With Any Unsolicited Adverse Events (AEs).
|
6 Subjects
|
5 Subjects
|
6 Subjects
|
SECONDARY outcome
Timeframe: Month 0 - Month 1Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with documented administration of the study booster vaccine, for whom data was available.
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Outcome measures
| Measure |
Boostrix Polio Group
n=67 Participants
Healthy subjects who had received one booster dose Boostrix™ Polio vaccine in the NCT01277705 study received one additional booster dose of Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
|
Boostrix+Poliorix Group
n=72 Participants
Healthy subjects who had received one booster dose of the co-administered Boostrix™ and Poliorix™ vaccines in the NCT01277705 study received one booster dose Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
|
Revaxis Group
n=72 Participants
Healthy subjects who had received one booster dose of Revaxis® vaccine in the NCT01277705 study received one booster dose of Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
|
|---|---|---|---|
|
Number of Subjects With Serious Adverse Events (SAEs).
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
Adverse Events
Boostrix Polio Group
Boostrix+Poliorix Group
Revaxis Group
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Boostrix Polio Group
n=67 participants at risk
Healthy subjects who had received one booster dose Boostrix™ Polio vaccine in the NCT01277705 study received one additional booster dose of Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
|
Boostrix+Poliorix Group
n=72 participants at risk
Healthy subjects who had received one booster dose of the co-administered Boostrix™ and Poliorix™ vaccines in the NCT01277705 study received one booster dose Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
|
Revaxis Group
n=72 participants at risk
Healthy subjects who had received one booster dose of Revaxis® vaccine in the NCT01277705 study received one booster dose of Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
|
|---|---|---|---|
|
General disorders
Pain
|
62.7%
42/67 • Solicited local/general symptoms during the 4-day post-vaccination period (Days 0-3), Unsolicited AEs during the 31-day post-vaccination (Days 0-30), SAEs during the entire study period (Month 0 - 1).
|
68.1%
49/72 • Solicited local/general symptoms during the 4-day post-vaccination period (Days 0-3), Unsolicited AEs during the 31-day post-vaccination (Days 0-30), SAEs during the entire study period (Month 0 - 1).
|
63.9%
46/72 • Solicited local/general symptoms during the 4-day post-vaccination period (Days 0-3), Unsolicited AEs during the 31-day post-vaccination (Days 0-30), SAEs during the entire study period (Month 0 - 1).
|
|
General disorders
Redness
|
32.8%
22/67 • Solicited local/general symptoms during the 4-day post-vaccination period (Days 0-3), Unsolicited AEs during the 31-day post-vaccination (Days 0-30), SAEs during the entire study period (Month 0 - 1).
|
36.1%
26/72 • Solicited local/general symptoms during the 4-day post-vaccination period (Days 0-3), Unsolicited AEs during the 31-day post-vaccination (Days 0-30), SAEs during the entire study period (Month 0 - 1).
|
44.4%
32/72 • Solicited local/general symptoms during the 4-day post-vaccination period (Days 0-3), Unsolicited AEs during the 31-day post-vaccination (Days 0-30), SAEs during the entire study period (Month 0 - 1).
|
|
General disorders
Swelling
|
26.9%
18/67 • Solicited local/general symptoms during the 4-day post-vaccination period (Days 0-3), Unsolicited AEs during the 31-day post-vaccination (Days 0-30), SAEs during the entire study period (Month 0 - 1).
|
29.2%
21/72 • Solicited local/general symptoms during the 4-day post-vaccination period (Days 0-3), Unsolicited AEs during the 31-day post-vaccination (Days 0-30), SAEs during the entire study period (Month 0 - 1).
|
26.4%
19/72 • Solicited local/general symptoms during the 4-day post-vaccination period (Days 0-3), Unsolicited AEs during the 31-day post-vaccination (Days 0-30), SAEs during the entire study period (Month 0 - 1).
|
|
General disorders
Fatigue
|
18.5%
12/65 • Solicited local/general symptoms during the 4-day post-vaccination period (Days 0-3), Unsolicited AEs during the 31-day post-vaccination (Days 0-30), SAEs during the entire study period (Month 0 - 1).
|
22.5%
16/71 • Solicited local/general symptoms during the 4-day post-vaccination period (Days 0-3), Unsolicited AEs during the 31-day post-vaccination (Days 0-30), SAEs during the entire study period (Month 0 - 1).
|
21.1%
15/71 • Solicited local/general symptoms during the 4-day post-vaccination period (Days 0-3), Unsolicited AEs during the 31-day post-vaccination (Days 0-30), SAEs during the entire study period (Month 0 - 1).
|
|
General disorders
Gastrointestinal symptom
|
10.8%
7/65 • Solicited local/general symptoms during the 4-day post-vaccination period (Days 0-3), Unsolicited AEs during the 31-day post-vaccination (Days 0-30), SAEs during the entire study period (Month 0 - 1).
|
12.7%
9/71 • Solicited local/general symptoms during the 4-day post-vaccination period (Days 0-3), Unsolicited AEs during the 31-day post-vaccination (Days 0-30), SAEs during the entire study period (Month 0 - 1).
|
5.6%
4/71 • Solicited local/general symptoms during the 4-day post-vaccination period (Days 0-3), Unsolicited AEs during the 31-day post-vaccination (Days 0-30), SAEs during the entire study period (Month 0 - 1).
|
|
General disorders
Headache
|
10.8%
7/65 • Solicited local/general symptoms during the 4-day post-vaccination period (Days 0-3), Unsolicited AEs during the 31-day post-vaccination (Days 0-30), SAEs during the entire study period (Month 0 - 1).
|
15.5%
11/71 • Solicited local/general symptoms during the 4-day post-vaccination period (Days 0-3), Unsolicited AEs during the 31-day post-vaccination (Days 0-30), SAEs during the entire study period (Month 0 - 1).
|
15.5%
11/71 • Solicited local/general symptoms during the 4-day post-vaccination period (Days 0-3), Unsolicited AEs during the 31-day post-vaccination (Days 0-30), SAEs during the entire study period (Month 0 - 1).
|
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