Trial Outcomes & Findings for A Long Term Follow-up Study up to 4 Years After Study Vaccination to Assess Immunogenicity and Safety of the Investigational Vaccine in Adults (NCT NCT03201211)
NCT ID: NCT03201211
Last Updated: 2021-04-08
Results Overview
Adjusted geometric mean concentration (GMC) and their 95% confidence interval (CI) was calculated. GMCs were estimated using an ANCOVA model including treatment group as fixed effect and Month 0 antibody concentration from NTHi Mcat-001 as covariate. The cut-off value of the enzyme-linked immunosorbent assay (ELISA) anti-PD assay was 153 ELISA unit per millilitre (EU/mL).
COMPLETED
PHASE1
81 participants
At Month 20
2021-04-08
Participant Flow
Participant milestones
| Measure |
10-10-10-AS
Subjects who received two doses of the AS01E adjuvanted GSK Biologicals' NTHi-Mcat investigational vaccine, containing 10µg of PD, PE-PilA and UspA2, and administered at Month 0 and Month 2 in NTHi-Mcat-001 study (NCT02547974), and were enrolled in the study.
|
10-10-3-AS
Subjects who received two doses of the AS01E-adjuvanted GSK Biologicals' NTHi-Mcat investigational vaccine, containing 10µg of PD, 10µg of PE-PilA, and 3.3µg of UspA2, and administered at Month 0 and Month 2 in NTHi-Mcat-001 study (NCT02547974), and were enrolled in the study.
|
PLACEBO
Subjects who received two doses of placebo (saline solution), administered at Month 0 and Month 2 in NTHi-Mcat-001 study (NCT02547974) and were enrolled in the study.
|
|---|---|---|---|
|
Overall Study
STARTED
|
27
|
26
|
28
|
|
Overall Study
COMPLETED
|
25
|
25
|
27
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
1
|
Reasons for withdrawal
| Measure |
10-10-10-AS
Subjects who received two doses of the AS01E adjuvanted GSK Biologicals' NTHi-Mcat investigational vaccine, containing 10µg of PD, PE-PilA and UspA2, and administered at Month 0 and Month 2 in NTHi-Mcat-001 study (NCT02547974), and were enrolled in the study.
|
10-10-3-AS
Subjects who received two doses of the AS01E-adjuvanted GSK Biologicals' NTHi-Mcat investigational vaccine, containing 10µg of PD, 10µg of PE-PilA, and 3.3µg of UspA2, and administered at Month 0 and Month 2 in NTHi-Mcat-001 study (NCT02547974), and were enrolled in the study.
|
PLACEBO
Subjects who received two doses of placebo (saline solution), administered at Month 0 and Month 2 in NTHi-Mcat-001 study (NCT02547974) and were enrolled in the study.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
0
|
|
Overall Study
Protocol Violation
|
1
|
0
|
0
|
|
Overall Study
CONSENT WITHDRAWAL NOT DUE TO ADV. EVENT
|
0
|
0
|
1
|
|
Overall Study
OTHER unknown reasons
|
0
|
1
|
0
|
Baseline Characteristics
A Long Term Follow-up Study up to 4 Years After Study Vaccination to Assess Immunogenicity and Safety of the Investigational Vaccine in Adults
Baseline characteristics by cohort
| Measure |
10-10-10-AS
n=27 Participants
Subjects who received two doses of the AS01E adjuvanted GSK Biologicals' NTHi-Mcat investigational vaccine, containing 10µg of PD, PE-PilA and UspA2, and administered at Month 0 and Month 2 in NTHi-Mcat-001 study (NCT02547974), and were enrolled in the study.
|
10-10-3-AS
n=26 Participants
Subjects who received two doses of the AS01E-adjuvanted GSK Biologicals' NTHi-Mcat investigational vaccine, containing 10µg of PD, 10µg of PE-PilA, and 3.3µg of UspA2, and administered at Month 0 and Month 2 in NTHi-Mcat-001 study (NCT02547974), and were enrolled in the study.
|
PLACEBO
n=28 Participants
Subjects who received two doses of placebo (saline solution), administered at Month 0 and Month 2 in NTHi-Mcat-001 study (NCT02547974) and were enrolled in the study.
|
Total
n=81 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
59.7 Years
STANDARD_DEVIATION 6.3 • n=5 Participants
|
59.0 Years
STANDARD_DEVIATION 5.9 • n=7 Participants
|
58.2 Years
STANDARD_DEVIATION 6.5 • n=5 Participants
|
58.9 Years
STANDARD_DEVIATION 6.2 • n=4 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
48 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
WHITE - CAUCASIAN / EUROPEAN HERITAGE
|
27 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
81 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: At Month 20Population: Analysis was performed on the Per Protocol Set (PPS) which included all subjects enrolled in this study, who provided informed consent, complied with the eligibility criteria, study procedures and with immunogenicity data for specified antibody at specified timepoint.
Adjusted geometric mean concentration (GMC) and their 95% confidence interval (CI) was calculated. GMCs were estimated using an ANCOVA model including treatment group as fixed effect and Month 0 antibody concentration from NTHi Mcat-001 as covariate. The cut-off value of the enzyme-linked immunosorbent assay (ELISA) anti-PD assay was 153 ELISA unit per millilitre (EU/mL).
Outcome measures
| Measure |
10-10-10-AS
n=26 Participants
Subjects who received two doses of the AS01E adjuvanted GSK Biologicals' NTHi-Mcat investigational vaccine, containing 10µg of PD, PE-PilA and UspA2, and administered at Month 0 and Month 2 in NTHi-Mcat-001 study (NCT02547974), and were enrolled in the study.
|
10-10-3-AS
n=26 Participants
Subjects who received two doses of the AS01E-adjuvanted GSK Biologicals' NTHi-Mcat investigational vaccine, containing 10µg of PD, 10µg of PE-PilA, and 3.3µg of UspA2, and administered at Month 0 and Month 2 in NTHi-Mcat-001 study (NCT02547974), and were enrolled in the study.
|
PLACEBO
n=28 Participants
Subjects who received two doses of placebo (saline solution), administered at Month 0 and Month 2 in NTHi-Mcat-001 study (NCT02547974) and were enrolled in the study.
|
|---|---|---|---|
|
Anti-Protein D (PD) Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine
|
382.7 EU/mL
Interval 279.2 to 524.4
|
511.9 EU/mL
Interval 376.4 to 696.2
|
90.5 EU/mL
Interval 67.1 to 121.9
|
PRIMARY outcome
Timeframe: At Month 26Population: Analysis was performed on the PPS which included all subjects enrolled in this study, who provided informed consent, complied with the eligibility criteria, study procedures and with immunogenicity data for specified antibody at specified timepoint.
Adjusted GMC and their 95% CI was calculated. GMCs were estimated using an ANCOVA model including treatment group as fixed effect and Month 0 antibody concentration from NTHi Mcat-001 as covariate. The cut-off value of the ELISA anti-PD assay was 153 EU/mL.
Outcome measures
| Measure |
10-10-10-AS
n=26 Participants
Subjects who received two doses of the AS01E adjuvanted GSK Biologicals' NTHi-Mcat investigational vaccine, containing 10µg of PD, PE-PilA and UspA2, and administered at Month 0 and Month 2 in NTHi-Mcat-001 study (NCT02547974), and were enrolled in the study.
|
10-10-3-AS
n=26 Participants
Subjects who received two doses of the AS01E-adjuvanted GSK Biologicals' NTHi-Mcat investigational vaccine, containing 10µg of PD, 10µg of PE-PilA, and 3.3µg of UspA2, and administered at Month 0 and Month 2 in NTHi-Mcat-001 study (NCT02547974), and were enrolled in the study.
|
PLACEBO
n=27 Participants
Subjects who received two doses of placebo (saline solution), administered at Month 0 and Month 2 in NTHi-Mcat-001 study (NCT02547974) and were enrolled in the study.
|
|---|---|---|---|
|
Anti-PD Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine
|
373.4 EU/mL
Interval 270.2 to 516.1
|
537.2 EU/mL
Interval 392.8 to 734.7
|
93.2 EU/mL
Interval 68.4 to 127.0
|
PRIMARY outcome
Timeframe: At Month 32Population: Analysis was performed on the PPS which included all subjects enrolled in this study, who provided informed consent, complied with the eligibility criteria, study procedures and with immunogenicity data for specified antibody at specified timepoint.
Adjusted GMC and their 95% CI was calculated. GMCs were estimated using an ANCOVA model including treatment group as fixed effect and Month 0 antibody concentration from NTHi Mcat-001 as covariate. The cut-off value of the ELISA anti-PD assay was 153 EU/mL.
Outcome measures
| Measure |
10-10-10-AS
n=25 Participants
Subjects who received two doses of the AS01E adjuvanted GSK Biologicals' NTHi-Mcat investigational vaccine, containing 10µg of PD, PE-PilA and UspA2, and administered at Month 0 and Month 2 in NTHi-Mcat-001 study (NCT02547974), and were enrolled in the study.
|
10-10-3-AS
n=26 Participants
Subjects who received two doses of the AS01E-adjuvanted GSK Biologicals' NTHi-Mcat investigational vaccine, containing 10µg of PD, 10µg of PE-PilA, and 3.3µg of UspA2, and administered at Month 0 and Month 2 in NTHi-Mcat-001 study (NCT02547974), and were enrolled in the study.
|
PLACEBO
n=27 Participants
Subjects who received two doses of placebo (saline solution), administered at Month 0 and Month 2 in NTHi-Mcat-001 study (NCT02547974) and were enrolled in the study.
|
|---|---|---|---|
|
Anti-PD Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine
|
371.8 EU/mL
Interval 271.4 to 509.5
|
480.8 EU/mL
Interval 356.2 to 649.0
|
94.1 EU/mL
Interval 70.0 to 126.6
|
PRIMARY outcome
Timeframe: At Month 38Population: Analysis was performed on the PPS which included all subjects enrolled in this study, who provided informed consent, complied with the eligibility criteria, study procedures and with immunogenicity data for specified antibody at specified timepoint.
Adjusted GMC and their 95% CI was calculated. GMCs were estimated using an ANCOVA model including treatment group as fixed effect and Month 0 antibody concentration from NTHi Mcat-001 as covariate. The cut-off value of the ELISA anti-PD assay was 153 EU/mL.
Outcome measures
| Measure |
10-10-10-AS
n=24 Participants
Subjects who received two doses of the AS01E adjuvanted GSK Biologicals' NTHi-Mcat investigational vaccine, containing 10µg of PD, PE-PilA and UspA2, and administered at Month 0 and Month 2 in NTHi-Mcat-001 study (NCT02547974), and were enrolled in the study.
|
10-10-3-AS
n=26 Participants
Subjects who received two doses of the AS01E-adjuvanted GSK Biologicals' NTHi-Mcat investigational vaccine, containing 10µg of PD, 10µg of PE-PilA, and 3.3µg of UspA2, and administered at Month 0 and Month 2 in NTHi-Mcat-001 study (NCT02547974), and were enrolled in the study.
|
PLACEBO
n=27 Participants
Subjects who received two doses of placebo (saline solution), administered at Month 0 and Month 2 in NTHi-Mcat-001 study (NCT02547974) and were enrolled in the study.
|
|---|---|---|---|
|
Anti-PD Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine
|
368 EU/mL
Interval 264.4 to 512.0
|
490.4 EU/mL
Interval 358.0 to 671.8
|
99.8 EU/mL
Interval 73.1 to 136.2
|
PRIMARY outcome
Timeframe: At Month 44Population: Analysis was performed on the PPS which included all subjects enrolled in this study, who provided informed consent, complied with the eligibility criteria, study procedures and with immunogenicity data for specified antibody at specified timepoint.
Adjusted GMC and their 95% CI was calculated. GMCs were estimated using an ANCOVA model including treatment group as fixed effect and Month 0 antibody concentration from NTHi Mcat-001 as covariate. The cut-off value of the ELISA anti-PD assay was 153 EU/mL.
Outcome measures
| Measure |
10-10-10-AS
n=25 Participants
Subjects who received two doses of the AS01E adjuvanted GSK Biologicals' NTHi-Mcat investigational vaccine, containing 10µg of PD, PE-PilA and UspA2, and administered at Month 0 and Month 2 in NTHi-Mcat-001 study (NCT02547974), and were enrolled in the study.
|
10-10-3-AS
n=26 Participants
Subjects who received two doses of the AS01E-adjuvanted GSK Biologicals' NTHi-Mcat investigational vaccine, containing 10µg of PD, 10µg of PE-PilA, and 3.3µg of UspA2, and administered at Month 0 and Month 2 in NTHi-Mcat-001 study (NCT02547974), and were enrolled in the study.
|
PLACEBO
n=27 Participants
Subjects who received two doses of placebo (saline solution), administered at Month 0 and Month 2 in NTHi-Mcat-001 study (NCT02547974) and were enrolled in the study.
|
|---|---|---|---|
|
Anti-PD Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine
|
321.4 EU/mL
Interval 235.1 to 439.2
|
466.2 EU/mL
Interval 346.4 to 627.6
|
95.6 EU/mL
Interval 71.2 to 128.3
|
PRIMARY outcome
Timeframe: At Month 50Population: Analysis was performed on the PPS which included all subjects enrolled in this study, who provided informed consent, complied with the eligibility criteria, study procedures and with immunogenicity data for specified antibody at specified timepoint.
Adjusted GMC and their 95% CI was calculated. GMCs were estimated using an ANCOVA model including treatment group as fixed effect and Month 0 antibody concentration from NTHi Mcat-001 as covariate. The cut-off value of the ELISA anti-PD assay was 153 EU/mL.
Outcome measures
| Measure |
10-10-10-AS
n=25 Participants
Subjects who received two doses of the AS01E adjuvanted GSK Biologicals' NTHi-Mcat investigational vaccine, containing 10µg of PD, PE-PilA and UspA2, and administered at Month 0 and Month 2 in NTHi-Mcat-001 study (NCT02547974), and were enrolled in the study.
|
10-10-3-AS
n=23 Participants
Subjects who received two doses of the AS01E-adjuvanted GSK Biologicals' NTHi-Mcat investigational vaccine, containing 10µg of PD, 10µg of PE-PilA, and 3.3µg of UspA2, and administered at Month 0 and Month 2 in NTHi-Mcat-001 study (NCT02547974), and were enrolled in the study.
|
PLACEBO
n=27 Participants
Subjects who received two doses of placebo (saline solution), administered at Month 0 and Month 2 in NTHi-Mcat-001 study (NCT02547974) and were enrolled in the study.
|
|---|---|---|---|
|
Anti-PD Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine
|
315.4 EU/mL
Interval 225.5 to 441.1
|
474.5 EU/mL
Interval 337.9 to 666.3
|
101.5 EU/mL
Interval 74.0 to 139.3
|
PRIMARY outcome
Timeframe: At Month 20Population: Analysis was performed on the PPS which included all subjects enrolled in this study, who provided informed consent, complied with the eligibility criteria, study procedures and with immunogenicity data for specified antibody at specified timepoint.
Adjusted GMC and their 95% CI was calculated. GMCs were estimated using an ANCOVA model including treatment group as fixed effect and Month 0 antibody concentration from NTHi Mcat-001 as covariate. The cut-off value of the ELISA anti-PE assay was 8 EU/mL.
Outcome measures
| Measure |
10-10-10-AS
n=27 Participants
Subjects who received two doses of the AS01E adjuvanted GSK Biologicals' NTHi-Mcat investigational vaccine, containing 10µg of PD, PE-PilA and UspA2, and administered at Month 0 and Month 2 in NTHi-Mcat-001 study (NCT02547974), and were enrolled in the study.
|
10-10-3-AS
n=26 Participants
Subjects who received two doses of the AS01E-adjuvanted GSK Biologicals' NTHi-Mcat investigational vaccine, containing 10µg of PD, 10µg of PE-PilA, and 3.3µg of UspA2, and administered at Month 0 and Month 2 in NTHi-Mcat-001 study (NCT02547974), and were enrolled in the study.
|
PLACEBO
n=28 Participants
Subjects who received two doses of placebo (saline solution), administered at Month 0 and Month 2 in NTHi-Mcat-001 study (NCT02547974) and were enrolled in the study.
|
|---|---|---|---|
|
Anti-Protein E (PE) Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine
|
762.7 EU/mL
Interval 549.4 to 1058.6
|
1215 EU/mL
Interval 869.5 to 1697.9
|
21.5 EU/mL
Interval 15.6 to 29.6
|
PRIMARY outcome
Timeframe: At Month 26Population: Analysis was performed on the PPS which included all subjects enrolled in this study, who provided informed consent, complied with the eligibility criteria, study procedures and with immunogenicity data for specified antibody at specified timepoint.
Adjusted GMC and their 95% CI was calculated. GMCs were estimated using an ANCOVA model including treatment group as fixed effect and Month 0 antibody concentration from NTHi Mcat-001 as covariate. The cut-off value of the ELISA anti-PE assay was 8 EU/mL.
Outcome measures
| Measure |
10-10-10-AS
n=26 Participants
Subjects who received two doses of the AS01E adjuvanted GSK Biologicals' NTHi-Mcat investigational vaccine, containing 10µg of PD, PE-PilA and UspA2, and administered at Month 0 and Month 2 in NTHi-Mcat-001 study (NCT02547974), and were enrolled in the study.
|
10-10-3-AS
n=26 Participants
Subjects who received two doses of the AS01E-adjuvanted GSK Biologicals' NTHi-Mcat investigational vaccine, containing 10µg of PD, 10µg of PE-PilA, and 3.3µg of UspA2, and administered at Month 0 and Month 2 in NTHi-Mcat-001 study (NCT02547974), and were enrolled in the study.
|
PLACEBO
n=27 Participants
Subjects who received two doses of placebo (saline solution), administered at Month 0 and Month 2 in NTHi-Mcat-001 study (NCT02547974) and were enrolled in the study.
|
|---|---|---|---|
|
Anti-PE Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine
|
729.5 EU/mL
Interval 519.2 to 1024.9
|
1258.9 EU/mL
Interval 895.5 to 1769.9
|
23.1 EU/mL
Interval 16.6 to 32.3
|
PRIMARY outcome
Timeframe: At Month 32Population: Analysis was performed on the PPS which included all subjects enrolled in this study, who provided informed consent, complied with the eligibility criteria, study procedures and with immunogenicity data for specified antibody at specified timepoint.
Adjusted GMC and their 95% CI was calculated. GMCs were estimated using an ANCOVA model including treatment group as fixed effect and Month 0 antibody concentration from NTHi Mcat-001 as covariate. The cut-off value of the ELISA anti-PE assay was 8 EU/mL.
Outcome measures
| Measure |
10-10-10-AS
n=25 Participants
Subjects who received two doses of the AS01E adjuvanted GSK Biologicals' NTHi-Mcat investigational vaccine, containing 10µg of PD, PE-PilA and UspA2, and administered at Month 0 and Month 2 in NTHi-Mcat-001 study (NCT02547974), and were enrolled in the study.
|
10-10-3-AS
n=26 Participants
Subjects who received two doses of the AS01E-adjuvanted GSK Biologicals' NTHi-Mcat investigational vaccine, containing 10µg of PD, 10µg of PE-PilA, and 3.3µg of UspA2, and administered at Month 0 and Month 2 in NTHi-Mcat-001 study (NCT02547974), and were enrolled in the study.
|
PLACEBO
n=27 Participants
Subjects who received two doses of placebo (saline solution), administered at Month 0 and Month 2 in NTHi-Mcat-001 study (NCT02547974) and were enrolled in the study.
|
|---|---|---|---|
|
Anti-PE Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine
|
603.9 EU/mL
Interval 424.1 to 859.8
|
998.1 EU/mL
Interval 705.4 to 1412.2
|
19.3 EU/mL
Interval 13.7 to 27.1
|
PRIMARY outcome
Timeframe: At Month 38Population: Analysis was performed on the PPS which included all subjects enrolled in this study, who provided informed consent, complied with the eligibility criteria, study procedures and with immunogenicity data for specified antibody at specified timepoint.
Adjusted GMC and their 95% CI was calculated. GMCs were estimated using an ANCOVA model including treatment group as fixed effect and Month 0 antibody concentration from NTHi Mcat-001 as covariate. The cut-off value of the F13ELISA anti-PE assay was 8 EU/mL.
Outcome measures
| Measure |
10-10-10-AS
n=24 Participants
Subjects who received two doses of the AS01E adjuvanted GSK Biologicals' NTHi-Mcat investigational vaccine, containing 10µg of PD, PE-PilA and UspA2, and administered at Month 0 and Month 2 in NTHi-Mcat-001 study (NCT02547974), and were enrolled in the study.
|
10-10-3-AS
n=26 Participants
Subjects who received two doses of the AS01E-adjuvanted GSK Biologicals' NTHi-Mcat investigational vaccine, containing 10µg of PD, 10µg of PE-PilA, and 3.3µg of UspA2, and administered at Month 0 and Month 2 in NTHi-Mcat-001 study (NCT02547974), and were enrolled in the study.
|
PLACEBO
n=27 Participants
Subjects who received two doses of placebo (saline solution), administered at Month 0 and Month 2 in NTHi-Mcat-001 study (NCT02547974) and were enrolled in the study.
|
|---|---|---|---|
|
Anti-PE Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine
|
596 EU/mL
Interval 414.8 to 856.4
|
1003.7 EU/mL
Interval 708.0 to 1422.8
|
20.2 EU/mL
Interval 14.4 to 28.5
|
PRIMARY outcome
Timeframe: At Month 44Population: Analysis was performed on the PPS which included all subjects enrolled in this study, who provided informed consent, complied with the eligibility criteria, study procedures and with immunogenicity data for specified antibody at specified timepoint.
Adjusted GMC and their 95% CI was calculated. GMCs were estimated using an ANCOVA model including treatment group as fixed effect and Month 0 antibody concentration from NTHi Mcat-001 as covariate. The cut-off value of the ELISA anti-PE assay was 8 EU/mL.
Outcome measures
| Measure |
10-10-10-AS
n=25 Participants
Subjects who received two doses of the AS01E adjuvanted GSK Biologicals' NTHi-Mcat investigational vaccine, containing 10µg of PD, PE-PilA and UspA2, and administered at Month 0 and Month 2 in NTHi-Mcat-001 study (NCT02547974), and were enrolled in the study.
|
10-10-3-AS
n=26 Participants
Subjects who received two doses of the AS01E-adjuvanted GSK Biologicals' NTHi-Mcat investigational vaccine, containing 10µg of PD, 10µg of PE-PilA, and 3.3µg of UspA2, and administered at Month 0 and Month 2 in NTHi-Mcat-001 study (NCT02547974), and were enrolled in the study.
|
PLACEBO
n=27 Participants
Subjects who received two doses of placebo (saline solution), administered at Month 0 and Month 2 in NTHi-Mcat-001 study (NCT02547974) and were enrolled in the study.
|
|---|---|---|---|
|
Anti-PE Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine
|
524.8 EU/mL
Interval 373.4 to 737.6
|
782.6 EU/mL
Interval 560.5 to 1092.9
|
19.4 EU/mL
Interval 14.0 to 27.0
|
PRIMARY outcome
Timeframe: At Month 50Population: Analysis was performed on the PPS which included all subjects enrolled in this study, who provided informed consent, complied with the eligibility criteria, study procedures and with immunogenicity data for specified antibody at specified timepoint.
Adjusted GMC and their 95% CI was calculated. GMCs were estimated using an ANCOVA model including treatment group as fixed effect and Month 0 antibody concentration from NTHi Mcat-001 as covariate. The cut-off value of the ELISA anti-PE assay was 8 EU/mL.
Outcome measures
| Measure |
10-10-10-AS
n=25 Participants
Subjects who received two doses of the AS01E adjuvanted GSK Biologicals' NTHi-Mcat investigational vaccine, containing 10µg of PD, PE-PilA and UspA2, and administered at Month 0 and Month 2 in NTHi-Mcat-001 study (NCT02547974), and were enrolled in the study.
|
10-10-3-AS
n=23 Participants
Subjects who received two doses of the AS01E-adjuvanted GSK Biologicals' NTHi-Mcat investigational vaccine, containing 10µg of PD, 10µg of PE-PilA, and 3.3µg of UspA2, and administered at Month 0 and Month 2 in NTHi-Mcat-001 study (NCT02547974), and were enrolled in the study.
|
PLACEBO
n=27 Participants
Subjects who received two doses of placebo (saline solution), administered at Month 0 and Month 2 in NTHi-Mcat-001 study (NCT02547974) and were enrolled in the study.
|
|---|---|---|---|
|
Anti-PE Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine
|
491.3 EU/mL
Interval 342.5 to 704.5
|
827.8 EU/mL
Interval 568.3 to 1205.7
|
22 EU/mL
Interval 15.6 to 31.2
|
PRIMARY outcome
Timeframe: At Month 20Population: Analysis was performed on the PPS which included all subjects enrolled in this study, who provided informed consent, complied with the eligibility criteria, study procedures and with immunogenicity data for specified antibody at specified timepoint.
Adjusted GMC and their 95% CI was calculated. GMCs were estimated using an ANCOVA model including treatment group as fixed effect and Month 0 antibody concentration from NTHi Mcat-001 as covariate.The cut-off value of the ELISA anti-PilA assay was 7 EU/mL.
Outcome measures
| Measure |
10-10-10-AS
n=27 Participants
Subjects who received two doses of the AS01E adjuvanted GSK Biologicals' NTHi-Mcat investigational vaccine, containing 10µg of PD, PE-PilA and UspA2, and administered at Month 0 and Month 2 in NTHi-Mcat-001 study (NCT02547974), and were enrolled in the study.
|
10-10-3-AS
n=26 Participants
Subjects who received two doses of the AS01E-adjuvanted GSK Biologicals' NTHi-Mcat investigational vaccine, containing 10µg of PD, 10µg of PE-PilA, and 3.3µg of UspA2, and administered at Month 0 and Month 2 in NTHi-Mcat-001 study (NCT02547974), and were enrolled in the study.
|
PLACEBO
n=28 Participants
Subjects who received two doses of placebo (saline solution), administered at Month 0 and Month 2 in NTHi-Mcat-001 study (NCT02547974) and were enrolled in the study.
|
|---|---|---|---|
|
Anti-type IV Pili Subunit (PilA) Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine
|
121.9 EU/mL
Interval 91.0 to 163.4
|
188.3 EU/mL
Interval 139.5 to 254.2
|
13.8 EU/mL
Interval 10.3 to 18.6
|
PRIMARY outcome
Timeframe: At Month 26Population: Analysis was performed on the PPS which included all subjects enrolled in this study, who provided informed consent, complied with the eligibility criteria, study procedures and with immunogenicity data for specified antibody at specified timepoint.
Adjusted GMC and their 95% CI was calculated. GMCs were estimated using an ANCOVA model including treatment group as fixed effect and Month 0 antibody concentration from NTHi Mcat-001 as covariate.The cut-off value of the ELISA anti-PilA assay was 7 EU/mL.
Outcome measures
| Measure |
10-10-10-AS
n=26 Participants
Subjects who received two doses of the AS01E adjuvanted GSK Biologicals' NTHi-Mcat investigational vaccine, containing 10µg of PD, PE-PilA and UspA2, and administered at Month 0 and Month 2 in NTHi-Mcat-001 study (NCT02547974), and were enrolled in the study.
|
10-10-3-AS
n=26 Participants
Subjects who received two doses of the AS01E-adjuvanted GSK Biologicals' NTHi-Mcat investigational vaccine, containing 10µg of PD, 10µg of PE-PilA, and 3.3µg of UspA2, and administered at Month 0 and Month 2 in NTHi-Mcat-001 study (NCT02547974), and were enrolled in the study.
|
PLACEBO
n=27 Participants
Subjects who received two doses of placebo (saline solution), administered at Month 0 and Month 2 in NTHi-Mcat-001 study (NCT02547974) and were enrolled in the study.
|
|---|---|---|---|
|
Anti-PilA Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine
|
96.4 EU/mL
Interval 73.2 to 126.9
|
171.6 EU/mL
Interval 130.1 to 226.4
|
13 EU/mL
Interval 9.9 to 17.2
|
PRIMARY outcome
Timeframe: At Month 32Population: Analysis was performed on the PPS which included all subjects enrolled in this study, who provided informed consent, complied with the eligibility criteria, study procedures and with immunogenicity data for specified antibody at specified timepoint.
Adjusted GMC and their 95% CI was calculated. GMCs were estimated using an ANCOVA model including treatment group as fixed effect and Month 0 antibody concentration from NTHi Mcat-001 as covariate.The cut-off value of the ELISA anti-PilA assay was 7 EU/mL.
Outcome measures
| Measure |
10-10-10-AS
n=25 Participants
Subjects who received two doses of the AS01E adjuvanted GSK Biologicals' NTHi-Mcat investigational vaccine, containing 10µg of PD, PE-PilA and UspA2, and administered at Month 0 and Month 2 in NTHi-Mcat-001 study (NCT02547974), and were enrolled in the study.
|
10-10-3-AS
n=26 Participants
Subjects who received two doses of the AS01E-adjuvanted GSK Biologicals' NTHi-Mcat investigational vaccine, containing 10µg of PD, 10µg of PE-PilA, and 3.3µg of UspA2, and administered at Month 0 and Month 2 in NTHi-Mcat-001 study (NCT02547974), and were enrolled in the study.
|
PLACEBO
n=27 Participants
Subjects who received two doses of placebo (saline solution), administered at Month 0 and Month 2 in NTHi-Mcat-001 study (NCT02547974) and were enrolled in the study.
|
|---|---|---|---|
|
Anti-PilA Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine
|
79.7 EU/mL
Interval 57.5 to 110.5
|
166.9 EU/mL
Interval 121.0 to 230.3
|
10 EU/mL
Interval 7.2 to 13.8
|
PRIMARY outcome
Timeframe: At Month 38Population: Analysis was performed on the PPS which included all subjects enrolled in this study, who provided informed consent, complied with the eligibility criteria, study procedures and with immunogenicity data for specified antibody at specified timepoint.
Adjusted GMC and their 95% CI was calculated. GMCs were estimated using an ANCOVA model including treatment group as fixed effect and Month 0 antibody concentration from NTHi Mcat-001 as covariate.The cut-off value of the ELISA anti-PilA assay was 7 EU/mL.
Outcome measures
| Measure |
10-10-10-AS
n=24 Participants
Subjects who received two doses of the AS01E adjuvanted GSK Biologicals' NTHi-Mcat investigational vaccine, containing 10µg of PD, PE-PilA and UspA2, and administered at Month 0 and Month 2 in NTHi-Mcat-001 study (NCT02547974), and were enrolled in the study.
|
10-10-3-AS
n=26 Participants
Subjects who received two doses of the AS01E-adjuvanted GSK Biologicals' NTHi-Mcat investigational vaccine, containing 10µg of PD, 10µg of PE-PilA, and 3.3µg of UspA2, and administered at Month 0 and Month 2 in NTHi-Mcat-001 study (NCT02547974), and were enrolled in the study.
|
PLACEBO
n=27 Participants
Subjects who received two doses of placebo (saline solution), administered at Month 0 and Month 2 in NTHi-Mcat-001 study (NCT02547974) and were enrolled in the study.
|
|---|---|---|---|
|
Anti-PilA Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine
|
68 EU/mL
Interval 48.6 to 95.2
|
147.5 EU/mL
Interval 106.6 to 204.2
|
9.6 EU/mL
Interval 6.9 to 13.3
|
PRIMARY outcome
Timeframe: At Month 44Population: Analysis was performed on the PPS which included all subjects enrolled in this study, who provided informed consent, complied with the eligibility criteria, study procedures and with immunogenicity data for specified antibody at specified timepoint.
Adjusted GMC and their 95% CI was calculated. GMCs were estimated using an ANCOVA model including treatment group as fixed effect and Month 0 antibody concentration from NTHi Mcat-001 as covariate.The cut-off value of the ELISA anti-PilA assay was 7 EU/mL.
Outcome measures
| Measure |
10-10-10-AS
n=25 Participants
Subjects who received two doses of the AS01E adjuvanted GSK Biologicals' NTHi-Mcat investigational vaccine, containing 10µg of PD, PE-PilA and UspA2, and administered at Month 0 and Month 2 in NTHi-Mcat-001 study (NCT02547974), and were enrolled in the study.
|
10-10-3-AS
n=26 Participants
Subjects who received two doses of the AS01E-adjuvanted GSK Biologicals' NTHi-Mcat investigational vaccine, containing 10µg of PD, 10µg of PE-PilA, and 3.3µg of UspA2, and administered at Month 0 and Month 2 in NTHi-Mcat-001 study (NCT02547974), and were enrolled in the study.
|
PLACEBO
n=27 Participants
Subjects who received two doses of placebo (saline solution), administered at Month 0 and Month 2 in NTHi-Mcat-001 study (NCT02547974) and were enrolled in the study.
|
|---|---|---|---|
|
Anti-PilA Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine
|
60.8 EU/mL
Interval 44.4 to 83.3
|
122.5 EU/mL
Interval 89.8 to 167.0
|
10.2 EU/mL
Interval 7.5 to 13.9
|
PRIMARY outcome
Timeframe: At Month 50Population: Analysis was performed on the PPS which included all subjects enrolled in this study, who provided informed consent, complied with the eligibility criteria, study procedures and with immunogenicity data for specified antibody at specified timepoint.
Adjusted GMC and their 95% CI was calculated. GMCs were estimated using an ANCOVA model including treatment group as fixed effect and Month 0 antibody concentration from NTHi Mcat-001 as covariate.The cut-off value of the ELISA anti-PilA assay was 7 EU/mL.
Outcome measures
| Measure |
10-10-10-AS
n=25 Participants
Subjects who received two doses of the AS01E adjuvanted GSK Biologicals' NTHi-Mcat investigational vaccine, containing 10µg of PD, PE-PilA and UspA2, and administered at Month 0 and Month 2 in NTHi-Mcat-001 study (NCT02547974), and were enrolled in the study.
|
10-10-3-AS
n=23 Participants
Subjects who received two doses of the AS01E-adjuvanted GSK Biologicals' NTHi-Mcat investigational vaccine, containing 10µg of PD, 10µg of PE-PilA, and 3.3µg of UspA2, and administered at Month 0 and Month 2 in NTHi-Mcat-001 study (NCT02547974), and were enrolled in the study.
|
PLACEBO
n=27 Participants
Subjects who received two doses of placebo (saline solution), administered at Month 0 and Month 2 in NTHi-Mcat-001 study (NCT02547974) and were enrolled in the study.
|
|---|---|---|---|
|
Anti-PilA Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine
|
54.2 EU/mL
Interval 39.0 to 75.3
|
106.5 EU/mL
Interval 75.6 to 150.1
|
9.8 EU/mL
Interval 7.1 to 13.6
|
PRIMARY outcome
Timeframe: At Month 20Population: Analysis was performed on the PPS which included all subjects enrolled in this study, who provided informed consent, complied with the eligibility criteria, study procedures and with immunogenicity data for specified antibody at specified timepoint.
Adjusted GMC and their 95% CI was calculated. GMCs were estimated using an ANCOVA model including treatment group as fixed effect and Month 0 antibody concentration from NTHi Mcat-001 as covariate.The cut-off value of the ELISA anti-UspA2 assay was 18 EU/mL.
Outcome measures
| Measure |
10-10-10-AS
n=27 Participants
Subjects who received two doses of the AS01E adjuvanted GSK Biologicals' NTHi-Mcat investigational vaccine, containing 10µg of PD, PE-PilA and UspA2, and administered at Month 0 and Month 2 in NTHi-Mcat-001 study (NCT02547974), and were enrolled in the study.
|
10-10-3-AS
n=26 Participants
Subjects who received two doses of the AS01E-adjuvanted GSK Biologicals' NTHi-Mcat investigational vaccine, containing 10µg of PD, 10µg of PE-PilA, and 3.3µg of UspA2, and administered at Month 0 and Month 2 in NTHi-Mcat-001 study (NCT02547974), and were enrolled in the study.
|
PLACEBO
n=28 Participants
Subjects who received two doses of placebo (saline solution), administered at Month 0 and Month 2 in NTHi-Mcat-001 study (NCT02547974) and were enrolled in the study.
|
|---|---|---|---|
|
Anti-ubiquitous Surface Protein A2 of Moraxella Catarrhalis (UspA2) Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine
|
719 EU/mL
Interval 600.9 to 860.2
|
578.2 EU/mL
Interval 481.5 to 694.3
|
456.1 EU/mL
Interval 382.7 to 543.6
|
PRIMARY outcome
Timeframe: At Month 26Population: Analysis was performed on the PPS which included all subjects enrolled in this study, who provided informed consent, complied with the eligibility criteria, study procedures and with immunogenicity data for specified antibody at specified timepoint.
Adjusted GMC and their 95% CI was calculated. GMCs were estimated using an ANCOVA model including treatment group as fixed effect and Month 0 antibody concentration from NTHi Mcat-001 as covariate.The cut-off value of the ELISA anti-UspA2 assay was 18 EU/mL.
Outcome measures
| Measure |
10-10-10-AS
n=26 Participants
Subjects who received two doses of the AS01E adjuvanted GSK Biologicals' NTHi-Mcat investigational vaccine, containing 10µg of PD, PE-PilA and UspA2, and administered at Month 0 and Month 2 in NTHi-Mcat-001 study (NCT02547974), and were enrolled in the study.
|
10-10-3-AS
n=26 Participants
Subjects who received two doses of the AS01E-adjuvanted GSK Biologicals' NTHi-Mcat investigational vaccine, containing 10µg of PD, 10µg of PE-PilA, and 3.3µg of UspA2, and administered at Month 0 and Month 2 in NTHi-Mcat-001 study (NCT02547974), and were enrolled in the study.
|
PLACEBO
n=27 Participants
Subjects who received two doses of placebo (saline solution), administered at Month 0 and Month 2 in NTHi-Mcat-001 study (NCT02547974) and were enrolled in the study.
|
|---|---|---|---|
|
Anti-UspA2 Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine
|
791.1 EU/mL
Interval 638.0 to 981.0
|
621.6 EU/mL
Interval 501.4 to 770.6
|
480.4 EU/mL
Interval 389.5 to 592.7
|
PRIMARY outcome
Timeframe: At Month 32Population: Analysis was performed on the PPS which included all subjects enrolled in this study, who provided informed consent, complied with the eligibility criteria, study procedures and with immunogenicity data for specified antibody at specified timepoint.
Adjusted GMC and their 95% CI was calculated. GMCs were estimated using an ANCOVA model including treatment group as fixed effect and Month 0 antibody concentration from NTHi Mcat-001 as covariate.The cut-off value of the ELISA anti-UspA2 assay was 18 EU/mL.
Outcome measures
| Measure |
10-10-10-AS
n=25 Participants
Subjects who received two doses of the AS01E adjuvanted GSK Biologicals' NTHi-Mcat investigational vaccine, containing 10µg of PD, PE-PilA and UspA2, and administered at Month 0 and Month 2 in NTHi-Mcat-001 study (NCT02547974), and were enrolled in the study.
|
10-10-3-AS
n=26 Participants
Subjects who received two doses of the AS01E-adjuvanted GSK Biologicals' NTHi-Mcat investigational vaccine, containing 10µg of PD, 10µg of PE-PilA, and 3.3µg of UspA2, and administered at Month 0 and Month 2 in NTHi-Mcat-001 study (NCT02547974), and were enrolled in the study.
|
PLACEBO
n=26 Participants
Subjects who received two doses of placebo (saline solution), administered at Month 0 and Month 2 in NTHi-Mcat-001 study (NCT02547974) and were enrolled in the study.
|
|---|---|---|---|
|
Anti-UspA2 Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine
|
666.6 EU/mL
Interval 556.9 to 797.8
|
530.5 EU/mL
Interval 444.7 to 632.8
|
434.7 EU/mL
Interval 364.8 to 517.9
|
PRIMARY outcome
Timeframe: At Month 38Population: Analysis was performed on the PPS which included all subjects enrolled in this study, who provided informed consent, complied with the eligibility criteria, study procedures and with immunogenicity data for specified antibody at specified timepoint.
Adjusted GMC and their 95% CI was calculated. GMCs were estimated using an ANCOVA model including treatment group as fixed effect and Month 0 antibody concentration from NTHi Mcat-001 as covariate.The cut-off value of the ELISA anti-UspA2 assay was 18 EU/mL.
Outcome measures
| Measure |
10-10-10-AS
n=24 Participants
Subjects who received two doses of the AS01E adjuvanted GSK Biologicals' NTHi-Mcat investigational vaccine, containing 10µg of PD, PE-PilA and UspA2, and administered at Month 0 and Month 2 in NTHi-Mcat-001 study (NCT02547974), and were enrolled in the study.
|
10-10-3-AS
n=26 Participants
Subjects who received two doses of the AS01E-adjuvanted GSK Biologicals' NTHi-Mcat investigational vaccine, containing 10µg of PD, 10µg of PE-PilA, and 3.3µg of UspA2, and administered at Month 0 and Month 2 in NTHi-Mcat-001 study (NCT02547974), and were enrolled in the study.
|
PLACEBO
n=27 Participants
Subjects who received two doses of placebo (saline solution), administered at Month 0 and Month 2 in NTHi-Mcat-001 study (NCT02547974) and were enrolled in the study.
|
|---|---|---|---|
|
Anti-UspA2 Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine
|
662.3 EU/mL
Interval 531.8 to 824.8
|
556.6 EU/mL
Interval 451.2 to 686.7
|
453.2 EU/mL
Interval 369.2 to 556.3
|
PRIMARY outcome
Timeframe: At Month 44Population: Analysis was performed on the PPS which included all subjects enrolled in this study, who provided informed consent, complied with the eligibility criteria, study procedures and with immunogenicity data for specified antibody at specified timepoint.
Adjusted GMC and their 95% CI was calculated. GMCs were estimated using an ANCOVA model including treatment group as fixed effect and Month 0 antibody concentration from NTHi Mcat-001 as covariate.The cut-off value of the ELISA anti-UspA2 assay was 18 EU/mL.
Outcome measures
| Measure |
10-10-10-AS
n=25 Participants
Subjects who received two doses of the AS01E adjuvanted GSK Biologicals' NTHi-Mcat investigational vaccine, containing 10µg of PD, PE-PilA and UspA2, and administered at Month 0 and Month 2 in NTHi-Mcat-001 study (NCT02547974), and were enrolled in the study.
|
10-10-3-AS
n=26 Participants
Subjects who received two doses of the AS01E-adjuvanted GSK Biologicals' NTHi-Mcat investigational vaccine, containing 10µg of PD, 10µg of PE-PilA, and 3.3µg of UspA2, and administered at Month 0 and Month 2 in NTHi-Mcat-001 study (NCT02547974), and were enrolled in the study.
|
PLACEBO
n=27 Participants
Subjects who received two doses of placebo (saline solution), administered at Month 0 and Month 2 in NTHi-Mcat-001 study (NCT02547974) and were enrolled in the study.
|
|---|---|---|---|
|
Anti-UspA2 Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine
|
561.5 EU/mL
Interval 451.9 to 697.6
|
400.1 EU/mL
Interval 323.3 to 495.2
|
339.4 EU/mL
Interval 275.7 to 417.8
|
PRIMARY outcome
Timeframe: At Month 50Population: Analysis was performed on the PPS which included all subjects enrolled in this study, who provided informed consent, complied with the eligibility criteria, study procedures and with immunogenicity data for specified antibody at specified timepoint.
Adjusted GMC and their 95% CI was calculated. GMCs were estimated using an ANCOVA model including treatment group as fixed effect and Month 0 antibody concentration from NTHi Mcat-001 as covariate.The cut-off value of the ELISA anti-UspA2 assay was 18 EU/mL.
Outcome measures
| Measure |
10-10-10-AS
n=25 Participants
Subjects who received two doses of the AS01E adjuvanted GSK Biologicals' NTHi-Mcat investigational vaccine, containing 10µg of PD, PE-PilA and UspA2, and administered at Month 0 and Month 2 in NTHi-Mcat-001 study (NCT02547974), and were enrolled in the study.
|
10-10-3-AS
n=23 Participants
Subjects who received two doses of the AS01E-adjuvanted GSK Biologicals' NTHi-Mcat investigational vaccine, containing 10µg of PD, 10µg of PE-PilA, and 3.3µg of UspA2, and administered at Month 0 and Month 2 in NTHi-Mcat-001 study (NCT02547974), and were enrolled in the study.
|
PLACEBO
n=27 Participants
Subjects who received two doses of placebo (saline solution), administered at Month 0 and Month 2 in NTHi-Mcat-001 study (NCT02547974) and were enrolled in the study.
|
|---|---|---|---|
|
Anti-UspA2 Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine
|
536.8 EU/mL
Interval 424.0 to 679.6
|
404.5 EU/mL
Interval 316.0 to 517.7
|
374.9 EU/mL
Interval 299.2 to 469.8
|
SECONDARY outcome
Timeframe: From first visit (Month 20) up to study conclusion (Month 50)Population: Analysis was performed on all the subjects enrolled in the study.
A SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalisation or prolongation of existing hospitalisation, results in disability/incapacity.
Outcome measures
| Measure |
10-10-10-AS
n=27 Participants
Subjects who received two doses of the AS01E adjuvanted GSK Biologicals' NTHi-Mcat investigational vaccine, containing 10µg of PD, PE-PilA and UspA2, and administered at Month 0 and Month 2 in NTHi-Mcat-001 study (NCT02547974), and were enrolled in the study.
|
10-10-3-AS
n=26 Participants
Subjects who received two doses of the AS01E-adjuvanted GSK Biologicals' NTHi-Mcat investigational vaccine, containing 10µg of PD, 10µg of PE-PilA, and 3.3µg of UspA2, and administered at Month 0 and Month 2 in NTHi-Mcat-001 study (NCT02547974), and were enrolled in the study.
|
PLACEBO
n=28 Participants
Subjects who received two doses of placebo (saline solution), administered at Month 0 and Month 2 in NTHi-Mcat-001 study (NCT02547974) and were enrolled in the study.
|
|---|---|---|---|
|
Number of Subjects Reported With Any Serious Adverse Event (SAE)
|
5 Participants
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: From first visit (Month 20) up to study conclusion (Month 50)Population: Analysis was performed on all the subjects enrolled in the study.
pIMD's are a subset of Adverse Events that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.
Outcome measures
| Measure |
10-10-10-AS
n=27 Participants
Subjects who received two doses of the AS01E adjuvanted GSK Biologicals' NTHi-Mcat investigational vaccine, containing 10µg of PD, PE-PilA and UspA2, and administered at Month 0 and Month 2 in NTHi-Mcat-001 study (NCT02547974), and were enrolled in the study.
|
10-10-3-AS
n=26 Participants
Subjects who received two doses of the AS01E-adjuvanted GSK Biologicals' NTHi-Mcat investigational vaccine, containing 10µg of PD, 10µg of PE-PilA, and 3.3µg of UspA2, and administered at Month 0 and Month 2 in NTHi-Mcat-001 study (NCT02547974), and were enrolled in the study.
|
PLACEBO
n=28 Participants
Subjects who received two doses of placebo (saline solution), administered at Month 0 and Month 2 in NTHi-Mcat-001 study (NCT02547974) and were enrolled in the study.
|
|---|---|---|---|
|
Number of Subjects Reported With Any Potential Immune-mediated Disease (pIMD)
|
0 Participants
|
1 Participants
|
0 Participants
|
Adverse Events
10-10-10-AS
10-10-3-AS
PLACEBO
Serious adverse events
| Measure |
10-10-10-AS
n=27 participants at risk
Subjects who received two doses of the AS01E adjuvanted GSK Biologicals' NTHi-Mcat investigational vaccine, containing 10µg of PD, PE-PilA and UspA2, and administered at Month 0 and Month 2 in NTHi-Mcat-001 study (NCT02547974), and were enrolled in the study.
|
10-10-3-AS
n=26 participants at risk
Subjects who received two doses of the AS01E-adjuvanted GSK Biologicals' NTHi-Mcat investigational vaccine, containing 10µg of PD, 10µg of PE-PilA, and 3.3µg of UspA2, and administered at Month 0 and Month 2 in NTHi-Mcat-001 study (NCT02547974), and were enrolled in the study.
|
PLACEBO
n=28 participants at risk
Subjects who received two doses of placebo (saline solution), administered at Month 0 and Month 2 in NTHi-Mcat-001 study (NCT02547974) and were enrolled in the study.
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
Humerus fracture
|
3.7%
1/27 • Number of events 1 • SAEs were collected from first visit (Month 20) up to study conclusion (Month 50). Other adverse events were not collected during the study period.
Other AEs are not collected in the study as no administration of vaccine.
|
0.00%
0/26 • SAEs were collected from first visit (Month 20) up to study conclusion (Month 50). Other adverse events were not collected during the study period.
Other AEs are not collected in the study as no administration of vaccine.
|
0.00%
0/28 • SAEs were collected from first visit (Month 20) up to study conclusion (Month 50). Other adverse events were not collected during the study period.
Other AEs are not collected in the study as no administration of vaccine.
|
|
Injury, poisoning and procedural complications
Post procedural fever
|
3.7%
1/27 • Number of events 1 • SAEs were collected from first visit (Month 20) up to study conclusion (Month 50). Other adverse events were not collected during the study period.
Other AEs are not collected in the study as no administration of vaccine.
|
0.00%
0/26 • SAEs were collected from first visit (Month 20) up to study conclusion (Month 50). Other adverse events were not collected during the study period.
Other AEs are not collected in the study as no administration of vaccine.
|
0.00%
0/28 • SAEs were collected from first visit (Month 20) up to study conclusion (Month 50). Other adverse events were not collected during the study period.
Other AEs are not collected in the study as no administration of vaccine.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
3.7%
1/27 • Number of events 1 • SAEs were collected from first visit (Month 20) up to study conclusion (Month 50). Other adverse events were not collected during the study period.
Other AEs are not collected in the study as no administration of vaccine.
|
0.00%
0/26 • SAEs were collected from first visit (Month 20) up to study conclusion (Month 50). Other adverse events were not collected during the study period.
Other AEs are not collected in the study as no administration of vaccine.
|
0.00%
0/28 • SAEs were collected from first visit (Month 20) up to study conclusion (Month 50). Other adverse events were not collected during the study period.
Other AEs are not collected in the study as no administration of vaccine.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/27 • SAEs were collected from first visit (Month 20) up to study conclusion (Month 50). Other adverse events were not collected during the study period.
Other AEs are not collected in the study as no administration of vaccine.
|
0.00%
0/26 • SAEs were collected from first visit (Month 20) up to study conclusion (Month 50). Other adverse events were not collected during the study period.
Other AEs are not collected in the study as no administration of vaccine.
|
3.6%
1/28 • Number of events 1 • SAEs were collected from first visit (Month 20) up to study conclusion (Month 50). Other adverse events were not collected during the study period.
Other AEs are not collected in the study as no administration of vaccine.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
3.7%
1/27 • Number of events 1 • SAEs were collected from first visit (Month 20) up to study conclusion (Month 50). Other adverse events were not collected during the study period.
Other AEs are not collected in the study as no administration of vaccine.
|
0.00%
0/26 • SAEs were collected from first visit (Month 20) up to study conclusion (Month 50). Other adverse events were not collected during the study period.
Other AEs are not collected in the study as no administration of vaccine.
|
0.00%
0/28 • SAEs were collected from first visit (Month 20) up to study conclusion (Month 50). Other adverse events were not collected during the study period.
Other AEs are not collected in the study as no administration of vaccine.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Schwannoma
|
3.7%
1/27 • Number of events 1 • SAEs were collected from first visit (Month 20) up to study conclusion (Month 50). Other adverse events were not collected during the study period.
Other AEs are not collected in the study as no administration of vaccine.
|
0.00%
0/26 • SAEs were collected from first visit (Month 20) up to study conclusion (Month 50). Other adverse events were not collected during the study period.
Other AEs are not collected in the study as no administration of vaccine.
|
0.00%
0/28 • SAEs were collected from first visit (Month 20) up to study conclusion (Month 50). Other adverse events were not collected during the study period.
Other AEs are not collected in the study as no administration of vaccine.
|
|
Gastrointestinal disorders
Ileus
|
3.7%
1/27 • Number of events 1 • SAEs were collected from first visit (Month 20) up to study conclusion (Month 50). Other adverse events were not collected during the study period.
Other AEs are not collected in the study as no administration of vaccine.
|
0.00%
0/26 • SAEs were collected from first visit (Month 20) up to study conclusion (Month 50). Other adverse events were not collected during the study period.
Other AEs are not collected in the study as no administration of vaccine.
|
0.00%
0/28 • SAEs were collected from first visit (Month 20) up to study conclusion (Month 50). Other adverse events were not collected during the study period.
Other AEs are not collected in the study as no administration of vaccine.
|
|
Gastrointestinal disorders
Ileus paralytic
|
3.7%
1/27 • Number of events 1 • SAEs were collected from first visit (Month 20) up to study conclusion (Month 50). Other adverse events were not collected during the study period.
Other AEs are not collected in the study as no administration of vaccine.
|
0.00%
0/26 • SAEs were collected from first visit (Month 20) up to study conclusion (Month 50). Other adverse events were not collected during the study period.
Other AEs are not collected in the study as no administration of vaccine.
|
0.00%
0/28 • SAEs were collected from first visit (Month 20) up to study conclusion (Month 50). Other adverse events were not collected during the study period.
Other AEs are not collected in the study as no administration of vaccine.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
3.7%
1/27 • Number of events 1 • SAEs were collected from first visit (Month 20) up to study conclusion (Month 50). Other adverse events were not collected during the study period.
Other AEs are not collected in the study as no administration of vaccine.
|
0.00%
0/26 • SAEs were collected from first visit (Month 20) up to study conclusion (Month 50). Other adverse events were not collected during the study period.
Other AEs are not collected in the study as no administration of vaccine.
|
0.00%
0/28 • SAEs were collected from first visit (Month 20) up to study conclusion (Month 50). Other adverse events were not collected during the study period.
Other AEs are not collected in the study as no administration of vaccine.
|
|
Infections and infestations
Postoperative wound infection
|
3.7%
1/27 • Number of events 1 • SAEs were collected from first visit (Month 20) up to study conclusion (Month 50). Other adverse events were not collected during the study period.
Other AEs are not collected in the study as no administration of vaccine.
|
0.00%
0/26 • SAEs were collected from first visit (Month 20) up to study conclusion (Month 50). Other adverse events were not collected during the study period.
Other AEs are not collected in the study as no administration of vaccine.
|
0.00%
0/28 • SAEs were collected from first visit (Month 20) up to study conclusion (Month 50). Other adverse events were not collected during the study period.
Other AEs are not collected in the study as no administration of vaccine.
|
|
Musculoskeletal and connective tissue disorders
Spinal stenosis
|
0.00%
0/27 • SAEs were collected from first visit (Month 20) up to study conclusion (Month 50). Other adverse events were not collected during the study period.
Other AEs are not collected in the study as no administration of vaccine.
|
3.8%
1/26 • Number of events 1 • SAEs were collected from first visit (Month 20) up to study conclusion (Month 50). Other adverse events were not collected during the study period.
Other AEs are not collected in the study as no administration of vaccine.
|
0.00%
0/28 • SAEs were collected from first visit (Month 20) up to study conclusion (Month 50). Other adverse events were not collected during the study period.
Other AEs are not collected in the study as no administration of vaccine.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/27 • SAEs were collected from first visit (Month 20) up to study conclusion (Month 50). Other adverse events were not collected during the study period.
Other AEs are not collected in the study as no administration of vaccine.
|
3.8%
1/26 • Number of events 1 • SAEs were collected from first visit (Month 20) up to study conclusion (Month 50). Other adverse events were not collected during the study period.
Other AEs are not collected in the study as no administration of vaccine.
|
0.00%
0/28 • SAEs were collected from first visit (Month 20) up to study conclusion (Month 50). Other adverse events were not collected during the study period.
Other AEs are not collected in the study as no administration of vaccine.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/27 • SAEs were collected from first visit (Month 20) up to study conclusion (Month 50). Other adverse events were not collected during the study period.
Other AEs are not collected in the study as no administration of vaccine.
|
0.00%
0/26 • SAEs were collected from first visit (Month 20) up to study conclusion (Month 50). Other adverse events were not collected during the study period.
Other AEs are not collected in the study as no administration of vaccine.
|
3.6%
1/28 • Number of events 1 • SAEs were collected from first visit (Month 20) up to study conclusion (Month 50). Other adverse events were not collected during the study period.
Other AEs are not collected in the study as no administration of vaccine.
|
Other adverse events
Adverse event data not reported
Additional Information
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