A Long Term Follow-up Study up to 4 Years After Study Vac... | NCT03201211

ID	Type	Description	Link
2016-004248-13	EudraCT Number

Label	Type	Description	Intervention Names
10-10-10-AS	Experimental	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.	Biological: Blood sampling Biological: GSK biologicals investigational NTHi Mcat vaccine containing 10µg of PD, PE-PilA and UspA2.
10-10-3-AS	Experimental	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.	Biological: Blood sampling Biological: GSK biologicals investigational NTHi Mcat vaccine containing 10µg of PD, 10µg of PE-PilA, and 3.3µg of UspA2.
PLACEBO	Placebo Comparator	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.	Biological: Blood sampling Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Blood sampling	Biological	A volume of approximately 20 mL of whole blood should be drawn from each subject, at each study visit, for antibody determination and assay validation/development.

Measure	Description	Time Frame
Anti-Protein D (PD) Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine	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).	At Month 20
Anti-PD Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine	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.	At Month 26
Anti-PD Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine	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.	At Month 32
Anti-PD Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine	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.	At Month 38
Anti-PD Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine	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.

Measure	Description	Time Frame
Number of Subjects Reported With Any Serious Adverse Event (SAE)	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.	From first visit (Month 20) up to study conclusion (Month 50)

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Ghent		9000	Belgium
GSK Investigational Site

ID	Title	Description
FG000	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.
FG001	10-10-3-AS

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jun 28, 2018	Mar 12, 2021

Primary

Anti-Protein D (PD) Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine

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).

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.

Posted

Geometric Mean

95% Confidence Interval

EU/mL

At Month 20

ID	Title	Description
OG000	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.
OG001	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.
OG002	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.

Units	Counts
Participants	OG00026 OG00126 OG00228

Title

Denominators

Categories

Title	Measurements
	OG000382.7(279.2 to 524.4) OG001511.9(376.4 to 696.2) OG00290.5(67.1 to 121.9)

Primary

Anti-PD Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine

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.

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.

Posted

Geometric Mean

95% Confidence Interval

EU/mL

At Month 26

ID	Title	Description
OG000	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.
OG001	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.
OG002	PLACEBO

Primary

Anti-PD Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine

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.

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.

Posted

Geometric Mean

95% Confidence Interval

EU/mL

At Month 32

ID	Title	Description
OG000	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.
OG001	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.
OG002	PLACEBO

Primary

Anti-PD Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine

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.

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.

Posted

Geometric Mean

95% Confidence Interval

EU/mL

At Month 38

ID	Title	Description
OG000	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.
OG001	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.
OG002	PLACEBO

Primary

Anti-PD Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine

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.

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.

Posted

Geometric Mean

95% Confidence Interval

EU/mL

At Month 44

ID	Title	Description
OG000	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.
OG001	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.
OG002	PLACEBO

Primary

Anti-PD Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine

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.

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.

Posted

Geometric Mean

95% Confidence Interval

EU/mL

At Month 50

ID	Title	Description
OG000	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.
OG001	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.
OG002	PLACEBO

Primary

Anti-Protein E (PE) Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine

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.

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.

Posted

Geometric Mean

95% Confidence Interval

EU/mL

At Month 20

ID	Title	Description
OG000	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.
OG001	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.
OG002	PLACEBO

Primary

Anti-PE Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine

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.

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.

Posted

Geometric Mean

95% Confidence Interval

EU/mL

At Month 26

ID	Title	Description
OG000	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.
OG001	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.
OG002	PLACEBO

Primary

Anti-PE Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine

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.

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.

Posted

Geometric Mean

95% Confidence Interval

EU/mL

At Month 32

ID	Title	Description
OG000	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.
OG001	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.
OG002	PLACEBO

Primary

Anti-PE Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine

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.

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.

Posted

Geometric Mean

95% Confidence Interval

EU/mL

At Month 38

ID	Title	Description
OG000	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.
OG001	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.
OG002	PLACEBO

Primary

Anti-PE Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine

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.

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.

Posted

Geometric Mean

95% Confidence Interval

EU/mL

At Month 44

ID	Title	Description
OG000	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.
OG001	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.
OG002	PLACEBO

Primary

Anti-PE Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine

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.

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.

Posted

Geometric Mean

95% Confidence Interval

EU/mL

At Month 50

ID	Title	Description
OG000	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.
OG001	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.
OG002	PLACEBO

Primary

Anti-type IV Pili Subunit (PilA) Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine

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.

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.

Posted

Geometric Mean

95% Confidence Interval

EU/mL

At Month 20

ID	Title	Description
OG000	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.
OG001	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.
OG002	PLACEBO

Primary

Anti-PilA Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine

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.

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.

Posted

Geometric Mean

95% Confidence Interval

EU/mL

At Month 26

ID	Title	Description
OG000	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.
OG001	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.
OG002	PLACEBO

Primary

Anti-PilA Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine

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.

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.

Posted

Geometric Mean

95% Confidence Interval

EU/mL

At Month 32

ID	Title	Description
OG000	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.
OG001	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.
OG002	PLACEBO

Primary

Anti-PilA Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine

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.

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.

Posted

Geometric Mean

95% Confidence Interval

EU/mL

At Month 38

ID	Title	Description
OG000	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.
OG001	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.
OG002	PLACEBO

Primary

Anti-PilA Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine

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.

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.

Posted

Geometric Mean

95% Confidence Interval

EU/mL

At Month 44

ID	Title	Description
OG000	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.
OG001	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.
OG002	PLACEBO

Primary

Anti-PilA Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine

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.

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.

Posted

Geometric Mean

95% Confidence Interval

EU/mL

At Month 50

ID	Title	Description
OG000	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.
OG001	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.
OG002	PLACEBO

Primary

Anti-ubiquitous Surface Protein A2 of Moraxella Catarrhalis (UspA2) Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine

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.

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.

Posted

Geometric Mean

95% Confidence Interval

EU/mL

At Month 20

ID	Title	Description
OG000	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.
OG001	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.
OG002

Primary

Anti-UspA2 Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine

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.

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.

Posted

Geometric Mean

95% Confidence Interval

EU/mL

At Month 26

ID	Title	Description
OG000	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.
OG001	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.
OG002	PLACEBO

Primary

Anti-UspA2 Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine

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.

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.

Posted

Geometric Mean

95% Confidence Interval

EU/mL

At Month 32

ID	Title	Description
OG000	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.
OG001	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.
OG002	PLACEBO

Primary

Anti-UspA2 Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine

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.

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.

Posted

Geometric Mean

95% Confidence Interval

EU/mL

At Month 38

ID	Title	Description
OG000	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.
OG001	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.
OG002	PLACEBO

Primary

Anti-UspA2 Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine

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.

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.

Posted

Geometric Mean

95% Confidence Interval

EU/mL

At Month 44

ID	Title	Description
OG000	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.
OG001	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.
OG002	PLACEBO

Primary

Anti-UspA2 Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine

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.

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.

Posted

Geometric Mean

95% Confidence Interval

EU/mL

At Month 50

ID	Title	Description
OG000	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.
OG001	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.
OG002	PLACEBO

Secondary

Number of Subjects Reported With Any Serious Adverse Event (SAE)

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.

Analysis was performed on all the subjects enrolled in the study.

Posted

Count of Participants

Participants

From first visit (Month 20) up to study conclusion (Month 50)

ID	Title	Description
OG000	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.
OG001	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.
OG002	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.

Secondary

Number of Subjects Reported With Any Potential Immune-mediated Disease (pIMD)

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.

Analysis was performed on all the subjects enrolled in the study.

Posted

Count of Participants

Participants

From first visit (Month 20) up to study conclusion (Month 50)

ID	Title	Description
OG000	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.
OG001	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.
OG002	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.

Term	Organ System	Assessment Type	Statistical Information
Humerus fracture	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected27 at risk EG0010 events0 affected26 at risk EG0020 events0 affected28 at risk
Post procedural fever	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected27 at risk EG0010 events0 affected26 at risk EG0020 events0 affected28 at risk
Tendon rupture	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected27 at risk EG0010 events0 affected26 at risk EG0020 events0 affected28 at risk
Tibia fracture	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected27 at risk EG0010 events0 affected26 at risk EG0021 events1 affected28 at risk
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 events1 affected27 at risk EG0010 events0 affected26 at risk EG0020 events0 affected28 at risk
Schwannoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 events1 affected27 at risk EG0010 events0 affected26 at risk EG0020 events0 affected28 at risk
Ileus	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected27 at risk EG0010 events0 affected26 at risk EG0020 events0 affected28 at risk
Ileus paralytic	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected27 at risk EG0010 events0 affected26 at risk EG0020 events0 affected28 at risk
Intestinal obstruction	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected27 at risk EG0010 events0 affected26 at risk EG0020 events0 affected28 at risk
Postoperative wound infection	Infections and infestations	Systematic Assessment	EG0001 events1 affected27 at risk EG0010 events0 affected26 at risk EG0020 events0 affected28 at risk
Spinal stenosis	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected27 at risk EG0011 events1 affected26 at risk EG0020 events0 affected28 at risk
Ischaemic stroke	Nervous system disorders	Systematic Assessment	EG0000 events0 affected27 at risk EG0011 events1 affected26 at risk EG0020 events0 affected28 at risk
Nephrolithiasis	Renal and urinary disorders	Systematic Assessment	EG0000 events0 affected27 at risk EG0010 events0 affected26 at risk EG0021 events1 affected28 at risk

ID	Term
D013048	Specimen Handling
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis
D011677	Punctures
D013514	Surgical Procedures, Operative
D008919	Investigative Techniques

ID	Title	Description
BG000	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.
BG001	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.
BG002	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.
BG003	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)
EG000	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.	1	27	5	27
EG001	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.	0	26	2	26
EG002	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.	0	28	2	28