A Long Term Follow-up Study up to 4 Years After Study Vaccination to Assess Immunogenicity and Safety of the Investigational Vaccine in Adults

• Sponsor: GlaxoSmithKline (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03201211
• Collaborator: (none)
• Enrollment: 81
• Locations: 3
• Arms: 3
• Actual Duration (Months): 32.9
• Patients Per Site: 27
• Patients Per Site Per Month: 0.8

Study Details

Study Description

Brief Summary

The purpose of this long-term follow-up of a Phase I study is to evaluate the kinetics of the antibody response to NTHi-Mcat antigens and long-term safety, in subjects aged between 50-71 years at the time of enrolment in the NTHi-Mcat-001 study. These subjects were previously exposed to two adjuvanted formulations of the NTHi-Mcat vaccine administered according to a 0, 2 months schedule in the NTHi-Mcat-001 (201281) study. The subjects that had received saline placebo controls will also be included in this follow-up study to make comparisons with the investigational vaccines. No vaccinations will be administered in this trial.

Condition or Disease	Intervention/Treatment	Phase
Respiratory Disorders	Biological: Blood sampling; Biological: GSK biologicals investigational NTHi Mcat vaccine containing 10µg of PD, PE-PilA and UspA2.; Biological: GSK biologicals investigational NTHi Mcat vaccine containing 10µg of PD, 10µg of PE-PilA, and 3.3µg of UspA2.; Drug: Placebo	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 81 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: A Long-term Follow-up Study of the Investigational GSK Biologicals' GSK3277511A Vaccine in Adults
• Actual Study Start Date: Jun 22, 2017
• Actual Primary Completion Date: Mar 19, 2020
• Actual Study Completion Date: Mar 19, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Biological: Blood sampling; 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.; Biological: GSK biologicals investigational NTHi Mcat vaccine containing 10µg of PD, PE-PilA and UspA2.; 2 doses, not administered as part of this study but administered at Day 0 and Day 60 during STEP 2 of NTHi Mcat-001 (201281 - NCT02547974) study, to subjects who were then enrolled in this study. Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule.
Experimental: 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.	Biological: Blood sampling; 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.; Biological: GSK biologicals investigational NTHi Mcat vaccine containing 10µg of PD, 10µg of PE-PilA, and 3.3µg of UspA2.; 2 doses, not administered as part of this study but administered at Day 0 and Day 60 during STEP 2 of NTHi Mcat-001 (201281 - NCT02547974) study, to subjects who were then enrolled in this study. Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule.
Placebo Comparator: 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.	Biological: Blood sampling; 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.; Drug: Placebo; 2 doses, not administered as part of this study but administered at Day 0 and Day 60 during STEP 2 of NTHi Mcat-001 (201281 - NCT02547974) study, to subjects who were then enrolled in this study. Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule.

Outcome Measures

Primary Outcome Measures

1. Anti-Protein D (PD) Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine [At Month 20]

   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).

2. Anti-PD Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine [At Month 26]

   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.

3. Anti-PD Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine [At Month 32]

   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.

4. Anti-PD Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine [At Month 38]

   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.

5. Anti-PD Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine [At Month 44]

   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.

6. Anti-PD Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine [At Month 50]

   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.

7. Anti-Protein E (PE) Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine [At Month 20]

   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.

8. Anti-PE Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine [At Month 26]

   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.

9. Anti-PE Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine [At Month 32]

   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.

10. Anti-PE Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine [At Month 38]

    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.

11. Anti-PE Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine [At Month 44]

    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.

12. Anti-PE Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine [At Month 50]

    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.

13. Anti-type IV Pili Subunit (PilA) Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine [At Month 20]

    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.

14. Anti-PilA Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine [At Month 26]

    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.

15. Anti-PilA Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine [At Month 32]

    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.

16. Anti-PilA Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine [At Month 38]

    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.

17. Anti-PilA Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine [At Month 44]

    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.

18. Anti-PilA Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine [At Month 50]

    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.

19. Anti-ubiquitous Surface Protein A2 of Moraxella Catarrhalis (UspA2) Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine [At Month 20]

    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.

20. Anti-UspA2 Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine [At Month 26]

    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.

21. Anti-UspA2 Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine [At Month 32]

    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.

22. Anti-UspA2 Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine [At Month 38]

    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.

23. Anti-UspA2 Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine [At Month 44]

    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.

24. Anti-UspA2 Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine [At Month 50]

    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.

Secondary Outcome Measures

1. Number of Subjects Reported With Any Serious Adverse Event (SAE) [From first visit (Month 20) up to study conclusion (Month 50)]

   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.

2. Number of Subjects Reported With Any Potential Immune-mediated Disease (pIMD) [From first visit (Month 20) up to study conclusion (Month 50)]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 51 Years to 73 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Subjects who previously participated in STEP 2 of study NTHi-Mcat-001 (201281), and performed the last study visit (Month 14) and received the 2 study vaccinations.

• Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g. return for follow-up visits). And subjects' Legally Acceptable Representative(s) [LAR(s)] who, in the opinion of the investigator, can and will comply, with the requirements of the protocol.

• Written informed consent obtained from the subject/ LAR(s) of the subject prior to performance of any study specific procedure.

Exclusion Criteria:

• Use of any investigational or non-registered product (drug or vaccine) during the period starting 30 days before the first follow-up study visit (Month 19 to Month 20), or planned use during the study period.

• Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs since the end of the NTHi-Mcat-001 study. For corticosteroids, this will mean prednisone ≥ 20 mg/day, or equivalent. Inhaled and topical steroids are allowed.

• Administration of long-acting immune-modifying drugs at any time during the study period (e.g. infliximab).

• Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product (pharmaceutical product or device).

• Administration of immunoglobulins and/or any blood products during the period starting 3 months before the first follow-up visit or planned administration during the study period.

• Current alcoholism and/or drug abuse.

• Has significant disease (including significant neurological or psychological disorders), in the opinion of the investigator, likely to interfere with the study and/or likely to cause death within the study duration.

• Any other condition that the investigator judges may interfere with study findings.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Gent		Belgium	9000
2	GSK Investigational Site	Leuven		Belgium	3000
3	GSK Investigational Site	Wilrijk		Belgium	2610

Sponsors and Collaborators

• GlaxoSmithKline

Investigators

• Study Director: GSK Clinical Trials, GlaxoSmithKline

Study Documents (Full-Text)

• Study Protocol - Jun 28, 2018
• Statistical Analysis Plan - Oct 24, 2017

More Information

Publications

None provided.

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT03201211
• Other Study ID Numbers: 204913; 2016-004248-13
• First Posted: Jun 28, 2017
• Last Update Posted: Apr 8, 2021
• Last Verified: Mar 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by GlaxoSmithKline: Safety; Immunogenicity
• Additional relevant MeSH terms: Respiration Disorders; Respiratory Tract Diseases; Vaccines

Study Results

Participant Flow

Arm/Group Title	10-10-10-AS	10-10-3-AS	PLACEBO
Arm/Group Description	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.	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.	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.
Period Title: Overall Study
STARTED	27	26	28
COMPLETED	25	25	27
NOT COMPLETED	2	1	1

Baseline Characteristics

Arm/Group Title	10-10-10-AS	10-10-3-AS	PLACEBO	Total
Arm/Group Description	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.	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.	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 of all reporting groups
Overall Participants	27	26	28	81
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	59.7 (6.3)	59.0 (5.9)	58.2 (6.5)	58.9 (6.2)
Sex: Female, Male (Count of Participants)
Female	12 44.4%	12 46.2%	9 32.1%	33 40.7%
Male	15 55.6%	14 53.8%	19 67.9%	48 59.3%
Race/Ethnicity, Customized (Count of Participants)
WHITE - CAUCASIAN / EUROPEAN HERITAGE	27 100%	26 100%	28 100%	81 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	10-10-10-AS	10-10-3-AS	PLACEBO
Arm/Group Description	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.	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.	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.
Measure Participants	26	26	28
Geometric Mean (95% Confidence Interval) [EU/mL]	382.7	511.9	90.5

2. Primary Outcome

Title	Anti-PD Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine
Description	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.
Time Frame	At Month 26

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	10-10-10-AS	10-10-3-AS	PLACEBO
Arm/Group Description	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.	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.	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.
Measure Participants	26	26	27
Geometric Mean (95% Confidence Interval) [EU/mL]	373.4	537.2	93.2

3. Primary Outcome

Title	Anti-PD Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine
Description	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.
Time Frame	At Month 32

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	10-10-10-AS	10-10-3-AS	PLACEBO
Arm/Group Description	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.	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.	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.
Measure Participants	25	26	27
Geometric Mean (95% Confidence Interval) [EU/mL]	371.8	480.8	94.1

4. Primary Outcome

Title	Anti-PD Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine
Description	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.
Time Frame	At Month 38

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	10-10-10-AS	10-10-3-AS	PLACEBO
Arm/Group Description	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.	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.	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.
Measure Participants	24	26	27
Geometric Mean (95% Confidence Interval) [EU/mL]	368	490.4	99.8

5. Primary Outcome

Title	Anti-PD Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine
Description	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.
Time Frame	At Month 44

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	10-10-10-AS	10-10-3-AS	PLACEBO
Arm/Group Description	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.	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.	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.
Measure Participants	25	26	27
Geometric Mean (95% Confidence Interval) [EU/mL]	321.4	466.2	95.6

6. Primary Outcome

Title	Anti-PD Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine
Description	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.
Time Frame	At Month 50

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	10-10-10-AS	10-10-3-AS	PLACEBO
Arm/Group Description	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.	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.	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.
Measure Participants	25	23	27
Geometric Mean (95% Confidence Interval) [EU/mL]	315.4	474.5	101.5

7. Primary Outcome

Title	Anti-Protein E (PE) Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine
Description	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.
Time Frame	At Month 20

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	10-10-10-AS	10-10-3-AS	PLACEBO
Arm/Group Description	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.	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.	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.
Measure Participants	27	26	28
Geometric Mean (95% Confidence Interval) [EU/mL]	762.7	1215	21.5

8. Primary Outcome

Title	Anti-PE Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine
Description	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.
Time Frame	At Month 26

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	10-10-10-AS	10-10-3-AS	PLACEBO
Arm/Group Description	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.	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.	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.
Measure Participants	26	26	27
Geometric Mean (95% Confidence Interval) [EU/mL]	729.5	1258.9	23.1

9. Primary Outcome

Title	Anti-PE Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine
Description	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.
Time Frame	At Month 32

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	10-10-10-AS	10-10-3-AS	PLACEBO
Arm/Group Description	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.	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.	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.
Measure Participants	25	26	27
Geometric Mean (95% Confidence Interval) [EU/mL]	603.9	998.1	19.3

10. Primary Outcome

Title	Anti-PE Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine
Description	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.
Time Frame	At Month 38

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	10-10-10-AS	10-10-3-AS	PLACEBO
Arm/Group Description	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.	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.	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.
Measure Participants	24	26	27
Geometric Mean (95% Confidence Interval) [EU/mL]	596	1003.7	20.2

11. Primary Outcome

Title	Anti-PE Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine
Description	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.
Time Frame	At Month 44

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	10-10-10-AS	10-10-3-AS	PLACEBO
Arm/Group Description	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.	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.	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.
Measure Participants	25	26	27
Geometric Mean (95% Confidence Interval) [EU/mL]	524.8	782.6	19.4

12. Primary Outcome

Title	Anti-PE Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine
Description	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.
Time Frame	At Month 50

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	10-10-10-AS	10-10-3-AS	PLACEBO
Arm/Group Description	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.	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.	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.
Measure Participants	25	23	27
Geometric Mean (95% Confidence Interval) [EU/mL]	491.3	827.8	22

13. Primary Outcome

Title	Anti-type IV Pili Subunit (PilA) Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine
Description	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.
Time Frame	At Month 20

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	10-10-10-AS	10-10-3-AS	PLACEBO
Arm/Group Description	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.	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.	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.
Measure Participants	27	26	28
Geometric Mean (95% Confidence Interval) [EU/mL]	121.9	188.3	13.8

14. Primary Outcome

Title	Anti-PilA Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine
Description	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.
Time Frame	At Month 26

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	10-10-10-AS	10-10-3-AS	PLACEBO
Arm/Group Description	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.	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.	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.
Measure Participants	26	26	27
Geometric Mean (95% Confidence Interval) [EU/mL]	96.4	171.6	13

15. Primary Outcome

Title	Anti-PilA Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine
Description	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.
Time Frame	At Month 32

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	10-10-10-AS	10-10-3-AS	PLACEBO
Arm/Group Description	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.	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.	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.
Measure Participants	25	26	27
Geometric Mean (95% Confidence Interval) [EU/mL]	79.7	166.9	10

16. Primary Outcome

Title	Anti-PilA Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine
Description	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.
Time Frame	At Month 38

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	10-10-10-AS	10-10-3-AS	PLACEBO
Arm/Group Description	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.	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.	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.
Measure Participants	24	26	27
Geometric Mean (95% Confidence Interval) [EU/mL]	68	147.5	9.6

17. Primary Outcome

Title	Anti-PilA Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine
Description	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.
Time Frame	At Month 44

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	10-10-10-AS	10-10-3-AS	PLACEBO
Arm/Group Description	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.	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.	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.
Measure Participants	25	26	27
Geometric Mean (95% Confidence Interval) [EU/mL]	60.8	122.5	10.2

18. Primary Outcome

Title	Anti-PilA Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine
Description	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.
Time Frame	At Month 50

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	10-10-10-AS	10-10-3-AS	PLACEBO
Arm/Group Description	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.	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.	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.
Measure Participants	25	23	27
Geometric Mean (95% Confidence Interval) [EU/mL]	54.2	106.5	9.8

19. Primary Outcome

Title	Anti-ubiquitous Surface Protein A2 of Moraxella Catarrhalis (UspA2) Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine
Description	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.
Time Frame	At Month 20

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	10-10-10-AS	10-10-3-AS	PLACEBO
Arm/Group Description	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.	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.	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.
Measure Participants	27	26	28
Geometric Mean (95% Confidence Interval) [EU/mL]	719	578.2	456.1

20. Primary Outcome

Title	Anti-UspA2 Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine
Description	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.
Time Frame	At Month 26

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	10-10-10-AS	10-10-3-AS	PLACEBO
Arm/Group Description	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.	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.	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.
Measure Participants	26	26	27
Geometric Mean (95% Confidence Interval) [EU/mL]	791.1	621.6	480.4

21. Primary Outcome

Title	Anti-UspA2 Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine
Description	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.
Time Frame	At Month 32

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	10-10-10-AS	10-10-3-AS	PLACEBO
Arm/Group Description	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.	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.	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.
Measure Participants	25	26	26
Geometric Mean (95% Confidence Interval) [EU/mL]	666.6	530.5	434.7

22. Primary Outcome

Title	Anti-UspA2 Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine
Description	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.
Time Frame	At Month 38

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	10-10-10-AS	10-10-3-AS	PLACEBO
Arm/Group Description	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.	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.	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.
Measure Participants	24	26	27
Geometric Mean (95% Confidence Interval) [EU/mL]	662.3	556.6	453.2

23. Primary Outcome

Title	Anti-UspA2 Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine
Description	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.
Time Frame	At Month 44

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	10-10-10-AS	10-10-3-AS	PLACEBO
Arm/Group Description	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.	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.	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.
Measure Participants	25	26	27
Geometric Mean (95% Confidence Interval) [EU/mL]	561.5	400.1	339.4

24. Primary Outcome

Title	Anti-UspA2 Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine
Description	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.
Time Frame	At Month 50

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	10-10-10-AS	10-10-3-AS	PLACEBO
Arm/Group Description	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.	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.	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.
Measure Participants	25	23	27
Geometric Mean (95% Confidence Interval) [EU/mL]	536.8	404.5	374.9

25. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	10-10-10-AS	10-10-3-AS	PLACEBO
Arm/Group Description	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.	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.	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.
Measure Participants	27	26	28
Count of Participants [Participants]	5 18.5%	2 7.7%	2 7.1%

26. Secondary Outcome

Title	Number of Subjects Reported With Any Potential Immune-mediated Disease (pIMD)
Description	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.
Time Frame	From first visit (Month 20) up to study conclusion (Month 50)

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	10-10-10-AS	10-10-3-AS	PLACEBO
Arm/Group Description	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.	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.	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.
Measure Participants	27	26	28
Count of Participants [Participants]	0 0%	1 3.8%	0 0%

Adverse Events

Time Frame	SAEs were collected from first visit (Month 20) up to study conclusion (Month 50). Other adverse events were not collected during the study period.
Adverse Event Reporting Description	Other AEs are not collected in the study as no administration of vaccine.
Arm/Group Title	10-10-10-AS		10-10-3-AS		PLACEBO
Arm/Group Description	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.		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.		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.
All Cause Mortality
	10-10-10-AS		10-10-3-AS		PLACEBO
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/27 (3.7%)		0/26 (0%)		0/28 (0%)
Serious Adverse Events
	10-10-10-AS		10-10-3-AS		PLACEBO
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	5/27 (18.5%)		2/26 (7.7%)		2/28 (7.1%)
Gastrointestinal disorders
Ileus	1/27 (3.7%)	1	0/26 (0%)	0	0/28 (0%)	0
Ileus paralytic	1/27 (3.7%)	1	0/26 (0%)	0	0/28 (0%)	0
Intestinal obstruction	1/27 (3.7%)	1	0/26 (0%)	0	0/28 (0%)	0
Infections and infestations
Postoperative wound infection	1/27 (3.7%)	1	0/26 (0%)	0	0/28 (0%)	0
Injury, poisoning and procedural complications
Humerus fracture	1/27 (3.7%)	1	0/26 (0%)	0	0/28 (0%)	0
Post procedural fever	1/27 (3.7%)	1	0/26 (0%)	0	0/28 (0%)	0
Tendon rupture	1/27 (3.7%)	1	0/26 (0%)	0	0/28 (0%)	0
Tibia fracture	0/27 (0%)	0	0/26 (0%)	0	1/28 (3.6%)	1
Musculoskeletal and connective tissue disorders
Spinal stenosis	0/27 (0%)	0	1/26 (3.8%)	1	0/28 (0%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant	1/27 (3.7%)	1	0/26 (0%)	0	0/28 (0%)	0
Schwannoma	1/27 (3.7%)	1	0/26 (0%)	0	0/28 (0%)	0
Nervous system disorders
Ischaemic stroke	0/27 (0%)	0	1/26 (3.8%)	1	0/28 (0%)	0
Renal and urinary disorders
Nephrolithiasis	0/27 (0%)	0	0/26 (0%)	0	1/28 (3.6%)	1
Other (Not Including Serious) Adverse Events
	10-10-10-AS		10-10-3-AS		PLACEBO
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)		0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.