| Primary | Number of Subjects With Any Solicited Local Adverse Events (AEs) | Assessed solicited local symptoms are pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. | Analysis was performed on the total vaccinated cohort which included all subjects with at least one vaccine administration documented. | Posted | | Count of Participants | | Participants | | During a 7-day follow-up period (Day 0 to Day 6) after first dose. | | | | ID | Title | Description |
|---|
| OG000 | GSK3277513A F1 Group | Subjects, 18 - 40 years, receiving two doses of the non adjuvanted GSK Biologicals' NTHi Mcat investigational vaccine (GSK3277513A ) containing formulation 1 (F1) of PD, PE-PilA and UspA2 during Step 1 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed. | | OG001 | GSK3277513A F2 Group | Subjects, 50 - 70 years, receiving two doses of the GSK Biologicals' NTHi-Mcat investigational vaccine(GSK3277513A) containing formulation 2 (F2) (adjuvanted) of PD, PE-PilA and UspA2 during Step 2 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed. | | OG002 | GSK3277513A F3 Group | Subjects, 50 - 70 years, receiving two doses of the GSK Biologicals' NTHi-Mcat investigational vaccine(GSK3277513A) containing formulation 3 (F3) (adjuvanted) of PD, PE-PilA and UspA2 during Step 2 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed. | | OG003 | PLACEBO Group | Subjects, 18 - 40 years, receiving two doses of placebo (saline solution) during Step 1 of the study and subjects, 50 - 70 years, receiving two doses of placebo (saline solution) during Step 2 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed. |
| | Units | Counts |
|---|
| Participants | - OG00015
- OG00131
- OG00230
- OG003
|
| | Title | Denominators | Categories |
|---|
| Any Pain | | | Title | Measurements |
|---|
| - OG0002
- OG00119
- OG00226
- OG003
|
|
| |
| Primary | Number of Subjects With Any Solicited Local Adverse Events (AEs) | Assessed solicited local symptoms are pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. | Analysis was performed on the total vaccinated cohort which included all subjects with at least one vaccine administration documented. | Posted | | Count of Participants | | Participants | | During a 7-day follow-up period (Day 60 to Day 66) after second dose | | | | ID | Title | Description |
|---|
| OG000 | GSK3277513A F1 Group | Subjects, 18 - 40 years, receiving two doses of the non adjuvanted GSK Biologicals' NTHi Mcat investigational vaccine (GSK3277513A ) containing formulation 1 (F1) of PD, PE-PilA and UspA2 during Step 1 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed. | | OG001 | GSK3277513A F2 Group | Subjects, 50 - 70 years, receiving two doses of the GSK Biologicals' NTHi-Mcat investigational vaccine(GSK3277513A) containing formulation 2 (F2) (adjuvanted) of PD, PE-PilA and UspA2 during Step 2 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed. | | OG002 |
|
| Primary | Number of Subjects With Any Solicited General Adverse Events (AEs) | Assessed solicited general symptoms are fatigue, gastrointestinal symptoms, headache, myalgia, fever [defined as oral temperature equal to or above 37.5 degrees Celsius (°C)]. | Analysis was performed on the total vaccinated cohort which included all subjects with at least one vaccine administration documented. | Posted | | Count of Participants | | Participants | | During a 7-day follow-up period (Day 0 to Day 6) after first dose. | | | | ID | Title | Description |
|---|
| OG000 | GSK3277513A F1 Group | Subjects, 18 - 40 years, receiving two doses of the non adjuvanted GSK Biologicals' NTHi Mcat investigational vaccine (GSK3277513A ) containing formulation 1 (F1) of PD, PE-PilA and UspA2 during Step 1 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed. | | OG001 | GSK3277513A F2 Group | Subjects, 50 - 70 years, receiving two doses of the GSK Biologicals' NTHi-Mcat investigational vaccine(GSK3277513A) containing formulation 2 (F2) (adjuvanted) of PD, PE-PilA and UspA2 during Step 2 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed. | |
|
| Primary | Number of Subjects With Any Solicited General Adverse Events (AEs) | Assessed solicited general symptoms are fatigue, gastrointestinal symptoms, headache, myalgia, fever [defined as oral temperature equal to or above 37.5 degrees Celsius (°C)]. | Analysis was performed on the total vaccinated cohort which included all subjects with at least one vaccine administration documented. | Posted | | Count of Participants | | Participants | | During a 7-day follow-up period (Day 60 to Day 66) after second dose. | | | | ID | Title | Description |
|---|
| OG000 | GSK3277513A F1 Group | Subjects, 18 - 40 years, receiving two doses of the non adjuvanted GSK Biologicals' NTHi Mcat investigational vaccine (GSK3277513A ) containing formulation 1 (F1) of PD, PE-PilA and UspA2 during Step 1 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed. | | OG001 | GSK3277513A F2 Group | Subjects, 50 - 70 years, receiving two doses of the GSK Biologicals' NTHi-Mcat investigational vaccine(GSK3277513A) containing formulation 2 (F2) (adjuvanted) of PD, PE-PilA and UspA2 during Step 2 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed. | |
|
| Primary | Number of Subjects With Any Unsolicited Adverse Events (AEs). | Assessed unsolicited AEs cover any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any is defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. | Analysis was performed on the total vaccinated cohort which included all subjects with at least one vaccine administration documented. | Posted | | Count of Participants | | Participants | | During a 30-day follow-up period (Day 0 to Day 29) after first dose. | | | | ID | Title | Description |
|---|
| OG000 | GSK3277513A F1 Group | Subjects, 18 - 40 years, receiving two doses of the non adjuvanted GSK Biologicals' NTHi Mcat investigational vaccine (GSK3277513A ) containing formulation 1 (F1) of PD, PE-PilA and UspA2 during Step 1 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed. | | OG001 | GSK3277513A F2 Group | Subjects, 50 - 70 years, receiving two doses of the GSK Biologicals' NTHi-Mcat investigational vaccine(GSK3277513A) containing formulation 2 (F2) (adjuvanted) of PD, PE-PilA and UspA2 during Step 2 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed. |
|
| Primary | Number of Subjects With Any Unsolicited Adverse Events (AEs) | Assessed unsolicited AEs cover any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any is defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. | Analysis was performed on the total vaccinated cohort which included all subjects with at least one vaccine administration documented. | Posted | | Count of Participants | | Participants | | During a 30-day follow-up period (Day 60 to Day 89) after second dose | | | | ID | Title | Description |
|---|
| OG000 | GSK3277513A F1 Group | Subjects, 18 - 40 years, receiving two doses of the non adjuvanted GSK Biologicals' NTHi Mcat investigational vaccine (GSK3277513A ) containing formulation 1 (F1) of PD, PE-PilA and UspA2 during Step 1 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed. | | OG001 | GSK3277513A F2 Group | Subjects, 50 - 70 years, receiving two doses of the GSK Biologicals' NTHi-Mcat investigational vaccine(GSK3277513A) containing formulation 2 (F2) (adjuvanted) of PD, PE-PilA and UspA2 during Step 2 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed. |
|
| Primary | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities, After Vaccination. | Assessed haematological parameters are complete blood cell count: Erythrocytes (RBC [red blood cells]), Leukocytes (WBC [white blood cells]), differential count (basophils, eosinophils, lymphocytes, monocytes, neutrophils), platelets count, and hemoglobin level below or above the normal laboratory ranges tabulated by time point. Assessed biochemical parameters are alanine aminotransferase [ALT], aspartate aminotransferase [AST] or creatinine below or above the normal laboratory ranges tabulated by time point. | Analysis was performed on the total vaccinated cohort which included all subjects with at least one vaccine administration documented. | Posted | | Count of Participants | | Participants | | At Day 7, post-dose 1. | | | | ID | Title | Description |
|---|
| OG000 | GSK3277513A F1 Group | Subjects, 18 - 40 years, receiving two doses of the non adjuvanted GSK Biologicals' NTHi Mcat investigational vaccine (GSK3277513A ) containing formulation 1 (F1) of PD, PE-PilA and UspA2 during Step 1 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed. | | OG001 | GSK3277513A F2 Group | Subjects, 50 - 70 years, receiving two doses of the GSK Biologicals' NTHi-Mcat investigational vaccine(GSK3277513A) containing formulation 2 (F2) (adjuvanted) of PD, PE-PilA and UspA2 during Step 2 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed. |
|
| Primary | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Assessed haematological parameters are complete blood cell count: Erythrocytes (RBC [red blood cells]), Leukocytes (WBC [white blood cells]), differential count (basophils, eosinophils, lymphocytes, monocytes, neutrophils), platelets count, and hemoglobin level below or above the normal laboratory ranges tabulated by time point. Assessed biochemical parameters are alanine aminotransferase [ALT], aspartate aminotransferase [AST] or creatinine below or above the normal laboratory ranges tabulated by time point. | Analysis was performed on the total vaccinated cohort which included all subjects with at least one vaccine administration documented. | Posted | | Count of Participants | | Participants | | At Day 60, post-dose 1. | | | | ID | Title | Description |
|---|
| OG000 | GSK3277513A F1 Group | Subjects, 18 - 40 years, receiving two doses of the non adjuvanted GSK Biologicals' NTHi Mcat investigational vaccine (GSK3277513A ) containing formulation 1 (F1) of PD, PE-PilA and UspA2 during Step 1 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed. | | OG001 | GSK3277513A F2 Group | Subjects, 50 - 70 years, receiving two doses of the GSK Biologicals' NTHi-Mcat investigational vaccine(GSK3277513A) containing formulation 2 (F2) (adjuvanted) of PD, PE-PilA and UspA2 during Step 2 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed. |
|
| Primary | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Assessed haematological parameters are complete blood cell count: Erythrocytes (RBC [red blood cells]), Leukocytes (WBC [white blood cells]), differential count (basophils, eosinophils, lymphocytes, monocytes, neutrophils), platelets count, and hemoglobin level below or above the normal laboratory ranges tabulated by time point. Assessed biochemical parameters are alanine aminotransferase [ALT], aspartate aminotransferase [AST] or creatinine below or above the normal laboratory ranges tabulated by time point. | Analysis was performed on the total vaccinated cohort which included all subjects with at least one vaccine administration documented. | Posted | | Count of Participants | | Participants | | At Day 67, post-dose 2. | | | | ID | Title | Description |
|---|
| OG000 | GSK3277513A F1 Group | Subjects, 18 - 40 years, receiving two doses of the non adjuvanted GSK Biologicals' NTHi Mcat investigational vaccine (GSK3277513A ) containing formulation 1 (F1) of PD, PE-PilA and UspA2 during Step 1 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed. | | OG001 | GSK3277513A F2 Group | Subjects, 50 - 70 years, receiving two doses of the GSK Biologicals' NTHi-Mcat investigational vaccine(GSK3277513A) containing formulation 2 (F2) (adjuvanted) of PD, PE-PilA and UspA2 during Step 2 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed. |
|
| Primary | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Assessed haematological parameters are complete blood cell count: Erythrocytes (RBC [red blood cells]), Leukocytes (WBC [white blood cells]), differential count (basophils, eosinophils, lymphocytes, monocytes, neutrophils), platelets count, and hemoglobin level below or above the normal laboratory ranges tabulated by time point. Assessed biochemical parameters are alanine aminotransferase [ALT], aspartate aminotransferase [AST] or creatinine below or above the normal laboratory ranges tabulated by time point. | Analysis was performed on the total vaccinated cohort which included all subjects with at least one vaccine administration documented. | Posted | | Count of Participants | | Participants | | At Day 210, post-dose 2. | | | | ID | Title | Description |
|---|
| OG000 | GSK3277513A F1 Group | Subjects, 18 - 40 years, receiving two doses of the non adjuvanted GSK Biologicals' NTHi Mcat investigational vaccine (GSK3277513A ) containing formulation 1 (F1) of PD, PE-PilA and UspA2 during Step 1 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed. | | OG001 | GSK3277513A F2 Group | Subjects, 50 - 70 years, receiving two doses of the GSK Biologicals' NTHi-Mcat investigational vaccine(GSK3277513A) containing formulation 2 (F2) (adjuvanted) of PD, PE-PilA and UspA2 during Step 2 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed. |
|
| Primary | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Assessed haematological parameters are complete blood cell count: Erythrocytes (RBC [red blood cells]), Leukocytes (WBC [white blood cells]), differential count (basophils, eosinophils, lymphocytes, monocytes, neutrophils), platelets count, and hemoglobin level below or above the normal laboratory ranges tabulated by time point. Assessed biochemical parameters are alanine aminotransferase [ALT], aspartate aminotransferase [AST] or creatinine below or above the normal laboratory ranges tabulated by time point. | Analysis was performed on the total vaccinated cohort which included all subjects with at least one vaccine administration documented. | Posted | | Count of Participants | | Participants | | At Day 420, post-dose 2. | | | | ID | Title | Description |
|---|
| OG000 | GSK3277513A F1 Group | Subjects, 18 - 40 years, receiving two doses of the non adjuvanted GSK Biologicals' NTHi Mcat investigational vaccine (GSK3277513A ) containing formulation 1 (F1) of PD, PE-PilA and UspA2 during Step 1 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed. | | OG001 | GSK3277513A F2 Group | Subjects, 50 - 70 years, receiving two doses of the GSK Biologicals' NTHi-Mcat investigational vaccine(GSK3277513A) containing formulation 2 (F2) (adjuvanted) of PD, PE-PilA and UspA2 during Step 2 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed. |
|
| Primary | Number of Subjects With Any Serious Adverse Events (SAEs) | Assessed SAEs include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. | Analysis was performed on the total vaccinated cohort which included all subjects with at least one vaccine administration documented. | Posted | | Count of Participants | | Participants | | From first vaccination up to study conclusion (Day 0 to Day 420) | | | | ID | Title | Description |
|---|
| OG000 | GSK3277513A F1 Group | Subjects, 18 - 40 years, receiving two doses of the non adjuvanted GSK Biologicals' NTHi Mcat investigational vaccine (GSK3277513A ) containing formulation 1 (F1) of PD, PE-PilA and UspA2 during Step 1 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed. | | OG001 | GSK3277513A F2 Group | Subjects, 50 - 70 years, receiving two doses of the GSK Biologicals' NTHi-Mcat investigational vaccine(GSK3277513A) containing formulation 2 (F2) (adjuvanted) of PD, PE-PilA and UspA2 during Step 2 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed. | |
|
| Primary | Number of Subjects With Any Potential Immune-mediated Diseases (pIMDs) | Potential immune-mediated diseases (pIMDs) are a subset of AEs 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 the total vaccinated cohort which included all subjects with at least one vaccine administration documented. | Posted | | Count of Participants | | Participants | | From first vaccination up to study conclusion (Day 0 to Day 420) | | | | ID | Title | Description |
|---|
| OG000 | GSK3277513A F1 Group | Subjects, 18 - 40 years, receiving two doses of the non adjuvanted GSK Biologicals' NTHi Mcat investigational vaccine (GSK3277513A ) containing formulation 1 (F1) of PD, PE-PilA and UspA2 during Step 1 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed. | | OG001 | GSK3277513A F2 Group | Subjects, 50 - 70 years, receiving two doses of the GSK Biologicals' NTHi-Mcat investigational vaccine(GSK3277513A) containing formulation 2 (F2) (adjuvanted) of PD, PE-PilA and UspA2 during Step 2 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed. |
|
| Secondary | Concentration of Antibodies Against the NTHi-Mcat Anti-PD (Protein D of Haemophilus Influenzae) Vaccine Component | Antibody concentrations are measured by enzyme-linked immunosorbent assay (ELISA) and expressed as geometric mean concentrations (GMCs) in ELISA units per millilitre (EL.U/mL). The cut-off of the assay is 153 EL.U/mL for anti-PD antibodies. | The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome variables were available. | Posted | | Geometric Mean | 95% Confidence Interval | EL.U/mL | | At Day 0 (pre-dose 1); at Day 30 and Day 60 (post-dose 1); at Day 90, Day 210 and Day 420 (post-dose2). | | | | ID | Title | Description |
|---|
| OG000 | GSK3277513A F1 Group | Subjects, 18 - 40 years, receiving two doses of the non adjuvanted GSK Biologicals' NTHi Mcat investigational vaccine (GSK3277513A ) containing formulation 1 (F1) of PD, PE-PilA and UspA2 during Step 1 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed. | | OG001 | GSK3277513A F2 Group | Subjects, 50 - 70 years, receiving two doses of the GSK Biologicals' NTHi-Mcat investigational vaccine(GSK3277513A) containing formulation 2 (F2) (adjuvanted) of PD, PE-PilA and UspA2 during Step 2 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed. |
|
| Secondary | Concentration of Antibodies Against the NTHi-Mcat Anti-PE (Protein E of Haemophilus Influenzae) Vaccine Component | Antibody concentrations are measured by enzyme-linked immunosorbent assay (ELISA) and expressed as geometric mean concentrations (GMCs) in ELISA units per millilitre (EL.U/mL). The cut-off of the assay is 25 EL.U/mL for anti-PE antibodies. | The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome variables were available. | Posted | | Geometric Mean | 95% Confidence Interval | EL.U/mL | | At Day 0 (pre-dose 1); at Day 30 and Day 60 (post-dose 1); at Day 90, Day 210 and Day 420 (post-dose2). | | | | ID | Title | Description |
|---|
| OG000 | GSK3277513A F1 Group | Subjects, 18 - 40 years, receiving two doses of the non adjuvanted GSK Biologicals' NTHi Mcat investigational vaccine (GSK3277513A ) containing formulation 1 (F1) of PD, PE-PilA and UspA2 during Step 1 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed. | | OG001 | GSK3277513A F2 Group | Subjects, 50 - 70 years, receiving two doses of the GSK Biologicals' NTHi-Mcat investigational vaccine(GSK3277513A) containing formulation 2 (F2) (adjuvanted) of PD, PE-PilA and UspA2 during Step 2 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed. |
|
| Secondary | Concentration of Antibodies Against the NTHi-Mcat Anti-PilA (Type IV Pili Subunit of Non-typeable Haemophilus Influenzae) Vaccine Component | Antibody concentrations are measured by enzyme-linked immunosorbent assay (ELISA) and expressed as geometric mean concentrations (GMCs) in ELISA units per millilitre (EL.U/mL). The cut-off of the assay is 7 EL.U/mL for anti-PilA antibodies. | The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome variables were available. | Posted | | Geometric Mean | 95% Confidence Interval | EL.U/mL | | At Day 0 (pre-dose 1); at Day 30 and Day 60 (post-dose 1); at Day 90 (post-dose2). | | | | ID | Title | Description |
|---|
| OG000 | GSK3277513A F1 Group | Subjects, 18 - 40 years, receiving two doses of the non adjuvanted GSK Biologicals' NTHi Mcat investigational vaccine (GSK3277513A ) containing formulation 1 (F1) of PD, PE-PilA and UspA2 during Step 1 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed. | | OG001 | GSK3277513A F2 Group | Subjects, 50 - 70 years, receiving two doses of the GSK Biologicals' NTHi-Mcat investigational vaccine(GSK3277513A) containing formulation 2 (F2) (adjuvanted) of PD, PE-PilA and UspA2 during Step 2 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed. |
|
| Secondary | Concentration of Antibodies Against the NTHi-Mcat Anti-PilA (Type IV Pili Subunit of Non-typeable Haemophilus Influenzae) Vaccine Component | Antibody concentrations are measured by enzyme-linked immunosorbent assay (ELISA) and expressed as geometric mean concentrations (GMCs) in ELISA units per millilitre (EL.U/mL). The cut-off of the assay is 16 EL.U/mL for anti-PilA antibodies. | The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome variables were available. | Posted | | Geometric Mean | 95% Confidence Interval | EL.U/mL | | At Day 210 and Day 420 (post-dose2). | | | | ID | Title | Description |
|---|
| OG000 | GSK3277513A F1 Group | Subjects, 18 - 40 years, receiving two doses of the non adjuvanted GSK Biologicals' NTHi Mcat investigational vaccine (GSK3277513A ) containing formulation 1 (F1) of PD, PE-PilA and UspA2 during Step 1 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed. | | OG001 | GSK3277513A F2 Group | Subjects, 50 - 70 years, receiving two doses of the GSK Biologicals' NTHi-Mcat investigational vaccine(GSK3277513A) containing formulation 2 (F2) (adjuvanted) of PD, PE-PilA and UspA2 during Step 2 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed. |
|
| Secondary | Concentration of Antibodies Against the NTHi-Mcat Anti-UspA2 (Ubiquitous Surface Protein A2 of Moraxella Catarrhalis) Vaccine Component | Antibody concentrations are measured by enzyme-linked immunosorbent assay (ELISA) and expressed as geometric mean concentrations (GMCs) in ELISA units per millilitre (EL.U/mL). The cut-off of the assay is 38 EL.U/mL for anti-UspA2 antibodies. | The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome variables were available. | Posted | | Geometric Mean | 95% Confidence Interval | EL.U/mL | | At Day 0 (pre-dose 1); at Day 30 and Day 60 (post-dose 1); at Day 90, Day 210 and Day 420 (post-dose2). | | | | ID | Title | Description |
|---|
| OG000 | GSK3277513A F1 Group | Subjects, 18 - 40 years, receiving two doses of the non adjuvanted GSK Biologicals' NTHi Mcat investigational vaccine (GSK3277513A ) containing formulation 1 (F1) of PD, PE-PilA and UspA2 during Step 1 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed. | | OG001 | GSK3277513A F2 Group | Subjects, 50 - 70 years, receiving two doses of the GSK Biologicals' NTHi-Mcat investigational vaccine(GSK3277513A) containing formulation 2 (F2) (adjuvanted) of PD, PE-PilA and UspA2 during Step 2 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed. |
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| Secondary | Frequency of Specific Cluster of Differentiation (CD)4+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response | Frequency of specific CD4+ T-cells are measured by flow cytometry intracellular cytokine staining (ICS) expressing two or more markers (such as Interleukin [IL]-2, IL-13, IL-17, Interferon gamma [FN-γ], Tumour necrosis factor alpha [TNF-α] and CD40L). The frequency of specific CD4+ T-cells are summarised [descriptive statistics: Mean and standard deviation (SD)] against each antigen (PD, PE, PilA and UspA2), by group in Step 2 at each time point during which blood samples are collected for CMI. | The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome variables were available. | Posted | | Mean | Standard Deviation | CD4+ T-cells/million cells | | At Day 0 (pre-dose 1); at Day 60 (post-dose 1); at Day 90, Day 210 and Day 420 (post-dose2). | | | | ID | Title | Description |
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| OG000 | GSK3277513A F2 Group | Subjects, 50 - 70 years, receiving two doses of the GSK Biologicals' NTHi-Mcat investigational vaccine(GSK3277513A) containing formulation 2 (F2) (adjuvanted) of PD, PE-PilA and UspA2 during Step 2 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed. | |
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| Secondary | Frequency of Specific CD8+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response | Frequency of specific CD8+ T-cells are measured by flow cytometry intracellular cytokine staining (ICS) expressing two or more markers (such as IL-2, IL-13, IL-17, IFN-γ, TNF-α and CD40L). The frequency of specific CD8+ T-cells are summarised [descriptive statistics: Mean and standard deviation (SD)] against each antigen (PD, PE, PilA and UspA2), by group in Step 2 at each time point during which blood samples are collected for CMI. | The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome variables were available. | Posted | | Mean | Standard Deviation | CD8+ T-cells/million cells | | At Day 0 (pre-dose 1); at Day 60 (post-dose 1); at Day 90, Day 210 and Day 420 (post-dose2). | | | | ID | Title | Description |
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| OG000 | GSK3277513A F2 Group | Subjects, 50 - 70 years, receiving two doses of the GSK Biologicals' NTHi-Mcat investigational vaccine(GSK3277513A) containing formulation 2 (F2) (adjuvanted) of PD, PE-PilA and UspA2 during Step 2 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed. | | OG001 | GSK3277513A F3 Group |
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