| Primary | Number of Subjects With Solicited Local Adverse Events | Assessed solicited local adverse events were pain, redness and swelling. Any = occurrence of any solicited local adverse event regardless of their intensity grade. Grade 3 Pain = significant pain at rest. Prevented normal every day activities. Grade 3 Redness/Swelling = redness/swelling spreading beyond 100 millimeters (mm) from injection site. | The analysis was performed on the Total Vaccinated Cohort - Adverse Event (AE) and Humoral Immunity Sub-cohort, which included all subjects with at least one vaccine administration documented, who filled in their symptom sheets. | Posted | | Count of Participants | | Participants | | During the 7-Day (Days 0-6) post-vaccination period | | | | ID | Title | Description |
|---|
| OG000 | GSK3390107A Group | Healthy male or female subjects, aged 18 or older at the time of screening, who received one dose of the investigational GSK3390107A vaccine, at Day 0, administered intramuscularly, into the deltoid region of the arm. | | OG001 | Placebo+GSK3390107A Group | Healthy male or female subjects, aged 18 or older at the time of screening, who received one dose of placebo at Day 0 and one dose of the investigational GSK3390107A vaccine at Month 6, administered intramuscularly, into the deltoid region of the arm. |
| | | Title | Denominators | Categories |
|---|
| Any Pain | | | | Grade 3 Pain | | |
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| Primary | Number of Subjects With Solicited General Adverse Events | Assessed solicited general adverse events were fatigue, fever [defined as axillary temperature higher than or equal to (≥) 37.5 degrees Celsius (°C)], gastrointestinal (gastro) adverse events [nausea, vomiting, diarrhoea and/or abdominal pain] and headache. Any = occurrence of any general adverse events regardless of intensity grade or relationship to vaccination. Grade 3 fatigue, gastrointestinal symptoms and headache = adverse event that prevented normal activities. Grade 3 fever = fever ≥ 39.5 °C. Related = adverse event assessed by the investigator as related to the vaccination. | The analysis was performed on the Total Vaccinated Cohort - AE and Humoral Immunity Sub-cohort, which included all subjects with at least one vaccine administration documented, who filled in their symptom sheets. | Posted | | Count of Participants | | Participants | | During the 7-Day (Days 0-6) post-vaccination period | | | | ID | Title | Description |
|---|
| OG000 | GSK3390107A Group | Healthy male or female subjects, aged 18 or older at the time of screening, who received one dose of the investigational GSK3390107A vaccine, at Day 0, administered intramuscularly, into the deltoid region of the arm. | | OG001 | Placebo+GSK3390107A Group | Healthy male or female subjects, aged 18 or older at the time of screening, who received one dose of placebo at Day 0 and one dose of the investigational GSK3390107A vaccine at Month 6, administered intramuscularly, into the deltoid region of the arm. |
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| Primary | Number of Subjects With Unsolicited Adverse Events (AEs) | An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset out-side the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. | The analysis was performed on the Total Vaccinated Cohort - AE and Humoral Immunity Sub-cohort, which included all subjects with at least one vaccine administration documented. | Posted | | Count of Participants | | Participants | | During the 30-Day (Days 0-29) post-vaccination period | | | | ID | Title | Description |
|---|
| OG000 | GSK3390107A Group | Healthy male or female subjects, aged 18 or older at the time of screening, who received one dose of the investigational GSK3390107A vaccine, at Day 0, administered intramuscularly, into the deltoid region of the arm. | | OG001 | Placebo+GSK3390107A Group | Healthy male or female subjects, aged 18 or older at the time of screening, who received one dose of placebo at Day 0 and one dose of the investigational GSK3390107A vaccine at Month 6, administered intramuscularly, into the deltoid region of the arm. |
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| Primary | Percentage of Subjects With Haematological Laboratory Abnormalities | Haematological parameters assessed included: complete blood count (red blood cells [RBC], neutrophils, lymphocytes, white blood cells [WBC], haemoglobin), as well as differential count and platelet count. Reference range indicators used were: high, low, normal. | The analysis was performed on the Total Vaccinated Cohort - AE and Humoral Immunity Sub-cohort, which included all subjects with at least one vaccine administration documented and with available results at Screening. | Posted | | Number | | Percentage of participants | | At Screening | | | | ID | Title | Description |
|---|
| OG000 | GSK3390107A Group | Healthy male or female subjects, aged 18 or older at the time of screening, who received one dose of the investigational GSK3390107A vaccine, at Day 0, administered intramuscularly, into the deltoid region of the arm. | | OG001 | Placebo+GSK3390107A Group | Healthy male or female subjects, aged 18 or older at the time of screening, who received one dose of placebo at Day 0 and one dose of the investigational GSK3390107A vaccine at Month 6, administered intramuscularly, into the deltoid region of the arm. |
| |
| Primary | Percentage of Subjects With Haematological Laboratory Abnormalities | Haematological parameters assessed included: complete blood count (red blood cells [RBC], neutrophils, lymphocytes, white blood cells [WBC], haemoglobin), as well as differential count and platelet count. Reference range indicators used were: high, low, normal. | The analysis was performed on the Total Vaccinated Cohort - AE and Humoral Immunity Sub-cohort, which included all subjects with at least one vaccine administration documented and with available results at Day 3. | Posted | | Number | | Percentage of participants | | At Day 3 | | | | ID | Title | Description |
|---|
| OG000 | GSK3390107A Group | Healthy male or female subjects, aged 18 or older at the time of screening, who received one dose of the investigational GSK3390107A vaccine, at Day 0, administered intramuscularly, into the deltoid region of the arm. | | OG001 | Placebo+GSK3390107A Group | Healthy male or female subjects, aged 18 or older at the time of screening, who received one dose of placebo at Day 0 and one dose of the investigational GSK3390107A vaccine at Month 6, administered intramuscularly, into the deltoid region of the arm. |
| |
| Primary | Percentage of Subjects With Haematological Laboratory Abnormalities | Haematological parameters assessed included: complete blood count (red blood cells [RBC], neutrophils, lymphocytes, white blood cells [WBC], haemoglobin), as well as differential count and platelet count. Reference range indicators used were: high, low, normal. | The analysis was performed on the Total Vaccinated Cohort - AE and Humoral Immunity Sub-cohort, which included all subjects with at least one vaccine administration documented and with available results at Day 6. | Posted | | Number | | Percentage of participants | | At Day 6 | | | | ID | Title | Description |
|---|
| OG000 | GSK3390107A Group | Healthy male or female subjects, aged 18 or older at the time of screening, who received one dose of the investigational GSK3390107A vaccine, at Day 0, administered intramuscularly, into the deltoid region of the arm. | | OG001 | Placebo+GSK3390107A Group | Healthy male or female subjects, aged 18 or older at the time of screening, who received one dose of placebo at Day 0 and one dose of the investigational GSK3390107A vaccine at Month 6, administered intramuscularly, into the deltoid region of the arm. |
| |
| Primary | Percentage of Subjects With Haematological Laboratory Abnormalities | Haematological parameters assessed included: complete blood count (red blood cells [RBC], neutrophils, lymphocytes, white blood cells [WBC], haemoglobin), as well as differential count and platelet count. Reference range indicators used were: high, low, normal. | The analysis was performed on the Total Vaccinated Cohort - AE and Humoral Immunity Sub-cohort, which included all subjects with at least one vaccine administration documented and with available results at Day 30. | Posted | | Number | | Percentage of participants | | At Day 30 | | | | ID | Title | Description |
|---|
| OG000 | GSK3390107A Group | Healthy male or female subjects, aged 18 or older at the time of screening, who received one dose of the investigational GSK3390107A vaccine, at Day 0, administered intramuscularly, into the deltoid region of the arm. | | OG001 | Placebo+GSK3390107A Group | Healthy male or female subjects, aged 18 or older at the time of screening, who received one dose of placebo at Day 0 and one dose of the investigational GSK3390107A vaccine at Month 6, administered intramuscularly, into the deltoid region of the arm. |
| |
| Primary | Percentage of Subjects With Haematological Laboratory Abnormalities | Haematological parameters assessed included: complete blood count (red blood cells [RBC], neutrophils, lymphocytes, white blood cells [WBC], haemoglobin), as well as differential count and platelet count. Reference range indicators used were: high, low, normal. | The analysis was performed on the Total Vaccinated Cohort - AE and Humoral Immunity Sub-cohort, which included all subjects with at least one vaccine administration documented and with available results at Month 6. | Posted | | Number | | Percentage of participants | | At Month 6 | | | | ID | Title | Description |
|---|
| OG000 | GSK3390107A Group | Healthy male or female subjects, aged 18 or older at the time of screening, who received one dose of the investigational GSK3390107A vaccine, at Day 0, administered intramuscularly, into the deltoid region of the arm. | | OG001 | Placebo+GSK3390107A Group | Healthy male or female subjects, aged 18 or older at the time of screening, who received one dose of placebo at Day 0 and one dose of the investigational GSK3390107A vaccine at Month 6, administered intramuscularly, into the deltoid region of the arm. |
| |
| Primary | Percentage of Subjects With Haematological Laboratory Abnormalities | Haematological parameters assessed included: complete blood count (red blood cells [RBC], neutrophils, lymphocytes, white blood cells [WBC], haemoglobin), as well as differential count and platelet count. Reference range indicators used were: high, low, normal. | The analysis was performed on the Total Vaccinated Cohort - AE and Humoral Immunity Sub-cohort, which included all subjects with at least one vaccine administration documented and with available results at Month 6 + 6 Days timepoint. | Posted | | Number | | Percentage of participants | | At Month 6 + 6 Days | | | | ID | Title | Description |
|---|
| OG000 | GSK3390107A Group | Healthy male or female subjects, aged 18 or older at the time of screening, who received one dose of the investigational GSK3390107A vaccine, at Day 0, administered intramuscularly, into the deltoid region of the arm. | | OG001 | Placebo+GSK3390107A Group | Healthy male or female subjects, aged 18 or older at the time of screening, who received one dose of placebo at Day 0 and one dose of the investigational GSK3390107A vaccine at Month 6, administered intramuscularly, into the deltoid region of the arm. |
| |
| Primary | Percentage of Subjects With Haematological Laboratory Abnormalities | Haematological parameters assessed included: complete blood count (red blood cells [RBC], neutrophils, lymphocytes, white blood cells [WBC], haemoglobin), as well as differential count and platelet count. Reference range indicators used were: high, low, normal. | The analysis was performed on the Total Vaccinated Cohort - AE and Humoral Immunity Sub-cohort, which included all subjects with at least one vaccine administration documented and with available results at Month 6 + 30 Days timepoint. | Posted | | Number | | Percentage of participants | | At Month 6 + 30 Days | | | | ID | Title | Description |
|---|
| OG000 | GSK3390107A Group | Healthy male or female subjects, aged 18 or older at the time of screening, who received one dose of the investigational GSK3390107A vaccine, at Day 0, administered intramuscularly, into the deltoid region of the arm. | | OG001 | Placebo+GSK3390107A Group | Healthy male or female subjects, aged 18 or older at the time of screening, who received one dose of placebo at Day 0 and one dose of the investigational GSK3390107A vaccine at Month 6, administered intramuscularly, into the deltoid region of the arm. |
| |
| Primary | Percentage of Subjects With Haematological Laboratory Abnormalities | Haematological parameters assessed included: complete blood count (red blood cells [RBC], neutrophils, lymphocytes, white blood cells [WBC], haemoglobin), as well as differential count and platelet count. Reference range indicators used were: high, low, normal. | The analysis was performed on the Total Vaccinated Cohort - AE and Humoral Immunity Sub-cohort, which included all subjects with at least one vaccine administration documented and with available results at Month 12. | Posted | | Number | | Percentage of participants | | At Month 12 | | | | ID | Title | Description |
|---|
| OG000 | GSK3390107A Group | Healthy male or female subjects, aged 18 or older at the time of screening, who received one dose of the investigational GSK3390107A vaccine, at Day 0, administered intramuscularly, into the deltoid region of the arm. | | OG001 | Placebo+GSK3390107A Group | Healthy male or female subjects, aged 18 or older at the time of screening, who received one dose of placebo at Day 0 and one dose of the investigational GSK3390107A vaccine at Month 6, administered intramuscularly, into the deltoid region of the arm. |
| |
| Primary | Percentage of Subjects With Biochemical Laboratory Abnormalities | Biochemical parameters assessed included: aminotransferase and creatinine. Reference range indicators used were: high, low, normal. | The analysis was performed on the Total Vaccinated Cohort - AE and Humoral Immunity Sub-cohort, which included all subjects with at least one vaccine administration documented and with available results at Screening. | Posted | | Number | | Percentage of participants | | At Screening | | | | ID | Title | Description |
|---|
| OG000 | GSK3390107A Group | Healthy male or female subjects, aged 18 or older at the time of screening, who received one dose of the investigational GSK3390107A vaccine, at Day 0, administered intramuscularly, into the deltoid region of the arm. | | OG001 | Placebo+GSK3390107A Group | Healthy male or female subjects, aged 18 or older at the time of screening, who received one dose of placebo at Day 0 and one dose of the investigational GSK3390107A vaccine at Month 6, administered intramuscularly, into the deltoid region of the arm. |
| |
| Primary | Percentage of Subjects With Biochemical Laboratory Abnormalities | Biochemical parameters assessed included: aminotransferase and creatinine. Reference range indicators used were: high, low, normal. | The analysis was performed on the Total Vaccinated Cohort - AE and Humoral Immunity Sub-cohort, which included all subjects with at least one vaccine administration documented and with available results at Day 3. | Posted | | Number | | Percentage of participants | | At Day 3 | | | | ID | Title | Description |
|---|
| OG000 | GSK3390107A Group | Healthy male or female subjects, aged 18 or older at the time of screening, who received one dose of the investigational GSK3390107A vaccine, at Day 0, administered intramuscularly, into the deltoid region of the arm. | | OG001 | Placebo+GSK3390107A Group | Healthy male or female subjects, aged 18 or older at the time of screening, who received one dose of placebo at Day 0 and one dose of the investigational GSK3390107A vaccine at Month 6, administered intramuscularly, into the deltoid region of the arm. |
| |
| Primary | Percentage of Subjects With Biochemical Laboratory Abnormalities | Biochemical parameters assessed included: aminotransferase and creatinine. Reference range indicators used were: high, low, normal. | The analysis was performed on the Total Vaccinated Cohort - AE and Humoral Immunity Sub-cohort, which included all subjects with at least one vaccine administration documented and with available results at Day 6. | Posted | | Number | | Percentage of participants | | At Day 6 | | | | ID | Title | Description |
|---|
| OG000 | GSK3390107A Group | Healthy male or female subjects, aged 18 or older at the time of screening, who received one dose of the investigational GSK3390107A vaccine, at Day 0, administered intramuscularly, into the deltoid region of the arm. | | OG001 | Placebo+GSK3390107A Group | Healthy male or female subjects, aged 18 or older at the time of screening, who received one dose of placebo at Day 0 and one dose of the investigational GSK3390107A vaccine at Month 6, administered intramuscularly, into the deltoid region of the arm. |
| |
| Primary | Percentage of Subjects With Biochemical Laboratory Abnormalities | Biochemical parameters assessed included: aminotransferase and creatinine. Reference range indicators used were: high, low, normal. | The analysis was performed on the Total Vaccinated Cohort - AE and Humoral Immunity Sub-cohort, which included all subjects with at least one vaccine administration documented and with available results at Day 30. | Posted | | Number | | Percentage of participants | | At Day 30 | | | | ID | Title | Description |
|---|
| OG000 | GSK3390107A Group | Healthy male or female subjects, aged 18 or older at the time of screening, who received one dose of the investigational GSK3390107A vaccine, at Day 0, administered intramuscularly, into the deltoid region of the arm. | | OG001 | Placebo+GSK3390107A Group | Healthy male or female subjects, aged 18 or older at the time of screening, who received one dose of placebo at Day 0 and one dose of the investigational GSK3390107A vaccine at Month 6, administered intramuscularly, into the deltoid region of the arm. |
| |
| Primary | Percentage of Subjects With Biochemical Laboratory Abnormalities | Biochemical parameters assessed included: aminotransferase and creatinine. Reference range indicators used were: high, low, normal. | The analysis was performed on the Total Vaccinated Cohort - AE and Humoral Immunity Sub-cohort, which included all subjects with at least one vaccine administration documented and with available results at Month 6. | Posted | | Number | | Percentage of participants | | At Month 6 | | | | ID | Title | Description |
|---|
| OG000 | GSK3390107A Group | Healthy male or female subjects, aged 18 or older at the time of screening, who received one dose of the investigational GSK3390107A vaccine, at Day 0, administered intramuscularly, into the deltoid region of the arm. | | OG001 | Placebo+GSK3390107A Group | Healthy male or female subjects, aged 18 or older at the time of screening, who received one dose of placebo at Day 0 and one dose of the investigational GSK3390107A vaccine at Month 6, administered intramuscularly, into the deltoid region of the arm. |
| |
| Primary | Percentage of Subjects With Biochemical Laboratory Abnormalities | Biochemical parameters assessed included: aminotransferase and creatinine. Reference range indicators used were: high, low, normal. | The analysis was performed on the Total Vaccinated Cohort - AE and Humoral Immunity Sub-cohort, which included all subjects with at least one vaccine administration documented and with available results at Month 6 + 6 Days timepoint. | Posted | | Number | | Percentage of participants | | At Month 6 + 6 Days | | | | ID | Title | Description |
|---|
| OG000 | GSK3390107A Group | Healthy male or female subjects, aged 18 or older at the time of screening, who received one dose of the investigational GSK3390107A vaccine, at Day 0, administered intramuscularly, into the deltoid region of the arm. | | OG001 | Placebo+GSK3390107A Group | Healthy male or female subjects, aged 18 or older at the time of screening, who received one dose of placebo at Day 0 and one dose of the investigational GSK3390107A vaccine at Month 6, administered intramuscularly, into the deltoid region of the arm. |
| |
| Primary | Percentage of Subjects With Biochemical Laboratory Abnormalities | Biochemical parameters assessed included: aminotransferase and creatinine. Reference range indicators used were: high, low, normal. | The analysis was performed on the Total Vaccinated Cohort - AE and Humoral Immunity Sub-cohort, which included all subjects with at least one vaccine administration documented and with available results at Month 6 + 30 Days timepoint. | Posted | | Number | | Percentage of participants | | At Month 6 + 30 Days | | | | ID | Title | Description |
|---|
| OG000 | GSK3390107A Group | Healthy male or female subjects, aged 18 or older at the time of screening, who received one dose of the investigational GSK3390107A vaccine, at Day 0, administered intramuscularly, into the deltoid region of the arm. | | OG001 | Placebo+GSK3390107A Group | Healthy male or female subjects, aged 18 or older at the time of screening, who received one dose of placebo at Day 0 and one dose of the investigational GSK3390107A vaccine at Month 6, administered intramuscularly, into the deltoid region of the arm. |
| |
| Primary | Percentage of Subjects With Biochemical Laboratory Abnormalities | Biochemical parameters assessed included: aminotransferase and creatinine. Reference range indicators used were: high, low, normal. | The analysis was performed on the Total Vaccinated Cohort - AE and Humoral Immunity Sub-cohort, which included all subjects with at least one vaccine administration documented and with available results at Month 12. | Posted | | Number | | Percentage of participants | | At Month 12 | | | | ID | Title | Description |
|---|
| OG000 | GSK3390107A Group | Healthy male or female subjects, aged 18 or older at the time of screening, who received one dose of the investigational GSK3390107A vaccine, at Day 0, administered intramuscularly, into the deltoid region of the arm. | | OG001 | Placebo+GSK3390107A Group | Healthy male or female subjects, aged 18 or older at the time of screening, who received one dose of placebo at Day 0 and one dose of the investigational GSK3390107A vaccine at Month 6, administered intramuscularly, into the deltoid region of the arm. |
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| Primary | Number of Subjects With Adverse Events of Specific Interest (AESI) | AESI included clinical symptoms of thrombocytopenia. | The analysis was performed on the Total Vaccinated Cohort - AE and Humoral Immunity Sub-cohort, which included all subjects with at least one vaccine administration documented. | Posted | | Count of Participants | | Participants | | During the 7-Day (Days 0-6) post-vaccination period | | | | ID | Title | Description |
|---|
| OG000 | GSK3390107A Group | Healthy male or female subjects, aged 18 or older at the time of screening, who received one dose of the investigational GSK3390107A vaccine, at Day 0, administered intramuscularly, into the deltoid region of the arm. | | OG001 | Placebo+GSK3390107A Group | Healthy male or female subjects, aged 18 or older at the time of screening, who received one dose of placebo at Day 0 and one dose of the investigational GSK3390107A vaccine at Month 6, administered intramuscularly, into the deltoid region of the arm. |
| |
| Primary | Number of Subjects With Serious Adverse Events (SAEs) | Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. | The 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 the entire study period (up to Month 12) | | | | ID | Title | Description |
|---|
| OG000 | GSK3390107A Group | Healthy male or female subjects, aged 18 or older at the time of screening, who received one dose of the investigational GSK3390107A vaccine, at Day 0, administered intramuscularly, into the deltoid region of the arm. | | OG001 | Placebo+GSK3390107A Group | Healthy male or female subjects, aged 18 or older at the time of screening, who received one dose of placebo at Day 0 and one dose of the investigational GSK3390107A vaccine at Month 6, administered intramuscularly, into the deltoid region of the arm. |
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| Secondary | Concentrations of Anti-glycoprotein Ebola Zaire Virus (Anti-GP EBOV) | Anti-GP EBOV antibody concentrations were measured by Enzyme-Linked Immunosorbent Assay (ELISA), presented as geometric mean concentrations (GMC), and expressed in ELISA units per milliliter (EU/mL). | The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity - AE and Humoral Immunity Sub-cohort, which included all evaluable subjects for whom data concerning immunogenicity outcome measure were available. | Posted | | Geometric Mean | 95% Confidence Interval | EU/mL | | At Day 0, Day 30, Month 6 and Month 12 | | | | ID | Title | Description |
|---|
| OG000 | GSK3390107A Group | Healthy male or female subjects, aged 18 or older at the time of screening, who received one dose of the investigational GSK3390107A vaccine, at Day 0, administered intramuscularly, into the deltoid region of the arm. | | OG001 | Placebo+GSK3390107A Group | Healthy male or female subjects, aged 18 or older at the time of screening, who received one dose of placebo at Day 0 and one dose of the investigational GSK3390107A vaccine at Month 6, administered intramuscularly, into the deltoid region of the arm. |
| |
| Secondary | Percentage of Seronegative/Seropositive Subjects for Anti-GP EBOV Antibodies | A seronegative subject (S-) is a subject whose titer is below (<) 36.11 EU/mL. A seropositive subject (S+) is a subject whose titer is greater than or equal to (≥) 36.11 EU/mL. | The analysis was performed on the According-to-Protocol (ATP) cohort for Immunogenicity - AE and Humoral Immunity Sub-cohort, which included all evaluable subjects for whom data concerning immunogenicity outcome measure were available. | Posted | | Number | | Percentage of participants | | At Day 0, Day 30, Month 6 and Month 12 | | | | ID | Title | Description |
|---|
| OG000 | GSK3390107A Group | Healthy male or female subjects, aged 18 or older at the time of screening, who received one dose of the investigational GSK3390107A vaccine, at Day 0, administered intramuscularly, into the deltoid region of the arm. | | OG001 | Placebo+GSK3390107A Group | Healthy male or female subjects, aged 18 or older at the time of screening, who received one dose of placebo at Day 0 and one dose of the investigational GSK3390107A vaccine at Month 6, administered intramuscularly, into the deltoid region of the arm. |
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