Trial Outcomes & Findings for A Study to Evaluate the Safety and Immunogenicity of a Candidate Ebola Vaccine in Adults (NCT NCT02485301)

Results Overview

Biochemical parameters assessed included: aminotransferase and creatinine. Reference range indicators used were: high, low, normal.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

3024 participants

Primary outcome timeframe

At Month 6 + 30 Days

Results posted on

2018-01-04

Participant Flow

During the screening period the following steps took place: signing of informed consent, checking of inclusion/exclusion criteria, demographic data collection, medical history collection, physical examination, pregnancy testing.

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	1509	1504
Overall Study COMPLETED	1471	1455
Overall Study NOT COMPLETED	38	49

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.
Overall Study Serious Adverse Events	2	1
Overall Study Protocol Violation	0	1
Overall Study Withdrawal by Subject	6	7
Overall Study Migrated/moved from study area	10	19
Overall Study Lost to Follow-up	17	17
Overall Study Other	3	4

Baseline Characteristics

A Study to Evaluate the Safety and Immunogenicity of a Candidate Ebola Vaccine in Adults

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	GSK3390107A Group n=1509 Participants 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.	Placebo+GSK3390107A Group n=1504 Participants 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.	Total n=3013 Participants Total of all reporting groups
Age, Continuous	32.4 Years STANDARD_DEVIATION 12.71 • n=5 Participants	33.0 Years STANDARD_DEVIATION 12.43 • n=7 Participants	32.7 Years STANDARD_DEVIATION 12.57 • n=5 Participants
Sex/Gender, Customized Female	697 Participants n=5 Participants	690 Participants n=7 Participants	1387 Participants n=5 Participants
Sex/Gender, Customized Male	812 Participants n=5 Participants	814 Participants n=7 Participants	1626 Participants n=5 Participants
Race/Ethnicity, Customized Geographic ancestry · African heritage/African American	1505 Participants n=5 Participants	1501 Participants n=7 Participants	3006 Participants n=5 Participants
Race/Ethnicity, Customized Geographic ancestry · American Indian or Alaskan native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Geographic ancestry · Asian - Japanese heritage	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Geographic ancestry · Asian - South East Asian heritage	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants

PRIMARY outcome

Timeframe: During the 7-Day (Days 0-6) post-vaccination period

Population: 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.

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.

Outcome measures

Outcome measures
Measure	GSK3390107A Group n=748 Participants 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.	Placebo+GSK3390107A Group n=751 Participants 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.
Number of Subjects With Solicited Local Adverse Events Any Pain	356 Participants	57 Participants
Number of Subjects With Solicited Local Adverse Events Grade 3 Pain	3 Participants	0 Participants
Number of Subjects With Solicited Local Adverse Events Any Redness	2 Participants	0 Participants
Number of Subjects With Solicited Local Adverse Events Grade 3 Redness	0 Participants	0 Participants
Number of Subjects With Solicited Local Adverse Events Any Swelling	9 Participants	5 Participants
Number of Subjects With Solicited Local Adverse Events Grade 3 Swelling	0 Participants	0 Participants

PRIMARY outcome

Timeframe: During the 7-Day (Days 0-6) post-vaccination period

Population: 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.

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.

Outcome measures

Outcome measures
Measure	GSK3390107A Group n=748 Participants 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.	Placebo+GSK3390107A Group n=751 Participants 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.
Number of Subjects With Solicited General Adverse Events Grade 3 Fatigue	11 Participants	3 Participants
Number of Subjects With Solicited General Adverse Events Related Fatigue	243 Participants	72 Participants
Number of Subjects With Solicited General Adverse Events Any Fever	106 Participants	24 Participants
Number of Subjects With Solicited General Adverse Events Grade 3 Fever	3 Participants	0 Participants
Number of Subjects With Solicited General Adverse Events Related Fever	88 Participants	17 Participants
Number of Subjects With Solicited General Adverse Events Any Gastro	73 Participants	49 Participants
Number of Subjects With Solicited General Adverse Events Grade 3 Gastro	2 Participants	0 Participants
Number of Subjects With Solicited General Adverse Events Related Gastro	57 Participants	40 Participants
Number of Subjects With Solicited General Adverse Events Any Headache	345 Participants	136 Participants
Number of Subjects With Solicited General Adverse Events Grade 3 Headache	10 Participants	4 Participants
Number of Subjects With Solicited General Adverse Events Related Headache	306 Participants	104 Participants
Number of Subjects With Solicited General Adverse Events Any Fatigue	284 Participants	94 Participants

PRIMARY outcome

Timeframe: During the 30-Day (Days 0-29) post-vaccination period

Population: 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.

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.

Outcome measures

Outcome measures
Measure	GSK3390107A Group n=749 Participants 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.	Placebo+GSK3390107A Group n=751 Participants 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.
Number of Subjects With Unsolicited Adverse Events (AEs)	123 Participants	119 Participants

PRIMARY outcome

Timeframe: At Screening

Population: 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.

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.

Outcome measures

Outcome measures
Measure	GSK3390107A Group n=665 Participants 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.	Placebo+GSK3390107A Group n=667 Participants 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.
Percentage of Subjects With Haematological Laboratory Abnormalities RBC, High	14.6 Percentage of participants	16.6 Percentage of participants
Percentage of Subjects With Haematological Laboratory Abnormalities WBC, Normal	88.6 Percentage of participants	89.7 Percentage of participants
Percentage of Subjects With Haematological Laboratory Abnormalities Platelets, Normal	90.4 Percentage of participants	92.5 Percentage of participants
Percentage of Subjects With Haematological Laboratory Abnormalities Neutrophils, Low	50.2 Percentage of participants	48.3 Percentage of participants
Percentage of Subjects With Haematological Laboratory Abnormalities Neutrophils, Normal	49.5 Percentage of participants	51.5 Percentage of participants
Percentage of Subjects With Haematological Laboratory Abnormalities Neutrophils, High	0.3 Percentage of participants	0.2 Percentage of participants
Percentage of Subjects With Haematological Laboratory Abnormalities Lymphocytes, Low	0.9 Percentage of participants	1.0 Percentage of participants
Percentage of Subjects With Haematological Laboratory Abnormalities Lymphocytes, Normal	97.8 Percentage of participants	98.0 Percentage of participants
Percentage of Subjects With Haematological Laboratory Abnormalities Lymphocytes, High	1.4 Percentage of participants	1.0 Percentage of participants
Percentage of Subjects With Haematological Laboratory Abnormalities WBC, Low	9.3 Percentage of participants	8.7 Percentage of participants
Percentage of Subjects With Haematological Laboratory Abnormalities WBC, High	2.1 Percentage of participants	1.6 Percentage of participants
Percentage of Subjects With Haematological Laboratory Abnormalities Haemoglobin, Low	17.6 Percentage of participants	18.1 Percentage of participants
Percentage of Subjects With Haematological Laboratory Abnormalities Haemoglobin, Normal	80.6 Percentage of participants	79.5 Percentage of participants
Percentage of Subjects With Haematological Laboratory Abnormalities Haemoglobin, High	1.8 Percentage of participants	2.4 Percentage of participants
Percentage of Subjects With Haematological Laboratory Abnormalities Platelets, Low	2.9 Percentage of participants	1.8 Percentage of participants
Percentage of Subjects With Haematological Laboratory Abnormalities Platelets, High	6.8 Percentage of participants	5.7 Percentage of participants
Percentage of Subjects With Haematological Laboratory Abnormalities RBC, Low	14.6 Percentage of participants	14.2 Percentage of participants
Percentage of Subjects With Haematological Laboratory Abnormalities RBC, Normal	70.8 Percentage of participants	69.1 Percentage of participants

PRIMARY outcome

Timeframe: At Day 3

Population: 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.

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.

Outcome measures

Outcome measures
Measure	GSK3390107A Group n=659 Participants 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.	Placebo+GSK3390107A Group n=662 Participants 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.
Percentage of Subjects With Haematological Laboratory Abnormalities RBC, Low	19.0 Percentage of participants	20.4 Percentage of participants
Percentage of Subjects With Haematological Laboratory Abnormalities RBC, Normal	70.9 Percentage of participants	66.5 Percentage of participants
Percentage of Subjects With Haematological Laboratory Abnormalities RBC, High	10.2 Percentage of participants	13.1 Percentage of participants
Percentage of Subjects With Haematological Laboratory Abnormalities Neutrophils, Low	77.9 Percentage of participants	56.8 Percentage of participants
Percentage of Subjects With Haematological Laboratory Abnormalities Neutrophils, Normal	21.8 Percentage of participants	42.7 Percentage of participants
Percentage of Subjects With Haematological Laboratory Abnormalities Neutrophils, High	0.3 Percentage of participants	0.5 Percentage of participants
Percentage of Subjects With Haematological Laboratory Abnormalities Lymphocytes, Low	2.9 Percentage of participants	1.4 Percentage of participants
Percentage of Subjects With Haematological Laboratory Abnormalities Lymphocytes, Normal	96.4 Percentage of participants	97.8 Percentage of participants
Percentage of Subjects With Haematological Laboratory Abnormalities Lymphocytes, High	0.7 Percentage of participants	0.9 Percentage of participants
Percentage of Subjects With Haematological Laboratory Abnormalities WBC, Low	17.9 Percentage of participants	10.7 Percentage of participants
Percentage of Subjects With Haematological Laboratory Abnormalities WBC, Normal	80.7 Percentage of participants	87.8 Percentage of participants
Percentage of Subjects With Haematological Laboratory Abnormalities WBC, High	1.4 Percentage of participants	1.5 Percentage of participants
Percentage of Subjects With Haematological Laboratory Abnormalities Haemoglobin, Low	25.9 Percentage of participants	27.0 Percentage of participants
Percentage of Subjects With Haematological Laboratory Abnormalities Haemoglobin, Normal	72.5 Percentage of participants	72.2 Percentage of participants
Percentage of Subjects With Haematological Laboratory Abnormalities Haemoglobin, High	1.5 Percentage of participants	0.8 Percentage of participants
Percentage of Subjects With Haematological Laboratory Abnormalities Platelets, Low	2.3 Percentage of participants	2.3 Percentage of participants
Percentage of Subjects With Haematological Laboratory Abnormalities Platelets, Normal	94.1 Percentage of participants	91.8 Percentage of participants
Percentage of Subjects With Haematological Laboratory Abnormalities Platelets, High	3.6 Percentage of participants	5.9 Percentage of participants

PRIMARY outcome

Timeframe: At Day 6

Population: 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.

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.

Outcome measures

Outcome measures
Measure	GSK3390107A Group n=659 Participants 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.	Placebo+GSK3390107A Group n=664 Participants 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.
Percentage of Subjects With Haematological Laboratory Abnormalities Neutrophils, Normal	34.2 Percentage of participants	46.2 Percentage of participants
Percentage of Subjects With Haematological Laboratory Abnormalities Neutrophils, High	0.5 Percentage of participants	0.3 Percentage of participants
Percentage of Subjects With Haematological Laboratory Abnormalities Lymphocytes, Normal	97.8 Percentage of participants	96.2 Percentage of participants
Percentage of Subjects With Haematological Laboratory Abnormalities Platelets, High	6.1 Percentage of participants	6.2 Percentage of participants
Percentage of Subjects With Haematological Laboratory Abnormalities RBC, High	10.8 Percentage of participants	11.3 Percentage of participants
Percentage of Subjects With Haematological Laboratory Abnormalities Haemoglobin, High	0.5 Percentage of participants	0.6 Percentage of participants
Percentage of Subjects With Haematological Laboratory Abnormalities Platelets, Low	2.4 Percentage of participants	2.0 Percentage of participants
Percentage of Subjects With Haematological Laboratory Abnormalities Platelets, Normal	91.5 Percentage of participants	91.9 Percentage of participants
Percentage of Subjects With Haematological Laboratory Abnormalities Lymphocytes, Low	0.9 Percentage of participants	2.4 Percentage of participants
Percentage of Subjects With Haematological Laboratory Abnormalities Lymphocytes, High	1.4 Percentage of participants	1.4 Percentage of participants
Percentage of Subjects With Haematological Laboratory Abnormalities WBC, Low	14.7 Percentage of participants	10.7 Percentage of participants
Percentage of Subjects With Haematological Laboratory Abnormalities WBC, Normal	83.5 Percentage of participants	87.7 Percentage of participants
Percentage of Subjects With Haematological Laboratory Abnormalities WBC, High	1.8 Percentage of participants	1.7 Percentage of participants
Percentage of Subjects With Haematological Laboratory Abnormalities Haemoglobin, Low	28.2 Percentage of participants	27.4 Percentage of participants
Percentage of Subjects With Haematological Laboratory Abnormalities Haemoglobin, Normal	71.3 Percentage of participants	72.0 Percentage of participants
Percentage of Subjects With Haematological Laboratory Abnormalities RBC, Low	20.6 Percentage of participants	21.5 Percentage of participants
Percentage of Subjects With Haematological Laboratory Abnormalities RBC, Normal	68.6 Percentage of participants	67.2 Percentage of participants
Percentage of Subjects With Haematological Laboratory Abnormalities Neutrophils, Low	65.2 Percentage of participants	53.5 Percentage of participants

PRIMARY outcome

Timeframe: At Day 30

Population: 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.

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.

Outcome measures

Outcome measures
Measure	GSK3390107A Group n=658 Participants 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.	Placebo+GSK3390107A Group n=661 Participants 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.
Percentage of Subjects With Haematological Laboratory Abnormalities RBC, Low	15.8 Percentage of participants	17.4 Percentage of participants
Percentage of Subjects With Haematological Laboratory Abnormalities RBC, Normal	67.0 Percentage of participants	67.6 Percentage of participants
Percentage of Subjects With Haematological Laboratory Abnormalities RBC, High	17.2 Percentage of participants	15.0 Percentage of participants
Percentage of Subjects With Haematological Laboratory Abnormalities Neutrophils, Low	56.4 Percentage of participants	55.6 Percentage of participants
Percentage of Subjects With Haematological Laboratory Abnormalities Neutrophils, Normal	43.6 Percentage of participants	43.7 Percentage of participants
Percentage of Subjects With Haematological Laboratory Abnormalities Neutrophils, High	0 Percentage of participants	0.7 Percentage of participants
Percentage of Subjects With Haematological Laboratory Abnormalities Lymphocytes, Low	2.4 Percentage of participants	2.2 Percentage of participants
Percentage of Subjects With Haematological Laboratory Abnormalities Lymphocytes, Normal	96.2 Percentage of participants	97.3 Percentage of participants
Percentage of Subjects With Haematological Laboratory Abnormalities Lymphocytes, High	1.4 Percentage of participants	0.5 Percentage of participants
Percentage of Subjects With Haematological Laboratory Abnormalities WBC, Low	12.3 Percentage of participants	12.1 Percentage of participants
Percentage of Subjects With Haematological Laboratory Abnormalities WBC, Normal	86.8 Percentage of participants	86.5 Percentage of participants
Percentage of Subjects With Haematological Laboratory Abnormalities WBC, High	0.9 Percentage of participants	1.4 Percentage of participants
Percentage of Subjects With Haematological Laboratory Abnormalities Haemoglobin, High	23.4 Percentage of participants	23.0 Percentage of participants
Percentage of Subjects With Haematological Laboratory Abnormalities Haemoglobin, Normal	75.4 Percentage of participants	75.8 Percentage of participants
Percentage of Subjects With Haematological Laboratory Abnormalities Haemoglobin, Low	1.2 Percentage of participants	1.2 Percentage of participants
Percentage of Subjects With Haematological Laboratory Abnormalities Platelets, Low	3.3 Percentage of participants	2.3 Percentage of participants
Percentage of Subjects With Haematological Laboratory Abnormalities Platelets, Normal	92.6 Percentage of participants	91.5 Percentage of participants
Percentage of Subjects With Haematological Laboratory Abnormalities Platelets, High	4.1 Percentage of participants	6.2 Percentage of participants

PRIMARY outcome

Timeframe: At Month 6

Population: 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.

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.

Outcome measures

Outcome measures
Measure	GSK3390107A Group n=649 Participants 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.	Placebo+GSK3390107A Group n=645 Participants 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.
Percentage of Subjects With Haematological Laboratory Abnormalities RBC, Low	16.2 Percentage of participants	17.2 Percentage of participants
Percentage of Subjects With Haematological Laboratory Abnormalities RBC, Normal	69.5 Percentage of participants	67.9 Percentage of participants
Percentage of Subjects With Haematological Laboratory Abnormalities RBC, High	14.3 Percentage of participants	14.9 Percentage of participants
Percentage of Subjects With Haematological Laboratory Abnormalities Neutrophils, Low	50.9 Percentage of participants	50.2 Percentage of participants
Percentage of Subjects With Haematological Laboratory Abnormalities Neutrophils, Normal	48.6 Percentage of participants	49.5 Percentage of participants
Percentage of Subjects With Haematological Laboratory Abnormalities Neutrophils, High	0.5 Percentage of participants	0.3 Percentage of participants
Percentage of Subjects With Haematological Laboratory Abnormalities Lymphocytes, Low	1.7 Percentage of participants	1.6 Percentage of participants
Percentage of Subjects With Haematological Laboratory Abnormalities Lymphocytes, Normal	96.9 Percentage of participants	97.4 Percentage of participants
Percentage of Subjects With Haematological Laboratory Abnormalities Lymphocytes, High	1.4 Percentage of participants	1.0 Percentage of participants
Percentage of Subjects With Haematological Laboratory Abnormalities WBC, Low	13.3 Percentage of participants	10.9 Percentage of participants
Percentage of Subjects With Haematological Laboratory Abnormalities WBC, Normal	85.4 Percentage of participants	88.2 Percentage of participants
Percentage of Subjects With Haematological Laboratory Abnormalities WBC, High	1.4 Percentage of participants	0.9 Percentage of participants
Percentage of Subjects With Haematological Laboratory Abnormalities Haemoglobin, Low	30.5 Percentage of participants	29.0 Percentage of participants
Percentage of Subjects With Haematological Laboratory Abnormalities Haemoglobin, Normal	68.7 Percentage of participants	70.1 Percentage of participants
Percentage of Subjects With Haematological Laboratory Abnormalities Haemoglobin, High	0.8 Percentage of participants	0.9 Percentage of participants
Percentage of Subjects With Haematological Laboratory Abnormalities Platelets, Low	2.6 Percentage of participants	2.0 Percentage of participants
Percentage of Subjects With Haematological Laboratory Abnormalities Platelets, Normal	93.2 Percentage of participants	94.6 Percentage of participants
Percentage of Subjects With Haematological Laboratory Abnormalities Platelets, High	4.2 Percentage of participants	3.4 Percentage of participants

PRIMARY outcome

Timeframe: At Month 6 + 6 Days

Population: 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.

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.

Outcome measures

Outcome measures
Measure	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.	Placebo+GSK3390107A Group n=619 Participants 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.
Percentage of Subjects With Haematological Laboratory Abnormalities RBC, Low	—	18.6 Percentage of participants
Percentage of Subjects With Haematological Laboratory Abnormalities RBC, Normal	—	70.1 Percentage of participants
Percentage of Subjects With Haematological Laboratory Abnormalities RBC, High	—	11.3 Percentage of participants
Percentage of Subjects With Haematological Laboratory Abnormalities Neutrophils, Low	—	57.4 Percentage of participants
Percentage of Subjects With Haematological Laboratory Abnormalities Neutrophils, Normal	—	42.4 Percentage of participants
Percentage of Subjects With Haematological Laboratory Abnormalities Neutrophils, High	—	0.2 Percentage of participants
Percentage of Subjects With Haematological Laboratory Abnormalities Lymphocytes, Low	—	0.7 Percentage of participants
Percentage of Subjects With Haematological Laboratory Abnormalities Lymphocytes, Normal	—	97.8 Percentage of participants
Percentage of Subjects With Haematological Laboratory Abnormalities Lymphocytes, High	—	1.5 Percentage of participants
Percentage of Subjects With Haematological Laboratory Abnormalities WBC, Low	—	12.3 Percentage of participants
Percentage of Subjects With Haematological Laboratory Abnormalities WBC, Normal	—	86.4 Percentage of participants
Percentage of Subjects With Haematological Laboratory Abnormalities WBC, High	—	1.3 Percentage of participants
Percentage of Subjects With Haematological Laboratory Abnormalities Haemoglobin, Low	—	36.3 Percentage of participants
Percentage of Subjects With Haematological Laboratory Abnormalities Haemoglobin, Normal	—	63.2 Percentage of participants
Percentage of Subjects With Haematological Laboratory Abnormalities Haemoglobin, High	—	0.5 Percentage of participants
Percentage of Subjects With Haematological Laboratory Abnormalities Platelets, Low	—	1.8 Percentage of participants
Percentage of Subjects With Haematological Laboratory Abnormalities Platelets, Normal	—	94.5 Percentage of participants
Percentage of Subjects With Haematological Laboratory Abnormalities Platelets, High	—	3.7 Percentage of participants

PRIMARY outcome

Timeframe: At Month 6 + 30 Days

Population: 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.

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.

Outcome measures

Outcome measures
Measure	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.	Placebo+GSK3390107A Group n=616 Participants 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.
Percentage of Subjects With Haematological Laboratory Abnormalities RBC, Low	—	21.6 Percentage of participants
Percentage of Subjects With Haematological Laboratory Abnormalities RBC, Normal	—	66.1 Percentage of participants
Percentage of Subjects With Haematological Laboratory Abnormalities RBC, High	—	12.3 Percentage of participants
Percentage of Subjects With Haematological Laboratory Abnormalities Neutrophils, Low	—	55.9 Percentage of participants
Percentage of Subjects With Haematological Laboratory Abnormalities Neutrophils, Normal	—	43.7 Percentage of participants
Percentage of Subjects With Haematological Laboratory Abnormalities Neutrophils, High	—	0.4 Percentage of participants
Percentage of Subjects With Haematological Laboratory Abnormalities Lymphocytes, Low	—	2.0 Percentage of participants
Percentage of Subjects With Haematological Laboratory Abnormalities Lymphocytes, Normal	—	96.3 Percentage of participants
Percentage of Subjects With Haematological Laboratory Abnormalities Lymphocytes, High	—	1.6 Percentage of participants
Percentage of Subjects With Haematological Laboratory Abnormalities WBC, Low	—	11.4 Percentage of participants
Percentage of Subjects With Haematological Laboratory Abnormalities WBC, Normal	—	87.7 Percentage of participants
Percentage of Subjects With Haematological Laboratory Abnormalities WBC, High	—	1.0 Percentage of participants
Percentage of Subjects With Haematological Laboratory Abnormalities Haemoglobin, Low	—	34.3 Percentage of participants
Percentage of Subjects With Haematological Laboratory Abnormalities Haemoglobin, Normal	—	65.1 Percentage of participants
Percentage of Subjects With Haematological Laboratory Abnormalities Haemoglobin, High	—	0.6 Percentage of participants
Percentage of Subjects With Haematological Laboratory Abnormalities Platelets, Low	—	2.4 Percentage of participants
Percentage of Subjects With Haematological Laboratory Abnormalities Platelets, Normal	—	94.6 Percentage of participants
Percentage of Subjects With Haematological Laboratory Abnormalities Platelets, High	—	2.9 Percentage of participants

PRIMARY outcome

Timeframe: At Month 12

Population: 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.

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.

Outcome measures

Outcome measures
Measure	GSK3390107A Group n=627 Participants 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.	Placebo+GSK3390107A Group n=631 Participants 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.
Percentage of Subjects With Haematological Laboratory Abnormalities WBC, High	1.9 Percentage of participants	1.1 Percentage of participants
Percentage of Subjects With Haematological Laboratory Abnormalities Haemoglobin, Low	23.6 Percentage of participants	25.7 Percentage of participants
Percentage of Subjects With Haematological Laboratory Abnormalities Haemoglobin, Normal	74.6 Percentage of participants	73.4 Percentage of participants
Percentage of Subjects With Haematological Laboratory Abnormalities Haemoglobin, High	1.8 Percentage of participants	1.0 Percentage of participants
Percentage of Subjects With Haematological Laboratory Abnormalities Platelets, Low	1.9 Percentage of participants	1.7 Percentage of participants
Percentage of Subjects With Haematological Laboratory Abnormalities Platelets, Normal	91.9 Percentage of participants	91.9 Percentage of participants
Percentage of Subjects With Haematological Laboratory Abnormalities Platelets, High	6.2 Percentage of participants	6.3 Percentage of participants
Percentage of Subjects With Haematological Laboratory Abnormalities RBC, Low	15.3 Percentage of participants	17.9 Percentage of participants
Percentage of Subjects With Haematological Laboratory Abnormalities RBC, Normal	67.0 Percentage of participants	65.8 Percentage of participants
Percentage of Subjects With Haematological Laboratory Abnormalities RBC, High	17.7 Percentage of participants	16.3 Percentage of participants
Percentage of Subjects With Haematological Laboratory Abnormalities Neutrophils, Low	55.0 Percentage of participants	54.0 Percentage of participants
Percentage of Subjects With Haematological Laboratory Abnormalities Neutrophils, Normal	44.6 Percentage of participants	45.6 Percentage of participants
Percentage of Subjects With Haematological Laboratory Abnormalities Neutrophils, High	0.4 Percentage of participants	0.4 Percentage of participants
Percentage of Subjects With Haematological Laboratory Abnormalities Lymphocytes, Low	1.8 Percentage of participants	3.7 Percentage of participants
Percentage of Subjects With Haematological Laboratory Abnormalities Lymphocytes, Normal	96.9 Percentage of participants	95.0 Percentage of participants
Percentage of Subjects With Haematological Laboratory Abnormalities Lymphocytes, High	1.3 Percentage of participants	1.2 Percentage of participants
Percentage of Subjects With Haematological Laboratory Abnormalities WBC, Low	12.4 Percentage of participants	12.8 Percentage of participants
Percentage of Subjects With Haematological Laboratory Abnormalities WBC, Normal	85.6 Percentage of participants	86.1 Percentage of participants

PRIMARY outcome

Timeframe: At Screening

Population: 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.

Biochemical parameters assessed included: aminotransferase and creatinine. Reference range indicators used were: high, low, normal.

Outcome measures

Outcome measures
Measure	GSK3390107A Group n=665 Participants 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.	Placebo+GSK3390107A Group n=667 Participants 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.
Percentage of Subjects With Biochemical Laboratory Abnormalities Aminotransferase, Low	4.7 Percentage of participants	5.1 Percentage of participants
Percentage of Subjects With Biochemical Laboratory Abnormalities Aminotransferase, Normal	92.9 Percentage of participants	93.3 Percentage of participants
Percentage of Subjects With Biochemical Laboratory Abnormalities Aminotransferase, High	2.4 Percentage of participants	1.6 Percentage of participants
Percentage of Subjects With Biochemical Laboratory Abnormalities Creatinine, Low	0 Percentage of participants	0.4 Percentage of participants
Percentage of Subjects With Biochemical Laboratory Abnormalities Creatinine, Normal	95.2 Percentage of participants	93.6 Percentage of participants
Percentage of Subjects With Biochemical Laboratory Abnormalities Creatinine, High	4.8 Percentage of participants	6.0 Percentage of participants

PRIMARY outcome

Timeframe: At Day 3

Population: 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.

Biochemical parameters assessed included: aminotransferase and creatinine. Reference range indicators used were: high, low, normal.

Outcome measures

Outcome measures
Measure	GSK3390107A Group n=660 Participants 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.	Placebo+GSK3390107A Group n=662 Participants 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.
Percentage of Subjects With Biochemical Laboratory Abnormalities Aminotransferase, Low	5.3 Percentage of participants	6.3 Percentage of participants
Percentage of Subjects With Biochemical Laboratory Abnormalities Aminotransferase, Normal	90.6 Percentage of participants	91.5 Percentage of participants
Percentage of Subjects With Biochemical Laboratory Abnormalities Aminotransferase, High	4.1 Percentage of participants	2.1 Percentage of participants
Percentage of Subjects With Biochemical Laboratory Abnormalities Creatinine, Low	0 Percentage of participants	0.2 Percentage of participants
Percentage of Subjects With Biochemical Laboratory Abnormalities Creatinine, Normal	94.4 Percentage of participants	93.8 Percentage of participants
Percentage of Subjects With Biochemical Laboratory Abnormalities Creatinine, High	5.6 Percentage of participants	6.0 Percentage of participants

PRIMARY outcome

Timeframe: At Day 6

Population: 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.

Biochemical parameters assessed included: aminotransferase and creatinine. Reference range indicators used were: high, low, normal.

Outcome measures

Outcome measures
Measure	GSK3390107A Group n=659 Participants 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.	Placebo+GSK3390107A Group n=664 Participants 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.
Percentage of Subjects With Biochemical Laboratory Abnormalities Aminotransferase, Low	5.6 Percentage of participants	6.9 Percentage of participants
Percentage of Subjects With Biochemical Laboratory Abnormalities Aminotransferase, Normal	91.8 Percentage of participants	89.5 Percentage of participants
Percentage of Subjects With Biochemical Laboratory Abnormalities Aminotransferase, High	2.6 Percentage of participants	3.6 Percentage of participants
Percentage of Subjects With Biochemical Laboratory Abnormalities Creatinine, Low	0 Percentage of participants	0.2 Percentage of participants
Percentage of Subjects With Biochemical Laboratory Abnormalities Creatinine, Normal	96.4 Percentage of participants	93.8 Percentage of participants
Percentage of Subjects With Biochemical Laboratory Abnormalities Creatinine, High	3.6 Percentage of participants	6.0 Percentage of participants

PRIMARY outcome

Timeframe: At Day 30

Population: 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.

Biochemical parameters assessed included: aminotransferase and creatinine. Reference range indicators used were: high, low, normal.

Outcome measures

Outcome measures
Measure	GSK3390107A Group n=659 Participants 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.	Placebo+GSK3390107A Group n=663 Participants 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.
Percentage of Subjects With Biochemical Laboratory Abnormalities Aminotransferase, Low	7.0 Percentage of participants	5.7 Percentage of participants
Percentage of Subjects With Biochemical Laboratory Abnormalities Aminotransferase, Normal	90.6 Percentage of participants	91.6 Percentage of participants
Percentage of Subjects With Biochemical Laboratory Abnormalities Aminotransferase, High	2.4 Percentage of participants	2.7 Percentage of participants
Percentage of Subjects With Biochemical Laboratory Abnormalities Creatinine, Low	0.2 Percentage of participants	0.3 Percentage of participants
Percentage of Subjects With Biochemical Laboratory Abnormalities Creatinine, Normal	93.8 Percentage of participants	93.5 Percentage of participants
Percentage of Subjects With Biochemical Laboratory Abnormalities Creatinine, High	6.1 Percentage of participants	6.2 Percentage of participants

PRIMARY outcome

Timeframe: At Month 6

Population: 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.

Biochemical parameters assessed included: aminotransferase and creatinine. Reference range indicators used were: high, low, normal.

Outcome measures

Outcome measures
Measure	GSK3390107A Group n=649 Participants 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.	Placebo+GSK3390107A Group n=646 Participants 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.
Percentage of Subjects With Biochemical Laboratory Abnormalities Aminotransferase, Low	6.5 Percentage of participants	6.2 Percentage of participants
Percentage of Subjects With Biochemical Laboratory Abnormalities Aminotransferase, Normal	91.8 Percentage of participants	90.4 Percentage of participants
Percentage of Subjects With Biochemical Laboratory Abnormalities Aminotransferase, High	1.7 Percentage of participants	3.4 Percentage of participants
Percentage of Subjects With Biochemical Laboratory Abnormalities Creatinine. Low	6.2 Percentage of participants	7.1 Percentage of participants
Percentage of Subjects With Biochemical Laboratory Abnormalities Creatinine, Normal	92.9 Percentage of participants	92.1 Percentage of participants
Percentage of Subjects With Biochemical Laboratory Abnormalities Creatinine, High	0.9 Percentage of participants	0.8 Percentage of participants

PRIMARY outcome

Timeframe: At Month 6 + 6 Days

Population: 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.

Biochemical parameters assessed included: aminotransferase and creatinine. Reference range indicators used were: high, low, normal.

Outcome measures

Outcome measures
Measure	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.	Placebo+GSK3390107A Group n=619 Participants 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.
Percentage of Subjects With Biochemical Laboratory Abnormalities Aminotransferase, Low	—	6.1 Percentage of participants
Percentage of Subjects With Biochemical Laboratory Abnormalities Aminotransferase, Normal	—	91.3 Percentage of participants
Percentage of Subjects With Biochemical Laboratory Abnormalities Aminotransferase, High	—	2.6 Percentage of participants
Percentage of Subjects With Biochemical Laboratory Abnormalities Creatinine, Low	—	6.6 Percentage of participants
Percentage of Subjects With Biochemical Laboratory Abnormalities Creatinine, Normal	—	91.9 Percentage of participants
Percentage of Subjects With Biochemical Laboratory Abnormalities Creatinine, High	—	1.5 Percentage of participants

PRIMARY outcome

Timeframe: At Month 6 + 30 Days

Population: 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.

Biochemical parameters assessed included: aminotransferase and creatinine. Reference range indicators used were: high, low, normal.

Outcome measures

Outcome measures
Measure	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.	Placebo+GSK3390107A Group n=616 Participants 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.
Percentage of Subjects With Biochemical Laboratory Abnormalities Aminotransferase, Low	—	4.2 Percentage of participants
Percentage of Subjects With Biochemical Laboratory Abnormalities Aminotransferase, Normal	—	93.5 Percentage of participants
Percentage of Subjects With Biochemical Laboratory Abnormalities Aminotransferase, High	—	2.3 Percentage of participants
Percentage of Subjects With Biochemical Laboratory Abnormalities Creatinine, Low	—	8.0 Percentage of participants
Percentage of Subjects With Biochemical Laboratory Abnormalities Creatinine, Normal	—	91.1 Percentage of participants
Percentage of Subjects With Biochemical Laboratory Abnormalities Creatinine, High	—	1.0 Percentage of participants

PRIMARY outcome

Timeframe: At Month 12

Population: 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.

Biochemical parameters assessed included: aminotransferase and creatinine. Reference range indicators used were: high, low, normal.

Outcome measures

Outcome measures
Measure	GSK3390107A Group n=627 Participants 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.	Placebo+GSK3390107A Group n=631 Participants 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.
Percentage of Subjects With Biochemical Laboratory Abnormalities Aminotransferase, Low	6.9 Percentage of participants	6.7 Percentage of participants
Percentage of Subjects With Biochemical Laboratory Abnormalities Aminotransferase, Normal	90.7 Percentage of participants	89.7 Percentage of participants
Percentage of Subjects With Biochemical Laboratory Abnormalities Aminotransferase, High	2.4 Percentage of participants	3.6 Percentage of participants
Percentage of Subjects With Biochemical Laboratory Abnormalities Creatinine, Low	3.5 Percentage of participants	4.8 Percentage of participants
Percentage of Subjects With Biochemical Laboratory Abnormalities Creatinine, Normal	93.9 Percentage of participants	93.3 Percentage of participants
Percentage of Subjects With Biochemical Laboratory Abnormalities Creatinine, High	2.6 Percentage of participants	1.9 Percentage of participants

PRIMARY outcome

Timeframe: During the 7-Day (Days 0-6) post-vaccination period

Population: 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.

AESI included clinical symptoms of thrombocytopenia.

Outcome measures

Outcome measures
Measure	GSK3390107A Group n=749 Participants 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.	Placebo+GSK3390107A Group n=751 Participants 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.
Number of Subjects With Adverse Events of Specific Interest (AESI)	0 Participants	0 Participants

PRIMARY outcome

Timeframe: During the entire study period (up to Month 12)

Population: The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented.

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.

Outcome measures

Outcome measures
Measure	GSK3390107A Group n=1509 Participants 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.	Placebo+GSK3390107A Group n=1504 Participants 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.
Number of Subjects With Serious Adverse Events (SAEs)	11 Participants	18 Participants

SECONDARY outcome

Timeframe: At Day 0, Day 30, Month 6 and Month 12

Population: 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.

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).

Outcome measures

Outcome measures
Measure	GSK3390107A Group n=738 Participants 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.	Placebo+GSK3390107A Group n=733 Participants 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.
Concentrations of Anti-glycoprotein Ebola Zaire Virus (Anti-GP EBOV) Anti-GP EBOV, Day 0	31.961 EU/mL Interval 29.401 to 34.745	31.954 EU/mL Interval 29.405 to 34.724
Concentrations of Anti-glycoprotein Ebola Zaire Virus (Anti-GP EBOV) Anti-GP EBOV, Day 30	900.025 EU/mL Interval 823.688 to 983.437	34.844 EU/mL Interval 31.864 to 38.103
Concentrations of Anti-glycoprotein Ebola Zaire Virus (Anti-GP EBOV) Anti-GP EBOV, Month 6	458.649 EU/mL Interval 428.628 to 490.771	26.535 EU/mL Interval 24.732 to 28.471
Concentrations of Anti-glycoprotein Ebola Zaire Virus (Anti-GP EBOV) Anti-GP EBOV, Month 12	432.145 EU/mL Interval 401.725 to 464.869	—

SECONDARY outcome

Timeframe: At Day 0, Day 30, Month 6 and Month 12

Population: 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.

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.

Outcome measures

Outcome measures
Measure	GSK3390107A Group n=738 Participants 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.	Placebo+GSK3390107A Group n=733 Participants 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.
Percentage of Seronegative/Seropositive Subjects for Anti-GP EBOV Antibodies Anti-GP EBOV, Day 30, S+	97.4 Percentage of participants	28.0 Percentage of participants
Percentage of Seronegative/Seropositive Subjects for Anti-GP EBOV Antibodies Anti-GP EBOV, Month 6, S-	0.7 Percentage of participants	81.9 Percentage of participants
Percentage of Seronegative/Seropositive Subjects for Anti-GP EBOV Antibodies Anti-GP EBOV, Day 0, S-	74.8 Percentage of participants	74.9 Percentage of participants
Percentage of Seronegative/Seropositive Subjects for Anti-GP EBOV Antibodies Anti-GP EBOV, Day 0, S+	25.2 Percentage of participants	25.1 Percentage of participants
Percentage of Seronegative/Seropositive Subjects for Anti-GP EBOV Antibodies Anti-GP EBOV, Day 30, S-	2.6 Percentage of participants	72.0 Percentage of participants
Percentage of Seronegative/Seropositive Subjects for Anti-GP EBOV Antibodies Anti-GP EBOV, Month 6, S+	99.3 Percentage of participants	18.1 Percentage of participants
Percentage of Seronegative/Seropositive Subjects for Anti-GP EBOV Antibodies Anti-GP EBOV, Month 12, S-	0.9 Percentage of participants	—
Percentage of Seronegative/Seropositive Subjects for Anti-GP EBOV Antibodies Anti-GP EBOV, Month 12, S+	99.1 Percentage of participants	—

Adverse Events

GSK3390107A Group

Serious events: 11 serious events

Other events: 530 other events

Deaths: 1 deaths

Placebo+GSK3390107A Group

Serious events: 18 serious events

Other events: 230 other events

Deaths: 2 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	GSK3390107A Group n=749 participants at risk；n=1509 participants at risk 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.	Placebo+GSK3390107A Group n=751 participants at risk；n=1504 participants at risk 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.
General disorders Pain	47.5% 356/749 • Number of events 680 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to study end (Month 12). Solicited and unsolicited AEs were collected only for subjects from the TVc- AEs and humoral immunity Sub-cohort, consisting of approximately 750 subjects per group, while SAEs were collected for all subjects included in the Total Vaccinated cohort (i.e. 3013).	8.0% 60/751 • Number of events 86 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to study end (Month 12). Solicited and unsolicited AEs were collected only for subjects from the TVc- AEs and humoral immunity Sub-cohort, consisting of approximately 750 subjects per group, while SAEs were collected for all subjects included in the Total Vaccinated cohort (i.e. 3013).
General disorders Fatigue	37.9% 284/749 • Number of events 448 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to study end (Month 12). Solicited and unsolicited AEs were collected only for subjects from the TVc- AEs and humoral immunity Sub-cohort, consisting of approximately 750 subjects per group, while SAEs were collected for all subjects included in the Total Vaccinated cohort (i.e. 3013).	12.5% 94/751 • Number of events 179 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to study end (Month 12). Solicited and unsolicited AEs were collected only for subjects from the TVc- AEs and humoral immunity Sub-cohort, consisting of approximately 750 subjects per group, while SAEs were collected for all subjects included in the Total Vaccinated cohort (i.e. 3013).
General disorders Pyrexia	14.2% 106/749 • Number of events 124 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to study end (Month 12). Solicited and unsolicited AEs were collected only for subjects from the TVc- AEs and humoral immunity Sub-cohort, consisting of approximately 750 subjects per group, while SAEs were collected for all subjects included in the Total Vaccinated cohort (i.e. 3013).	3.3% 25/751 • Number of events 30 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to study end (Month 12). Solicited and unsolicited AEs were collected only for subjects from the TVc- AEs and humoral immunity Sub-cohort, consisting of approximately 750 subjects per group, while SAEs were collected for all subjects included in the Total Vaccinated cohort (i.e. 3013).
Nervous system disorders Headache	46.1% 345/749 • Number of events 570 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to study end (Month 12). Solicited and unsolicited AEs were collected only for subjects from the TVc- AEs and humoral immunity Sub-cohort, consisting of approximately 750 subjects per group, while SAEs were collected for all subjects included in the Total Vaccinated cohort (i.e. 3013).	18.1% 136/751 • Number of events 249 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to study end (Month 12). Solicited and unsolicited AEs were collected only for subjects from the TVc- AEs and humoral immunity Sub-cohort, consisting of approximately 750 subjects per group, while SAEs were collected for all subjects included in the Total Vaccinated cohort (i.e. 3013).
Gastrointestinal disorders Gastrointestinal disorder	9.7% 73/749 • Number of events 125 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to study end (Month 12). Solicited and unsolicited AEs were collected only for subjects from the TVc- AEs and humoral immunity Sub-cohort, consisting of approximately 750 subjects per group, while SAEs were collected for all subjects included in the Total Vaccinated cohort (i.e. 3013).	6.5% 49/751 • Number of events 93 • Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to study end (Month 12). Solicited and unsolicited AEs were collected only for subjects from the TVc- AEs and humoral immunity Sub-cohort, consisting of approximately 750 subjects per group, while SAEs were collected for all subjects included in the Total Vaccinated cohort (i.e. 3013).

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Publication restrictions are in place

Restriction type: OTHER