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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02485301
Recruitment Status : Completed
First Posted : June 30, 2015
Results First Posted : January 4, 2018
Last Update Posted : January 4, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Outcomes Assessor);   Primary Purpose: Prevention
Condition Virus Diseases
Interventions Biological: GlaxoSmithKline (GSK) Biologicals' investigational recombinant chimpanzee adenovirus Type 3-vectored Ebola Zaire vaccine (ChAd3-EBO-Z) (GSK3390107A)
Drug: Placebo
Enrollment 3024
Recruitment Details  
Pre-assignment Details 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.
Arm/Group Title GSK3390107A Group Placebo+GSK3390107A Group
Hide Arm/Group Description 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. 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.
Period Title: Overall Study
Started [1] 1509 1504
Completed 1471 1455
Not Completed 38 49
Reason Not Completed
Serious Adverse Events             2             1
Protocol Violation             0             1
Withdrawal by Subject             6             7
Migrated/moved from study area             10             19
Lost to Follow-up             17             17
Other             3             4
[1]
Out of 3024 subjects originally enrolled, only 3013 subjects received vaccination.
Arm/Group Title GSK3390107A Group Placebo+GSK3390107A Group Total
Hide Arm/Group Description 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. 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 of all reporting groups
Overall Number of Baseline Participants 1509 1504 3013
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1509 participants 1504 participants 3013 participants
32.4  (12.71) 33.0  (12.43) 32.7  (12.57)
Sex/Gender, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1509 participants 1504 participants 3013 participants
Female
697
  46.2%
690
  45.9%
1387
  46.0%
Male
812
  53.8%
814
  54.1%
1626
  54.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Geographic ancestry Number Analyzed 1509 participants 1504 participants 3013 participants
African heritage/African American
1505
  99.7%
1501
  99.8%
3006
  99.8%
American Indian or Alaskan native
1
   0.1%
0
   0.0%
1
   0.0%
Asian - Japanese heritage
1
   0.1%
0
   0.0%
1
   0.0%
Asian - South East Asian heritage
2
   0.1%
3
   0.2%
5
   0.2%
1.Primary Outcome
Title Number of Subjects With Solicited Local Adverse Events
Hide Description 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.
Time Frame During the 7-Day (Days 0-6) post-vaccination period
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title GSK3390107A Group Placebo+GSK3390107A Group
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 748 751
Measure Type: Count of Participants
Unit of Measure: Participants
Any Pain
356
  47.6%
57
   7.6%
Grade 3 Pain
3
   0.4%
0
   0.0%
Any Redness
2
   0.3%
0
   0.0%
Grade 3 Redness
0
   0.0%
0
   0.0%
Any Swelling
9
   1.2%
5
   0.7%
Grade 3 Swelling
0
   0.0%
0
   0.0%
2.Primary Outcome
Title Number of Subjects With Solicited General Adverse Events
Hide Description 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.
Time Frame During the 7-Day (Days 0-6) post-vaccination period
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title GSK3390107A Group Placebo+GSK3390107A Group
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 748 751
Measure Type: Count of Participants
Unit of Measure: Participants
Any Fatigue
284
  38.0%
94
  12.5%
Grade 3 Fatigue
11
   1.5%
3
   0.4%
Related Fatigue
243
  32.5%
72
   9.6%
Any Fever
106
  14.2%
24
   3.2%
Grade 3 Fever
3
   0.4%
0
   0.0%
Related Fever
88
  11.8%
17
   2.3%
Any Gastro
73
   9.8%
49
   6.5%
Grade 3 Gastro
2
   0.3%
0
   0.0%
Related Gastro
57
   7.6%
40
   5.3%
Any Headache
345
  46.1%
136
  18.1%
Grade 3 Headache
10
   1.3%
4
   0.5%
Related Headache
306
  40.9%
104
  13.8%
3.Primary Outcome
Title Number of Subjects With Unsolicited Adverse Events (AEs)
Hide Description 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.
Time Frame During the 30-Day (Days 0-29) post-vaccination period
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title GSK3390107A Group Placebo+GSK3390107A Group
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 749 751
Measure Type: Count of Participants
Unit of Measure: Participants
123
  16.4%
119
  15.8%
4.Primary Outcome
Title Percentage of Subjects With Haematological Laboratory Abnormalities
Hide Description 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.
Time Frame At Screening
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title GSK3390107A Group Placebo+GSK3390107A Group
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 665 667
Measure Type: Number
Unit of Measure: Percentage of participants
RBC, Low Number Analyzed 665 participants 667 participants
14.6 14.2
RBC, Normal Number Analyzed 665 participants 667 participants
70.8 69.1
RBC, High Number Analyzed 665 participants 667 participants
14.6 16.6
Neutrophils, Low Number Analyzed 588 participants 588 participants
50.2 48.3
Neutrophils, Normal Number Analyzed 588 participants 588 participants
49.5 51.5
Neutrophils, High Number Analyzed 588 participants 588 participants
0.3 0.2
Lymphocytes, Low Number Analyzed 588 participants 588 participants
0.9 1.0
Lymphocytes, Normal Number Analyzed 588 participants 588 participants
97.8 98.0
Lymphocytes, High Number Analyzed 588 participants 588 participants
1.4 1.0
WBC, Low Number Analyzed 665 participants 667 participants
9.3 8.7
WBC, Normal Number Analyzed 665 participants 667 participants
88.6 89.7
WBC, High Number Analyzed 665 participants 667 participants
2.1 1.6
Haemoglobin, Low Number Analyzed 665 participants 667 participants
17.6 18.1
Haemoglobin, Normal Number Analyzed 665 participants 667 participants
80.6 79.5
Haemoglobin, High Number Analyzed 665 participants 667 participants
1.8 2.4
Platelets, Low Number Analyzed 665 participants 667 participants
2.9 1.8
Platelets, Normal Number Analyzed 665 participants 667 participants
90.4 92.5
Platelets, High Number Analyzed 665 participants 667 participants
6.8 5.7
5.Primary Outcome
Title Percentage of Subjects With Haematological Laboratory Abnormalities
Hide Description 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.
Time Frame At Day 3
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title GSK3390107A Group Placebo+GSK3390107A Group
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 659 662
Measure Type: Number
Unit of Measure: Percentage of participants
RBC, Low Number Analyzed 659 participants 662 participants
19.0 20.4
RBC, Normal Number Analyzed 659 participants 662 participants
70.9 66.5
RBC, High Number Analyzed 659 participants 662 participants
10.2 13.1
Neutrophils, Low Number Analyzed 583 participants 583 participants
77.9 56.8
Neutrophils, Normal Number Analyzed 583 participants 583 participants
21.8 42.7
Neutrophils, High Number Analyzed 583 participants 583 participants
0.3 0.5
Lymphocytes, Low Number Analyzed 583 participants 583 participants
2.9 1.4
Lymphocytes, Normal Number Analyzed 583 participants 583 participants
96.4 97.8
Lymphocytes, High Number Analyzed 583 participants 583 participants
0.7 0.9
WBC, Low Number Analyzed 659 participants 662 participants
17.9 10.7
WBC, Normal Number Analyzed 659 participants 662 participants
80.7 87.8
WBC, High Number Analyzed 659 participants 662 participants
1.4 1.5
Haemoglobin, Low Number Analyzed 659 participants 662 participants
25.9 27.0
Haemoglobin, Normal Number Analyzed 659 participants 662 participants
72.5 72.2
Haemoglobin, High Number Analyzed 659 participants 662 participants
1.5 0.8
Platelets, Low Number Analyzed 659 participants 662 participants
2.3 2.3
Platelets, Normal Number Analyzed 659 participants 662 participants
94.1 91.8
Platelets, High Number Analyzed 659 participants 662 participants
3.6 5.9
6.Primary Outcome
Title Percentage of Subjects With Haematological Laboratory Abnormalities
Hide Description 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.
Time Frame At Day 6
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title GSK3390107A Group Placebo+GSK3390107A Group
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 659 664
Measure Type: Number
Unit of Measure: Percentage of participants
RBC, Low Number Analyzed 659 participants 664 participants
20.6 21.5
RBC, Normal Number Analyzed 659 participants 664 participants
68.6 67.2
RBC, High Number Analyzed 659 participants 664 participants
10.8 11.3
Neutrophils, Low Number Analyzed 584 participants 585 participants
65.2 53.5
Neutrophils, Normal Number Analyzed 584 participants 585 participants
34.2 46.2
Neutrophils, High Number Analyzed 584 participants 585 participants
0.5 0.3
Lymphocytes, Low Number Analyzed 584 participants 585 participants
0.9 2.4
Lymphocytes, Normal Number Analyzed 584 participants 585 participants
97.8 96.2
Lymphocytes, High Number Analyzed 584 participants 585 participants
1.4 1.4
WBC, Low Number Analyzed 659 participants 664 participants
14.7 10.7
WBC, Normal Number Analyzed 659 participants 664 participants
83.5 87.7
WBC, High Number Analyzed 659 participants 664 participants
1.8 1.7
Haemoglobin, Low Number Analyzed 659 participants 664 participants
28.2 27.4
Haemoglobin, Normal Number Analyzed 659 participants 664 participants
71.3 72.0
Haemoglobin, High Number Analyzed 659 participants 664 participants
0.5 0.6
Platelets, Low Number Analyzed 659 participants 664 participants
2.4 2.0
Platelets, Normal Number Analyzed 659 participants 664 participants
91.5 91.9
Platelets, High Number Analyzed 659 participants 664 participants
6.1 6.2
7.Primary Outcome
Title Percentage of Subjects With Haematological Laboratory Abnormalities
Hide Description 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.
Time Frame At Day 30
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title GSK3390107A Group Placebo+GSK3390107A Group
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 658 661
Measure Type: Number
Unit of Measure: Percentage of participants
RBC, Low Number Analyzed 658 participants 661 participants
15.8 17.4
RBC, Normal Number Analyzed 658 participants 661 participants
67.0 67.6
RBC, High Number Analyzed 658 participants 661 participants
17.2 15.0
Neutrophils, Low Number Analyzed 583 participants 583 participants
56.4 55.6
Neutrophils, Normal Number Analyzed 583 participants 583 participants
43.6 43.7
Neutrophils, High Number Analyzed 583 participants 583 participants
0 0.7
Lymphocytes, Low Number Analyzed 583 participants 583 participants
2.4 2.2
Lymphocytes, Normal Number Analyzed 583 participants 583 participants
96.2 97.3
Lymphocytes, High Number Analyzed 583 participants 583 participants
1.4 0.5
WBC, Low Number Analyzed 658 participants 661 participants
12.3 12.1
WBC, Normal Number Analyzed 658 participants 661 participants
86.8 86.5
WBC, High Number Analyzed 658 participants 661 participants
0.9 1.4
Haemoglobin, High Number Analyzed 658 participants 661 participants
23.4 23.0
Haemoglobin, Normal Number Analyzed 658 participants 661 participants
75.4 75.8
Haemoglobin, Low Number Analyzed 658 participants 661 participants
1.2 1.2
Platelets, Low Number Analyzed 658 participants 661 participants
3.3 2.3
Platelets, Normal Number Analyzed 658 participants 661 participants
92.6 91.5
Platelets, High Number Analyzed 658 participants 661 participants
4.1 6.2
8.Primary Outcome
Title Percentage of Subjects With Haematological Laboratory Abnormalities
Hide Description 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.
Time Frame At Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title GSK3390107A Group Placebo+GSK3390107A Group
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 649 645
Measure Type: Number
Unit of Measure: Percentage of participants
RBC, Low Number Analyzed 649 participants 645 participants
16.2 17.2
RBC, Normal Number Analyzed 649 participants 645 participants
69.5 67.9
RBC, High Number Analyzed 649 participants 645 participants
14.3 14.9
Neutrophils, Low Number Analyzed 574 participants 572 participants
50.9 50.2
Neutrophils, Normal Number Analyzed 574 participants 572 participants
48.6 49.5
Neutrophils, High Number Analyzed 574 participants 572 participants
0.5 0.3
Lymphocytes, Low Number Analyzed 574 participants 572 participants
1.7 1.6
Lymphocytes, Normal Number Analyzed 574 participants 572 participants
96.9 97.4
Lymphocytes, High Number Analyzed 574 participants 572 participants
1.4 1.0
WBC, Low Number Analyzed 649 participants 645 participants
13.3 10.9
WBC, Normal Number Analyzed 649 participants 645 participants
85.4 88.2
WBC, High Number Analyzed 649 participants 645 participants
1.4 0.9
Haemoglobin, Low Number Analyzed 649 participants 645 participants
30.5 29.0
Haemoglobin, Normal Number Analyzed 649 participants 645 participants
68.7 70.1
Haemoglobin, High Number Analyzed 649 participants 645 participants
0.8 0.9
Platelets, Low Number Analyzed 649 participants 645 participants
2.6 2.0
Platelets, Normal Number Analyzed 649 participants 645 participants
93.2 94.6
Platelets, High Number Analyzed 649 participants 645 participants
4.2 3.4
9.Primary Outcome
Title Percentage of Subjects With Haematological Laboratory Abnormalities
Hide Description 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.
Time Frame At Month 6 + 6 Days
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title GSK3390107A Group Placebo+GSK3390107A Group
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 0 619
Measure Type: Number
Unit of Measure: Percentage of participants
RBC, Low Number Analyzed 0 participants 619 participants
18.6
RBC, Normal Number Analyzed 0 participants 619 participants
70.1
RBC, High Number Analyzed 0 participants 619 participants
11.3
Neutrophils, Low Number Analyzed 0 participants 549 participants
57.4
Neutrophils, Normal Number Analyzed 0 participants 549 participants
42.4
Neutrophils, High Number Analyzed 0 participants 549 participants
0.2
Lymphocytes, Low Number Analyzed 0 participants 549 participants
0.7
Lymphocytes, Normal Number Analyzed 0 participants 549 participants
97.8
Lymphocytes, High Number Analyzed 0 participants 549 participants
1.5
WBC, Low Number Analyzed 0 participants 619 participants
12.3
WBC, Normal Number Analyzed 0 participants 619 participants
86.4
WBC, High Number Analyzed 0 participants 619 participants
1.3
Haemoglobin, Low Number Analyzed 0 participants 619 participants
36.3
Haemoglobin, Normal Number Analyzed 0 participants 619 participants
63.2
Haemoglobin, High Number Analyzed 0 participants 619 participants
0.5
Platelets, Low Number Analyzed 0 participants 619 participants
1.8
Platelets, Normal Number Analyzed 0 participants 619 participants
94.5
Platelets, High Number Analyzed 0 participants 619 participants
3.7
10.Primary Outcome
Title Percentage of Subjects With Haematological Laboratory Abnormalities
Hide Description 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.
Time Frame At Month 6 + 30 Days
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title GSK3390107A Group Placebo+GSK3390107A Group
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 0 616
Measure Type: Number
Unit of Measure: Percentage of participants
RBC, Low Number Analyzed 0 participants 616 participants
21.6
RBC, Normal Number Analyzed 0 participants 616 participants
66.1
RBC, High Number Analyzed 0 participants 616 participants
12.3
Neutrophils, Low Number Analyzed 0 participants 547 participants
55.9
Neutrophils, Normal Number Analyzed 0 participants 547 participants
43.7
Neutrophils, High Number Analyzed 0 participants 547 participants
0.4
Lymphocytes, Low Number Analyzed 0 participants 547 participants
2
Lymphocytes, Normal Number Analyzed 0 participants 547 participants
96.3
Lymphocytes, High Number Analyzed 0 participants 547 participants
1.6
WBC, Low Number Analyzed 0 participants 616 participants
11.4
WBC, Normal Number Analyzed 0 participants 616 participants
87.7
WBC, High Number Analyzed 0 participants 616 participants
1
Haemoglobin, Low Number Analyzed 0 participants 616 participants
34.3
Haemoglobin, Normal Number Analyzed 0 participants 616 participants
65.1
Haemoglobin, High Number Analyzed 0 participants 616 participants
0.6
Platelets, Low Number Analyzed 0 participants 616 participants
2.4
Platelets, Normal Number Analyzed 0 participants 616 participants
94.6
Platelets, High Number Analyzed 0 participants 616 participants
2.9
11.Primary Outcome
Title Percentage of Subjects With Haematological Laboratory Abnormalities
Hide Description 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.
Time Frame At Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title GSK3390107A Group Placebo+GSK3390107A Group
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 627 631
Measure Type: Number
Unit of Measure: Percentage of participants
RBC, Low Number Analyzed 627 participants 631 participants
15.3 17.9
RBC, Normal Number Analyzed 627 participants 631 participants
67.0 65.8
RBC, High Number Analyzed 627 participants 631 participants
17.7 16.3
Neutrophils, Low Number Analyzed 556 participants 563 participants
55.0 54.0
Neutrophils, Normal Number Analyzed 556 participants 563 participants
44.6 45.6
Neutrophils, High Number Analyzed 556 participants 563 participants
0.4 0.4
Lymphocytes, Low Number Analyzed 556 participants 563 participants
1.8 3.7
Lymphocytes, Normal Number Analyzed 556 participants 563 participants
96.9 95.0
Lymphocytes, High Number Analyzed 556 participants 563 participants
1.3 1.2
WBC, Low Number Analyzed 627 participants 631 participants
12.4 12.8
WBC, Normal Number Analyzed 627 participants 631 participants
85.6 86.1
WBC, High Number Analyzed 627 participants 631 participants
1.9 1.1
Haemoglobin, Low Number Analyzed 627 participants 631 participants
23.6 25.7
Haemoglobin, Normal Number Analyzed 627 participants 631 participants
74.6 73.4
Haemoglobin, High Number Analyzed 627 participants 631 participants
1.8 1.0
Platelets, Low Number Analyzed 627 participants 631 participants
1.9 1.7
Platelets, Normal Number Analyzed 627 participants 631 participants
91.9 91.9
Platelets, High Number Analyzed 627 participants 631 participants
6.2 6.3
12.Primary Outcome
Title Percentage of Subjects With Biochemical Laboratory Abnormalities
Hide Description Biochemical parameters assessed included: aminotransferase and creatinine. Reference range indicators used were: high, low, normal.
Time Frame At Screening
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title GSK3390107A Group Placebo+GSK3390107A Group
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 665 667
Measure Type: Number
Unit of Measure: Percentage of participants
Aminotransferase, Low 4.7 5.1
Aminotransferase, Normal 92.9 93.3
Aminotransferase, High 2.4 1.6
Creatinine, Low 0 0.4
Creatinine, Normal 95.2 93.6
Creatinine, High 4.8 6.0
13.Primary Outcome
Title Percentage of Subjects With Biochemical Laboratory Abnormalities
Hide Description Biochemical parameters assessed included: aminotransferase and creatinine. Reference range indicators used were: high, low, normal.
Time Frame At Day 3
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title GSK3390107A Group Placebo+GSK3390107A Group
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 660 662
Measure Type: Number
Unit of Measure: Percentage of participants
Aminotransferase, Low 5.3 6.3
Aminotransferase, Normal 90.6 91.5
Aminotransferase, High 4.1 2.1
Creatinine, Low 0 0.2
Creatinine, Normal 94.4 93.8
Creatinine, High 5.6 6.0
14.Primary Outcome
Title Percentage of Subjects With Biochemical Laboratory Abnormalities
Hide Description Biochemical parameters assessed included: aminotransferase and creatinine. Reference range indicators used were: high, low, normal.
Time Frame At Day 6
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title GSK3390107A Group Placebo+GSK3390107A Group
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 659 664
Measure Type: Number
Unit of Measure: Percentage of participants
Aminotransferase, Low 5.6 6.9
Aminotransferase, Normal 91.8 89.5
Aminotransferase, High 2.6 3.6
Creatinine, Low 0 0.2
Creatinine, Normal 96.4 93.8
Creatinine, High 3.6 6.0
15.Primary Outcome
Title Percentage of Subjects With Biochemical Laboratory Abnormalities
Hide Description Biochemical parameters assessed included: aminotransferase and creatinine. Reference range indicators used were: high, low, normal.
Time Frame At Day 30
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title GSK3390107A Group Placebo+GSK3390107A Group
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 659 663
Measure Type: Number
Unit of Measure: Percentage of participants
Aminotransferase, Low 7.0 5.7
Aminotransferase, Normal 90.6 91.6
Aminotransferase, High 2.4 2.7
Creatinine, Low 0.2 0.3
Creatinine, Normal 93.8 93.5
Creatinine, High 6.1 6.2
16.Primary Outcome
Title Percentage of Subjects With Biochemical Laboratory Abnormalities
Hide Description Biochemical parameters assessed included: aminotransferase and creatinine. Reference range indicators used were: high, low, normal.
Time Frame At Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title GSK3390107A Group Placebo+GSK3390107A Group
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 649 646
Measure Type: Number
Unit of Measure: Percentage of participants
Aminotransferase, Low 6.5 6.2
Aminotransferase, Normal 91.8 90.4
Aminotransferase, High 1.7 3.4
Creatinine. Low 6.2 7.1
Creatinine, Normal 92.9 92.1
Creatinine, High 0.9 0.8
17.Primary Outcome
Title Percentage of Subjects With Biochemical Laboratory Abnormalities
Hide Description Biochemical parameters assessed included: aminotransferase and creatinine. Reference range indicators used were: high, low, normal.
Time Frame At Month 6 + 6 Days
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title GSK3390107A Group Placebo+GSK3390107A Group
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 0 619
Measure Type: Number
Unit of Measure: Percentage of participants
Aminotransferase, Low 6.1
Aminotransferase, Normal 91.3
Aminotransferase, High 2.6
Creatinine, Low 6.6
Creatinine, Normal 91.9
Creatinine, High 1.5
18.Primary Outcome
Title Percentage of Subjects With Biochemical Laboratory Abnormalities
Hide Description Biochemical parameters assessed included: aminotransferase and creatinine. Reference range indicators used were: high, low, normal.
Time Frame At Month 6 + 30 Days
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title GSK3390107A Group Placebo+GSK3390107A Group
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 0 616
Measure Type: Number
Unit of Measure: Percentage of participants
Aminotransferase, Low 4.2
Aminotransferase, Normal 93.5
Aminotransferase, High 2.3
Creatinine, Low 8
Creatinine, Normal 91.1
Creatinine, High 1
19.Primary Outcome
Title Percentage of Subjects With Biochemical Laboratory Abnormalities
Hide Description Biochemical parameters assessed included: aminotransferase and creatinine. Reference range indicators used were: high, low, normal.
Time Frame At Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title GSK3390107A Group Placebo+GSK3390107A Group
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 627 631
Measure Type: Number
Unit of Measure: Percentage of participants
Aminotransferase, Low 6.9 6.7
Aminotransferase, Normal 90.7 89.7
Aminotransferase, High 2.4 3.6
Creatinine, Low 3.5 4.8
Creatinine, Normal 93.9 93.3
Creatinine, High 2.6 1.9
20.Primary Outcome
Title Number of Subjects With Adverse Events of Specific Interest (AESI)
Hide Description AESI included clinical symptoms of thrombocytopenia.
Time Frame During the 7-Day (Days 0-6) post-vaccination period
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title GSK3390107A Group Placebo+GSK3390107A Group
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 749 751
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
21.Primary Outcome
Title Number of Subjects With Serious Adverse Events (SAEs)
Hide Description 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.
Time Frame During the entire study period (up to Month 12)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented.
Arm/Group Title GSK3390107A Group Placebo+GSK3390107A Group
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 1509 1504
Measure Type: Count of Participants
Unit of Measure: Participants
11
   0.7%
18
   1.2%
22.Secondary Outcome
Title Concentrations of Anti-glycoprotein Ebola Zaire Virus (Anti-GP EBOV)
Hide Description 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).
Time Frame At Day 0, Day 30, Month 6 and Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title GSK3390107A Group Placebo+GSK3390107A Group
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 738 733
Geometric Mean (95% Confidence Interval)
Unit of Measure: EU/mL
Anti-GP EBOV, Day 0 Number Analyzed 738 participants 733 participants
31.961
(29.401 to 34.745)
31.954
(29.405 to 34.724)
Anti-GP EBOV, Day 30 Number Analyzed 738 participants 733 participants
900.025
(823.688 to 983.437)
34.844
(31.864 to 38.103)
Anti-GP EBOV, Month 6 Number Analyzed 738 participants 733 participants
458.649
(428.628 to 490.771)
26.535
(24.732 to 28.471)
Anti-GP EBOV, Month 12 Number Analyzed 738 participants 0 participants
432.145
(401.725 to 464.869)
23.Secondary Outcome
Title Percentage of Seronegative/Seropositive Subjects for Anti-GP EBOV Antibodies
Hide Description 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.
Time Frame At Day 0, Day 30, Month 6 and Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title GSK3390107A Group Placebo+GSK3390107A Group
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 738 733
Measure Type: Number
Unit of Measure: Percentage of participants
Anti-GP EBOV, Day 0, S- Number Analyzed 738 participants 733 participants
74.8 74.9
Anti-GP EBOV, Day 0, S+ Number Analyzed 738 participants 733 participants
25.2 25.1
Anti-GP EBOV, Day 30, S- Number Analyzed 731 participants 726 participants
2.6 72.0
Anti-GP EBOV, Day 30, S+ Number Analyzed 731 participants 726 participants
97.4 28.0
Anti-GP EBOV, Month 6, S- Number Analyzed 721 participants 701 participants
0.7 81.9
Anti-GP EBOV, Month 6, S+ Number Analyzed 721 participants 701 participants
99.3 18.1
Anti-GP EBOV, Month 12, S- Number Analyzed 693 participants 0 participants
0.9
Anti-GP EBOV, Month 12, S+ Number Analyzed 693 participants 0 participants
99.1
Time Frame Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to study end (Month 12).
Adverse Event Reporting Description 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).
 
Arm/Group Title GSK3390107A Group Placebo+GSK3390107A Group
Hide Arm/Group Description 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. 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.
All-Cause Mortality
GSK3390107A Group Placebo+GSK3390107A Group
Affected / at Risk (%) Affected / at Risk (%)
Total   1/1509 (0.07%)      2/1504 (0.13%)    
Hide Serious Adverse Events
GSK3390107A Group Placebo+GSK3390107A Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   11/1509 (0.73%)      18/1504 (1.20%)    
Gastrointestinal disorders     
Inguinal hernia  1  0/1509 (0.00%)  0 1/1504 (0.07%)  1
General disorders     
Macrosomia  1  0/1509 (0.00%)  0 1/1504 (0.07%)  1
Sudden death  1  0/1509 (0.00%)  0 1/1504 (0.07%)  1
Hepatobiliary disorders     
Drug-induced liver injury  1  1/1509 (0.07%)  1 0/1504 (0.00%)  0
Infections and infestations     
Gastroenteritis  1  1/1509 (0.07%)  1 0/1504 (0.00%)  0
Malaria  1  2/1509 (0.13%)  2 2/1504 (0.13%)  2
Appendicitis  1  1/1509 (0.07%)  1 0/1504 (0.00%)  0
Nasopharyngitis  1  1/1509 (0.07%)  1 0/1504 (0.00%)  0
Pneumonia  1  1/1509 (0.07%)  1 0/1504 (0.00%)  0
Pneumonia bacterial  1  0/1509 (0.00%)  0 1/1504 (0.07%)  1
Pulmonary tuberculosis  1  1/1509 (0.07%)  1 1/1504 (0.07%)  1
Gastroenteritis bacterial  1  0/1509 (0.00%)  0 1/1504 (0.07%)  1
Infection  1  0/1509 (0.00%)  0 1/1504 (0.07%)  1
Injury, poisoning and procedural complications     
Craniocerebral injury  1  1/1509 (0.07%)  1 0/1504 (0.00%)  0
Snake bite  1  1/1509 (0.07%)  1 0/1504 (0.00%)  0
Subdural haematoma  1  1/1509 (0.07%)  1 0/1504 (0.00%)  0
Multiple injuries  1  0/1509 (0.00%)  0 1/1504 (0.07%)  1
Metabolism and nutrition disorders     
Type 2 diabetes mellitus  1  0/1509 (0.00%)  0 2/1504 (0.13%)  2
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Uterine leiomyoma  1  1/1509 (0.07%)  1 0/1504 (0.00%)  0
Ovarian cancer  1  0/1509 (0.00%)  0 1/1504 (0.07%)  1
Pregnancy, puerperium and perinatal conditions     
Abortion spontaneous  1  0/1509 (0.00%)  0 3/1504 (0.20%)  3
Foetal distress syndrome  1  0/1509 (0.00%)  0 2/1504 (0.13%)  2
Face presentation  1  0/1509 (0.00%)  0 1/1504 (0.07%)  1
Postpartum haemorrhage  1  0/1509 (0.00%)  0 1/1504 (0.07%)  1
Renal and urinary disorders     
Bladder outlet Obstruction  1  1/1509 (0.07%)  1 0/1504 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Pneumothorax  1  1/1509 (0.07%)  1 0/1504 (0.00%)  0
Vascular disorders     
Vena cava thrombosis  1  0/1509 (0.00%)  0 1/1504 (0.07%)  2
1
Term from vocabulary, MedDRA 20.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
GSK3390107A Group Placebo+GSK3390107A Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   530/749 (70.76%)      230/751 (30.63%)    
Gastrointestinal disorders     
Gastrointestinal disorder  1  73/749 (9.75%)  125 49/751 (6.52%)  93
General disorders     
Pain  1  356/749 (47.53%)  680 60/751 (7.99%)  86
Fatigue  1  284/749 (37.92%)  448 94/751 (12.52%)  179
Pyrexia  1  106/749 (14.15%)  124 25/751 (3.33%)  30
Nervous system disorders     
Headache  1  345/749 (46.06%)  570 136/751 (18.11%)  249
1
Term from vocabulary, MedDRA 20.0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Layout table for additonal information
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT02485301    
Other Study ID Numbers: 202091
First Submitted: June 18, 2015
First Posted: June 30, 2015
Results First Submitted: May 16, 2017
Results First Posted: January 4, 2018
Last Update Posted: January 4, 2018