Virus Diseases
Conditions
Keywords
Protection against Ebola Zaire virus
Brief summary
The purpose of this study is to assess the safety and immunogenicity of the investigational ChAd3-EBO-Z vaccine administered to approximately 3 000 adults in Africa as a single IM dose Considering the risk of exposure to Ebola and the potential (based on animal data) for the investigational ChAd3-EBO-Z vaccine to afford at least partial protection, all subjects in the study will receive the investigational ChAd3-EBO-Z vaccine. The subjects in the Group EBO-Z will receive the vaccine at Day 0 of the study, whereas the subjects in the Group Placebo/ EBO-Z will receive a placebo at Day 0 (as a control) and will receive the investigational ChAd3-EBO-Z vaccine at Month 6, provided that no safety concerns are raised. In addition, vaccinating all subjects in the study with the investigational ChAd3 EBO Z vaccine will allow an increase of the safety database of the investigational vaccine. In case the geographic range of Ebola virus Zaire (EBOV) transmission expands to encompass any of the regions where this trial is conducted, earlier administration of the investigational ChAd3-EBO-Z vaccine to the subjects in the Group Placebo/ EBO-Z will be considered in that region.
Interventions
A single dose administrated intramuscular
DRUGPlacebo
A single dose administrated intramuscular
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Subjects who, in the opinion of the Investigator, can and will comply with the requirements of the protocol (e.g. capability of or availability for Diary Card completion, return for follow-up visits, availability for clinical follow-up throughout the study period). * Written/ thumb printed informed consent obtained from the subject prior to performing any study specific procedure or written/ thumb printed informed consent obtained from the subject's parent(s)/ legally acceptable representative(s) (LAR\[s\]) and written/ thumb printed informed assent obtained from the subject, for minor subjects. This will only be applicable for countries where the legal age of majority is ≥ 21 years. * A male or female aged 18 years of age or older at the time of Screening. * Healthy subjects as per Investigator judgement, as established by medical history, clinical examination and haematology/ biochemistry laboratory parameters screening before entering into the study. * Female subjects of non-childbearing potential may be enrolled in the study. * Non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy, ovariectomy or post-menopause. * Female subjects of childbearing potential may be enrolled in the study, if the subject: * has practiced adequate contraception for 30 days prior to the Day 0 visit, and * has a negative pregnancy test at the Day 0 visit, and * has agreed to continue adequate contraception until 30 days after the Month 6 visit.
Exclusion criteria
* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine during the period starting 30 days before the Day 0 visit, or planned use during the study period. * Previous vaccination with an investigational EBOV or Marburg vaccine, or previous vaccination with a chimpanzee adenoviral vectored investigational vaccine. * Known prior EBOV or SUDV disease. * Travel to a country affected by the EBOV epidemic or direct contact with a person with EVD within 21 days prior to the Day 0 visit. * History of any reaction or hypersensitivity (such as anaphylaxis, urticaria \[hives\], respiratory difficulty, angioedema, or abdominal pain) likely to be exacerbated by any component of the study vaccine. * Planned administration/ administration of a vaccine not foreseen by the study protocol in the period starting 30 days before and ending 30 days after each vaccination visit. * Serious acute or chronic illness determined by medical history and clinical examination including, but not limited to: * Clinically significant immunosuppressive or immunodeficient condition (e.g. clinical acquired immune deficiency syndrome \[AIDS\]). * Any clinically significant haematological (CBC, including differential count and platelet count) or biochemical (ALT, creatinine) laboratory abnormality. * Any chronic illness with recent signs of exacerbation, or imposing a change in the chronic treatment regimen, within 3 months prior to the Day 0 visit. * Any unstable chronic medical condition (e.g. uncontrolled asthma). * Pregnant female.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Serious Adverse Events (SAEs) | During the entire study period (up to Month 12) | 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. |
| Percentage of Subjects With Biochemical Laboratory Abnormalities | At Screening | Biochemical parameters assessed included: aminotransferase and creatinine. Reference range indicators used were: high, low, normal. |
| Number of Subjects With Adverse Events of Specific Interest (AESI) | During the 7-Day (Days 0-6) post-vaccination period | AESI included clinical symptoms of thrombocytopenia. |
| Number of Subjects With Solicited Local Adverse Events | During the 7-Day (Days 0-6) post-vaccination period | 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. |
| Number of Subjects With Solicited General Adverse Events | During the 7-Day (Days 0-6) post-vaccination period | 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. |
| Number of Subjects With Unsolicited Adverse Events (AEs) | During the 30-Day (Days 0-29) post-vaccination period | 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. |
| Percentage of Subjects With Haematological Laboratory Abnormalities | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Seronegative/Seropositive Subjects for Anti-GP EBOV Antibodies | At Day 0, Day 30, Month 6 and Month 12 | 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. |
| Concentrations of Anti-glycoprotein Ebola Zaire Virus (Anti-GP EBOV) | At Day 0, Day 30, Month 6 and Month 12 | 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). |
Countries
Cameroon, Mali, Nigeria, Senegal
Participant flow
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 1,509 |
| 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. | 1,504 |
| Total | 3,013 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 17 | 17 |
| Overall Study | Migrated/moved from study area | 10 | 19 |
| Overall Study | Other | 3 | 4 |
| Overall Study | Protocol Violation | 0 | 1 |
| Overall Study | Serious Adverse Events | 2 | 1 |
| Overall Study | Withdrawal by Subject | 6 | 7 |
Baseline characteristics
| Characteristic | GSK3390107A Group | Placebo+GSK3390107A Group | Total |
|---|---|---|---|
| Age, Continuous | 32.4 Years STANDARD_DEVIATION 12.71 | 33.0 Years STANDARD_DEVIATION 12.43 | 32.7 Years STANDARD_DEVIATION 12.57 |
| Race/Ethnicity, Customized Geographic ancestry African heritage/African American | 1505 Participants | 1501 Participants | 3006 Participants |
| Race/Ethnicity, Customized Geographic ancestry American Indian or Alaskan native | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Geographic ancestry Asian - Japanese heritage | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Geographic ancestry Asian - South East Asian heritage | 2 Participants | 3 Participants | 5 Participants |
| Sex/Gender, Customized Female | 697 Participants | 690 Participants | 1387 Participants |
| Sex/Gender, Customized Male | 812 Participants | 814 Participants | 1626 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 1,509 | 2 / 1,504 |
| other Total, other adverse events | 530 / 749 | 230 / 751 |
| serious Total, serious adverse events | 11 / 1,509 | 18 / 1,504 |
Outcome results
Primary
Number of Subjects With Adverse Events of Specific Interest (AESI)
AESI included clinical symptoms of thrombocytopenia.
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK3390107A Group | Number of Subjects With Adverse Events of Specific Interest (AESI) | 0 Participants |
| Placebo+GSK3390107A Group | Number of Subjects With Adverse Events of Specific Interest (AESI) | 0 Participants |
Primary
Number of Subjects With Serious Adverse Events (SAEs)
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK3390107A Group | Number of Subjects With Serious Adverse Events (SAEs) | 11 Participants |
| Placebo+GSK3390107A Group | Number of Subjects With Serious Adverse Events (SAEs) | 18 Participants |
Primary
Number of Subjects With Solicited General Adverse Events
Assessed solicited general adverse events were fatigue, fever \[defined as axillary temperature higher than or equal to (≥) 37.5 degrees Celsius (°C)\], gastrointestinal (gastro) adverse events \[nausea, vomiting, diarrhoea and/or abdominal pain\] and headache. Any = occurrence of any general adverse events regardless of intensity grade or relationship to vaccination. Grade 3 fatigue, gastrointestinal symptoms and headache = adverse event that prevented normal activities. Grade 3 fever = fever ≥ 39.5 °C. Related = adverse event assessed by the investigator as related to the vaccination.
Time frame: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK3390107A Group | Number of Subjects With Solicited General Adverse Events | Any Fatigue | 284 Participants |
| GSK3390107A Group | Number of Subjects With Solicited General Adverse Events | Grade 3 Fatigue | 11 Participants |
| GSK3390107A Group | Number of Subjects With Solicited General Adverse Events | Related Fatigue | 243 Participants |
| GSK3390107A Group | Number of Subjects With Solicited General Adverse Events | Any Fever | 106 Participants |
| GSK3390107A Group | Number of Subjects With Solicited General Adverse Events | Grade 3 Fever | 3 Participants |
| GSK3390107A Group | Number of Subjects With Solicited General Adverse Events | Related Fever | 88 Participants |
| GSK3390107A Group | Number of Subjects With Solicited General Adverse Events | Any Gastro | 73 Participants |
| GSK3390107A Group | Number of Subjects With Solicited General Adverse Events | Grade 3 Gastro | 2 Participants |
| GSK3390107A Group | Number of Subjects With Solicited General Adverse Events | Related Gastro | 57 Participants |
| GSK3390107A Group | Number of Subjects With Solicited General Adverse Events | Any Headache | 345 Participants |
| GSK3390107A Group | Number of Subjects With Solicited General Adverse Events | Grade 3 Headache | 10 Participants |
| GSK3390107A Group | Number of Subjects With Solicited General Adverse Events | Related Headache | 306 Participants |
| Placebo+GSK3390107A Group | Number of Subjects With Solicited General Adverse Events | Grade 3 Headache | 4 Participants |
| Placebo+GSK3390107A Group | Number of Subjects With Solicited General Adverse Events | Any Fatigue | 94 Participants |
| Placebo+GSK3390107A Group | Number of Subjects With Solicited General Adverse Events | Any Gastro | 49 Participants |
| Placebo+GSK3390107A Group | Number of Subjects With Solicited General Adverse Events | Grade 3 Fatigue | 3 Participants |
| Placebo+GSK3390107A Group | Number of Subjects With Solicited General Adverse Events | Any Headache | 136 Participants |
| Placebo+GSK3390107A Group | Number of Subjects With Solicited General Adverse Events | Related Fatigue | 72 Participants |
| Placebo+GSK3390107A Group | Number of Subjects With Solicited General Adverse Events | Grade 3 Gastro | 0 Participants |
| Placebo+GSK3390107A Group | Number of Subjects With Solicited General Adverse Events | Any Fever | 24 Participants |
| Placebo+GSK3390107A Group | Number of Subjects With Solicited General Adverse Events | Related Headache | 104 Participants |
| Placebo+GSK3390107A Group | Number of Subjects With Solicited General Adverse Events | Grade 3 Fever | 0 Participants |
| Placebo+GSK3390107A Group | Number of Subjects With Solicited General Adverse Events | Related Gastro | 40 Participants |
| Placebo+GSK3390107A Group | Number of Subjects With Solicited General Adverse Events | Related Fever | 17 Participants |
Primary
Number of Subjects With Solicited Local Adverse Events
Assessed solicited local adverse events were pain, redness and swelling. Any = occurrence of any solicited local adverse event regardless of their intensity grade. Grade 3 Pain = significant pain at rest. Prevented normal every day activities. Grade 3 Redness/Swelling = redness/swelling spreading beyond 100 millimeters (mm) from injection site.
Time frame: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK3390107A Group | Number of Subjects With Solicited Local Adverse Events | Grade 3 Pain | 3 Participants |
| GSK3390107A Group | Number of Subjects With Solicited Local Adverse Events | Grade 3 Redness | 0 Participants |
| GSK3390107A Group | Number of Subjects With Solicited Local Adverse Events | Any Pain | 356 Participants |
| GSK3390107A Group | Number of Subjects With Solicited Local Adverse Events | Any Swelling | 9 Participants |
| GSK3390107A Group | Number of Subjects With Solicited Local Adverse Events | Any Redness | 2 Participants |
| GSK3390107A Group | Number of Subjects With Solicited Local Adverse Events | Grade 3 Swelling | 0 Participants |
| Placebo+GSK3390107A Group | Number of Subjects With Solicited Local Adverse Events | Grade 3 Swelling | 0 Participants |
| Placebo+GSK3390107A Group | Number of Subjects With Solicited Local Adverse Events | Any Pain | 57 Participants |
| Placebo+GSK3390107A Group | Number of Subjects With Solicited Local Adverse Events | Grade 3 Pain | 0 Participants |
| Placebo+GSK3390107A Group | Number of Subjects With Solicited Local Adverse Events | Any Redness | 0 Participants |
| Placebo+GSK3390107A Group | Number of Subjects With Solicited Local Adverse Events | Grade 3 Redness | 0 Participants |
| Placebo+GSK3390107A Group | Number of Subjects With Solicited Local Adverse Events | Any Swelling | 5 Participants |
Primary
Number of Subjects With Unsolicited Adverse Events (AEs)
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset out-side the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK3390107A Group | Number of Subjects With Unsolicited Adverse Events (AEs) | 123 Participants |
| Placebo+GSK3390107A Group | Number of Subjects With Unsolicited Adverse Events (AEs) | 119 Participants |
Primary
Percentage of Subjects With Biochemical Laboratory Abnormalities
Biochemical parameters assessed included: aminotransferase and creatinine. Reference range indicators used were: high, low, normal.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities | Aminotransferase, Low | 4.7 Percentage of participants |
| GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities | Aminotransferase, Normal | 92.9 Percentage of participants |
| GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities | Aminotransferase, High | 2.4 Percentage of participants |
| GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities | Creatinine, Low | 0 Percentage of participants |
| GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities | Creatinine, Normal | 95.2 Percentage of participants |
| GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities | Creatinine, High | 4.8 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities | Creatinine, Normal | 93.6 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities | Aminotransferase, Low | 5.1 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities | Creatinine, Low | 0.4 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities | Aminotransferase, Normal | 93.3 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities | Creatinine, High | 6.0 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities | Aminotransferase, High | 1.6 Percentage of participants |
Primary
Percentage of Subjects With Biochemical Laboratory Abnormalities
Biochemical parameters assessed included: aminotransferase and creatinine. Reference range indicators used were: high, low, normal.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities | Aminotransferase, Low | 5.3 Percentage of participants |
| GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities | Aminotransferase, Normal | 90.6 Percentage of participants |
| GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities | Aminotransferase, High | 4.1 Percentage of participants |
| GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities | Creatinine, Low | 0 Percentage of participants |
| GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities | Creatinine, Normal | 94.4 Percentage of participants |
| GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities | Creatinine, High | 5.6 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities | Creatinine, Normal | 93.8 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities | Aminotransferase, Low | 6.3 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities | Creatinine, Low | 0.2 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities | Aminotransferase, Normal | 91.5 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities | Creatinine, High | 6.0 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities | Aminotransferase, High | 2.1 Percentage of participants |
Primary
Percentage of Subjects With Biochemical Laboratory Abnormalities
Biochemical parameters assessed included: aminotransferase and creatinine. Reference range indicators used were: high, low, normal.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities | Aminotransferase, Low | 5.6 Percentage of participants |
| GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities | Aminotransferase, Normal | 91.8 Percentage of participants |
| GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities | Aminotransferase, High | 2.6 Percentage of participants |
| GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities | Creatinine, Low | 0 Percentage of participants |
| GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities | Creatinine, Normal | 96.4 Percentage of participants |
| GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities | Creatinine, High | 3.6 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities | Creatinine, Normal | 93.8 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities | Aminotransferase, Low | 6.9 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities | Creatinine, Low | 0.2 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities | Aminotransferase, Normal | 89.5 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities | Creatinine, High | 6.0 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities | Aminotransferase, High | 3.6 Percentage of participants |
Primary
Percentage of Subjects With Biochemical Laboratory Abnormalities
Biochemical parameters assessed included: aminotransferase and creatinine. Reference range indicators used were: high, low, normal.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities | Aminotransferase, Low | 7.0 Percentage of participants |
| GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities | Aminotransferase, Normal | 90.6 Percentage of participants |
| GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities | Aminotransferase, High | 2.4 Percentage of participants |
| GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities | Creatinine, Low | 0.2 Percentage of participants |
| GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities | Creatinine, Normal | 93.8 Percentage of participants |
| GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities | Creatinine, High | 6.1 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities | Creatinine, Normal | 93.5 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities | Aminotransferase, Low | 5.7 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities | Creatinine, Low | 0.3 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities | Aminotransferase, Normal | 91.6 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities | Creatinine, High | 6.2 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities | Aminotransferase, High | 2.7 Percentage of participants |
Primary
Percentage of Subjects With Biochemical Laboratory Abnormalities
Biochemical parameters assessed included: aminotransferase and creatinine. Reference range indicators used were: high, low, normal.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities | Aminotransferase, Low | 6.5 Percentage of participants |
| GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities | Aminotransferase, Normal | 91.8 Percentage of participants |
| GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities | Aminotransferase, High | 1.7 Percentage of participants |
| GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities | Creatinine. Low | 6.2 Percentage of participants |
| GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities | Creatinine, Normal | 92.9 Percentage of participants |
| GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities | Creatinine, High | 0.9 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities | Creatinine, Normal | 92.1 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities | Aminotransferase, Low | 6.2 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities | Creatinine. Low | 7.1 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities | Aminotransferase, Normal | 90.4 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities | Creatinine, High | 0.8 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities | Aminotransferase, High | 3.4 Percentage of participants |
Primary
Percentage of Subjects With Biochemical Laboratory Abnormalities
Biochemical parameters assessed included: aminotransferase and creatinine. Reference range indicators used were: high, low, normal.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo+GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities | Aminotransferase, Low | 6.1 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities | Aminotransferase, Normal | 91.3 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities | Aminotransferase, High | 2.6 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities | Creatinine, Low | 6.6 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities | Creatinine, Normal | 91.9 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities | Creatinine, High | 1.5 Percentage of participants |
Primary
Percentage of Subjects With Biochemical Laboratory Abnormalities
Biochemical parameters assessed included: aminotransferase and creatinine. Reference range indicators used were: high, low, normal.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo+GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities | Aminotransferase, Low | 4.2 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities | Aminotransferase, Normal | 93.5 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities | Aminotransferase, High | 2.3 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities | Creatinine, Low | 8.0 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities | Creatinine, Normal | 91.1 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities | Creatinine, High | 1.0 Percentage of participants |
Primary
Percentage of Subjects With Biochemical Laboratory Abnormalities
Biochemical parameters assessed included: aminotransferase and creatinine. Reference range indicators used were: high, low, normal.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities | Aminotransferase, Low | 6.9 Percentage of participants |
| GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities | Aminotransferase, Normal | 90.7 Percentage of participants |
| GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities | Aminotransferase, High | 2.4 Percentage of participants |
| GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities | Creatinine, Low | 3.5 Percentage of participants |
| GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities | Creatinine, Normal | 93.9 Percentage of participants |
| GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities | Creatinine, High | 2.6 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities | Creatinine, Normal | 93.3 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities | Aminotransferase, Low | 6.7 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities | Creatinine, Low | 4.8 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities | Aminotransferase, Normal | 89.7 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities | Creatinine, High | 1.9 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities | Aminotransferase, High | 3.6 Percentage of participants |
Primary
Percentage of Subjects With Haematological Laboratory Abnormalities
Haematological parameters assessed included: complete blood count (red blood cells \[RBC\], neutrophils, lymphocytes, white blood cells \[WBC\], haemoglobin), as well as differential count and platelet count. Reference range indicators used were: high, low, normal.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | RBC, Low | 14.6 Percentage of participants |
| GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | RBC, Normal | 70.8 Percentage of participants |
| GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | RBC, High | 14.6 Percentage of participants |
| GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Neutrophils, Low | 50.2 Percentage of participants |
| GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Neutrophils, Normal | 49.5 Percentage of participants |
| GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Neutrophils, High | 0.3 Percentage of participants |
| GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Lymphocytes, Low | 0.9 Percentage of participants |
| GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Lymphocytes, Normal | 97.8 Percentage of participants |
| GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Lymphocytes, High | 1.4 Percentage of participants |
| GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | WBC, Low | 9.3 Percentage of participants |
| GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | WBC, Normal | 88.6 Percentage of participants |
| GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | WBC, High | 2.1 Percentage of participants |
| GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Haemoglobin, Low | 17.6 Percentage of participants |
| GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Haemoglobin, Normal | 80.6 Percentage of participants |
| GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Haemoglobin, High | 1.8 Percentage of participants |
| GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Platelets, Low | 2.9 Percentage of participants |
| GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Platelets, Normal | 90.4 Percentage of participants |
| GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Platelets, High | 6.8 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Haemoglobin, Normal | 79.5 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | RBC, Low | 14.2 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | WBC, Low | 8.7 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | RBC, Normal | 69.1 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Platelets, High | 5.7 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | RBC, High | 16.6 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | WBC, Normal | 89.7 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Neutrophils, Low | 48.3 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Haemoglobin, High | 2.4 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Neutrophils, Normal | 51.5 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | WBC, High | 1.6 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Neutrophils, High | 0.2 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Platelets, Normal | 92.5 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Lymphocytes, Low | 1.0 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Haemoglobin, Low | 18.1 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Lymphocytes, Normal | 98.0 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Platelets, Low | 1.8 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Lymphocytes, High | 1.0 Percentage of participants |
Primary
Percentage of Subjects With Haematological Laboratory Abnormalities
Haematological parameters assessed included: complete blood count (red blood cells \[RBC\], neutrophils, lymphocytes, white blood cells \[WBC\], haemoglobin), as well as differential count and platelet count. Reference range indicators used were: high, low, normal.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | RBC, Low | 15.3 Percentage of participants |
| GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | RBC, Normal | 67.0 Percentage of participants |
| GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | RBC, High | 17.7 Percentage of participants |
| GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Neutrophils, Low | 55.0 Percentage of participants |
| GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Neutrophils, Normal | 44.6 Percentage of participants |
| GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Neutrophils, High | 0.4 Percentage of participants |
| GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Lymphocytes, Low | 1.8 Percentage of participants |
| GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Lymphocytes, Normal | 96.9 Percentage of participants |
| GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Lymphocytes, High | 1.3 Percentage of participants |
| GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | WBC, Low | 12.4 Percentage of participants |
| GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | WBC, Normal | 85.6 Percentage of participants |
| GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | WBC, High | 1.9 Percentage of participants |
| GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Haemoglobin, Low | 23.6 Percentage of participants |
| GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Haemoglobin, Normal | 74.6 Percentage of participants |
| GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Haemoglobin, High | 1.8 Percentage of participants |
| GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Platelets, Low | 1.9 Percentage of participants |
| GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Platelets, Normal | 91.9 Percentage of participants |
| GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Platelets, High | 6.2 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Haemoglobin, Normal | 73.4 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | RBC, Low | 17.9 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | WBC, Low | 12.8 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | RBC, Normal | 65.8 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Platelets, High | 6.3 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | RBC, High | 16.3 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | WBC, Normal | 86.1 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Neutrophils, Low | 54.0 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Haemoglobin, High | 1.0 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Neutrophils, Normal | 45.6 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | WBC, High | 1.1 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Neutrophils, High | 0.4 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Platelets, Normal | 91.9 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Lymphocytes, Low | 3.7 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Haemoglobin, Low | 25.7 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Lymphocytes, Normal | 95.0 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Platelets, Low | 1.7 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Lymphocytes, High | 1.2 Percentage of participants |
Primary
Percentage of Subjects With Haematological Laboratory Abnormalities
Haematological parameters assessed included: complete blood count (red blood cells \[RBC\], neutrophils, lymphocytes, white blood cells \[WBC\], haemoglobin), as well as differential count and platelet count. Reference range indicators used were: high, low, normal.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | RBC, Low | 20.6 Percentage of participants |
| GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | RBC, Normal | 68.6 Percentage of participants |
| GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | RBC, High | 10.8 Percentage of participants |
| GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Neutrophils, Low | 65.2 Percentage of participants |
| GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Neutrophils, Normal | 34.2 Percentage of participants |
| GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Neutrophils, High | 0.5 Percentage of participants |
| GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Lymphocytes, Low | 0.9 Percentage of participants |
| GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Lymphocytes, Normal | 97.8 Percentage of participants |
| GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Lymphocytes, High | 1.4 Percentage of participants |
| GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | WBC, Low | 14.7 Percentage of participants |
| GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | WBC, Normal | 83.5 Percentage of participants |
| GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | WBC, High | 1.8 Percentage of participants |
| GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Haemoglobin, Low | 28.2 Percentage of participants |
| GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Haemoglobin, Normal | 71.3 Percentage of participants |
| GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Haemoglobin, High | 0.5 Percentage of participants |
| GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Platelets, Low | 2.4 Percentage of participants |
| GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Platelets, Normal | 91.5 Percentage of participants |
| GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Platelets, High | 6.1 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Haemoglobin, Normal | 72.0 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | RBC, Low | 21.5 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | WBC, Low | 10.7 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | RBC, Normal | 67.2 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Platelets, High | 6.2 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | RBC, High | 11.3 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | WBC, Normal | 87.7 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Neutrophils, Low | 53.5 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Haemoglobin, High | 0.6 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Neutrophils, Normal | 46.2 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | WBC, High | 1.7 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Neutrophils, High | 0.3 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Platelets, Normal | 91.9 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Lymphocytes, Low | 2.4 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Haemoglobin, Low | 27.4 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Lymphocytes, Normal | 96.2 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Platelets, Low | 2.0 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Lymphocytes, High | 1.4 Percentage of participants |
Primary
Percentage of Subjects With Haematological Laboratory Abnormalities
Haematological parameters assessed included: complete blood count (red blood cells \[RBC\], neutrophils, lymphocytes, white blood cells \[WBC\], haemoglobin), as well as differential count and platelet count. Reference range indicators used were: high, low, normal.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | RBC, Low | 19.0 Percentage of participants |
| GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | RBC, Normal | 70.9 Percentage of participants |
| GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | RBC, High | 10.2 Percentage of participants |
| GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Neutrophils, Low | 77.9 Percentage of participants |
| GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Neutrophils, Normal | 21.8 Percentage of participants |
| GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Neutrophils, High | 0.3 Percentage of participants |
| GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Lymphocytes, Low | 2.9 Percentage of participants |
| GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Lymphocytes, Normal | 96.4 Percentage of participants |
| GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Lymphocytes, High | 0.7 Percentage of participants |
| GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | WBC, Low | 17.9 Percentage of participants |
| GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | WBC, Normal | 80.7 Percentage of participants |
| GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | WBC, High | 1.4 Percentage of participants |
| GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Haemoglobin, Low | 25.9 Percentage of participants |
| GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Haemoglobin, Normal | 72.5 Percentage of participants |
| GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Haemoglobin, High | 1.5 Percentage of participants |
| GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Platelets, Low | 2.3 Percentage of participants |
| GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Platelets, Normal | 94.1 Percentage of participants |
| GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Platelets, High | 3.6 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Haemoglobin, Normal | 72.2 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | RBC, Low | 20.4 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | WBC, Low | 10.7 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | RBC, Normal | 66.5 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Platelets, High | 5.9 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | RBC, High | 13.1 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | WBC, Normal | 87.8 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Neutrophils, Low | 56.8 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Haemoglobin, High | 0.8 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Neutrophils, Normal | 42.7 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | WBC, High | 1.5 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Neutrophils, High | 0.5 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Platelets, Normal | 91.8 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Lymphocytes, Low | 1.4 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Haemoglobin, Low | 27.0 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Lymphocytes, Normal | 97.8 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Platelets, Low | 2.3 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Lymphocytes, High | 0.9 Percentage of participants |
Primary
Percentage of Subjects With Haematological Laboratory Abnormalities
Haematological parameters assessed included: complete blood count (red blood cells \[RBC\], neutrophils, lymphocytes, white blood cells \[WBC\], haemoglobin), as well as differential count and platelet count. Reference range indicators used were: high, low, normal.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | RBC, Low | 15.8 Percentage of participants |
| GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | RBC, Normal | 67.0 Percentage of participants |
| GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | RBC, High | 17.2 Percentage of participants |
| GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Neutrophils, Low | 56.4 Percentage of participants |
| GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Neutrophils, Normal | 43.6 Percentage of participants |
| GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Neutrophils, High | 0 Percentage of participants |
| GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Lymphocytes, Low | 2.4 Percentage of participants |
| GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Lymphocytes, Normal | 96.2 Percentage of participants |
| GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Lymphocytes, High | 1.4 Percentage of participants |
| GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | WBC, Low | 12.3 Percentage of participants |
| GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | WBC, Normal | 86.8 Percentage of participants |
| GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | WBC, High | 0.9 Percentage of participants |
| GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Haemoglobin, High | 23.4 Percentage of participants |
| GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Haemoglobin, Normal | 75.4 Percentage of participants |
| GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Haemoglobin, Low | 1.2 Percentage of participants |
| GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Platelets, Low | 3.3 Percentage of participants |
| GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Platelets, Normal | 92.6 Percentage of participants |
| GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Platelets, High | 4.1 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Haemoglobin, Normal | 75.8 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | RBC, Low | 17.4 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | WBC, Low | 12.1 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | RBC, Normal | 67.6 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Platelets, High | 6.2 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | RBC, High | 15.0 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | WBC, Normal | 86.5 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Neutrophils, Low | 55.6 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Haemoglobin, Low | 1.2 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Neutrophils, Normal | 43.7 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | WBC, High | 1.4 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Neutrophils, High | 0.7 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Platelets, Normal | 91.5 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Lymphocytes, Low | 2.2 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Haemoglobin, High | 23.0 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Lymphocytes, Normal | 97.3 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Platelets, Low | 2.3 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Lymphocytes, High | 0.5 Percentage of participants |
Primary
Percentage of Subjects With Haematological Laboratory Abnormalities
Haematological parameters assessed included: complete blood count (red blood cells \[RBC\], neutrophils, lymphocytes, white blood cells \[WBC\], haemoglobin), as well as differential count and platelet count. Reference range indicators used were: high, low, normal.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | RBC, Low | 16.2 Percentage of participants |
| GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | RBC, Normal | 69.5 Percentage of participants |
| GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | RBC, High | 14.3 Percentage of participants |
| GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Neutrophils, Low | 50.9 Percentage of participants |
| GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Neutrophils, Normal | 48.6 Percentage of participants |
| GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Neutrophils, High | 0.5 Percentage of participants |
| GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Lymphocytes, Low | 1.7 Percentage of participants |
| GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Lymphocytes, Normal | 96.9 Percentage of participants |
| GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Lymphocytes, High | 1.4 Percentage of participants |
| GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | WBC, Low | 13.3 Percentage of participants |
| GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | WBC, Normal | 85.4 Percentage of participants |
| GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | WBC, High | 1.4 Percentage of participants |
| GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Haemoglobin, Low | 30.5 Percentage of participants |
| GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Haemoglobin, Normal | 68.7 Percentage of participants |
| GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Haemoglobin, High | 0.8 Percentage of participants |
| GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Platelets, Low | 2.6 Percentage of participants |
| GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Platelets, Normal | 93.2 Percentage of participants |
| GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Platelets, High | 4.2 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Haemoglobin, Normal | 70.1 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | RBC, Low | 17.2 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | WBC, Low | 10.9 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | RBC, Normal | 67.9 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Platelets, High | 3.4 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | RBC, High | 14.9 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | WBC, Normal | 88.2 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Neutrophils, Low | 50.2 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Haemoglobin, High | 0.9 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Neutrophils, Normal | 49.5 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | WBC, High | 0.9 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Neutrophils, High | 0.3 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Platelets, Normal | 94.6 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Lymphocytes, Low | 1.6 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Haemoglobin, Low | 29.0 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Lymphocytes, Normal | 97.4 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Platelets, Low | 2.0 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Lymphocytes, High | 1.0 Percentage of participants |
Primary
Percentage of Subjects With Haematological Laboratory Abnormalities
Haematological parameters assessed included: complete blood count (red blood cells \[RBC\], neutrophils, lymphocytes, white blood cells \[WBC\], haemoglobin), as well as differential count and platelet count. Reference range indicators used were: high, low, normal.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | RBC, Low | 18.6 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | RBC, Normal | 70.1 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | RBC, High | 11.3 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Neutrophils, Low | 57.4 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Neutrophils, Normal | 42.4 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Neutrophils, High | 0.2 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Lymphocytes, Low | 0.7 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Lymphocytes, Normal | 97.8 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Lymphocytes, High | 1.5 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | WBC, Low | 12.3 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | WBC, Normal | 86.4 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | WBC, High | 1.3 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Haemoglobin, Low | 36.3 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Haemoglobin, Normal | 63.2 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Haemoglobin, High | 0.5 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Platelets, Low | 1.8 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Platelets, Normal | 94.5 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Platelets, High | 3.7 Percentage of participants |
Primary
Percentage of Subjects With Haematological Laboratory Abnormalities
Haematological parameters assessed included: complete blood count (red blood cells \[RBC\], neutrophils, lymphocytes, white blood cells \[WBC\], haemoglobin), as well as differential count and platelet count. Reference range indicators used were: high, low, normal.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | RBC, Low | 21.6 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | RBC, Normal | 66.1 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | RBC, High | 12.3 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Neutrophils, Low | 55.9 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Neutrophils, Normal | 43.7 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Neutrophils, High | 0.4 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Lymphocytes, Low | 2.0 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Lymphocytes, Normal | 96.3 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Lymphocytes, High | 1.6 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | WBC, Low | 11.4 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | WBC, Normal | 87.7 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | WBC, High | 1.0 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Haemoglobin, Low | 34.3 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Haemoglobin, Normal | 65.1 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Haemoglobin, High | 0.6 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Platelets, Low | 2.4 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Platelets, Normal | 94.6 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities | Platelets, High | 2.9 Percentage of participants |
Secondary
Concentrations of Anti-glycoprotein Ebola Zaire Virus (Anti-GP EBOV)
Anti-GP EBOV antibody concentrations were measured by Enzyme-Linked Immunosorbent Assay (ELISA), presented as geometric mean concentrations (GMC), and expressed in ELISA units per milliliter (EU/mL).
Time frame: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK3390107A Group | Concentrations of Anti-glycoprotein Ebola Zaire Virus (Anti-GP EBOV) | Anti-GP EBOV, Month 6 | 458.649 EU/mL |
| GSK3390107A Group | Concentrations of Anti-glycoprotein Ebola Zaire Virus (Anti-GP EBOV) | Anti-GP EBOV, Day 30 | 900.025 EU/mL |
| GSK3390107A Group | Concentrations of Anti-glycoprotein Ebola Zaire Virus (Anti-GP EBOV) | Anti-GP EBOV, Month 12 | 432.145 EU/mL |
| GSK3390107A Group | Concentrations of Anti-glycoprotein Ebola Zaire Virus (Anti-GP EBOV) | Anti-GP EBOV, Day 0 | 31.961 EU/mL |
| Placebo+GSK3390107A Group | Concentrations of Anti-glycoprotein Ebola Zaire Virus (Anti-GP EBOV) | Anti-GP EBOV, Day 30 | 34.844 EU/mL |
| Placebo+GSK3390107A Group | Concentrations of Anti-glycoprotein Ebola Zaire Virus (Anti-GP EBOV) | Anti-GP EBOV, Day 0 | 31.954 EU/mL |
| Placebo+GSK3390107A Group | Concentrations of Anti-glycoprotein Ebola Zaire Virus (Anti-GP EBOV) | Anti-GP EBOV, Month 6 | 26.535 EU/mL |
Secondary
Percentage of Seronegative/Seropositive Subjects for Anti-GP EBOV Antibodies
A seronegative subject (S-) is a subject whose titer is below (\<) 36.11 EU/mL. A seropositive subject (S+) is a subject whose titer is greater than or equal to (≥) 36.11 EU/mL.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK3390107A Group | Percentage of Seronegative/Seropositive Subjects for Anti-GP EBOV Antibodies | Anti-GP EBOV, Day 0, S- | 74.8 Percentage of participants |
| GSK3390107A Group | Percentage of Seronegative/Seropositive Subjects for Anti-GP EBOV Antibodies | Anti-GP EBOV, Day 30, S- | 2.6 Percentage of participants |
| GSK3390107A Group | Percentage of Seronegative/Seropositive Subjects for Anti-GP EBOV Antibodies | Anti-GP EBOV, Day 30, S+ | 97.4 Percentage of participants |
| GSK3390107A Group | Percentage of Seronegative/Seropositive Subjects for Anti-GP EBOV Antibodies | Anti-GP EBOV, Month 6, S- | 0.7 Percentage of participants |
| GSK3390107A Group | Percentage of Seronegative/Seropositive Subjects for Anti-GP EBOV Antibodies | Anti-GP EBOV, Month 6, S+ | 99.3 Percentage of participants |
| GSK3390107A Group | Percentage of Seronegative/Seropositive Subjects for Anti-GP EBOV Antibodies | Anti-GP EBOV, Month 12, S- | 0.9 Percentage of participants |
| GSK3390107A Group | Percentage of Seronegative/Seropositive Subjects for Anti-GP EBOV Antibodies | Anti-GP EBOV, Month 12, S+ | 99.1 Percentage of participants |
| GSK3390107A Group | Percentage of Seronegative/Seropositive Subjects for Anti-GP EBOV Antibodies | Anti-GP EBOV, Day 0, S+ | 25.2 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Seronegative/Seropositive Subjects for Anti-GP EBOV Antibodies | Anti-GP EBOV, Day 0, S- | 74.9 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Seronegative/Seropositive Subjects for Anti-GP EBOV Antibodies | Anti-GP EBOV, Day 30, S+ | 28.0 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Seronegative/Seropositive Subjects for Anti-GP EBOV Antibodies | Anti-GP EBOV, Day 0, S+ | 25.1 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Seronegative/Seropositive Subjects for Anti-GP EBOV Antibodies | Anti-GP EBOV, Month 6, S+ | 18.1 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Seronegative/Seropositive Subjects for Anti-GP EBOV Antibodies | Anti-GP EBOV, Day 30, S- | 72.0 Percentage of participants |
| Placebo+GSK3390107A Group | Percentage of Seronegative/Seropositive Subjects for Anti-GP EBOV Antibodies | Anti-GP EBOV, Month 6, S- | 81.9 Percentage of participants |