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A Study to Assess the Safety, Reactogenicity and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' RSV Investigational Vaccine (ChAd155-RSV) (GSK3389245A) in Healthy Adults

Sponsor
GlaxoSmithKline (Industry)
Overall Status
Completed
CT.gov ID
NCT02491463
Collaborator
(none)
73
Enrollment
1
Location
4
Arms
18.2
Actual Duration (Months)
4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this first time in human (FTiH) study is to assess the safety, reactogenicity and immunogenicity of 2 doses of the RSV investigational vaccine, when administered intramuscularly according to a 0, 1 month schedule, in healthy adults aged 18 to 45 years.

Condition or Disease Intervention/Treatment Phase
  • Biological: GSK3389245A_LD GROUP
  • Biological: GSK3389245A_HD GROUP
  • Biological: Bexsero
  • Drug: Placebo
 Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
73 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
A Study to Evaluate Safety, Reactogenicity and Immunogenicity of GSK Biologicals' RSV Investigational Vaccine Based on Viral Proteins Encoded by Chimpanzee-derived Adenovector (ChAd155-RSV) (GSK3389245A) in Healthy Adults
Actual Study Start Date :
Jul 23, 2015
Actual Primary Completion Date :
Apr 8, 2016
Actual Study Completion Date :
Jan 26, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: GSK3389245A_LD GROUP

Subjects in this group will receive 2 doses, one month apart of the GSK3389245A vaccine low dose

Biological: GSK3389245A_LD GROUP
2 doses administered intramuscularly at Day 0 and Day 30 in the deltoid region of the non-dominant arm
Experimental: GSK3389245A_HD GROUP

Subjects in this group will receive 2 doses, one month apart, of the GSK3389245A vaccine high dose

Biological: GSK3389245A_HD GROUP
2 doses administered intramuscularly at Day 0 and Day 30 in the deltoid region of the non-dominant arm
Active Comparator: Bexsero Group

Subjects in this group will receive 2 doses, one month apart, of Bexsero

Biological: Bexsero
2 doses administered intramuscularly at Day 0 and Day 30 in the deltoid region of the non-dominant arm
Other Names:
  • Meningococcal group B Vaccine

    		•
    Placebo Comparator: Placebo Group

    Subjects in this group will receive 2 doses, one month apart, of placebo

    Drug: Placebo
    2 doses administered intramuscularly at Day 0 and Day 30 in the deltoid region of the non-dominant arm

    Outcome Measures

    Primary Outcome Measures

    1. Number of Subjects With Solicited Local Symptoms [During the 7-day (Days 0-6) post-vaccination period following each dose and across doses]

      Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site. All solicited local symptoms are considered as related to the vaccination.

    2. Number of Subjects With Solicited General Symptoms [During the 7-day (Days 0-6) post-vaccination period following each dose and across doses]

      Assessed solicited general symptoms were fatigue, fever [defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)] gastrointestinal symptoms (gastro) [nausea, vomiting, diarrhoea and/or abdominal pain] and headache. Any = occurrence of the symptom regardless of intensity grade and relationship to the vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination.

    3. Number of Subjects With Haematological and Biochemical Laboratory Abnormalities [At Day 1]

      Haematological/Biochemical parameters assessed were haemoglobin level [HgL], red blood cells [RBC], white blood cell [WBC], lymphocyte [LYM], neutrophil [NEU], eosinophil [EOS], reticulocyte [RET], platelet count [PLC], haptoglobin [Hpg], prothrombin time [PT] and partial thromboplastin time [PTT]. alanine aminotransferase [ALT], aspartate aminotransferase [AST], creatinine [CRE], lactate dehydrogenase [LDH] and bilirubin direct or total [BLD/BLT].Values were: unknown at baseline and below at Day 1 (U-B), unknown at baseline and within at Day 1 (U-W), unknown at baseline and above at Day 1 (U-A), below at baseline and below at Day 1 (B-B), below at baseline and within at Day 1 (B-W), below at baseline and above at Day 1(B-A), within at baseline and below at Day 1 (W-B), within at baseline and within at Day 1(W-W), within at baseline and above at Day 1(W-A), above at baseline and below at Day 1(A-B), above at baseline and within at Day 1 (A-W), above at baseline and above at Day 1(A-A)

    4. Number of Subjects With Haematological and Biochemical Laboratory Abnormalities [At Day 3]

      Haematological/ Biochemical parameters assessed were haemoglobin level [HgL], red blood cell [RBC], white blood cell [WBC], lymphocyte [LYM], neutrophil [NEU], eosinophil [EOS], reticulocyte [RET], platelet count [PLC], haptoglobin [Hpg], prothrombin time [PT] and partial thromboplastin time [PTT]. alanine aminotransferase [ALT], aspartate aminotransferase [AST], creatinine [CRE], lactate dehydrogenase [LDH] and bilirubin direct or total [BLD/BLT].Values were: unknown at baseline and below at Day 3 (U-B), unknown at baseline and within at Day 3 (U-W), unknown at baseline and above at Day 3 (U-A), below at baseline and below at Day 3 (B-B), below at baseline and within at Day 3 (B-W), below at baseline and above at Day 3(B-A), within at baseline and below at Day 3 (W-B), within at baseline and within at Day 3(W-W), within at baseline and above at Day 3(W-A), above at baseline and below at Day 3(A-B), above at baseline and within at Day 3(A-W), above at baseline and above at Day 3(A-A).

    5. Number of Subjects With Haematological and Biochemical Laboratory Abnormalities [At Day 7]

      Haematological/ Biochemical parameters assessed were haemoglobin level [HgL], red blood cell [RBC], white blood cell [WBC], lymphocyte [LYM], neutrophil [NEU], eosinophil [EOS], reticulocyte [RET], platelet count [PLC], haptoglobin [Hpg], prothrombin time [PT] and partial thromboplastin time [PTT]. alanine aminotransferase [ALT], aspartate aminotransferase [AST], creatinine [CRE], lactate dehydrogenase [LDH] and bilirubin direct or total [BLD/BLT].Values were: unknown at baseline and below at Day 7 (U-B), unknown at baseline and within at Day 7 (U-W), unknown at baseline and above at Day 7 (U-A), below at baseline and below at Day 7 (B-B), below at baseline and within at Day 7 (B-W), below at baseline and above at Day 7(B-A), within at baseline and below at Day 7 (W-B), within at baseline and within at Day 7(W-W), within at baseline and above at Day 7(W-A), above at baseline and below at Day 7(A-B), above at baseline and within at Day 7(A-W), above at baseline and above at Day 7(A-A).

    6. Number of Subjects With Haematological and Biochemical Laboratory Abnormalities [At Day 30]

      Haematological/Biochemical parameters assessed were haemoglobin level [HgL], red blood cell [RBC], white blood cell [WBC], lymphocyte [LYM], neutrophil [NEU], eosinophil [EOS], reticulocyte [RET], platelet count [PLC], haptoglobin [Hpg], prothrombin time [PT] and partial thromboplastin time [PTT]. alanine aminotransferase [ALT], aspartate aminotransferase [AST], creatinine [CRE], lactate dehydrogenase [LDH] and bilirubin direct or total [BLD/BLT].Values were: unknown at baseline and below at Day 30(U-B), unknown at baseline and within at Day30(U-W), unknown at baseline and above at Day 30(U-A), below at baseline and below at Day30(B-B), below at baseline and within at Day30(B-W), below at baseline and above at Day 30(B-A), within at baseline and below at Day 30 (W-B), within at baseline and within at Day 30(W-W), within at baseline and above at Day30(W-A), above at baseline and below at Day30(A-B), above at baseline and within at Day30(A-W), above at baseline and above at Day30(A-A).

    7. Number of Subjects With Haematological and Biochemical Laboratory Abnormalities [At Day 31]

      Haematological/Biochemical parameters assessed were haemoglobin level [HgL], red blood cell [RBC], white blood cell [WBC], lymphocyte [LYM], neutrophil [NEU], eosinophil [EOS], reticulocyte [RET], platelet count [PLC], haptoglobin [Hpg], prothrombin time [PT] and partial thromboplastin time [PTT]. alanine aminotransferase [ALT], aspartate aminotransferase [AST], creatinine [CRE], lactate dehydrogenase [LDH] and bilirubin direct or total [BLD/BLT].Values were: unknown at baseline and below at Day 31(U-B), unknown at baseline and within at Day31(U-W), unknown at baseline and above at Day 31(U-A), below at baseline and below at Day31(B-B), below at baseline and within at Day31(B-W), below at baseline and above at Day 31(B-A), within at baseline and below at Day 31(W-B), within at baseline and within at Day 31(W-W), within at baseline and above at Day31(W-A), above at baseline and below at Day31(A-B), above at baseline and within at Day31(A-W), above at baseline and above at Day31(A-A).

    8. Number of Subjects With Haematological and Biochemical Laboratory Abnormalities [At Day 33]

      Haematological/Biochemical parameters assessed were haemoglobin level [HgL], red blood cell [RBC], white blood cell [WBC], lymphocyte [LYM], neutrophil [NEU], eosinophil [EOS], reticulocyte [RET], platelet count [PLC], haptoglobin [Hpg], prothrombin time [PT] and partial thromboplastin time [PTT]. alanine aminotransferase [ALT], aspartate aminotransferase [AST], creatinine [CRE], lactate dehydrogenase [LDH] and bilirubin direct or total [BLD/BLT].Values were: unknown at baseline and below at Day 33(U-B), unknown at baseline and within at Day33(U-W), unknown at baseline and above at Day 33(U-A), below at baseline and below at Day33(B-B), below at baseline and within at Day33(B-W), below at baseline and above at Day 33 (B-A), within at baseline and below at Day 33(W-B), within at baseline and within at Day 33(W-W), within at baseline and above at Day33(W-A), above at baseline and below at Day33(A-B), above at baseline and within at Day33(A-W), above at baseline and above at Day33(A-A).

    9. Number of Subjects With Haematological and Biochemical Laboratory Abnormalities [At Day 37]

      Haematological/Biochemical parameters assessed were haemoglobin level [HgL], red blood cell [RBC], white blood cell [WBC], lymphocyte [LYM], neutrophil [NEU], eosinophil [EOS], reticulocyte [RET], platelet count [PLC], haptoglobin [Hpg], prothrombin time [PT] and partial thromboplastin time [PTT]. alanine aminotransferase [ALT], aspartate aminotransferase [AST], creatinine [CRE], lactate dehydrogenase [LDH] and bilirubin direct or total [BLD/BLT].Values were: unknown at baseline and below at Day 37(U-B), unknown at baseline and within at Day37(U-W), unknown at baseline and above at Day 37(U-A), below at baseline and below at Day37(B-B), below at baseline and within at Day37(B-W), below at baseline and above at Day 37(B-A), within at baseline and below at Day 37(W-B), within at baseline and within at Day 37(W-W), within at baseline and above at Day37(W-A), above at baseline and below at Day37(A-B), above at baseline and within at Day37(A-W), above at baseline and above at Day37(A-A).

    10. Number of Subjects With Haematological and Biochemical Laboratory Abnormalities [At Day 60]

      Haematological/Biochemical parameters assessed were haemoglobin level [HgL], red blood cell [RBC], white blood cell [WBC], lymphocyte [LYM], neutrophil [NEU], eosinophil [EOS], reticulocyte [RET], platelet count [PLC], haptoglobin [Hpg], prothrombin time [PT] and partial thromboplastin time [PTT]. alanine aminotransferase [ALT], aspartate aminotransferase [AST], creatinine [CRE], lactate dehydrogenase [LDH] and bilirubin direct or total [BLD/BLT].Values were: unknown at baseline and below at Day 60(U-B), unknown at baseline and within at Day60(U-W), unknown at baseline and above at Day 60(U-A), below at baseline and below at Day60(B-B), below at baseline and within at Day60(B-W), below at baseline and above at Day60(B-A), within at baseline and below at Day 60(W-B), within at baseline and within at Day 60(W-W), within at baseline and above at Day60(W-A), above at baseline and below at Day60(A-B), above at baseline and within at Day60(A-W), above at baseline and above at Day60(A-A).

    11. Number of Subjects With Haematological and Biochemical Laboratory Abnormalities [At Day 180]

      Haematological/Biochemical parameters assessed were haemoglobin level [HgL], red blood cell [RBC], white blood cell [WBC], lymphocyte [LYM], neutrophil [NEU], eosinophil [EOS], reticulocyte [RET], platelet count [PLC], haptoglobin [Hpg], prothrombin time [PT] and partial thromboplastin time [PTT], alanine aminotransferase [ALT], aspartate aminotransferase [AST], creatinine [CRE], lactate dehydrogenase [LDH] and bilirubin direct or total [BLD/BLT].Values were: unknown at baseline and below at Day180(U-B), unknown at baseline and within at Day180(U-W), unknown at baseline and above at Day180(U-A), below at baseline and below at Day180(B-B), below at baseline and within at Day180(B-W),below at baseline and above at Day180(B-A), within at baseline and below at Day180(W-B),within at baseline and within at Day180(W-W), within at baseline and above at Day180(W-A),above at baseline and below at Day180(A-B),above at baseline and within at Day180(A-W),above at baseline and above at Day180(A-A).

    12. Number of Subjects With Haematological and Biochemical Laboratory Abnormalities [At Day 360]

      Haematological/Biochemical parameters assessed were haemoglobin level [HgL], red blood cell [RBC], white blood cell [WBC], lymphocyte [LYM], neutrophil [NEU], eosinophil [EOS], reticulocyte [RET], platelet count [PLC], haptoglobin [Hpg], prothrombin time [PT] and partial thromboplastin time [PTT], alanine aminotransferase [ALT], aspartate aminotransferase [AST], creatinine [CRE], lactate dehydrogenase [LDH] and bilirubin direct or total [BLD/BLT].Values were: unknown at baseline and below at Day360(U-B), unknown at baseline and within at Day360(U-W), unknown at baseline and above at Day360(U-A), below at baseline and below at Day360(B-B), below at baseline and within at Day360(B-W),below at baseline and above at Day360(B-A), within at baseline and below at Day360(W-B),within at baseline and within at Day360(W-W), within at baseline and above at Day360(W-A),above at baseline and below at Day360(A-B),above at baseline and within at Day360(A-W),above at baseline and above at Day360(A-A).

    13. Number of Subjects With Haematological and Biochemical Results by Maximum Grade [From Day 1 to Day 60]

      Parameters analysed were ALT, activated partial thromboplastin time [APTT], AST, total bilirubin [TB], CRE, EOS, haemoglobin decrease [HgD], LYM, NEU, platelets [PLA], PT, white blood cells decrease [WBCD] and white blood cells increase [WBCI]. Assessed grades were: Unknown [UG], grade 0 [G0] = no grade, 1 [G1] = mild grade, 2 [G2] = moderate grade, 3 [G3] = severe grade, 4 [G4] = potentially life threatening and overall grading [GTotal]. Parameter grade combinations expressed were: parameter plus UG/G0/1/2/3/4/Total at baseline versus grading G0/1/2/3/4/Total from Day 1 up to Day 60, for the same parameter, e.g. ALT G0-G2.

    14. 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.

    15. Number of Subjects With Serious Adverse Events (SAEs) [From Day 0 to Day 360]

      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.

    Secondary Outcome Measures

    1. Number of Subjects With Haematological and Biochemical Results by Maximum Grade [From Day 1 up to Day 360]

      Parameters analysed were ALT, activated partial thromboplastin time [APTT], AST, total bilirubin [TB], CRE, EOS, haemoglobin decrease [HgD], LYM, NEU, platelets [PLA], PT, white blood cells decrease [WBCD] and white blood cells increase [WBCI]. Assessed grades were: Unknown [UG], grade 0 [G0] = no grade, 1 [G1] = mild grade, 2 [G2] = moderate grade, 3 [G3] = severe grade, 4 [G4] = potentially life threatening and overall grading [GTotal]. Parameter grade combinations expressed were: parameter plus UG/G0/1/2/3/4/Total at baseline versus grading G0/1/2/3/4/Total from Day 1 up to Day 360, for the same parameter, e.g. ALT G0-G2.

    2. Anti-respiratory Syncytial Virus (RSV) Neutralizing Antibodies Titers [At pre-vaccination (Day 0), post-Dose 1 (Day 30) and post-Dose 2 (Day 60)]

      Serum neutralizing antibody titers were reported as the inverse of the serum dilution which yielded a 60% reduction in the number of viral plaques compared to virus control without serum (Estimated Dilution: ED60). Antibody titers were expressed as Geometric Mean Titers (GMTs).

    3. Number of Subjects With Anti-RSV Neutralizing Antibodies Above the Cut-off Value [At pre-vaccination (Day 0), post-Dose 1 (Day 30) and post-Dose 2 (Day 60)]

      Pre-defined cut-off values was higher than or equal to (≥) 8 ED60.

    4. Frequency of RSV Viral Protein F, N, M2-1 Specific Interferon-gamma (IFN-γ) Secreting T-cells [At pre-vaccination (Day 0) and post-Dose 1 (Day 7, Day 30) and post-Dose 2 (Day 37, Day 60)]

      Interferon-gamma specific T-cells, expressed as T-cells per (/) million cells, were determined by the Enzyme Linked ImmunoSpot (ELISpot) assay.

    5. Frequency of Anti-F Immunoglobulin g (IgG) and/or Immunoglobulin A (IgA) Antibody Secreting B-cells (ASC) [At pre-vaccination (Day 0) and post-Dose 1 (Day 7, Day 30) and post-Dose 2 (Day 37, Day 60)]

      IgG/IgA antibody specific B-cells/ expressed as B-cells per million cells, were determined by the ELISpot assay.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol

    • Written informed consent obtained from the subject prior to performing any study specific procedure

    • A male or female between, and including, 18 and 45 years of age at the time of first vaccination

    • Healthy subjects as established by medical history and clinical examination before entering into the study

    • Female subjects of non-childbearing potential may be enrolled in the study

    • Female subjects of childbearing potential may be enrolled in the study, if the subject:

    • has practiced adequate contraception for 30 days prior to vaccination, and

    • has a negative pregnancy test on the day of vaccina-tion, and

    • has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series

    Exclusion Criteria:

    • Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product

    • Use of any investigational or non-registered product other than the study vaccines during the period starting 30 days before the first dose of study vaccines, or planned use during the study period

    • Chronic administration of immunosuppressants or other immune-modifying drugs within 6 months prior to study vaccination, or planned administration during the study period

    • Planned administration/administration of a vaccine not foreseen by the study protocol in the period starting 30 days before the first dose and ending 30 days after the last dose of vaccine administration, with the exception of any licensed influenza vaccine which may be administered ≥ 15 days before the first dose and ≥ 15 days after the last dose of study vaccine

    • Administration of immunoglobulins and/or any blood products during the period starting 3 months before the first dose of study vaccines or planned administration during the study period

    • Blood donation within 4 months prior to study entry or planned blood donation at any time during the study

    • Previous vaccination against RSV

    • Previous vaccination with a recombinant simian or human adenoviral vaccine

    • Previous Bexsero or other vaccination against Neisseria meningitidis serogroup B

    • History of or current autoimmune disease

    • Family history of congenital or hereditary immunodefi-ciency

    • History of any reaction or hypersensitivity likely to be exacerbated by any component of the study vaccines.

    • History of any neurological disorders or seizures

    • History of transient thrombocytopenia or neurological complications following any prior vaccination

    • Hypersensitivity to latex

    • Hypersensitivity to Bexsero's active substances or to any of its excipients

    • Allergic reaction to kanamycin

    • Any medical condition that in the judgment of the investi-gator would make intramuscular injection unsafe

    • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination

    • Acute disease and/or fever at the time of enrolment

    • Acute or chronic, clinically significant pulmonary, cardio-vascular, hepatic or renal functional abnormality, as de-termined by physical examination or laboratory screening tests

    • Malignancy within previous 5 years or lymphoproliferative disorders

    • Any clinically significant or any ≥ Grade 2 haematological laboratory abnormality

    • Body mass index > 40 kg/m2

    • Current alcohol and/or drug abuse

    • Pregnant or lactating female

    • Any other condition that the investigator judges may interfere with study procedures or findings

    • Planned move to a location that will prohibit participating in the trial until study end

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 GSK Investigational Site Oxford Oxfordshire United Kingdom OX3 7LJ

    Sponsors and Collaborators

    • GlaxoSmithKline

    Investigators

    • Study Director: GSK Clinical Trials, GlaxoSmithKline

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    GlaxoSmithKline
    ClinicalTrials.gov Identifier:
    NCT02491463
    Other Study ID Numbers:
    • 201974
    First Posted:
    Jul 8, 2015
    Last Update Posted:
    Aug 20, 2018
    Last Verified:
    May 1, 2018
    Keywords provided by GlaxoSmithKline
    Reactogenicity
    Safety
    Respiratory syncytial virus (RSV)
    Vaccine
    Immunogenicity
    Additional relevant MeSH terms:
    Virus Diseases
    Vaccines

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail Out of 73 subjects originally enrolled in this study, only 72 subjects received the study vaccination and were hence included in the Total Vaccinated Cohort.
    Arm/Group Title GSK3389245A_LD Group GSK3389245A_HD Group Placebo Group Bexsero Group
    Arm/Group Description Subjects received 2 doses of the investigational GSK3389245A low dose (LD) vaccine, one month apart, at Day 0 and Day 30. Subjects received 2 doses of the investigational GSK3389245A high dose (HD) vaccine, one month apart, at Day 0 and Day 30. Subjects received 2 doses of placebo vaccine, one month apart, at Day 0 and Day 30. Subjects received 2 doses of the active control vaccine, one month apart, at Day 0 and Day 30.
    Period Title: Overall Study
    STARTED 7 31 19 15
    COMPLETED 5 21 15 14
    NOT COMPLETED 2 10 4 1

    Baseline Characteristics

    Arm/Group Title GSK3389245A_LD Group GSK3389245A_HD Group Placebo Group Bexsero Group Total
    Arm/Group Description Subjects received 2 doses of the investigational GSK3389245A low dose (LD) vaccine, one month apart, at Day 0 and Day 30. Subjects received 2 doses of the investigational GSK3389245A high dose (HD) vaccine, one month apart, at Day 0 and Day 30. Subjects received 2 doses of placebo vaccine, one month apart, at Day 0 and Day 30. Subjects received 2 doses of the active control vaccine, one month apart, at Day 0 and Day 30. Total of all reporting groups
    Overall Participants 7 31 19 15 72
    Age (Years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [Years]
    32.9
    (8.2)
    30.6
    (8.7)
    31.3
    (8.6)
    29.5
    (7.6)
    30.8
    (8.3)
    Sex: Female, Male (Count of Participants)
    Female
    5
    71.4%
    14
    45.2%
    12
    63.2%
    10
    66.7%
    41
    56.9%
    Male
    2
    28.6%
    17
    54.8%
    7
    36.8%
    5
    33.3%
    31
    43.1%
    Race/Ethnicity, Customized (Count of Participants)
    Asian - Central/South Asian Heritage
    0
    0%
    3
    9.7%
    1
    5.3%
    0
    0%
    4
    5.6%
    Asian - East Asian Heritage
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    1
    1.4%
    Asian - Japanese Heritage
    0
    0%
    0
    0%
    1
    5.3%
    0
    0%
    1
    1.4%
    Asian - South East Asian Heritage
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    1
    1.4%
    White - Caucasian / European Heritage
    7
    100%
    26
    83.9%
    17
    89.5%
    14
    93.3%
    64
    88.9%
    Other
    0
    0%
    0
    0%
    0
    0%
    1
    6.7%
    1
    1.4%

    Outcome Measures

    1. Primary Outcome
    Title Number of Subjects With Solicited Local Symptoms
    Description Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site. All solicited local symptoms are considered as related to the vaccination.
    Time Frame During the 7-day (Days 0-6) post-vaccination period following each dose and across doses

    Outcome Measure Data

    Analysis Population Description
    The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administration documented, who had filled in their symptom sheets.
    Arm/Group Title GSK3389245A_LD Group GSK3389245A_HD Group Placebo Group Bexsero Group
    Arm/Group Description Subjects received 2 doses of the investigational GSK3389245A low dose (LD) vaccine, one month apart, at Day 0 and Day 30. Subjects received 2 doses of the investigational GSK3389245A high dose (HD) vaccine, one month apart, at Day 0 and Day 30. Subjects received 2 doses of placebo vaccine, one month apart, at Day 0 and Day 30. Subjects received 2 doses of the active control vaccine, one month apart, at Day 0 and Day 30.
    Measure Participants 7 30 19 15
    Any Pain Dose 1
    2
    28.6%
    23
    74.2%
    1
    5.3%
    15
    100%
    Grade 3 Pain Dose 1
    0
    0%
    1
    3.2%
    0
    0%
    3
    20%
    Any Redness Dose 1
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Grade 3 Redness Dose 1
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Any Swelling Dose 1
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Grade 3 Swelling Dose 1
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Any Pain Dose 2
    2
    28.6%
    19
    61.3%
    0
    0%
    15
    100%
    Grade 3 Pain Dose 2
    0
    0%
    1
    3.2%
    0
    0%
    2
    13.3%
    Any Redness Dose 2
    0
    0%
    0
    0%
    0
    0%
    3
    20%
    Grade 3 Redness Dose 2
    0
    0%
    0
    0%
    0
    0%
    1
    6.7%
    Any Swelling Dose 2
    0
    0%
    0
    0%
    0
    0%
    1
    6.7%
    Grade 3 Swelling Dose 2
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Any Pain Across doses
    4
    57.1%
    27
    87.1%
    1
    5.3%
    15
    100%
    Grade 3 Pain Across doses
    0
    0%
    2
    6.5%
    0
    0%
    4
    26.7%
    Any Redness Across doses
    0
    0%
    0
    0%
    0
    0%
    3
    20%
    Grade 3 Redness Across doses
    0
    0%
    0
    0%
    0
    0%
    1
    6.7%
    Any Swelling Across doses
    0
    0%
    0
    0%
    0
    0%
    1
    6.7%
    Grade 3 Swelling Across doses
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    2. Primary Outcome
    Title Number of Subjects With Solicited General Symptoms
    Description Assessed solicited general symptoms were fatigue, fever [defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)] gastrointestinal symptoms (gastro) [nausea, vomiting, diarrhoea and/or abdominal pain] and headache. Any = occurrence of the symptom regardless of intensity grade and relationship to the vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination.
    Time Frame During the 7-day (Days 0-6) post-vaccination period following each dose and across doses

    Outcome Measure Data

    Analysis Population Description
    The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one study vaccine administration documented, who had filled in their symptom sheets.
    Arm/Group Title GSK3389245A_LD Group GSK3389245A_HD Group Placebo Group Bexsero Group
    Arm/Group Description Subjects received 2 doses of the investigational GSK3389245A low dose (LD) vaccine, one month apart, at Day 0 and Day 30. Subjects received 2 doses of the investigational GSK3389245A high dose (HD) vaccine, one month apart, at Day 0 and Day 30. Subjects received 2 doses of placebo vaccine, one month apart, at Day 0 and Day 30. Subjects received 2 doses of the active control vaccine, one month apart, at Day 0 and Day 30.
    Measure Participants 7 30 19 15
    Any Fatigue Dose 1
    3
    42.9%
    19
    61.3%
    8
    42.1%
    8
    53.3%
    Grade 3 Fatigue Dose 1
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Related Fatigue Dose 1
    3
    42.9%
    19
    61.3%
    8
    42.1%
    8
    53.3%
    Any Gastro Dose 1
    2
    28.6%
    5
    16.1%
    6
    31.6%
    3
    20%
    Grade 3 Gastro Dose 1
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Related Gastro Dose 1
    2
    28.6%
    5
    16.1%
    6
    31.6%
    3
    20%
    Any Headache Dose 1
    5
    71.4%
    14
    45.2%
    8
    42.1%
    10
    66.7%
    Grade 3 Headache Dose 1
    1
    14.3%
    0
    0%
    0
    0%
    0
    0%
    Related Headache Dose 1
    5
    71.4%
    14
    45.2%
    8
    42.1%
    10
    66.7%
    Any Fever Dose 1
    0
    0%
    5
    16.1%
    0
    0%
    1
    6.7%
    Grade 3 Fever Dose 1
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Related Fever Dose 1
    0
    0%
    5
    16.1%
    0
    0%
    1
    6.7%
    Any Fatigue Dose 2
    1
    14.3%
    10
    32.3%
    6
    31.6%
    9
    60%
    Grade 3 Fatigue Dose 2
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    Related Fatigue Dose 2
    1
    14.3%
    10
    32.3%
    6
    31.6%
    9
    60%
    Any Gastro Dose 2
    2
    28.6%
    4
    12.9%
    4
    21.1%
    2
    13.3%
    Grade 3 Gastro Dose 2
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Related Gastro Dose 2
    1
    14.3%
    4
    12.9%
    4
    21.1%
    1
    6.7%
    Any Headache Dose 2
    1
    14.3%
    6
    19.4%
    5
    26.3%
    9
    60%
    Grade 3 Headache Dose 2
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Related Headache Dose 2
    1
    14.3%
    6
    19.4%
    5
    26.3%
    9
    60%
    Any Fever Dose 2
    0
    0%
    4
    12.9%
    1
    5.3%
    2
    13.3%
    Grade 3 Fever Dose 2
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Related Fever Dose 2
    0
    0%
    4
    12.9%
    1
    5.3%
    2
    13.3%
    Any Fatigue Across doses
    4
    57.1%
    19
    61.3%
    9
    47.4%
    11
    73.3%
    Grade 3 Fatigue Across doses
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    Related Fatigue Across doses
    4
    57.1%
    19
    61.3%
    9
    47.4%
    11
    73.3%
    Any Gastro Across doses
    3
    42.9%
    7
    22.6%
    9
    47.4%
    4
    26.7%
    Grade 3 Gastro Across doses
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Related Gastro Across doses
    2
    28.6%
    7
    22.6%
    9
    47.4%
    4
    26.7%
    Any Headache Across doses
    5
    71.4%
    16
    51.6%
    10
    52.6%
    12
    80%
    Grade 3 Headache Across doses
    1
    14.3%
    0
    0%
    0
    0%
    0
    0%
    Related Headache Across doses
    5
    71.4%
    16
    51.6%
    10
    52.6%
    12
    80%
    Any Fever Across doses
    0
    0%
    8
    25.8%
    1
    5.3%
    2
    13.3%
    Grade 3 Fever Across doses
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Related Fever Across doses
    0
    0%
    8
    25.8%
    1
    5.3%
    2
    13.3%
    3. Primary Outcome
    Title Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
    Description Haematological/Biochemical parameters assessed were haemoglobin level [HgL], red blood cells [RBC], white blood cell [WBC], lymphocyte [LYM], neutrophil [NEU], eosinophil [EOS], reticulocyte [RET], platelet count [PLC], haptoglobin [Hpg], prothrombin time [PT] and partial thromboplastin time [PTT]. alanine aminotransferase [ALT], aspartate aminotransferase [AST], creatinine [CRE], lactate dehydrogenase [LDH] and bilirubin direct or total [BLD/BLT].Values were: unknown at baseline and below at Day 1 (U-B), unknown at baseline and within at Day 1 (U-W), unknown at baseline and above at Day 1 (U-A), below at baseline and below at Day 1 (B-B), below at baseline and within at Day 1 (B-W), below at baseline and above at Day 1(B-A), within at baseline and below at Day 1 (W-B), within at baseline and within at Day 1(W-W), within at baseline and above at Day 1(W-A), above at baseline and below at Day 1(A-B), above at baseline and within at Day 1 (A-W), above at baseline and above at Day 1(A-A)
    Time Frame At Day 1

    Outcome Measure Data

    Analysis Population Description
    The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one study vaccine administration documented and with available results at Day 1.
    Arm/Group Title GSK3389245A_LD Group GSK3389245A_HD Group Placebo Group Bexsero Group
    Arm/Group Description Subjects received 2 doses of the investigational GSK3389245A low dose (LD) vaccine, one month apart, at Day 0 and Day 30. Subjects received 2 doses of the investigational GSK3389245A high dose (HD) vaccine, one month apart, at Day 0 and Day 30. Subjects received 2 doses of placebo vaccine, one month apart, at Day 0 and Day 30. Subjects received 2 doses of the active control vaccine, one month apart, at Day 0 and Day 30.
    Measure Participants 7 31 19 15
    PTT, U-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PTT, U-W
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    PTT, U-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PTT, B-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PTT, B-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PTT, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PTT, W-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PTT, W-W
    7
    100%
    29
    93.5%
    18
    94.7%
    11
    73.3%
    PTT, W-A
    0
    0%
    0
    0%
    0
    0%
    1
    6.7%
    PTT, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PTT, A-W
    0
    0%
    0
    0%
    1
    5.3%
    1
    6.7%
    PTT, A-A
    0
    0%
    0
    0%
    0
    0%
    1
    6.7%
    ALT, B-B
    0
    0%
    2
    6.5%
    1
    5.3%
    0
    0%
    ALT, B-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    ALT, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    ALT, W-B
    0
    0%
    0
    0%
    2
    10.5%
    2
    13.3%
    ALT, W-W
    7
    100%
    27
    87.1%
    13
    68.4%
    12
    80%
    ALT, W-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    ALT, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    ALT, A-W
    0
    0%
    0
    0%
    1
    5.3%
    0
    0%
    ALT, A-A
    0
    0%
    2
    6.5%
    2
    10.5%
    1
    6.7%
    AST, B-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    AST, B-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    AST, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    AST, W-B
    1
    14.3%
    0
    0%
    0
    0%
    0
    0%
    AST, W-W
    6
    85.7%
    29
    93.5%
    19
    100%
    15
    100%
    AST, W-A
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    AST, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    AST, A-W
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    AST, A-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    BLD, B-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    BLD, B-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    BLD, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    BLD, W-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    BLD, W-W
    5
    71.4%
    22
    71%
    13
    68.4%
    9
    60%
    BLD, W-A
    1
    14.3%
    5
    16.1%
    3
    15.8%
    5
    33.3%
    BLD, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    BLD, A-W
    0
    0%
    0
    0%
    1
    5.3%
    0
    0%
    BLD, A-A
    1
    14.3%
    4
    12.9%
    2
    10.5%
    1
    6.7%
    CRE, U-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    CRE, U-W
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    CRE, U-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    CRE, B-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    CRE, B-W
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    CRE, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    CRE, W-B
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    CRE, W-W
    7
    100%
    24
    77.4%
    19
    100%
    15
    100%
    CRE, W-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    CRE, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    CRE, A-W
    0
    0%
    2
    6.5%
    0
    0%
    0
    0%
    CRE, A-A
    0
    0%
    2
    6.5%
    0
    0%
    0
    0%
    EOS, B-B
    0
    0%
    0
    0%
    0
    0%
    1
    6.7%
    EOS, B-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    EOS, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    EOS, W-B
    0
    0%
    3
    9.7%
    0
    0%
    1
    6.7%
    EOS, W-W
    6
    85.7%
    27
    87.1%
    18
    94.7%
    12
    80%
    EOS, W-A
    0
    0%
    0
    0%
    1
    5.3%
    0
    0%
    EOS, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    EOS, A-W
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    EOS, A-A
    1
    14.3%
    0
    0%
    0
    0%
    1
    6.7%
    RBC, B-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    RBC, B-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    RBC, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    RBC, W-B
    0
    0%
    2
    6.5%
    0
    0%
    1
    6.7%
    RBC, W-W
    6
    85.7%
    24
    77.4%
    11
    57.9%
    13
    86.7%
    RBC, W-A
    1
    14.3%
    0
    0%
    1
    5.3%
    1
    6.7%
    RBC, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    RBC, A-W
    0
    0%
    0
    0%
    4
    21.1%
    0
    0%
    RBC, A-A
    0
    0%
    5
    16.1%
    3
    15.8%
    0
    0%
    Hpg, B-B
    1
    14.3%
    1
    3.2%
    2
    10.5%
    0
    0%
    Hpg, B-W
    0
    0%
    2
    6.5%
    0
    0%
    1
    6.7%
    Hpg, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Hpg, W-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Hpg, W-W
    6
    85.7%
    27
    87.1%
    17
    89.5%
    14
    93.3%
    Hpg, W-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Hpg, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Hpg, A-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Hpg, A-A
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    HgL, B-B
    0
    0%
    2
    6.5%
    0
    0%
    0
    0%
    HgL, B-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    HgL, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    HgL, W-B
    1
    14.3%
    0
    0%
    0
    0%
    2
    13.3%
    HgL, W-W
    6
    85.7%
    28
    90.3%
    18
    94.7%
    12
    80%
    HgL, W-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    HgL, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    HgL, A-W
    0
    0%
    0
    0%
    1
    5.3%
    1
    6.7%
    HgL, A-A
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    LDH, B-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    LDH, B-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    LDH, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    LDH, W-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    LDH, W-W
    5
    71.4%
    22
    71%
    16
    84.2%
    12
    80%
    LDH, W-A
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    LDH, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    LDH, A-W
    1
    14.3%
    6
    19.4%
    3
    15.8%
    2
    13.3%
    LDH, A-A
    1
    14.3%
    2
    6.5%
    0
    0%
    1
    6.7%
    WBC, B-B
    1
    14.3%
    0
    0%
    0
    0%
    0
    0%
    WBC, B-W
    0
    0%
    1
    3.2%
    1
    5.3%
    1
    6.7%
    WBC, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    WBC, W-B
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    WBC, W-W
    6
    85.7%
    29
    93.5%
    18
    94.7%
    12
    80%
    WBC, W-A
    0
    0%
    0
    0%
    0
    0%
    2
    13.3%
    WBC, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    WBC, A-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    WBC, A-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    LYM, B-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    LYM, B-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    LYM, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    LYM, W-B
    0
    0%
    8
    25.8%
    0
    0%
    0
    0%
    LYM, W-W
    7
    100%
    21
    67.7%
    19
    100%
    15
    100%
    LYM, W-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    LYM, A-B
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    LYM, A-W
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    LYM, A-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    NEU, B-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    NEU, B-W
    1
    14.3%
    0
    0%
    1
    5.3%
    1
    6.7%
    NEU, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    NEU, W-B
    0
    0%
    1
    3.2%
    1
    5.3%
    0
    0%
    NEU, W-W
    6
    85.7%
    30
    96.8%
    17
    89.5%
    11
    73.3%
    NEU, W-A
    0
    0%
    0
    0%
    0
    0%
    3
    20%
    NEU, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    NEU, A-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    NEU, A-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PLC, B-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PLC, B-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PLC, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PLC, W-B
    0
    0%
    0
    0%
    0
    0%
    1
    6.7%
    PLC, W-W
    7
    100%
    31
    100%
    16
    84.2%
    14
    93.3%
    PLC, W-A
    0
    0%
    0
    0%
    2
    10.5%
    0
    0%
    PLC, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PLC, A-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PLC, A-A
    0
    0%
    0
    0%
    1
    5.3%
    0
    0%
    PT, U-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PT, U-W
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    PT, U-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PT, B-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PT, B-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PT, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PT, W-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PT, W-W
    7
    100%
    26
    83.9%
    19
    100%
    13
    86.7%
    PT, W-A
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    PT, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PT, A-W
    0
    0%
    0
    0%
    0
    0%
    1
    6.7%
    PT, A-A
    0
    0%
    2
    6.5%
    0
    0%
    0
    0%
    RET, B-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    RET, B-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    RET, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    RET, W-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    RET, W-W
    7
    100%
    31
    100%
    18
    94.7%
    15
    100%
    RET, W-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    RET, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    RET, A-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    RET, A-A
    0
    0%
    0
    0%
    1
    5.3%
    0
    0%
    BLT, B-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    BLT, B-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    BLT, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    BLT, W-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    BLT, W-W
    7
    100%
    27
    87.1%
    19
    100%
    14
    93.3%
    BLT, W-A
    0
    0%
    2
    6.5%
    0
    0%
    1
    6.7%
    BLT, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    BLT, A-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    BLT, A-A
    0
    0%
    2
    6.5%
    0
    0%
    0
    0%
    4. Primary Outcome
    Title Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
    Description Haematological/ Biochemical parameters assessed were haemoglobin level [HgL], red blood cell [RBC], white blood cell [WBC], lymphocyte [LYM], neutrophil [NEU], eosinophil [EOS], reticulocyte [RET], platelet count [PLC], haptoglobin [Hpg], prothrombin time [PT] and partial thromboplastin time [PTT]. alanine aminotransferase [ALT], aspartate aminotransferase [AST], creatinine [CRE], lactate dehydrogenase [LDH] and bilirubin direct or total [BLD/BLT].Values were: unknown at baseline and below at Day 3 (U-B), unknown at baseline and within at Day 3 (U-W), unknown at baseline and above at Day 3 (U-A), below at baseline and below at Day 3 (B-B), below at baseline and within at Day 3 (B-W), below at baseline and above at Day 3(B-A), within at baseline and below at Day 3 (W-B), within at baseline and within at Day 3(W-W), within at baseline and above at Day 3(W-A), above at baseline and below at Day 3(A-B), above at baseline and within at Day 3(A-W), above at baseline and above at Day 3(A-A).
    Time Frame At Day 3

    Outcome Measure Data

    Analysis Population Description
    The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one study vaccine administration documented and with available results at Day 3.
    Arm/Group Title GSK3389245A_LD Group GSK3389245A_HD Group Placebo Group Bexsero Group
    Arm/Group Description Subjects received 2 doses of the investigational GSK3389245A low dose (LD) vaccine, one month apart, at Day 0 and Day 30. Subjects received 2 doses of the investigational GSK3389245A high dose (HD) vaccine, one month apart, at Day 0 and Day 30. Subjects received 2 doses of placebo vaccine, one month apart, at Day 0 and Day 30. Subjects received 2 doses of the active control vaccine, one month apart, at Day 0 and Day 30.
    Measure Participants 7 30 19 15
    PTT, U-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PTT, U-W
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    PTT, U-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PTT, B-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PTT, B-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PTT, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PTT, W-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PTT, W-W
    7
    100%
    29
    93.5%
    18
    94.7%
    11
    73.3%
    PTT, W-A
    0
    0%
    0
    0%
    0
    0%
    1
    6.7%
    PTT, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PTT, A-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PTT, A-A
    0
    0%
    0
    0%
    1
    5.3%
    2
    13.3%
    ALT, B-B
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    ALT, B-W
    0
    0%
    1
    3.2%
    1
    5.3%
    0
    0%
    ALT, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    ALT, W-B
    0
    0%
    0
    0%
    2
    10.5%
    2
    13.3%
    ALT, W-W
    7
    100%
    26
    83.9%
    13
    68.4%
    12
    80%
    ALT, W-A
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    ALT, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    ALT, A-W
    0
    0%
    1
    3.2%
    2
    10.5%
    1
    6.7%
    ALT, A-A
    0
    0%
    0
    0%
    1
    5.3%
    0
    0%
    AST, B-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    AST, B-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    AST, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    AST, W-B
    1
    14.3%
    0
    0%
    0
    0%
    0
    0%
    AST, W-W
    6
    85.7%
    29
    93.5%
    19
    100%
    15
    100%
    AST, W-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    AST, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    AST, A-W
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    AST, A-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    BLD, B-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    BLD, B-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    BLD, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    BLD, W-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    BLD, W-W
    6
    85.7%
    27
    87.1%
    15
    78.9%
    12
    80%
    BLD, W-A
    0
    0%
    0
    0%
    1
    5.3%
    2
    13.3%
    BLD, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    BLD, A-W
    1
    14.3%
    0
    0%
    0
    0%
    0
    0%
    BLD, A-A
    0
    0%
    3
    9.7%
    3
    15.8%
    1
    6.7%
    CRE, U-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    CRE, U-W
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    CRE, U-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    CRE, B-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    CRE, B-W
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    CRE, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    CRE, W-B
    0
    0%
    2
    6.5%
    0
    0%
    0
    0%
    CRE, W-W
    7
    100%
    23
    74.2%
    19
    100%
    15
    100%
    CRE, W-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    CRE, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    CRE, A-W
    0
    0%
    2
    6.5%
    0
    0%
    0
    0%
    CRE, A-A
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    EOS, B-B
    0
    0%
    0
    0%
    0
    0%
    1
    6.7%
    EOS, B-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    EOS, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    EOS, W-B
    0
    0%
    0
    0%
    0
    0%
    1
    6.7%
    EOS, W-W
    6
    85.7%
    28
    90.3%
    18
    94.7%
    12
    80%
    EOS, W-A
    0
    0%
    1
    3.2%
    1
    5.3%
    0
    0%
    EOS, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    EOS, A-W
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    EOS, A-A
    1
    14.3%
    0
    0%
    0
    0%
    1
    6.7%
    RBC, B-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    RBC, B-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    RBC, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    RBC, W-B
    1
    14.3%
    2
    6.5%
    1
    5.3%
    2
    13.3%
    RBC, W-W
    5
    71.4%
    24
    77.4%
    10
    52.6%
    13
    86.7%
    RBC, W-A
    1
    14.3%
    0
    0%
    1
    5.3%
    0
    0%
    RBC, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    RBC, A-W
    0
    0%
    3
    9.7%
    6
    31.6%
    0
    0%
    RBC, A-A
    0
    0%
    1
    3.2%
    1
    5.3%
    0
    0%
    HPG, B-B
    1
    14.3%
    1
    3.2%
    2
    10.5%
    0
    0%
    HPG, B-W
    0
    0%
    2
    6.5%
    0
    0%
    1
    6.7%
    HPG, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    HPG, W-B
    0
    0%
    0
    0%
    2
    10.5%
    0
    0%
    HPG, W-W
    5
    71.4%
    26
    83.9%
    15
    78.9%
    13
    86.7%
    HPG, W-A
    1
    14.3%
    0
    0%
    0
    0%
    1
    6.7%
    HPG, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    HPG, A-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    HPG, A-A
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    HGL, B-B
    0
    0%
    2
    6.5%
    0
    0%
    0
    0%
    HGL, B-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    HGL, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    HGL, W-B
    3
    42.9%
    3
    9.7%
    2
    10.5%
    1
    6.7%
    HGL, W-W
    4
    57.1%
    24
    77.4%
    16
    84.2%
    13
    86.7%
    HGL, W-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    HGL, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    HGL, A-W
    0
    0%
    1
    3.2%
    1
    5.3%
    1
    6.7%
    HGL, A-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    LDH, B-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    LDH, B-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    LDH, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    LDH, W-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    LDH, W-W
    4
    57.1%
    20
    64.5%
    13
    68.4%
    10
    66.7%
    LDH, W-A
    1
    14.3%
    2
    6.5%
    3
    15.8%
    2
    13.3%
    LDH, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    LDH, A-W
    2
    28.6%
    8
    25.8%
    2
    10.5%
    2
    13.3%
    LDH, A-A
    0
    0%
    0
    0%
    1
    5.3%
    1
    6.7%
    WBC, B-B
    1
    14.3%
    1
    3.2%
    0
    0%
    1
    6.7%
    WBC, B-W
    0
    0%
    0
    0%
    1
    5.3%
    0
    0%
    WBC, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    WBC, W-B
    0
    0%
    0
    0%
    1
    5.3%
    0
    0%
    WBC, W-W
    6
    85.7%
    29
    93.5%
    17
    89.5%
    13
    86.7%
    WBC, W-A
    0
    0%
    0
    0%
    0
    0%
    1
    6.7%
    WBC, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    WBC, A-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    WBC, A-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    LYM, B-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    LYM, B-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    LYM, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    LYM, W-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    LYM, W-W
    7
    100%
    27
    87.1%
    19
    100%
    15
    100%
    LYM, W-A
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    LYM, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    LYM, A-W
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    LYM, A-A
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    NEU, B-B
    1
    14.3%
    0
    0%
    0
    0%
    0
    0%
    NEU, B-W
    0
    0%
    0
    0%
    1
    5.3%
    1
    6.7%
    NEU, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    NEU, W-B
    1
    14.3%
    5
    16.1%
    2
    10.5%
    0
    0%
    NEU, W-W
    5
    71.4%
    25
    80.6%
    16
    84.2%
    13
    86.7%
    NEU, W-A
    0
    0%
    0
    0%
    0
    0%
    1
    6.7%
    NEU, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    NEU, A-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    NEU, A-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PLC, B-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PLC, B-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PLC, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PLC, W-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PLC, W-W
    7
    100%
    29
    93.5%
    17
    89.5%
    15
    100%
    PLC, W-A
    0
    0%
    1
    3.2%
    1
    5.3%
    0
    0%
    PLC, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PLC, A-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PLC, A-A
    0
    0%
    0
    0%
    1
    5.3%
    0
    0%
    PT, U-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PT, U-W
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    PT, U-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PT, B-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PT, B-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PT, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PT, W-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PT, W-W
    7
    100%
    27
    87.1%
    19
    100%
    13
    86.7%
    PT, W-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PT, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PT, A-W
    0
    0%
    1
    3.2%
    0
    0%
    1
    6.7%
    PT, A-A
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    RET, B-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    RET, B-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    RET, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    RET, W-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    RET, W-W
    7
    100%
    30
    96.8%
    18
    94.7%
    15
    100%
    RET, W-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    RET, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    RET, A-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    RET, A-A
    0
    0%
    0
    0%
    1
    5.3%
    0
    0%
    BLT, B-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    BLT, B-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    BLT, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    BLT, W-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    BLT, W-W
    7
    100%
    28
    90.3%
    17
    89.5%
    15
    100%
    BLT, W-A
    0
    0%
    1
    3.2%
    2
    10.5%
    0
    0%
    BLT, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    BLT, A-W
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    BLT, A-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    5. Primary Outcome
    Title Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
    Description Haematological/ Biochemical parameters assessed were haemoglobin level [HgL], red blood cell [RBC], white blood cell [WBC], lymphocyte [LYM], neutrophil [NEU], eosinophil [EOS], reticulocyte [RET], platelet count [PLC], haptoglobin [Hpg], prothrombin time [PT] and partial thromboplastin time [PTT]. alanine aminotransferase [ALT], aspartate aminotransferase [AST], creatinine [CRE], lactate dehydrogenase [LDH] and bilirubin direct or total [BLD/BLT].Values were: unknown at baseline and below at Day 7 (U-B), unknown at baseline and within at Day 7 (U-W), unknown at baseline and above at Day 7 (U-A), below at baseline and below at Day 7 (B-B), below at baseline and within at Day 7 (B-W), below at baseline and above at Day 7(B-A), within at baseline and below at Day 7 (W-B), within at baseline and within at Day 7(W-W), within at baseline and above at Day 7(W-A), above at baseline and below at Day 7(A-B), above at baseline and within at Day 7(A-W), above at baseline and above at Day 7(A-A).
    Time Frame At Day 7

    Outcome Measure Data

    Analysis Population Description
    The analysis was performed on the Total Vaccinated cohort which which included all subjects with at least one study vaccine administration documented and with available results at Day 7.
    Arm/Group Title GSK3389245A_LD Group GSK3389245A_HD Group Placebo Group Bexsero Group
    Arm/Group Description Subjects received 2 doses of the investigational GSK3389245A low dose (LD) vaccine, one month apart, at Day 0 and Day 30. Subjects received 2 doses of the investigational GSK3389245A high dose (HD) vaccine, one month apart, at Day 0 and Day 30. Subjects received 2 doses of placebo vaccine, one month apart, at Day 0 and Day 30. Subjects received 2 doses of the active control vaccine, one month apart, at Day 0 and Day 30.
    Measure Participants 7 30 19 15
    PTT, U-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PTT, U-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PTT, U-A
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    PTT, B-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PTT, B-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PTT, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PTT, W-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PTT, W-W
    7
    100%
    29
    93.5%
    17
    89.5%
    11
    73.3%
    PTT, W-A
    0
    0%
    0
    0%
    0
    0%
    1
    6.7%
    PTT, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PTT, A-W
    0
    0%
    0
    0%
    1
    5.3%
    1
    6.7%
    PTT, A-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    ALT, B-B
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    ALT, B-W
    0
    0%
    1
    3.2%
    1
    5.3%
    0
    0%
    ALT, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    ALT, W-B
    0
    0%
    0
    0%
    1
    5.3%
    1
    6.7%
    ALT, W-W
    7
    100%
    27
    87.1%
    14
    73.7%
    13
    86.7%
    ALT, W-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    ALT, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    ALT, A-W
    0
    0%
    1
    3.2%
    3
    15.8%
    1
    6.7%
    ALT, A-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    AST, B-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    AST, B-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    AST, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    AST, W-B
    1
    14.3%
    0
    0%
    0
    0%
    1
    6.7%
    AST, W-W
    6
    85.7%
    28
    90.3%
    18
    94.7%
    14
    93.3%
    AST, W-A
    0
    0%
    1
    3.2%
    1
    5.3%
    0
    0%
    AST, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    AST, A-W
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    AST, A-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    BLD, B-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    BLD, B-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    BLD, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    BLD, W-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    BLD, W-W
    5
    71.4%
    25
    80.6%
    15
    78.9%
    14
    93.3%
    BLD, W-A
    1
    14.3%
    2
    6.5%
    1
    5.3%
    0
    0%
    BLD, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    BLD, A-W
    1
    14.3%
    0
    0%
    0
    0%
    1
    6.7%
    BLD, A-A
    0
    0%
    3
    9.7%
    3
    15.8%
    0
    0%
    CRE, U-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    CRE, U-W
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    CRE, U-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    CRE, B-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    CRE, B-W
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    CRE, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    CRE, W-B
    0
    0%
    2
    6.5%
    0
    0%
    0
    0%
    CRE, W-W
    7
    100%
    23
    74.2%
    19
    100%
    15
    100%
    CRE, W-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    CRE, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    CRE, A-W
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    CRE, A-A
    0
    0%
    2
    6.5%
    0
    0%
    0
    0%
    EOS, B-B
    0
    0%
    0
    0%
    0
    0%
    1
    6.7%
    EOS, B-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    EOS, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    EOS, W-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    EOS, W-W
    6
    85.7%
    29
    93.5%
    18
    94.7%
    13
    86.7%
    EOS, W-A
    0
    0%
    0
    0%
    1
    5.3%
    0
    0%
    EOS, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    EOS, A-W
    0
    0%
    0
    0%
    0
    0%
    1
    6.7%
    EOS, A-A
    1
    14.3%
    1
    3.2%
    0
    0%
    0
    0%
    RBC, B-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    RBC, B-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    RBC, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    RBC, W-B
    1
    14.3%
    0
    0%
    0
    0%
    1
    6.7%
    RBC, W-W
    5
    71.4%
    26
    83.9%
    12
    63.2%
    12
    80%
    RBC, W-A
    1
    14.3%
    0
    0%
    0
    0%
    2
    13.3%
    RBC, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    RBC, A-W
    0
    0%
    1
    3.2%
    4
    21.1%
    0
    0%
    RBC, A-A
    0
    0%
    3
    9.7%
    3
    15.8%
    0
    0%
    HPG, B-B
    1
    14.3%
    2
    6.5%
    2
    10.5%
    0
    0%
    HPG, B-W
    0
    0%
    1
    3.2%
    0
    0%
    1
    6.7%
    HPG, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    HPG, W-B
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    HPG, W-W
    5
    71.4%
    25
    80.6%
    17
    89.5%
    13
    86.7%
    HPG, W-A
    1
    14.3%
    0
    0%
    0
    0%
    1
    6.7%
    HPG, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    HPG, A-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    HPG, A-A
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    HGL, B-B
    0
    0%
    2
    6.5%
    0
    0%
    0
    0%
    HGL, B-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    HGL, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    HGL, W-B
    0
    0%
    0
    0%
    1
    5.3%
    1
    6.7%
    HGL, W-W
    7
    100%
    27
    87.1%
    16
    84.2%
    13
    86.7%
    HGL, W-A
    0
    0%
    0
    0%
    1
    5.3%
    0
    0%
    HGL, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    HGL, A-W
    0
    0%
    1
    3.2%
    1
    5.3%
    0
    0%
    HGL, A-A
    0
    0%
    0
    0%
    0
    0%
    1
    6.7%
    LDH, B-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    LDH, B-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    LDH, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    LDH, W-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    LDH, W-W
    4
    57.1%
    15
    48.4%
    12
    63.2%
    10
    66.7%
    LDH, W-A
    1
    14.3%
    7
    22.6%
    4
    21.1%
    2
    13.3%
    LDH, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    LDH, A-W
    2
    28.6%
    4
    12.9%
    2
    10.5%
    0
    0%
    LDH, A-A
    0
    0%
    4
    12.9%
    1
    5.3%
    3
    20%
    WBC, B-B
    0
    0%
    1
    3.2%
    1
    5.3%
    1
    6.7%
    WBC, B-W
    1
    14.3%
    0
    0%
    0
    0%
    0
    0%
    WBC, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    WBC, W-B
    0
    0%
    0
    0%
    1
    5.3%
    0
    0%
    WBC, W-W
    6
    85.7%
    29
    93.5%
    17
    89.5%
    14
    93.3%
    WBC, W-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    WBC, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    WBC, A-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    WBC, A-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    LYM, B-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    LYM, B-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    LYM, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    LYM, W-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    LYM, W-W
    0
    0%
    28
    90.3%
    18
    94.7%
    15
    100%
    LYM, W-A
    0
    0%
    0
    0%
    1
    5.3%
    0
    0%
    LYM, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    LYM, A-W
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    LYM, A-A
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    NEU, B-B
    1
    14.3%
    0
    0%
    1
    5.3%
    1
    6.7%
    NEU, B-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    NEU, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    NEU, W-B
    0
    0%
    2
    6.5%
    2
    10.5%
    1
    6.7%
    NEU, W-W
    6
    85.7%
    27
    87.1%
    15
    78.9%
    13
    86.7%
    NEU, W-A
    0
    0%
    1
    3.2%
    1
    5.3%
    0
    0%
    NEU, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    NEU, A-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    NEU, A-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PLC, B-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PLC, B-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PLC, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PLC, W-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PLC, W-W
    7
    100%
    29
    93.5%
    17
    89.5%
    15
    100%
    PLC, W-A
    0
    0%
    1
    3.2%
    1
    5.3%
    0
    0%
    PLC, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PLC, A-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PLC, A-A
    0
    0%
    0
    0%
    1
    5.3%
    0
    0%
    PT, U-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PT, U-W
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    PT, U-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PT, B-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PT, B-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PT, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PT, W-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PT, W-W
    7
    100%
    26
    83.9%
    17
    89.5%
    11
    73.3%
    PT, W-A
    0
    0%
    1
    3.2%
    1
    5.3%
    1
    6.7%
    PT, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PT, A-W
    0
    0%
    1
    3.2%
    0
    0%
    1
    6.7%
    PT, A-A
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    RET, B-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    RET, B-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    RET, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    RET, W-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    RET, W-W
    7
    100%
    30
    96.8%
    18
    94.7%
    15
    100%
    RET, W-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    RET, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    RET, A-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    RET, A-A
    0
    0%
    0
    0%
    1
    5.3%
    0
    0%
    BLT, B-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    BLT, B-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    BLT, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    BLT, W-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    BLT, W-W
    7
    100%
    28
    90.3%
    17
    89.5%
    15
    100%
    BLT, W-A
    0
    0%
    1
    3.2%
    2
    10.5%
    0
    0%
    BLT, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    BLT, A-W
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    BLT, A-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    6. Primary Outcome
    Title Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
    Description Haematological/Biochemical parameters assessed were haemoglobin level [HgL], red blood cell [RBC], white blood cell [WBC], lymphocyte [LYM], neutrophil [NEU], eosinophil [EOS], reticulocyte [RET], platelet count [PLC], haptoglobin [Hpg], prothrombin time [PT] and partial thromboplastin time [PTT]. alanine aminotransferase [ALT], aspartate aminotransferase [AST], creatinine [CRE], lactate dehydrogenase [LDH] and bilirubin direct or total [BLD/BLT].Values were: unknown at baseline and below at Day 30(U-B), unknown at baseline and within at Day30(U-W), unknown at baseline and above at Day 30(U-A), below at baseline and below at Day30(B-B), below at baseline and within at Day30(B-W), below at baseline and above at Day 30(B-A), within at baseline and below at Day 30 (W-B), within at baseline and within at Day 30(W-W), within at baseline and above at Day30(W-A), above at baseline and below at Day30(A-B), above at baseline and within at Day30(A-W), above at baseline and above at Day30(A-A).
    Time Frame At Day 30

    Outcome Measure Data

    Analysis Population Description
    The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one study vaccine administration documented and with available results at Day 30.
    Arm/Group Title GSK3389245A_LD Group GSK3389245A_HD Group Placebo Group Bexsero Group
    Arm/Group Description Subjects received 2 doses of the investigational GSK3389245A low dose (LD) vaccine, one month apart, at Day 0 and Day 30. Subjects received 2 doses of the investigational GSK3389245A high dose (HD) vaccine, one month apart, at Day 0 and Day 30. Subjects received 2 doses of placebo vaccine, one month apart, at Day 0 and Day 30. Subjects received 2 doses of the active control vaccine, one month apart, at Day 0 and Day 30.
    Measure Participants 7 27 19 15
    PTT, U-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PTT, U-W
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    PTT, U-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PTT, B-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PTT, B-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PTT, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PTT, W-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PTT, W-W
    7
    100%
    27
    87.1%
    18
    94.7%
    13
    86.7%
    PTT, W-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PTT, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PTT, A-W
    0
    0%
    0
    0%
    1
    5.3%
    1
    6.7%
    PTT, A-A
    0
    0%
    0
    0%
    0
    0%
    1
    6.7%
    ALT, B-B
    0
    0%
    1
    3.2%
    1
    5.3%
    0
    0%
    ALT, B-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    ALT, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    ALT, W-B
    0
    0%
    0
    0%
    2
    10.5%
    2
    13.3%
    ALT, W-W
    7
    100%
    25
    80.6%
    13
    68.4%
    12
    80%
    ALT, W-A
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    ALT, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    ALT, A-W
    0
    0%
    0
    0%
    3
    15.8%
    1
    6.7%
    ALT, A-A
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    AST, B-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    AST, B-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    AST, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    AST, W-B
    1
    14.3%
    0
    0%
    1
    5.3%
    1
    6.7%
    AST, W-W
    6
    85.7%
    27
    87.1%
    18
    94.7%
    14
    93.3%
    AST, W-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    AST, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    AST, A-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    AST, A-A
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    BLD, B-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    BLD, B-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    BLD, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    BLD, W-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    BLD, W-W
    4
    57.1%
    24
    77.4%
    16
    84.2%
    11
    73.3%
    BLD, W-A
    2
    28.6%
    1
    3.2%
    0
    0%
    3
    20%
    BLD, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    BLD, A-W
    1
    14.3%
    0
    0%
    2
    10.5%
    0
    0%
    BLD, A-A
    0
    0%
    3
    9.7%
    1
    5.3%
    1
    6.7%
    CRE, U-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    CRE, U-W
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    CRE, U-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    CRE, B-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    CRE, B-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    CRE, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    CRE, W-B
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    CRE, W-W
    7
    100%
    21
    67.7%
    19
    100%
    15
    100%
    CRE, W-A
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    CRE, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    CRE, A-W
    0
    0%
    2
    6.5%
    0
    0%
    0
    0%
    CRE, A-A
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    EOS, B-B
    0
    0%
    0
    0%
    0
    0%
    1
    6.7%
    EOS, B-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    EOS, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    EOS, W-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    EOS, W-W
    6
    85.7%
    27
    87.1%
    19
    100%
    13
    86.7%
    EOS, W-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    EOS, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    EOS, A-W
    1
    14.3%
    0
    0%
    0
    0%
    1
    6.7%
    EOS, A-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    RBC, B-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    RBC, B-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    RBC, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    RBC, W-B
    1
    14.3%
    0
    0%
    0
    0%
    0
    0%
    RBC, W-W
    5
    71.4%
    20
    64.5%
    10
    52.6%
    14
    93.3%
    RBC, W-A
    1
    14.3%
    3
    9.7%
    2
    10.5%
    1
    6.7%
    RBC, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    RBC, A-W
    0
    0%
    2
    6.5%
    5
    26.3%
    0
    0%
    RBC, A-A
    0
    0%
    2
    6.5%
    2
    10.5%
    0
    0%
    HPG, B-B
    1
    14.3%
    2
    6.5%
    2
    10.5%
    1
    6.7%
    HPG, B-W
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    HPG, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    HPG, W-B
    0
    0%
    3
    9.7%
    1
    5.3%
    1
    6.7%
    HPG, W-W
    6
    85.7%
    21
    67.7%
    15
    78.9%
    13
    86.7%
    HPG, W-A
    0
    0%
    0
    0%
    1
    5.3%
    0
    0%
    HPG, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    HPG, A-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    HPG, A-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    HGL, B-B
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    HGL, B-W
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    HGL, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    HGL, W-B
    0
    0%
    0
    0%
    1
    5.3%
    0
    0%
    HGL, W-W
    7
    100%
    24
    77.4%
    16
    84.2%
    14
    93.3%
    HGL, W-A
    0
    0%
    0
    0%
    1
    5.3%
    0
    0%
    HGL, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    HGL, A-W
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    HGL, A-A
    0
    0%
    0
    0%
    1
    5.3%
    1
    6.7%
    LDH, B-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    LDH, B-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    LDH, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    LDH, W-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    LDH, W-W
    5
    71.4%
    17
    54.8%
    16
    84.2%
    12
    80%
    LDH, W-A
    0
    0%
    4
    12.9%
    0
    0%
    0
    0%
    LDH, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    LDH, A-W
    2
    28.6%
    7
    22.6%
    1
    5.3%
    3
    20%
    LDH, A-A
    0
    0%
    4
    12.9%
    2
    10.5%
    0
    0%
    WBC, B-B
    1
    14.3%
    0
    0%
    0
    0%
    1
    6.7%
    WBC, B-W
    0
    0%
    1
    3.2%
    1
    5.3%
    0
    0%
    WBC, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    WBC, W-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    WBC, W-W
    6
    85.7%
    26
    83.9%
    18
    94.7%
    14
    93.3%
    WBC, W-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    WBC, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    WBC, A-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    WBC, A-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    LYM, B-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    LYM, B-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    LYM, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    LYM, W-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    LYM, W-W
    7
    100%
    26
    83.9%
    18
    94.7%
    15
    100%
    LYM, W-A
    0
    0%
    0
    0%
    1
    5.3%
    0
    0%
    LYM, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    LYM, A-W
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    LYM, A-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    NEU, B-B
    1
    14.3%
    0
    0%
    0
    0%
    1
    6.7%
    NEU, B-W
    0
    0%
    0
    0%
    1
    5.3%
    0
    0%
    NEU, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    NEU, W-B
    0
    0%
    1
    3.2%
    1
    5.3%
    0
    0%
    NEU, W-W
    5
    71.4%
    26
    83.9%
    17
    89.5%
    14
    93.3%
    NEU, W-A
    1
    14.3%
    0
    0%
    0
    0%
    0
    0%
    NEU, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    NEU, A-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    NEU, A-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PLC, B-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PLC, B-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PLC, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PLC, W-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PLC, W-W
    7
    100%
    26
    83.9%
    17
    89.5%
    15
    100%
    PLC, W-A
    0
    0%
    1
    3.2%
    1
    5.3%
    0
    0%
    PLC, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PLC, A-W
    0
    0%
    0
    0%
    1
    5.3%
    0
    0%
    PLC, A-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PT, U-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PT, U-W
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    PT, U-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PT, B-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PT, B-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PT, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PT, W-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PT, W-W
    7
    100%
    25
    80.6%
    19
    100%
    14
    93.3%
    PT, W-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PT, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PT, A-W
    0
    0%
    1
    3.2%
    0
    0%
    1
    6.7%
    PT, A-A
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    RET, B-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    RET, B-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    RET, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    RET, W-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    RET, W-W
    7
    100%
    26
    83.9%
    18
    94.7%
    15
    100%
    RET, W-A
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    RET, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    RET, A-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    RET, A-A
    0
    0%
    0
    0%
    1
    5.3%
    0
    0%
    BLT, B-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    BLT, B-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    BLT, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    BLT, W-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    BLT, W-W
    7
    100%
    26
    83.9%
    18
    94.7%
    14
    93.3%
    BLT, W-A
    0
    0%
    1
    3.2%
    1
    5.3%
    1
    6.7%
    BLT, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    BLT, A-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    BLT, A-A
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    7. Primary Outcome
    Title Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
    Description Haematological/Biochemical parameters assessed were haemoglobin level [HgL], red blood cell [RBC], white blood cell [WBC], lymphocyte [LYM], neutrophil [NEU], eosinophil [EOS], reticulocyte [RET], platelet count [PLC], haptoglobin [Hpg], prothrombin time [PT] and partial thromboplastin time [PTT]. alanine aminotransferase [ALT], aspartate aminotransferase [AST], creatinine [CRE], lactate dehydrogenase [LDH] and bilirubin direct or total [BLD/BLT].Values were: unknown at baseline and below at Day 31(U-B), unknown at baseline and within at Day31(U-W), unknown at baseline and above at Day 31(U-A), below at baseline and below at Day31(B-B), below at baseline and within at Day31(B-W), below at baseline and above at Day 31(B-A), within at baseline and below at Day 31(W-B), within at baseline and within at Day 31(W-W), within at baseline and above at Day31(W-A), above at baseline and below at Day31(A-B), above at baseline and within at Day31(A-W), above at baseline and above at Day31(A-A).
    Time Frame At Day 31

    Outcome Measure Data

    Analysis Population Description
    The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one study vaccine administration documented and with available results at Day 31.
    Arm/Group Title GSK3389245A_LD Group GSK3389245A_HD Group Placebo Group Bexsero Group
    Arm/Group Description Subjects received 2 doses of the investigational GSK3389245A low dose (LD) vaccine, one month apart, at Day 0 and Day 30. Subjects received 2 doses of the investigational GSK3389245A high dose (HD) vaccine, one month apart, at Day 0 and Day 30. Subjects received 2 doses of placebo vaccine, one month apart, at Day 0 and Day 30. Subjects received 2 doses of the active control vaccine, one month apart, at Day 0 and Day 30.
    Measure Participants 7 29 19 15
    PTT, U-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PTT, U-W
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    PTT, U-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PTT, B-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PTT, B-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PTT, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PTT, W-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PTT, W-W
    7
    100%
    26
    83.9%
    18
    94.7%
    12
    80%
    PTT, W-A
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    PTT, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PTT, A-W
    0
    0%
    0
    0%
    1
    5.3%
    2
    13.3%
    PTT, A-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    ALT, B-B
    0
    0%
    1
    3.2%
    1
    5.3%
    0
    0%
    ALT, B-W
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    ALT, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    ALT, W-B
    0
    0%
    0
    0%
    0
    0%
    3
    20%
    ALT, W-W
    7
    100%
    26
    83.9%
    15
    78.9%
    11
    73.3%
    ALT, W-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    ALT, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    ALT, A-W
    0
    0%
    0
    0%
    3
    15.8%
    1
    6.7%
    ALT, A-A
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    AST, B-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    AST, B-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    AST, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    AST, W-B
    1
    14.3%
    1
    3.2%
    0
    0%
    2
    13.3%
    AST, W-W
    6
    85.7%
    27
    87.1%
    19
    100%
    13
    86.7%
    AST, W-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    AST, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    AST, A-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    AST, A-A
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    BLD, B-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    BLD, B-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    BLD, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    BLD, W-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    BLD, W-W
    5
    71.4%
    24
    77.4%
    16
    84.2%
    11
    73.3%
    BLD, W-A
    1
    14.3%
    2
    6.5%
    0
    0%
    3
    20%
    BLD, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    BLD, A-W
    0
    0%
    0
    0%
    2
    10.5%
    0
    0%
    BLD, A-A
    1
    14.3%
    3
    9.7%
    1
    5.3%
    1
    6.7%
    CRE, U-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    CRE, U-W
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    CRE, U-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    CRE, B-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    CRE, B-W
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    CRE, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    CRE, W-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    CRE, W-W
    7
    100%
    22
    71%
    19
    100%
    15
    100%
    CRE, W-A
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    CRE, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    CRE, A-W
    0
    0%
    2
    6.5%
    0
    0%
    0
    0%
    CRE, A-A
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    EOS, B-B
    0
    0%
    0
    0%
    0
    0%
    1
    6.7%
    EOS, B-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    EOS, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    EOS, W-B
    0
    0%
    0
    0%
    1
    5.3%
    0
    0%
    EOS, W-W
    6
    85.7%
    28
    90.3%
    18
    94.7%
    13
    86.7%
    EOS, W-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    EOS, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    EOS, A-W
    0
    0%
    1
    3.2%
    0
    0%
    1
    6.7%
    EOS, A-A
    1
    14.3%
    0
    0%
    0
    0%
    0
    0%
    RBC, B-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    RBC, B-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    RBC, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    RBC, W-B
    1
    14.3%
    0
    0%
    2
    10.5%
    1
    6.7%
    RBC, W-W
    5
    71.4%
    25
    80.6%
    9
    47.4%
    14
    93.3%
    RBC, W-A
    1
    14.3%
    0
    0%
    1
    5.3%
    0
    0%
    RBC, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    RBC, A-W
    0
    0%
    2
    6.5%
    4
    21.1%
    0
    0%
    RBC, A-A
    0
    0%
    2
    6.5%
    3
    15.8%
    0
    0%
    HPG, B-B
    1
    14.3%
    2
    6.5%
    2
    10.5%
    1
    6.7%
    HPG, B-W
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    HPG, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    HPG, W-B
    0
    0%
    1
    3.2%
    2
    10.5%
    0
    0%
    HPG, W-W
    6
    85.7%
    24
    77.4%
    15
    78.9%
    14
    93.3%
    HPG, W-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    HPG, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    HPG, A-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    HPG, A-A
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    HGL, B-B
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    HGL, B-W
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    HGL, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    HGL, W-B
    2
    28.6%
    2
    6.5%
    2
    10.5%
    3
    20%
    HGL, W-W
    5
    71.4%
    24
    77.4%
    16
    84.2%
    11
    73.3%
    HGL, W-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    HGL, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    HGL, A-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    HGL, A-A
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    LDH, B-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    LDH, B-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    LDH, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    LDH, W-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    LDH, W-W
    5
    71.4%
    17
    54.8%
    16
    84.2%
    12
    80%
    LDH, W-A
    0
    0%
    4
    12.9%
    0
    0%
    0
    0%
    LDH, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    LDH, A-W
    2
    28.6%
    7
    22.6%
    3
    15.8%
    2
    13.3%
    LDH, A-A
    0
    0%
    1
    3.2%
    0
    0%
    1
    6.7%
    WBC, B-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    WBC, B-W
    1
    14.3%
    1
    3.2%
    1
    5.3%
    1
    6.7%
    WBC, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    WBC, W-B
    0
    0%
    3
    9.7%
    0
    0%
    0
    0%
    WBC, W-W
    6
    85.7%
    25
    80.6%
    18
    94.7%
    11
    73.3%
    WBC, W-A
    0
    0%
    0
    0%
    0
    0%
    3
    20%
    WBC, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    WBC, A-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    WBC, A-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    LYM, B-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    LYM, B-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    LYM, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    LYM, W-B
    0
    0%
    3
    9.7%
    1
    5.3%
    1
    6.7%
    LYM, W-W
    7
    100%
    24
    77.4%
    16
    84.2%
    13
    86.7%
    LYM, W-A
    0
    0%
    0
    0%
    2
    10.5%
    1
    6.7%
    LYM, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    LYM, A-W
    0
    0%
    2
    6.5%
    0
    0%
    0
    0%
    LYM, A-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    NEU, B-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    NEU, B-W
    1
    14.3%
    0
    0%
    1
    5.3%
    1
    6.7%
    NEU, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    NEU, W-B
    0
    0%
    3
    9.7%
    1
    5.3%
    0
    0%
    NEU, W-W
    6
    85.7%
    26
    83.9%
    17
    89.5%
    7
    46.7%
    NEU, W-A
    0
    0%
    0
    0%
    0
    0%
    7
    46.7%
    NEU, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    NEU, A-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    NEU, A-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PLC, B-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PLC, B-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PLC, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PLC, W-B
    0
    0%
    0
    0%
    0
    0%
    1
    6.7%
    PLC, W-W
    7
    100%
    29
    93.5%
    15
    78.9%
    14
    93.3%
    PLC, W-A
    0
    0%
    0
    0%
    3
    15.8%
    0
    0%
    PLC, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PLC, A-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PLC, A-A
    0
    0%
    0
    0%
    1
    5.3%
    0
    0%
    PT, U-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PT, U-W
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    PT, U-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PT, B-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PT, B-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PT, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PT, W-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PT, W-W
    7
    100%
    25
    80.6%
    19
    100%
    13
    86.7%
    PT, W-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PT, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PT, A-W
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    PT, A-A
    0
    0%
    1
    3.2%
    0
    0%
    1
    6.7%
    RET, B-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    RET, B-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    RET, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    RET, W-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    RET, W-W
    7
    100%
    28
    90.3%
    18
    94.7%
    15
    100%
    RET, W-A
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    RET, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    RET, A-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    RET, A-A
    0
    0%
    0
    0%
    1
    5.3%
    0
    0%
    BLT, B-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    BLT, B-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    BLT, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    BLT, W-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    BLT, W-W
    7
    100%
    27
    87.1%
    18
    94.7%
    15
    100%
    BLT, W-A
    0
    0%
    1
    3.2%
    1
    5.3%
    0
    0%
    BLT, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    BLT, A-W
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    BLT, A-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    8. Primary Outcome
    Title Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
    Description Haematological/Biochemical parameters assessed were haemoglobin level [HgL], red blood cell [RBC], white blood cell [WBC], lymphocyte [LYM], neutrophil [NEU], eosinophil [EOS], reticulocyte [RET], platelet count [PLC], haptoglobin [Hpg], prothrombin time [PT] and partial thromboplastin time [PTT]. alanine aminotransferase [ALT], aspartate aminotransferase [AST], creatinine [CRE], lactate dehydrogenase [LDH] and bilirubin direct or total [BLD/BLT].Values were: unknown at baseline and below at Day 33(U-B), unknown at baseline and within at Day33(U-W), unknown at baseline and above at Day 33(U-A), below at baseline and below at Day33(B-B), below at baseline and within at Day33(B-W), below at baseline and above at Day 33 (B-A), within at baseline and below at Day 33(W-B), within at baseline and within at Day 33(W-W), within at baseline and above at Day33(W-A), above at baseline and below at Day33(A-B), above at baseline and within at Day33(A-W), above at baseline and above at Day33(A-A).
    Time Frame At Day 33

    Outcome Measure Data

    Analysis Population Description
    The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one study vaccine administration documented and with available results at Day 33.
    Arm/Group Title GSK3389245A_LD Group GSK3389245A_HD Group Placebo Group Bexsero Group
    Arm/Group Description Subjects received 2 doses of the investigational GSK3389245A low dose (LD) vaccine, one month apart, at Day 0 and Day 30. Subjects received 2 doses of the investigational GSK3389245A high dose (HD) vaccine, one month apart, at Day 0 and Day 30. Subjects received 2 doses of placebo vaccine, one month apart, at Day 0 and Day 30. Subjects received 2 doses of the active control vaccine, one month apart, at Day 0 and Day 30.
    Measure Participants 7 28 19 15
    PTT, U-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PTT, U-W
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    PTT, U-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PTT, B-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PTT, B-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PTT, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PTT, W-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PTT, W-W
    7
    100%
    27
    87.1%
    18
    94.7%
    11
    73.3%
    PTT, W-A
    0
    0%
    0
    0%
    0
    0%
    2
    13.3%
    PTT, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PTT, A-W
    0
    0%
    0
    0%
    1
    5.3%
    1
    6.7%
    PTT, A-A
    0
    0%
    0
    0%
    0
    0%
    1
    6.7%
    ALT, B-B
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    ALT, B-W
    0
    0%
    1
    3.2%
    1
    5.3%
    0
    0%
    ALT, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    ALT, W-B
    0
    0%
    0
    0%
    0
    0%
    1
    6.7%
    ALT, W-W
    7
    100%
    24
    77.4%
    14
    73.7%
    13
    86.7%
    ALT, W-A
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    ALT, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    ALT, A-W
    0
    0%
    0
    0%
    3
    15.8%
    1
    6.7%
    ALT, A-A
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    AST, B-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    AST, B-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    AST, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    AST, W-B
    1
    14.3%
    2
    6.5%
    0
    0%
    1
    6.7%
    AST, W-W
    6
    85.7%
    25
    80.6%
    19
    100%
    14
    93.3%
    AST, W-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    AST, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    AST, A-W
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    AST, A-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    BLD, B-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    BLD, B-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    BLD, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    BLD, W-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    BLD, W-W
    6
    85.7%
    25
    80.6%
    16
    84.2%
    12
    80%
    BLD, W-A
    0
    0%
    0
    0%
    0
    0%
    2
    13.3%
    BLD, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    BLD, A-W
    0
    0%
    2
    6.5%
    1
    5.3%
    0
    0%
    BLD, A-A
    1
    14.3%
    1
    3.2%
    2
    10.5%
    1
    6.7%
    CRE, U-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    CRE, U-W
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    CRE, U-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    CRE, B-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    CRE, B-W
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    CRE, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    CRE, W-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    CRE, W-W
    7
    100%
    24
    77.4%
    19
    100%
    15
    100%
    CRE, W-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    CRE, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    CRE, A-W
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    CRE, A-A
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    EOS, B-B
    0
    0%
    0
    0%
    0
    0%
    1
    6.7%
    EOS, B-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    EOS, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    EOS, W-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    EOS, W-W
    6
    85.7%
    27
    87.1%
    19
    100%
    13
    86.7%
    EOS, W-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    EOS, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    EOS, A-W
    0
    0%
    1
    3.2%
    0
    0%
    1
    6.7%
    EOS, A-A
    1
    14.3%
    0
    0%
    0
    0%
    0
    0%
    RBC, B-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    RBC, B-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    RBC, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    RBC, W-B
    2
    28.6%
    2
    6.5%
    2
    10.5%
    2
    13.3%
    RBC, W-W
    5
    71.4%
    22
    71%
    10
    52.6%
    12
    80%
    RBC, W-A
    0
    0%
    0
    0%
    0
    0%
    1
    6.7%
    RBC, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    RBC, A-W
    0
    0%
    3
    9.7%
    4
    21.1%
    0
    0%
    RBC, A-A
    0
    0%
    1
    3.2%
    3
    15.8%
    0
    0%
    HPG, B-B
    1
    14.3%
    2
    6.5%
    2
    10.5%
    0
    0%
    HPG, B-W
    0
    0%
    1
    3.2%
    0
    0%
    1
    6.7%
    HPG, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    HPG, W-B
    0
    0%
    2
    6.5%
    1
    5.3%
    0
    0%
    HPG, W-W
    5
    71.4%
    22
    71%
    16
    84.2%
    12
    80%
    HPG, W-A
    0
    0%
    0
    0%
    0
    0%
    1
    6.7%
    HPG, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    HPG, A-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    HPG, A-A
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    HGL, B-B
    0
    0%
    2
    6.5%
    0
    0%
    0
    0%
    HGL, B-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    HGL, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    HGL, W-B
    4
    57.1%
    2
    6.5%
    3
    15.8%
    2
    13.3%
    HGL, W-W
    3
    42.9%
    23
    74.2%
    15
    78.9%
    12
    80%
    HGL, W-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    HGL, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    HGL, A-W
    0
    0%
    1
    3.2%
    1
    5.3%
    1
    6.7%
    HGL, A-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    LDH, B-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    LDH, B-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    LDH, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    LDH, W-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    LDH, W-W
    5
    71.4%
    14
    45.2%
    14
    73.7%
    12
    80%
    LDH, W-A
    0
    0%
    6
    19.4%
    2
    10.5%
    0
    0%
    LDH, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    LDH, A-W
    1
    14.3%
    8
    25.8%
    3
    15.8%
    2
    13.3%
    LDH, A-A
    1
    14.3%
    0
    0%
    0
    0%
    1
    6.7%
    WBC, B-B
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    WBC, B-W
    1
    14.3%
    0
    0%
    1
    5.3%
    1
    6.7%
    WBC, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    WBC, W-B
    0
    0%
    1
    3.2%
    0
    0%
    1
    6.7%
    WBC, W-W
    6
    85.7%
    26
    83.9%
    18
    94.7%
    13
    86.7%
    WBC, W-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    WBC, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    WBC, A-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    WBC, A-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    LYM, B-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    LYM, B-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    LYM, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    LYM, W-B
    0
    0%
    0
    0%
    0
    0%
    1
    6.7%
    LYM, W-W
    7
    100%
    26
    83.9%
    18
    94.7%
    14
    93.3%
    LYM, W-A
    0
    0%
    0
    0%
    1
    5.3%
    0
    0%
    LYM, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    LYM, A-W
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    LYM, A-A
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    NEU, B-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    NEU, B-W
    1
    14.3%
    0
    0%
    1
    5.3%
    1
    6.7%
    NEU, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    NEU, W-B
    0
    0%
    6
    19.4%
    0
    0%
    0
    0%
    NEU, W-W
    6
    85.7%
    21
    67.7%
    17
    89.5%
    13
    86.7%
    NEU, W-A
    0
    0%
    1
    3.2%
    1
    5.3%
    1
    6.7%
    NEU, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    NEU, A-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    NEU, A-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PLC, B-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PLC, B-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PLC, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PLC, W-B
    0
    0%
    0
    0%
    0
    0%
    1
    6.7%
    PLC, W-W
    7
    100%
    28
    90.3%
    16
    84.2%
    14
    93.3%
    PLC, W-A
    0
    0%
    0
    0%
    2
    10.5%
    0
    0%
    PLC, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PLC, A-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PLC, A-A
    0
    0%
    0
    0%
    1
    5.3%
    0
    0%
    PT, U-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PT, U-W
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    PT, U-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PT, B-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PT, B-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PT, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PT, W-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PT, W-W
    7
    100%
    25
    80.6%
    19
    100%
    14
    93.3%
    PT, W-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PT, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PT, A-W
    0
    0%
    1
    3.2%
    0
    0%
    1
    6.7%
    PT, A-A
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    RET, B-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    RET, B-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    RET, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    RET, W-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    RET, W-W
    7
    100%
    28
    90.3%
    18
    94.7%
    15
    100%
    RET, W-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    RET, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    RET, A-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    RET, A-A
    0
    0%
    0
    0%
    1
    5.3%
    0
    0%
    BLT, B-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    BLT, B-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    BLT, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    BLT, W-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    BLT, W-W
    7
    100%
    26
    83.9%
    19
    100%
    14
    93.3%
    BLT, W-A
    0
    0%
    1
    3.2%
    0
    0%
    1
    6.7%
    BLT, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    BLT, A-W
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    BLT, A-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    9. Primary Outcome
    Title Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
    Description Haematological/Biochemical parameters assessed were haemoglobin level [HgL], red blood cell [RBC], white blood cell [WBC], lymphocyte [LYM], neutrophil [NEU], eosinophil [EOS], reticulocyte [RET], platelet count [PLC], haptoglobin [Hpg], prothrombin time [PT] and partial thromboplastin time [PTT]. alanine aminotransferase [ALT], aspartate aminotransferase [AST], creatinine [CRE], lactate dehydrogenase [LDH] and bilirubin direct or total [BLD/BLT].Values were: unknown at baseline and below at Day 37(U-B), unknown at baseline and within at Day37(U-W), unknown at baseline and above at Day 37(U-A), below at baseline and below at Day37(B-B), below at baseline and within at Day37(B-W), below at baseline and above at Day 37(B-A), within at baseline and below at Day 37(W-B), within at baseline and within at Day 37(W-W), within at baseline and above at Day37(W-A), above at baseline and below at Day37(A-B), above at baseline and within at Day37(A-W), above at baseline and above at Day37(A-A).
    Time Frame At Day 37

    Outcome Measure Data

    Analysis Population Description
    The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one study vaccine administration documented and with available results at Day 37.
    Arm/Group Title GSK3389245A_LD Group GSK3389245A_HD Group Placebo Group Bexsero Group
    Arm/Group Description Subjects received 2 doses of the investigational GSK3389245A low dose (LD) vaccine, one month apart, at Day 0 and Day 30. Subjects received 2 doses of the investigational GSK3389245A high dose (HD) vaccine, one month apart, at Day 0 and Day 30. Subjects received 2 doses of placebo vaccine, one month apart, at Day 0 and Day 30. Subjects received 2 doses of the active control vaccine, one month apart, at Day 0 and Day 30.
    Measure Participants 7 29 19 15
    PTT, U-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PTT, U-W
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    PTT, U-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PTT, B-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PTT, B-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PTT, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PTT, W-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PTT, W-W
    7
    100%
    27
    87.1%
    16
    84.2%
    10
    66.7%
    PTT, W-A
    0
    0%
    0
    0%
    0
    0%
    1
    6.7%
    PTT, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PTT, A-W
    0
    0%
    0
    0%
    1
    5.3%
    1
    6.7%
    PTT, A-A
    0
    0%
    0
    0%
    0
    0%
    1
    6.7%
    ALT, B-B
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    ALT, B-W
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    ALT, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    ALT, W-B
    0
    0%
    0
    0%
    1
    5.3%
    1
    6.7%
    ALT, W-W
    7
    100%
    23
    74.2%
    14
    73.7%
    13
    86.7%
    ALT, W-A
    0
    0%
    3
    9.7%
    0
    0%
    0
    0%
    ALT, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    ALT, A-W
    0
    0%
    0
    0%
    3
    15.8%
    1
    6.7%
    ALT, A-A
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    AST, B-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    AST, B-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    AST, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    AST, W-B
    1
    14.3%
    0
    0%
    1
    5.3%
    1
    6.7%
    AST, W-W
    6
    85.7%
    26
    83.9%
    15
    78.9%
    14
    93.3%
    AST, W-A
    0
    0%
    2
    6.5%
    1
    5.3%
    0
    0%
    AST, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    AST, A-W
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    AST, A-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    BLD, B-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    BLD, B-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    BLD, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    BLD, W-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    BLD, W-W
    5
    71.4%
    25
    80.6%
    14
    73.7%
    14
    93.3%
    BLD, W-A
    1
    14.3%
    1
    3.2%
    1
    5.3%
    0
    0%
    BLD, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    BLD, A-W
    0
    0%
    1
    3.2%
    2
    10.5%
    1
    6.7%
    BLD, A-A
    1
    14.3%
    2
    6.5%
    1
    5.3%
    0
    0%
    CRE, U-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    CRE, U-W
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    CRE, U-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    CRE, B-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    CRE, B-W
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    CRE, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    CRE, W-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    CRE, W-W
    7
    100%
    23
    74.2%
    18
    94.7%
    14
    93.3%
    CRE, W-A
    0
    0%
    0
    0%
    0
    0%
    1
    6.7%
    CRE, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    CRE, A-W
    0
    0%
    2
    6.5%
    0
    0%
    0
    0%
    CRE, A-A
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    EOS, B-B
    0
    0%
    0
    0%
    0
    0%
    1
    6.7%
    EOS, B-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    EOS, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    EOS, W-B
    0
    0%
    0
    0%
    2
    10.5%
    0
    0%
    EOS, W-W
    6
    85.7%
    28
    90.3%
    14
    73.7%
    13
    86.7%
    EOS, W-A
    0
    0%
    0
    0%
    1
    5.3%
    0
    0%
    EOS, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    EOS, A-W
    0
    0%
    0
    0%
    0
    0%
    1
    6.7%
    EOS, A-A
    1
    14.3%
    0
    0%
    0
    0%
    0
    0%
    RBC, B-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    RBC, B-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    RBC, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    RBC, W-B
    1
    14.3%
    1
    3.2%
    1
    5.3%
    2
    13.3%
    RBC, W-W
    5
    71.4%
    24
    77.4%
    8
    42.1%
    12
    80%
    RBC, W-A
    1
    14.3%
    0
    0%
    1
    5.3%
    1
    6.7%
    RBC, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    RBC, A-W
    0
    0%
    2
    6.5%
    6
    31.6%
    0
    0%
    RBC, A-A
    0
    0%
    2
    6.5%
    1
    5.3%
    0
    0%
    HPG, B-B
    1
    14.3%
    2
    6.5%
    2
    10.5%
    0
    0%
    HPG, B-W
    0
    0%
    1
    3.2%
    0
    0%
    1
    6.7%
    HPG, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    HPG, W-B
    0
    0%
    2
    6.5%
    1
    5.3%
    0
    0%
    HPG, W-W
    6
    85.7%
    23
    74.2%
    14
    73.7%
    14
    93.3%
    HPG, W-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    HPG, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    HPG, A-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    HPG, A-A
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    HGL, B-B
    0
    0%
    2
    6.5%
    0
    0%
    0
    0%
    HGL, B-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    HGL, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    HGL, W-B
    1
    14.3%
    2
    6.5%
    2
    10.5%
    3
    20%
    HGL, W-W
    5
    71.4%
    24
    77.4%
    14
    73.7%
    11
    73.3%
    HGL, W-A
    1
    14.3%
    0
    0%
    0
    0%
    0
    0%
    HGL, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    HGL, A-W
    0
    0%
    1
    3.2%
    1
    5.3%
    1
    6.7%
    HGL, A-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    LDH, B-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    LDH, B-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    LDH, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    LDH, W-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    LDH, W-W
    5
    71.4%
    19
    61.3%
    10
    52.6%
    10
    66.7%
    LDH, W-A
    0
    0%
    2
    6.5%
    5
    26.3%
    2
    13.3%
    LDH, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    LDH, A-W
    2
    28.6%
    7
    22.6%
    2
    10.5%
    2
    13.3%
    LDH, A-A
    0
    0%
    1
    3.2%
    1
    5.3%
    1
    6.7%
    WBC, B-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    WBC, B-W
    1
    14.3%
    1
    3.2%
    1
    5.3%
    1
    6.7%
    WBC, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    WBC, W-B
    0
    0%
    3
    9.7%
    0
    0%
    0
    0%
    WBC, W-W
    6
    85.7%
    25
    80.6%
    16
    84.2%
    14
    93.3%
    WBC, W-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    WBC, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    WBC, A-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    WBC, A-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    LYM, B-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    LYM, B-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    LYM, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    LYM, W-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    LYM, W-W
    7
    100%
    27
    87.1%
    15
    78.9%
    15
    100%
    LYM, W-A
    0
    0%
    0
    0%
    2
    10.5%
    0
    0%
    LYM, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    LYM, A-W
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    LYM, A-A
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    NEU, B-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    NEU, B-W
    1
    14.3%
    0
    0%
    1
    5.3%
    1
    6.7%
    NEU, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    NEU, W-B
    0
    0%
    4
    12.9%
    1
    5.3%
    0
    0%
    NEU, W-W
    6
    85.7%
    25
    80.6%
    13
    68.4%
    14
    93.3%
    NEU, W-A
    0
    0%
    0
    0%
    2
    10.5%
    0
    0%
    NEU, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    NEU, A-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    NEU, A-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PLC, B-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PLC, B-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PLC, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PLC, W-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PLC, W-W
    7
    100%
    28
    90.3%
    14
    73.7%
    15
    100%
    PLC, W-A
    0
    0%
    1
    3.2%
    2
    10.5%
    0
    0%
    PLC, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PLC, A-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PLC, A-A
    0
    0%
    0
    0%
    1
    5.3%
    0
    0%
    PT, U-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PT, U-W
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    PT, U-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PT, B-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PT, B-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PT, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PT, W-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PT, W-W
    7
    100%
    24
    77.4%
    17
    89.5%
    12
    80%
    PT, W-A
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    PT, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PT, A-W
    0
    0%
    1
    3.2%
    0
    0%
    1
    6.7%
    PT, A-A
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    RET, B-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    RET, B-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    RET, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    RET, W-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    RET, W-W
    7
    100%
    29
    93.5%
    16
    84.2%
    15
    100%
    RET, W-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    RET, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    RET, A-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    RET, A-A
    0
    0%
    0
    0%
    1
    5.3%
    0
    0%
    BLT, B-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    BLT, B-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    BLT, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    BLT, W-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    BLT, W-W
    7
    100%
    27
    87.1%
    16
    84.2%
    15
    100%
    BLT, W-A
    0
    0%
    1
    3.2%
    1
    5.3%
    0
    0%
    BLT, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    BLT, A-W
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    BLT, A-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    10. Primary Outcome
    Title Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
    Description Haematological/Biochemical parameters assessed were haemoglobin level [HgL], red blood cell [RBC], white blood cell [WBC], lymphocyte [LYM], neutrophil [NEU], eosinophil [EOS], reticulocyte [RET], platelet count [PLC], haptoglobin [Hpg], prothrombin time [PT] and partial thromboplastin time [PTT]. alanine aminotransferase [ALT], aspartate aminotransferase [AST], creatinine [CRE], lactate dehydrogenase [LDH] and bilirubin direct or total [BLD/BLT].Values were: unknown at baseline and below at Day 60(U-B), unknown at baseline and within at Day60(U-W), unknown at baseline and above at Day 60(U-A), below at baseline and below at Day60(B-B), below at baseline and within at Day60(B-W), below at baseline and above at Day60(B-A), within at baseline and below at Day 60(W-B), within at baseline and within at Day 60(W-W), within at baseline and above at Day60(W-A), above at baseline and below at Day60(A-B), above at baseline and within at Day60(A-W), above at baseline and above at Day60(A-A).
    Time Frame At Day 60

    Outcome Measure Data

    Analysis Population Description
    The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one study vaccine administration documented and with available results at Day 60.
    Arm/Group Title GSK3389245A_LD Group GSK3389245A_HD Group Placebo Group Bexsero Group
    Arm/Group Description Subjects received 2 doses of the investigational GSK3389245A low dose (LD) vaccine, one month apart, at Day 0 and Day 30. Subjects received 2 doses of the investigational GSK3389245A high dose (HD) vaccine, one month apart, at Day 0 and Day 30. Subjects received 2 doses of placebo vaccine, one month apart, at Day 0 and Day 30. Subjects received 2 doses of the active control vaccine, one month apart, at Day 0 and Day 30.
    Measure Participants 7 28 19 15
    PTT, U-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PTT, U-W
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    PTT, U-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PTT, B-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PTT, B-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PTT, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PTT, W-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PTT, W-W
    6
    85.7%
    26
    83.9%
    18
    94.7%
    10
    66.7%
    PTT, W-A
    0
    0%
    0
    0%
    0
    0%
    2
    13.3%
    PTT, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PTT, A-W
    0
    0%
    0
    0%
    1
    5.3%
    1
    6.7%
    PTT, A-A
    0
    0%
    0
    0%
    0
    0%
    1
    6.7%
    ALT, B-B
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    ALT, B-W
    0
    0%
    1
    3.2%
    1
    5.3%
    0
    0%
    ALT, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    ALT, W-B
    0
    0%
    0
    0%
    2
    10.5%
    0
    0%
    ALT, W-W
    7
    100%
    24
    77.4%
    13
    68.4%
    14
    93.3%
    ALT, W-A
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    ALT, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    ALT, A-W
    0
    0%
    1
    3.2%
    2
    10.5%
    1
    6.7%
    ALT, A-A
    0
    0%
    0
    0%
    1
    5.3%
    0
    0%
    AST, B-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    AST, B-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    AST, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    AST, W-B
    0
    0%
    0
    0%
    1
    5.3%
    0
    0%
    AST, W-W
    7
    100%
    27
    87.1%
    17
    89.5%
    15
    100%
    AST, W-A
    0
    0%
    0
    0%
    1
    5.3%
    0
    0%
    AST, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    AST, A-W
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    AST, A-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    BLD, B-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    BLD, B-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    BLD, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    BLD, W-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    BLD, W-W
    5
    71.4%
    25
    80.6%
    15
    78.9%
    13
    86.7%
    BLD, W-A
    1
    14.3%
    0
    0%
    1
    5.3%
    1
    6.7%
    BLD, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    BLD, A-W
    1
    14.3%
    1
    3.2%
    0
    0%
    1
    6.7%
    BLD, A-A
    0
    0%
    2
    6.5%
    3
    15.8%
    0
    0%
    CRE, U-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    CRE, U-W
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    CRE, U-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    CRE, B-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    CRE, B-W
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    CRE, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    CRE, W-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    CRE, W-W
    7
    100%
    23
    74.2%
    18
    94.7%
    15
    100%
    CRE, W-A
    0
    0%
    0
    0%
    1
    5.3%
    0
    0%
    CRE, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    CRE, A-W
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    CRE, A-A
    0
    0%
    2
    6.5%
    0
    0%
    0
    0%
    EOS, B-B
    0
    0%
    0
    0%
    0
    0%
    1
    6.7%
    EOS, B-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    EOS, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    EOS, W-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    EOS, W-W
    6
    85.7%
    27
    87.1%
    19
    100%
    13
    86.7%
    EOS, W-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    EOS, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    EOS, A-W
    0
    0%
    1
    3.2%
    0
    0%
    1
    6.7%
    EOS, A-A
    1
    14.3%
    0
    0%
    0
    0%
    0
    0%
    RBC, B-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    RBC, B-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    RBC, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    RBC, W-B
    0
    0%
    3
    9.7%
    1
    5.3%
    0
    0%
    RBC, W-W
    5
    71.4%
    20
    64.5%
    11
    57.9%
    14
    93.3%
    RBC, W-A
    2
    28.6%
    1
    3.2%
    0
    0%
    1
    6.7%
    RBC, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    RBC, A-W
    0
    0%
    3
    9.7%
    3
    15.8%
    0
    0%
    RBC, A-A
    0
    0%
    1
    3.2%
    4
    21.1%
    0
    0%
    HPG, B-B
    1
    14.3%
    2
    6.5%
    2
    10.5%
    1
    6.7%
    HPG, B-W
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    HPG, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    HPG, W-B
    0
    0%
    1
    3.2%
    1
    5.3%
    1
    6.7%
    HPG, W-W
    6
    85.7%
    22
    71%
    16
    84.2%
    13
    86.7%
    HPG, W-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    HPG, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    HPG, A-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    HPG, A-A
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    HGL, B-B
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    HGL, B-W
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    HGL, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    HGL, W-B
    1
    14.3%
    1
    3.2%
    6
    31.6%
    1
    6.7%
    HGL, W-W
    6
    85.7%
    24
    77.4%
    11
    57.9%
    13
    86.7%
    HGL, W-A
    0
    0%
    0
    0%
    1
    5.3%
    0
    0%
    HGL, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    HGL, A-W
    0
    0%
    1
    3.2%
    1
    5.3%
    1
    6.7%
    HGL, A-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    LDH, B-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    LDH, B-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    LDH, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    LDH, W-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    LDH, W-W
    3
    42.9%
    16
    51.6%
    14
    73.7%
    10
    66.7%
    LDH, W-A
    2
    28.6%
    4
    12.9%
    2
    10.5%
    2
    13.3%
    LDH, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    LDH, A-W
    1
    14.3%
    6
    19.4%
    3
    15.8%
    2
    13.3%
    LDH, A-A
    1
    14.3%
    2
    6.5%
    0
    0%
    1
    6.7%
    WBC, B-B
    0
    0%
    1
    3.2%
    0
    0%
    1
    6.7%
    WBC, B-W
    1
    14.3%
    0
    0%
    1
    5.3%
    0
    0%
    WBC, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    WBC, W-B
    0
    0%
    1
    3.2%
    1
    5.3%
    0
    0%
    WBC, W-W
    6
    85.7%
    26
    83.9%
    17
    89.5%
    14
    93.3%
    WBC, W-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    WBC, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    WBC, A-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    WBC, A-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    LYM, B-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    LYM, B-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    LYM, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    LYM, W-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    LYM, W-W
    7
    100%
    25
    80.6%
    18
    94.7%
    15
    100%
    LYM, W-A
    0
    0%
    1
    3.2%
    1
    5.3%
    0
    0%
    LYM, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    LYM, A-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    LYM, A-A
    0
    0%
    2
    6.5%
    0
    0%
    0
    0%
    NEU, B-B
    0
    0%
    0
    0%
    0
    0%
    1
    6.7%
    NEU, B-W
    1
    14.3%
    0
    0%
    1
    5.3%
    0
    0%
    NEU, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    NEU, W-B
    0
    0%
    4
    12.9%
    0
    0%
    0
    0%
    NEU, W-W
    6
    85.7%
    22
    71%
    18
    94.7%
    14
    93.3%
    NEU, W-A
    0
    0%
    2
    6.5%
    0
    0%
    0
    0%
    NEU, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    NEU, A-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    NEU, A-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PLC, B-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PLC, B-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PLC, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PLC, W-B
    0
    0%
    0
    0%
    0
    0%
    1
    6.7%
    PLC, W-W
    7
    100%
    28
    90.3%
    18
    94.7%
    14
    93.3%
    PLC, W-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PLC, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PLC, A-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PLC, A-A
    0
    0%
    0
    0%
    1
    5.3%
    0
    0%
    PT, U-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PT, U-W
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    PT, U-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PT, B-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PT, B-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PT, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PT, W-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PT, W-W
    6
    85.7%
    24
    77.4%
    18
    94.7%
    13
    86.7%
    PT, W-A
    0
    0%
    0
    0%
    1
    5.3%
    0
    0%
    PT, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PT, A-W
    0
    0%
    1
    3.2%
    0
    0%
    1
    6.7%
    PT, A-A
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    RET, B-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    RET, B-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    RET, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    RET, W-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    RET, W-W
    7
    100%
    28
    90.3%
    18
    94.7%
    15
    100%
    RET, W-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    RET, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    RET, A-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    RET, A-A
    0
    0%
    0
    0%
    1
    5.3%
    0
    0%
    BLT, B-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    BLT, B-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    BLT, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    BLT, W-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    BLT, W-W
    7
    100%
    26
    83.9%
    18
    94.7%
    15
    100%
    BLT, W-A
    0
    0%
    1
    3.2%
    1
    5.3%
    0
    0%
    BLT, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    BLT, A-W
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    BLT, A-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    11. Primary Outcome
    Title Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
    Description Haematological/Biochemical parameters assessed were haemoglobin level [HgL], red blood cell [RBC], white blood cell [WBC], lymphocyte [LYM], neutrophil [NEU], eosinophil [EOS], reticulocyte [RET], platelet count [PLC], haptoglobin [Hpg], prothrombin time [PT] and partial thromboplastin time [PTT], alanine aminotransferase [ALT], aspartate aminotransferase [AST], creatinine [CRE], lactate dehydrogenase [LDH] and bilirubin direct or total [BLD/BLT].Values were: unknown at baseline and below at Day180(U-B), unknown at baseline and within at Day180(U-W), unknown at baseline and above at Day180(U-A), below at baseline and below at Day180(B-B), below at baseline and within at Day180(B-W),below at baseline and above at Day180(B-A), within at baseline and below at Day180(W-B),within at baseline and within at Day180(W-W), within at baseline and above at Day180(W-A),above at baseline and below at Day180(A-B),above at baseline and within at Day180(A-W),above at baseline and above at Day180(A-A).
    Time Frame At Day 180

    Outcome Measure Data

    Analysis Population Description
    The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administration documented and with available results at Day 180.
    Arm/Group Title GSK3389245A_LD Group GSK3389245A_HD Group Placebo Group Bexsero Group
    Arm/Group Description Subjects received 2 doses of the investigational GSK3389245A low dose (LD) vaccine, one month apart, at Day 0 and Day 30. Subjects received 2 doses of the investigational GSK3389245A high dose (HD) vaccine, one month apart, at Day 0 and Day 30. Subjects received 2 doses of placebo vaccine, one month apart, at Day 0 and Day 30. Subjects received 2 doses of the active control vaccine, one month apart, at Day 0 and Day 30.
    Measure Participants 6 23 16 14
    PTT, U-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PTT, U-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PTT,U-A
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    PTT, B-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PTT, B-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PTT, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PTT, W-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PTT, W-W
    6
    85.7%
    21
    67.7%
    15
    78.9%
    12
    80%
    PTT, W-A
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    PTT, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PTT, A-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PTT, A-A
    0
    0%
    0
    0%
    1
    5.3%
    2
    13.3%
    ALT, B-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    ALT, B-W
    0
    0%
    1
    3.2%
    1
    5.3%
    0
    0%
    ALT, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    ALT, W-B
    0
    0%
    0
    0%
    1
    5.3%
    0
    0%
    ALT, W-W
    5
    71.4%
    21
    67.7%
    11
    57.9%
    13
    86.7%
    ALT, W-A
    1
    14.3%
    0
    0%
    0
    0%
    0
    0%
    ALT, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    ALT, A-W
    0
    0%
    1
    3.2%
    3
    15.8%
    1
    6.7%
    ALT, A-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    AST, B-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    AST, B-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    AST, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    AST, W-B
    0
    0%
    1
    3.2%
    1
    5.3%
    0
    0%
    AST, W-W
    5
    71.4%
    20
    64.5%
    15
    78.9%
    14
    93.3%
    AST, W-A
    1
    14.3%
    1
    3.2%
    0
    0%
    0
    0%
    AST, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    AST, A-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    AST, A-A
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    BLD, B-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    BLD, B-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    BLD, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    BLD, W-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    BLD, W-W
    4
    57.1%
    21
    67.7%
    11
    57.9%
    11
    73.3%
    BLD, W-A
    1
    14.3%
    0
    0%
    2
    10.5%
    2
    13.3%
    BLD, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    BLD, A-W
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    BLD, A-A
    1
    14.3%
    1
    3.2%
    3
    15.8%
    1
    6.7%
    CRE, U-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    CRE, U-W
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    CRE, U-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    CRE, B-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    CRE, B-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    CRE, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    CRE, W-B
    0
    0%
    0
    0%
    1
    5.3%
    0
    0%
    CRE, W-W
    6
    85.7%
    19
    61.3%
    15
    78.9%
    13
    86.7%
    CRE, W-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    CRE, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    CRE, A-W
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    CRE, A-A
    0
    0%
    2
    6.5%
    0
    0%
    0
    0%
    EOS, B-B
    0
    0%
    0
    0%
    0
    0%
    1
    6.7%
    EOS, B-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    EOS, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    EOS, W-B
    1
    14.3%
    0
    0%
    0
    0%
    0
    0%
    EOS, W-W
    5
    71.4%
    21
    67.7%
    16
    84.2%
    12
    80%
    EOS, W-A
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    EOS, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    EOS, A-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    EOS, A-A
    0
    0%
    1
    3.2%
    0
    0%
    1
    6.7%
    RBC, B-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    RBC, B-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    RBC, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    RBC, W-B
    0
    0%
    1
    3.2%
    0
    0%
    1
    6.7%
    RBC, W-W
    5
    71.4%
    16
    51.6%
    9
    47.4%
    11
    73.3%
    RBC, W-A
    1
    14.3%
    3
    9.7%
    1
    5.3%
    2
    13.3%
    RBC, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    RBC, A-W
    0
    0%
    2
    6.5%
    4
    21.1%
    0
    0%
    RBC, A-A
    0
    0%
    1
    3.2%
    2
    10.5%
    0
    0%
    Hpg, B-B
    1
    14.3%
    2
    6.5%
    1
    5.3%
    1
    6.7%
    Hpg, B-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Hpg, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Hpg, W-B
    0
    0%
    1
    3.2%
    1
    5.3%
    0
    0%
    Hpg, W-W
    4
    57.1%
    19
    61.3%
    14
    73.7%
    11
    73.3%
    Hpg, W-A
    0
    0%
    0
    0%
    0
    0%
    1
    6.7%
    Hpg, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Hpg, A-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Hpg, A-A
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    HgL, B-B
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    HgL, B-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    HgL, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    HgL, W-B
    1
    14.3%
    2
    6.5%
    1
    5.3%
    1
    6.7%
    HgL, W-W
    5
    71.4%
    20
    64.5%
    14
    73.7%
    12
    80%
    HgL, W-A
    0
    0%
    0
    0%
    1
    5.3%
    0
    0%
    HgL, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    HgL, A-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    HgL, A-A
    0
    0%
    0
    0%
    0
    0%
    1
    6.7%
    LDH, B-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    LDH, B-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    LDH,B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    LDH, W-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    LDH, W-W
    4
    57.1%
    9
    29%
    13
    68.4%
    11
    73.3%
    LDH, W-A
    0
    0%
    7
    22.6%
    1
    5.3%
    0
    0%
    LDH, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    LDH, A-W
    1
    14.3%
    3
    9.7%
    1
    5.3%
    1
    6.7%
    LDH, A-A
    1
    14.3%
    4
    12.9%
    1
    5.3%
    1
    6.7%
    WBC, B-B
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    WBC, B-W
    1
    14.3%
    0
    0%
    1
    5.3%
    1
    6.7%
    WBC, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    WBC, W-B
    0
    0%
    1
    3.2%
    2
    10.5%
    0
    0%
    WBC, W-W
    5
    71.4%
    21
    67.7%
    13
    68.4%
    13
    86.7%
    WBC, W-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    WBC, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    WBC, A-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    WBC, A-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    LYM, B-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    LYM, B-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    LYM, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    LYM, W-B
    0
    0%
    0
    0%
    0
    0%
    1
    6.7%
    LYM, W-W
    6
    85.7%
    21
    67.7%
    14
    73.7%
    11
    73.3%
    LYM, W-A
    0
    0%
    0
    0%
    2
    10.5%
    2
    13.3%
    LYM, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    LYM, A-W
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    LYM, A-A
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    NEU, B-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    NEU, B-W
    1
    14.3%
    0
    0%
    1
    5.3%
    1
    6.7%
    NEU, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    NEU, W-B
    0
    0%
    2
    6.5%
    1
    5.3%
    0
    0%
    NEU, W-W
    5
    71.4%
    21
    67.7%
    14
    73.7%
    13
    86.7%
    NEU, W-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    NEU, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    NEU, A-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    NEU, A-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PLC, B-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PLC, B-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PLC, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PLC, W-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PLC, W-W
    6
    85.7%
    23
    74.2%
    14
    73.7%
    14
    93.3%
    PLC, W-A
    0
    0%
    0
    0%
    1
    5.3%
    0
    0%
    PLC, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PLC, A-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PLC, A-A
    0
    0%
    0
    0%
    1
    5.3%
    0
    0%
    PT, U-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PT, U-W
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    PT, U-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PT, B-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PT, B-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PT, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PT, W-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PT, W-W
    6
    85.7%
    21
    67.7%
    15
    78.9%
    13
    86.7%
    PT, W-A
    0
    0%
    0
    0%
    1
    5.3%
    0
    0%
    PT, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PT, A-W
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    PT, A-A
    0
    0%
    0
    0%
    0
    0%
    1
    6.7%
    RET, B-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    RET, B-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    RET, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    RET, W-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    RET, W-W
    6
    85.7%
    23
    74.2%
    15
    78.9%
    14
    93.3%
    RET, W-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    RET, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    RET, A-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    RET, A-A
    0
    0%
    0
    0%
    1
    5.3%
    0
    0%
    BLT, B-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    BLT, B-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    BLT, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    BLT, W-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    BLT, W-W
    6
    85.7%
    22
    71%
    14
    73.7%
    14
    93.3%
    BLT, W-A
    0
    0%
    0
    0%
    2
    10.5%
    0
    0%
    BLT, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    BLT, A-W
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    BLT, A-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    12. Primary Outcome
    Title Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
    Description Haematological/Biochemical parameters assessed were haemoglobin level [HgL], red blood cell [RBC], white blood cell [WBC], lymphocyte [LYM], neutrophil [NEU], eosinophil [EOS], reticulocyte [RET], platelet count [PLC], haptoglobin [Hpg], prothrombin time [PT] and partial thromboplastin time [PTT], alanine aminotransferase [ALT], aspartate aminotransferase [AST], creatinine [CRE], lactate dehydrogenase [LDH] and bilirubin direct or total [BLD/BLT].Values were: unknown at baseline and below at Day360(U-B), unknown at baseline and within at Day360(U-W), unknown at baseline and above at Day360(U-A), below at baseline and below at Day360(B-B), below at baseline and within at Day360(B-W),below at baseline and above at Day360(B-A), within at baseline and below at Day360(W-B),within at baseline and within at Day360(W-W), within at baseline and above at Day360(W-A),above at baseline and below at Day360(A-B),above at baseline and within at Day360(A-W),above at baseline and above at Day360(A-A).
    Time Frame At Day 360

    Outcome Measure Data

    Analysis Population Description
    The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administration documented and with available results at Day 360.
    Arm/Group Title GSK3389245A_LD Group GSK3389245A_HD Group Placebo Group Bexsero Group
    Arm/Group Description Subjects received 2 doses of the investigational GSK3389245A low dose (LD) vaccine, one month apart, at Day 0 and Day 30. Subjects received 2 doses of the investigational GSK3389245A high dose (HD) vaccine, one month apart, at Day 0 and Day 30. Subjects received 2 doses of placebo vaccine, one month apart, at Day 0 and Day 30. Subjects received 2 doses of the active control vaccine, one month apart, at Day 0 and Day 30.
    Measure Participants 5 21 15 14
    PTT, U-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PTT, U-W
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    PTT, U-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PTT, B-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PTT, B-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PTT, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PTT, W-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PTT, W-W
    5
    71.4%
    19
    61.3%
    13
    68.4%
    10
    66.7%
    PTT, W-A
    0
    0%
    1
    3.2%
    0
    0%
    1
    6.7%
    PTT, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PTT, A-W
    0
    0%
    0
    0%
    1
    5.3%
    0
    0%
    PTT, A-A
    0
    0%
    0
    0%
    0
    0%
    2
    13.3%
    ALT, B-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    ALT, B-W
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    ALT, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    ALT, W-B
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    ALT, W-W
    5
    71.4%
    17
    54.8%
    12
    63.2%
    12
    80%
    ALT, W-A
    0
    0%
    1
    3.2%
    0
    0%
    1
    6.7%
    ALT, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    ALT, A-W
    0
    0%
    1
    3.2%
    2
    10.5%
    1
    6.7%
    ALT, A-A
    0
    0%
    0
    0%
    1
    5.3%
    0
    0%
    AST, B-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    AST, B-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    AST, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    AST, W-B
    0
    0%
    3
    9.7%
    1
    5.3%
    2
    13.3%
    AST, W-W
    5
    71.4%
    18
    58.1%
    13
    68.4%
    11
    73.3%
    AST, W-A
    0
    0%
    0
    0%
    0
    0%
    1
    6.7%
    AST, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    AST, A-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    AST, A-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    BLD, B-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    BLD, B-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    BLD, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    BLD, W-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    BLD, W-W
    3
    42.9%
    17
    54.8%
    12
    63.2%
    12
    80%
    BLD, W-A
    1
    14.3%
    2
    6.5%
    1
    5.3%
    1
    6.7%
    BLD, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    BLD, A-W
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    BLD, A-A
    1
    14.3%
    1
    3.2%
    1
    5.3%
    1
    6.7%
    CRE, U-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    CRE, U-W
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    CRE, U-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    CRE, B-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    CRE, B-W
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    CRE, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    CRE, W-B
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    CRE, W-W
    5
    71.4%
    17
    54.8%
    15
    78.9%
    13
    86.7%
    CRE, W-A
    0
    0%
    0
    0%
    0
    0%
    1
    6.7%
    CRE, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    CRE, A-W
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    CRE, A-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    EOS, B-B
    0
    0%
    0
    0%
    0
    0%
    1
    6.7%
    EOS, B-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    EOS, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    EOS, W-B
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    EOS, W-W
    5
    71.4%
    19
    61.3%
    15
    78.9%
    12
    80%
    EOS, W-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    EOS, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    EOS, A-W
    0
    0%
    1
    3.2%
    0
    0%
    1
    6.7%
    EOS, A-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    RBC, B-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    RBC, B-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    RBC, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    RBC, W-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    RBC, W-W
    5
    71.4%
    17
    54.8%
    7
    36.8%
    12
    80%
    RBC, W-A
    0
    0%
    1
    3.2%
    1
    5.3%
    2
    13.3%
    RBC, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    RBC, A-W
    0
    0%
    1
    3.2%
    3
    15.8%
    0
    0%
    RBC, A-A
    0
    0%
    2
    6.5%
    4
    21.1%
    0
    0%
    HPG, B-B
    1
    14.3%
    1
    3.2%
    1
    5.3%
    1
    6.7%
    HPG, B-W
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    HPG, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    HPG, W-B
    0
    0%
    1
    3.2%
    0
    0%
    1
    6.7%
    HPG, W-W
    4
    57.1%
    17
    54.8%
    13
    68.4%
    12
    80%
    HPG, W-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    HPG, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    HPG, A-W
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    HPG, A-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    HGL, B-B
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    HGL, B-W
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    HGL, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    HGL, W-B
    0
    0%
    0
    0%
    1
    5.3%
    0
    0%
    HGL, W-W
    5
    71.4%
    19
    61.3%
    13
    68.4%
    13
    86.7%
    HGL, W-A
    0
    0%
    0
    0%
    1
    5.3%
    0
    0%
    HGL, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    HGL, A-W
    0
    0%
    0
    0%
    0
    0%
    1
    6.7%
    HGL, A-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    LDH, B-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    LDH, B-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    LDH, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    LDH, W-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    LDH, W-W
    3
    42.9%
    12
    38.7%
    11
    57.9%
    10
    66.7%
    LDH, W-A
    0
    0%
    2
    6.5%
    0
    0%
    1
    6.7%
    LDH, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    LDH, A-W
    2
    28.6%
    6
    19.4%
    3
    15.8%
    2
    13.3%
    LDH, A-A
    0
    0%
    1
    3.2%
    0
    0%
    1
    6.7%
    WBC, B-B
    0
    0%
    1
    3.2%
    1
    5.3%
    1
    6.7%
    WBC,B-W
    1
    14.3%
    0
    0%
    0
    0%
    0
    0%
    WBC, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    WBC, W-B
    0
    0%
    1
    3.2%
    0
    0%
    1
    6.7%
    WBC, W-W
    4
    57.1%
    18
    58.1%
    13
    68.4%
    12
    80%
    WBC, W-A
    0
    0%
    1
    3.2%
    1
    5.3%
    0
    0%
    WBC, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    WBC, A-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    WBC, A-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    LYM, B-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    LYM, B-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    LYM, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    LYM, W-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    LYM, W-W
    5
    71.4%
    18
    58.1%
    14
    73.7%
    14
    93.3%
    LYM, W-A
    0
    0%
    1
    3.2%
    1
    5.3%
    0
    0%
    LYM, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    LYM, A-W
    0
    0%
    2
    6.5%
    0
    0%
    0
    0%
    LYM, A-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    NEU, B-B
    0
    0%
    0
    0%
    1
    5.3%
    1
    6.7%
    NEU, B-W
    1
    14.3%
    0
    0%
    0
    0%
    0
    0%
    NEU, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    NEU, W-B
    0
    0%
    3
    9.7%
    0
    0%
    1
    6.7%
    NEU, W-W
    4
    57.1%
    17
    54.8%
    13
    68.4%
    12
    80%
    NEU, W-A
    0
    0%
    1
    3.2%
    1
    5.3%
    0
    0%
    NEU, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    NEU, A-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    NEU, A-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PLC, B-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PLC, B-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PLC, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PLC, W-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PLC, W-W
    5
    71.4%
    21
    67.7%
    12
    63.2%
    14
    93.3%
    PLC, W-A
    0
    0%
    0
    0%
    2
    10.5%
    0
    0%
    PLC, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PLC, A-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PLC, A-A
    0
    0%
    0
    0%
    1
    5.3%
    0
    0%
    PT, U-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PT, U-W
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    PT, U-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PT, B-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PT, B-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PT, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PT, W-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PT, W-W
    5
    71.4%
    20
    64.5%
    14
    73.7%
    12
    80%
    PT, W-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PT, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PT, A-W
    0
    0%
    0
    0%
    0
    0%
    1
    6.7%
    PT, A-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    RET, B-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    RET, B-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    RET, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    RET, W-B
    0
    0%
    0
    0%
    1
    5.3%
    0
    0%
    RET, W-W
    5
    71.4%
    21
    67.7%
    12
    63.2%
    14
    93.3%
    RET, W-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    RET, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    RET, A-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    RET, A-A
    0
    0%
    0
    0%
    1
    5.3%
    0
    0%
    BLT, B-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    BLT, B-W
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    BLT, B-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    BLT, W-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    BLT, W-W
    5
    71.4%
    20
    64.5%
    14
    73.7%
    13
    86.7%
    BLT, W-A
    0
    0%
    0
    0%
    1
    5.3%
    1
    6.7%
    BLT, A-B
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    BLT, A-W
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    BLT, A-A
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    13. Primary Outcome
    Title Number of Subjects With Haematological and Biochemical Results by Maximum Grade
    Description Parameters analysed were ALT, activated partial thromboplastin time [APTT], AST, total bilirubin [TB], CRE, EOS, haemoglobin decrease [HgD], LYM, NEU, platelets [PLA], PT, white blood cells decrease [WBCD] and white blood cells increase [WBCI]. Assessed grades were: Unknown [UG], grade 0 [G0] = no grade, 1 [G1] = mild grade, 2 [G2] = moderate grade, 3 [G3] = severe grade, 4 [G4] = potentially life threatening and overall grading [GTotal]. Parameter grade combinations expressed were: parameter plus UG/G0/1/2/3/4/Total at baseline versus grading G0/1/2/3/4/Total from Day 1 up to Day 60, for the same parameter, e.g. ALT G0-G2.
    Time Frame From Day 1 to Day 60

    Outcome Measure Data

    Analysis Population Description
    The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administration documented.
    Arm/Group Title GSK3389245A_LD Group GSK3389245A_HD Group Placebo Group Bexsero Group
    Arm/Group Description Subjects received 2 doses of the investigational GSK3389245A low dose (LD) vaccine, one month apart, at Day 0 and Day 30. Subjects received 2 doses of the investigational GSK3389245A high dose (HD) vaccine, one month apart, at Day 0 and Day 30. Subjects received 2 doses of placebo vaccine, one month apart, at Day 0 and Day 30. Subjects received 2 doses of the active control vaccine, one month apart, at Day 0 and Day 30.
    Measure Participants 7 31 19 15
    ALT, G0-G0
    7
    100%
    25
    80.6%
    17
    89.5%
    14
    93.3%
    ALT, G0-G1
    0
    0%
    4
    12.9%
    0
    0%
    1
    6.7%
    ALT, G0-G2
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    ALT, G0-G3
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    ALT, G0-G4
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    ALT, G1-G0
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    ALT, G1-G1
    0
    0%
    2
    6.5%
    2
    10.5%
    0
    0%
    ALT, G1-G2
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    ALT, G1-G3
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    ALT, G1-G4
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    ALT, GTotal-G0
    7
    100%
    25
    80.6%
    17
    89.5%
    14
    93.3%
    ALT, GTotal-G1
    0
    0%
    6
    19.4%
    2
    10.5%
    1
    6.7%
    ALT, GTotal-G2
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    ALT, GTotal-G3
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    ALT, GTotal-G4
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    APTT, UG-G0
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    APTT, UG-G1
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    APTT, UG-G2
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    APTT, UG-G3
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    APTT, UG-G4
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    APTT, G0-G0
    7
    100%
    29
    93.5%
    18
    94.7%
    11
    73.3%
    APTT, G0-G1
    0
    0%
    1
    3.2%
    0
    0%
    1
    6.7%
    APTT, G0-G2
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    APTT, G0-G3
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    APTT, G0-G4
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    APTT, G1-G0
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    APTT, G1-G1
    0
    0%
    0
    0%
    1
    5.3%
    2
    13.3%
    APTT, G1-G2
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    APTT, G1-G3
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    APTT, G1-G4
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    APTT, G4-G0
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    APTT, G4-G1
    0
    0%
    0
    0%
    0
    0%
    1
    6.7%
    APTT, G4-G2
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    APTT, G4-G3
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    APTT, G4-G4
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    APTT, GTotal-G0
    7
    100%
    29
    93.5%
    18
    94.7%
    11
    73.3%
    APTT, GTotal-G1
    0
    0%
    2
    6.5%
    1
    5.3%
    4
    26.7%
    APTT, GTotal-G2
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    APTT, GTotal-G3
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    APTT, GTotal-G4
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    AST, G0-G0
    7
    100%
    28
    90.3%
    18
    94.7%
    15
    100%
    AST, G0-G1
    0
    0%
    2
    6.5%
    1
    5.3%
    0
    0%
    AST, G0-G2
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    AST, G0-G3
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    AST, G0-G4
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    AST, G1-G0
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    AST, G1-G1
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    AST, G1-G2
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    AST, G1-G3
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    AST, G1-G4
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    AST, GTotal-G0
    7
    100%
    28
    90.3%
    18
    94.7%
    15
    100%
    AST, GTotal-G1
    0
    0%
    3
    9.7%
    1
    5.3%
    0
    0%
    AST, GTotal-G2
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    AST, GTotal-G3
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    AST, GTotal-G4
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    TB, G0-G0
    7
    100%
    28
    90.3%
    17
    89.5%
    13
    86.7%
    TB, G0-G1
    0
    0%
    0
    0%
    2
    10.5%
    2
    13.3%
    TB, G0-G2
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    TB, G0-G3
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    TB, G0-G4
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    TB, G1-G0
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    TB, G1-G1
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    TB, G1-G2
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    TB, G1-G3
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    TB, G1-G4
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    TB, G3-G0
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    TB, G3-G1
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    TB, G3-G2
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    TB, G3-G3
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    TB, G3-G4
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    TB, GTotal-G0
    7
    100%
    28
    90.3%
    17
    89.5%
    13
    86.7%
    TB, GTotal-G1
    0
    0%
    1
    3.2%
    2
    10.5%
    2
    13.3%
    TB, GTotal-G2
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    TB, GTotal-G3
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    TB, GTotal-G4
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    CRE, UG-G0
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    CRE, UG-G1
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    CRE, UG-G2
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    CRE, UG-G3
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    CRE, UG-G4
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    CRE, G0-G0
    7
    100%
    30
    96.8%
    19
    100%
    15
    100%
    CRE, G0-G1
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    CRE, G0-G2
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    CRE, G0-G3
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    CRE, G0-G4
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    CRE, GTotal-G0
    7
    100%
    31
    100%
    19
    100%
    15
    100%
    CRE, GTotal-G1
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    CRE, GTotal-G2
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    CRE, GTotal-G3
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    CRE, GTotal-G4
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    EOS, G0-G0
    6
    85.7%
    31
    100%
    17
    89.5%
    15
    100%
    EOS, G0-G1
    0
    0%
    0
    0%
    2
    10.5%
    0
    0%
    EOS, G0-G2
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    EOS, G0-G3
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    EOS, G0-G4
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    EOS, G1-G0
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    EOS, G1-G1
    1
    14.3%
    0
    0%
    0
    0%
    0
    0%
    EOS, G1-G2
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    EOS, G1-G3
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    EOS, G1-G4
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    EOS, GTotal-G0
    6
    85.7%
    31
    100%
    17
    89.5%
    15
    100%
    EOS, GTotal-G1
    1
    14.3%
    0
    0%
    2
    10.5%
    0
    0%
    EOS, GTotal-G2
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    EOS, GTotal-G3
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    EOS, GTotal-G4
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    HgD, G0-G0
    2
    28.6%
    22
    71%
    12
    63.2%
    10
    66.7%
    HgD, G0-G1
    5
    71.4%
    5
    16.1%
    6
    31.6%
    4
    26.7%
    HgD, G0-G2
    0
    0%
    1
    3.2%
    1
    5.3%
    0
    0%
    HgD, G0-G3
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    HgD, G0-G4
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    HgD, G1-G0
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    HgD, G1-G1
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    HgD, G1-G2
    0
    0%
    2
    6.5%
    0
    0%
    1
    6.7%
    HgD, G1-G3
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    HgD, G1-G4
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    HgD, GTotal-G0
    2
    28.6%
    22
    71%
    12
    63.2%
    10
    66.7%
    HgD, GTotal-G1
    5
    71.4%
    6
    19.4%
    6
    31.6%
    4
    26.7%
    HgD, GTotal-G2
    0
    0%
    3
    9.7%
    1
    5.3%
    1
    6.7%
    HgD, GTotal-G3
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    HgD, GTotal-G4
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    LYM, G0-G0
    7
    100%
    21
    67.7%
    18
    94.7%
    14
    93.3%
    LYM, G0-G1
    0
    0%
    9
    29%
    0
    0%
    1
    6.7%
    LYM, G0-G2
    0
    0%
    1
    3.2%
    1
    5.3%
    0
    0%
    LYM, G0-G3
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    LYM, G0-G4
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    LYM, GTotal-G0
    7
    100%
    21
    67.7%
    18
    94.7%
    14
    93.3%
    LYM, GTotal-G1
    0
    0%
    9
    29%
    0
    0%
    1
    6.7%
    LYM, GTotal-G2
    0
    0%
    1
    3.2%
    1
    5.3%
    0
    0%
    LYM, GTotal-G3
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    LYM, GTotal-G4
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    NEU, G0-G0
    5
    71.4%
    22
    71%
    15
    78.9%
    13
    86.7%
    NEU, G0-G1
    1
    14.3%
    7
    22.6%
    3
    15.8%
    1
    6.7%
    NEU, G0-G2
    0
    0%
    2
    6.5%
    0
    0%
    0
    0%
    NEU, G0-G3
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    NEU, G0-G4
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    NEU, G1-G0
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    NEU, G1-G1
    1
    14.3%
    0
    0%
    1
    5.3%
    0
    0%
    NEU, G1-G2
    0
    0%
    0
    0%
    0
    0%
    1
    6.7%
    NEU, G1-G3
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    NEU, G1-G4
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    NEU, GTotal-G0
    5
    71.4%
    22
    71%
    15
    78.9%
    13
    86.7%
    NEU, GTotal-G1
    2
    28.6%
    7
    22.6%
    4
    21.1%
    1
    6.7%
    NEU, GTotal-G2
    0
    0%
    2
    6.5%
    0
    0%
    1
    6.7%
    NEU, GTotal-G3
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    NEU, GTotal-G4
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PLA, G0-G0
    7
    100%
    31
    100%
    19
    100%
    14
    93.3%
    PLA, G0-G1
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PLA, G0-G2
    0
    0%
    0
    0%
    0
    0%
    1
    6.7%
    PLA, G0-G3
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PLA, G0-G4
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PLA, GTotal-G0
    7
    100%
    31
    100%
    19
    100%
    14
    93.3%
    PLA, GTotal-G1
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PLA, GTotal-G2
    0
    0%
    0
    0%
    0
    0%
    1
    6.7%
    PLA, GTotal-G3
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PLA, GTotal-G4
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PT, UG-G0
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    PT, UG-G1
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PT, UG-G2
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PT, UG-G3
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PT, UG-G4
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PT, G0-G0
    7
    100%
    26
    83.9%
    17
    89.5%
    13
    86.7%
    PT, G0-G1
    0
    0%
    2
    6.5%
    2
    10.5%
    1
    6.7%
    PT, G0-G2
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PT, G0-G3
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PT, G0-G4
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PT, G1-G0
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PT, G1-G1
    0
    0%
    2
    6.5%
    0
    0%
    0
    0%
    PT, G1-G2
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PT, G1-G3
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PT, G1-G4
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PT, G4-G0
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PT, G4-G1
    0
    0%
    0
    0%
    0
    0%
    1
    6.7%
    PT, G4-G2
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PT, G4-G3
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PT, G4-G4
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PT, GTotal-G0
    7
    100%
    27
    87.1%
    17
    89.5%
    13
    86.7%
    PT, GTotal-G1
    0
    0%
    4
    12.9%
    2
    10.5%
    2
    13.3%
    PT, GTotal-G2
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PT, GTotal-G3
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PT, GTotal-G4
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    WBCD, G0-G0
    7
    100%
    29
    93.5%
    18
    94.7%
    14
    93.3%
    WBCD, G0-G1
    0
    0%
    2
    6.5%
    1
    5.3%
    0
    0%
    WBCD, G0-G2
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    WBCD, G0-G3
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    WBCD, G0-G4
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    WBCD, G1-G0
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    WBCD, G1-G1
    0
    0%
    0
    0%
    0
    0%
    1
    6.7%
    WBCD, G1-G2
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    WBCD, G1-G3
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    WBCD, G1-G4
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    WBCD, GTotal-G0
    7
    100%
    29
    93.5%
    18
    94.7%
    14
    93.3%
    WBCD, GTotal-G1
    0
    0%
    2
    6.5%
    1
    5.3%
    1
    6.7%
    WBCD, GTotal-G2
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    WBCD, GTotal-G3
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    WBCD, GTotal-G4
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    WBCI, G0-G0
    7
    100%
    30
    96.8%
    19
    100%
    11
    73.3%
    WBCI, G0-G1
    0
    0%
    1
    3.2%
    0
    0%
    2
    13.3%
    WBCI, G0-G2
    0
    0%
    0
    0%
    0
    0%
    2
    13.3%
    WBCI, G0-G3
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    WBCI, G0-G4
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    WBCI, GTotal-G0
    7
    100%
    30
    96.8%
    19
    100%
    11
    73.3%
    WBCI, GTotal-G1
    0
    0%
    1
    3.2%
    0
    0%
    2
    13.3%
    WBCI, GTotal-G2
    0
    0%
    0
    0%
    0
    0%
    2
    13.3%
    WBCI, GTotal-G3
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    WBCI, GTotal-G4
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    14. Primary Outcome
    Title Number of Subjects With Unsolicited Adverse Events (AEs)
    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

    Outcome Measure Data

    Analysis Population Description
    The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administration documented.
    Arm/Group Title GSK3389245A_LD Group GSK3389245A_HD Group Placebo Group Bexsero Group
    Arm/Group Description Subjects received 2 doses of the investigational GSK3389245A low dose (LD) vaccine, one month apart, at Day 0 and Day 30. Subjects received 2 doses of the investigational GSK3389245A high dose (HD) vaccine, one month apart, at Day 0 and Day 30. Subjects received 2 doses of placebo vaccine, one month apart, at Day 0 and Day 30. Subjects received 2 doses of the active control vaccine, one month apart, at Day 0 and Day 30.
    Measure Participants 7 31 19 15
    Count of Participants [Participants]
    5
    71.4%
    21
    67.7%
    14
    73.7%
    12
    80%
    15. Primary Outcome
    Title Number of Subjects With Serious Adverse Events (SAEs)
    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 From Day 0 to Day 360

    Outcome Measure Data

    Analysis Population Description
    The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administration documented.
    Arm/Group Title GSK3389245A_LD Group GSK3389245A_HD Group Placebo Group Bexsero Group
    Arm/Group Description Subjects received 2 doses of the investigational GSK3389245A low dose (LD) vaccine, one month apart, at Day 0 and Day 30. Subjects received 2 doses of the investigational GSK3389245A high dose (HD) vaccine, one month apart, at Day 0 and Day 30. Subjects received 2 doses of placebo vaccine, one month apart, at Day 0 and Day 30. Subjects received 2 doses of the active control vaccine, one month apart, at Day 0 and Day 30.
    Measure Participants 7 31 19 15
    Up to Day 60
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Up to Day 360
    1
    14.3%
    0
    0%
    1
    5.3%
    0
    0%
    16. Secondary Outcome
    Title Number of Subjects With Haematological and Biochemical Results by Maximum Grade
    Description Parameters analysed were ALT, activated partial thromboplastin time [APTT], AST, total bilirubin [TB], CRE, EOS, haemoglobin decrease [HgD], LYM, NEU, platelets [PLA], PT, white blood cells decrease [WBCD] and white blood cells increase [WBCI]. Assessed grades were: Unknown [UG], grade 0 [G0] = no grade, 1 [G1] = mild grade, 2 [G2] = moderate grade, 3 [G3] = severe grade, 4 [G4] = potentially life threatening and overall grading [GTotal]. Parameter grade combinations expressed were: parameter plus UG/G0/1/2/3/4/Total at baseline versus grading G0/1/2/3/4/Total from Day 1 up to Day 360, for the same parameter, e.g. ALT G0-G2.
    Time Frame From Day 1 up to Day 360

    Outcome Measure Data

    Analysis Population Description
    The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administration documented.
    Arm/Group Title GSK3389245A_LD Group GSK3389245A_HD Group Placebo Group Bexsero Group
    Arm/Group Description Subjects received 2 doses of the investigational GSK3389245A low dose (LD) vaccine, one month apart, at Day 0 and Day 30. Subjects received 2 doses of the investigational GSK3389245A high dose (HD) vaccine, one month apart, at Day 0 and Day 30. Subjects received 2 doses of placebo vaccine, one month apart, at Day 0 and Day 30. Subjects received 2 doses of the active control vaccine, one month apart, at Day 0 and Day 30.
    Measure Participants 7 31 19 15
    ALT, G0-G0
    6
    85.7%
    25
    80.6%
    17
    89.5%
    13
    86.7%
    ALT, G0-G1
    1
    14.3%
    4
    12.9%
    0
    0%
    2
    13.3%
    ALT, G0-G2
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    ALT, G0-G3
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    ALT, G0-G4
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    ALT, G1-G0
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    ALT, G1-G1
    0
    0%
    2
    6.5%
    2
    10.5%
    0
    0%
    ALT, G1-G2
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    ALT, G1-G3
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    ALT, G1-G4
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    ALT, GTotal-G0
    6
    85.7%
    25
    80.6%
    17
    89.5%
    13
    86.7%
    ALT, GTotal-G1
    1
    14.3%
    6
    19.4%
    2
    10.5%
    2
    13.3%
    ALT, GTotal-G2
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    ALT, GTotal-G3
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    ALT, GTotal-G4
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    APTT, UG-G0
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    APTT, UG-G1
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    APTT, UG-G2
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    APTT, UG-G3
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    APTT, UG-G4
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    APTT, G0-G0
    7
    100%
    28
    90.3%
    18
    94.7%
    11
    73.3%
    APTT, G0-G1
    0
    0%
    2
    6.5%
    0
    0%
    1
    6.7%
    APTT, G0-G2
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    APTT, G0-G3
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    APTT, G0-G4
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    APTT, G1-G0
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    APTT, G1-G1
    0
    0%
    0
    0%
    1
    5.3%
    2
    13.3%
    APTT, G1-G2
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    APTT, G1-G3
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    APTT, G1-G4
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    APTT, G4-G0
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    APTT, G4-G1
    0
    0%
    0
    0%
    0
    0%
    1
    6.7%
    APTT, G4-G2
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    APTT, G4-G3
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    APTT, G4-G4
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    APTT, GTotal-G0
    7
    100%
    28
    90.3%
    18
    94.7%
    11
    73.3%
    APTT, GTotal-G1
    0
    0%
    3
    9.7%
    1
    5.3%
    4
    26.7%
    APTT, GTotal-G2
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    APTT, GTotal-G3
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    APTT, GTotal-G4
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    AST, G0-G0
    6
    85.7%
    28
    90.3%
    18
    94.7%
    15
    100%
    AST, G0-G1
    1
    14.3%
    2
    6.5%
    1
    5.3%
    0
    0%
    AST, G0-G2
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    AST, G0-G3
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    AST, G0-G4
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    AST, G1-G0
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    AST, G1-G1
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    AST, G1-G2
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    AST, G1-G3
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    AST, G1-G4
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    AST, GTotal-G0
    6
    85.7%
    28
    90.3%
    18
    94.7%
    15
    100%
    AST, GTotal-G1
    1
    14.3%
    3
    9.7%
    1
    5.3%
    0
    0%
    AST, GTotal-G2
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    AST, GTotal-G3
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    AST, GTotal-G4
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    TB, G0-G0
    7
    100%
    28
    90.3%
    17
    89.5%
    13
    86.7%
    TB, G0-G1
    0
    0%
    0
    0%
    2
    10.5%
    2
    13.3%
    TB, G0-G2
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    TB, G0-G3
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    TB, G0-G4
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    TB, G1-G0
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    TB, G1-G1
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    TB, G1-G2
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    TB, G1-G3
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    TB, G1-G4
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    TB, G3-G0
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    TB, G3-G1
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    TB, G3-G2
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    TB, G3-G3
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    TB, G3-G4
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    TB, GTotal-G0
    7
    100%
    28
    90.3%
    17
    89.5%
    13
    86.7%
    TB, GTotal-G1
    0
    0%
    1
    3.2%
    2
    10.5%
    2
    13.3%
    TB, GTotal-G2
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    TB, GTotal-G3
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    TB, GTotal-G4
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    CRE, UG-G0
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    CRE, UG-G1
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    CRE, UG-G2
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    CRE, UG-G3
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    CRE, UG-G4
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    CRE, G0-G0
    7
    100%
    30
    96.8%
    19
    100%
    15
    100%
    CRE, G0-G1
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    CRE, G0-G2
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    CRE, G0-G3
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    CRE, G0-G4
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    CRE, GTotal-G0
    7
    100%
    31
    100%
    19
    100%
    15
    100%
    CRE, GTotal-G1
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    CRE, GTotal-G2
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    CRE, GTotal-G3
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    CRE, GTotal-G4
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    EOS, G0-G0
    6
    85.7%
    31
    100%
    17
    89.5%
    14
    93.3%
    EOS, G0-G1
    0
    0%
    0
    0%
    2
    10.5%
    1
    6.7%
    EOS, G0-G2
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    EOS, G0-G3
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    EOS, G0-G4
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    EOS, G1-G0
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    EOS, G1-G1
    1
    14.3%
    0
    0%
    0
    0%
    0
    0%
    EOS, G1-G2
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    EOS, G1-G3
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    EOS, G1-G4
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    EOS, GTotal-G0
    6
    85.7%
    31
    100%
    17
    89.5%
    14
    93.3%
    EOS, GTotal-G1
    1
    14.3%
    0
    0%
    2
    10.5%
    1
    6.7%
    EOS, GTotal-G2
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    EOS, GTotal-G3
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    EOS, GTotal-G4
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    HgD, G0-G0
    2
    28.6%
    22
    71%
    12
    63.2%
    9
    60%
    HgD, G0-G1
    5
    71.4%
    4
    12.9%
    5
    26.3%
    5
    33.3%
    HgD, G0-G2
    0
    0%
    2
    6.5%
    2
    10.5%
    0
    0%
    HgD, G0-G3
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    HgD, G0-G4
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    HgD, G1-G0
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    HgD, G1-G1
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    HgD, G1-G2
    0
    0%
    2
    6.5%
    0
    0%
    1
    6.7%
    HgD, G1-G3
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    HgD, G1-G4
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    HgD, GTotal-G0
    2
    28.6%
    22
    71%
    12
    63.2%
    9
    60%
    HgD, GTotal-G1
    5
    71.4%
    5
    16.1%
    5
    26.3%
    5
    33.3%
    HgD, GTotal-G2
    0
    0%
    4
    12.9%
    2
    10.5%
    1
    6.7%
    HgD, GTotal-G3
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    HgD, GTotal-G4
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    LYM, G0-G0
    7
    100%
    21
    67.7%
    18
    94.7%
    13
    86.7%
    LYM, G0-G1
    0
    0%
    9
    29%
    0
    0%
    2
    13.3%
    LYM, G0-G2
    0
    0%
    1
    3.2%
    1
    5.3%
    0
    0%
    LYM, G0-G3
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    LYM, G0-G4
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    LYM, GTotal-G0
    7
    100%
    21
    67.7%
    18
    94.7%
    13
    86.7%
    LYM, GTotal-G1
    0
    0%
    9
    29%
    0
    0%
    2
    13.3%
    LYM, GTotal-G2
    0
    0%
    1
    3.2%
    1
    5.3%
    0
    0%
    LYM, GTotal-G3
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    LYM, GTotal-G4
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    NEU, G0-G0
    5
    71.4%
    21
    67.7%
    14
    73.7%
    13
    86.7%
    NEU, G0-G1
    1
    14.3%
    8
    25.8%
    4
    21.1%
    1
    6.7%
    NEU, G0-G2
    0
    0%
    2
    6.5%
    0
    0%
    0
    0%
    NEU, G0-G3
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    NEU, G0-G4
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    NEU, G1-G0
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    NEU, G1-G1
    1
    14.3%
    0
    0%
    1
    5.3%
    0
    0%
    NEU, G1-G2
    0
    0%
    0
    0%
    0
    0%
    1
    6.7%
    NEU, G1-G3
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    NEU, G1-G4
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    NEU, GTotal-G0
    5
    71.4%
    21
    67.7%
    14
    73.7%
    13
    86.7%
    NEU, GTotal-G1
    2
    28.6%
    8
    25.8%
    5
    26.3%
    1
    6.7%
    NEU, GTotal-G2
    0
    0%
    2
    6.5%
    0
    0%
    1
    6.7%
    NEU, GTotal-G3
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    NEU, GTotal-G4
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PLA, G0-G0
    7
    100%
    31
    100%
    19
    100%
    14
    93.3%
    PLA, G0-G1
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PLA, G0-G2
    0
    0%
    0
    0%
    0
    0%
    1
    6.7%
    PLA, G0-G3
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PLA, G0-G4
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PLA, GTotal-G0
    7
    100%
    31
    100%
    19
    100%
    14
    93.3%
    PLA, GTotal-G1
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PLA, GTotal-G2
    0
    0%
    0
    0%
    0
    0%
    1
    6.7%
    PLA, GTotal-G3
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PLA, GTotal-G4
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PT, UG-G0
    0
    0%
    1
    3.2%
    0
    0%
    0
    0%
    PT, UG-G1
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PT, UG-G2
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PT, UG-G3
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PT, UG-G4
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PT, G0-G0
    6
    85.7%
    24
    77.4%
    17
    89.5%
    12
    80%
    PT, G0-G1
    1
    14.3%
    4
    12.9%
    2
    10.5%
    2
    13.3%
    PT, G0-G2
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PT, G0-G3
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PT, G0-G4
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PT, G1-G0
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PT, G1-G1
    0
    0%
    2
    6.5%
    0
    0%
    0
    0%
    PT, G1-G2
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PT, G1-G3
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PT, G1-G4
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PT, G4-G0
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PT, G4-G1
    0
    0%
    0
    0%
    0
    0%
    1
    6.7%
    PT, G4-G2
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PT, G4-G3
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PT, G4-G4
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PT, GTotal-G0
    6
    85.7%
    25
    80.6%
    17
    89.5%
    12
    80%
    PT, GTotal-G1
    1
    14.3%
    6
    19.4%
    2
    10.5%
    3
    20%
    PT, GTotal-G2
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PT, GTotal-G3
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    PT, GTotal-G4
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    WBCD, G0-G0
    7
    100%
    29
    93.5%
    18
    94.7%
    14
    93.3%
    WBCD, G0-G1
    0
    0%
    2
    6.5%
    1
    5.3%
    0
    0%
    WBCD, G0-G2
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    WBCD, G0-G3
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    WBCD, G0-G4
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    WBCD, G1-G0
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    WBCD, G1-G1
    0
    0%
    0
    0%
    0
    0%
    1
    6.7%
    WBCD, G1-G2
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    WBCD, G1-G3
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    WBCD, G1-G4
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    WBCD, GTotal-G0
    7
    100%
    29
    93.5%
    18
    94.7%
    14
    93.3%
    WBCD, GTotal-G1
    0
    0%
    2
    6.5%
    1
    5.3%
    1
    6.7%
    WBCD, GTotal-G2
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    WBCD, GTotal-G3
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    WBCD, GTotal-G4
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    WBCI, G0-G0
    7
    100%
    29
    93.5%
    18
    94.7%
    11
    73.3%
    WBCI, G0-G1
    0
    0%
    2
    6.5%
    1
    5.3%
    2
    13.3%
    WBCI, G0-G2
    0
    0%
    0
    0%
    0
    0%
    2
    13.3%
    WBCI, G0-G3
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    WBCI, G0-G4
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    WBCI, GTotal-G0
    7
    100%
    29
    93.5%
    18
    94.7%
    11
    73.3%
    WBCI, GTotal-G1
    0
    0%
    2
    6.5%
    1
    5.3%
    2
    13.3%
    WBCI, GTotal-G2
    0
    0%
    0
    0%
    0
    0%
    2
    13.3%
    WBCI, GTotal-G3
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    WBCI, GTotal-G4
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    17. Secondary Outcome
    Title Anti-respiratory Syncytial Virus (RSV) Neutralizing Antibodies Titers
    Description Serum neutralizing antibody titers were reported as the inverse of the serum dilution which yielded a 60% reduction in the number of viral plaques compared to virus control without serum (Estimated Dilution: ED60). Antibody titers were expressed as Geometric Mean Titers (GMTs).
    Time Frame At pre-vaccination (Day 0), post-Dose 1 (Day 30) and post-Dose 2 (Day 60)

    Outcome Measure Data

    Analysis Population Description
    The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects, i.e. those who were included in the Total Vaccinated Cohort and who received at least one dose of study vaccine.
    Arm/Group Title GSK3389245A_LD Group GSK3389245A_HD Group Placebo Group Bexsero Group
    Arm/Group Description Subjects received 2 doses of the investigational GSK3389245A low dose (LD) vaccine, one month apart, at Day 0 and Day 30. Subjects received 2 doses of the investigational GSK3389245A high dose (HD) vaccine, one month apart, at Day 0 and Day 30. Subjects received 2 doses of placebo vaccine, one month apart, at Day 0 and Day 30. Subjects received 2 doses of the active control vaccine, one month apart, at Day 0 and Day 30.
    Measure Participants 5 28 18 15
    Anti-RSV, (Day 0)
    605.9
    519.4
    346.1
    409.4
    Anti-RSV, (Day 30)
    1474.1
    1293.1
    492.4
    493.8
    Anti-RSV, (Day 60)
    847.4
    1211.3
    347.3
    376.9
    18. Secondary Outcome
    Title Number of Subjects With Anti-RSV Neutralizing Antibodies Above the Cut-off Value
    Description Pre-defined cut-off values was higher than or equal to (≥) 8 ED60.
    Time Frame At pre-vaccination (Day 0), post-Dose 1 (Day 30) and post-Dose 2 (Day 60)

    Outcome Measure Data

    Analysis Population Description
    The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects, i.e. those who were included in the Total Vaccinated Cohort and who received at least one dose of study vaccine.
    Arm/Group Title GSK3389245A_LD Group GSK3389245A_HD Group Placebo Group Bexsero Group
    Arm/Group Description Subjects received 2 doses of the investigational GSK3389245A low dose (LD) vaccine, one month apart, at Day 0 and Day 30. Subjects received 2 doses of the investigational GSK3389245A high dose (HD) vaccine, one month apart, at Day 0 and Day 30. Subjects received 2 doses of placebo vaccine, one month apart, at Day 0 and Day 30. Subjects received 2 doses of the active control vaccine, one month apart, at Day 0 and Day 30.
    Measure Participants 5 28 18 15
    ANTI-RSV, (Day 0)
    5
    71.4%
    28
    90.3%
    18
    94.7%
    15
    100%
    ANTI-RSV, (Day 30)
    5
    71.4%
    26
    83.9%
    18
    94.7%
    15
    100%
    ANTI-RSV, (Day 60)
    5
    71.4%
    26
    83.9%
    18
    94.7%
    15
    100%
    19. Secondary Outcome
    Title Frequency of RSV Viral Protein F, N, M2-1 Specific Interferon-gamma (IFN-γ) Secreting T-cells
    Description Interferon-gamma specific T-cells, expressed as T-cells per (/) million cells, were determined by the Enzyme Linked ImmunoSpot (ELISpot) assay.
    Time Frame At pre-vaccination (Day 0) and post-Dose 1 (Day 7, Day 30) and post-Dose 2 (Day 37, Day 60)

    Outcome Measure Data

    Analysis Population Description
    The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects, i.e. those who were included in the Total Vaccinated Cohort and who received at least one dose of study vaccine.
    Arm/Group Title GSK3389245A_LD Group GSK3389245A_HD Group Placebo Group Bexsero Group
    Arm/Group Description Subjects received 2 doses of the investigational GSK3389245A low dose (LD) vaccine, one month apart, at Day 0 and Day 30. Subjects received 2 doses of the investigational GSK3389245A high dose (HD) vaccine, one month apart, at Day 0 and Day 30. Subjects received 2 doses of placebo vaccine, one month apart, at Day 0 and Day 30. Subjects received 2 doses of the active control vaccine, one month apart, at Day 0 and Day 30.
    Measure Participants 5 27 17 14
    RSV F, (Day 0)
    33.3
    35
    15
    23.3
    RSV F, (Day 7)
    28.3
    94.2
    20
    36.7
    RSV F, (Day 30)
    1.7
    108.3
    41.7
    41.7
    RSV F, (Day 37)
    18
    75
    33.3
    35
    RSV F, (Day 60)
    20
    70.8
    52.5
    48.3
    RSV M2-1, (Day 0)
    21.7
    6.7
    2.5
    5
    RSV M2-1, (Day 7)
    3.3
    25
    6.7
    3.3
    RSV M2-1, (Day 30)
    5
    31.7
    13.3
    7.5
    RSV M2-1, (Day 37)
    20.5
    37.5
    5.8
    6.7
    RSV M2-1, (Day 60)
    11.7
    20
    15
    10
    RSV N, (Day 0)
    10
    11.7
    5
    10
    RSV N, (Day 7)
    3.3
    21.7
    3.3
    11.7
    RSV N, (Day 30)
    1
    36.7
    18.3
    19.2
    RSV N, (Day 37)
    8.8
    50
    10.8
    18.3
    RSV N, (Day 60)
    15
    34.2
    24.2
    20
    20. Secondary Outcome
    Title Frequency of Anti-F Immunoglobulin g (IgG) and/or Immunoglobulin A (IgA) Antibody Secreting B-cells (ASC)
    Description IgG/IgA antibody specific B-cells/ expressed as B-cells per million cells, were determined by the ELISpot assay.
    Time Frame At pre-vaccination (Day 0) and post-Dose 1 (Day 7, Day 30) and post-Dose 2 (Day 37, Day 60)

    Outcome Measure Data

    Analysis Population Description
    The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects, i.e. those who were included in the Total Vaccinated Cohort and who received at least one dose of study vaccine.
    Arm/Group Title GSK3389245A_LD Group GSK3389245A_HD Group Placebo Group Bexsero Group
    Arm/Group Description Subjects received 2 doses of the investigational GSK3389245A low dose (LD) vaccine, one month apart, at Day 0 and Day 30. Subjects received 2 doses of the investigational GSK3389245A high dose (HD) vaccine, one month apart, at Day 0 and Day 30. Subjects received 2 doses of placebo vaccine, one month apart, at Day 0 and Day 30. Subjects received 2 doses of the active control vaccine, one month apart, at Day 0 and Day 30.
    Measure Participants 5 28 18 15
    Memory B-cell IgA, (Day 0)
    1
    1
    1
    1
    Memory B-cell IgA, (Day 7)
    1
    16.7
    1
    1
    Memory B-cell IgA, (Day 30)
    1
    1
    1
    1
    Memory B-cell IgA, (Day 37)
    1
    1
    1
    1
    Memory B-cell IgA, (Day 60)
    1
    1
    1
    1
    Memory B-cell IgG, (Day 0)
    1
    1
    1
    1
    Memory B-cell IgG, (Day 7)
    45
    133.3
    1
    1
    Memory B-cell IgG, (Day 30)
    1
    1
    1
    1
    Memory B-cell IgG, (Day 37)
    1
    1
    1
    1
    Memory B-cell IgG, (Day 60)
    1
    1
    1
    1

    Adverse Events

    Time Frame Solicited and unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period (up to Day 360).
    Adverse Event Reporting Description
    Arm/Group Title GSK3389245A_LD Group GSK3389245A_HD Group Placebo Group Bexsero Group
    Arm/Group Description Subjects received 2 doses of the investigational GSK3389245A low dose (LD) vaccine, one month apart, at Day 0 and Day 30. Subjects received 2 doses of the investigational GSK3389245A high dose (HD) vaccine, one month apart, at Day 0 and Day 30. Subjects received 2 doses of placebo vaccine, one month apart, at Day 0 and Day 30. Subjects received 2 doses of the active control vaccine, one month apart, at Day 0 and Day 30.
    All Cause Mortality
    GSK3389245A_LD Group GSK3389245A_HD Group Placebo Group Bexsero Group
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/7 (0%) 0/31 (0%) 0/19 (0%) 0/15 (0%)
    Serious Adverse Events
    GSK3389245A_LD Group GSK3389245A_HD Group Placebo Group Bexsero Group
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 1/7 (14.3%) 0/31 (0%) 1/19 (5.3%) 0/15 (0%)
    Infections and infestations
    Appendicitis 0/7 (0%) 0 0/31 (0%) 0 1/19 (5.3%) 1 0/15 (0%) 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Basal cell carcinoma 1/7 (14.3%) 1 0/31 (0%) 0 0/19 (0%) 0 0/15 (0%) 0
    Other (Not Including Serious) Adverse Events
    GSK3389245A_LD Group GSK3389245A_HD Group Placebo Group Bexsero Group
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 7/7 (100%) 30/31 (96.8%) 17/19 (89.5%) 15/15 (100%)
    Blood and lymphatic system disorders
    Lymphadenopathy 0/7 (0%) 0 0/31 (0%) 0 0/19 (0%) 0 1/15 (6.7%) 1
    Ear and labyrinth disorders
    Ear pain 0/7 (0%) 0 2/31 (6.5%) 2 0/19 (0%) 0 0/15 (0%) 0
    Gastrointestinal disorders
    Abdominal pain upper 0/7 (0%) 0 2/31 (6.5%) 3 0/19 (0%) 0 0/15 (0%) 0
    Diarrhoea 1/7 (14.3%) 1 0/31 (0%) 0 1/19 (5.3%) 1 0/15 (0%) 0
    Gastrointestinal disorder 3/7 (42.9%) 4 7/31 (22.6%) 9 9/19 (47.4%) 10 4/15 (26.7%) 5
    Toothache 0/7 (0%) 0 2/31 (6.5%) 2 0/19 (0%) 0 0/15 (0%) 0
    General disorders
    Chills 0/7 (0%) 0 1/31 (3.2%) 1 0/19 (0%) 0 2/15 (13.3%) 2
    Fatigue 5/7 (71.4%) 6 19/31 (61.3%) 29 9/19 (47.4%) 16 11/15 (73.3%) 17
    Feeling cold 0/7 (0%) 0 0/31 (0%) 0 1/19 (5.3%) 1 0/15 (0%) 0
    Hangover 0/7 (0%) 0 0/31 (0%) 0 0/19 (0%) 0 1/15 (6.7%) 2
    Influenza like illness 0/7 (0%) 0 3/31 (9.7%) 3 0/19 (0%) 0 0/15 (0%) 0
    Injection site bruising 0/7 (0%) 0 0/31 (0%) 0 1/19 (5.3%) 1 0/15 (0%) 0
    Pain 4/7 (57.1%) 4 27/31 (87.1%) 43 1/19 (5.3%) 1 15/15 (100%) 30
    Pyrexia 0/7 (0%) 0 11/31 (35.5%) 13 1/19 (5.3%) 1 2/15 (13.3%) 3
    Swelling 0/7 (0%) 0 0/31 (0%) 0 0/19 (0%) 0 1/15 (6.7%) 1
    Vaccination site bruising 1/7 (14.3%) 1 0/31 (0%) 0 0/19 (0%) 0 0/15 (0%) 0
    Vaccination site warmth 1/7 (14.3%) 1 0/31 (0%) 0 0/19 (0%) 0 0/15 (0%) 0
    Immune system disorders
    Food allergy 0/7 (0%) 0 0/31 (0%) 0 0/19 (0%) 0 1/15 (6.7%) 1
    Infections and infestations
    Candida infection 0/7 (0%) 0 0/31 (0%) 0 1/19 (5.3%) 1 0/15 (0%) 0
    Gastroenteritis 0/7 (0%) 0 2/31 (6.5%) 3 1/19 (5.3%) 1 0/15 (0%) 0
    Herpes simplex 1/7 (14.3%) 2 0/31 (0%) 0 0/19 (0%) 0 0/15 (0%) 0
    Influenza 0/7 (0%) 0 0/31 (0%) 0 1/19 (5.3%) 1 0/15 (0%) 0
    Nasopharyngitis 0/7 (0%) 0 3/31 (9.7%) 3 4/19 (21.1%) 4 6/15 (40%) 6
    Pharyngitis 0/7 (0%) 0 0/31 (0%) 0 1/19 (5.3%) 1 0/15 (0%) 0
    Rhinitis 0/7 (0%) 0 2/31 (6.5%) 2 0/19 (0%) 0 2/15 (13.3%) 2
    Tonsillitis 0/7 (0%) 0 0/31 (0%) 0 1/19 (5.3%) 1 1/15 (6.7%) 1
    Tooth infection 0/7 (0%) 0 0/31 (0%) 0 0/19 (0%) 0 1/15 (6.7%) 1
    Urinary tract infection 0/7 (0%) 0 0/31 (0%) 0 1/19 (5.3%) 1 0/15 (0%) 0
    Injury, poisoning and procedural complications
    Arthropod bite 0/7 (0%) 0 1/31 (3.2%) 2 0/19 (0%) 0 1/15 (6.7%) 1
    Contusion 1/7 (14.3%) 1 0/31 (0%) 0 0/19 (0%) 0 0/15 (0%) 0
    Joint injury 0/7 (0%) 0 0/31 (0%) 0 1/19 (5.3%) 1 0/15 (0%) 0
    Limb injury 1/7 (14.3%) 1 0/31 (0%) 0 0/19 (0%) 0 0/15 (0%) 0
    Post procedural contusion 0/7 (0%) 0 0/31 (0%) 0 0/19 (0%) 0 1/15 (6.7%) 1
    Sports injury 1/7 (14.3%) 1 0/31 (0%) 0 0/19 (0%) 0 0/15 (0%) 0
    Musculoskeletal and connective tissue disorders
    Arthralgia 0/7 (0%) 0 1/31 (3.2%) 2 0/19 (0%) 0 1/15 (6.7%) 1
    Back pain 0/7 (0%) 0 1/31 (3.2%) 1 2/19 (10.5%) 3 1/15 (6.7%) 1
    Joint stiffness 0/7 (0%) 0 0/31 (0%) 0 1/19 (5.3%) 1 0/15 (0%) 0
    Musculoskeletal stiffness 0/7 (0%) 0 0/31 (0%) 0 0/19 (0%) 0 1/15 (6.7%) 2
    Myalgia 1/7 (14.3%) 1 1/31 (3.2%) 1 2/19 (10.5%) 3 1/15 (6.7%) 1
    Neck pain 0/7 (0%) 0 0/31 (0%) 0 1/19 (5.3%) 1 0/15 (0%) 0
    Pain in extremity 0/7 (0%) 0 0/31 (0%) 0 1/19 (5.3%) 1 0/15 (0%) 0
    Nervous system disorders
    Aphonia 0/7 (0%) 0 0/31 (0%) 0 0/19 (0%) 0 1/15 (6.7%) 1
    Headache 6/7 (85.7%) 13 18/31 (58.1%) 35 11/19 (57.9%) 23 12/15 (80%) 24
    Lethargy 0/7 (0%) 0 0/31 (0%) 0 1/19 (5.3%) 1 0/15 (0%) 0
    Migraine 0/7 (0%) 0 1/31 (3.2%) 2 1/19 (5.3%) 1 0/15 (0%) 0
    Sinus headache 0/7 (0%) 0 0/31 (0%) 0 0/19 (0%) 0 1/15 (6.7%) 1
    Psychiatric disorders
    Insomnia 0/7 (0%) 0 0/31 (0%) 0 1/19 (5.3%) 1 0/15 (0%) 0
    Respiratory, thoracic and mediastinal disorders
    Cough 1/7 (14.3%) 1 2/31 (6.5%) 2 4/19 (21.1%) 4 4/15 (26.7%) 4
    Epistaxis 0/7 (0%) 0 0/31 (0%) 0 0/19 (0%) 0 1/15 (6.7%) 1
    Nasal congestion 0/7 (0%) 0 0/31 (0%) 0 1/19 (5.3%) 1 0/15 (0%) 0
    Nasal obstruction 0/7 (0%) 0 2/31 (6.5%) 3 0/19 (0%) 0 1/15 (6.7%) 1
    Oropharyngeal pain 3/7 (42.9%) 3 5/31 (16.1%) 10 3/19 (15.8%) 4 5/15 (33.3%) 6
    Rhinorrhoea 1/7 (14.3%) 1 1/31 (3.2%) 2 2/19 (10.5%) 2 3/15 (20%) 4
    Skin and subcutaneous tissue disorders
    Dermatitis contact 0/7 (0%) 0 0/31 (0%) 0 0/19 (0%) 0 1/15 (6.7%) 1
    Eczema 0/7 (0%) 0 0/31 (0%) 0 0/19 (0%) 0 1/15 (6.7%) 2
    Erythema 0/7 (0%) 0 0/31 (0%) 0 0/19 (0%) 0 3/15 (20%) 3

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    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

    Name/Title GSK Response Center
    Organization GlaxoSmithKline
    Phone 866-435-7343
    Email
    Responsible Party:
    GlaxoSmithKline
    ClinicalTrials.gov Identifier:
    NCT02491463
    Other Study ID Numbers:
    • 201974
    First Posted:
    Jul 8, 2015
    Last Update Posted:
    Aug 20, 2018
    Last Verified:
    May 1, 2018