Respiratory Disorders
Conditions
Keywords
Safety, Immunogenicity, Reactogenicity
Brief summary
The purpose of this study is to assess the safety, reactogenicity and immunogenicity of the investigational GSK Biologicals' GSK3277511A vaccine in adults
Interventions
BIOLOGICALFormulation 1 (plain): NTHi/Mcat vaccine GSK3277513A
2 doses at Day 0 and Day 60, Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule
BIOLOGICALFormulation 2 (adjuvanted): NTHi/Mcat vaccine GSK3277513A
2 doses at Day 0 and Day 60, Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule
BIOLOGICALFormulation 3 (adjuvanted): NTHi/Mcat vaccine GSK3339036A
2 doses at Day 0 and Day 60, Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule
DRUGPlacebo
2 doses at Day 0 and Day 60, Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
applicable for both Step 1 ((healthy volunteers) and Step 2 (\[ex-\]smokers) * 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. * Female subjects of non-childbearing potential may be enrolled in the study. * Non-childbearing potential is defined as pre-menarche, hysterectomy, ovariectomy or post-menopause. * Female subjects of childbearing potential may be enrolled in the study, if the subject: * has practiced adequate contraception for 30 days prior to vaccination, and * has a negative pregnancy test on the day of vacci-nation, and * has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series. only applicable for Step 1 * A male or female between, and including, 18 and 40 years of age at the time of the Screening Visit. * Healthy subjects without acute or chronic, clinically sig-nificant pulmonary, cardiovascular, hepatic or renal func-tional abnormality, as determined by physical examination or laboratory screening tests. only applicable for Step 2 * A male or female between, and including, 50 and 70 years of age at the time of the screening visit. * Subjects without medical history, clinical finding or laboratory finding which in the opinion of the investigator could pose a safety concern or interfere with the protocol. * Current or former smoker with a cigarette smoking history ≥ 10 pack-years.
Exclusion criteria
applicable for both Step 1 and Step 2 * Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period. * 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. * Previous vaccination with any vaccine containing NTHi and/or Mcat antigens. * Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs within 6 months prior to the first vaccine dose. For corticosteroids, this will mean prednisone ≥20 mg/day, or equivalent. Only topical steroids are allowed. * Administration of long-acting immune-modifying drugs at any time during the study period. * Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period. * Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. * History of or current autoimmune disease. * Acute disease and/or fever at the time of enrolment. * Fever is defined as temperature \>= 37.5°C for oral or axillary route. The preferred route for recording temperature in this study will be oral. * Subjects with a minor illness without fever may, be enrolled at the discretion of the investigator. * Current alcoholism and/or drug abuse. * History of or current condition preventing intramuscular injection as bleeding or coagulation disorder. * Malignancies within previous 5 years or lymphoproliferative disorders. * Pregnant or lactating female. * Female planning to become pregnant or planning to discontinue contraceptive precautions. * Any other condition that the investigator judges may interfere with study findings. only applicable for Step 1 * 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, with the exception of any influenza vaccine which may be administered ≥ 15 days preceding or following any study vaccine dose. * Laboratory evidence of clinically significant haematological (complete blood cell count \[RBC, WBC\], WBC differential count \[lymphocytes, neutrophils and eosinophils\], platelets count or haemoglobin level) and biochemical (alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\] or creatinine) abnormalities as per the opinion of the investigator. only applicable for Step 2 * 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, with the exception of any influenza or pneumococcal licensed vaccine which may be admin-istered ≥ 15 days preceding or following any study vaccine dose. * Post-bronchodilator FEV1 \< 80% of predicted normal value. * Diagnosed with a respiratory disorder (e.g. asthma, COPD, sarcoidosis, tuberculosis, bronchiectasis, lung fi-brosis, pulmonary embolism, pneumothorax, or physi-cian confirmed lung cancer). Please note that subjects with mild pulmonary obstruction (i.e. FEV1/ FVC ratio \< 0.7 with FEV1 ≥ 80% of normal predicted values \[GOLD grade 1\]) can be enrolled. * Has contraindication for spirometry testing (such as recent eye surgery, recent thoracic or abdominal surgery procedures, unstable cardiovascular status, recent myo-cardial infection or pulmonary embolism). * Laboratory evidence of clinically significant haematological (complete blood cell count \[RBC, WBC\], WBC differential count \[lymphocytes, neutrophils and eosinophils\], platelets count or haemoglobin level) and biochemical (ALT, AST or creatinine) abnormalities. * Has significant disease, in the opinion of the investigator, likely to interfere with the study and/or likely to cause death within the study duration.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Any Potential Immune-mediated Diseases (pIMDs) | From first vaccination up to study conclusion (Day 0 to Day 420) | Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology. |
| Number of Subjects With Any Solicited General Adverse Events (AEs) | During a 7-day follow-up period (Day 0 to Day 6) after first dose. | Assessed solicited general symptoms are fatigue, gastrointestinal symptoms, headache, myalgia, fever \[defined as oral temperature equal to or above 37.5 degrees Celsius (°C)\]. |
| Number of Subjects With Any Unsolicited Adverse Events (AEs). | During a 30-day follow-up period (Day 0 to Day 29) after first dose. | Assessed unsolicited AEs cover 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 outside the specified period of follow-up for solicited symptoms. Any is defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. |
| Number of Subjects With Any Unsolicited Adverse Events (AEs) | During a 30-day follow-up period (Day 60 to Day 89) after second dose | Assessed unsolicited AEs cover 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 outside the specified period of follow-up for solicited symptoms. Any is defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. |
| Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities, After Vaccination. | At Day 7, post-dose 1. | Assessed haematological parameters are complete blood cell count: Erythrocytes (RBC \[red blood cells\]), Leukocytes (WBC \[white blood cells\]), differential count (basophils, eosinophils, lymphocytes, monocytes, neutrophils), platelets count, and hemoglobin level below or above the normal laboratory ranges tabulated by time point. Assessed biochemical parameters are alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\] or creatinine below or above the normal laboratory ranges tabulated by time point. |
| Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | At Day 60, post-dose 1. | Assessed haematological parameters are complete blood cell count: Erythrocytes (RBC \[red blood cells\]), Leukocytes (WBC \[white blood cells\]), differential count (basophils, eosinophils, lymphocytes, monocytes, neutrophils), platelets count, and hemoglobin level below or above the normal laboratory ranges tabulated by time point. Assessed biochemical parameters are alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\] or creatinine below or above the normal laboratory ranges tabulated by time point. |
| Number of Subjects With Any Serious Adverse Events (SAEs) | From first vaccination up to study conclusion (Day 0 to Day 420) | Assessed SAEs include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. |
| Number of Subjects With Any Solicited Local Adverse Events (AEs) | During a 7-day follow-up period (Day 0 to Day 6) after first dose. | Assessed solicited local symptoms are pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Concentration of Antibodies Against the NTHi-Mcat Anti-PE (Protein E of Haemophilus Influenzae) Vaccine Component | At Day 0 (pre-dose 1); at Day 30 and Day 60 (post-dose 1); at Day 90, Day 210 and Day 420 (post-dose2). | Antibody concentrations are measured by enzyme-linked immunosorbent assay (ELISA) and expressed as geometric mean concentrations (GMCs) in ELISA units per millilitre (EL.U/mL). The cut-off of the assay is 25 EL.U/mL for anti-PE antibodies. |
| Concentration of Antibodies Against the NTHi-Mcat Anti-PilA (Type IV Pili Subunit of Non-typeable Haemophilus Influenzae) Vaccine Component | At Day 0 (pre-dose 1); at Day 30 and Day 60 (post-dose 1); at Day 90 (post-dose2). | Antibody concentrations are measured by enzyme-linked immunosorbent assay (ELISA) and expressed as geometric mean concentrations (GMCs) in ELISA units per millilitre (EL.U/mL). The cut-off of the assay is 7 EL.U/mL for anti-PilA antibodies. |
| Concentration of Antibodies Against the NTHi-Mcat Anti-UspA2 (Ubiquitous Surface Protein A2 of Moraxella Catarrhalis) Vaccine Component | At Day 0 (pre-dose 1); at Day 30 and Day 60 (post-dose 1); at Day 90, Day 210 and Day 420 (post-dose2). | Antibody concentrations are measured by enzyme-linked immunosorbent assay (ELISA) and expressed as geometric mean concentrations (GMCs) in ELISA units per millilitre (EL.U/mL). The cut-off of the assay is 38 EL.U/mL for anti-UspA2 antibodies. |
| Frequency of Specific Cluster of Differentiation (CD)4+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response | At Day 0 (pre-dose 1); at Day 60 (post-dose 1); at Day 90, Day 210 and Day 420 (post-dose2). | Frequency of specific CD4+ T-cells are measured by flow cytometry intracellular cytokine staining (ICS) expressing two or more markers (such as Interleukin \[IL\]-2, IL-13, IL-17, Interferon gamma \[FN-γ\], Tumour necrosis factor alpha \[TNF-α\] and CD40L). The frequency of specific CD4+ T-cells are summarised \[descriptive statistics: Mean and standard deviation (SD)\] against each antigen (PD, PE, PilA and UspA2), by group in Step 2 at each time point during which blood samples are collected for CMI. |
| Frequency of Specific CD8+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response | At Day 0 (pre-dose 1); at Day 60 (post-dose 1); at Day 90, Day 210 and Day 420 (post-dose2). | Frequency of specific CD8+ T-cells are measured by flow cytometry intracellular cytokine staining (ICS) expressing two or more markers (such as IL-2, IL-13, IL-17, IFN-γ, TNF-α and CD40L). The frequency of specific CD8+ T-cells are summarised \[descriptive statistics: Mean and standard deviation (SD)\] against each antigen (PD, PE, PilA and UspA2), by group in Step 2 at each time point during which blood samples are collected for CMI. |
| Concentration of Antibodies Against the NTHi-Mcat Anti-PD (Protein D of Haemophilus Influenzae) Vaccine Component | At Day 0 (pre-dose 1); at Day 30 and Day 60 (post-dose 1); at Day 90, Day 210 and Day 420 (post-dose2). | Antibody concentrations are measured by enzyme-linked immunosorbent assay (ELISA) and expressed as geometric mean concentrations (GMCs) in ELISA units per millilitre (EL.U/mL). The cut-off of the assay is 153 EL.U/mL for anti-PD antibodies. |
Countries
Belgium
Participant flow
Recruitment details
120 subjects were enrolled in the study. All subjects received at least one dose of the vaccine.
Pre-assignment details
For each subject, the study lasted approximately 15 months, from screening (Pre-Day 0) to study end (Day 420). Vaccination schedules: 0, 2 months (i.e. at Day 0 and Day 60).
Participants by arm
| Arm | Count |
|---|---|
| GSK3277513A F1 Group Subjects, 18 - 40 years, receiving two doses of the non adjuvanted GSK Biologicals' NTHi Mcat investigational vaccine (GSK3277513A ) containing formulation 1 (F1) of PD, PE-PilA and UspA2 during Step 1 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed. | 15 |
| GSK3277513A F2 Group Subjects, 50 - 70 years, receiving two doses of the GSK Biologicals' NTHi-Mcat investigational vaccine(GSK3277513A) containing formulation 2 (F2) (adjuvanted) of PD, PE-PilA and UspA2 during Step 2 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed. | 31 |
| GSK3277513A F3 Group Subjects, 50 - 70 years, receiving two doses of the GSK Biologicals' NTHi-Mcat investigational vaccine(GSK3277513A) containing formulation 3 (F3) (adjuvanted) of PD, PE-PilA and UspA2 during Step 2 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed. | 30 |
| PLACEBO Group Subjects, 18 - 40 years, receiving two doses of placebo (saline solution) during Step 1 of the study and subjects, 50 - 70 years, receiving two doses of placebo (saline solution) during Step 2 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed. | 44 |
| Total | 120 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | GSK3277513A F1 Group | GSK3277513A F2 Group | GSK3277513A F3 Group | PLACEBO Group | Total |
|---|---|---|---|---|---|
| Age, Continuous | 29.1 Years STANDARD_DEVIATION 5.91 | 58.9 Years STANDARD_DEVIATION 6.49 | 58.5 Years STANDARD_DEVIATION 5.82 | 47.2 Years STANDARD_DEVIATION 16.72 | 50.8 Years STANDARD_DEVIATION 14.83 |
| Race/Ethnicity, Customized White - Caucasian / European Heritage | 15 Participants | 31 Participants | 30 Participants | 44 Participants | 120 Participants |
| Sex: Female, Male Female | 11 Participants | 13 Participants | 13 Participants | 21 Participants | 58 Participants |
| Sex: Female, Male Male | 4 Participants | 18 Participants | 17 Participants | 23 Participants | 62 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 31 | 0 / 30 | 0 / 44 |
| other Total, other adverse events | 11 / 15 | 28 / 31 | 29 / 30 | 32 / 44 |
| serious Total, serious adverse events | 1 / 15 | 0 / 31 | 1 / 30 | 2 / 44 |
Outcome results
Primary
Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination
Assessed haematological parameters are complete blood cell count: Erythrocytes (RBC \[red blood cells\]), Leukocytes (WBC \[white blood cells\]), differential count (basophils, eosinophils, lymphocytes, monocytes, neutrophils), platelets count, and hemoglobin level below or above the normal laboratory ranges tabulated by time point. Assessed biochemical parameters are alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\] or creatinine below or above the normal laboratory ranges tabulated by time point.
Time frame: At Day 420, post-dose 2.
Population: Analysis was performed on the total vaccinated cohort which included all subjects with at least one vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK3277513A F1 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Basophils above | 0 Participants |
| GSK3277513A F1 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Platelets below | 0 Participants |
| GSK3277513A F1 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Hemoglobin below | 0 Participants |
| GSK3277513A F1 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Neutrophils above | 0 Participants |
| GSK3277513A F1 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Creatinine above | 0 Participants |
| GSK3277513A F1 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | AST below | 0 Participants |
| GSK3277513A F1 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Hemoglobin above | 0 Participants |
| GSK3277513A F1 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Monocytes below | 3 Participants |
| GSK3277513A F1 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Eosinophils above | 0 Participants |
| GSK3277513A F1 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Basophils below | 0 Participants |
| GSK3277513A F1 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Leucocytes below | 0 Participants |
| GSK3277513A F1 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Erythrocytes below | 0 Participants |
| GSK3277513A F1 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Creatinine below | 1 Participants |
| GSK3277513A F1 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | ALT above | 0 Participants |
| GSK3277513A F1 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Leucocytes above | 0 Participants |
| GSK3277513A F1 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Neutrophils below | 0 Participants |
| GSK3277513A F1 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Platelets above | 0 Participants |
| GSK3277513A F1 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | AST above | 0 Participants |
| GSK3277513A F1 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Lymphocytes below | 0 Participants |
| GSK3277513A F1 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Erythrocytes above | 0 Participants |
| GSK3277513A F1 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Eosinophils below | 4 Participants |
| GSK3277513A F1 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | ALT below | 0 Participants |
| GSK3277513A F1 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Lymphocytes above | 0 Participants |
| GSK3277513A F1 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Monocytes above | 0 Participants |
| GSK3277513A F2 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Lymphocytes above | 0 Participants |
| GSK3277513A F2 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Platelets above | 0 Participants |
| GSK3277513A F2 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Monocytes below | 0 Participants |
| GSK3277513A F2 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Monocytes above | 0 Participants |
| GSK3277513A F2 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Platelets below | 0 Participants |
| GSK3277513A F2 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Neutrophils below | 1 Participants |
| GSK3277513A F2 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Eosinophils above | 1 Participants |
| GSK3277513A F2 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Neutrophils above | 3 Participants |
| GSK3277513A F2 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Creatinine below | 1 Participants |
| GSK3277513A F2 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | AST above | 1 Participants |
| GSK3277513A F2 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Erythrocytes below | 0 Participants |
| GSK3277513A F2 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Basophils above | 0 Participants |
| GSK3277513A F2 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Erythrocytes above | 1 Participants |
| GSK3277513A F2 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | AST below | 0 Participants |
| GSK3277513A F2 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Hemoglobin below | 1 Participants |
| GSK3277513A F2 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Hemoglobin above | 1 Participants |
| GSK3277513A F2 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Creatinine above | 1 Participants |
| GSK3277513A F2 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | ALT above | 1 Participants |
| GSK3277513A F2 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Leucocytes below | 0 Participants |
| GSK3277513A F2 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Leucocytes above | 3 Participants |
| GSK3277513A F2 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Basophils below | 0 Participants |
| GSK3277513A F2 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | ALT below | 0 Participants |
| GSK3277513A F2 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Lymphocytes below | 1 Participants |
| GSK3277513A F2 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Eosinophils below | 0 Participants |
| GSK3277513A F3 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Neutrophils below | 1 Participants |
| GSK3277513A F3 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Basophils above | 0 Participants |
| GSK3277513A F3 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Creatinine below | 2 Participants |
| GSK3277513A F3 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Creatinine above | 0 Participants |
| GSK3277513A F3 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Eosinophils above | 0 Participants |
| GSK3277513A F3 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Erythrocytes below | 1 Participants |
| GSK3277513A F3 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Erythrocytes above | 1 Participants |
| GSK3277513A F3 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Hemoglobin below | 0 Participants |
| GSK3277513A F3 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Hemoglobin above | 0 Participants |
| GSK3277513A F3 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Leucocytes below | 0 Participants |
| GSK3277513A F3 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Leucocytes above | 1 Participants |
| GSK3277513A F3 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Lymphocytes below | 0 Participants |
| GSK3277513A F3 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Lymphocytes above | 0 Participants |
| GSK3277513A F3 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Monocytes below | 0 Participants |
| GSK3277513A F3 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Monocytes above | 0 Participants |
| GSK3277513A F3 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Eosinophils below | 1 Participants |
| GSK3277513A F3 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Neutrophils above | 1 Participants |
| GSK3277513A F3 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Platelets below | 1 Participants |
| GSK3277513A F3 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Platelets above | 0 Participants |
| GSK3277513A F3 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | ALT below | 0 Participants |
| GSK3277513A F3 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | ALT above | 0 Participants |
| GSK3277513A F3 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | AST below | 0 Participants |
| GSK3277513A F3 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | AST above | 0 Participants |
| GSK3277513A F3 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Basophils below | 0 Participants |
| PLACEBO Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Eosinophils below | 2 Participants |
| PLACEBO Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Platelets above | 0 Participants |
| PLACEBO Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Lymphocytes below | 0 Participants |
| PLACEBO Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Leucocytes above | 1 Participants |
| PLACEBO Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Creatinine above | 0 Participants |
| PLACEBO Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | ALT below | 0 Participants |
| PLACEBO Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Leucocytes below | 0 Participants |
| PLACEBO Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Hemoglobin above | 1 Participants |
| PLACEBO Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Basophils above | 0 Participants |
| PLACEBO Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | ALT above | 1 Participants |
| PLACEBO Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Hemoglobin below | 2 Participants |
| PLACEBO Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Erythrocytes above | 0 Participants |
| PLACEBO Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Basophils below | 0 Participants |
| PLACEBO Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | AST below | 0 Participants |
| PLACEBO Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Erythrocytes below | 2 Participants |
| PLACEBO Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Eosinophils above | 1 Participants |
| PLACEBO Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Creatinine below | 3 Participants |
| PLACEBO Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Neutrophils above | 1 Participants |
| PLACEBO Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Neutrophils below | 1 Participants |
| PLACEBO Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Monocytes above | 1 Participants |
| PLACEBO Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | AST above | 0 Participants |
| PLACEBO Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Platelets below | 0 Participants |
| PLACEBO Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Monocytes below | 1 Participants |
| PLACEBO Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Lymphocytes above | 0 Participants |
Primary
Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination
Assessed haematological parameters are complete blood cell count: Erythrocytes (RBC \[red blood cells\]), Leukocytes (WBC \[white blood cells\]), differential count (basophils, eosinophils, lymphocytes, monocytes, neutrophils), platelets count, and hemoglobin level below or above the normal laboratory ranges tabulated by time point. Assessed biochemical parameters are alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\] or creatinine below or above the normal laboratory ranges tabulated by time point.
Time frame: At Day 210, post-dose 2.
Population: Analysis was performed on the total vaccinated cohort which included all subjects with at least one vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK3277513A F1 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | AST below | 0 Participants |
| GSK3277513A F1 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Lymphocytes above | 0 Participants |
| GSK3277513A F1 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Basophils above | 0 Participants |
| GSK3277513A F1 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Lymphocytes below | 0 Participants |
| GSK3277513A F1 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Creatinine below | 0 Participants |
| GSK3277513A F1 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Leucocytes above | 0 Participants |
| GSK3277513A F1 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Hemoglobin above | 0 Participants |
| GSK3277513A F1 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Neutrophils below | 0 Participants |
| GSK3277513A F1 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Creatinine above | 1 Participants |
| GSK3277513A F1 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Platelets above | 0 Participants |
| GSK3277513A F1 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Hemoglobin below | 2 Participants |
| GSK3277513A F1 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Eosinophils below | 4 Participants |
| GSK3277513A F1 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | AST above | 0 Participants |
| GSK3277513A F1 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | ALT above | 0 Participants |
| GSK3277513A F1 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Monocytes above | 0 Participants |
| GSK3277513A F1 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Eosinophils above | 0 Participants |
| GSK3277513A F1 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Platelets below | 0 Participants |
| GSK3277513A F1 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | ALT below | 0 Participants |
| GSK3277513A F1 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Neutrophils above | 0 Participants |
| GSK3277513A F1 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Erythrocytes below | 1 Participants |
| GSK3277513A F1 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Basophils below | 0 Participants |
| GSK3277513A F1 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Leucocytes below | 0 Participants |
| GSK3277513A F1 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Monocytes below | 1 Participants |
| GSK3277513A F1 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Erythrocytes above | 0 Participants |
| GSK3277513A F2 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Platelets above | 0 Participants |
| GSK3277513A F2 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Lymphocytes above | 0 Participants |
| GSK3277513A F2 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Hemoglobin below | 2 Participants |
| GSK3277513A F2 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Hemoglobin above | 0 Participants |
| GSK3277513A F2 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Lymphocytes below | 2 Participants |
| GSK3277513A F2 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Leucocytes below | 0 Participants |
| GSK3277513A F2 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | AST below | 0 Participants |
| GSK3277513A F2 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Leucocytes above | 2 Participants |
| GSK3277513A F2 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Neutrophils above | 2 Participants |
| GSK3277513A F2 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | AST above | 1 Participants |
| GSK3277513A F2 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Basophils below | 0 Participants |
| GSK3277513A F2 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | ALT below | 0 Participants |
| GSK3277513A F2 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Neutrophils below | 0 Participants |
| GSK3277513A F2 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Basophils above | 0 Participants |
| GSK3277513A F2 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Creatinine below | 2 Participants |
| GSK3277513A F2 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Erythrocytes above | 1 Participants |
| GSK3277513A F2 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Platelets below | 0 Participants |
| GSK3277513A F2 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Monocytes above | 0 Participants |
| GSK3277513A F2 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Eosinophils below | 2 Participants |
| GSK3277513A F2 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Eosinophils above | 0 Participants |
| GSK3277513A F2 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | ALT above | 2 Participants |
| GSK3277513A F2 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Monocytes below | 2 Participants |
| GSK3277513A F2 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Erythrocytes below | 1 Participants |
| GSK3277513A F2 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Creatinine above | 1 Participants |
| GSK3277513A F3 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Basophils below | 0 Participants |
| GSK3277513A F3 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Hemoglobin above | 0 Participants |
| GSK3277513A F3 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Monocytes above | 0 Participants |
| GSK3277513A F3 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | ALT below | 0 Participants |
| GSK3277513A F3 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | ALT above | 1 Participants |
| GSK3277513A F3 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | AST below | 0 Participants |
| GSK3277513A F3 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | AST above | 1 Participants |
| GSK3277513A F3 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Basophils above | 0 Participants |
| GSK3277513A F3 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Creatinine below | 2 Participants |
| GSK3277513A F3 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Creatinine above | 0 Participants |
| GSK3277513A F3 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Eosinophils below | 3 Participants |
| GSK3277513A F3 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Eosinophils above | 1 Participants |
| GSK3277513A F3 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Erythrocytes below | 1 Participants |
| GSK3277513A F3 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Erythrocytes above | 1 Participants |
| GSK3277513A F3 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Hemoglobin below | 1 Participants |
| GSK3277513A F3 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Leucocytes below | 0 Participants |
| GSK3277513A F3 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Leucocytes above | 0 Participants |
| GSK3277513A F3 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Lymphocytes below | 0 Participants |
| GSK3277513A F3 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Lymphocytes above | 0 Participants |
| GSK3277513A F3 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Monocytes below | 1 Participants |
| GSK3277513A F3 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Neutrophils below | 0 Participants |
| GSK3277513A F3 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Neutrophils above | 1 Participants |
| GSK3277513A F3 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Platelets below | 1 Participants |
| GSK3277513A F3 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Platelets above | 0 Participants |
| PLACEBO Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Erythrocytes above | 0 Participants |
| PLACEBO Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Platelets above | 0 Participants |
| PLACEBO Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Erythrocytes below | 1 Participants |
| PLACEBO Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Eosinophils above | 0 Participants |
| PLACEBO Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Platelets below | 0 Participants |
| PLACEBO Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Monocytes below | 2 Participants |
| PLACEBO Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Eosinophils below | 4 Participants |
| PLACEBO Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Creatinine above | 1 Participants |
| PLACEBO Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Creatinine below | 2 Participants |
| PLACEBO Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Basophils below | 0 Participants |
| PLACEBO Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Monocytes above | 0 Participants |
| PLACEBO Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Neutrophils below | 0 Participants |
| PLACEBO Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | AST above | 0 Participants |
| PLACEBO Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | AST below | 0 Participants |
| PLACEBO Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Basophils above | 0 Participants |
| PLACEBO Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Neutrophils above | 1 Participants |
| PLACEBO Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | ALT above | 1 Participants |
| PLACEBO Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Leucocytes above | 1 Participants |
| PLACEBO Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Leucocytes below | 0 Participants |
| PLACEBO Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Hemoglobin above | 0 Participants |
| PLACEBO Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | ALT below | 0 Participants |
| PLACEBO Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Lymphocytes below | 0 Participants |
| PLACEBO Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Hemoglobin below | 6 Participants |
| PLACEBO Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Lymphocytes above | 1 Participants |
Primary
Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination
Assessed haematological parameters are complete blood cell count: Erythrocytes (RBC \[red blood cells\]), Leukocytes (WBC \[white blood cells\]), differential count (basophils, eosinophils, lymphocytes, monocytes, neutrophils), platelets count, and hemoglobin level below or above the normal laboratory ranges tabulated by time point. Assessed biochemical parameters are alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\] or creatinine below or above the normal laboratory ranges tabulated by time point.
Time frame: At Day 67, post-dose 2.
Population: Analysis was performed on the total vaccinated cohort which included all subjects with at least one vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK3277513A F1 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Basophils below | 0 Participants |
| GSK3277513A F1 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Leucocytes above | 0 Participants |
| GSK3277513A F1 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Hemoglobin below | 1 Participants |
| GSK3277513A F1 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Neutrophils below | 0 Participants |
| GSK3277513A F1 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Basophils above | 0 Participants |
| GSK3277513A F1 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | AST below | 0 Participants |
| GSK3277513A F1 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Creatinine below | 1 Participants |
| GSK3277513A F1 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Lymphocytes below | 0 Participants |
| GSK3277513A F1 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Erythrocytes above | 0 Participants |
| GSK3277513A F1 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Monocytes above | 0 Participants |
| GSK3277513A F1 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Creatinine above | 1 Participants |
| GSK3277513A F1 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Leucocytes below | 0 Participants |
| GSK3277513A F1 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Platelets above | 0 Participants |
| GSK3277513A F1 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | AST above | 0 Participants |
| GSK3277513A F1 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Eosinophils below | 1 Participants |
| GSK3277513A F1 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Hemoglobin above | 0 Participants |
| GSK3277513A F1 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Platelets below | 0 Participants |
| GSK3277513A F1 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Monocytes below | 0 Participants |
| GSK3277513A F1 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Eosinophils above | 0 Participants |
| GSK3277513A F1 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | ALT above | 0 Participants |
| GSK3277513A F1 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | ALT below | 0 Participants |
| GSK3277513A F1 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Neutrophils above | 0 Participants |
| GSK3277513A F1 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Erythrocytes below | 0 Participants |
| GSK3277513A F1 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Lymphocytes above | 0 Participants |
| GSK3277513A F2 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Erythrocytes below | 1 Participants |
| GSK3277513A F2 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Lymphocytes below | 0 Participants |
| GSK3277513A F2 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | ALT below | 0 Participants |
| GSK3277513A F2 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Hemoglobin below | 3 Participants |
| GSK3277513A F2 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Basophils above | 0 Participants |
| GSK3277513A F2 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Leucocytes above | 4 Participants |
| GSK3277513A F2 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Hemoglobin above | 0 Participants |
| GSK3277513A F2 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Platelets below | 0 Participants |
| GSK3277513A F2 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Leucocytes below | 0 Participants |
| GSK3277513A F2 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | ALT above | 1 Participants |
| GSK3277513A F2 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | AST below | 0 Participants |
| GSK3277513A F2 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Neutrophils above | 3 Participants |
| GSK3277513A F2 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | AST above | 0 Participants |
| GSK3277513A F2 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Erythrocytes above | 1 Participants |
| GSK3277513A F2 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Basophils below | 0 Participants |
| GSK3277513A F2 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Platelets above | 0 Participants |
| GSK3277513A F2 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Monocytes above | 0 Participants |
| GSK3277513A F2 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Creatinine below | 1 Participants |
| GSK3277513A F2 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Neutrophils below | 1 Participants |
| GSK3277513A F2 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Creatinine above | 2 Participants |
| GSK3277513A F2 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Monocytes below | 0 Participants |
| GSK3277513A F2 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Eosinophils below | 0 Participants |
| GSK3277513A F2 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Eosinophils above | 0 Participants |
| GSK3277513A F2 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Lymphocytes above | 1 Participants |
| GSK3277513A F3 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Erythrocytes below | 1 Participants |
| GSK3277513A F3 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Basophils above | 0 Participants |
| GSK3277513A F3 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | ALT below | 0 Participants |
| GSK3277513A F3 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | ALT above | 1 Participants |
| GSK3277513A F3 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | AST below | 0 Participants |
| GSK3277513A F3 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | AST above | 0 Participants |
| GSK3277513A F3 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Basophils below | 0 Participants |
| GSK3277513A F3 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Creatinine below | 1 Participants |
| GSK3277513A F3 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Creatinine above | 0 Participants |
| GSK3277513A F3 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Eosinophils below | 1 Participants |
| GSK3277513A F3 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Eosinophils above | 1 Participants |
| GSK3277513A F3 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Erythrocytes above | 1 Participants |
| GSK3277513A F3 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Hemoglobin below | 1 Participants |
| GSK3277513A F3 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Hemoglobin above | 0 Participants |
| GSK3277513A F3 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Leucocytes below | 0 Participants |
| GSK3277513A F3 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Leucocytes above | 1 Participants |
| GSK3277513A F3 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Lymphocytes below | 1 Participants |
| GSK3277513A F3 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Lymphocytes above | 0 Participants |
| GSK3277513A F3 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Monocytes below | 0 Participants |
| GSK3277513A F3 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Monocytes above | 1 Participants |
| GSK3277513A F3 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Neutrophils below | 0 Participants |
| GSK3277513A F3 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Neutrophils above | 1 Participants |
| GSK3277513A F3 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Platelets below | 1 Participants |
| GSK3277513A F3 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Platelets above | 0 Participants |
| PLACEBO Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Eosinophils above | 1 Participants |
| PLACEBO Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | ALT below | 0 Participants |
| PLACEBO Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Lymphocytes above | 0 Participants |
| PLACEBO Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Eosinophils below | 2 Participants |
| PLACEBO Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Creatinine above | 1 Participants |
| PLACEBO Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Hemoglobin above | 0 Participants |
| PLACEBO Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Monocytes below | 0 Participants |
| PLACEBO Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Creatinine below | 1 Participants |
| PLACEBO Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Basophils above | 0 Participants |
| PLACEBO Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Platelets below | 0 Participants |
| PLACEBO Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Monocytes above | 0 Participants |
| PLACEBO Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Basophils below | 0 Participants |
| PLACEBO Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Neutrophils above | 1 Participants |
| PLACEBO Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Neutrophils below | 0 Participants |
| PLACEBO Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | AST above | 2 Participants |
| PLACEBO Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Leucocytes below | 0 Participants |
| PLACEBO Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Hemoglobin below | 3 Participants |
| PLACEBO Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | AST below | 0 Participants |
| PLACEBO Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Leucocytes above | 1 Participants |
| PLACEBO Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Erythrocytes above | 1 Participants |
| PLACEBO Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Erythrocytes below | 2 Participants |
| PLACEBO Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Platelets above | 0 Participants |
| PLACEBO Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Lymphocytes below | 0 Participants |
| PLACEBO Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | ALT above | 1 Participants |
Primary
Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination
Assessed haematological parameters are complete blood cell count: Erythrocytes (RBC \[red blood cells\]), Leukocytes (WBC \[white blood cells\]), differential count (basophils, eosinophils, lymphocytes, monocytes, neutrophils), platelets count, and hemoglobin level below or above the normal laboratory ranges tabulated by time point. Assessed biochemical parameters are alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\] or creatinine below or above the normal laboratory ranges tabulated by time point.
Time frame: At Day 60, post-dose 1.
Population: Analysis was performed on the total vaccinated cohort which included all subjects with at least one vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK3277513A F1 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Basophils above | 0 Participants |
| GSK3277513A F1 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Hemoglobin above | 0 Participants |
| GSK3277513A F1 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Erythrocytes above | 0 Participants |
| GSK3277513A F1 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Erythrocytes below | 0 Participants |
| GSK3277513A F1 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Creatinine below | 0 Participants |
| GSK3277513A F1 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Eosinophils above | 1 Participants |
| GSK3277513A F1 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | ALT below | 0 Participants |
| GSK3277513A F1 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Creatinine above | 1 Participants |
| GSK3277513A F1 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Neutrophils above | 0 Participants |
| GSK3277513A F1 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Eosinophils below | 5 Participants |
| GSK3277513A F1 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | ALT above | 0 Participants |
| GSK3277513A F1 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Platelets above | 0 Participants |
| GSK3277513A F1 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Neutrophils below | 0 Participants |
| GSK3277513A F1 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Monocytes above | 0 Participants |
| GSK3277513A F1 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Platelets below | 0 Participants |
| GSK3277513A F1 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Monocytes below | 0 Participants |
| GSK3277513A F1 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Lymphocytes above | 0 Participants |
| GSK3277513A F1 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | AST above | 0 Participants |
| GSK3277513A F1 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | AST below | 0 Participants |
| GSK3277513A F1 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Lymphocytes below | 0 Participants |
| GSK3277513A F1 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Leucocytes above | 0 Participants |
| GSK3277513A F1 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Basophils below | 0 Participants |
| GSK3277513A F1 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Leucocytes below | 0 Participants |
| GSK3277513A F1 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Hemoglobin below | 1 Participants |
| GSK3277513A F2 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Eosinophils below | 2 Participants |
| GSK3277513A F2 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | ALT below | 0 Participants |
| GSK3277513A F2 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Basophils below | 0 Participants |
| GSK3277513A F2 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Creatinine below | 1 Participants |
| GSK3277513A F2 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Eosinophils above | 0 Participants |
| GSK3277513A F2 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | ALT above | 1 Participants |
| GSK3277513A F2 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | AST below | 0 Participants |
| GSK3277513A F2 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | AST above | 1 Participants |
| GSK3277513A F2 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Basophils above | 0 Participants |
| GSK3277513A F2 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Creatinine above | 1 Participants |
| GSK3277513A F2 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Erythrocytes below | 0 Participants |
| GSK3277513A F2 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Erythrocytes above | 1 Participants |
| GSK3277513A F2 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Hemoglobin below | 0 Participants |
| GSK3277513A F2 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Hemoglobin above | 1 Participants |
| GSK3277513A F2 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Leucocytes below | 0 Participants |
| GSK3277513A F2 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Leucocytes above | 1 Participants |
| GSK3277513A F2 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Lymphocytes below | 1 Participants |
| GSK3277513A F2 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Lymphocytes above | 0 Participants |
| GSK3277513A F2 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Monocytes below | 0 Participants |
| GSK3277513A F2 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Monocytes above | 0 Participants |
| GSK3277513A F2 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Neutrophils below | 0 Participants |
| GSK3277513A F2 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Neutrophils above | 1 Participants |
| GSK3277513A F2 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Platelets below | 0 Participants |
| GSK3277513A F2 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Platelets above | 0 Participants |
| GSK3277513A F3 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | AST below | 0 Participants |
| GSK3277513A F3 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Platelets below | 1 Participants |
| GSK3277513A F3 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Monocytes below | 1 Participants |
| GSK3277513A F3 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Leucocytes above | 0 Participants |
| GSK3277513A F3 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Basophils below | 0 Participants |
| GSK3277513A F3 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | AST above | 0 Participants |
| GSK3277513A F3 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Monocytes above | 0 Participants |
| GSK3277513A F3 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Neutrophils above | 0 Participants |
| GSK3277513A F3 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | ALT above | 0 Participants |
| GSK3277513A F3 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | ALT below | 0 Participants |
| GSK3277513A F3 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Lymphocytes below | 0 Participants |
| GSK3277513A F3 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Creatinine above | 0 Participants |
| GSK3277513A F3 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Leucocytes below | 1 Participants |
| GSK3277513A F3 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Eosinophils below | 1 Participants |
| GSK3277513A F3 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Hemoglobin above | 1 Participants |
| GSK3277513A F3 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Creatinine below | 3 Participants |
| GSK3277513A F3 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Eosinophils above | 1 Participants |
| GSK3277513A F3 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Platelets above | 0 Participants |
| GSK3277513A F3 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Lymphocytes above | 0 Participants |
| GSK3277513A F3 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Neutrophils below | 0 Participants |
| GSK3277513A F3 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Erythrocytes below | 1 Participants |
| GSK3277513A F3 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Hemoglobin below | 2 Participants |
| GSK3277513A F3 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Basophils above | 0 Participants |
| GSK3277513A F3 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Erythrocytes above | 1 Participants |
| PLACEBO Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Neutrophils below | 0 Participants |
| PLACEBO Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Erythrocytes above | 1 Participants |
| PLACEBO Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Basophils below | 0 Participants |
| PLACEBO Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Leucocytes below | 0 Participants |
| PLACEBO Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Hemoglobin below | 3 Participants |
| PLACEBO Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Platelets above | 0 Participants |
| PLACEBO Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Hemoglobin above | 0 Participants |
| PLACEBO Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | AST above | 1 Participants |
| PLACEBO Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Neutrophils above | 0 Participants |
| PLACEBO Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Leucocytes above | 1 Participants |
| PLACEBO Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | ALT below | 0 Participants |
| PLACEBO Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Lymphocytes below | 0 Participants |
| PLACEBO Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | AST below | 0 Participants |
| PLACEBO Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Lymphocytes above | 0 Participants |
| PLACEBO Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Monocytes below | 0 Participants |
| PLACEBO Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | ALT above | 1 Participants |
| PLACEBO Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Platelets below | 0 Participants |
| PLACEBO Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Monocytes above | 0 Participants |
| PLACEBO Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Creatinine above | 1 Participants |
| PLACEBO Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Creatinine below | 2 Participants |
| PLACEBO Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Eosinophils below | 2 Participants |
| PLACEBO Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Eosinophils above | 0 Participants |
| PLACEBO Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Basophils above | 0 Participants |
| PLACEBO Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination | Erythrocytes below | 1 Participants |
Primary
Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities, After Vaccination.
Assessed haematological parameters are complete blood cell count: Erythrocytes (RBC \[red blood cells\]), Leukocytes (WBC \[white blood cells\]), differential count (basophils, eosinophils, lymphocytes, monocytes, neutrophils), platelets count, and hemoglobin level below or above the normal laboratory ranges tabulated by time point. Assessed biochemical parameters are alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\] or creatinine below or above the normal laboratory ranges tabulated by time point.
Time frame: At Day 7, post-dose 1.
Population: Analysis was performed on the total vaccinated cohort which included all subjects with at least one vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK3277513A F1 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities, After Vaccination. | Hemoglobin below | 0 Participants |
| GSK3277513A F1 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities, After Vaccination. | Erythrocytes above | 0 Participants |
| GSK3277513A F1 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities, After Vaccination. | AST below | 0 Participants |
| GSK3277513A F1 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities, After Vaccination. | Monocytes below | 2 Participants |
| GSK3277513A F1 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities, After Vaccination. | Erythrocytes below | 0 Participants |
| GSK3277513A F1 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities, After Vaccination. | Eosinophils above | 0 Participants |
| GSK3277513A F1 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities, After Vaccination. | Neutrophils above | 0 Participants |
| GSK3277513A F1 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities, After Vaccination. | Eosinophils below | 2 Participants |
| GSK3277513A F1 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities, After Vaccination. | Creatinine above | 1 Participants |
| GSK3277513A F1 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities, After Vaccination. | Basophils above | 0 Participants |
| GSK3277513A F1 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities, After Vaccination. | ALT below | 0 Participants |
| GSK3277513A F1 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities, After Vaccination. | Creatinine below | 0 Participants |
| GSK3277513A F1 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities, After Vaccination. | Leucocytes above | 0 Participants |
| GSK3277513A F1 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities, After Vaccination. | Lymphocytes below | 0 Participants |
| GSK3277513A F1 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities, After Vaccination. | Lymphocytes above | 0 Participants |
| GSK3277513A F1 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities, After Vaccination. | Basophils below | 0 Participants |
| GSK3277513A F1 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities, After Vaccination. | AST above | 0 Participants |
| GSK3277513A F1 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities, After Vaccination. | Platelets above | 0 Participants |
| GSK3277513A F1 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities, After Vaccination. | Neutrophils below | 1 Participants |
| GSK3277513A F1 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities, After Vaccination. | Monocytes above | 1 Participants |
| GSK3277513A F1 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities, After Vaccination. | Leucocytes below | 0 Participants |
| GSK3277513A F1 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities, After Vaccination. | Hemoglobin above | 0 Participants |
| GSK3277513A F1 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities, After Vaccination. | ALT above | 0 Participants |
| GSK3277513A F1 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities, After Vaccination. | Platelets below | 0 Participants |
| GSK3277513A F2 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities, After Vaccination. | Lymphocytes below | 0 Participants |
| GSK3277513A F2 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities, After Vaccination. | Basophils below | 0 Participants |
| GSK3277513A F2 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities, After Vaccination. | Eosinophils above | 0 Participants |
| GSK3277513A F2 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities, After Vaccination. | Erythrocytes above | 2 Participants |
| GSK3277513A F2 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities, After Vaccination. | Lymphocytes above | 0 Participants |
| GSK3277513A F2 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities, After Vaccination. | Platelets below | 0 Participants |
| GSK3277513A F2 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities, After Vaccination. | Platelets above | 0 Participants |
| GSK3277513A F2 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities, After Vaccination. | ALT below | 0 Participants |
| GSK3277513A F2 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities, After Vaccination. | ALT above | 0 Participants |
| GSK3277513A F2 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities, After Vaccination. | AST below | 0 Participants |
| GSK3277513A F2 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities, After Vaccination. | AST above | 0 Participants |
| GSK3277513A F2 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities, After Vaccination. | Basophils above | 0 Participants |
| GSK3277513A F2 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities, After Vaccination. | Creatinine below | 1 Participants |
| GSK3277513A F2 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities, After Vaccination. | Creatinine above | 1 Participants |
| GSK3277513A F2 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities, After Vaccination. | Eosinophils below | 2 Participants |
| GSK3277513A F2 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities, After Vaccination. | Erythrocytes below | 0 Participants |
| GSK3277513A F2 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities, After Vaccination. | Hemoglobin below | 1 Participants |
| GSK3277513A F2 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities, After Vaccination. | Hemoglobin above | 0 Participants |
| GSK3277513A F2 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities, After Vaccination. | Leucocytes below | 1 Participants |
| GSK3277513A F2 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities, After Vaccination. | Leucocytes above | 3 Participants |
| GSK3277513A F2 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities, After Vaccination. | Monocytes below | 1 Participants |
| GSK3277513A F2 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities, After Vaccination. | Monocytes above | 0 Participants |
| GSK3277513A F2 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities, After Vaccination. | Neutrophils below | 0 Participants |
| GSK3277513A F2 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities, After Vaccination. | Neutrophils above | 3 Participants |
| GSK3277513A F3 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities, After Vaccination. | Lymphocytes below | 0 Participants |
| GSK3277513A F3 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities, After Vaccination. | Lymphocytes above | 0 Participants |
| GSK3277513A F3 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities, After Vaccination. | Hemoglobin above | 0 Participants |
| GSK3277513A F3 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities, After Vaccination. | Eosinophils above | 1 Participants |
| GSK3277513A F3 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities, After Vaccination. | Platelets below | 0 Participants |
| GSK3277513A F3 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities, After Vaccination. | Monocytes below | 0 Participants |
| GSK3277513A F3 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities, After Vaccination. | Erythrocytes below | 2 Participants |
| GSK3277513A F3 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities, After Vaccination. | ALT below | 0 Participants |
| GSK3277513A F3 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities, After Vaccination. | Hemoglobin below | 4 Participants |
| GSK3277513A F3 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities, After Vaccination. | Monocytes above | 0 Participants |
| GSK3277513A F3 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities, After Vaccination. | Leucocytes below | 0 Participants |
| GSK3277513A F3 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities, After Vaccination. | Creatinine below | 2 Participants |
| GSK3277513A F3 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities, After Vaccination. | AST below | 0 Participants |
| GSK3277513A F3 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities, After Vaccination. | Basophils above | 0 Participants |
| GSK3277513A F3 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities, After Vaccination. | Platelets above | 0 Participants |
| GSK3277513A F3 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities, After Vaccination. | AST above | 0 Participants |
| GSK3277513A F3 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities, After Vaccination. | Leucocytes above | 1 Participants |
| GSK3277513A F3 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities, After Vaccination. | Neutrophils below | 0 Participants |
| GSK3277513A F3 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities, After Vaccination. | Creatinine above | 0 Participants |
| GSK3277513A F3 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities, After Vaccination. | ALT above | 0 Participants |
| GSK3277513A F3 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities, After Vaccination. | Basophils below | 0 Participants |
| GSK3277513A F3 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities, After Vaccination. | Neutrophils above | 0 Participants |
| GSK3277513A F3 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities, After Vaccination. | Eosinophils below | 0 Participants |
| GSK3277513A F3 Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities, After Vaccination. | Erythrocytes above | 1 Participants |
| PLACEBO Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities, After Vaccination. | Monocytes below | 1 Participants |
| PLACEBO Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities, After Vaccination. | AST above | 1 Participants |
| PLACEBO Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities, After Vaccination. | Erythrocytes below | 3 Participants |
| PLACEBO Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities, After Vaccination. | ALT above | 3 Participants |
| PLACEBO Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities, After Vaccination. | Erythrocytes above | 1 Participants |
| PLACEBO Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities, After Vaccination. | Platelets above | 0 Participants |
| PLACEBO Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities, After Vaccination. | Hemoglobin below | 4 Participants |
| PLACEBO Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities, After Vaccination. | ALT below | 0 Participants |
| PLACEBO Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities, After Vaccination. | Hemoglobin above | 0 Participants |
| PLACEBO Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities, After Vaccination. | Neutrophils above | 1 Participants |
| PLACEBO Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities, After Vaccination. | Leucocytes below | 0 Participants |
| PLACEBO Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities, After Vaccination. | Leucocytes above | 1 Participants |
| PLACEBO Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities, After Vaccination. | Lymphocytes below | 0 Participants |
| PLACEBO Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities, After Vaccination. | Lymphocytes above | 0 Participants |
| PLACEBO Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities, After Vaccination. | Eosinophils above | 1 Participants |
| PLACEBO Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities, After Vaccination. | Eosinophils below | 0 Participants |
| PLACEBO Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities, After Vaccination. | Platelets below | 0 Participants |
| PLACEBO Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities, After Vaccination. | Monocytes above | 0 Participants |
| PLACEBO Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities, After Vaccination. | Basophils above | 0 Participants |
| PLACEBO Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities, After Vaccination. | Creatinine below | 1 Participants |
| PLACEBO Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities, After Vaccination. | Basophils below | 0 Participants |
| PLACEBO Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities, After Vaccination. | Creatinine above | 1 Participants |
| PLACEBO Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities, After Vaccination. | Neutrophils below | 0 Participants |
| PLACEBO Group | Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities, After Vaccination. | AST below | 0 Participants |
Primary
Number of Subjects With Any Potential Immune-mediated Diseases (pIMDs)
Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.
Time frame: From first vaccination up to study conclusion (Day 0 to Day 420)
Population: Analysis was performed on the total vaccinated cohort which included all subjects with at least one vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK3277513A F1 Group | Number of Subjects With Any Potential Immune-mediated Diseases (pIMDs) | 1 Participants |
| GSK3277513A F2 Group | Number of Subjects With Any Potential Immune-mediated Diseases (pIMDs) | 0 Participants |
| GSK3277513A F3 Group | Number of Subjects With Any Potential Immune-mediated Diseases (pIMDs) | 1 Participants |
| PLACEBO Group | Number of Subjects With Any Potential Immune-mediated Diseases (pIMDs) | 0 Participants |
Primary
Number of Subjects With Any Serious Adverse Events (SAEs)
Assessed SAEs include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time frame: From first vaccination up to study conclusion (Day 0 to Day 420)
Population: Analysis was performed on the total vaccinated cohort which included all subjects with at least one vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK3277513A F1 Group | Number of Subjects With Any Serious Adverse Events (SAEs) | 1 Participants |
| GSK3277513A F2 Group | Number of Subjects With Any Serious Adverse Events (SAEs) | 0 Participants |
| GSK3277513A F3 Group | Number of Subjects With Any Serious Adverse Events (SAEs) | 1 Participants |
| PLACEBO Group | Number of Subjects With Any Serious Adverse Events (SAEs) | 2 Participants |
Primary
Number of Subjects With Any Solicited General Adverse Events (AEs)
Assessed solicited general symptoms are fatigue, gastrointestinal symptoms, headache, myalgia, fever \[defined as oral temperature equal to or above 37.5 degrees Celsius (°C)\].
Time frame: During a 7-day follow-up period (Day 60 to Day 66) after second dose.
Population: Analysis was performed on the total vaccinated cohort which included all subjects with at least one vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK3277513A F1 Group | Number of Subjects With Any Solicited General Adverse Events (AEs) | Any Temperature (Oral) (°C) | 0 Participants |
| GSK3277513A F1 Group | Number of Subjects With Any Solicited General Adverse Events (AEs) | Any Headache | 3 Participants |
| GSK3277513A F1 Group | Number of Subjects With Any Solicited General Adverse Events (AEs) | Any Myalgia | 1 Participants |
| GSK3277513A F1 Group | Number of Subjects With Any Solicited General Adverse Events (AEs) | Any Gastrointestinal symptoms | 3 Participants |
| GSK3277513A F1 Group | Number of Subjects With Any Solicited General Adverse Events (AEs) | Any Fatigue | 3 Participants |
| GSK3277513A F2 Group | Number of Subjects With Any Solicited General Adverse Events (AEs) | Any Gastrointestinal symptoms | 2 Participants |
| GSK3277513A F2 Group | Number of Subjects With Any Solicited General Adverse Events (AEs) | Any Fatigue | 9 Participants |
| GSK3277513A F2 Group | Number of Subjects With Any Solicited General Adverse Events (AEs) | Any Temperature (Oral) (°C) | 3 Participants |
| GSK3277513A F2 Group | Number of Subjects With Any Solicited General Adverse Events (AEs) | Any Headache | 5 Participants |
| GSK3277513A F2 Group | Number of Subjects With Any Solicited General Adverse Events (AEs) | Any Myalgia | 9 Participants |
| GSK3277513A F3 Group | Number of Subjects With Any Solicited General Adverse Events (AEs) | Any Fatigue | 13 Participants |
| GSK3277513A F3 Group | Number of Subjects With Any Solicited General Adverse Events (AEs) | Any Gastrointestinal symptoms | 3 Participants |
| GSK3277513A F3 Group | Number of Subjects With Any Solicited General Adverse Events (AEs) | Any Headache | 8 Participants |
| GSK3277513A F3 Group | Number of Subjects With Any Solicited General Adverse Events (AEs) | Any Temperature (Oral) (°C) | 3 Participants |
| GSK3277513A F3 Group | Number of Subjects With Any Solicited General Adverse Events (AEs) | Any Myalgia | 8 Participants |
| PLACEBO Group | Number of Subjects With Any Solicited General Adverse Events (AEs) | Any Temperature (Oral) (°C) | 1 Participants |
| PLACEBO Group | Number of Subjects With Any Solicited General Adverse Events (AEs) | Any Fatigue | 6 Participants |
| PLACEBO Group | Number of Subjects With Any Solicited General Adverse Events (AEs) | Any Myalgia | 3 Participants |
| PLACEBO Group | Number of Subjects With Any Solicited General Adverse Events (AEs) | Any Gastrointestinal symptoms | 1 Participants |
| PLACEBO Group | Number of Subjects With Any Solicited General Adverse Events (AEs) | Any Headache | 2 Participants |
Primary
Number of Subjects With Any Solicited General Adverse Events (AEs)
Assessed solicited general symptoms are fatigue, gastrointestinal symptoms, headache, myalgia, fever \[defined as oral temperature equal to or above 37.5 degrees Celsius (°C)\].
Time frame: During a 7-day follow-up period (Day 0 to Day 6) after first dose.
Population: Analysis was performed on the total vaccinated cohort which included all subjects with at least one vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK3277513A F1 Group | Number of Subjects With Any Solicited General Adverse Events (AEs) | Any Gastrointestinal symptoms | 1 Participants |
| GSK3277513A F1 Group | Number of Subjects With Any Solicited General Adverse Events (AEs) | Any Fatigue | 3 Participants |
| GSK3277513A F1 Group | Number of Subjects With Any Solicited General Adverse Events (AEs) | Any Headache | 4 Participants |
| GSK3277513A F1 Group | Number of Subjects With Any Solicited General Adverse Events (AEs) | Any Myalgia | 2 Participants |
| GSK3277513A F1 Group | Number of Subjects With Any Solicited General Adverse Events (AEs) | Any Temperature (Oral) (°C) | 1 Participants |
| GSK3277513A F2 Group | Number of Subjects With Any Solicited General Adverse Events (AEs) | Any Fatigue | 3 Participants |
| GSK3277513A F2 Group | Number of Subjects With Any Solicited General Adverse Events (AEs) | Any Temperature (Oral) (°C) | 0 Participants |
| GSK3277513A F2 Group | Number of Subjects With Any Solicited General Adverse Events (AEs) | Any Myalgia | 6 Participants |
| GSK3277513A F2 Group | Number of Subjects With Any Solicited General Adverse Events (AEs) | Any Gastrointestinal symptoms | 0 Participants |
| GSK3277513A F2 Group | Number of Subjects With Any Solicited General Adverse Events (AEs) | Any Headache | 2 Participants |
| GSK3277513A F3 Group | Number of Subjects With Any Solicited General Adverse Events (AEs) | Any Temperature (Oral) (°C) | 2 Participants |
| GSK3277513A F3 Group | Number of Subjects With Any Solicited General Adverse Events (AEs) | Any Fatigue | 11 Participants |
| GSK3277513A F3 Group | Number of Subjects With Any Solicited General Adverse Events (AEs) | Any Myalgia | 7 Participants |
| GSK3277513A F3 Group | Number of Subjects With Any Solicited General Adverse Events (AEs) | Any Gastrointestinal symptoms | 4 Participants |
| GSK3277513A F3 Group | Number of Subjects With Any Solicited General Adverse Events (AEs) | Any Headache | 10 Participants |
| PLACEBO Group | Number of Subjects With Any Solicited General Adverse Events (AEs) | Any Gastrointestinal symptoms | 3 Participants |
| PLACEBO Group | Number of Subjects With Any Solicited General Adverse Events (AEs) | Any Headache | 7 Participants |
| PLACEBO Group | Number of Subjects With Any Solicited General Adverse Events (AEs) | Any Temperature (Oral) (°C) | 0 Participants |
| PLACEBO Group | Number of Subjects With Any Solicited General Adverse Events (AEs) | Any Myalgia | 4 Participants |
| PLACEBO Group | Number of Subjects With Any Solicited General Adverse Events (AEs) | Any Fatigue | 10 Participants |
Primary
Number of Subjects With Any Solicited Local Adverse Events (AEs)
Assessed solicited local symptoms are pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.
Time frame: During a 7-day follow-up period (Day 60 to Day 66) after second dose
Population: Analysis was performed on the total vaccinated cohort which included all subjects with at least one vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK3277513A F1 Group | Number of Subjects With Any Solicited Local Adverse Events (AEs) | Any Pain | 7 Participants |
| GSK3277513A F1 Group | Number of Subjects With Any Solicited Local Adverse Events (AEs) | Any Swelling (mm) | 0 Participants |
| GSK3277513A F1 Group | Number of Subjects With Any Solicited Local Adverse Events (AEs) | Any Redness (mm) | 0 Participants |
| GSK3277513A F2 Group | Number of Subjects With Any Solicited Local Adverse Events (AEs) | Any Pain | 23 Participants |
| GSK3277513A F2 Group | Number of Subjects With Any Solicited Local Adverse Events (AEs) | Any Swelling (mm) | 2 Participants |
| GSK3277513A F2 Group | Number of Subjects With Any Solicited Local Adverse Events (AEs) | Any Redness (mm) | 3 Participants |
| GSK3277513A F3 Group | Number of Subjects With Any Solicited Local Adverse Events (AEs) | Any Redness (mm) | 4 Participants |
| GSK3277513A F3 Group | Number of Subjects With Any Solicited Local Adverse Events (AEs) | Any Pain | 25 Participants |
| GSK3277513A F3 Group | Number of Subjects With Any Solicited Local Adverse Events (AEs) | Any Swelling (mm) | 3 Participants |
| PLACEBO Group | Number of Subjects With Any Solicited Local Adverse Events (AEs) | Any Pain | 8 Participants |
| PLACEBO Group | Number of Subjects With Any Solicited Local Adverse Events (AEs) | Any Swelling (mm) | 0 Participants |
| PLACEBO Group | Number of Subjects With Any Solicited Local Adverse Events (AEs) | Any Redness (mm) | 0 Participants |
Primary
Number of Subjects With Any Solicited Local Adverse Events (AEs)
Assessed solicited local symptoms are pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.
Time frame: During a 7-day follow-up period (Day 0 to Day 6) after first dose.
Population: Analysis was performed on the total vaccinated cohort which included all subjects with at least one vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK3277513A F1 Group | Number of Subjects With Any Solicited Local Adverse Events (AEs) | Any Swelling (mm) | 0 Participants |
| GSK3277513A F1 Group | Number of Subjects With Any Solicited Local Adverse Events (AEs) | Any Redness (mm) | 0 Participants |
| GSK3277513A F1 Group | Number of Subjects With Any Solicited Local Adverse Events (AEs) | Any Pain | 2 Participants |
| GSK3277513A F2 Group | Number of Subjects With Any Solicited Local Adverse Events (AEs) | Any Swelling (mm) | 4 Participants |
| GSK3277513A F2 Group | Number of Subjects With Any Solicited Local Adverse Events (AEs) | Any Redness (mm) | 3 Participants |
| GSK3277513A F2 Group | Number of Subjects With Any Solicited Local Adverse Events (AEs) | Any Pain | 19 Participants |
| GSK3277513A F3 Group | Number of Subjects With Any Solicited Local Adverse Events (AEs) | Any Pain | 26 Participants |
| GSK3277513A F3 Group | Number of Subjects With Any Solicited Local Adverse Events (AEs) | Any Swelling (mm) | 0 Participants |
| GSK3277513A F3 Group | Number of Subjects With Any Solicited Local Adverse Events (AEs) | Any Redness (mm) | 2 Participants |
| PLACEBO Group | Number of Subjects With Any Solicited Local Adverse Events (AEs) | Any Swelling (mm) | 0 Participants |
| PLACEBO Group | Number of Subjects With Any Solicited Local Adverse Events (AEs) | Any Redness (mm) | 0 Participants |
| PLACEBO Group | Number of Subjects With Any Solicited Local Adverse Events (AEs) | Any Pain | 6 Participants |
Primary
Number of Subjects With Any Unsolicited Adverse Events (AEs)
Assessed unsolicited AEs cover 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 outside the specified period of follow-up for solicited symptoms. Any is defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Time frame: During a 30-day follow-up period (Day 60 to Day 89) after second dose
Population: Analysis was performed on the total vaccinated cohort which included all subjects with at least one vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK3277513A F1 Group | Number of Subjects With Any Unsolicited Adverse Events (AEs) | 6 Participants |
| GSK3277513A F2 Group | Number of Subjects With Any Unsolicited Adverse Events (AEs) | 14 Participants |
| GSK3277513A F3 Group | Number of Subjects With Any Unsolicited Adverse Events (AEs) | 14 Participants |
| PLACEBO Group | Number of Subjects With Any Unsolicited Adverse Events (AEs) | 19 Participants |
Primary
Number of Subjects With Any Unsolicited Adverse Events (AEs).
Assessed unsolicited AEs cover 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 outside the specified period of follow-up for solicited symptoms. Any is defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Time frame: During a 30-day follow-up period (Day 0 to Day 29) after first dose.
Population: Analysis was performed on the total vaccinated cohort which included all subjects with at least one vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK3277513A F1 Group | Number of Subjects With Any Unsolicited Adverse Events (AEs). | 6 Participants |
| GSK3277513A F2 Group | Number of Subjects With Any Unsolicited Adverse Events (AEs). | 13 Participants |
| GSK3277513A F3 Group | Number of Subjects With Any Unsolicited Adverse Events (AEs). | 14 Participants |
| PLACEBO Group | Number of Subjects With Any Unsolicited Adverse Events (AEs). | 21 Participants |
Secondary
Concentration of Antibodies Against the NTHi-Mcat Anti-PD (Protein D of Haemophilus Influenzae) Vaccine Component
Antibody concentrations are measured by enzyme-linked immunosorbent assay (ELISA) and expressed as geometric mean concentrations (GMCs) in ELISA units per millilitre (EL.U/mL). The cut-off of the assay is 153 EL.U/mL for anti-PD antibodies.
Time frame: At Day 0 (pre-dose 1); at Day 30 and Day 60 (post-dose 1); at Day 90, Day 210 and Day 420 (post-dose2).
Population: The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome variables were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK3277513A F1 Group | Concentration of Antibodies Against the NTHi-Mcat Anti-PD (Protein D of Haemophilus Influenzae) Vaccine Component | Anti-PD antibody, Day 90 | 289.2 EL.U/mL |
| GSK3277513A F1 Group | Concentration of Antibodies Against the NTHi-Mcat Anti-PD (Protein D of Haemophilus Influenzae) Vaccine Component | Anti-PD antibody, Day 0 | 109.7 EL.U/mL |
| GSK3277513A F1 Group | Concentration of Antibodies Against the NTHi-Mcat Anti-PD (Protein D of Haemophilus Influenzae) Vaccine Component | Anti-PD antibody, Day 60 | 220.9 EL.U/mL |
| GSK3277513A F1 Group | Concentration of Antibodies Against the NTHi-Mcat Anti-PD (Protein D of Haemophilus Influenzae) Vaccine Component | Anti-PD antibody, Day 30 | 239.8 EL.U/mL |
| GSK3277513A F1 Group | Concentration of Antibodies Against the NTHi-Mcat Anti-PD (Protein D of Haemophilus Influenzae) Vaccine Component | Anti-PD antibody, Day 210 | 179.5 EL.U/mL |
| GSK3277513A F1 Group | Concentration of Antibodies Against the NTHi-Mcat Anti-PD (Protein D of Haemophilus Influenzae) Vaccine Component | Anti-PD antibody, Day 420 | 165.1 EL.U/mL |
| GSK3277513A F2 Group | Concentration of Antibodies Against the NTHi-Mcat Anti-PD (Protein D of Haemophilus Influenzae) Vaccine Component | Anti-PD antibody, Day 210 | 471.8 EL.U/mL |
| GSK3277513A F2 Group | Concentration of Antibodies Against the NTHi-Mcat Anti-PD (Protein D of Haemophilus Influenzae) Vaccine Component | Anti-PD antibody, Day 420 | 370.2 EL.U/mL |
| GSK3277513A F2 Group | Concentration of Antibodies Against the NTHi-Mcat Anti-PD (Protein D of Haemophilus Influenzae) Vaccine Component | Anti-PD antibody, Day 30 | 569.4 EL.U/mL |
| GSK3277513A F2 Group | Concentration of Antibodies Against the NTHi-Mcat Anti-PD (Protein D of Haemophilus Influenzae) Vaccine Component | Anti-PD antibody, Day 60 | 327.1 EL.U/mL |
| GSK3277513A F2 Group | Concentration of Antibodies Against the NTHi-Mcat Anti-PD (Protein D of Haemophilus Influenzae) Vaccine Component | Anti-PD antibody, Day 0 | 102.8 EL.U/mL |
| GSK3277513A F2 Group | Concentration of Antibodies Against the NTHi-Mcat Anti-PD (Protein D of Haemophilus Influenzae) Vaccine Component | Anti-PD antibody, Day 90 | 984.4 EL.U/mL |
| GSK3277513A F3 Group | Concentration of Antibodies Against the NTHi-Mcat Anti-PD (Protein D of Haemophilus Influenzae) Vaccine Component | Anti-PD antibody, Day 30 | 818 EL.U/mL |
| GSK3277513A F3 Group | Concentration of Antibodies Against the NTHi-Mcat Anti-PD (Protein D of Haemophilus Influenzae) Vaccine Component | Anti-PD antibody, Day 210 | 806.1 EL.U/mL |
| GSK3277513A F3 Group | Concentration of Antibodies Against the NTHi-Mcat Anti-PD (Protein D of Haemophilus Influenzae) Vaccine Component | Anti-PD antibody, Day 90 | 1538.5 EL.U/mL |
| GSK3277513A F3 Group | Concentration of Antibodies Against the NTHi-Mcat Anti-PD (Protein D of Haemophilus Influenzae) Vaccine Component | Anti-PD antibody, Day 0 | 88.1 EL.U/mL |
| GSK3277513A F3 Group | Concentration of Antibodies Against the NTHi-Mcat Anti-PD (Protein D of Haemophilus Influenzae) Vaccine Component | Anti-PD antibody, Day 60 | 495 EL.U/mL |
| GSK3277513A F3 Group | Concentration of Antibodies Against the NTHi-Mcat Anti-PD (Protein D of Haemophilus Influenzae) Vaccine Component | Anti-PD antibody, Day 420 | 538.1 EL.U/mL |
| PLACEBO Group | Concentration of Antibodies Against the NTHi-Mcat Anti-PD (Protein D of Haemophilus Influenzae) Vaccine Component | Anti-PD antibody, Day 420 | 88.8 EL.U/mL |
| PLACEBO Group | Concentration of Antibodies Against the NTHi-Mcat Anti-PD (Protein D of Haemophilus Influenzae) Vaccine Component | Anti-PD antibody, Day 30 | 90.8 EL.U/mL |
| PLACEBO Group | Concentration of Antibodies Against the NTHi-Mcat Anti-PD (Protein D of Haemophilus Influenzae) Vaccine Component | Anti-PD antibody, Day 60 | 88.6 EL.U/mL |
| PLACEBO Group | Concentration of Antibodies Against the NTHi-Mcat Anti-PD (Protein D of Haemophilus Influenzae) Vaccine Component | Anti-PD antibody, Day 90 | 91.8 EL.U/mL |
| PLACEBO Group | Concentration of Antibodies Against the NTHi-Mcat Anti-PD (Protein D of Haemophilus Influenzae) Vaccine Component | Anti-PD antibody, Day 210 | 92.9 EL.U/mL |
| PLACEBO Group | Concentration of Antibodies Against the NTHi-Mcat Anti-PD (Protein D of Haemophilus Influenzae) Vaccine Component | Anti-PD antibody, Day 0 | 89 EL.U/mL |
Secondary
Concentration of Antibodies Against the NTHi-Mcat Anti-PE (Protein E of Haemophilus Influenzae) Vaccine Component
Antibody concentrations are measured by enzyme-linked immunosorbent assay (ELISA) and expressed as geometric mean concentrations (GMCs) in ELISA units per millilitre (EL.U/mL). The cut-off of the assay is 25 EL.U/mL for anti-PE antibodies.
Time frame: At Day 0 (pre-dose 1); at Day 30 and Day 60 (post-dose 1); at Day 90, Day 210 and Day 420 (post-dose2).
Population: The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome variables were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK3277513A F1 Group | Concentration of Antibodies Against the NTHi-Mcat Anti-PE (Protein E of Haemophilus Influenzae) Vaccine Component | Anti-PE antibody, Day 0 | 31.3 EL.U/mL |
| GSK3277513A F1 Group | Concentration of Antibodies Against the NTHi-Mcat Anti-PE (Protein E of Haemophilus Influenzae) Vaccine Component | Anti-PE antibody, Day 30 | 178.3 EL.U/mL |
| GSK3277513A F1 Group | Concentration of Antibodies Against the NTHi-Mcat Anti-PE (Protein E of Haemophilus Influenzae) Vaccine Component | Anti-PE antibody, Day 60 | 151.9 EL.U/mL |
| GSK3277513A F1 Group | Concentration of Antibodies Against the NTHi-Mcat Anti-PE (Protein E of Haemophilus Influenzae) Vaccine Component | Anti-PE antibody, Day 90 | 719.1 EL.U/mL |
| GSK3277513A F1 Group | Concentration of Antibodies Against the NTHi-Mcat Anti-PE (Protein E of Haemophilus Influenzae) Vaccine Component | Anti-PE antibody, Day 210 | 385.8 EL.U/mL |
| GSK3277513A F1 Group | Concentration of Antibodies Against the NTHi-Mcat Anti-PE (Protein E of Haemophilus Influenzae) Vaccine Component | Anti-PE antibody, Day 420 | 244.1 EL.U/mL |
| GSK3277513A F2 Group | Concentration of Antibodies Against the NTHi-Mcat Anti-PE (Protein E of Haemophilus Influenzae) Vaccine Component | Anti-PE antibody, Day 420 | 1206.6 EL.U/mL |
| GSK3277513A F2 Group | Concentration of Antibodies Against the NTHi-Mcat Anti-PE (Protein E of Haemophilus Influenzae) Vaccine Component | Anti-PE antibody, Day 90 | 5945.2 EL.U/mL |
| GSK3277513A F2 Group | Concentration of Antibodies Against the NTHi-Mcat Anti-PE (Protein E of Haemophilus Influenzae) Vaccine Component | Anti-PE antibody, Day 0 | 20.6 EL.U/mL |
| GSK3277513A F2 Group | Concentration of Antibodies Against the NTHi-Mcat Anti-PE (Protein E of Haemophilus Influenzae) Vaccine Component | Anti-PE antibody, Day 60 | 573.1 EL.U/mL |
| GSK3277513A F2 Group | Concentration of Antibodies Against the NTHi-Mcat Anti-PE (Protein E of Haemophilus Influenzae) Vaccine Component | Anti-PE antibody, Day 30 | 627.2 EL.U/mL |
| GSK3277513A F2 Group | Concentration of Antibodies Against the NTHi-Mcat Anti-PE (Protein E of Haemophilus Influenzae) Vaccine Component | Anti-PE antibody, Day 210 | 2390.9 EL.U/mL |
| GSK3277513A F3 Group | Concentration of Antibodies Against the NTHi-Mcat Anti-PE (Protein E of Haemophilus Influenzae) Vaccine Component | Anti-PE antibody, Day 30 | 1287.8 EL.U/mL |
| GSK3277513A F3 Group | Concentration of Antibodies Against the NTHi-Mcat Anti-PE (Protein E of Haemophilus Influenzae) Vaccine Component | Anti-PE antibody, Day 60 | 1207.1 EL.U/mL |
| GSK3277513A F3 Group | Concentration of Antibodies Against the NTHi-Mcat Anti-PE (Protein E of Haemophilus Influenzae) Vaccine Component | Anti-PE antibody, Day 90 | 8983.9 EL.U/mL |
| GSK3277513A F3 Group | Concentration of Antibodies Against the NTHi-Mcat Anti-PE (Protein E of Haemophilus Influenzae) Vaccine Component | Anti-PE antibody, Day 420 | 1701 EL.U/mL |
| GSK3277513A F3 Group | Concentration of Antibodies Against the NTHi-Mcat Anti-PE (Protein E of Haemophilus Influenzae) Vaccine Component | Anti-PE antibody, Day 210 | 3247.6 EL.U/mL |
| GSK3277513A F3 Group | Concentration of Antibodies Against the NTHi-Mcat Anti-PE (Protein E of Haemophilus Influenzae) Vaccine Component | Anti-PE antibody, Day 0 | 19.7 EL.U/mL |
| PLACEBO Group | Concentration of Antibodies Against the NTHi-Mcat Anti-PE (Protein E of Haemophilus Influenzae) Vaccine Component | Anti-PE antibody, Day 210 | 20.7 EL.U/mL |
| PLACEBO Group | Concentration of Antibodies Against the NTHi-Mcat Anti-PE (Protein E of Haemophilus Influenzae) Vaccine Component | Anti-PE antibody, Day 420 | 22.8 EL.U/mL |
| PLACEBO Group | Concentration of Antibodies Against the NTHi-Mcat Anti-PE (Protein E of Haemophilus Influenzae) Vaccine Component | Anti-PE antibody, Day 30 | 21.3 EL.U/mL |
| PLACEBO Group | Concentration of Antibodies Against the NTHi-Mcat Anti-PE (Protein E of Haemophilus Influenzae) Vaccine Component | Anti-PE antibody, Day 90 | 21.8 EL.U/mL |
| PLACEBO Group | Concentration of Antibodies Against the NTHi-Mcat Anti-PE (Protein E of Haemophilus Influenzae) Vaccine Component | Anti-PE antibody, Day 0 | 21.9 EL.U/mL |
| PLACEBO Group | Concentration of Antibodies Against the NTHi-Mcat Anti-PE (Protein E of Haemophilus Influenzae) Vaccine Component | Anti-PE antibody, Day 60 | 20.3 EL.U/mL |
Secondary
Concentration of Antibodies Against the NTHi-Mcat Anti-PilA (Type IV Pili Subunit of Non-typeable Haemophilus Influenzae) Vaccine Component
Antibody concentrations are measured by enzyme-linked immunosorbent assay (ELISA) and expressed as geometric mean concentrations (GMCs) in ELISA units per millilitre (EL.U/mL). The cut-off of the assay is 16 EL.U/mL for anti-PilA antibodies.
Time frame: At Day 210 and Day 420 (post-dose2).
Population: The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome variables were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK3277513A F1 Group | Concentration of Antibodies Against the NTHi-Mcat Anti-PilA (Type IV Pili Subunit of Non-typeable Haemophilus Influenzae) Vaccine Component | Anti-PilA antibody, Day 210 | 52 EL.U/mL |
| GSK3277513A F1 Group | Concentration of Antibodies Against the NTHi-Mcat Anti-PilA (Type IV Pili Subunit of Non-typeable Haemophilus Influenzae) Vaccine Component | Anti-PilA antibody, Day 420 | 40.8 EL.U/mL |
| GSK3277513A F2 Group | Concentration of Antibodies Against the NTHi-Mcat Anti-PilA (Type IV Pili Subunit of Non-typeable Haemophilus Influenzae) Vaccine Component | Anti-PilA antibody, Day 420 | 181.8 EL.U/mL |
| GSK3277513A F2 Group | Concentration of Antibodies Against the NTHi-Mcat Anti-PilA (Type IV Pili Subunit of Non-typeable Haemophilus Influenzae) Vaccine Component | Anti-PilA antibody, Day 210 | 367.2 EL.U/mL |
| GSK3277513A F3 Group | Concentration of Antibodies Against the NTHi-Mcat Anti-PilA (Type IV Pili Subunit of Non-typeable Haemophilus Influenzae) Vaccine Component | Anti-PilA antibody, Day 210 | 671 EL.U/mL |
| GSK3277513A F3 Group | Concentration of Antibodies Against the NTHi-Mcat Anti-PilA (Type IV Pili Subunit of Non-typeable Haemophilus Influenzae) Vaccine Component | Anti-PilA antibody, Day 420 | 322.2 EL.U/mL |
| PLACEBO Group | Concentration of Antibodies Against the NTHi-Mcat Anti-PilA (Type IV Pili Subunit of Non-typeable Haemophilus Influenzae) Vaccine Component | Anti-PilA antibody, Day 210 | 11.5 EL.U/mL |
| PLACEBO Group | Concentration of Antibodies Against the NTHi-Mcat Anti-PilA (Type IV Pili Subunit of Non-typeable Haemophilus Influenzae) Vaccine Component | Anti-PilA antibody, Day 420 | 11.9 EL.U/mL |
Secondary
Concentration of Antibodies Against the NTHi-Mcat Anti-PilA (Type IV Pili Subunit of Non-typeable Haemophilus Influenzae) Vaccine Component
Antibody concentrations are measured by enzyme-linked immunosorbent assay (ELISA) and expressed as geometric mean concentrations (GMCs) in ELISA units per millilitre (EL.U/mL). The cut-off of the assay is 7 EL.U/mL for anti-PilA antibodies.
Time frame: At Day 0 (pre-dose 1); at Day 30 and Day 60 (post-dose 1); at Day 90 (post-dose2).
Population: The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome variables were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK3277513A F1 Group | Concentration of Antibodies Against the NTHi-Mcat Anti-PilA (Type IV Pili Subunit of Non-typeable Haemophilus Influenzae) Vaccine Component | Anti-PilA antibody, Day 0 | 11.6 EL.U/mL |
| GSK3277513A F1 Group | Concentration of Antibodies Against the NTHi-Mcat Anti-PilA (Type IV Pili Subunit of Non-typeable Haemophilus Influenzae) Vaccine Component | Anti-PilA antibody, Day 30 | 37.2 EL.U/mL |
| GSK3277513A F1 Group | Concentration of Antibodies Against the NTHi-Mcat Anti-PilA (Type IV Pili Subunit of Non-typeable Haemophilus Influenzae) Vaccine Component | Anti-PilA antibody, Day 60 | 33.2 EL.U/mL |
| GSK3277513A F1 Group | Concentration of Antibodies Against the NTHi-Mcat Anti-PilA (Type IV Pili Subunit of Non-typeable Haemophilus Influenzae) Vaccine Component | Anti-PilA antibody, Day 90 | 165.8 EL.U/mL |
| GSK3277513A F2 Group | Concentration of Antibodies Against the NTHi-Mcat Anti-PilA (Type IV Pili Subunit of Non-typeable Haemophilus Influenzae) Vaccine Component | Anti-PilA antibody, Day 30 | 238.6 EL.U/mL |
| GSK3277513A F2 Group | Concentration of Antibodies Against the NTHi-Mcat Anti-PilA (Type IV Pili Subunit of Non-typeable Haemophilus Influenzae) Vaccine Component | Anti-PilA antibody, Day 60 | 177 EL.U/mL |
| GSK3277513A F2 Group | Concentration of Antibodies Against the NTHi-Mcat Anti-PilA (Type IV Pili Subunit of Non-typeable Haemophilus Influenzae) Vaccine Component | Anti-PilA antibody, Day 90 | 1127.5 EL.U/mL |
| GSK3277513A F2 Group | Concentration of Antibodies Against the NTHi-Mcat Anti-PilA (Type IV Pili Subunit of Non-typeable Haemophilus Influenzae) Vaccine Component | Anti-PilA antibody, Day 0 | 13.5 EL.U/mL |
| GSK3277513A F3 Group | Concentration of Antibodies Against the NTHi-Mcat Anti-PilA (Type IV Pili Subunit of Non-typeable Haemophilus Influenzae) Vaccine Component | Anti-PilA antibody, Day 60 | 321.2 EL.U/mL |
| GSK3277513A F3 Group | Concentration of Antibodies Against the NTHi-Mcat Anti-PilA (Type IV Pili Subunit of Non-typeable Haemophilus Influenzae) Vaccine Component | Anti-PilA antibody, Day 30 | 330.9 EL.U/mL |
| GSK3277513A F3 Group | Concentration of Antibodies Against the NTHi-Mcat Anti-PilA (Type IV Pili Subunit of Non-typeable Haemophilus Influenzae) Vaccine Component | Anti-PilA antibody, Day 90 | 1722.3 EL.U/mL |
| GSK3277513A F3 Group | Concentration of Antibodies Against the NTHi-Mcat Anti-PilA (Type IV Pili Subunit of Non-typeable Haemophilus Influenzae) Vaccine Component | Anti-PilA antibody, Day 0 | 17.1 EL.U/mL |
| PLACEBO Group | Concentration of Antibodies Against the NTHi-Mcat Anti-PilA (Type IV Pili Subunit of Non-typeable Haemophilus Influenzae) Vaccine Component | Anti-PilA antibody, Day 90 | 8.6 EL.U/mL |
| PLACEBO Group | Concentration of Antibodies Against the NTHi-Mcat Anti-PilA (Type IV Pili Subunit of Non-typeable Haemophilus Influenzae) Vaccine Component | Anti-PilA antibody, Day 30 | 9.2 EL.U/mL |
| PLACEBO Group | Concentration of Antibodies Against the NTHi-Mcat Anti-PilA (Type IV Pili Subunit of Non-typeable Haemophilus Influenzae) Vaccine Component | Anti-PilA antibody, Day 0 | 8.8 EL.U/mL |
| PLACEBO Group | Concentration of Antibodies Against the NTHi-Mcat Anti-PilA (Type IV Pili Subunit of Non-typeable Haemophilus Influenzae) Vaccine Component | Anti-PilA antibody, Day 60 | 9 EL.U/mL |
Secondary
Concentration of Antibodies Against the NTHi-Mcat Anti-UspA2 (Ubiquitous Surface Protein A2 of Moraxella Catarrhalis) Vaccine Component
Antibody concentrations are measured by enzyme-linked immunosorbent assay (ELISA) and expressed as geometric mean concentrations (GMCs) in ELISA units per millilitre (EL.U/mL). The cut-off of the assay is 38 EL.U/mL for anti-UspA2 antibodies.
Time frame: At Day 0 (pre-dose 1); at Day 30 and Day 60 (post-dose 1); at Day 90, Day 210 and Day 420 (post-dose2).
Population: The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome variables were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK3277513A F1 Group | Concentration of Antibodies Against the NTHi-Mcat Anti-UspA2 (Ubiquitous Surface Protein A2 of Moraxella Catarrhalis) Vaccine Component | Anti-UspA2 IgG antibody, Day 0 | 572.5 EL.U/mL |
| GSK3277513A F1 Group | Concentration of Antibodies Against the NTHi-Mcat Anti-UspA2 (Ubiquitous Surface Protein A2 of Moraxella Catarrhalis) Vaccine Component | Anti-UspA2 IgG antibody, Day 30 | 879.9 EL.U/mL |
| GSK3277513A F1 Group | Concentration of Antibodies Against the NTHi-Mcat Anti-UspA2 (Ubiquitous Surface Protein A2 of Moraxella Catarrhalis) Vaccine Component | Anti-UspA2 IgG antibody, Day 60 | 780.7 EL.U/mL |
| GSK3277513A F1 Group | Concentration of Antibodies Against the NTHi-Mcat Anti-UspA2 (Ubiquitous Surface Protein A2 of Moraxella Catarrhalis) Vaccine Component | Anti-UspA2 IgG antibody, Day 90 | 1172 EL.U/mL |
| GSK3277513A F1 Group | Concentration of Antibodies Against the NTHi-Mcat Anti-UspA2 (Ubiquitous Surface Protein A2 of Moraxella Catarrhalis) Vaccine Component | Anti-UspA2 IgG antibody, Day 210 | 775.1 EL.U/mL |
| GSK3277513A F1 Group | Concentration of Antibodies Against the NTHi-Mcat Anti-UspA2 (Ubiquitous Surface Protein A2 of Moraxella Catarrhalis) Vaccine Component | Anti-UspA2 IgG antibody, Day 420 | 732 EL.U/mL |
| GSK3277513A F2 Group | Concentration of Antibodies Against the NTHi-Mcat Anti-UspA2 (Ubiquitous Surface Protein A2 of Moraxella Catarrhalis) Vaccine Component | Anti-UspA2 IgG antibody, Day 420 | 703.6 EL.U/mL |
| GSK3277513A F2 Group | Concentration of Antibodies Against the NTHi-Mcat Anti-UspA2 (Ubiquitous Surface Protein A2 of Moraxella Catarrhalis) Vaccine Component | Anti-UspA2 IgG antibody, Day 90 | 1440.7 EL.U/mL |
| GSK3277513A F2 Group | Concentration of Antibodies Against the NTHi-Mcat Anti-UspA2 (Ubiquitous Surface Protein A2 of Moraxella Catarrhalis) Vaccine Component | Anti-UspA2 IgG antibody, Day 0 | 384.1 EL.U/mL |
| GSK3277513A F2 Group | Concentration of Antibodies Against the NTHi-Mcat Anti-UspA2 (Ubiquitous Surface Protein A2 of Moraxella Catarrhalis) Vaccine Component | Anti-UspA2 IgG antibody, Day 60 | 754.4 EL.U/mL |
| GSK3277513A F2 Group | Concentration of Antibodies Against the NTHi-Mcat Anti-UspA2 (Ubiquitous Surface Protein A2 of Moraxella Catarrhalis) Vaccine Component | Anti-UspA2 IgG antibody, Day 30 | 1006.7 EL.U/mL |
| GSK3277513A F2 Group | Concentration of Antibodies Against the NTHi-Mcat Anti-UspA2 (Ubiquitous Surface Protein A2 of Moraxella Catarrhalis) Vaccine Component | Anti-UspA2 IgG antibody, Day 210 | 882.5 EL.U/mL |
| GSK3277513A F3 Group | Concentration of Antibodies Against the NTHi-Mcat Anti-UspA2 (Ubiquitous Surface Protein A2 of Moraxella Catarrhalis) Vaccine Component | Anti-UspA2 IgG antibody, Day 30 | 913.5 EL.U/mL |
| GSK3277513A F3 Group | Concentration of Antibodies Against the NTHi-Mcat Anti-UspA2 (Ubiquitous Surface Protein A2 of Moraxella Catarrhalis) Vaccine Component | Anti-UspA2 IgG antibody, Day 60 | 714.7 EL.U/mL |
| GSK3277513A F3 Group | Concentration of Antibodies Against the NTHi-Mcat Anti-UspA2 (Ubiquitous Surface Protein A2 of Moraxella Catarrhalis) Vaccine Component | Anti-UspA2 IgG antibody, Day 90 | 1279 EL.U/mL |
| GSK3277513A F3 Group | Concentration of Antibodies Against the NTHi-Mcat Anti-UspA2 (Ubiquitous Surface Protein A2 of Moraxella Catarrhalis) Vaccine Component | Anti-UspA2 IgG antibody, Day 420 | 673.4 EL.U/mL |
| GSK3277513A F3 Group | Concentration of Antibodies Against the NTHi-Mcat Anti-UspA2 (Ubiquitous Surface Protein A2 of Moraxella Catarrhalis) Vaccine Component | Anti-UspA2 IgG antibody, Day 210 | 767.2 EL.U/mL |
| GSK3277513A F3 Group | Concentration of Antibodies Against the NTHi-Mcat Anti-UspA2 (Ubiquitous Surface Protein A2 of Moraxella Catarrhalis) Vaccine Component | Anti-UspA2 IgG antibody, Day 0 | 468.1 EL.U/mL |
| PLACEBO Group | Concentration of Antibodies Against the NTHi-Mcat Anti-UspA2 (Ubiquitous Surface Protein A2 of Moraxella Catarrhalis) Vaccine Component | Anti-UspA2 IgG antibody, Day 210 | 525.7 EL.U/mL |
| PLACEBO Group | Concentration of Antibodies Against the NTHi-Mcat Anti-UspA2 (Ubiquitous Surface Protein A2 of Moraxella Catarrhalis) Vaccine Component | Anti-UspA2 IgG antibody, Day 420 | 552.9 EL.U/mL |
| PLACEBO Group | Concentration of Antibodies Against the NTHi-Mcat Anti-UspA2 (Ubiquitous Surface Protein A2 of Moraxella Catarrhalis) Vaccine Component | Anti-UspA2 IgG antibody, Day 30 | 571.5 EL.U/mL |
| PLACEBO Group | Concentration of Antibodies Against the NTHi-Mcat Anti-UspA2 (Ubiquitous Surface Protein A2 of Moraxella Catarrhalis) Vaccine Component | Anti-UspA2 IgG antibody, Day 90 | 621.5 EL.U/mL |
| PLACEBO Group | Concentration of Antibodies Against the NTHi-Mcat Anti-UspA2 (Ubiquitous Surface Protein A2 of Moraxella Catarrhalis) Vaccine Component | Anti-UspA2 IgG antibody, Day 0 | 548.3 EL.U/mL |
| PLACEBO Group | Concentration of Antibodies Against the NTHi-Mcat Anti-UspA2 (Ubiquitous Surface Protein A2 of Moraxella Catarrhalis) Vaccine Component | Anti-UspA2 IgG antibody, Day 60 | 567 EL.U/mL |
Secondary
Frequency of Specific CD8+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response
Frequency of specific CD8+ T-cells are measured by flow cytometry intracellular cytokine staining (ICS) expressing two or more markers (such as IL-2, IL-13, IL-17, IFN-γ, TNF-α and CD40L). The frequency of specific CD8+ T-cells are summarised \[descriptive statistics: Mean and standard deviation (SD)\] against each antigen (PD, PE, PilA and UspA2), by group in Step 2 at each time point during which blood samples are collected for CMI.
Time frame: At Day 0 (pre-dose 1); at Day 60 (post-dose 1); at Day 90, Day 210 and Day 420 (post-dose2).
Population: The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome variables were available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK3277513A F1 Group | Frequency of Specific CD8+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response | CD8+.UspA2, Day 60 | 29.3 CD8+ T-cells/million cells | Standard Deviation 67.7 |
| GSK3277513A F1 Group | Frequency of Specific CD8+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response | CD8+.PE, Day 60 | 27.8 CD8+ T-cells/million cells | Standard Deviation 46.77 |
| GSK3277513A F1 Group | Frequency of Specific CD8+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response | CD8+.PilA, Day 420 | 28 CD8+ T-cells/million cells | Standard Deviation 50.45 |
| GSK3277513A F1 Group | Frequency of Specific CD8+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response | CD8+.PD, Day 0 | 66 CD8+ T-cells/million cells | Standard Deviation 88.69 |
| GSK3277513A F1 Group | Frequency of Specific CD8+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response | CD8+.PE, Day 90 | 30.4 CD8+ T-cells/million cells | Standard Deviation 52.48 |
| GSK3277513A F1 Group | Frequency of Specific CD8+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response | CD8+.PD, Day 60 | 29.4 CD8+ T-cells/million cells | Standard Deviation 49.67 |
| GSK3277513A F1 Group | Frequency of Specific CD8+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response | CD8+.PD, Day 90 | 66.5 CD8+ T-cells/million cells | Standard Deviation 97.16 |
| GSK3277513A F1 Group | Frequency of Specific CD8+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response | CD8+.PE, Day 210 | 31.8 CD8+ T-cells/million cells | Standard Deviation 52.08 |
| GSK3277513A F1 Group | Frequency of Specific CD8+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response | CD8+.UspA2, Day 90 | 74.1 CD8+ T-cells/million cells | Standard Deviation 99.92 |
| GSK3277513A F1 Group | Frequency of Specific CD8+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response | CD8+.PilA, Day 210 | 11.3 CD8+ T-cells/million cells | Standard Deviation 19.17 |
| GSK3277513A F1 Group | Frequency of Specific CD8+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response | CD8+.PE, Day 420 | 5.7 CD8+ T-cells/million cells | Standard Deviation 10.89 |
| GSK3277513A F1 Group | Frequency of Specific CD8+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response | CD8+.UspA2, Day 0 | 22.5 CD8+ T-cells/million cells | Standard Deviation 35.07 |
| GSK3277513A F1 Group | Frequency of Specific CD8+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response | CD8+.PE, Day 0 | 42.4 CD8+ T-cells/million cells | Standard Deviation 52.5 |
| GSK3277513A F1 Group | Frequency of Specific CD8+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response | CD8+.PilA, Day 0 | 34.6 CD8+ T-cells/million cells | Standard Deviation 57.02 |
| GSK3277513A F1 Group | Frequency of Specific CD8+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response | CD8+.UspA2, Day 420 | 16.7 CD8+ T-cells/million cells | Standard Deviation 24.45 |
| GSK3277513A F1 Group | Frequency of Specific CD8+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response | CD8+.PD, Day 210 | 66.4 CD8+ T-cells/million cells | Standard Deviation 101.79 |
| GSK3277513A F1 Group | Frequency of Specific CD8+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response | CD8+.PilA, Day 60 | 26 CD8+ T-cells/million cells | Standard Deviation 82.07 |
| GSK3277513A F1 Group | Frequency of Specific CD8+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response | CD8+.UspA2, Day 210 | 61.5 CD8+ T-cells/million cells | Standard Deviation 89.07 |
| GSK3277513A F1 Group | Frequency of Specific CD8+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response | CD8+.PD, Day 420 | 43.2 CD8+ T-cells/million cells | Standard Deviation 51.32 |
| GSK3277513A F1 Group | Frequency of Specific CD8+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response | CD8+.PilA, Day 90 | 50.8 CD8+ T-cells/million cells | Standard Deviation 82.01 |
| GSK3277513A F2 Group | Frequency of Specific CD8+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response | CD8+.PD, Day 60 | 1 CD8+ T-cells/million cells | Standard Deviation 0 |
| GSK3277513A F2 Group | Frequency of Specific CD8+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response | CD8+.PilA, Day 210 | 30.9 CD8+ T-cells/million cells | Standard Deviation 70.04 |
| GSK3277513A F2 Group | Frequency of Specific CD8+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response | CD8+.PilA, Day 420 | 23 CD8+ T-cells/million cells | Standard Deviation 37.7 |
| GSK3277513A F2 Group | Frequency of Specific CD8+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response | CD8+.UspA2, Day 0 | 34.9 CD8+ T-cells/million cells | Standard Deviation 50.24 |
| GSK3277513A F2 Group | Frequency of Specific CD8+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response | CD8+.PD, Day 420 | 10.6 CD8+ T-cells/million cells | Standard Deviation 17.98 |
| GSK3277513A F2 Group | Frequency of Specific CD8+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response | CD8+.UspA2, Day 60 | 27.7 CD8+ T-cells/million cells | Standard Deviation 50.12 |
| GSK3277513A F2 Group | Frequency of Specific CD8+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response | CD8+.UspA2, Day 90 | 20.6 CD8+ T-cells/million cells | Standard Deviation 26.17 |
| GSK3277513A F2 Group | Frequency of Specific CD8+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response | CD8+.UspA2, Day 210 | 17.3 CD8+ T-cells/million cells | Standard Deviation 26.54 |
| GSK3277513A F2 Group | Frequency of Specific CD8+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response | CD8+.UspA2, Day 420 | 25.3 CD8+ T-cells/million cells | Standard Deviation 70.42 |
| GSK3277513A F2 Group | Frequency of Specific CD8+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response | CD8+.PE, Day 0 | 33.3 CD8+ T-cells/million cells | Standard Deviation 59.32 |
| GSK3277513A F2 Group | Frequency of Specific CD8+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response | CD8+.PilA, Day 90 | 27.9 CD8+ T-cells/million cells | Standard Deviation 43.03 |
| GSK3277513A F2 Group | Frequency of Specific CD8+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response | CD8+.PE, Day 60 | 26.1 CD8+ T-cells/million cells | Standard Deviation 40.81 |
| GSK3277513A F2 Group | Frequency of Specific CD8+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response | CD8+.PE, Day 90 | 19.8 CD8+ T-cells/million cells | Standard Deviation 43.69 |
| GSK3277513A F2 Group | Frequency of Specific CD8+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response | CD8+.PE, Day 210 | 30.6 CD8+ T-cells/million cells | Standard Deviation 62.25 |
| GSK3277513A F2 Group | Frequency of Specific CD8+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response | CD8+.PD, Day 90 | 7.7 CD8+ T-cells/million cells | Standard Deviation 21.19 |
| GSK3277513A F2 Group | Frequency of Specific CD8+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response | CD8+.PE, Day 420 | 27 CD8+ T-cells/million cells | Standard Deviation 58.46 |
| GSK3277513A F2 Group | Frequency of Specific CD8+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response | CD8+.PD, Day 0 | 27.9 CD8+ T-cells/million cells | Standard Deviation 80.68 |
| GSK3277513A F2 Group | Frequency of Specific CD8+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response | CD8+.PilA, Day 0 | 16 CD8+ T-cells/million cells | Standard Deviation 40.27 |
| GSK3277513A F2 Group | Frequency of Specific CD8+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response | CD8+.PilA, Day 60 | 35.1 CD8+ T-cells/million cells | Standard Deviation 39.81 |
| GSK3277513A F2 Group | Frequency of Specific CD8+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response | CD8+.PD, Day 210 | 16.8 CD8+ T-cells/million cells | Standard Deviation 42.84 |
| GSK3277513A F3 Group | Frequency of Specific CD8+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response | CD8+.UspA2, Day 420 | 48.8 CD8+ T-cells/million cells | Standard Deviation 86.71 |
| GSK3277513A F3 Group | Frequency of Specific CD8+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response | CD8+.UspA2, Day 90 | 37.4 CD8+ T-cells/million cells | Standard Deviation 76.73 |
| GSK3277513A F3 Group | Frequency of Specific CD8+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response | CD8+.PD, Day 0 | 46.9 CD8+ T-cells/million cells | Standard Deviation 73.28 |
| GSK3277513A F3 Group | Frequency of Specific CD8+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response | CD8+.PD, Day 60 | 20.5 CD8+ T-cells/million cells | Standard Deviation 55.1 |
| GSK3277513A F3 Group | Frequency of Specific CD8+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response | CD8+.PD, Day 90 | 49 CD8+ T-cells/million cells | Standard Deviation 64.89 |
| GSK3277513A F3 Group | Frequency of Specific CD8+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response | CD8+.PD, Day 210 | 17.7 CD8+ T-cells/million cells | Standard Deviation 33.01 |
| GSK3277513A F3 Group | Frequency of Specific CD8+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response | CD8+.PD, Day 420 | 37.3 CD8+ T-cells/million cells | Standard Deviation 70.58 |
| GSK3277513A F3 Group | Frequency of Specific CD8+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response | CD8+.PE, Day 0 | 74.4 CD8+ T-cells/million cells | Standard Deviation 175.42 |
| GSK3277513A F3 Group | Frequency of Specific CD8+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response | CD8+.PE, Day 60 | 42.7 CD8+ T-cells/million cells | Standard Deviation 107.03 |
| GSK3277513A F3 Group | Frequency of Specific CD8+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response | CD8+.PE, Day 90 | 45.4 CD8+ T-cells/million cells | Standard Deviation 82.76 |
| GSK3277513A F3 Group | Frequency of Specific CD8+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response | CD8+.PE, Day 210 | 44.2 CD8+ T-cells/million cells | Standard Deviation 85.37 |
| GSK3277513A F3 Group | Frequency of Specific CD8+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response | CD8+.PE, Day 420 | 19.4 CD8+ T-cells/million cells | Standard Deviation 44.74 |
| GSK3277513A F3 Group | Frequency of Specific CD8+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response | CD8+.PilA, Day 0 | 44.7 CD8+ T-cells/million cells | Standard Deviation 58.58 |
| GSK3277513A F3 Group | Frequency of Specific CD8+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response | CD8+.PilA, Day 60 | 28.7 CD8+ T-cells/million cells | Standard Deviation 72.65 |
| GSK3277513A F3 Group | Frequency of Specific CD8+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response | CD8+.PilA, Day 90 | 28.3 CD8+ T-cells/million cells | Standard Deviation 45.69 |
| GSK3277513A F3 Group | Frequency of Specific CD8+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response | CD8+.PilA, Day 210 | 21.4 CD8+ T-cells/million cells | Standard Deviation 35.86 |
| GSK3277513A F3 Group | Frequency of Specific CD8+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response | CD8+.UspA2, Day 0 | 85.3 CD8+ T-cells/million cells | Standard Deviation 140.42 |
| GSK3277513A F3 Group | Frequency of Specific CD8+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response | CD8+.UspA2, Day 60 | 21 CD8+ T-cells/million cells | Standard Deviation 36.81 |
| GSK3277513A F3 Group | Frequency of Specific CD8+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response | CD8+.UspA2, Day 210 | 48.1 CD8+ T-cells/million cells | Standard Deviation 53.97 |
| GSK3277513A F3 Group | Frequency of Specific CD8+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response | CD8+.PilA, Day 420 | 28 CD8+ T-cells/million cells | Standard Deviation 39.21 |
Secondary
Frequency of Specific Cluster of Differentiation (CD)4+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response
Frequency of specific CD4+ T-cells are measured by flow cytometry intracellular cytokine staining (ICS) expressing two or more markers (such as Interleukin \[IL\]-2, IL-13, IL-17, Interferon gamma \[FN-γ\], Tumour necrosis factor alpha \[TNF-α\] and CD40L). The frequency of specific CD4+ T-cells are summarised \[descriptive statistics: Mean and standard deviation (SD)\] against each antigen (PD, PE, PilA and UspA2), by group in Step 2 at each time point during which blood samples are collected for CMI.
Time frame: At Day 0 (pre-dose 1); at Day 60 (post-dose 1); at Day 90, Day 210 and Day 420 (post-dose2).
Population: The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome variables were available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK3277513A F1 Group | Frequency of Specific Cluster of Differentiation (CD)4+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response | CD4+.PilA, Day 420 | 348.8 CD4+ T-cells/million cells | Standard Deviation 376.87 |
| GSK3277513A F1 Group | Frequency of Specific Cluster of Differentiation (CD)4+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response | CD4+.PE, Day 90 | 1182.2 CD4+ T-cells/million cells | Standard Deviation 1507.29 |
| GSK3277513A F1 Group | Frequency of Specific Cluster of Differentiation (CD)4+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response | CD4+.PD, Day 0 | 28.3 CD4+ T-cells/million cells | Standard Deviation 42.1 |
| GSK3277513A F1 Group | Frequency of Specific Cluster of Differentiation (CD)4+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response | CD4+.PilA, Day 210 | 326 CD4+ T-cells/million cells | Standard Deviation 208.31 |
| GSK3277513A F1 Group | Frequency of Specific Cluster of Differentiation (CD)4+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response | CD4+.PE, Day 210 | 469.1 CD4+ T-cells/million cells | Standard Deviation 381.87 |
| GSK3277513A F1 Group | Frequency of Specific Cluster of Differentiation (CD)4+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response | CD4+.PD, Day 210 | 120.4 CD4+ T-cells/million cells | Standard Deviation 99.23 |
| GSK3277513A F1 Group | Frequency of Specific Cluster of Differentiation (CD)4+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response | CD4+.PilA, Day 90 | 508.6 CD4+ T-cells/million cells | Standard Deviation 474.31 |
| GSK3277513A F1 Group | Frequency of Specific Cluster of Differentiation (CD)4+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response | CD4+.PE, Day 420 | 545 CD4+ T-cells/million cells | Standard Deviation 735.89 |
| GSK3277513A F1 Group | Frequency of Specific Cluster of Differentiation (CD)4+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response | CD4+.UspA2, Day 420 | 723.2 CD4+ T-cells/million cells | Standard Deviation 763.51 |
| GSK3277513A F1 Group | Frequency of Specific Cluster of Differentiation (CD)4+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response | CD4+.PilA, Day 60 | 169.1 CD4+ T-cells/million cells | Standard Deviation 150.22 |
| GSK3277513A F1 Group | Frequency of Specific Cluster of Differentiation (CD)4+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response | CD4+.PilA, Day 0 | 32.8 CD4+ T-cells/million cells | Standard Deviation 43.6 |
| GSK3277513A F1 Group | Frequency of Specific Cluster of Differentiation (CD)4+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response | CD4+.UspA2, Day 90 | 1392.6 CD4+ T-cells/million cells | Standard Deviation 1145.48 |
| GSK3277513A F1 Group | Frequency of Specific Cluster of Differentiation (CD)4+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response | CD4+.PD, Day 420 | 154.3 CD4+ T-cells/million cells | Standard Deviation 165.98 |
| GSK3277513A F1 Group | Frequency of Specific Cluster of Differentiation (CD)4+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response | CD4+.UspA2, Day 210 | 582.9 CD4+ T-cells/million cells | Standard Deviation 376.54 |
| GSK3277513A F1 Group | Frequency of Specific Cluster of Differentiation (CD)4+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response | CD4+.UspA2, Day 60 | 383.9 CD4+ T-cells/million cells | Standard Deviation 326.2 |
| GSK3277513A F1 Group | Frequency of Specific Cluster of Differentiation (CD)4+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response | CD4+.PE, Day 0 | 89.2 CD4+ T-cells/million cells | Standard Deviation 199.87 |
| GSK3277513A F1 Group | Frequency of Specific Cluster of Differentiation (CD)4+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response | CD4+.PD, Day 90 | 283.3 CD4+ T-cells/million cells | Standard Deviation 236.93 |
| GSK3277513A F1 Group | Frequency of Specific Cluster of Differentiation (CD)4+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response | CD4+.UspA2, Day 0 | 115.4 CD4+ T-cells/million cells | Standard Deviation 154.96 |
| GSK3277513A F1 Group | Frequency of Specific Cluster of Differentiation (CD)4+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response | CD4+.PE, Day 60 | 370.7 CD4+ T-cells/million cells | Standard Deviation 372.5 |
| GSK3277513A F1 Group | Frequency of Specific Cluster of Differentiation (CD)4+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response | CD4+.PD, Day 60 | 105.4 CD4+ T-cells/million cells | Standard Deviation 123.95 |
| GSK3277513A F2 Group | Frequency of Specific Cluster of Differentiation (CD)4+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response | CD4+.UspA2, Day 90 | 979.2 CD4+ T-cells/million cells | Standard Deviation 807.03 |
| GSK3277513A F2 Group | Frequency of Specific Cluster of Differentiation (CD)4+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response | CD4+.PD, Day 0 | 81.8 CD4+ T-cells/million cells | Standard Deviation 92.29 |
| GSK3277513A F2 Group | Frequency of Specific Cluster of Differentiation (CD)4+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response | CD4+.PD, Day 60 | 107.8 CD4+ T-cells/million cells | Standard Deviation 117.92 |
| GSK3277513A F2 Group | Frequency of Specific Cluster of Differentiation (CD)4+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response | CD4+.PD, Day 90 | 349.9 CD4+ T-cells/million cells | Standard Deviation 216.5 |
| GSK3277513A F2 Group | Frequency of Specific Cluster of Differentiation (CD)4+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response | CD4+.PD, Day 210 | 176.9 CD4+ T-cells/million cells | Standard Deviation 101.39 |
| GSK3277513A F2 Group | Frequency of Specific Cluster of Differentiation (CD)4+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response | CD4+.PD, Day 420 | 164.8 CD4+ T-cells/million cells | Standard Deviation 123.33 |
| GSK3277513A F2 Group | Frequency of Specific Cluster of Differentiation (CD)4+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response | CD4+.PE, Day 0 | 41.4 CD4+ T-cells/million cells | Standard Deviation 48.55 |
| GSK3277513A F2 Group | Frequency of Specific Cluster of Differentiation (CD)4+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response | CD4+.PE, Day 60 | 176.9 CD4+ T-cells/million cells | Standard Deviation 172.74 |
| GSK3277513A F2 Group | Frequency of Specific Cluster of Differentiation (CD)4+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response | CD4+.PE, Day 90 | 732.7 CD4+ T-cells/million cells | Standard Deviation 804.67 |
| GSK3277513A F2 Group | Frequency of Specific Cluster of Differentiation (CD)4+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response | CD4+.PE, Day 210 | 337.4 CD4+ T-cells/million cells | Standard Deviation 228.12 |
| GSK3277513A F2 Group | Frequency of Specific Cluster of Differentiation (CD)4+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response | CD4+.PE, Day 420 | 215.8 CD4+ T-cells/million cells | Standard Deviation 137.79 |
| GSK3277513A F2 Group | Frequency of Specific Cluster of Differentiation (CD)4+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response | CD4+.PilA, Day 0 | 60.5 CD4+ T-cells/million cells | Standard Deviation 92.87 |
| GSK3277513A F2 Group | Frequency of Specific Cluster of Differentiation (CD)4+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response | CD4+.PilA, Day 60 | 110.2 CD4+ T-cells/million cells | Standard Deviation 67.81 |
| GSK3277513A F2 Group | Frequency of Specific Cluster of Differentiation (CD)4+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response | CD4+.PilA, Day 90 | 330.5 CD4+ T-cells/million cells | Standard Deviation 412.4 |
| GSK3277513A F2 Group | Frequency of Specific Cluster of Differentiation (CD)4+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response | CD4+.PilA, Day 210 | 220.8 CD4+ T-cells/million cells | Standard Deviation 148.59 |
| GSK3277513A F2 Group | Frequency of Specific Cluster of Differentiation (CD)4+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response | CD4+.PilA, Day 420 | 131.1 CD4+ T-cells/million cells | Standard Deviation 75.89 |
| GSK3277513A F2 Group | Frequency of Specific Cluster of Differentiation (CD)4+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response | CD4+.UspA2, Day 0 | 126.3 CD4+ T-cells/million cells | Standard Deviation 97.92 |
| GSK3277513A F2 Group | Frequency of Specific Cluster of Differentiation (CD)4+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response | CD4+.UspA2, Day 60 | 253 CD4+ T-cells/million cells | Standard Deviation 202.76 |
| GSK3277513A F2 Group | Frequency of Specific Cluster of Differentiation (CD)4+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response | CD4+.UspA2, Day 210 | 322.8 CD4+ T-cells/million cells | Standard Deviation 273.5 |
| GSK3277513A F2 Group | Frequency of Specific Cluster of Differentiation (CD)4+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response | CD4+.UspA2, Day 420 | 385.4 CD4+ T-cells/million cells | Standard Deviation 174.08 |
| GSK3277513A F3 Group | Frequency of Specific Cluster of Differentiation (CD)4+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response | CD4+.PD, Day 60 | 55 CD4+ T-cells/million cells | Standard Deviation 91.94 |
| GSK3277513A F3 Group | Frequency of Specific Cluster of Differentiation (CD)4+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response | CD4+.PilA, Day 210 | 43.7 CD4+ T-cells/million cells | Standard Deviation 69.03 |
| GSK3277513A F3 Group | Frequency of Specific Cluster of Differentiation (CD)4+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response | CD4+.PE, Day 60 | 50.9 CD4+ T-cells/million cells | Standard Deviation 47.91 |
| GSK3277513A F3 Group | Frequency of Specific Cluster of Differentiation (CD)4+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response | CD4+.UspA2, Day 420 | 126.6 CD4+ T-cells/million cells | Standard Deviation 187.52 |
| GSK3277513A F3 Group | Frequency of Specific Cluster of Differentiation (CD)4+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response | CD4+.PilA, Day 420 | 59.1 CD4+ T-cells/million cells | Standard Deviation 53.4 |
| GSK3277513A F3 Group | Frequency of Specific Cluster of Differentiation (CD)4+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response | CD4+.PE, Day 0 | 47.1 CD4+ T-cells/million cells | Standard Deviation 70.65 |
| GSK3277513A F3 Group | Frequency of Specific Cluster of Differentiation (CD)4+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response | CD4+.UspA2, Day 210 | 143.9 CD4+ T-cells/million cells | Standard Deviation 242.72 |
| GSK3277513A F3 Group | Frequency of Specific Cluster of Differentiation (CD)4+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response | CD4+.UspA2, Day 0 | 131.1 CD4+ T-cells/million cells | Standard Deviation 182.97 |
| GSK3277513A F3 Group | Frequency of Specific Cluster of Differentiation (CD)4+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response | CD4+.PD, Day 420 | 60.3 CD4+ T-cells/million cells | Standard Deviation 82.01 |
| GSK3277513A F3 Group | Frequency of Specific Cluster of Differentiation (CD)4+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response | CD4+.PD, Day 0 | 37.4 CD4+ T-cells/million cells | Standard Deviation 46.29 |
| GSK3277513A F3 Group | Frequency of Specific Cluster of Differentiation (CD)4+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response | CD4+.UspA2, Day 60 | 278.7 CD4+ T-cells/million cells | Standard Deviation 672.84 |
| GSK3277513A F3 Group | Frequency of Specific Cluster of Differentiation (CD)4+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response | CD4+.PD, Day 210 | 78.7 CD4+ T-cells/million cells | Standard Deviation 112.16 |
| GSK3277513A F3 Group | Frequency of Specific Cluster of Differentiation (CD)4+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response | CD4+.PilA, Day 0 | 32.6 CD4+ T-cells/million cells | Standard Deviation 48.69 |
| GSK3277513A F3 Group | Frequency of Specific Cluster of Differentiation (CD)4+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response | CD4+.PE, Day 420 | 26.6 CD4+ T-cells/million cells | Standard Deviation 51.74 |
| GSK3277513A F3 Group | Frequency of Specific Cluster of Differentiation (CD)4+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response | CD4+.PD, Day 90 | 90.5 CD4+ T-cells/million cells | Standard Deviation 117.41 |
| GSK3277513A F3 Group | Frequency of Specific Cluster of Differentiation (CD)4+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response | CD4+.PilA, Day 60 | 57.1 CD4+ T-cells/million cells | Standard Deviation 99.26 |
| GSK3277513A F3 Group | Frequency of Specific Cluster of Differentiation (CD)4+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response | CD4+.PE, Day 210 | 39.1 CD4+ T-cells/million cells | Standard Deviation 65.14 |
| GSK3277513A F3 Group | Frequency of Specific Cluster of Differentiation (CD)4+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response | CD4+.UspA2, Day 90 | 143.5 CD4+ T-cells/million cells | Standard Deviation 237.29 |
| GSK3277513A F3 Group | Frequency of Specific Cluster of Differentiation (CD)4+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response | CD4+.PilA, Day 90 | 99 CD4+ T-cells/million cells | Standard Deviation 152.45 |
| GSK3277513A F3 Group | Frequency of Specific Cluster of Differentiation (CD)4+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response | CD4+.PE, Day 90 | 52.4 CD4+ T-cells/million cells | Standard Deviation 56.2 |