Herpes Zoster
Conditions
Keywords
immunogenicity, vaccine, safety, HIV, Herpes Zoster
Brief summary
This observer-blind study will evaluate the safety and immunogenicity of GlaxoSmithKline (GSK) Biologicals' investigational Herpes Zoster (HZ) vaccine GSK1437173A in Human Immunodeficiency Virus (HIV) infected subjects, firstly enrolling subjects treated with antiretroviral therapy (ART) and with high CD4 T cell counts, and subsequently ART-treated subjects with low CD4 T cell counts, and ART-naïve subjects with high CD4 T cell counts. This Protocol Posting has been updated following Amendment 1 of the Protocol, August 2010. The impacted sections is exclusion criteria.
Interventions
BIOLOGICALHerpes Zoster Vaccine GSK1437173A
intramuscular injection
BIOLOGICALPlacebo
intramuscular injection
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects who the investigator believes that they can and will comply with the requirements of the protocol; * Male and female subjects at least 18 years old at the time of vaccination; * Subjects born before 1985 and not from a tropical region. Subjects born in 1985 or later and subjects born before 1985 in tropical regions must have a history of Varicella Zoster virus (VZV) infection or serological evidence of prior VZV infection; * 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 current tubal ligation, hysterectomy, ovariectomy or post-menopause. OR 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 vaccination, and has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series; * Known to be human immunodeficiency virus-1 (HIV-1) infected, diagnosed at least 1 year prior to enrolment; * For the antiretroviral therapyART High CD4 and ART Low CD4 cohorts: * Stable on ART for at least one year * CD4 T cell count \>= 50 cells /mm3 at screening * Undetectable VL at screening; * For the non-ART High CD4 cohort: * ART-naïve subjects who have never received anti-retroviral therapy after HIV diagnosis and for whom commencement of ART is not expected based on current assessment within next seven months; * HIV VL \>= 1000 copies/mL and \<= 100 000 copies/mL at screening * CD4 T cell count \>= 500 cells/mm3 at screening.
Exclusion criteria
* Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period; * Vaccination against varicella or herpes zoster (HZ) within the previous 12 months; * Occurrence of a varicella or HZ episode within the previous 12 months; * History of allergic disease or reactions likely to be exacerbated by any component of the vaccine. Additionally, consider allergic reactions to other material or equipment related to study participation. Please note, the vaccine and vials in this study do not contain latex; * Has currently an Acquired Immunodeficiency Syndrome (AIDS) defining condition; * Opportunistic infection or AIDS-associated malignancy in the previous year; * Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease other than HIV infection or immunosuppressive/cytotoxic therapy; * Administration of immunoglobulins, and/or any blood products within 90 days preceding the first dose of study vaccine/placebo or planned administration during the study period; * Chronic administration of immunosuppressive or other immune-modifying drugs within 6 months prior to the first vaccine dose; * Administration and/or planned administration of a vaccine not foreseen by the study protocol within 30 days before dose 1, dose 2 and/or 3 of vaccine and/or within 30 days after any dose. However, licensed non-replicating vaccines may be administered up to 8 days prior to dose 1, 2 and/or 3, and/or at least 14 days after any dose of study vaccine; * 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 product; * Acute disease at the time of enrolment; * Any contraindication to receiving intramuscular injections; * Any condition or illness which might interfere with the evaluation of the safety or immunogenicity of the vaccine; * Active hepatitis B (HBV) infection or active hepatitis C (HCV) infection. * Current use of HIV fusion inhibitors, chemokine (C-C motif) receptor (CCR5) inhibitors or Interleukin-2/ Interleukin-7/ Interferon; * For subjects in the ART cohorts, any change in anti-retroviral drug regimen within 12 weeks prior to vaccination; * Pregnant or lactating female; * Female planning to become pregnant or planning to discontinue contraceptive precautions; * Abnormal biochemical and hematological laboratory values obtained for blood samples collected at screening.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| -Anti-gE Antibody (Ab) Concentrations | At Month 7 | -Anti-gE antibody (Ab) concentrations were determined by Enzyme-Linked Immunosorbent Assay (ELISA) at Month 7 in ART and non-ART cohorts presenting high CD4 counts at enrolment. Antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL). |
| Number of Subjects With Any Significant Change in Antiretroviral Therapy (ART), Including Initiation of ART in ART-naïve Subjects | From Month 0 until Month 18 | In this analysis, results were tabulated for the main study groups. Significant changes to ART appeared due to failure to control HIV viral load and due to failure to maintain high CD4 cells count. |
| Number of Subjects With Any AIDS-defining Condition | From Month 0 until Month 18 | In this analysis, results were tabulated for the main study groups. |
| Number of Subjects With Any Pre-defined Changes in HIV Viral Load (VL) and CD4 T-cell Count | From Month 1 to Month 7 | In this analysis, results were tabulated for the main study groups. |
| Number of Subjects With Any Significant Change in Antiretroviral Therapy (ART), Including Initiation of ART in ART-naïve Subjects, by HIV Status | From Month 0 to Month 18 | In this analysis, results were tabulated by HIV status |
| Number of Subjects With Any AIDS-defining Condition, by HIV Status | From Month 0 to Month 18 | In this analysis, results were tabulated by HIV status |
| Number of Subjects With Any Pre-defined Changes in HIV Viral Load (VL) and CD4 T-cell Count, by HIV Status | From Month 1 to Month 7 | In this analysis, results were tabulated by HIV status. |
| Frequency of gE-specific CD4 T-cells | At Month 7 | The analysis focused on CD4 T-cells expressing at least 2 cytokines (among interferon-gamma (IFN-g) , interleukin-2 (IL-2), tumour necrosis factor-alpha (TNF-a) and/or CD40 ligand (CD40L)) as determined by in vitro intracellular cytokine staining (ICS) at Month 7 in ART and non-ART cohorts presenting high CD4 counts at enrollment. |
| Number of Subjects With Serious Adverse Events (SAEs) | From Month 0 to Month 18 | Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. |
| Number of Subjects With SAEs Related to Study Participation or to a Concurrent GSK Medication/Vaccine | From screening (up to 21 days prior to Month 0) until Month 18 | Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. |
| Number of Subjects With Any Fatal SAEs | From screening (up to 21 days prior to Month 0) until Month 18 | Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. |
| Number of Subjects With Any Adverse Events (AEs) of Specific Interest | From Month 0 until Month 18 | AEs of specific interest include new onset of autoimmune diseases (NOADs) and other immune mediated inflammatory disorders from administration of the first dose of vaccine/placebo. |
| Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms | Within the 7-day (Days 0-6) post-vaccination period following each dose and across doses | Assessed solicited local symptoms were pain, redness and swelling. Any = incidence of a particular symptom regardless of their intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site. |
| Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Within the 7-day (Days 0-6) post-vaccination period following each dose and across doses | Assessed solicited general symptoms were fatigue, gastrointestinal (symptoms included nausea, vomiting, diarrhoea and/or abdominal pain), headache, myalgia, shivering and temperature \[defined as oral/axillary temperature above (\>) 37.5 degrees Celsius (°C)\]. Any = incidence of a particular symptom regardless of their intensity grade or relationship to vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever \> 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. |
| Number of Subjects With Unsolicited AEs | Within 30 days (Days 0-29) after each vaccination | An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination. |
| Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | At Screening Visit (up to 21 days prior to Month 0) | The assessed parameters were Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Aspartate Aminotransferase, Basophils, Bilirubin Total, Bilirubin Conjugated / Direct, Creatinine, Eosinophils, Glucose, Bicarbonate, Haemoglobin, Potassium, Lymphocytes, Monocytes, Sodium, Neutrophils, Platelets and White Blood Cells. Tabulation was made by relation to the normal laboratory ranges: below, within or above, and also status unknown. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| -Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells, by HIV Status | At Months 0, 1, 2, 3, 6, 7 and 18 | The analysis focused on CD4 T-cells expressing at least 2 cytokines (among IFN-g, IL-2, TNF-a and/or CD40L as determined by ICS at Months 0, 1, 2, 3, 6, 7 and 18 and tabulated by HIV status. |
| -Anti-VZV and Anti-gE Antibody Concentrations | At Months 0, 1, 2, 3, 6, 7 and 18 | Antibody concentrations were as determined by ELISA and tabulated for the main study groups. Anti-VZV and anti-gE antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in mIU/mL. |
| -Anti-VZV and Anti-gE Antibody Concentrations, by HIV Status | At Months 0, 1, 2, 3, 6, 7 and 18 | Antibody concentrations were as determined by ELISA and tabulated by HIV status. Anti-VZV and anti-gE antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in mIU/mL. |
| Number of Subjects With Any Herpes Zoster (HZ) Cases and Complications | From Month 0 until Month 18 | — |
| CD4 Count | At Screening Visit (up to 21 days prior to Month 0), Months 1, 2, 3, 6, 7 and 18 | CD4 count was tabulated by HIV status. |
| HIV VL | At Screening Visit (up to 21 days prior to Month 0), Months 1, 2, 3, 6, 7 and 18 | HIV VL was tabulated by HIV status, for subjects with a number of available results greater than or equal to (≥) 40 copies/mL. |
| -Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells | At Month 0, 1, 2, 3, 6, 7 and 18 | The analysis focused on CD4 T cells expressing at least 2 cytokines (among IFN-g, IL-2, TNF-a and/or CD40L as determined by ICS at Months 0, 1, 2, 3, 6, 7 and 18 and tabulated for the main study groups. |
Countries
Germany, United Kingdom, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| GSK1437173A Group Subjects who received three doses of GSK1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm. | 74 |
| Placebo Group Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm. | 49 |
| Total | 123 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Active Phase | Lost to Follow-up | 2 | 0 |
| Active Phase | Migrated/moved from study area | 0 | 1 |
| Active Phase | Serious Adverse Event | 1 | 0 |
| Active Phase | Withdrawal by Subject | 2 | 1 |
| Extended Safety Follow-up Phase | Lost to Follow-up | 2 | 0 |
| Extended Safety Follow-up Phase | Migrated/moved from study area | 2 | 1 |
| Extended Safety Follow-up Phase | Other-subjects business reasons | 0 | 1 |
| Extended Safety Follow-up Phase | Serious Adverse Event | 1 | 0 |
| Extended Safety Follow-up Phase | Withdrawal by Subject | 2 | 2 |
Baseline characteristics
| Characteristic | GSK1437173A Group | Placebo Group | Total |
|---|---|---|---|
| Age, Continuous | 46.6 Years STANDARD_DEVIATION 10.68 | 45.1 Years STANDARD_DEVIATION 11.36 | 46.0 Years STANDARD_DEVIATION 10.93 |
| Race/Ethnicity, Customized African heritage/African American | 6 Participants | 2 Participants | 8 Participants |
| Race/Ethnicity, Customized Asian-East Asian heritage | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Asian-Japanese heritage | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Unspecified | 1 Participants | 4 Participants | 5 Participants |
| Race/Ethnicity, Customized White-Caucasian/European heritage | 66 Participants | 42 Participants | 108 Participants |
| Sex: Female, Male Female | 5 Participants | 2 Participants | 7 Participants |
| Sex: Female, Male Male | 69 Participants | 47 Participants | 116 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 74 | 0 / 49 |
| other Total, other adverse events | 72 / 74 | 29 / 49 |
| serious Total, serious adverse events | 6 / 74 | 2 / 49 |
Outcome results
Primary
-Anti-gE Antibody (Ab) Concentrations
-Anti-gE antibody (Ab) concentrations were determined by Enzyme-Linked Immunosorbent Assay (ELISA) at Month 7 in ART and non-ART cohorts presenting high CD4 counts at enrolment. Antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL).
Time frame: At Month 7
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| GSK1437173A Group | -Anti-gE Antibody (Ab) Concentrations | 63812.6 mIU/mL |
| Placebo Group | -Anti-gE Antibody (Ab) Concentrations | 1028.4 mIU/mL |
Primary
Frequency of gE-specific CD4 T-cells
The analysis focused on CD4 T-cells expressing at least 2 cytokines (among interferon-gamma (IFN-g) , interleukin-2 (IL-2), tumour necrosis factor-alpha (TNF-a) and/or CD40 ligand (CD40L)) as determined by in vitro intracellular cytokine staining (ICS) at Month 7 in ART and non-ART cohorts presenting high CD4 counts at enrollment.
Time frame: At Month 7
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available at Month 7.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GSK1437173A Group | Frequency of gE-specific CD4 T-cells | 4684.50 CD4 T-cells/million T-cells | Standard Deviation 5376.83 |
| Placebo Group | Frequency of gE-specific CD4 T-cells | 158.64 CD4 T-cells/million T-cells | Standard Deviation 151.15 |
Primary
Number of Subjects With Any Adverse Events (AEs) of Specific Interest
AEs of specific interest include new onset of autoimmune diseases (NOADs) and other immune mediated inflammatory disorders from administration of the first dose of vaccine/placebo.
Time frame: From Month 0 until Month 18
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK1437173A Group | Number of Subjects With Any Adverse Events (AEs) of Specific Interest | 0 Participants |
| Placebo Group | Number of Subjects With Any Adverse Events (AEs) of Specific Interest | 0 Participants |
Primary
Number of Subjects With Any AIDS-defining Condition
In this analysis, results were tabulated for the main study groups.
Time frame: From Month 0 until Month 18
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK1437173A Group | Number of Subjects With Any AIDS-defining Condition | 0 Participants |
| Placebo Group | Number of Subjects With Any AIDS-defining Condition | 0 Participants |
Primary
Number of Subjects With Any AIDS-defining Condition, by HIV Status
In this analysis, results were tabulated by HIV status
Time frame: From Month 0 to Month 18
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK1437173A Group | Number of Subjects With Any AIDS-defining Condition, by HIV Status | 0 Participants |
| Placebo Group | Number of Subjects With Any AIDS-defining Condition, by HIV Status | 0 Participants |
| ART Low CD4 Cohort - GSK 1437173A | Number of Subjects With Any AIDS-defining Condition, by HIV Status | 0 Participants |
| ART Low CD4 Cohort - Placebo | Number of Subjects With Any AIDS-defining Condition, by HIV Status | 0 Participants |
| Non-ART High CD4 Cohort - GSK 1437173A | Number of Subjects With Any AIDS-defining Condition, by HIV Status | 0 Participants |
| Non-ART High CD4 Cohort - Placebo | Number of Subjects With Any AIDS-defining Condition, by HIV Status | 0 Participants |
Primary
Number of Subjects With Any Fatal SAEs
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time frame: From screening (up to 21 days prior to Month 0) until Month 18
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK1437173A Group | Number of Subjects With Any Fatal SAEs | 0 Participants |
| Placebo Group | Number of Subjects With Any Fatal SAEs | 0 Participants |
Primary
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Assessed solicited general symptoms were fatigue, gastrointestinal (symptoms included nausea, vomiting, diarrhoea and/or abdominal pain), headache, myalgia, shivering and temperature \[defined as oral/axillary temperature above (\>) 37.5 degrees Celsius (°C)\]. Any = incidence of a particular symptom regardless of their intensity grade or relationship to vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever \> 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
Time frame: Within the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Dose 1 | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Temperature, Dose 2 | 12 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Temperature, Dose 1 | 7 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Temperature, Dose 2 | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Dose 1 | 25 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Temperature, Dose 2 | 10 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Temperature, Dose 1 | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Dose 3 | 36 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Temperature, Across doses | 17 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Dose 3 | 7 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Temperature, Dose 1 | 2 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Dose 3 | 24 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Dose 1 | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal, Dose 3 | 8 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Dose 2 | 41 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal, Dose 3 | 1 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Dose 1 | 17 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal, Dose 3 | 5 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Myalgia, Across doses | 10 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Dose 3 | 33 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Dose 2 | 7 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Dose 3 | 4 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Dose 1 | 16 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Dose 3 | 21 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Dose 2 | 25 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Myalgia, Dose 3 | 32 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Temperature, Across doses | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Myalgia, Dose 3 | 6 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal, Dose 2 | 18 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Myalgia, Dose 3 | 22 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Myalgia, Dose 1 | 34 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Shivering, Dose 3 | 20 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal, Dose 2 | 1 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Shivering, Dose 3 | 7 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal, Dose 1 | 13 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Shivering, Dose 3 | 14 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal, Dose 2 | 8 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Temperature, Dose 3 | 11 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Myalgia, Dose 1 | 4 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Temperature, Dose 3 | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Dose 2 | 32 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Temperature, Dose 3 | 6 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Dose 1 | 30 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Across doses | 55 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Dose 2 | 3 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Across doses | 12 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Myalgia, Dose 1 | 26 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Across doses | 41 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Dose 2 | 18 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal, Across doses | 28 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal, Dose 1 | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal, Across doses | 2 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Myalgia, Dose 2 | 33 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal, Across doses | 16 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Shivering, Dose 1 | 19 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Across doses | 47 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Temperature, Across doses | 22 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Across doses | 6 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Myalgia, Dose 2 | 1 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Across doses | 34 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Shivering, Dose 1 | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Myalgia, Across doses | 54 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Myalgia, Dose 2 | 24 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Shivering, Dose 2 | 23 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Myalgia, Across doses | 44 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal, Dose 1 | 6 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Shivering, Across doses | 37 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Shivering, Dose 2 | 4 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Shivering, Across doses | 11 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Shivering, Dose 1 | 11 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Shivering, Across doses | 29 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Shivering, Dose 2 | 17 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal, Dose 3 | 2 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Temperature, Across doses | 3 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Temperature, Across doses | 0 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Temperature, Across doses | 2 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Dose 1 | 13 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Dose 1 | 3 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Dose 1 | 8 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal, Dose 1 | 8 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal, Dose 1 | 0 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal, Dose 1 | 6 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Dose 1 | 10 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Dose 1 | 1 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Dose 1 | 6 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Myalgia, Dose 1 | 6 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Myalgia, Dose 1 | 0 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Myalgia, Dose 1 | 6 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Shivering, Dose 1 | 5 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Shivering, Dose 1 | 0 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Shivering, Dose 1 | 5 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Temperature, Dose 1 | 2 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Temperature, Dose 1 | 0 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Temperature, Dose 1 | 2 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Dose 2 | 8 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Dose 2 | 3 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Dose 2 | 5 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal, Dose 2 | 3 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal, Dose 2 | 1 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal, Dose 2 | 1 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Dose 2 | 3 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Dose 2 | 0 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Dose 2 | 1 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Myalgia, Dose 2 | 2 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Myalgia, Dose 2 | 4 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Myalgia, Dose 2 | 1 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Shivering, Dose 2 | 1 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Shivering, Dose 2 | 0 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Shivering, Dose 2 | 1 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Temperature, Dose 2 | 1 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Temperature, Dose 2 | 0 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Temperature, Dose 2 | 0 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Dose 3 | 6 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Dose 3 | 1 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Dose 3 | 3 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal, Dose 3 | 4 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal, Dose 3 | 0 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Dose 3 | 7 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Dose 3 | 1 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Dose 3 | 3 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Myalgia, Dose 3 | 1 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Myalgia, Dose 3 | 0 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Myalgia, Dose 3 | 1 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Shivering, Dose 3 | 1 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Shivering, Dose 3 | 0 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Shivering, Dose 3 | 1 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Temperature, Dose 3 | 1 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Temperature, Dose 3 | 0 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Temperature, Dose 3 | 0 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Across doses | 14 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Across doses | 4 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Across doses | 8 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal, Across doses | 11 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal, Across doses | 1 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal, Across doses | 7 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Across doses | 15 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Across doses | 2 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Across doses | 8 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Myalgia, Across doses | 9 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Myalgia, Across doses | 1 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Myalgia, Across doses | 8 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Shivering, Across doses | 5 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Shivering, Across doses | 0 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Shivering, Across doses | 5 Participants |
Primary
Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms
Assessed solicited local symptoms were pain, redness and swelling. Any = incidence of a particular symptom regardless of their intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.
Time frame: Within the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented, who had their symptom sheets filled in.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms | Grade 3 Pain, Dose 1 | 4 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms | Any Pain, Dose 3 | 43 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms | Any Pain, Dose 2 | 57 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms | Grade 3 Pain, Dose 3 | 7 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms | Grade 3 Redness, Dose 1 | 2 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms | Any Redness, Dose 3 | 9 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms | Grade 3 Swelling, Across doses | 1 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms | Grade 3 Redness, Dose 3 | 2 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms | Grade 3 Pain, Dose 2 | 8 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms | Any Swelling, Dose 3 | 5 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms | Any Pain, Dose 1 | 69 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms | Grade 3 Swelling, Dose 3 | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms | Any Redness, Dose 2 | 19 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms | Any Pain, Across doses | 72 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms | Any Swelling, Dose 1 | 12 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms | Grade 3 Pain, Across doses | 12 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms | Grade 3 Redness, Dose 2 | 1 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms | Any Redness, Across doses | 28 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms | Any Redness, Dose 1 | 17 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms | Grade 3 Redness, Across doses | 4 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms | Any Swelling, Dose 2 | 11 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms | Any Swelling, Across doses | 20 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms | Grade 3 Swelling, Dose 1 | 1 Participants |
| GSK1437173A Group | Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms | Grade 3 Swelling, Dose 2 | 0 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms | Any Redness, Dose 3 | 0 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms | Any Pain, Dose 1 | 4 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms | Grade 3 Pain, Dose 1 | 0 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms | Any Redness, Dose 1 | 0 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms | Grade 3 Redness, Dose 1 | 0 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms | Any Swelling, Dose 1 | 0 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms | Grade 3 Swelling, Dose 1 | 0 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms | Any Pain, Dose 2 | 3 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms | Grade 3 Pain, Dose 2 | 0 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms | Any Redness, Dose 2 | 0 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms | Grade 3 Redness, Dose 2 | 0 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms | Any Swelling, Dose 2 | 0 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms | Grade 3 Swelling, Dose 2 | 0 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms | Any Pain, Dose 3 | 1 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms | Grade 3 Pain, Dose 3 | 0 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms | Grade 3 Redness, Dose 3 | 0 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms | Any Swelling, Dose 3 | 0 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms | Grade 3 Swelling, Dose 3 | 0 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms | Any Pain, Across doses | 6 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms | Grade 3 Pain, Across doses | 0 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms | Any Redness, Across doses | 0 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms | Grade 3 Redness, Across doses | 0 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms | Any Swelling, Across doses | 0 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms | Grade 3 Swelling, Across doses | 0 Participants |
Primary
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
The assessed parameters were Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Aspartate Aminotransferase, Basophils, Bilirubin Total, Bilirubin Conjugated / Direct, Creatinine, Eosinophils, Glucose, Bicarbonate, Haemoglobin, Potassium, Lymphocytes, Monocytes, Sodium, Neutrophils, Platelets and White Blood Cells. Tabulation was made by relation to the normal laboratory ranges: below, within or above, and also status unknown.
Time frame: At Month 2
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Lymphocytes | Above | 2 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Haemoglobin | Unknown | 1 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Neutrophils | Below | 7 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Alanine Aminotransferase | Unknown | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Alanine Aminotransferase | Below | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Alanine Aminotransferase | Within | 67 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Alanine Aminotransferase | Above | 4 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Albumin | Unknown | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Albumin | Below | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Albumin | Within | 67 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Albumin | Above | 4 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Alkaline Phosphatase | Unknown | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Alkaline Phosphatase | Below | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Alkaline Phosphatase | Within | 68 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Alkaline Phosphatase | Above | 3 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Aspartate Aminotransferase | Unknown | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Aspartate Aminotransferase | Below | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Aspartate Aminotransferase | Within | 67 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Aspartate Aminotransferase | Above | 4 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Basophils | Unknown | 1 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Basophils | Below | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Basophils | Within | 70 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Basophils | Above | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Total Bilirubin | Unknown | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Total Bilirubin | Below | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Total Bilirubin | Above | 7 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Bilirubin Conjugated/Direct | Unknown | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Bilirubin Conjugated/Direct | Below | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Bilirubin Conjugated/Direct | Within | 69 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Bilirubin Conjugated/Direct | Above | 2 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Creatinine | Unknown | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Creatinine | Below | 5 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Creatinine | Within | 65 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Creatinine | Above | 1 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Eosinophils | Unknown | 1 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Eosinophils | Below | 9 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Eosinophils | Within | 61 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Eosinophils | Above | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Glucose | Unknown | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Glucose | Below | 2 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Glucose | Within | 59 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Glucose | Above | 10 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Bicarbonate | Unknown | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Bicarbonate | Below | 2 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Bicarbonate | Within | 69 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Bicarbonate | Above | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Haemoglobin | Below | 15 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Haemoglobin | Within | 53 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Haemoglobin | Above | 2 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Potassium | Unknown | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Potassium | Below | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Potassium | Within | 70 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Potassium | Above | 1 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Lymphocytes | Unknown | 1 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Lymphocytes | Below | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Lymphocytes | Within | 68 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Total Bilirubin | Within | 64 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Monocytes | Unknown | 1 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Monocytes | Below | 4 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Monocytes | Within | 66 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Monocytes | Above | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Sodium | Unknown | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Sodium | Below | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Sodium | Within | 70 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Sodium | Above | 1 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Neutrophils | Unknown | 1 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Neutrophils | Within | 63 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Neutrophils | Above | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Platelets | Unknown | 1 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Platelets | Below | 1 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Platelets | Within | 69 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Platelets | Above | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | White Blood Cells | Unknown | 1 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | White Blood Cells | Below | 6 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | White Blood Cells | Within | 64 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | White Blood Cells | Above | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Lymphocytes | Above | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Total Bilirubin | Within | 44 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Bilirubin Conjugated/Direct | Above | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Glucose | Unknown | 1 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Monocytes | Below | 4 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Neutrophils | Unknown | 2 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Neutrophils | Within | 43 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Glucose | Below | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Alanine Aminotransferase | Unknown | 1 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Monocytes | Unknown | 2 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Alanine Aminotransferase | Below | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Glucose | Within | 38 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Alanine Aminotransferase | Within | 40 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Platelets | Above | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Alanine Aminotransferase | Above | 6 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Glucose | Above | 8 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Albumin | Unknown | 1 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Neutrophils | Above | 1 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Albumin | Below | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Bicarbonate | Unknown | 1 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Albumin | Within | 44 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Monocytes | Within | 41 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Albumin | Above | 2 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Bicarbonate | Below | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Alkaline Phosphatase | Unknown | 1 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | White Blood Cells | Above | 2 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Alkaline Phosphatase | Below | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Bicarbonate | Within | 46 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Alkaline Phosphatase | Within | 42 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Monocytes | Above | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Alkaline Phosphatase | Above | 4 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Bicarbonate | Above | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Aspartate Aminotransferase | Unknown | 1 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Haemoglobin | Unknown | 2 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Aspartate Aminotransferase | Below | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Platelets | Unknown | 2 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Aspartate Aminotransferase | Within | 43 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Haemoglobin | Below | 5 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Aspartate Aminotransferase | Above | 3 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Sodium | Unknown | 1 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Basophils | Unknown | 2 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Haemoglobin | Within | 38 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Basophils | Below | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | White Blood Cells | Unknown | 2 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Basophils | Within | 45 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Haemoglobin | Above | 2 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Basophils | Above | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Sodium | Below | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Total Bilirubin | Unknown | 1 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Potassium | Unknown | 1 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Total Bilirubin | Below | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Platelets | Below | 2 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Total Bilirubin | Above | 2 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Potassium | Below | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Bilirubin Conjugated/Direct | Unknown | 1 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Sodium | Within | 46 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Bilirubin Conjugated/Direct | Below | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Potassium | Within | 46 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Bilirubin Conjugated/Direct | Within | 46 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | White Blood Cells | Within | 41 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Potassium | Above | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Creatinine | Unknown | 1 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Sodium | Above | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Creatinine | Below | 7 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Lymphocytes | Unknown | 2 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Creatinine | Within | 39 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Platelets | Within | 43 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Creatinine | Above | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Lymphocytes | Below | 1 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Eosinophils | Unknown | 2 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Neutrophils | Below | 1 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Eosinophils | Below | 7 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Lymphocytes | Within | 44 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Eosinophils | Within | 37 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | White Blood Cells | Below | 2 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Eosinophils | Above | 1 Participants |
Primary
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
The assessed parameters were Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Aspartate Aminotransferase, Basophils, Bilirubin Total, Bilirubin Conjugated / Direct, Creatinine, Eosinophils, Glucose, Bicarbonate, Haemoglobin, Potassium, Lymphocytes, Monocytes, Sodium, Neutrophils, Platelets and White Blood Cells. Tabulation was made by relation to the normal laboratory ranges: below, within or above, and also status unknown.
Time frame: At Screening Visit (up to 21 days prior to Month 0)
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Bicarbonate | Above | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Neutrophils | Below | 5 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Neutrophils | Within | 69 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Platelets | Within | 70 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Platelets | Above | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Alanine Aminotransferase | Unknown | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Alanine Aminotransferase | Below | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Alanine Aminotransferase | Within | 70 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Alanine Aminotransferase | Above | 4 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Albumin | Unknown | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Albumin | Below | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Albumin | Within | 72 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Albumin | Above | 2 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Alkaline Phosphatase | Unknown | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Alkaline Phosphatase | Below | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Alkaline Phosphatase | Within | 70 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Alkaline Phosphatase | Above | 4 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Aspartate Aminotransferase | Unknown | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Aspartate Aminotransferase | Below | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Aspartate Aminotransferase | Within | 69 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Aspartate Aminotransferase | Above | 5 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Basophils | Unknown | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Basophils | Below | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Basophils | Within | 74 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Basophils | Above | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | White Blood Cells | Unknown | 1 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | White Blood Cells | Below | 3 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | White Blood Cells | Within | 69 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | White Blood Cells | Above | 1 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Total Bilirubin | Unknown | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Total Bilirubin | Below | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Total Bilirubin | Within | 65 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Total Bilirubin | Above | 9 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Bilirubin Conjugated / Direct | Unknown | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Bilirubin Conjugated / Direct | Below | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Bilirubin Conjugated / Direct | Within | 73 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Bilirubin Conjugated / Direct | Above | 1 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Creatinine | Unknown | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Creatinine | Below | 6 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Creatinine | Within | 68 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Creatinine | Above | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Eosinophils | Unknown | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Eosinophils | Below | 14 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Eosinophils | Within | 59 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Eosinophils | Above | 1 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Glucose | Unknown | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Glucose | Below | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Glucose | Within | 69 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Glucose | Above | 5 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Bicarbonate | Unknown | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Bicarbonate | Below | 5 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Bicarbonate | Within | 69 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Haemoglobin | Unknown | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Haemoglobin | Below | 13 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Haemoglobin | Within | 58 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Haemoglobin | Above | 3 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Potassium | Unknown | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Potassium | Below | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Potassium | Within | 74 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Potassium | Above | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Lymphocytes | Unknown | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Lymphocytes | Below | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Lymphocytes | Within | 74 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Lymphocytes | Above | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Monocytes | Unknown | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Monocytes | Below | 2 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Monocytes | Within | 71 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Monocytes | Above | 1 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Sodium | Unknown | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Sodium | Below | 1 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Sodium | Within | 73 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Sodium | Above | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Neutrophils | Unknown | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Neutrophils | Above | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Platelets | Unknown | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Platelets | Below | 4 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Creatinine | Below | 8 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Bicarbonate | Above | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Monocytes | Above | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Neutrophils | Below | 3 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Creatinine | Within | 40 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Platelets | Below | 1 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Potassium | Within | 49 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Platelets | Within | 48 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Creatinine | Above | 1 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Neutrophils | Unknown | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Alanine Aminotransferase | Unknown | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Eosinophils | Unknown | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Alanine Aminotransferase | Below | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Potassium | Above | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Alanine Aminotransferase | Within | 41 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Eosinophils | Below | 10 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Alanine Aminotransferase | Above | 8 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Sodium | Unknown | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Albumin | Unknown | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Eosinophils | Within | 38 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Albumin | Below | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Lymphocytes | Unknown | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Albumin | Within | 47 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Eosinophils | Above | 1 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Albumin | Above | 2 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Neutrophils | Within | 45 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Alkaline Phosphatase | Unknown | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Glucose | Unknown | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Alkaline Phosphatase | Below | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Lymphocytes | Below | 1 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Alkaline Phosphatase | Within | 44 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Glucose | Below | 1 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Alkaline Phosphatase | Above | 5 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Sodium | Below | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Aspartate Aminotransferase | Unknown | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Glucose | Within | 43 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Aspartate Aminotransferase | Below | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Lymphocytes | Within | 48 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Aspartate Aminotransferase | Within | 45 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Glucose | Above | 5 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Aspartate Aminotransferase | Above | 4 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Platelets | Unknown | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Basophils | Unknown | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Bicarbonate | Unknown | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Basophils | Below | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Lymphocytes | Above | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Basophils | Within | 49 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Bicarbonate | Below | 2 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Basophils | Above | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Sodium | Within | 49 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | White Blood Cells | Unknown | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Bicarbonate | Within | 47 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | White Blood Cells | Below | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Monocytes | Unknown | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | White Blood Cells | Within | 47 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Haemoglobin | Unknown | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | White Blood Cells | Above | 2 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Neutrophils | Above | 1 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Total Bilirubin | Unknown | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Haemoglobin | Below | 5 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Total Bilirubin | Below | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Monocytes | Below | 4 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Total Bilirubin | Within | 46 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Haemoglobin | Within | 42 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Total Bilirubin | Above | 3 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Sodium | Above | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Bilirubin Conjugated / Direct | Unknown | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Haemoglobin | Above | 2 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Bilirubin Conjugated / Direct | Below | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Monocytes | Within | 45 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Bilirubin Conjugated / Direct | Within | 49 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Potassium | Unknown | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Bilirubin Conjugated / Direct | Above | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Platelets | Above | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Creatinine | Unknown | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Potassium | Below | 0 Participants |
Primary
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
The assessed parameters were Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Aspartate Aminotransferase, Basophils, Bilirubin Total, Bilirubin Conjugated / Direct, Creatinine, Eosinophils, Glucose, Bicarbonate, Haemoglobin, Potassium, Lymphocytes, Monocytes, Sodium, Neutrophils, Platelets and White Blood Cells. Tabulation was made by relation to the normal laboratory ranges: below, within or above, and also status unknown.
Time frame: At Month 1
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Alanine Aminotransferase | Above | 6 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Albumin | Within | 69 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Alkaline Phosphatase | Below | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Alkaline Phosphatase | Above | 2 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Basophils | Above | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Total Bilirubin | Below | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Bilirubin Conjugated/Direct | Below | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Creatinine | Below | 4 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Glucose | Unknown | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Glucose | Above | 9 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Alanine Aminotransferase | Unknown | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Alanine Aminotransferase | Below | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Alanine Aminotransferase | Within | 67 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Albumin | Unknown | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Albumin | Below | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Albumin | Above | 4 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Alkaline Phosphatase | Unknown | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Alkaline Phosphatase | Within | 71 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Neutrophils | Unknown | 1 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Neutrophils | Below | 8 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Neutrophils | Within | 64 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Neutrophils | Above | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Platelets | Unknown | 1 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Platelets | Below | 2 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Platelets | Within | 70 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Platelets | Above | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | White Blood Cells | Unknown | 1 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | White Blood Cells | Below | 5 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | White Blood Cells | Within | 67 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | White Blood Cells | Above | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Aspartate Aminotransferase | Unknown | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Aspartate Aminotransferase | Below | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Aspartate Aminotransferase | Within | 69 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Aspartate Aminotransferase | Above | 4 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Basophils | Unknown | 1 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Basophils | Below | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Basophils | Within | 72 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Total Bilirubin | Unknown | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Total Bilirubin | Within | 65 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Total Bilirubin | Above | 8 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Bilirubin Conjugated/Direct | Unknown | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Bilirubin Conjugated/Direct | Within | 73 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Bilirubin Conjugated/Direct | Above | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Creatinine | Unknown | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Creatinine | Within | 66 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Creatinine | Above | 3 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Eosinophils | Unknown | 1 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Eosinophils | Below | 13 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Eosinophils | Within | 57 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Eosinophils | Above | 2 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Glucose | Below | 2 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Glucose | Within | 62 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Bicarbonate | Unknown | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Bicarbonate | Below | 7 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Bicarbonate | Within | 66 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Bicarbonate | Above | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Haemoglobin | Unknown | 1 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Haemoglobin | Below | 12 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Haemoglobin | Within | 57 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Haemoglobin | Above | 3 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Potassium | Unknown | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Potassium | Below | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Potassium | Within | 73 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Potassium | Above | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Lymphocytes | Unknown | 1 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Lymphocytes | Below | 1 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Lymphocytes | Within | 71 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Lymphocytes | Above | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Monocytes | Unknown | 1 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Monocytes | Below | 6 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Monocytes | Within | 66 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Monocytes | Above | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Sodium | Unknown | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Sodium | Below | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Sodium | Within | 73 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Sodium | Above | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Basophils | Below | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Alanine Aminotransferase | Above | 4 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Sodium | Below | 1 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Albumin | Within | 43 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Basophils | Within | 45 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Alkaline Phosphatase | Below | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Alkaline Phosphatase | Within | 43 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Haemoglobin | Unknown | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Basophils | Unknown | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Total Bilirubin | Unknown | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Basophils | Above | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Total Bilirubin | Below | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Total Bilirubin | Within | 42 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Total Bilirubin | Above | 3 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Bilirubin Conjugated/Direct | Unknown | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Lymphocytes | Within | 45 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Bilirubin Conjugated/Direct | Below | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Creatinine | Unknown | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Haemoglobin | Below | 3 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Eosinophils | Unknown | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Eosinophils | Below | 6 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Eosinophils | Above | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Monocytes | Above | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Glucose | Within | 34 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Haemoglobin | Within | 40 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Bicarbonate | Above | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Bilirubin Conjugated/Direct | Within | 44 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Alanine Aminotransferase | Unknown | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Lymphocytes | Above | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Alanine Aminotransferase | Below | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Bilirubin Conjugated/Direct | Above | 1 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Alanine Aminotransferase | Within | 41 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Haemoglobin | Above | 2 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Albumin | Unknown | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Creatinine | Below | 7 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Albumin | Below | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Sodium | Above | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Albumin | Above | 2 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Creatinine | Within | 38 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Alkaline Phosphatase | Unknown | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Potassium | Unknown | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Creatinine | Above | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Neutrophils | Unknown | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Monocytes | Unknown | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Neutrophils | Below | 3 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Potassium | Below | 1 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Neutrophils | Within | 40 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Sodium | Unknown | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Neutrophils | Above | 2 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Eosinophils | Within | 39 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Platelets | Unknown | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Potassium | Within | 44 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Platelets | Below | 3 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Glucose | Unknown | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Platelets | Within | 42 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Monocytes | Below | 3 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Platelets | Above | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Glucose | Below | 1 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | White Blood Cells | Unknown | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Potassium | Above | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | White Blood Cells | Below | 4 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Glucose | Above | 10 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | White Blood Cells | Within | 39 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Sodium | Within | 44 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | White Blood Cells | Above | 2 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Alkaline Phosphatase | Above | 2 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Bicarbonate | Unknown | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Aspartate Aminotransferase | Unknown | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Lymphocytes | Unknown | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Aspartate Aminotransferase | Below | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Bicarbonate | Below | 1 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Aspartate Aminotransferase | Within | 42 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Monocytes | Within | 42 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Aspartate Aminotransferase | Above | 3 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Bicarbonate | Within | 44 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Lymphocytes | Below | 0 Participants |
Primary
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
The assessed parameters were Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Aspartate Aminotransferase, Basophils, Bilirubin Total, Bilirubin Conjugated / Direct, Creatinine, Eosinophils, Glucose, Bicarbonate, Haemoglobin, Potassium, Lymphocytes, Monocytes, Sodium, Neutrophils, Platelets and White Blood Cells. Tabulation was made by relation to the normal laboratory ranges: below, within or above, and also staus unknown.
Time frame: At Month 3
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Glucose | Within | 62 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Alkaline Phosphatase | Within | 67 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Glucose | Above | 7 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Total Bilirubin | Unknown | 1 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Bicarbonate | Unknown | 1 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Alanine Aminotransferase | Above | 5 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Bicarbonate | Below | 5 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Total Bilirubin | Below | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Bicarbonate | Within | 66 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Alkaline Phosphatase | Above | 4 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Bicarbonate | Above | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Total Bilirubin | Within | 61 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Haemoglobin | Unknown | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Albumin | Within | 67 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Haemoglobin | Below | 14 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Total Bilirubin | Above | 10 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Haemoglobin | Within | 57 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Aspartate Aminotransferase | Unknown | 1 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Haemoglobin | Above | 1 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Bilirubin Conjugated/Direct | Unknown | 1 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Potassium | Unknown | 1 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Alanine Aminotransferase | Within | 66 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Potassium | Below | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Bilirubin Conjugated/Direct | Below | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Potassium | Within | 71 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Aspartate Aminotransferase | Below | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Potassium | Above | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Bilirubin Conjugated/Direct | Within | 70 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Lymphocytes | Unknown | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Albumin | Above | 4 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Lymphocytes | Below | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Bilirubin Conjugated/Direct | Above | 1 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Lymphocytes | Within | 72 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Aspartate Aminotransferase | Within | 68 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Lymphocytes | Above | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Creatinine | Unknown | 1 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Monocytes | Unknown | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Albumin | Unknown | 1 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Monocytes | Below | 6 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Creatinine | Below | 5 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Monocytes | Within | 66 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Aspartate Aminotransferase | Above | 3 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Monocytes | Above | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Creatinine | Within | 66 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Sodium | Unknown | 1 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Alkaline Phosphatase | Unknown | 1 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Sodium | Below | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Creatinine | Above | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Sodium | Within | 71 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Basophils | Unknown | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Sodium | Above | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Eosinophils | Unknown | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Neutrophils | Unknown | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Alanine Aminotransferase | Below | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Neutrophils | Below | 6 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Eosinophils | Below | 12 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Neutrophils | Within | 66 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Basophils | Below | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Neutrophils | Above | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Eosinophils | Within | 59 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Platelets | Unknown | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Alkaline Phosphatase | Below | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Platelets | Below | 3 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Eosinophils | Above | 1 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Platelets | Within | 69 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Basophils | Within | 72 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Platelets | Above | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Glucose | Unknown | 1 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | White Blood Cells | Unknown | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Albumin | Below | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | White Blood Cells | Below | 5 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Glucose | Below | 2 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | White Blood Cells | Within | 67 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Basophils | Above | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | White Blood Cells | Above | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Alanine Aminotransferase | Unknown | 1 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | White Blood Cells | Above | 2 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Alanine Aminotransferase | Unknown | 2 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Alanine Aminotransferase | Below | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Alanine Aminotransferase | Within | 36 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Alanine Aminotransferase | Above | 9 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Albumin | Unknown | 2 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Albumin | Below | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Albumin | Within | 43 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Albumin | Above | 2 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Alkaline Phosphatase | Unknown | 2 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Alkaline Phosphatase | Below | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Alkaline Phosphatase | Within | 40 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Alkaline Phosphatase | Above | 5 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Aspartate Aminotransferase | Unknown | 2 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Aspartate Aminotransferase | Below | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Aspartate Aminotransferase | Within | 41 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Aspartate Aminotransferase | Above | 4 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Basophils | Unknown | 1 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Basophils | Below | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Basophils | Within | 46 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Basophils | Above | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Total Bilirubin | Unknown | 2 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Total Bilirubin | Below | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Total Bilirubin | Within | 43 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Total Bilirubin | Above | 2 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Bilirubin Conjugated/Direct | Unknown | 2 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Bilirubin Conjugated/Direct | Below | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Bilirubin Conjugated/Direct | Within | 44 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Bilirubin Conjugated/Direct | Above | 1 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Creatinine | Unknown | 2 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Creatinine | Below | 7 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Creatinine | Within | 37 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Creatinine | Above | 1 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Eosinophils | Unknown | 1 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Eosinophils | Below | 5 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Eosinophils | Within | 41 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Eosinophils | Above | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Glucose | Unknown | 2 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Glucose | Below | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Glucose | Within | 38 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Glucose | Above | 7 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Bicarbonate | Unknown | 2 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Bicarbonate | Below | 2 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Bicarbonate | Within | 43 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Bicarbonate | Above | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Haemoglobin | Unknown | 1 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Haemoglobin | Below | 5 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Haemoglobin | Within | 37 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Haemoglobin | Above | 4 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Potassium | Unknown | 2 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Potassium | Below | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Potassium | Within | 45 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Potassium | Above | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Lymphocytes | Unknown | 1 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Lymphocytes | Below | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Lymphocytes | Within | 46 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Lymphocytes | Above | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Monocytes | Unknown | 1 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Monocytes | Below | 6 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Monocytes | Within | 40 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Monocytes | Above | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Sodium | Unknown | 2 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Sodium | Below | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Sodium | Within | 45 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Sodium | Above | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Neutrophils | Unknown | 1 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Neutrophils | Below | 5 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Neutrophils | Within | 39 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Neutrophils | Above | 2 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Platelets | Unknown | 1 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Platelets | Below | 2 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Platelets | Within | 44 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Platelets | Above | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | White Blood Cells | Unknown | 1 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | White Blood Cells | Below | 7 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | White Blood Cells | Within | 37 Participants |
Primary
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
The assessed parameters were Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Aspartate Aminotransferase, Basophils, Bilirubin Total, Bilirubin Conjugated / Direct, Creatinine, Eosinophils, Glucose, Bicarbonate, Haemoglobin, Potassium, Lymphocytes, Monocytes, Sodium, Neutrophils, Platelets and White Blood Cells. Tabulation was made by relation to the normal laboratory ranges: below, within or above, and also status unknown.
Time frame: At Month 6
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Total Bilirubin | Unknown | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Eosinophils | Unknown | 2 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Glucose | Below | 1 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Haemoglobin | Below | 13 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Alanine Aminotransferase | Unknown | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Alanine Aminotransferase | Below | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Alanine Aminotransferase | Within | 67 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Alanine Aminotransferase | Above | 4 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Albumin | Unknown | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Albumin | Below | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Albumin | Within | 68 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Albumin | Above | 3 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Alkaline Phosphatase | Unknown | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Alkaline Phosphatase | Below | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Alkaline Phosphatase | Within | 67 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Alkaline Phosphatase | Above | 4 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Aspartate Aminotransferase | Unknown | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Aspartate Aminotransferase | Below | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Aspartate Aminotransferase | Within | 66 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Aspartate Aminotransferase | Above | 5 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Basophils | Unknown | 2 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Basophils | Below | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Basophils | Within | 69 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Basophils | Above | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Total Bilirubin | Below | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Total Bilirubin | Within | 60 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Total Bilirubin | Above | 11 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Bilirubin Conjugated/Direct | Unknown | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Bilirubin Conjugated/Direct | Below | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Bilirubin Conjugated/Direct | Within | 68 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Bilirubin Conjugated/Direct | Above | 3 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Creatinine | Unknown | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Creatinine | Below | 7 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Creatinine | Within | 62 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Creatinine | Above | 2 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Eosinophils | Below | 13 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Eosinophils | Within | 55 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Eosinophils | Above | 1 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Glucose | Unknown | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Glucose | Within | 62 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Glucose | Above | 8 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Bicarbonate | Unknown | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Bicarbonate | Below | 7 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Bicarbonate | Within | 63 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Bicarbonate | Above | 1 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Haemoglobin | Unknown | 2 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Haemoglobin | Within | 55 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Haemoglobin | Above | 1 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Potassium | Unknown | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Potassium | Below | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Potassium | Within | 70 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Potassium | Above | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Lymphocytes | Unknown | 2 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Lymphocytes | Below | 4 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Lymphocytes | Within | 65 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Lymphocytes | Above | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Monocytes | Unknown | 2 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Monocytes | Below | 2 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Monocytes | Within | 67 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Monocytes | Above | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Sodium | Unknown | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Sodium | Below | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Sodium | Within | 71 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Sodium | Above | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Neutrophils | Unknown | 2 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Neutrophils | Below | 5 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Neutrophils | Within | 64 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Neutrophils | Above | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Platelets | Unknown | 2 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Platelets | Below | 2 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Platelets | Within | 67 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Platelets | Above | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | White Blood Cells | Unknown | 2 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | White Blood Cells | Below | 6 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | White Blood Cells | Within | 62 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | White Blood Cells | Above | 1 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Eosinophils | Above | 1 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Total Bilirubin | Unknown | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Creatinine | Unknown | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Monocytes | Unknown | 1 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Eosinophils | Unknown | 1 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Glucose | Unknown | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Glucose | Below | 1 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Neutrophils | Within | 37 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Haemoglobin | Below | 6 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Sodium | Above | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Glucose | Within | 37 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Alanine Aminotransferase | Unknown | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Monocytes | Below | 4 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Alanine Aminotransferase | Below | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Glucose | Above | 9 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Alanine Aminotransferase | Within | 41 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Platelets | Above | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Alanine Aminotransferase | Above | 6 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Bicarbonate | Unknown | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Albumin | Unknown | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Monocytes | Within | 42 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Albumin | Below | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Bicarbonate | Below | 7 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Albumin | Within | 44 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Neutrophils | Above | 4 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Albumin | Above | 3 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Bicarbonate | Within | 40 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Alkaline Phosphatase | Unknown | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Monocytes | Above | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Alkaline Phosphatase | Below | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Bicarbonate | Above | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Alkaline Phosphatase | Within | 42 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | White Blood Cells | Above | 3 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Alkaline Phosphatase | Above | 5 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Haemoglobin | Unknown | 1 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Aspartate Aminotransferase | Unknown | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Sodium | Unknown | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Aspartate Aminotransferase | Below | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Haemoglobin | Within | 37 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Aspartate Aminotransferase | Within | 45 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Platelets | Unknown | 1 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Aspartate Aminotransferase | Above | 2 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Haemoglobin | Above | 3 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Basophils | Unknown | 1 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Sodium | Below | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Basophils | Below | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Potassium | Unknown | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Basophils | Within | 46 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | White Blood Cells | Unknown | 1 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Basophils | Above | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Potassium | Below | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Total Bilirubin | Below | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Sodium | Within | 47 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Total Bilirubin | Within | 45 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Potassium | Within | 47 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Total Bilirubin | Above | 2 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Platelets | Below | 2 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Bilirubin Conjugated/Direct | Unknown | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Potassium | Above | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Bilirubin Conjugated/Direct | Below | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | White Blood Cells | Within | 39 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Bilirubin Conjugated/Direct | Within | 46 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Lymphocytes | Unknown | 1 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Bilirubin Conjugated/Direct | Above | 1 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Neutrophils | Unknown | 1 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Lymphocytes | Below | 3 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Creatinine | Below | 7 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Platelets | Within | 44 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Creatinine | Within | 39 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Lymphocytes | Within | 42 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Creatinine | Above | 1 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Neutrophils | Below | 5 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Eosinophils | Below | 9 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Lymphocytes | Above | 1 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Eosinophils | Within | 36 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | White Blood Cells | Below | 4 Participants |
Primary
Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges
The assessed parameters were Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Aspartate Aminotransferase, Basophils, Bilirubin Total, Bilirubin Conjugated / Direct, Creatinine, Eosinophils, Glucose, Bicarbonate, Haemoglobin, Potassium, Lymphocytes, Monocytes, Sodium, Neutrophils, Platelets and White Blood Cells. Tabulation was made by relation to the normal laboratory ranges: below, within or above, and also staus unknown.
Time frame: At Month 7
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Lymphocytes | Below | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Eosinophils | Within | 56 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Bicarbonate | Above | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Lymphocytes | Within | 67 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Monocytes | Above | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Platelets | Below | 2 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Platelets | Above | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Alanine Aminotransferase | Unknown | 1 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Alanine Aminotransferase | Below | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Alanine Aminotransferase | Within | 64 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Alanine Aminotransferase | Above | 3 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Albumin | Unknown | 1 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Albumin | Below | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Albumin | Within | 64 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Albumin | Above | 3 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Alkaline Phosphatase | Unknown | 1 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Alkaline Phosphatase | Below | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Alkaline Phosphatase | Within | 63 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Alkaline Phosphatase | Above | 4 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Aspartate Aminotransferase | Unknown | 1 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Aspartate Aminotransferase | Below | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Aspartate Aminotransferase | Within | 65 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Aspartate Aminotransferase | Above | 2 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Basophils | Unknown | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Basophils | Below | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Basophils | Within | 68 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Basophils | Above | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Total Bilirubin | Unknown | 1 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Total Bilirubin | Below | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Total Bilirubin | Within | 57 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Total Bilirubin | Above | 10 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Bilirubin Conjugated/Direct | Unknown | 1 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Bilirubin Conjugated/Direct | Below | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Bilirubin Conjugated/Direct | Within | 67 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Bilirubin Conjugated/Direct | Above | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Creatinine | Below | 7 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Creatinine | Within | 57 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Creatinine | Above | 3 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Eosinophils | Unknown | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Eosinophils | Below | 11 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Eosinophils | Above | 1 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Glucose | Unknown | 1 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Glucose | Below | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Glucose | Within | 63 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Glucose | Above | 4 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Bicarbonate | Unknown | 1 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Bicarbonate | Below | 6 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Bicarbonate | Within | 61 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Haemoglobin | Unknown | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Haemoglobin | Below | 19 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Haemoglobin | Within | 49 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Haemoglobin | Above | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Potassium | Unknown | 1 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Potassium | Below | 1 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Potassium | Within | 66 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Potassium | Above | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Lymphocytes | Unknown | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Creatinine | Unknown | 1 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Lymphocytes | Above | 1 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Monocytes | Unknown | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Monocytes | Below | 5 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Monocytes | Within | 63 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Sodium | Unknown | 1 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Sodium | Below | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Sodium | Within | 67 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Sodium | Above | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Neutrophils | Unknown | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Neutrophils | Below | 7 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Neutrophils | Within | 61 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Neutrophils | Above | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Platelets | Unknown | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Platelets | Within | 66 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | White Blood Cells | Unknown | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | White Blood Cells | Below | 6 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | White Blood Cells | Within | 62 Participants |
| GSK1437173A Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | White Blood Cells | Above | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Creatinine | Above | 1 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Creatinine | Unknown | 1 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Lymphocytes | Below | 1 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Eosinophils | Within | 39 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Bicarbonate | Below | 4 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Bicarbonate | Within | 42 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Eosinophils | Unknown | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Bicarbonate | Above | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Lymphocytes | Within | 46 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Monocytes | Unknown | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Eosinophils | Below | 7 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Platelets | Within | 46 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Platelets | Below | 1 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Eosinophils | Above | 1 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | White Blood Cells | Unknown | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Lymphocytes | Above | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Alanine Aminotransferase | Unknown | 1 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Glucose | Unknown | 1 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Alanine Aminotransferase | Below | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Neutrophils | Below | 1 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Alanine Aminotransferase | Within | 42 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Glucose | Below | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Alanine Aminotransferase | Above | 4 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Platelets | Above | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Albumin | Unknown | 1 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Glucose | Within | 39 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Albumin | Below | 1 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Monocytes | Below | 2 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Albumin | Within | 41 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Glucose | Above | 7 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Albumin | Above | 4 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Neutrophils | Within | 44 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Alkaline Phosphatase | Unknown | 1 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Bicarbonate | Unknown | 1 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Alkaline Phosphatase | Below | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Monocytes | Within | 45 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Alkaline Phosphatase | Within | 42 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Monocytes | Above | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Alkaline Phosphatase | Above | 4 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | White Blood Cells | Above | 2 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Aspartate Aminotransferase | Unknown | 1 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Haemoglobin | Unknown | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Aspartate Aminotransferase | Below | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Sodium | Unknown | 1 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Aspartate Aminotransferase | Within | 43 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Haemoglobin | Below | 6 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Aspartate Aminotransferase | Above | 3 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Neutrophils | Above | 2 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Basophils | Unknown | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Haemoglobin | Within | 40 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Basophils | Below | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Sodium | Below | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Basophils | Within | 47 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Haemoglobin | Above | 1 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Basophils | Above | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | White Blood Cells | Within | 44 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Total Bilirubin | Unknown | 1 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Potassium | Unknown | 1 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Total Bilirubin | Below | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Sodium | Within | 46 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Total Bilirubin | Within | 43 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Potassium | Below | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Total Bilirubin | Above | 3 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Platelets | Unknown | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Bilirubin Conjugated/Direct | Unknown | 1 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Potassium | Within | 46 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Bilirubin Conjugated/Direct | Below | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Sodium | Above | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Bilirubin Conjugated/Direct | Within | 46 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Potassium | Above | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Bilirubin Conjugated/Direct | Above | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | White Blood Cells | Below | 1 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Creatinine | Below | 6 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Lymphocytes | Unknown | 0 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Creatinine | Within | 39 Participants |
| Placebo Group | Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges | Neutrophils | Unknown | 0 Participants |
Primary
Number of Subjects With Any Pre-defined Changes in HIV Viral Load (VL) and CD4 T-cell Count
In this analysis, results were tabulated for the main study groups.
Time frame: From Month 1 to Month 7
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK1437173A Group | Number of Subjects With Any Pre-defined Changes in HIV Viral Load (VL) and CD4 T-cell Count | Change in HIV viral load | 3 Participants |
| GSK1437173A Group | Number of Subjects With Any Pre-defined Changes in HIV Viral Load (VL) and CD4 T-cell Count | Change in CD4 cells count | 7 Participants |
| Placebo Group | Number of Subjects With Any Pre-defined Changes in HIV Viral Load (VL) and CD4 T-cell Count | Change in HIV viral load | 1 Participants |
| Placebo Group | Number of Subjects With Any Pre-defined Changes in HIV Viral Load (VL) and CD4 T-cell Count | Change in CD4 cells count | 4 Participants |
Primary
Number of Subjects With Any Pre-defined Changes in HIV Viral Load (VL) and CD4 T-cell Count, by HIV Status
In this analysis, results were tabulated by HIV status.
Time frame: From Month 1 to Month 7
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK1437173A Group | Number of Subjects With Any Pre-defined Changes in HIV Viral Load (VL) and CD4 T-cell Count, by HIV Status | Change in HIV viral load | 1 Participants |
| GSK1437173A Group | Number of Subjects With Any Pre-defined Changes in HIV Viral Load (VL) and CD4 T-cell Count, by HIV Status | Change in CD4 cells count | 5 Participants |
| Placebo Group | Number of Subjects With Any Pre-defined Changes in HIV Viral Load (VL) and CD4 T-cell Count, by HIV Status | Change in HIV viral load | 0 Participants |
| Placebo Group | Number of Subjects With Any Pre-defined Changes in HIV Viral Load (VL) and CD4 T-cell Count, by HIV Status | Change in CD4 cells count | 3 Participants |
| ART Low CD4 Cohort - GSK 1437173A | Number of Subjects With Any Pre-defined Changes in HIV Viral Load (VL) and CD4 T-cell Count, by HIV Status | Change in HIV viral load | 1 Participants |
| ART Low CD4 Cohort - GSK 1437173A | Number of Subjects With Any Pre-defined Changes in HIV Viral Load (VL) and CD4 T-cell Count, by HIV Status | Change in CD4 cells count | 1 Participants |
| ART Low CD4 Cohort - Placebo | Number of Subjects With Any Pre-defined Changes in HIV Viral Load (VL) and CD4 T-cell Count, by HIV Status | Change in HIV viral load | 0 Participants |
| ART Low CD4 Cohort - Placebo | Number of Subjects With Any Pre-defined Changes in HIV Viral Load (VL) and CD4 T-cell Count, by HIV Status | Change in CD4 cells count | 1 Participants |
| Non-ART High CD4 Cohort - GSK 1437173A | Number of Subjects With Any Pre-defined Changes in HIV Viral Load (VL) and CD4 T-cell Count, by HIV Status | Change in HIV viral load | 1 Participants |
| Non-ART High CD4 Cohort - GSK 1437173A | Number of Subjects With Any Pre-defined Changes in HIV Viral Load (VL) and CD4 T-cell Count, by HIV Status | Change in CD4 cells count | 1 Participants |
| Non-ART High CD4 Cohort - Placebo | Number of Subjects With Any Pre-defined Changes in HIV Viral Load (VL) and CD4 T-cell Count, by HIV Status | Change in HIV viral load | 1 Participants |
| Non-ART High CD4 Cohort - Placebo | Number of Subjects With Any Pre-defined Changes in HIV Viral Load (VL) and CD4 T-cell Count, by HIV Status | Change in CD4 cells count | 0 Participants |
Primary
Number of Subjects With Any Significant Change in Antiretroviral Therapy (ART), Including Initiation of ART in ART-naïve Subjects
In this analysis, results were tabulated for the main study groups. Significant changes to ART appeared due to failure to control HIV viral load and due to failure to maintain high CD4 cells count.
Time frame: From Month 0 until Month 18
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK1437173A Group | Number of Subjects With Any Significant Change in Antiretroviral Therapy (ART), Including Initiation of ART in ART-naïve Subjects | Failure to control HIV viral load | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Significant Change in Antiretroviral Therapy (ART), Including Initiation of ART in ART-naïve Subjects | Failure to maintain high CD4 cells count | 0 Participants |
| Placebo Group | Number of Subjects With Any Significant Change in Antiretroviral Therapy (ART), Including Initiation of ART in ART-naïve Subjects | Failure to control HIV viral load | 0 Participants |
| Placebo Group | Number of Subjects With Any Significant Change in Antiretroviral Therapy (ART), Including Initiation of ART in ART-naïve Subjects | Failure to maintain high CD4 cells count | 0 Participants |
Primary
Number of Subjects With Any Significant Change in Antiretroviral Therapy (ART), Including Initiation of ART in ART-naïve Subjects, by HIV Status
In this analysis, results were tabulated by HIV status
Time frame: From Month 0 to Month 18
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK1437173A Group | Number of Subjects With Any Significant Change in Antiretroviral Therapy (ART), Including Initiation of ART in ART-naïve Subjects, by HIV Status | Due to failure to control HIV viral load | 0 Participants |
| GSK1437173A Group | Number of Subjects With Any Significant Change in Antiretroviral Therapy (ART), Including Initiation of ART in ART-naïve Subjects, by HIV Status | Due to failure to maintain high CD4 cells count | 0 Participants |
| Placebo Group | Number of Subjects With Any Significant Change in Antiretroviral Therapy (ART), Including Initiation of ART in ART-naïve Subjects, by HIV Status | Due to failure to control HIV viral load | 0 Participants |
| Placebo Group | Number of Subjects With Any Significant Change in Antiretroviral Therapy (ART), Including Initiation of ART in ART-naïve Subjects, by HIV Status | Due to failure to maintain high CD4 cells count | 0 Participants |
| ART Low CD4 Cohort - GSK 1437173A | Number of Subjects With Any Significant Change in Antiretroviral Therapy (ART), Including Initiation of ART in ART-naïve Subjects, by HIV Status | Due to failure to control HIV viral load | 0 Participants |
| ART Low CD4 Cohort - GSK 1437173A | Number of Subjects With Any Significant Change in Antiretroviral Therapy (ART), Including Initiation of ART in ART-naïve Subjects, by HIV Status | Due to failure to maintain high CD4 cells count | 0 Participants |
| ART Low CD4 Cohort - Placebo | Number of Subjects With Any Significant Change in Antiretroviral Therapy (ART), Including Initiation of ART in ART-naïve Subjects, by HIV Status | Due to failure to control HIV viral load | 0 Participants |
| ART Low CD4 Cohort - Placebo | Number of Subjects With Any Significant Change in Antiretroviral Therapy (ART), Including Initiation of ART in ART-naïve Subjects, by HIV Status | Due to failure to maintain high CD4 cells count | 0 Participants |
| Non-ART High CD4 Cohort - GSK 1437173A | Number of Subjects With Any Significant Change in Antiretroviral Therapy (ART), Including Initiation of ART in ART-naïve Subjects, by HIV Status | Due to failure to control HIV viral load | 0 Participants |
| Non-ART High CD4 Cohort - GSK 1437173A | Number of Subjects With Any Significant Change in Antiretroviral Therapy (ART), Including Initiation of ART in ART-naïve Subjects, by HIV Status | Due to failure to maintain high CD4 cells count | 0 Participants |
| Non-ART High CD4 Cohort - Placebo | Number of Subjects With Any Significant Change in Antiretroviral Therapy (ART), Including Initiation of ART in ART-naïve Subjects, by HIV Status | Due to failure to control HIV viral load | 0 Participants |
| Non-ART High CD4 Cohort - Placebo | Number of Subjects With Any Significant Change in Antiretroviral Therapy (ART), Including Initiation of ART in ART-naïve Subjects, by HIV Status | Due to failure to maintain high CD4 cells count | 0 Participants |
Primary
Number of Subjects With SAEs Related to Study Participation or to a Concurrent GSK Medication/Vaccine
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time frame: From screening (up to 21 days prior to Month 0) until Month 18
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK1437173A Group | Number of Subjects With SAEs Related to Study Participation or to a Concurrent GSK Medication/Vaccine | 0 Participants |
| Placebo Group | Number of Subjects With SAEs Related to Study Participation or to a Concurrent GSK Medication/Vaccine | 0 Participants |
Primary
Number of Subjects With Serious Adverse Events (SAEs)
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time frame: From Month 0 to Month 18
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK1437173A Group | Number of Subjects With Serious Adverse Events (SAEs) | 6 Participants |
| Placebo Group | Number of Subjects With Serious Adverse Events (SAEs) | 2 Participants |
Primary
Number of Subjects With Unsolicited AEs
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.
Time frame: Within 30 days (Days 0-29) after each vaccination
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK1437173A Group | Number of Subjects With Unsolicited AEs | Any AE(s) | 41 Participants |
| GSK1437173A Group | Number of Subjects With Unsolicited AEs | Grade 3 AE(s) | 4 Participants |
| GSK1437173A Group | Number of Subjects With Unsolicited AEs | Related AE(s) | 11 Participants |
| Placebo Group | Number of Subjects With Unsolicited AEs | Any AE(s) | 26 Participants |
| Placebo Group | Number of Subjects With Unsolicited AEs | Grade 3 AE(s) | 2 Participants |
| Placebo Group | Number of Subjects With Unsolicited AEs | Related AE(s) | 3 Participants |
Secondary
-Anti-VZV and Anti-gE Antibody Concentrations
Antibody concentrations were as determined by ELISA and tabulated for the main study groups. Anti-VZV and anti-gE antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in mIU/mL.
Time frame: At Months 0, 1, 2, 3, 6, 7 and 18
Population: The analysis was performed on the ATP cohorts for immunogenicity and for persistence, which included all evaluable subjects for whom data concerning immunogenicity measures were available at the considered time points (up to Month 7 for the ATP cohort for immunogenicity and at Month 18 for the ATP cohort for persistence).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK1437173A Group | -Anti-VZV and Anti-gE Antibody Concentrations | Anti-VZV, Pre-vaccination | 1292.7 mIU/mL |
| GSK1437173A Group | -Anti-VZV and Anti-gE Antibody Concentrations | Anti-VZV, Month 1 | 6953.8 mIU/mL |
| GSK1437173A Group | -Anti-VZV and Anti-gE Antibody Concentrations | Anti-VZV, Month 2 | 5170.9 mIU/mL |
| GSK1437173A Group | -Anti-VZV and Anti-gE Antibody Concentrations | Anti-VZV, Month 3 | 11119.7 mIU/mL |
| GSK1437173A Group | -Anti-VZV and Anti-gE Antibody Concentrations | Anti-VZV, Month 6 | 8244.0 mIU/mL |
| GSK1437173A Group | -Anti-VZV and Anti-gE Antibody Concentrations | Anti-VZV, Month 7 | 14560.8 mIU/mL |
| GSK1437173A Group | -Anti-VZV and Anti-gE Antibody Concentrations | Anti-VZV, Month 18 | 7493.3 mIU/mL |
| GSK1437173A Group | -Anti-VZV and Anti-gE Antibody Concentrations | Anti-gE, Pre-vaccination | 1218.4 mIU/mL |
| GSK1437173A Group | -Anti-VZV and Anti-gE Antibody Concentrations | Anti-gE, Month 1 | 24113.2 mIU/mL |
| GSK1437173A Group | -Anti-VZV and Anti-gE Antibody Concentrations | Anti-gE, Month 2 | 17112.6 mIU/mL |
| GSK1437173A Group | -Anti-VZV and Anti-gE Antibody Concentrations | Anti-gE, Month 3 | 50443.0 mIU/mL |
| GSK1437173A Group | -Anti-VZV and Anti-gE Antibody Concentrations | Anti-gE, Month 6 | 34159.4 mIU/mL |
| GSK1437173A Group | -Anti-VZV and Anti-gE Antibody Concentrations | Anti-gE, Month 7 | 63812.6 mIU/mL |
| GSK1437173A Group | -Anti-VZV and Anti-gE Antibody Concentrations | Anti-gE, Month 18 | 25242.2 mIU/mL |
| Placebo Group | -Anti-VZV and Anti-gE Antibody Concentrations | Anti-gE, Month 3 | 992.9 mIU/mL |
| Placebo Group | -Anti-VZV and Anti-gE Antibody Concentrations | Anti-VZV, Pre-vaccination | 1074.7 mIU/mL |
| Placebo Group | -Anti-VZV and Anti-gE Antibody Concentrations | Anti-gE, Pre-vaccination | 849.5 mIU/mL |
| Placebo Group | -Anti-VZV and Anti-gE Antibody Concentrations | Anti-VZV, Month 1 | 1173.8 mIU/mL |
| Placebo Group | -Anti-VZV and Anti-gE Antibody Concentrations | Anti-gE, Month 7 | 1028.4 mIU/mL |
| Placebo Group | -Anti-VZV and Anti-gE Antibody Concentrations | Anti-VZV, Month 2 | 987.6 mIU/mL |
| Placebo Group | -Anti-VZV and Anti-gE Antibody Concentrations | Anti-gE, Month 1 | 1059.0 mIU/mL |
| Placebo Group | -Anti-VZV and Anti-gE Antibody Concentrations | Anti-VZV, Month 3 | 1037.8 mIU/mL |
| Placebo Group | -Anti-VZV and Anti-gE Antibody Concentrations | Anti-gE, Month 6 | 1013.1 mIU/mL |
| Placebo Group | -Anti-VZV and Anti-gE Antibody Concentrations | Anti-VZV, Month 6 | 1069.8 mIU/mL |
| Placebo Group | -Anti-VZV and Anti-gE Antibody Concentrations | Anti-gE, Month 2 | 903.3 mIU/mL |
| Placebo Group | -Anti-VZV and Anti-gE Antibody Concentrations | Anti-VZV, Month 7 | 999.3 mIU/mL |
| Placebo Group | -Anti-VZV and Anti-gE Antibody Concentrations | Anti-gE, Month 18 | 918.0 mIU/mL |
| Placebo Group | -Anti-VZV and Anti-gE Antibody Concentrations | Anti-VZV, Month 18 | 922.9 mIU/mL |
Secondary
-Anti-VZV and Anti-gE Antibody Concentrations, by HIV Status
Antibody concentrations were as determined by ELISA and tabulated by HIV status. Anti-VZV and anti-gE antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in mIU/mL.
Time frame: At Months 0, 1, 2, 3, 6, 7 and 18
Population: The analysis was performed on the ATP cohorts for immunogenicity and for persistence, which included all evaluable subjects for whom data concerning immunogenicity measures were available at the considered time points (up to Month 7 for the ATP cohort for immunogenicity and at Month 18 for the ATP cohort for persistence).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK1437173A Group | -Anti-VZV and Anti-gE Antibody Concentrations, by HIV Status | Anti-VZV, Pre-vaccination | 1161.5 mIU/mL |
| GSK1437173A Group | -Anti-VZV and Anti-gE Antibody Concentrations, by HIV Status | Anti-VZV, Month 6 | 9027.6 mIU/mL |
| GSK1437173A Group | -Anti-VZV and Anti-gE Antibody Concentrations, by HIV Status | Anti-gE, Month 3 | 54777.7 mIU/mL |
| GSK1437173A Group | -Anti-VZV and Anti-gE Antibody Concentrations, by HIV Status | Anti-gE, Month 2 | 18208.6 mIU/mL |
| GSK1437173A Group | -Anti-VZV and Anti-gE Antibody Concentrations, by HIV Status | Anti-VZV, Month 2 | 5056.5 mIU/mL |
| GSK1437173A Group | -Anti-VZV and Anti-gE Antibody Concentrations, by HIV Status | Anti-VZV, Month 18 | 8242.2 mIU/mL |
| GSK1437173A Group | -Anti-VZV and Anti-gE Antibody Concentrations, by HIV Status | Anti-gE, Month 7 | 71309.6 mIU/mL |
| GSK1437173A Group | -Anti-VZV and Anti-gE Antibody Concentrations, by HIV Status | Anti-gE, Month 6 | 38068.2 mIU/mL |
| GSK1437173A Group | -Anti-VZV and Anti-gE Antibody Concentrations, by HIV Status | Anti-gE, Month 1 | 25530.6 mIU/mL |
| GSK1437173A Group | -Anti-VZV and Anti-gE Antibody Concentrations, by HIV Status | Anti-VZV, Month 1 | 7017.8 mIU/mL |
| GSK1437173A Group | -Anti-VZV and Anti-gE Antibody Concentrations, by HIV Status | Anti-VZV, Month 3 | 11631.9 mIU/mL |
| GSK1437173A Group | -Anti-VZV and Anti-gE Antibody Concentrations, by HIV Status | Anti-VZV, Month 7 | 15278.5 mIU/mL |
| GSK1437173A Group | -Anti-VZV and Anti-gE Antibody Concentrations, by HIV Status | Anti-gE, Month 18 | 28854.6 mIU/mL |
| GSK1437173A Group | -Anti-VZV and Anti-gE Antibody Concentrations, by HIV Status | Anti-gE, Pre-vaccination | 1113.2 mIU/mL |
| Placebo Group | -Anti-VZV and Anti-gE Antibody Concentrations, by HIV Status | Anti-gE, Month 18 | 849.4 mIU/mL |
| Placebo Group | -Anti-VZV and Anti-gE Antibody Concentrations, by HIV Status | Anti-VZV, Month 6 | 957.0 mIU/mL |
| Placebo Group | -Anti-VZV and Anti-gE Antibody Concentrations, by HIV Status | Anti-gE, Month 7 | 928.8 mIU/mL |
| Placebo Group | -Anti-VZV and Anti-gE Antibody Concentrations, by HIV Status | Anti-VZV, Month 7 | 930.5 mIU/mL |
| Placebo Group | -Anti-VZV and Anti-gE Antibody Concentrations, by HIV Status | Anti-VZV, Pre-vaccination | 985.1 mIU/mL |
| Placebo Group | -Anti-VZV and Anti-gE Antibody Concentrations, by HIV Status | Anti-gE, Month 6 | 932.8 mIU/mL |
| Placebo Group | -Anti-VZV and Anti-gE Antibody Concentrations, by HIV Status | Anti-VZV, Month 1 | 1059.6 mIU/mL |
| Placebo Group | -Anti-VZV and Anti-gE Antibody Concentrations, by HIV Status | Anti-VZV, Month 18 | 838.1 mIU/mL |
| Placebo Group | -Anti-VZV and Anti-gE Antibody Concentrations, by HIV Status | Anti-gE, Month 3 | 955.6 mIU/mL |
| Placebo Group | -Anti-VZV and Anti-gE Antibody Concentrations, by HIV Status | Anti-VZV, Month 2 | 886.9 mIU/mL |
| Placebo Group | -Anti-VZV and Anti-gE Antibody Concentrations, by HIV Status | Anti-gE, Month 2 | 839.8 mIU/mL |
| Placebo Group | -Anti-VZV and Anti-gE Antibody Concentrations, by HIV Status | Anti-gE, Month 1 | 1029.5 mIU/mL |
| Placebo Group | -Anti-VZV and Anti-gE Antibody Concentrations, by HIV Status | Anti-gE, Pre-vaccination | 791.0 mIU/mL |
| Placebo Group | -Anti-VZV and Anti-gE Antibody Concentrations, by HIV Status | Anti-VZV, Month 3 | 1002.7 mIU/mL |
| ART Low CD4 Cohort - GSK 1437173A | -Anti-VZV and Anti-gE Antibody Concentrations, by HIV Status | Anti-VZV, Month 2 | 5649.6 mIU/mL |
| ART Low CD4 Cohort - GSK 1437173A | -Anti-VZV and Anti-gE Antibody Concentrations, by HIV Status | Anti-gE, Month 2 | 13106.4 mIU/mL |
| ART Low CD4 Cohort - GSK 1437173A | -Anti-VZV and Anti-gE Antibody Concentrations, by HIV Status | Anti-gE, Month 6 | 24725.0 mIU/mL |
| ART Low CD4 Cohort - GSK 1437173A | -Anti-VZV and Anti-gE Antibody Concentrations, by HIV Status | Anti-VZV, Pre-vaccination | 2272.6 mIU/mL |
| ART Low CD4 Cohort - GSK 1437173A | -Anti-VZV and Anti-gE Antibody Concentrations, by HIV Status | Anti-VZV, Month 1 | 6731.0 mIU/mL |
| ART Low CD4 Cohort - GSK 1437173A | -Anti-VZV and Anti-gE Antibody Concentrations, by HIV Status | Anti-VZV, Month 3 | 9110.7 mIU/mL |
| ART Low CD4 Cohort - GSK 1437173A | -Anti-VZV and Anti-gE Antibody Concentrations, by HIV Status | Anti-VZV, Month 6 | 7634.7 mIU/mL |
| ART Low CD4 Cohort - GSK 1437173A | -Anti-VZV and Anti-gE Antibody Concentrations, by HIV Status | Anti-VZV, Month 7 | 14763.2 mIU/mL |
| ART Low CD4 Cohort - GSK 1437173A | -Anti-VZV and Anti-gE Antibody Concentrations, by HIV Status | Anti-VZV, Month 18 | 6106.2 mIU/mL |
| ART Low CD4 Cohort - GSK 1437173A | -Anti-VZV and Anti-gE Antibody Concentrations, by HIV Status | Anti-gE, Pre-vaccination | 1845.1 mIU/mL |
| ART Low CD4 Cohort - GSK 1437173A | -Anti-VZV and Anti-gE Antibody Concentrations, by HIV Status | Anti-gE, Month 1 | 18767.2 mIU/mL |
| ART Low CD4 Cohort - GSK 1437173A | -Anti-VZV and Anti-gE Antibody Concentrations, by HIV Status | Anti-gE, Month 3 | 36592.6 mIU/mL |
| ART Low CD4 Cohort - GSK 1437173A | -Anti-VZV and Anti-gE Antibody Concentrations, by HIV Status | Anti-gE, Month 7 | 47382.6 mIU/mL |
| ART Low CD4 Cohort - GSK 1437173A | -Anti-VZV and Anti-gE Antibody Concentrations, by HIV Status | Anti-gE, Month 18 | 18995.8 mIU/mL |
| ART Low CD4 Cohort - Placebo | -Anti-VZV and Anti-gE Antibody Concentrations, by HIV Status | Anti-VZV, Pre-vaccination | 2511.9 mIU/mL |
| ART Low CD4 Cohort - Placebo | -Anti-VZV and Anti-gE Antibody Concentrations, by HIV Status | Anti-gE, Month 1 | 2328.1 mIU/mL |
| ART Low CD4 Cohort - Placebo | -Anti-VZV and Anti-gE Antibody Concentrations, by HIV Status | Anti-gE, Month 6 | 2629.2 mIU/mL |
| ART Low CD4 Cohort - Placebo | -Anti-VZV and Anti-gE Antibody Concentrations, by HIV Status | Anti-VZV, Month 3 | 2479.3 mIU/mL |
| ART Low CD4 Cohort - Placebo | -Anti-VZV and Anti-gE Antibody Concentrations, by HIV Status | Anti-VZV, Month 6 | 3164.8 mIU/mL |
| ART Low CD4 Cohort - Placebo | -Anti-VZV and Anti-gE Antibody Concentrations, by HIV Status | Anti-gE, Month 2 | 2465.5 mIU/mL |
| ART Low CD4 Cohort - Placebo | -Anti-VZV and Anti-gE Antibody Concentrations, by HIV Status | Anti-gE, Month 7 | 2553.0 mIU/mL |
| ART Low CD4 Cohort - Placebo | -Anti-VZV and Anti-gE Antibody Concentrations, by HIV Status | Anti-VZV, Month 18 | 1955.3 mIU/mL |
| ART Low CD4 Cohort - Placebo | -Anti-VZV and Anti-gE Antibody Concentrations, by HIV Status | Anti-VZV, Month 7 | 2177.3 mIU/mL |
| ART Low CD4 Cohort - Placebo | -Anti-VZV and Anti-gE Antibody Concentrations, by HIV Status | Anti-VZV, Month 1 | 2871.0 mIU/mL |
| ART Low CD4 Cohort - Placebo | -Anti-VZV and Anti-gE Antibody Concentrations, by HIV Status | Anti-gE, Month 18 | 1953.7 mIU/mL |
| ART Low CD4 Cohort - Placebo | -Anti-VZV and Anti-gE Antibody Concentrations, by HIV Status | Anti-gE, Month 3 | 2166.3 mIU/mL |
| ART Low CD4 Cohort - Placebo | -Anti-VZV and Anti-gE Antibody Concentrations, by HIV Status | Anti-VZV, Month 2 | 2902.1 mIU/mL |
| ART Low CD4 Cohort - Placebo | -Anti-VZV and Anti-gE Antibody Concentrations, by HIV Status | Anti-gE, Pre-vaccination | 2420.7 mIU/mL |
| Non-ART High CD4 Cohort - GSK 1437173A | -Anti-VZV and Anti-gE Antibody Concentrations, by HIV Status | Anti-VZV, Month 3 | 8990.7 mIU/mL |
| Non-ART High CD4 Cohort - GSK 1437173A | -Anti-VZV and Anti-gE Antibody Concentrations, by HIV Status | Anti-gE, Month 6 | 18189.6 mIU/mL |
| Non-ART High CD4 Cohort - GSK 1437173A | -Anti-VZV and Anti-gE Antibody Concentrations, by HIV Status | Anti-gE, Pre-vaccination | 1748.6 mIU/mL |
| Non-ART High CD4 Cohort - GSK 1437173A | -Anti-VZV and Anti-gE Antibody Concentrations, by HIV Status | Anti-VZV, Month 18 | 4361.7 mIU/mL |
| Non-ART High CD4 Cohort - GSK 1437173A | -Anti-VZV and Anti-gE Antibody Concentrations, by HIV Status | Anti-VZV, Month 2 | 6100.0 mIU/mL |
| Non-ART High CD4 Cohort - GSK 1437173A | -Anti-VZV and Anti-gE Antibody Concentrations, by HIV Status | Anti-VZV, Month 6 | 4384.3 mIU/mL |
| Non-ART High CD4 Cohort - GSK 1437173A | -Anti-VZV and Anti-gE Antibody Concentrations, by HIV Status | Anti-VZV, Month 7 | 8845.8 mIU/mL |
| Non-ART High CD4 Cohort - GSK 1437173A | -Anti-VZV and Anti-gE Antibody Concentrations, by HIV Status | Anti-VZV, Pre-vaccination | 1658.0 mIU/mL |
| Non-ART High CD4 Cohort - GSK 1437173A | -Anti-VZV and Anti-gE Antibody Concentrations, by HIV Status | Anti-gE, Month 1 | 18742.3 mIU/mL |
| Non-ART High CD4 Cohort - GSK 1437173A | -Anti-VZV and Anti-gE Antibody Concentrations, by HIV Status | Anti-gE, Month 7 | 32334.6 mIU/mL |
| Non-ART High CD4 Cohort - GSK 1437173A | -Anti-VZV and Anti-gE Antibody Concentrations, by HIV Status | Anti-gE, Month 2 | 13100.6 mIU/mL |
| Non-ART High CD4 Cohort - GSK 1437173A | -Anti-VZV and Anti-gE Antibody Concentrations, by HIV Status | Anti-VZV, Month 1 | 6706.0 mIU/mL |
| Non-ART High CD4 Cohort - GSK 1437173A | -Anti-VZV and Anti-gE Antibody Concentrations, by HIV Status | Anti-gE, Month 18 | 10869.2 mIU/mL |
| Non-ART High CD4 Cohort - GSK 1437173A | -Anti-VZV and Anti-gE Antibody Concentrations, by HIV Status | Anti-gE, Month 3 | 33662.4 mIU/mL |
| Non-ART High CD4 Cohort - Placebo | -Anti-VZV and Anti-gE Antibody Concentrations, by HIV Status | Anti-VZV, Month 7 | 1076.7 mIU/mL |
| Non-ART High CD4 Cohort - Placebo | -Anti-VZV and Anti-gE Antibody Concentrations, by HIV Status | Anti-VZV, Month 18 | 1209.2 mIU/mL |
| Non-ART High CD4 Cohort - Placebo | -Anti-VZV and Anti-gE Antibody Concentrations, by HIV Status | Anti-VZV, Month 2 | 1191.1 mIU/mL |
| Non-ART High CD4 Cohort - Placebo | -Anti-VZV and Anti-gE Antibody Concentrations, by HIV Status | Anti-gE, Month 7 | 1087.6 mIU/mL |
| Non-ART High CD4 Cohort - Placebo | -Anti-VZV and Anti-gE Antibody Concentrations, by HIV Status | Anti-gE, Pre-vaccination | 661.2 mIU/mL |
| Non-ART High CD4 Cohort - Placebo | -Anti-VZV and Anti-gE Antibody Concentrations, by HIV Status | Anti-gE, Month 18 | 757.8 mIU/mL |
| Non-ART High CD4 Cohort - Placebo | -Anti-VZV and Anti-gE Antibody Concentrations, by HIV Status | Anti-gE, Month 1 | 720.0 mIU/mL |
| Non-ART High CD4 Cohort - Placebo | -Anti-VZV and Anti-gE Antibody Concentrations, by HIV Status | Anti-VZV, Month 1 | 1167.3 mIU/mL |
| Non-ART High CD4 Cohort - Placebo | -Anti-VZV and Anti-gE Antibody Concentrations, by HIV Status | Anti-gE, Month 2 | 735.0 mIU/mL |
| Non-ART High CD4 Cohort - Placebo | -Anti-VZV and Anti-gE Antibody Concentrations, by HIV Status | Anti-gE, Month 3 | 736.6 mIU/mL |
| Non-ART High CD4 Cohort - Placebo | -Anti-VZV and Anti-gE Antibody Concentrations, by HIV Status | Anti-gE, Month 6 | 920.6 mIU/mL |
| Non-ART High CD4 Cohort - Placebo | -Anti-VZV and Anti-gE Antibody Concentrations, by HIV Status | Anti-VZV, Pre-vaccination | 1068.5 mIU/mL |
| Non-ART High CD4 Cohort - Placebo | -Anti-VZV and Anti-gE Antibody Concentrations, by HIV Status | Anti-VZV, Month 6 | 1006.3 mIU/mL |
| Non-ART High CD4 Cohort - Placebo | -Anti-VZV and Anti-gE Antibody Concentrations, by HIV Status | Anti-VZV, Month 3 | 1062.0 mIU/mL |
Secondary
CD4 Count
CD4 count was tabulated by HIV status.
Time frame: At Screening Visit (up to 21 days prior to Month 0), Months 1, 2, 3, 6, 7 and 18
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK1437173A Group | CD4 Count | CD4+, Month 1 | 630.55 CD4 T-cells/million T-cells | Standard Deviation 241.78 |
| GSK1437173A Group | CD4 Count | CD4+, Month 3 | 633.60 CD4 T-cells/million T-cells | Standard Deviation 228.75 |
| GSK1437173A Group | CD4 Count | CD4+, Month 2 | 667.69 CD4 T-cells/million T-cells | Standard Deviation 309.22 |
| GSK1437173A Group | CD4 Count | CD4+, Month 6 | 655.02 CD4 T-cells/million T-cells | Standard Deviation 264.67 |
| GSK1437173A Group | CD4 Count | CD4+, pre-vaccination | 631.46 CD4 T-cells/million T-cells | Standard Deviation 236.36 |
| GSK1437173A Group | CD4 Count | CD4+, Month 7 | 654.69 CD4 T-cells/million T-cells | Standard Deviation 271.31 |
| GSK1437173A Group | CD4 Count | CD4+, Month 18 | 679.71 CD4 T-cells/million T-cells | Standard Deviation 247.57 |
| Placebo Group | CD4 Count | CD4+, Month 3 | 640.14 CD4 T-cells/million T-cells | Standard Deviation 238.05 |
| Placebo Group | CD4 Count | CD4+, Month 6 | 668.28 CD4 T-cells/million T-cells | Standard Deviation 308.64 |
| Placebo Group | CD4 Count | CD4+, Month 18 | 651.06 CD4 T-cells/million T-cells | Standard Deviation 247.3 |
| Placebo Group | CD4 Count | CD4+, Month 1 | 694.69 CD4 T-cells/million T-cells | Standard Deviation 307.98 |
| Placebo Group | CD4 Count | CD4+, Month 2 | 656.14 CD4 T-cells/million T-cells | Standard Deviation 262.43 |
| Placebo Group | CD4 Count | CD4+, Month 7 | 658.81 CD4 T-cells/million T-cells | Standard Deviation 246.53 |
| Placebo Group | CD4 Count | CD4+, pre-vaccination | 683.39 CD4 T-cells/million T-cells | Standard Deviation 228.29 |
| ART Low CD4 Cohort - GSK 1437173A | CD4 Count | CD4+, Month 7 | 170.25 CD4 T-cells/million T-cells | Standard Deviation 44.52 |
| ART Low CD4 Cohort - GSK 1437173A | CD4 Count | CD4+, Month 3 | 153.11 CD4 T-cells/million T-cells | Standard Deviation 54.27 |
| ART Low CD4 Cohort - GSK 1437173A | CD4 Count | CD4+, Month 18 | 168.43 CD4 T-cells/million T-cells | Standard Deviation 58.49 |
| ART Low CD4 Cohort - GSK 1437173A | CD4 Count | CD4+, pre-vaccination | 152.11 CD4 T-cells/million T-cells | Standard Deviation 38.39 |
| ART Low CD4 Cohort - GSK 1437173A | CD4 Count | CD4+, Month 1 | 151.11 CD4 T-cells/million T-cells | Standard Deviation 38.72 |
| ART Low CD4 Cohort - GSK 1437173A | CD4 Count | CD4+, Month 6 | 145.33 CD4 T-cells/million T-cells | Standard Deviation 29.74 |
| ART Low CD4 Cohort - GSK 1437173A | CD4 Count | CD4+, Month 2 | 131.13 CD4 T-cells/million T-cells | Standard Deviation 39.57 |
| ART Low CD4 Cohort - Placebo | CD4 Count | CD4+, Month 6 | 145.20 CD4 T-cells/million T-cells | Standard Deviation 43.18 |
| ART Low CD4 Cohort - Placebo | CD4 Count | CD4+, Month 2 | 133.75 CD4 T-cells/million T-cells | Standard Deviation 31.86 |
| ART Low CD4 Cohort - Placebo | CD4 Count | CD4+, Month 7 | 150.40 CD4 T-cells/million T-cells | Standard Deviation 35.11 |
| ART Low CD4 Cohort - Placebo | CD4 Count | CD4+, Month 18 | 151.40 CD4 T-cells/million T-cells | Standard Deviation 57.48 |
| ART Low CD4 Cohort - Placebo | CD4 Count | CD4+, pre-vaccination | 132.20 CD4 T-cells/million T-cells | Standard Deviation 11.19 |
| ART Low CD4 Cohort - Placebo | CD4 Count | CD4+, Month 3 | 142.60 CD4 T-cells/million T-cells | Standard Deviation 36.49 |
| ART Low CD4 Cohort - Placebo | CD4 Count | CD4+, Month 1 | 163.00 CD4 T-cells/million T-cells | Standard Deviation 53.66 |
| Non-ART High CD4 Cohort - GSK 1437173A | CD4 Count | CD4+, Month 1 | 879.67 CD4 T-cells/million T-cells | Standard Deviation 277.37 |
| Non-ART High CD4 Cohort - GSK 1437173A | CD4 Count | CD4+, Month 7 | 869.14 CD4 T-cells/million T-cells | Standard Deviation 297.04 |
| Non-ART High CD4 Cohort - GSK 1437173A | CD4 Count | CD4+, Month 18 | 720.00 CD4 T-cells/million T-cells | Standard Deviation 228.77 |
| Non-ART High CD4 Cohort - GSK 1437173A | CD4 Count | CD4+, pre-vaccination | 805.33 CD4 T-cells/million T-cells | Standard Deviation 132.38 |
| Non-ART High CD4 Cohort - GSK 1437173A | CD4 Count | CD4+, Month 2 | 808.75 CD4 T-cells/million T-cells | Standard Deviation 211.32 |
| Non-ART High CD4 Cohort - GSK 1437173A | CD4 Count | CD4+, Month 3 | 783.63 CD4 T-cells/million T-cells | Standard Deviation 239.92 |
| Non-ART High CD4 Cohort - GSK 1437173A | CD4 Count | CD4+, Month 6 | 776.43 CD4 T-cells/million T-cells | Standard Deviation 303.3 |
| Non-ART High CD4 Cohort - Placebo | CD4 Count | CD4+, Month 1 | 773.40 CD4 T-cells/million T-cells | Standard Deviation 144.85 |
| Non-ART High CD4 Cohort - Placebo | CD4 Count | CD4+, Month 2 | 804.00 CD4 T-cells/million T-cells | Standard Deviation 199.09 |
| Non-ART High CD4 Cohort - Placebo | CD4 Count | CD4+, Month 7 | 866.00 CD4 T-cells/million T-cells | Standard Deviation 144.3 |
| Non-ART High CD4 Cohort - Placebo | CD4 Count | CD4+, Month 6 | 1082.80 CD4 T-cells/million T-cells | Standard Deviation 649.82 |
| Non-ART High CD4 Cohort - Placebo | CD4 Count | CD4+, pre-vaccination | 901.67 CD4 T-cells/million T-cells | Standard Deviation 177.61 |
| Non-ART High CD4 Cohort - Placebo | CD4 Count | CD4+, Month 18 | 824.40 CD4 T-cells/million T-cells | Standard Deviation 207.57 |
| Non-ART High CD4 Cohort - Placebo | CD4 Count | CD4+, Month 3 | 762.60 CD4 T-cells/million T-cells | Standard Deviation 185.66 |
Secondary
-Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells
The analysis focused on CD4 T cells expressing at least 2 cytokines (among IFN-g, IL-2, TNF-a and/or CD40L as determined by ICS at Months 0, 1, 2, 3, 6, 7 and 18 and tabulated for the main study groups.
Time frame: At Month 0, 1, 2, 3, 6, 7 and 18
Population: The analysis was performed on the ATP cohorts for immunogenicity and for persistence, which included all evaluable subjects for whom data concerning immunogenicity measures were available at the considered time points (up to Month 7 for the ATP cohort for immunogenicity and at Month 18 for the ATP cohort for persistence).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK1437173A Group | -Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells | VZV-specific CD4 [2+] T-cells, pre-vaccination | 750.20 CD4 T-cells/million T-cells | Standard Deviation 989.36 |
| GSK1437173A Group | -Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells | VZV-specific CD4 [2+] T-cells, Month 1 | 768.60 CD4 T-cells/million T-cells | Standard Deviation 739.68 |
| GSK1437173A Group | -Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells | VZV-specific CD4 [2+] T-cells, Month 2 | 734.09 CD4 T-cells/million T-cells | Standard Deviation 680.34 |
| GSK1437173A Group | -Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells | VZV-specific CD4 [2+] T-cells, Month 3 | 1878.81 CD4 T-cells/million T-cells | Standard Deviation 1615.2 |
| GSK1437173A Group | -Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells | VZV-specific CD4 [2+] T-cells, Month 6 | 1646.83 CD4 T-cells/million T-cells | Standard Deviation 1202.32 |
| GSK1437173A Group | -Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells | VZV-specific CD4 [2+] T-cells, Month 7 | 2626.71 CD4 T-cells/million T-cells | Standard Deviation 2514.4 |
| GSK1437173A Group | -Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells | VZV-specific CD4 [2+] T-cells, Month 18 | 995.35 CD4 T-cells/million T-cells | Standard Deviation 842.96 |
| GSK1437173A Group | -Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells | gE-specific CD4 [2+] T-cells, pre-vaccination | 218.26 CD4 T-cells/million T-cells | Standard Deviation 254.94 |
| GSK1437173A Group | -Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells | gE-specific CD4 [2+] T-cells, Month 1 | 704.06 CD4 T-cells/million T-cells | Standard Deviation 614.49 |
| GSK1437173A Group | -Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells | gE-specific CD4 [2+] T-cells, Month 2 | 649.68 CD4 T-cells/million T-cells | Standard Deviation 555.51 |
| GSK1437173A Group | -Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells | gE-specific CD4 [2+] T-cells, Month 3 | 3503.69 CD4 T-cells/million T-cells | Standard Deviation 2971.74 |
| GSK1437173A Group | -Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells | gE-specific CD4 [2+] T-cells, Month 6 | 2647.71 CD4 T-cells/million T-cells | Standard Deviation 1972 |
| GSK1437173A Group | -Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells | gE-specific CD4 [2+] T-cells, Month 7 | 4684.50 CD4 T-cells/million T-cells | Standard Deviation 5376.83 |
| GSK1437173A Group | -Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells | gE-specific CD4 [2+] T-cells, Month 18 | 1929.30 CD4 T-cells/million T-cells | Standard Deviation 1603.5 |
| Placebo Group | -Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells | gE-specific CD4 [2+] T-cells, Month 3 | 160.10 CD4 T-cells/million T-cells | Standard Deviation 220.32 |
| Placebo Group | -Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells | VZV-specific CD4 [2+] T-cells, pre-vaccination | 835.80 CD4 T-cells/million T-cells | Standard Deviation 1949.39 |
| Placebo Group | -Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells | gE-specific CD4 [2+] T-cells, pre-vaccination | 123.15 CD4 T-cells/million T-cells | Standard Deviation 170.79 |
| Placebo Group | -Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells | VZV-specific CD4 [2+] T-cells, Month 1 | 913.87 CD4 T-cells/million T-cells | Standard Deviation 2262.66 |
| Placebo Group | -Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells | gE-specific CD4 [2+] T-cells, Month 7 | 158.64 CD4 T-cells/million T-cells | Standard Deviation 151.15 |
| Placebo Group | -Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells | VZV-specific CD4 [2+] T-cells, Month 2 | 874.13 CD4 T-cells/million T-cells | Standard Deviation 2027.95 |
| Placebo Group | -Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells | gE-specific CD4 [2+] T-cells, Month 1 | 132.49 CD4 T-cells/million T-cells | Standard Deviation 213.05 |
| Placebo Group | -Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells | VZV-specific CD4 [2+] T-cells, Month 3 | 987.24 CD4 T-cells/million T-cells | Standard Deviation 1988.86 |
| Placebo Group | -Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells | gE-specific CD4 [2+] T-cells, Month 6 | 133.70 CD4 T-cells/million T-cells | Standard Deviation 137.94 |
| Placebo Group | -Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells | VZV-specific CD4 [2+] T-cells, Month 6 | 674.20 CD4 T-cells/million T-cells | Standard Deviation 657 |
| Placebo Group | -Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells | gE-specific CD4 [2+] T-cells, Month 2 | 140.95 CD4 T-cells/million T-cells | Standard Deviation 197.99 |
| Placebo Group | -Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells | VZV-specific CD4 [2+] T-cells, Month 7 | 1204.44 CD4 T-cells/million T-cells | Standard Deviation 1911.53 |
| Placebo Group | -Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells | gE-specific CD4 [2+] T-cells, Month 18 | 139.50 CD4 T-cells/million T-cells | Standard Deviation 219.57 |
| Placebo Group | -Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells | VZV-specific CD4 [2+] T-cells, Month 18 | 531.24 CD4 T-cells/million T-cells | Standard Deviation 579.63 |
Secondary
-Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells, by HIV Status
The analysis focused on CD4 T-cells expressing at least 2 cytokines (among IFN-g, IL-2, TNF-a and/or CD40L as determined by ICS at Months 0, 1, 2, 3, 6, 7 and 18 and tabulated by HIV status.
Time frame: At Months 0, 1, 2, 3, 6, 7 and 18
Population: The analysis was performed on the ATP cohorts for immunogenicity and for persistence, which included all evaluable subjects for whom data concerning immunogenicity measures were available at the considered time points (up to Month 7 for the ATP cohort for immunogenicity and at Month 18 for the ATP cohort for persistence).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK1437173A Group | -Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells, by HIV Status | VZV-specific CD4 [2+] T-cells, Month 7 | 2285.90 CD4 T-cells/million T-cells | Standard Deviation 1998.16 |
| GSK1437173A Group | -Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells, by HIV Status | gE-specific CD4 [2+] T-cells, Month 7 | 3649.92 CD4 T-cells/million T-cells | Standard Deviation 3112.69 |
| GSK1437173A Group | -Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells, by HIV Status | gE-specific CD4 [2+] T-cells, Month 3 | 3722.21 CD4 T-cells/million T-cells | Standard Deviation 2789.7 |
| GSK1437173A Group | -Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells, by HIV Status | VZV-specific CD4 [2+] T-cells, Month 2 | 716.33 CD4 T-cells/million T-cells | Standard Deviation 699.22 |
| GSK1437173A Group | -Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells, by HIV Status | VZV-specific CD4 [2+] T-cells, Month 3 | 1973.47 CD4 T-cells/million T-cells | Standard Deviation 1669.57 |
| GSK1437173A Group | -Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells, by HIV Status | gE-specific CD4 [2+] T-cells, pre-vaccination | 215.99 CD4 T-cells/million T-cells | Standard Deviation 266.22 |
| GSK1437173A Group | -Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells, by HIV Status | gE-specific CD4 [2+] T-cells, Month 6 | 2386.40 CD4 T-cells/million T-cells | Standard Deviation 1571.28 |
| GSK1437173A Group | -Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells, by HIV Status | VZV-specific CD4 [2+] T-cells, Month 1 | 830.78 CD4 T-cells/million T-cells | Standard Deviation 775.61 |
| GSK1437173A Group | -Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells, by HIV Status | gE-specific CD4 [2+] T-cells, Month 2 | 610.30 CD4 T-cells/million T-cells | Standard Deviation 558.27 |
| GSK1437173A Group | -Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells, by HIV Status | VZV-specific CD4 [2+] T-cells, Month 18 | 1051.12 CD4 T-cells/million T-cells | Standard Deviation 816.86 |
| GSK1437173A Group | -Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells, by HIV Status | VZV-specific CD4 [2+] T-cells, Month 6 | 1624.32 CD4 T-cells/million T-cells | Standard Deviation 1161.05 |
| GSK1437173A Group | -Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells, by HIV Status | gE-specific CD4 [2+] T-cells, Month 18 | 2071.17 CD4 T-cells/million T-cells | Standard Deviation 1583.58 |
| GSK1437173A Group | -Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells, by HIV Status | VZV-specific CD4 [2+] T-cells, pre-vaccination | 789.48 CD4 T-cells/million T-cells | Standard Deviation 1037.59 |
| GSK1437173A Group | -Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells, by HIV Status | gE-specific CD4 [2+] T-cells, Month 1 | 682.62 CD4 T-cells/million T-cells | Standard Deviation 595.89 |
| Placebo Group | -Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells, by HIV Status | VZV-specific CD4 [2+] T-cells, Month 2 | 991.07 CD4 T-cells/million T-cells | Standard Deviation 2190.7 |
| Placebo Group | -Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells, by HIV Status | VZV-specific CD4 [2+] T-cells, Month 7 | 1261.84 CD4 T-cells/million T-cells | Standard Deviation 1946.12 |
| Placebo Group | -Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells, by HIV Status | VZV-specific CD4 [2+] T-cells, pre-vaccination | 927.27 CD4 T-cells/million T-cells | Standard Deviation 2053.32 |
| Placebo Group | -Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells, by HIV Status | VZV-specific CD4 [2+] T-cells, Month 18 | 599.00 CD4 T-cells/million T-cells | Standard Deviation 587.08 |
| Placebo Group | -Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells, by HIV Status | gE-specific CD4 [2+] T-cells, Month 18 | 159.05 CD4 T-cells/million T-cells | Standard Deviation 239.5 |
| Placebo Group | -Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells, by HIV Status | gE-specific CD4 [2+] T-cells, Month 6 | 152.52 CD4 T-cells/million T-cells | Standard Deviation 141.5 |
| Placebo Group | -Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells, by HIV Status | VZV-specific CD4 [2+] T-cells, Month 1 | 1049.73 CD4 T-cells/million T-cells | Standard Deviation 2442.95 |
| Placebo Group | -Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells, by HIV Status | gE-specific CD4 [2+] T-cells, pre-vaccination | 136.29 CD4 T-cells/million T-cells | Standard Deviation 176.85 |
| Placebo Group | -Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells, by HIV Status | gE-specific CD4 [2+] T-cells, Month 3 | 190.58 CD4 T-cells/million T-cells | Standard Deviation 233.81 |
| Placebo Group | -Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells, by HIV Status | VZV-specific CD4 [2+] T-cells, Month 3 | 1075.62 CD4 T-cells/million T-cells | Standard Deviation 2186.45 |
| Placebo Group | -Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells, by HIV Status | gE-specific CD4 [2+] T-cells, Month 7 | 166.94 CD4 T-cells/million T-cells | Standard Deviation 150.54 |
| Placebo Group | -Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells, by HIV Status | gE-specific CD4 [2+] T-cells, Month 2 | 157.92 CD4 T-cells/million T-cells | Standard Deviation 208.48 |
| Placebo Group | -Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells, by HIV Status | gE-specific CD4 [2+] T-cells, Month 1 | 134.21 CD4 T-cells/million T-cells | Standard Deviation 224.96 |
| Placebo Group | -Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells, by HIV Status | VZV-specific CD4 [2+] T-cells, Month 6 | 786.72 CD4 T-cells/million T-cells | Standard Deviation 657.24 |
| ART Low CD4 Cohort - GSK 1437173A | -Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells, by HIV Status | gE-specific CD4 [2+] T-cells, Month 3 | 4754.94 CD4 T-cells/million T-cells | Standard Deviation 6004.05 |
| ART Low CD4 Cohort - GSK 1437173A | -Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells, by HIV Status | VZV-specific CD4 [2+] T-cells, Month 2 | 814.64 CD4 T-cells/million T-cells | Standard Deviation 920.49 |
| ART Low CD4 Cohort - GSK 1437173A | -Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells, by HIV Status | VZV-specific CD4 [2+] T-cells, pre-vaccination | 1.00 CD4 T-cells/million T-cells | Standard Deviation 0 |
| ART Low CD4 Cohort - GSK 1437173A | -Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells, by HIV Status | VZV-specific CD4 [2+] T-cells, Month 1 | 114.79 CD4 T-cells/million T-cells | Standard Deviation 114.03 |
| ART Low CD4 Cohort - GSK 1437173A | -Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells, by HIV Status | VZV-specific CD4 [2+] T-cells, Month 3 | 1804.94 CD4 T-cells/million T-cells | Standard Deviation 2350.96 |
| ART Low CD4 Cohort - GSK 1437173A | -Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells, by HIV Status | VZV-specific CD4 [2+] T-cells, Month 6 | 1996.37 CD4 T-cells/million T-cells | Standard Deviation 1937.58 |
| ART Low CD4 Cohort - GSK 1437173A | -Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells, by HIV Status | VZV-specific CD4 [2+] T-cells, Month 7 | 6235.67 CD4 T-cells/million T-cells | Standard Deviation 4334.14 |
| ART Low CD4 Cohort - GSK 1437173A | -Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells, by HIV Status | VZV-specific CD4 [2+] T-cells, Month 18 | 853.05 CD4 T-cells/million T-cells | Standard Deviation 1235.35 |
| ART Low CD4 Cohort - GSK 1437173A | -Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells, by HIV Status | gE-specific CD4 [2+] T-cells, pre-vaccination | 51.15 CD4 T-cells/million T-cells | Standard Deviation 70.92 |
| ART Low CD4 Cohort - GSK 1437173A | -Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells, by HIV Status | gE-specific CD4 [2+] T-cells, Month 1 | 584.10 CD4 T-cells/million T-cells | Standard Deviation 652.67 |
| ART Low CD4 Cohort - GSK 1437173A | -Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells, by HIV Status | gE-specific CD4 [2+] T-cells, Month 2 | 960.39 CD4 T-cells/million T-cells | Standard Deviation 632.86 |
| ART Low CD4 Cohort - GSK 1437173A | -Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells, by HIV Status | gE-specific CD4 [2+] T-cells, Month 6 | 5403.79 CD4 T-cells/million T-cells | Standard Deviation 3326.03 |
| ART Low CD4 Cohort - GSK 1437173A | -Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells, by HIV Status | gE-specific CD4 [2+] T-cells, Month 7 | 14925.30 CD4 T-cells/million T-cells | Standard Deviation 10934.07 |
| ART Low CD4 Cohort - GSK 1437173A | -Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells, by HIV Status | gE-specific CD4 [2+] T-cells, Month 18 | 2035.18 CD4 T-cells/million T-cells | Standard Deviation 2100.82 |
| ART Low CD4 Cohort - Placebo | -Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells, by HIV Status | gE-specific CD4 [2+] T-cells, Month 2 | 94.19 CD4 T-cells/million T-cells | Standard Deviation 131.79 |
| ART Low CD4 Cohort - Placebo | -Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells, by HIV Status | VZV-specific CD4 [2+] T-cells, Month 6 | 136.42 CD4 T-cells/million T-cells | — |
| ART Low CD4 Cohort - Placebo | -Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells, by HIV Status | gE-specific CD4 [2+] T-cells, Month 6 | 97.99 CD4 T-cells/million T-cells | — |
| ART Low CD4 Cohort - Placebo | -Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells, by HIV Status | gE-specific CD4 [2+] T-cells, Month 18 | 109.97 CD4 T-cells/million T-cells | Standard Deviation 93.9 |
| ART Low CD4 Cohort - Placebo | -Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells, by HIV Status | VZV-specific CD4 [2+] T-cells, Month 7 | 113.88 CD4 T-cells/million T-cells | — |
| ART Low CD4 Cohort - Placebo | -Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells, by HIV Status | VZV-specific CD4 [2+] T-cells, Month 1 | 146.91 CD4 T-cells/million T-cells | Standard Deviation 142.99 |
| ART Low CD4 Cohort - Placebo | -Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells, by HIV Status | gE-specific CD4 [2+] T-cells, Month 3 | 1.00 CD4 T-cells/million T-cells | Standard Deviation 0 |
| ART Low CD4 Cohort - Placebo | -Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells, by HIV Status | VZV-specific CD4 [2+] T-cells, Month 2 | 329.96 CD4 T-cells/million T-cells | Standard Deviation 53.46 |
| ART Low CD4 Cohort - Placebo | -Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells, by HIV Status | gE-specific CD4 [2+] T-cells, Month 1 | 161.73 CD4 T-cells/million T-cells | Standard Deviation 227.3 |
| ART Low CD4 Cohort - Placebo | -Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells, by HIV Status | gE-specific CD4 [2+] T-cells, pre-vaccination | 1.00 CD4 T-cells/million T-cells | — |
| ART Low CD4 Cohort - Placebo | -Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells, by HIV Status | gE-specific CD4 [2+] T-cells, Month 7 | 1.00 CD4 T-cells/million T-cells | — |
| ART Low CD4 Cohort - Placebo | -Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells, by HIV Status | VZV-specific CD4 [2+] T-cells, Month 18 | 580.71 CD4 T-cells/million T-cells | Standard Deviation 683.08 |
| ART Low CD4 Cohort - Placebo | -Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells, by HIV Status | VZV-specific CD4 [2+] T-cells, Month 3 | 408.18 CD4 T-cells/million T-cells | Standard Deviation 330.78 |
| ART Low CD4 Cohort - Placebo | -Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells, by HIV Status | VZV-specific CD4 [2+] T-cells, pre-vaccination | 86.96 CD4 T-cells/million T-cells | — |
| Non-ART High CD4 Cohort - GSK 1437173A | -Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells, by HIV Status | VZV-specific CD4 [2+] T-cells, Month 6 | 1160.93 CD4 T-cells/million T-cells | — |
| Non-ART High CD4 Cohort - GSK 1437173A | -Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells, by HIV Status | VZV-specific CD4 [2+] T-cells, Month 2 | 769.13 CD4 T-cells/million T-cells | Standard Deviation 469.02 |
| Non-ART High CD4 Cohort - GSK 1437173A | -Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells, by HIV Status | gE-specific CD4 [2+] T-cells, pre-vaccination | 350.86 CD4 T-cells/million T-cells | Standard Deviation 161.96 |
| Non-ART High CD4 Cohort - GSK 1437173A | -Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells, by HIV Status | gE-specific CD4 [2+] T-cells, Month 1 | 952.65 CD4 T-cells/million T-cells | Standard Deviation 763.24 |
| Non-ART High CD4 Cohort - GSK 1437173A | -Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells, by HIV Status | VZV-specific CD4 [2+] T-cells, Month 3 | 1298.35 CD4 T-cells/million T-cells | Standard Deviation 725.44 |
| Non-ART High CD4 Cohort - GSK 1437173A | -Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells, by HIV Status | gE-specific CD4 [2+] T-cells, Month 2 | 629.54 CD4 T-cells/million T-cells | Standard Deviation 513.99 |
| Non-ART High CD4 Cohort - GSK 1437173A | -Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells, by HIV Status | VZV-specific CD4 [2+] T-cells, Month 1 | 1049.36 CD4 T-cells/million T-cells | Standard Deviation 546.09 |
| Non-ART High CD4 Cohort - GSK 1437173A | -Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells, by HIV Status | gE-specific CD4 [2+] T-cells, Month 3 | 1310.76 CD4 T-cells/million T-cells | Standard Deviation 670.56 |
| Non-ART High CD4 Cohort - GSK 1437173A | -Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells, by HIV Status | VZV-specific CD4 [2+] T-cells, pre-vaccination | 896.13 CD4 T-cells/million T-cells | Standard Deviation 749.7 |
| Non-ART High CD4 Cohort - GSK 1437173A | -Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells, by HIV Status | gE-specific CD4 [2+] T-cells, Month 6 | 912.30 CD4 T-cells/million T-cells | — |
| Non-ART High CD4 Cohort - GSK 1437173A | -Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells, by HIV Status | gE-specific CD4 [2+] T-cells, Month 18 | 709.62 CD4 T-cells/million T-cells | Standard Deviation 1011.03 |
| Non-ART High CD4 Cohort - GSK 1437173A | -Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells, by HIV Status | VZV-specific CD4 [2+] T-cells, Month 7 | 660.88 CD4 T-cells/million T-cells | — |
| Non-ART High CD4 Cohort - GSK 1437173A | -Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells, by HIV Status | gE-specific CD4 [2+] T-cells, Month 7 | 861.21 CD4 T-cells/million T-cells | — |
| Non-ART High CD4 Cohort - GSK 1437173A | -Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells, by HIV Status | VZV-specific CD4 [2+] T-cells, Month 18 | 634.55 CD4 T-cells/million T-cells | Standard Deviation 933.54 |
| Non-ART High CD4 Cohort - Placebo | -Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells, by HIV Status | gE-specific CD4 [2+] T-cells, Month 6 | 1.00 CD4 T-cells/million T-cells | Standard Deviation 0 |
| Non-ART High CD4 Cohort - Placebo | -Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells, by HIV Status | gE-specific CD4 [2+] T-cells, Month 18 | 24.81 CD4 T-cells/million T-cells | Standard Deviation 47.63 |
| Non-ART High CD4 Cohort - Placebo | -Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells, by HIV Status | VZV-specific CD4 [2+] T-cells, Month 2 | 131.90 CD4 T-cells/million T-cells | Standard Deviation 185.13 |
| Non-ART High CD4 Cohort - Placebo | -Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells, by HIV Status | gE-specific CD4 [2+] T-cells, pre-vaccination | 26.57 CD4 T-cells/million T-cells | Standard Deviation 36.17 |
| Non-ART High CD4 Cohort - Placebo | -Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells, by HIV Status | gE-specific CD4 [2+] T-cells, Month 1 | 84.33 CD4 T-cells/million T-cells | Standard Deviation 117.84 |
| Non-ART High CD4 Cohort - Placebo | -Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells, by HIV Status | VZV-specific CD4 [2+] T-cells, Month 6 | 42.92 CD4 T-cells/million T-cells | Standard Deviation 37.09 |
| Non-ART High CD4 Cohort - Placebo | -Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells, by HIV Status | gE-specific CD4 [2+] T-cells, Month 3 | 95.71 CD4 T-cells/million T-cells | Standard Deviation 164.04 |
| Non-ART High CD4 Cohort - Placebo | -Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells, by HIV Status | VZV-specific CD4 [2+] T-cells, pre-vaccination | 112.66 CD4 T-cells/million T-cells | Standard Deviation 157.91 |
| Non-ART High CD4 Cohort - Placebo | -Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells, by HIV Status | VZV-specific CD4 [2+] T-cells, Month 3 | 918.17 CD4 T-cells/million T-cells | Standard Deviation 1580.86 |
| Non-ART High CD4 Cohort - Placebo | -Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells, by HIV Status | VZV-specific CD4 [2+] T-cells, Month 1 | 186.38 CD4 T-cells/million T-cells | Standard Deviation 31.21 |
| Non-ART High CD4 Cohort - Placebo | -Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells, by HIV Status | gE-specific CD4 [2+] T-cells, Month 2 | 1.00 CD4 T-cells/million T-cells | Standard Deviation 0 |
| Non-ART High CD4 Cohort - Placebo | -Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells, by HIV Status | VZV-specific CD4 [2+] T-cells, Month 18 | 19.77 CD4 T-cells/million T-cells | Standard Deviation 22.14 |
Secondary
HIV VL
HIV VL was tabulated by HIV status, for subjects with a number of available results greater than or equal to (≥) 40 copies/mL.
Time frame: At Screening Visit (up to 21 days prior to Month 0), Months 1, 2, 3, 6, 7 and 18
Population: The analysis was performed on the Total Vaccinated cohort, which included only vaccinated subjects with at least one vaccine administration documented, who had available results of ≥ 40 copies/mL.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK1437173A Group | HIV VL | HIV VL, Month 18 | 70.33 HIV-RNA copies/mL | Standard Deviation 29.54 |
| GSK1437173A Group | HIV VL | HIV VL, Month 2 | 48.67 HIV-RNA copies/mL | Standard Deviation 10.79 |
| GSK1437173A Group | HIV VL | HIV VL, Month 1 | 42.00 HIV-RNA copies/mL | — |
| GSK1437173A Group | HIV VL | HIV VL, Month 6 | 19699.25 HIV-RNA copies/mL | Standard Deviation 39272.5 |
| GSK1437173A Group | HIV VL | HIV VL, Month 7 | 530.67 HIV-RNA copies/mL | Standard Deviation 785.5 |
| GSK1437173A Group | HIV VL | HIV VL, Month 3 | 75.00 HIV-RNA copies/mL | Standard Deviation 37.75 |
| Placebo Group | HIV VL | HIV VL, Month 18 | 92.67 HIV-RNA copies/mL | Standard Deviation 64.53 |
| Placebo Group | HIV VL | HIV VL, Month 6 | 112.00 HIV-RNA copies/mL | — |
| Placebo Group | HIV VL | HIV VL, Month 7 | 55.75 HIV-RNA copies/mL | Standard Deviation 6.29 |
| Placebo Group | HIV VL | HIV VL, Month 2 | 55.00 HIV-RNA copies/mL | — |
| ART Low CD4 Cohort - GSK 1437173A | HIV VL | HIV VL, pre-vaccination | 62.00 HIV-RNA copies/mL | — |
| ART Low CD4 Cohort - GSK 1437173A | HIV VL | HIV VL, Month 1 | 48.00 HIV-RNA copies/mL | — |
| ART Low CD4 Cohort - GSK 1437173A | HIV VL | HIV VL, Month 2 | 48.00 HIV-RNA copies/mL | Standard Deviation 2.83 |
| ART Low CD4 Cohort - GSK 1437173A | HIV VL | HIV VL, Month 7 | 248.00 HIV-RNA copies/mL | — |
| ART Low CD4 Cohort - GSK 1437173A | HIV VL | HIV VL, Month 18 | 48.00 HIV-RNA copies/mL | — |
| ART Low CD4 Cohort - GSK 1437173A | HIV VL | HIV VL, Month 3 | 84.00 HIV-RNA copies/mL | — |
| ART Low CD4 Cohort - GSK 1437173A | HIV VL | HIV VL, Month 6 | 66053.50 HIV-RNA copies/mL | Standard Deviation 93328.9 |
| ART Low CD4 Cohort - Placebo | HIV VL | HIV VL, Month 6 | 51.00 HIV-RNA copies/mL | — |
| Non-ART High CD4 Cohort - GSK 1437173A | HIV VL | HIV VL, pre-vaccination | 23014.11 HIV-RNA copies/mL | Standard Deviation 18435.1 |
| Non-ART High CD4 Cohort - GSK 1437173A | HIV VL | HIV VL, Month 1 | 24538.89 HIV-RNA copies/mL | Standard Deviation 19056.1 |
| Non-ART High CD4 Cohort - GSK 1437173A | HIV VL | HIV VL, Month 6 | 37091.29 HIV-RNA copies/mL | Standard Deviation 33678.6 |
| Non-ART High CD4 Cohort - GSK 1437173A | HIV VL | HIV VL, Month 18 | 60597.00 HIV-RNA copies/mL | Standard Deviation 48313.15 |
| Non-ART High CD4 Cohort - GSK 1437173A | HIV VL | HIV VL, Month 3 | 19453.50 HIV-RNA copies/mL | Standard Deviation 11878.74 |
| Non-ART High CD4 Cohort - GSK 1437173A | HIV VL | HIV VL, Month 2 | 24134.25 HIV-RNA copies/mL | Standard Deviation 13753.92 |
| Non-ART High CD4 Cohort - GSK 1437173A | HIV VL | HIV VL, Month 7 | 35534.00 HIV-RNA copies/mL | Standard Deviation 39549.42 |
| Non-ART High CD4 Cohort - Placebo | HIV VL | HIV VL, Month 2 | 18188.25 HIV-RNA copies/mL | Standard Deviation 15199.35 |
| Non-ART High CD4 Cohort - Placebo | HIV VL | HIV VL, Month 1 | 14415.80 HIV-RNA copies/mL | Standard Deviation 9289.92 |
| Non-ART High CD4 Cohort - Placebo | HIV VL | HIV VL, Month 3 | 16270.00 HIV-RNA copies/mL | Standard Deviation 15785.91 |
| Non-ART High CD4 Cohort - Placebo | HIV VL | HIV VL, pre-vaccination | 16022.17 HIV-RNA copies/mL | Standard Deviation 23652.18 |
| Non-ART High CD4 Cohort - Placebo | HIV VL | HIV VL, Month 6 | 46429.60 HIV-RNA copies/mL | Standard Deviation 52567.42 |
| Non-ART High CD4 Cohort - Placebo | HIV VL | HIV VL, Month 18 | 14742.60 HIV-RNA copies/mL | Standard Deviation 18306.17 |
| Non-ART High CD4 Cohort - Placebo | HIV VL | HIV VL, Month 7 | 25774.60 HIV-RNA copies/mL | Standard Deviation 27360.66 |
Secondary
Number of Subjects With Any Herpes Zoster (HZ) Cases and Complications
Time frame: From Month 0 until Month 18
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK1437173A Group | Number of Subjects With Any Herpes Zoster (HZ) Cases and Complications | 1 Participants |
| Placebo Group | Number of Subjects With Any Herpes Zoster (HZ) Cases and Complications | 0 Participants |