A Study to Assess the Safety, Reactogenicity and Immune R... | NCT03814590 | Trialant
NCT03814590
Sponsor
GlaxoSmithKline
Status
Completed
Last Update Posted
Aug 5, 2022Actual
Enrollment
1,053Actual
Phase
Phase 1Phase 2
Conditions
Respiratory Syncytial Virus Infections
Interventions
RSV Vaccine (GSK3844766A) unadjuvanted low dose
RSV Vaccine (GSK3844766A) low dose adjuvanted with AS01E
RSV Vaccine (GSK3844766A) low dose adjuvanted with AS01B
RSV Vaccine (GSK3844766A) unadjuvanted medium dose
RSV Vaccine (GSK3844766A) medium dose adjuvanted with AS01E
RSV Vaccine (GSK3844766A) medium dose adjuvanted with AS01B
RSV Vaccine (GSK3844766A) unadjuvanted high dose
RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01E
RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01B
Placebo (Saline solution)
Countries
United States
Belgium
Protocol Section
Identification Module
NCT ID
NCT03814590
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
208851
Secondary IDs
ID
Type
Description
Link
2018-000849-38
EudraCT Number
Brief Title
A Study to Assess the Safety, Reactogenicity and Immune Response of GlaxoSmithKline (GSK) Biologicals' Investigational Respiratory Syncytial Virus (RSV) Vaccine (GSK3844766A) in Older Adults
Official Title
Phase I/II, Observer-blind, Safety, Reactogenicity and Immunogenicity Study of GSK Biologicals' Respiratory Syncytial Virus (RSV) Vaccine GSK3844766A in Subjects Aged 18-40 or 60-80 Years
Acronym
Not provided
Organization
GlaxoSmithKlineINDUSTRY
Status Module
Record Verification Date
Jul 2022
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Jan 21, 2019Actual
Primary Completion Date
Dec 12, 2019Actual
Completion Date
Nov 30, 2020Actual
First Submitted Date
Jan 11, 2019
First Submission Date that Met QC Criteria
Jan 18, 2019
First Posted Date
Jan 24, 2019Actual
Results Waived
Not provided
Results First Submitted Date
Feb 22, 2022
Results First Submitted that Met QC Criteria
Feb 22, 2022
Results First Posted Date
Mar 23, 2022Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Dec 11, 2020
Certification/Extension First Submitted that Passed QC Review
Dec 15, 2020
Certification/Extension First Posted Date
Dec 21, 2020Actual
Last Update Submitted Date
Aug 4, 2022
Last Update Posted Date
Aug 5, 2022Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
GlaxoSmithKlineINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this study is to assess the safety, reactogenicity and immune responses of two doses of the investigational RSV vaccines (with different formulations), when administered intramuscularly (IM) according to a 0, 2 month schedule, in older adults aged 60 to 80 years.
As the investigational vaccines have not yet been tested in humans before, the study will first assess the safety, reactogenicity and immune responses in young adults aged 18 to 40 years. The study will thus be conducted in 2 parts (Part A and Part B).
Detailed Description
Not provided
Conditions Module
Conditions
Respiratory Syncytial Virus Infections
Keywords
Respiratory syncytial virus (RSV)
Vaccine
Safety
Reactogenicity
Immunogenicity
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
1,053Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Group Low Dose_PLAIN_A
Experimental
Subjects in Part A, aged 18-40 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted low dose on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
Subjects in Part A aged 18-40 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted medium dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
Biological: RSV Vaccine (GSK3844766A) unadjuvanted medium dose
Group High Dose_PLAIN_A
Experimental
Subjects in Part A aged 18-40 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted high dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
Biological: RSV Vaccine (GSK3844766A) unadjuvanted high dose
Group Placebo_A
Placebo Comparator
Subjects in Part A aged 18-40 years, receiving 2 doses of placebo (saline solution) control, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
Drug: Placebo (Saline solution)
Group Low Dose_PLAIN_B
Experimental
Interventions
Name
Type
Description
Arm Group Labels
Other Names
RSV Vaccine (GSK3844766A) unadjuvanted low dose
Biological
Two doses administered intramuscularly at Days 1 and 61 in the deltoid region of the arm
Group Low Dose_PLAIN_A
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Subjects With Any Solicited Local Symptoms After First Vaccination Dose
Assessed solicited local AEs at injection site are pain, erythema and swelling. Any erythema/swelling was scored as injection site erythema/swelling with a diameter larger than (>) 20 millimeters (mm)
During a 7-day follow-up period after first vaccination dose (i.e., on the day of vaccination [at Day 1] and 6 subsequent days)
Number of Subjects With Any Solicited Local Symptoms After Second Vaccination Dose
Assessed solicited local AEs at injection site are pain, erythema and swelling. Any erythema/swelling was scored as injection site erythema/swelling with a diameter larger than (>) 20 millimeters (mm)
During a 7-day follow-up period after second vaccination dose (i.e., on the day of vaccination [at Day 61] and 6 subsequent days)
Number of Subjects With Any Solicited General Symptom After First Vaccination Dose
Assessed solicited general symptoms include arthralgia, fatigue, fever [defined as temperature equal to or above 38.0 degrees Celsius (°C)], gastrointestinal symptoms [nausea, vomiting, diarrhea and/or abdominal pain], headache, myalgia and shivering.
During a 7-day follow-up period after the first vaccination dose (i.e., on the day of vaccination [at Day 1] and 6 subsequent days)
Number of Subjects With Any Solicited General Symptom After Second Vaccination Dose
Assessed solicited general symptoms include arthralgia, fatigue, fever [defined as temperature equal to or above 38.0 degrees Celsius (°C)], gastrointestinal symptoms [nausea, vomiting, diarrhea and/or abdominal pain], headache, myalgia and shivering.
During a 7-day follow-up period after the second vaccination dose (i.e., on the day of vaccination [at Day 61] and 6 subsequent days)
Number of Subjects With Any Unsolicited Adverse Events (AEs) After Any Vaccination Dose
Secondary Outcomes
Measure
Description
Time Frame
Number of Subjects With Any SAEs, up the End of Follow-up Period (Month 14) - Part B Groups
A SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization or results in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study subject.
From Day 1 up to the end of follow-up period (Month 14)
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
For all subjects:
Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
Written informed consent obtained from the subject prior to performing any study specific procedure.
For Part A:
• A male or female between, and including, 18 and 40 years of age at the time of the first vaccination.
For Part B:
A male or female between, and including, 60 and 80 years of age at the time of the first vaccination.
Subjects with residence status allowing free mixing with general community or in an assisted-living facility that provides minimal assistance, such that the subject is primarily responsible for self-care and activities of daily living.
Exclusion Criteria:
For all subjects:
Use of any investigational or non-registered product other than the study vaccine during the period starting 30 days before the first dose of study vaccine, or planned use during the study period.
Any medical condition that in the judgment of the investigator would make IM injection unsafe.
Chronic administration of immunosuppressants or other immune-modifying drugs during the period starting 6 months prior to the first vaccine dose. For corticosteroids, this will mean prednisone (≥ 20 mg/day, or equivalent). Inhaled and topical steroids are allowed.
Administration of long-acting immune-modifying drugs or planned administration at any time during the study period.
Planned administration/administration of a vaccine not foreseen by the study protocol in the period starting 30 days before the first dose and ending 30 days after the last dose of study vaccine administration, with the exception of inactivated and subunit influenza vaccines which can be administered up to 14 days before or from 30 days after each study vaccination.
Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product.
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
Hypersensitivity to latex.
Serious or unstable chronic illness. Patients with chronic stable conditions with or without specific treatment, such as diabetes, hypertension or cardiac disease, are allowed to participate in this study.
Any other condition (e.g. chronic obstructive pulmonary disease or severe respiratory condition) that, in the opinion of the investigator, might interfere with the evaluations required by the study.
History of any neurological disorders or seizures.
Acute disease and/or fever at the time of enrolment.
Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by the investigator based on medical history, physical examination or laboratory screening tests.
Hepatomegaly, right upper quadrant abdominal pain or tenderness.
Administration of immunoglobulins and/or any blood products during the period starting 3 months before the first dose of study vaccine or planned administration during the study period.
History of chronic alcohol consumption and/or drug abuse as deemed by the investigator to render the potential subject unable/unlikely to provide accurate safety reports.
Significant underlying illness that in the opinion of the investigator would be expected to prevent completion of the study.
Previous vaccination with an RSV vaccine.
Lymphoproliferative disorder and malignancy within 5 years.
Body mass index > 40 kg/m².
Planned move to a location that will prohibit participating in the trial until study end.
At screening: Hematology parameters (complete blood cell count [red blood cells, white blood cells], white blood cells differential count [lymphocytes, neutrophils and eosinophils], platelets count or hemoglobin level) and/or biochemistry parameters (creatinine, blood urea nitrogen or liver enzymes [alanine aminotransferase or aspartate aminotransferase]) outside the normal laboratory ranges, unless the laboratory abnormalities are considered not clinically significant by the investigator.
For Part A:
Pregnant or lactating female.
Female subjects of childbearing potential, except 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.
For Part B:
Known previous administration of a vaccine containing MPL, QS-21 and/or MF59 (e.g. GSK Biologicals' vaccine against human papillomavirus infection marketed as Cervarix, GSK Biologicals' Herpes Zoster vaccine marketed as Shingrix, an adjuvanted recombinant varicella zoster virus envelope gE subunit vaccine [HZ/su], or MF59 adjuvanted influenza vaccines [e.g. Fluad]).
Planned administration of GSK Biologicals' Herpes Zoster vaccine marketed as Shingrix or an adjuvanted recombinant varicella zoster virus envelope gE subunit vaccine [HZ/su] within 180 days after the second dose of the study vaccine.
Leroux-Roels I, Davis MG, Steenackers K, Essink B, Vandermeulen C, Fogarty C, Andrews CP, Kerwin E, David MP, Fissette L, Vanden Abeele C, Collete D, de Heusch M, Salaun B, De Schrevel N, Koch J, Verheust C, Dezutter N, Struyf F, Mesaros N, Tica J, Hulstrom V. Safety and Immunogenicity of a Respiratory Syncytial Virus Prefusion F (RSVPreF3) Candidate Vaccine in Older Adults: Phase 1/2 Randomized Clinical Trial. J Infect Dis. 2023 Mar 28;227(6):761-772. doi: 10.1093/infdis/jiac327.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
Plan to Share IPD
Yes
Description
IPD for this study will be made available via the Clinical Study Data Request site.
Types
Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame
IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study
Access Criteria
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
1053 participants received the study vaccine or placebo and were included in the Exposed Set.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Low Dose_PLAIN_A Group
Subjects in Part A, aged 18-40 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted low dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
FG001
Medium Dose_PLAIN_A Group
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
0
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
May 13, 2020
Feb 22, 2022
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Prevention
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Triple
Masking Description
Not provided
Who Masked
ParticipantInvestigatorOutcomes Assessor
Subjects in Part B aged 60-80 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted low dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) low dose adjuvanted with AS01E, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
Biological: RSV Vaccine (GSK3844766A) low dose adjuvanted with AS01E
Group Low Dose_AS01B_B
Experimental
Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) low dose adjuvanted with AS01B, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
Biological: RSV Vaccine (GSK3844766A) low dose adjuvanted with AS01B
Group Medium Dose_PLAIN_B
Experimental
Subjects in Part B aged 60-80 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted medium dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
Biological: RSV Vaccine (GSK3844766A) unadjuvanted medium dose
Group Medium Dose_AS01E_B
Experimental
Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) medium dose adjuvanted with AS01E, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
Biological: RSV Vaccine (GSK3844766A) medium dose adjuvanted with AS01E
Group Medium Dose_AS01B_B
Experimental
Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) medium dose adjuvanted with AS01B, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
Biological: RSV Vaccine (GSK3844766A) medium dose adjuvanted with AS01B
Group High Dose_PLAIN_B
Experimental
Subjects in Part B aged 60-80 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted high dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
Biological: RSV Vaccine (GSK3844766A) unadjuvanted high dose
Group High Dose_AS01E_B
Experimental
Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01E, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
Biological: RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01E
Group High Dose_AS01B_B
Experimental
Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01B, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
Biological: RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01B
Group Placebo_B
Placebo Comparator
Subjects in Part B aged 60-80 years, receiving 2 doses of placebo (saline solution) control, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
Drug: Placebo (Saline solution)
Group Low Dose_PLAIN_B
RSV Vaccine (GSK3844766A) low dose adjuvanted with AS01E
Biological
Two doses administered intramuscularly at Days 1 and 61 in the deltoid region of the arm.
Group Low Dose_AS01E_B
RSV Vaccine (GSK3844766A) low dose adjuvanted with AS01B
Biological
Two doses administered intramuscularly at Days 1 and 61 in the deltoid region of the arm
Group Low Dose_AS01B_B
RSV Vaccine (GSK3844766A) unadjuvanted medium dose
Biological
Two doses administered intramuscularly at Days 1 and 61 in the deltoid region of the arm.
Group Medium Dose_PLAIN_A
Group Medium Dose_PLAIN_B
RSV Vaccine (GSK3844766A) medium dose adjuvanted with AS01E
Biological
Two doses administered intramuscularly at Days 1 and 61 in the deltoid region of the arm.
Group Medium Dose_AS01E_B
RSV Vaccine (GSK3844766A) medium dose adjuvanted with AS01B
Biological
Two doses administered intramuscularly at Days 1 and 61 in the deltoid region of the arm.
Group Medium Dose_AS01B_B
RSV Vaccine (GSK3844766A) unadjuvanted high dose
Biological
Two doses administered intramuscularly at Days 1 and 61 in the deltoid region of the arm.
Group High Dose_PLAIN_A
Group High Dose_PLAIN_B
RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01E
Biological
Two doses administered intramuscularly at Days 1 and 61 in the deltoid region of the arm
Group High Dose_AS01E_B
RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01B
Biological
Two doses administered intramuscularly at Days 1 and 61 in the deltoid region of the arm.
Group High Dose_AS01B_B
Placebo (Saline solution)
Drug
Two doses administered intramuscularly at Days 1 and 61 in the deltoid region of the arm.
Group Placebo_A
Group Placebo_B
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/or any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any is defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
During a 30-day follow-up period (i.e., on the day of vaccination and 29 subsequent days) after any vaccination dose (across doses)
Number of Subjects Presenting Change From Baseline in Hematology and Biochemistry With Respect of Normal Laboratory Ranges, After First Vaccine Dose (Part A Groups)
Assessed hematological laboratory parameters include basophils, eosinophils, erythrocytes, hemoglobin, lymphocytes, monocytes, neutrophils, platelets, white blood cells. Biochemical laboratory parameters include alanine aminotransferase [ALT], aspartate aminotransferase [AST], creatinine, urea nitrogen and uric acid. Categories reported when comparing Day 1 (pre-vaccination dose 1=baseline) and Day 8 hematological and biochemical laboratory results are defined as follows: <parameter>-<range at baseline>-<range at timing> (e.g. ALT-Within-Within). Ranges level being classified as unknown, below, within or above the normal ranges.
At baseline and at 7 days after the first vaccine dose (Day 8)
Number of Subjects Presenting Change From Baseline in Hematology and Biochemistry With Respect of Normal Laboratory Ranges, After First Vaccine Dose (Part B Groups)
Assessed hematological laboratory parameters include basophils, eosinophils, erythrocytes, hemoglobin, lymphocytes, monocytes, neutrophils, platelets, white blood cells. Biochemical laboratory parameters include alanine aminotransferase [ALT], aspartate aminotransferase [AST], creatinine, urea nitrogen and uric acid. Categories reported when comparing Day 1 (pre-vaccination dose 1=baseline) and Day 8 hematological and biochemical laboratory results are defined as follows: <parameter>-<range at baseline>-<range at timing> (e.g. ALT-Within-Within). Ranges level being classified as unknown, below, within or above the normal ranges.
At baseline and at 7 days after the first vaccine dose (Day 8)
Number of Subjects Presenting Change From Baseline in Hematology and Biochemistry With Respect of Normal Laboratory Ranges, After Second Vaccine Dose (Part A Groups)
Assessed hematological laboratory parameters include basophils, eosinophils, erythrocytes, hemoglobin, lymphocytes, monocytes, neutrophils, platelets, white blood cells. Biochemical laboratory parameters include alanine aminotransferase [ALT], aspartate aminotransferase [AST], creatinine, urea nitrogen and uric acid. Categories reported when comparing Day 61 (pre-vaccination dose 2=baseline) and Day 68 hematological and biochemical laboratory results are defined as follows: <parameter>-<range at baseline>-<range at timing> (e.g. ALT-Within-Within). Ranges level being classified as unknown, below, within or above the normal ranges.
At baseline and at 7 days after the second vaccine dose (Day 68)
Number of Subjects Presenting Change From Baseline in Hematology and Biochemistry With Respect of Normal Laboratory Ranges, After Second Vaccine Dose (Part B Groups)
Assessed hematological laboratory parameters include basophils, eosinophils, erythrocytes, hemoglobin, lymphocytes, monocytes, neutrophils, platelets, white blood cells. Biochemical laboratory parameters include alanine aminotransferase [ALT], aspartate aminotransferase [AST], creatinine, urea nitrogen and uric acid. Categories reported when comparing Day 61 (pre-vaccination dose 2=baseline) and Day 68 hematological and biochemical laboratory results are defined as follows: <parameter>-<range at baseline>-<range at timing> (e.g. ALT-Within-Within). Ranges level being classified as unknown, below, within or above the normal ranges.
At baseline and at 7 days after the second vaccine dose (Day 68)
Number of Subjects With Any Grade 3 Non-serious AEs (Solicited and Unsolicited) After First Dose of Vaccination
A Grade 3 AE is any AE assessed as severe, i.e. which prevents normal, everyday activities. In adults, such an AE would, for example, prevent attendance at work and would necessitate the administration of corrective therapy.
During a 30-day follow-up period (i.e., on the day of vaccination at Day 1, and 29 subsequent days) after first dose of vaccination
Number of Subjects With Any Grade 3 Non-serious AEs (Solicited and Unsolicited) After Second Dose of Vaccination
A Grade 3 AE is any AE assessed as severe, i.e. which prevents normal, everyday activities. In adults, such an AE would, for example, prevent attendance at work and would necessitate the administration of corrective therapy.
During a 30-day follow-up period (i.e., on the day of vaccination at Day 61, and 29 subsequent days) after second dose of vaccination
Number of Subjects With Any Serious Adverse Events (SAEs) up to 30 Days After the Second Vaccination
A SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization or results in disability/incapacity.
From first vaccination (Day 1) up to 30 days post second vaccination (Day 91)
Number of Subjects With Any Potential Immune-mediated Diseases (pIMDs) up to 30 Days After the Second Vaccination (Part B Groups)
pIMDs are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology.
From first vaccination (Day 1) up to 30 days post second vaccination (Day 91)
Number of Subjects Reporting pIMDs up to the End of Follow-up Period (Month 14) - Part B Groups
pIMDs are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology.
From Day 1 up to the end of follow-up period (Month 14)
Number of Subjects With at Least One RSV-confirmed Respiratory Tract Infection (RTI) Episode Post-vaccination Reported During RTI Surveillance - Part B Groups
The number of subjects with at least one RTI case was provided by group. Reported categories are RSV+ (= RTI episode tested as RSV positive by quantitative reverse transcription polymerase chain reaction (qRT-PCR) on nasal/throat swab) and RSV- (= RTI episode tested as RSV negative by qRT-PCR on nasal/throat swab).
During the RSV season (from October 2019 to March 2020)
Humoral Immune Response With Respect to Components of the Investigational Vaccine in Terms of Neutralizing Antibody Titers Against RSV-serotype A
Serological assays for the determination of functional antibodies against RSV-A were performed by neutralization assay. Anti RSV-A neutralizing antibody titers are given as geometric mean titers (GMTs) and expressed as Estimated Dose: serum dilution giving a 60% reduction of the signal compared to a control without serum (ED60).
At pre-vaccination (Day 1), 30 days post-Dose 1 (Day 31), on the day of second vaccination (Day 61) and 30 days post-Dose 2 (Day 91)
Humoral Immune Response With Respect to Components of the Investigational Vaccine in Terms of RSVPreF3-specific Immunoglobulin G (IgG) Antibody Concentrations
The detection and the quantification of total IgG antibodies directed against RSVPreF3 in human serum samples were based on an indirect enzyme-linked immunosorbent assay (ELISA). Anti RSVPreF3 antibody concentration is given in geometric mean concentration (GMC) and is expressed in ELISA Laboratory Units per milliliter (ELU/mL).
At pre-vaccination (Day 1), 30 days post-Dose 1 (Day 31), on the day of second vaccination (Day 61) and 30 days post-Dose 2 (Day 91)
Descriptive Statistics of the Frequency of RSVPreF3 Specific Cluster of Differentiation 4+ (CD4+) T Cells Expressing at Least 2 Markers
Among markers expressed were interleukin-2 (IL2), cluster of 40 ligand (CD40L), tumor necrosis factor alpha (TNF α) and interferon gamma (IFN γ), in vitro upon stimulation with RSVPreF3 peptide preparations. Reported statistics at each time point during which blood sample were collected for cell-mediated immunity, are geometric mean and inter-quartile range.
At pre-vaccination (Day 1), 30 days post-Dose 1 (Day 31), on the day of second vaccination (Day 61) and 30 days post-Dose 2 (Day 91)
Miami
Florida
33143
United States
GSK Investigational Site
Stockbridge
Georgia
30281
United States
GSK Investigational Site
Lenexa
Kansas
66219
United States
GSK Investigational Site
Wichita
Kansas
67207
United States
GSK Investigational Site
Elkridge
Maryland
21075
United States
GSK Investigational Site
Kansas City
Missouri
64114
United States
GSK Investigational Site
Omaha
Nebraska
68134
United States
GSK Investigational Site
Rochester
New York
14609
United States
GSK Investigational Site
Hickory
North Carolina
28602
United States
GSK Investigational Site
Wilmington
North Carolina
28401
United States
GSK Investigational Site
Cleveland
Ohio
44122
United States
GSK Investigational Site
Medford
Oregon
97504
United States
GSK Investigational Site
Mt. Pleasant
South Carolina
29464
United States
GSK Investigational Site
Spartanburg
South Carolina
29303
United States
GSK Investigational Site
Fort Worth
Texas
76135
United States
GSK Investigational Site
Houston
Texas
77081
United States
GSK Investigational Site
San Antonio
Texas
78229
United States
GSK Investigational Site
Ghent
9000
Belgium
GSK Investigational Site
Leuven
3000
Belgium
GSK Investigational Site
Wilrijk
2610
Belgium
Subjects in Part A aged 18-40 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted medium dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
FG002
High Dose_PLAIN_A Group
Subjects in Part A aged 18-40 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted high dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
FG003
Placebo_A Group
Subjects in Part A aged 18-40 years, receiving 2 doses of placebo (Saline solution) control, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
FG004
Low Dose_PLAIN_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted low dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
FG005
Medium Dose_PLAIN_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted medium dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
FG006
High Dose_PLAIN_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted high dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
FG007
Low Dose_AS01E_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) low dose adjuvanted with AS01E, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
FG008
Medium Dose_AS01E_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) medium dose adjuvanted with AS01E, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
FG009
High Dose_AS01E_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01E, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
FG010
Low Dose_AS01B_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) low dose adjuvanted with AS01B, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
FG011
Medium Dose_AS01B_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) medium dose adjuvanted with AS01B, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
FG012
High Dose_AS01B_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01B, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
FG013
Placebo_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of placebo (Saline solution) control, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
FG00012 subjects
FG00112 subjects
FG00212 subjects
FG00312 subjects
FG004101 subjects
FG00597 subjects
FG006100 subjects
FG007101 subjects
FG008101 subjects
FG009100 subjects
FG010103 subjects
FG011100 subjects
FG012101 subjects
FG013101 subjects
COMPLETED
FG00012 subjects
FG00110 subjects
FG00211 subjects
FG00312 subjects
FG004100 subjects
FG00592 subjects
FG00697 subjects
FG00795 subjects
FG008101 subjects
FG00995 subjects
FG010100 subjects
FG011100 subjects
FG01297 subjects
FG01398 subjects
NOT COMPLETED
FG0000 subjects
FG0012 subjects
FG0021 subjects
FG0030 subjects
FG0041 subjects
FG0055 subjects
FG0063 subjects
FG0076 subjects
FG0080 subjects
FG0095 subjects
FG0103 subjects
FG0110 subjects
FG0124 subjects
FG0133 subjects
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0051 subjects
FG0061 subjects
FG0071 subjects
FG0080 subjects
FG0090 subjects
FG0101 subjects
FG0110 subjects
FG0123 subjects
FG0130 subjects
Lost to Follow-up
FG0000 subjects
FG0012 subjects
FG0021 subjects
FG0030 subjects
FG004
CONSENT WITHDRAWAL, DUE TO COVID-19 BUT NOT DUE TO AN ADVERSE EVENT
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
CONSENT WITHDRAWAL, NOT DUE TO COVID-19 AND NOT DUE TO AN ADVERSE EVENT
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
MIGRATED / MOVED FROM THE STUDY AREA
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
UNKNOWN REASON
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Low Dose_PLAIN_A Group
Subjects in Part A, aged 18-40 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted low dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
BG001
Medium Dose_PLAIN_A Group
Subjects in Part A aged 18-40 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted medium dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
BG002
High Dose_PLAIN_A Group
Subjects in Part A aged 18-40 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted high dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
BG003
Placebo_A Group
Subjects in Part A aged 18-40 years, receiving 2 doses of placebo (Saline solution) control, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
BG004
Low Dose_PLAIN_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted low dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
BG005
Medium Dose_PLAIN_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted medium dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
BG006
High Dose_PLAIN_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted high dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
BG007
Low Dose_AS01E_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) low dose adjuvanted with AS01E, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
BG008
Medium Dose_AS01E_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) medium dose adjuvanted with AS01E, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
BG009
High Dose_AS01E_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01E, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
BG010
Low Dose_AS01B_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) low dose adjuvanted with AS01B, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
BG011
Medium Dose_AS01B_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) medium dose adjuvanted with AS01B, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
BG012
High Dose_AS01B_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01B, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
BG013
Placebo_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of placebo (Saline solution) control, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
BG014
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00012
BG00112
BG00212
BG00312
BG004101
BG00597
BG006100
BG007101
BG008101
BG009100
BG010103
BG011100
BG012101
BG013101
BG0141053
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00031.2± 7.0
BG00126.5± 4.0
BG00229.9± 6.1
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0008
BG0017
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
AMERICAN INDIAN OR ALASKA NATIVE
Title
Measurements
BG0000
BG0010
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Number of Subjects With Any Solicited Local Symptoms After First Vaccination Dose
Assessed solicited local AEs at injection site are pain, erythema and swelling. Any erythema/swelling was scored as injection site erythema/swelling with a diameter larger than (>) 20 millimeters (mm)
The analysis was performed on the Exposed Set that includes all subjects with at least one study vaccine administration documented and with the subject diary completed after the first vaccination.
Posted
Count of Participants
Participants
During a 7-day follow-up period after first vaccination dose (i.e., on the day of vaccination [at Day 1] and 6 subsequent days)
ID
Title
Description
OG000
Low Dose_PLAIN_A Group
Subjects in Part A, aged 18-40 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted low dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG001
Medium Dose_PLAIN_A Group
Subjects in Part A aged 18-40 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted medium dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG002
High Dose_PLAIN_A Group
Subjects in Part A aged 18-40 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted high dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG003
Placebo_A Group
Subjects in Part A aged 18-40 years, receiving 2 doses of placebo (Saline solution) control, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG004
Low Dose_PLAIN_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted low dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG005
Medium Dose_PLAIN_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted medium dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG006
High Dose_PLAIN_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted high dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG007
Low Dose_AS01E_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) low dose adjuvanted with AS01E, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG008
Medium Dose_AS01E_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) medium dose adjuvanted with AS01E, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG009
High Dose_AS01E_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01E, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG010
Low Dose_AS01B_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) low dose adjuvanted with AS01B, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG011
Medium Dose_AS01B_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) medium dose adjuvanted with AS01B, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG012
High Dose_AS01B_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01B, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG013
Placebo_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of placebo (Saline solution) control, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
Units
Counts
Participants
OG00012
OG00112
OG00211
OG003
Title
Denominators
Categories
Erythema
Title
Measurements
OG0000
OG0011
OG0020
OG003
Primary
Number of Subjects With Any Solicited Local Symptoms After Second Vaccination Dose
Assessed solicited local AEs at injection site are pain, erythema and swelling. Any erythema/swelling was scored as injection site erythema/swelling with a diameter larger than (>) 20 millimeters (mm)
The analysis was performed on the Exposed Set that includes all subjects with at least one study vaccine administration documented and with the subject diary completed after the second vaccination.
Posted
Count of Participants
Participants
During a 7-day follow-up period after second vaccination dose (i.e., on the day of vaccination [at Day 61] and 6 subsequent days)
ID
Title
Description
OG000
Low Dose_PLAIN_A Group
Subjects in Part A, aged 18-40 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted low dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG001
Medium Dose_PLAIN_A Group
Subjects in Part A aged 18-40 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted medium dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG002
High Dose_PLAIN_A Group
Subjects in Part A aged 18-40 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted high dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
Primary
Number of Subjects With Any Solicited General Symptom After First Vaccination Dose
Assessed solicited general symptoms include arthralgia, fatigue, fever [defined as temperature equal to or above 38.0 degrees Celsius (°C)], gastrointestinal symptoms [nausea, vomiting, diarrhea and/or abdominal pain], headache, myalgia and shivering.
The analysis was performed on the Exposed Set that includes all subjects with at least one study vaccine administration documented and with the subject diary completed after the first vaccination.
Posted
Count of Participants
Participants
During a 7-day follow-up period after the first vaccination dose (i.e., on the day of vaccination [at Day 1] and 6 subsequent days)
ID
Title
Description
OG000
Low Dose_PLAIN_A Group
Subjects in Part A, aged 18-40 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted low dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG001
Medium Dose_PLAIN_A Group
Subjects in Part A aged 18-40 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted medium dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG002
High Dose_PLAIN_A Group
Primary
Number of Subjects With Any Solicited General Symptom After Second Vaccination Dose
Assessed solicited general symptoms include arthralgia, fatigue, fever [defined as temperature equal to or above 38.0 degrees Celsius (°C)], gastrointestinal symptoms [nausea, vomiting, diarrhea and/or abdominal pain], headache, myalgia and shivering.
The analysis was performed on the Exposed Set that includes all subjects with at least one study vaccine administration documented and with the subject diary completed after the second vaccination.
Posted
Count of Participants
Participants
During a 7-day follow-up period after the second vaccination dose (i.e., on the day of vaccination [at Day 61] and 6 subsequent days)
ID
Title
Description
OG000
Low Dose_PLAIN_A Group
Subjects in Part A, aged 18-40 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted low dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG001
Medium Dose_PLAIN_A Group
Subjects in Part A aged 18-40 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted medium dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG002
High Dose_PLAIN_A Group
Primary
Number of Subjects With Any Unsolicited Adverse Events (AEs) After Any Vaccination Dose
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/or any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any is defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
The analysis was performed on the Exposed Set that includes all subjects with at least one study vaccine administration documented.
Posted
Count of Participants
Participants
During a 30-day follow-up period (i.e., on the day of vaccination and 29 subsequent days) after any vaccination dose (across doses)
ID
Title
Description
OG000
Low Dose_PLAIN_A Group
Subjects in Part A, aged 18-40 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted low dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG001
Medium Dose_PLAIN_A Group
Subjects in Part A aged 18-40 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted medium dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
Primary
Number of Subjects Presenting Change From Baseline in Hematology and Biochemistry With Respect of Normal Laboratory Ranges, After First Vaccine Dose (Part A Groups)
Assessed hematological laboratory parameters include basophils, eosinophils, erythrocytes, hemoglobin, lymphocytes, monocytes, neutrophils, platelets, white blood cells. Biochemical laboratory parameters include alanine aminotransferase [ALT], aspartate aminotransferase [AST], creatinine, urea nitrogen and uric acid. Categories reported when comparing Day 1 (pre-vaccination dose 1=baseline) and Day 8 hematological and biochemical laboratory results are defined as follows: <parameter>-<range at baseline>-<range at timing> (e.g. ALT-Within-Within). Ranges level being classified as unknown, below, within or above the normal ranges.
The analysis was performed on the Exposed Set that includes all subjects from Part A groups, with at least one study vaccine administration documented.
Posted
Count of Participants
Participants
At baseline and at 7 days after the first vaccine dose (Day 8)
ID
Title
Description
OG000
Low Dose_PLAIN_A Group
Subjects in Part A, aged 18-40 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted low dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG001
Medium Dose_PLAIN_A Group
Subjects in Part A aged 18-40 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted medium dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
Primary
Number of Subjects Presenting Change From Baseline in Hematology and Biochemistry With Respect of Normal Laboratory Ranges, After First Vaccine Dose (Part B Groups)
Assessed hematological laboratory parameters include basophils, eosinophils, erythrocytes, hemoglobin, lymphocytes, monocytes, neutrophils, platelets, white blood cells. Biochemical laboratory parameters include alanine aminotransferase [ALT], aspartate aminotransferase [AST], creatinine, urea nitrogen and uric acid. Categories reported when comparing Day 1 (pre-vaccination dose 1=baseline) and Day 8 hematological and biochemical laboratory results are defined as follows: <parameter>-<range at baseline>-<range at timing> (e.g. ALT-Within-Within). Ranges level being classified as unknown, below, within or above the normal ranges.
The analysis was performed on the Exposed Set that includes all subjects from Part B groups, with at least one study vaccine administration documented.
Posted
Count of Participants
Participants
At baseline and at 7 days after the first vaccine dose (Day 8)
ID
Title
Description
OG000
Low Dose_PLAIN_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted low dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG001
Medium Dose_PLAIN_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted medium dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
Primary
Number of Subjects Presenting Change From Baseline in Hematology and Biochemistry With Respect of Normal Laboratory Ranges, After Second Vaccine Dose (Part A Groups)
Assessed hematological laboratory parameters include basophils, eosinophils, erythrocytes, hemoglobin, lymphocytes, monocytes, neutrophils, platelets, white blood cells. Biochemical laboratory parameters include alanine aminotransferase [ALT], aspartate aminotransferase [AST], creatinine, urea nitrogen and uric acid. Categories reported when comparing Day 61 (pre-vaccination dose 2=baseline) and Day 68 hematological and biochemical laboratory results are defined as follows: <parameter>-<range at baseline>-<range at timing> (e.g. ALT-Within-Within). Ranges level being classified as unknown, below, within or above the normal ranges.
The analysis was performed on the Exposed Set that includes all subjects from Part A groups, with at least one study vaccine administration documented.
Posted
Count of Participants
Participants
At baseline and at 7 days after the second vaccine dose (Day 68)
ID
Title
Description
OG000
Low Dose_PLAIN_A Group
Subjects in Part A, aged 18-40 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted low dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG001
Medium Dose_PLAIN_A Group
Subjects in Part A aged 18-40 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted medium dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
Primary
Number of Subjects Presenting Change From Baseline in Hematology and Biochemistry With Respect of Normal Laboratory Ranges, After Second Vaccine Dose (Part B Groups)
Assessed hematological laboratory parameters include basophils, eosinophils, erythrocytes, hemoglobin, lymphocytes, monocytes, neutrophils, platelets, white blood cells. Biochemical laboratory parameters include alanine aminotransferase [ALT], aspartate aminotransferase [AST], creatinine, urea nitrogen and uric acid. Categories reported when comparing Day 61 (pre-vaccination dose 2=baseline) and Day 68 hematological and biochemical laboratory results are defined as follows: <parameter>-<range at baseline>-<range at timing> (e.g. ALT-Within-Within). Ranges level being classified as unknown, below, within or above the normal ranges.
The analysis was performed on the Exposed Set that includes all subjects from Part B groups, with at least one study vaccine administration documented.
Posted
Count of Participants
Participants
At baseline and at 7 days after the second vaccine dose (Day 68)
ID
Title
Description
OG000
Low Dose_PLAIN_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted low dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG001
Medium Dose_PLAIN_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted medium dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
Primary
Number of Subjects With Any Grade 3 Non-serious AEs (Solicited and Unsolicited) After First Dose of Vaccination
A Grade 3 AE is any AE assessed as severe, i.e. which prevents normal, everyday activities. In adults, such an AE would, for example, prevent attendance at work and would necessitate the administration of corrective therapy.
The analysis was performed on the Exposed Set that includes all subjects with at least one study vaccine administration documented.
Posted
Count of Participants
Participants
During a 30-day follow-up period (i.e., on the day of vaccination at Day 1, and 29 subsequent days) after first dose of vaccination
ID
Title
Description
OG000
Low Dose_PLAIN_A Group
Subjects in Part A, aged 18-40 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted low dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG001
Medium Dose_PLAIN_A Group
Subjects in Part A aged 18-40 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted medium dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG002
High Dose_PLAIN_A Group
Subjects in Part A aged 18-40 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted high dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
Primary
Number of Subjects With Any Grade 3 Non-serious AEs (Solicited and Unsolicited) After Second Dose of Vaccination
A Grade 3 AE is any AE assessed as severe, i.e. which prevents normal, everyday activities. In adults, such an AE would, for example, prevent attendance at work and would necessitate the administration of corrective therapy.
The analysis was performed on the Exposed Set that includes all subjects with at least one study vaccine administration documented.
Posted
Count of Participants
Participants
During a 30-day follow-up period (i.e., on the day of vaccination at Day 61, and 29 subsequent days) after second dose of vaccination
ID
Title
Description
OG000
Low Dose_PLAIN_A Group
Subjects in Part A, aged 18-40 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted low dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG001
Medium Dose_PLAIN_A Group
Subjects in Part A aged 18-40 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted medium dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG002
High Dose_PLAIN_A Group
Subjects in Part A aged 18-40 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted high dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
Primary
Number of Subjects With Any Serious Adverse Events (SAEs) up to 30 Days After the Second Vaccination
A SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization or results in disability/incapacity.
The analysis was performed on the Exposed Set that includes all subjects with at least one study vaccine administration documented.
Posted
Count of Participants
Participants
From first vaccination (Day 1) up to 30 days post second vaccination (Day 91)
ID
Title
Description
OG000
Low Dose_PLAIN_A Group
Subjects in Part A, aged 18-40 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted low dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG001
Medium Dose_PLAIN_A Group
Subjects in Part A aged 18-40 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted medium dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG002
High Dose_PLAIN_A Group
Subjects in Part A aged 18-40 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted high dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
Primary
Number of Subjects With Any Potential Immune-mediated Diseases (pIMDs) up to 30 Days After the Second Vaccination (Part B Groups)
pIMDs are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology.
The analysis was performed on the Exposed Set that includes all subjects from Part B groups with at least one study vaccine administration documented.
Posted
Count of Participants
Participants
From first vaccination (Day 1) up to 30 days post second vaccination (Day 91)
ID
Title
Description
OG000
Low Dose_PLAIN_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted low dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG001
Medium Dose_PLAIN_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted medium dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG002
High Dose_PLAIN_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted high dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
Secondary
Number of Subjects With Any SAEs, up the End of Follow-up Period (Month 14) - Part B Groups
A SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization or results in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study subject.
The analysis was performed on the Exposed Set that includes all subjects from Part B with at least one study vaccine administration documented.
Posted
Count of Participants
Participants
From Day 1 up to the end of follow-up period (Month 14)
ID
Title
Description
OG000
Low Dose_PLAIN_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted low dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG001
Medium Dose_PLAIN_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted medium dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG002
High Dose_PLAIN_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted high dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
Secondary
Number of Subjects Reporting pIMDs up to the End of Follow-up Period (Month 14) - Part B Groups
pIMDs are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology.
The analysis was performed on the Exposed Set that includes all subjects from Part B groups with at least one study vaccine administration documented.
Posted
Count of Participants
Participants
From Day 1 up to the end of follow-up period (Month 14)
ID
Title
Description
OG000
Low Dose_PLAIN_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted low dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG001
Medium Dose_PLAIN_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted medium dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG002
High Dose_PLAIN_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted high dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
Secondary
Number of Subjects With at Least One RSV-confirmed Respiratory Tract Infection (RTI) Episode Post-vaccination Reported During RTI Surveillance - Part B Groups
The number of subjects with at least one RTI case was provided by group. Reported categories are RSV+ (= RTI episode tested as RSV positive by quantitative reverse transcription polymerase chain reaction (qRT-PCR) on nasal/throat swab) and RSV- (= RTI episode tested as RSV negative by qRT-PCR on nasal/throat swab).
The analysis was performed on the Exposed Set that includes all subjects from part B groups with at least one study vaccine administration documented.
Posted
Count of Participants
Participants
During the RSV season (from October 2019 to March 2020)
ID
Title
Description
OG000
Low Dose_PLAIN_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted low dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG001
Medium Dose_PLAIN_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted medium dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG002
High Dose_PLAIN_B Group
Secondary
Humoral Immune Response With Respect to Components of the Investigational Vaccine in Terms of Neutralizing Antibody Titers Against RSV-serotype A
Serological assays for the determination of functional antibodies against RSV-A were performed by neutralization assay. Anti RSV-A neutralizing antibody titers are given as geometric mean titers (GMTs) and expressed as Estimated Dose: serum dilution giving a 60% reduction of the signal compared to a control without serum (ED60).
The analysis was performed on the Per Protocol Set (PPS) that includes all subjects who receive the study treatment to which they are randomized and have post-vaccination data, minus subjects with protocol deviations that lead to exclusion.
Posted
Geometric Mean
95% Confidence Interval
Titers
At pre-vaccination (Day 1), 30 days post-Dose 1 (Day 31), on the day of second vaccination (Day 61) and 30 days post-Dose 2 (Day 91)
ID
Title
Description
OG000
Low Dose_PLAIN_A Group
Subjects in Part A, aged 18-40 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted low dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG001
Medium Dose_PLAIN_A Group
Subjects in Part A aged 18-40 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted medium dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
Secondary
Humoral Immune Response With Respect to Components of the Investigational Vaccine in Terms of RSVPreF3-specific Immunoglobulin G (IgG) Antibody Concentrations
The detection and the quantification of total IgG antibodies directed against RSVPreF3 in human serum samples were based on an indirect enzyme-linked immunosorbent assay (ELISA). Anti RSVPreF3 antibody concentration is given in geometric mean concentration (GMC) and is expressed in ELISA Laboratory Units per milliliter (ELU/mL).
The analysis was performed on the PPS that includes all subjects who receive at least 1 dose of the study treatment to which they are randomized and have post-vaccination data, minus subjects with protocol deviations that lead to exclusion.
Posted
Geometric Mean
95% Confidence Interval
ELU/mL
At pre-vaccination (Day 1), 30 days post-Dose 1 (Day 31), on the day of second vaccination (Day 61) and 30 days post-Dose 2 (Day 91)
ID
Title
Description
OG000
Low Dose_PLAIN_A Group
Subjects in Part A, aged 18-40 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted low dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG001
Medium Dose_PLAIN_A Group
Subjects in Part A aged 18-40 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted medium dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
Secondary
Descriptive Statistics of the Frequency of RSVPreF3 Specific Cluster of Differentiation 4+ (CD4+) T Cells Expressing at Least 2 Markers
Among markers expressed were interleukin-2 (IL2), cluster of 40 ligand (CD40L), tumor necrosis factor alpha (TNF α) and interferon gamma (IFN γ), in vitro upon stimulation with RSVPreF3 peptide preparations. Reported statistics at each time point during which blood sample were collected for cell-mediated immunity, are geometric mean and inter-quartile range.
The analysis was performed on the PPS that includes all subjects who receive at least 1 dose of the study treatment to which they are randomized and have post-vaccination data, minus subjects with protocol deviations that lead to exclusion.
Posted
Median
Inter-Quartile Range
Cells per million CD4+ T Cells
At pre-vaccination (Day 1), 30 days post-Dose 1 (Day 31), on the day of second vaccination (Day 61) and 30 days post-Dose 2 (Day 91)
ID
Title
Description
OG000
Low Dose_PLAIN_A Group
Subjects in Part A, aged 18-40 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted low dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG001
Medium Dose_PLAIN_A Group
Subjects in Part A aged 18-40 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted medium dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
Time Frame
Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 30-day follow-up period after any vaccination. SAEs were collected during the whole study period, from Day 1 till Day 91 for Part A groups and till Month 14 for Part B groups.
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Low Dose_PLAIN_A Group
Subjects in Part A, aged 18-40 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted low dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
0
12
0
12
9
12
EG001
Medium Dose_PLAIN_A Group
Subjects in Part A aged 18-40 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted medium dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
0
12
0
12
10
12
EG002
High Dose_PLAIN_A Group
Subjects in Part A aged 18-40 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted high dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
0
12
0
12
9
12
EG003
Placebo_A Group
Subjects in Part A aged 18-40 years, receiving 2 doses of placebo (Saline solution) control, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
0
12
0
12
10
12
EG004
Low Dose_PLAIN_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted low dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
0
101
13
101
62
101
EG005
Medium Dose_PLAIN_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted medium dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
1
97
3
97
54
97
EG006
High Dose_PLAIN_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted high dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
1
100
5
100
61
100
EG007
Low Dose_AS01E_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) low dose adjuvanted with AS01E, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
0
101
8
101
77
101
EG008
Medium Dose_AS01E_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) medium dose adjuvanted with AS01E, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
0
101
6
101
80
101
EG009
High Dose_AS01E_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01E, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
0
100
11
100
83
100
EG010
Low Dose_AS01B_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) low dose adjuvanted with AS01B, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
1
103
9
103
91
103
EG011
Medium Dose_AS01B_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) medium dose adjuvanted with AS01B, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
0
100
5
100
88
100
EG012
High Dose_AS01B_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01B, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
1
101
9
101
93
101
EG013
Placebo_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of placebo (Saline solution) control, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
0
101
9
101
54
101
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Iron deficiency anaemia
Blood and lymphatic system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG0030 events0 affected12 at risk
EG004
Acute myocardial infarction
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Arrhythmia
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Atrioventricular block complete
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Cardiac arrest
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Cardio-respiratory arrest
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Cardiomyopathy
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Ventricular extrasystoles
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Ventricular tachycardia
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Pancreatitis
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Upper gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Chest pain
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Death
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Biliary colic
Hepatobiliary disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Cholecystitis
Hepatobiliary disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Appendicitis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Arthritis bacterial
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Arthritis infective
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Bacteraemia
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
COVID-19
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Device related infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Postoperative wound infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Spinal cord abscess
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Spinal cord infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Staphylococcal infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Acetabulum fracture
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Chest injury
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Femur fracture
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Head injury
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Injury
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Jaw fracture
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Meniscus injury
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Patella fracture
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Rib fracture
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Skin laceration
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Subdural haematoma
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Upper limb fracture
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Diabetes mellitus
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Cervical spinal stenosis
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Intervertebral disc protrusion
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Lumbar spinal stenosis
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Spondylolisthesis
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Anal cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Breast cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Clear cell renal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Hormone receptor positive breast cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Invasive ductal breast carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Lung carcinoma cell type unspecified stage IV
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Malignant peritoneal neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Prostate cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Sarcoma uterus
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Uterine cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Cervicobrachial syndrome
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Encephalitis autoimmune
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Ischaemic stroke
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Loss of consciousness
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Alcohol abuse
Psychiatric disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Bipolar disorder
Psychiatric disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Major depression
Psychiatric disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Cervical dysplasia
Reproductive system and breast disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Rectocele
Reproductive system and breast disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Respiratory distress
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Aortic aneurysm rupture
Vascular disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Shock haemorrhagic
Vascular disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Thrombophlebitis superficial
Vascular disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Injection site pain
General disorders
MedDRA 22.0
Systematic Assessment
EG0006 events6 affected12 at risk
EG00114 events9 affected12 at risk
EG00214 events8 affected12 at risk
EG0031 events1 affected12 at risk
EG00427 events23 affected101 at risk
EG00523 events19 affected97 at risk
EG00637 events31 affected100 at risk
EG00789 events60 affected101 at risk
EG008105 events63 affected101 at risk
EG009103 events65 affected100 at risk
EG010136 events81 affected103 at risk
EG011120 events78 affected100 at risk
EG012137 events82 affected101 at risk
EG0138 events8 affected101 at risk
Fatigue
General disorders
MedDRA 22.0
Systematic Assessment
EG0007 events5 affected12 at risk
EG0017 events5 affected12 at risk
EG0025 events4 affected12 at risk
EG003
Chills
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0012 events2 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Injection site swelling
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Hangover
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0021 events1 affected12 at risk
EG003
Pyrexia
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Influenza like illness
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Injection site pruritus
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Injection site warmth
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Malaise
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Feeling hot
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Injection site haemorrhage
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Injection site bruising
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Peripheral swelling
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Chest discomfort
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Feeling cold
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Oedema peripheral
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Swelling
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Inflammation
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Injection site reaction
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Pain
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Asthenia
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Axillary pain
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Chest pain
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Impaired healing
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Injection site induration
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Injection site movement impairment
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Injection site paraesthesia
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected12 at risk
EG0021 events1 affected12 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Tendonitis
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Bursitis
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Pain in jaw
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Joint effusion
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Groin pain
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Osteoporosis
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Rotator cuff syndrome
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Joint range of motion decreased
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Joint swelling
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Muscle discomfort
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Fibromyalgia
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Headache
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0004 events3 affected12 at risk
EG0016 events5 affected12 at risk
EG0026 events5 affected12 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Sciatica
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Nerve compression
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Sinus headache
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Enteritis
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Gastrointestinal disorder
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0002 events2 affected12 at risk
EG0013 events2 affected12 at risk
EG0023 events2 affected12 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Faeces soft
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Palatal disorder
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Aphthous ulcer
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Cheilitis
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Eructation
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Gastric disorder
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Large intestine polyp
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Lip swelling
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Pancreatic cyst
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Dermatitis contact
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Ecchymosis
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Hidradenitis
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Blister
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Dermatitis allergic
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Intertrigo
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Photosensitivity reaction
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Skin hyperpigmentation
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Skin lesion
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Cold sweat
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Night sweats
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Rash pruritic
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Tonsillitis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0021 events1 affected12 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected12 at risk
EG0021 events1 affected12 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Rhinitis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected12 at risk
EG0021 events1 affected12 at risk
EG003
Tooth abscess
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Viral infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Tooth infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Cystitis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Laryngitis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Otitis externa
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Wound infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Paronychia
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Sialoadenitis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Chronic sinusitis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Dermatophytosis of nail
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Fungal skin infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Hordeolum
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Pulpitis dental
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Vulvovaginitis streptococcal
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Body tinea
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Folliculitis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Gastroenteritis norovirus
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Gastroenteritis viral
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Gingivitis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Herpes simplex
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Oral herpes
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Pharyngitis streptococcal
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Tracheitis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Bacterial infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Furuncle
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Otitis media
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Nasal discharge discolouration
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Sneezing
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Lower respiratory tract congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Paranasal sinus hypersecretion
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Pulmonary mass
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Respiratory disorder
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Rhonchi
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Sinus congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Joint dislocation
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Arthropod bite
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Muscle strain
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Foot fracture
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Skin laceration
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Ligament sprain
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Back injury
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Hand fracture
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Limb injury
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Tendon rupture
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Arthropod sting
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Bone contusion
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Patella fracture
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Post procedural inflammation
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Thermal burn
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Tooth fracture
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Upper limb fracture
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Ear pain
Ear and labyrinth disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
External ear pain
Ear and labyrinth disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Deafness
Ear and labyrinth disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Ear discomfort
Ear and labyrinth disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Ear disorder
Ear and labyrinth disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Cardiac murmur
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Haemoglobin decreased
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
White blood cell count decreased
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Basophil count increased
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Heart rate irregular
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Hypertension
Vascular disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Haematoma
Vascular disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Phlebitis
Vascular disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Hyperlipidaemia
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Hypoferritinaemia
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Type 2 diabetes mellitus
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Leukocytosis
Blood and lymphatic system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Lymphadenopathy
Blood and lymphatic system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0012 events1 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Lymphocytosis
Blood and lymphatic system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Monoclonal gammopathy
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Benign anorectal neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Large intestine benign neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Lipoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Squamous cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Allergy to arthropod bite
Immune system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Hypersensitivity
Immune system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Reaction to preservatives
Immune system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Seasonal allergy
Immune system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Dysmenorrhoea
Reproductive system and breast disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Benign prostatic hyperplasia
Reproductive system and breast disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Breast pain
Reproductive system and breast disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Erectile dysfunction
Reproductive system and breast disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Pelvic pain
Reproductive system and breast disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Palpitations
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Blepharitis
Eye disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Conjunctivitis allergic
Eye disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Dermoid cyst
Congenital, familial and genetic disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
Subjects in Part A aged 18-40 years, receiving 2 doses of placebo (Saline solution) control, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG004
Low Dose_PLAIN_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted low dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG005
Medium Dose_PLAIN_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted medium dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG006
High Dose_PLAIN_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted high dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG007
Low Dose_AS01E_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) low dose adjuvanted with AS01E, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG008
Medium Dose_AS01E_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) medium dose adjuvanted with AS01E, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG009
High Dose_AS01E_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01E, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG010
Low Dose_AS01B_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) low dose adjuvanted with AS01B, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG011
Medium Dose_AS01B_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) medium dose adjuvanted with AS01B, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG012
High Dose_AS01B_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01B, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG013
Placebo_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of placebo (Saline solution) control, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
Units
Counts
Participants
OG00012
OG00110
OG00211
OG00312
OG00495
OG00591
OG00690
OG00794
OG00894
OG00995
OG01096
OG01193
OG01293
OG01397
Title
Denominators
Categories
Erythema
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0041
OG0050
OG0062
OG0073
OG0083
OG0097
OG01016
OG01114
OG01212
OG0130
Pain
Title
Measurements
OG0005
OG0017
OG0028
OG003
Swelling
Title
Measurements
OG0000
OG0010
OG0020
OG003
Subjects in Part A aged 18-40 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted high dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG003
Placebo_A Group
Subjects in Part A aged 18-40 years, receiving 2 doses of placebo (Saline solution) control, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG004
Low Dose_PLAIN_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted low dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG005
Medium Dose_PLAIN_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted medium dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG006
High Dose_PLAIN_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted high dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG007
Low Dose_AS01E_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) low dose adjuvanted with AS01E, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG008
Medium Dose_AS01E_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) medium dose adjuvanted with AS01E, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG009
High Dose_AS01E_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01E, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG010
Low Dose_AS01B_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) low dose adjuvanted with AS01B, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG011
Medium Dose_AS01B_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) medium dose adjuvanted with AS01B, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG012
High Dose_AS01B_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01B, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG013
Placebo_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of placebo (Saline solution) control, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
Units
Counts
Participants
OG00012
OG00112
OG00211
OG00312
OG004100
OG00596
OG00699
OG007101
OG008100
OG009100
OG010103
OG01199
OG012101
OG01398
Title
Denominators
Categories
Arthralgia
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0047
OG0054
OG0060
OG0077
OG00812
OG0096
OG01015
OG0119
OG01217
OG0137
Fatigue
Title
Measurements
OG0004
OG0015
OG0021
OG003
Fever
Title
Measurements
OG0000
OG0010
OG0020
OG003
Gastrointestinal symptoms
Title
Measurements
OG0001
OG0012
OG0021
OG003
Headache
Title
Measurements
OG0002
OG0014
OG0023
OG003
Myalgia
Title
Measurements
OG0000
OG0011
OG0021
OG003
Shivering
Title
Measurements
OG0000
OG0012
OG0020
OG003
Subjects in Part A aged 18-40 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted high dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG003
Placebo_A Group
Subjects in Part A aged 18-40 years, receiving 2 doses of placebo (Saline solution) control, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG004
Low Dose_PLAIN_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted low dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG005
Medium Dose_PLAIN_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted medium dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG006
High Dose_PLAIN_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted high dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG007
Low Dose_AS01E_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) low dose adjuvanted with AS01E, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG008
Medium Dose_AS01E_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) medium dose adjuvanted with AS01E, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG009
High Dose_AS01E_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01E, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG010
Low Dose_AS01B_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) low dose adjuvanted with AS01B, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG011
Medium Dose_AS01B_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) medium dose adjuvanted with AS01B, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG012
High Dose_AS01B_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01B, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG013
Placebo_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of placebo (Saline solution) control, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
Units
Counts
Participants
OG00012
OG00110
OG00211
OG00312
OG00495
OG00591
OG00690
OG00794
OG00894
OG00995
OG01096
OG01193
OG01293
OG01397
Title
Denominators
Categories
Arthralgia
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0041
OG0054
OG0062
OG0078
OG0088
OG00910
OG01021
OG01111
OG01213
OG0134
Fatigue
Title
Measurements
OG0003
OG0012
OG0024
OG003
Fever
Title
Measurements
OG0000
OG0010
OG0020
OG003
Gastrointestinal symptoms
Title
Measurements
OG0001
OG0011
OG0022
OG003
Headache
Title
Measurements
OG0002
OG0012
OG0023
OG003
Myalgia
Title
Measurements
OG0000
OG0010
OG0020
OG003
Shivering
Title
Measurements
OG0000
OG0010
OG0020
OG003
OG002
High Dose_PLAIN_A Group
Subjects in Part A aged 18-40 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted high dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG003
Placebo_A Group
Subjects in Part A aged 18-40 years, receiving 2 doses of placebo (Saline solution) control, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG004
Low Dose_PLAIN_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted low dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG005
Medium Dose_PLAIN_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted medium dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG006
High Dose_PLAIN_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted high dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG007
Low Dose_AS01E_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) low dose adjuvanted with AS01E, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG008
Medium Dose_AS01E_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) medium dose adjuvanted with AS01E, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG009
High Dose_AS01E_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01E, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG010
Low Dose_AS01B_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) low dose adjuvanted with AS01B, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG011
Medium Dose_AS01B_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) medium dose adjuvanted with AS01B, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG012
High Dose_AS01B_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01B, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG013
Placebo_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of placebo (Saline solution) control, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
Units
Counts
Participants
OG00012
OG00112
OG00212
OG00312
OG004101
OG00597
OG006100
OG007101
OG008101
OG009100
OG010103
OG011100
OG012101
OG013101
Title
Denominators
Categories
Title
Measurements
OG0002
OG0014
OG0024
OG0036
OG00434
OG00528
OG00630
OG00740
OG00829
OG00936
OG01039
OG01134
OG01243
OG01333
OG002
High Dose_PLAIN_A Group
Subjects in Part A aged 18-40 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted high dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG003
Placebo_A Group
Subjects in Part A aged 18-40 years, receiving 2 doses of placebo (Saline solution) control, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
Units
Counts
Participants
OG00012
OG00112
OG00211
OG00312
Title
Denominators
Categories
ALT-WITHIN-WITHIN
ParticipantsOG00012
ParticipantsOG00112
ParticipantsOG00211
ParticipantsOG00312
Title
Measurements
OG00012
OG00112
OG00211
OG003
AST-WITHIN-WITHIN
ParticipantsOG00011
ParticipantsOG00112
ParticipantsOG00211
ParticipantsOG00311
AST-ABOVE-WITHIN
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0031
Basophils-WITHIN-WITHIN
ParticipantsOG00012
ParticipantsOG00112
ParticipantsOG00211
ParticipantsOG00312
Creatinine-BELOW-BELOW
ParticipantsOG0001
ParticipantsOG0012
ParticipantsOG0020
ParticipantsOG0031
Creatinine-BELOW-WITHIN
ParticipantsOG0001
ParticipantsOG0012
ParticipantsOG0020
ParticipantsOG0031
Creatinine-WITHIN-WITHIN
ParticipantsOG00011
ParticipantsOG0019
ParticipantsOG00211
ParticipantsOG00311
Creatinine-ABOVE-ABOVE
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0030
Eosinophils-BELOW-BELOW
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0021
ParticipantsOG0030
Eosinophils-BELOW-WITHIN
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0021
ParticipantsOG0030
Eosinophils-WITHIN-WITHIN
ParticipantsOG00011
ParticipantsOG00110
ParticipantsOG00210
ParticipantsOG00312
Eosinophils-ABOVE-WITHIN
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0030
Erythrocytes-BELOW-WITHIN
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0031
Erythrocytes-WITHIN-WITHIN
ParticipantsOG00011
ParticipantsOG00111
ParticipantsOG00211
ParticipantsOG00311
Erythrocytes-ABOVE-WITHIN
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0030
Hemoglobin-BELOW-BELOW
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0031
Hemoglobin-BELOW-WITHIN
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0031
Hemoglobin-WITHIN-WITHIN
ParticipantsOG00011
ParticipantsOG00112
ParticipantsOG00211
ParticipantsOG00311
Lymphocytes-BELOW-WITHIN
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0031
Lymphocytes-WITHIN-WITHIN
ParticipantsOG00012
ParticipantsOG00111
ParticipantsOG00211
ParticipantsOG00311
Monocytes-BELOW-WITHIN
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0030
Monocytes-WITHIN-WITHIN
ParticipantsOG00012
ParticipantsOG00111
ParticipantsOG00211
ParticipantsOG00312
Neutrophis-BELOW-BELOW
ParticipantsOG0002
ParticipantsOG0011
ParticipantsOG0021
ParticipantsOG0030
Neutrophils-BELOW-WITHIN
ParticipantsOG0002
ParticipantsOG0011
ParticipantsOG0021
ParticipantsOG0030
Neutrophils-WITHIN-WITHIN
ParticipantsOG0008
ParticipantsOG00111
ParticipantsOG00210
ParticipantsOG00312
Neutrophils-ABOVE-WITHIN
ParticipantsOG0002
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Neutrophils-ABOVE-ABOVE
ParticipantsOG0002
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Platelets-WITHIN-WITHIN
ParticipantsOG00012
ParticipantsOG00112
ParticipantsOG00211
ParticipantsOG00312
Urea Nitrogen-WITHIN-BELOW
ParticipantsOG00012
ParticipantsOG00112
ParticipantsOG00211
ParticipantsOG00312
Urea Nitrogen-WITHIN-WITHIN
ParticipantsOG00012
ParticipantsOG00112
ParticipantsOG00211
ParticipantsOG00312
Uric Acid-BELOW-WITHIN
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Uric Acid-WITHIN-WITHIN
ParticipantsOG00011
ParticipantsOG00112
ParticipantsOG00211
ParticipantsOG00312
White Blood Cells-BELOW-BELOW
ParticipantsOG0002
ParticipantsOG0011
ParticipantsOG0021
ParticipantsOG0031
White Blood Cells-BELOW-WITHIN
ParticipantsOG0002
ParticipantsOG0011
ParticipantsOG0021
ParticipantsOG0031
White Blood Cells-WITHIN-WITHIN
ParticipantsOG0008
ParticipantsOG00111
ParticipantsOG00210
ParticipantsOG00311
White Blood Cells-ABOVE-WITHIN
ParticipantsOG0002
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
White Blood Cells-ABOVE-ABOVE
ParticipantsOG0002
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
OG002
High Dose_PLAIN_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted high dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG003
Low Dose_AS01E_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) low dose adjuvanted with AS01E, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG004
Medium Dose_AS01E_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) medium dose adjuvanted with AS01E, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG005
High Dose_AS01E_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01E, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG006
Low Dose_AS01B_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) low dose adjuvanted with AS01B, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG007
Medium Dose_AS01B_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) medium dose adjuvanted with AS01B, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG008
High Dose_AS01B_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01B, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG009
Placebo_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of placebo (Saline solution) control, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
Units
Counts
Participants
OG000101
OG00197
OG00299
OG003100
OG004100
OG005100
OG006103
OG007100
OG008101
OG009101
Title
Denominators
Categories
ALT-WITHIN-UNKNOWN
ParticipantsOG000100
ParticipantsOG00197
ParticipantsOG00299
ParticipantsOG00398
ParticipantsOG00498
ParticipantsOG005100
ParticipantsOG006100
ParticipantsOG00795
ParticipantsOG00899
ParticipantsOG009100
Title
Measurements
OG0000
OG0010
OG0020
OG003
ALT-WITHIN-WITHIN
ParticipantsOG000100
ParticipantsOG00197
ParticipantsOG00299
ParticipantsOG00398
ALT-WITHIN-ABOVE
ParticipantsOG000100
ParticipantsOG00197
ParticipantsOG00299
ParticipantsOG00398
ALT-ABOVE-WITHIN
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0032
ALT-ABOVE-ABOVE
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0032
AST-WITHIN-UNKNOWN
ParticipantsOG000101
ParticipantsOG00197
ParticipantsOG00299
ParticipantsOG003100
AST-WITHIN-WITHIN
ParticipantsOG000101
ParticipantsOG00197
ParticipantsOG00299
ParticipantsOG003100
AST-WITHIN-ABOVE
ParticipantsOG000101
ParticipantsOG00197
ParticipantsOG00299
ParticipantsOG003100
AST-ABOVE-WITHIN
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
AST-ABOVE-ABOVE
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Basophils-WITHIN-UNKNOWN
ParticipantsOG000101
ParticipantsOG00197
ParticipantsOG00299
ParticipantsOG003100
Basophils-WITHIN-WITHIN
ParticipantsOG000101
ParticipantsOG00197
ParticipantsOG00299
ParticipantsOG003100
Basophils-WITHIN-ABOVE
ParticipantsOG000101
ParticipantsOG00197
ParticipantsOG00299
ParticipantsOG003100
Creatinine-BELOW-BELOW
ParticipantsOG0001
ParticipantsOG0018
ParticipantsOG0026
ParticipantsOG0033
Creatinine-BELOW-WITHIN
ParticipantsOG0001
ParticipantsOG0018
ParticipantsOG0026
ParticipantsOG0033
Creatinine-WITHIN-UNKNOWN
ParticipantsOG00094
ParticipantsOG00185
ParticipantsOG00292
ParticipantsOG00394
Creatinine-WITHIN-BELOW
ParticipantsOG00094
ParticipantsOG00185
ParticipantsOG00292
ParticipantsOG00394
Creatinine-WITHIN-WITHIN
ParticipantsOG00094
ParticipantsOG00185
ParticipantsOG00292
ParticipantsOG00394
Creatinine-WITHIN-ABOVE
ParticipantsOG00094
ParticipantsOG00185
ParticipantsOG00292
ParticipantsOG00394
Creatinine-ABOVE-UNKNOWN
ParticipantsOG0006
ParticipantsOG0014
ParticipantsOG0021
ParticipantsOG0033
Creatinine-ABOVE-WITHIN
ParticipantsOG0006
ParticipantsOG0014
ParticipantsOG0021
ParticipantsOG0033
Creatinine-ABOVE-ABOVE
ParticipantsOG0006
ParticipantsOG0014
ParticipantsOG0021
ParticipantsOG0033
Eosinophils-BELOW-BELOW
ParticipantsOG0007
ParticipantsOG0016
ParticipantsOG0025
ParticipantsOG0034
Eosinophils-BELOW-WITHIN
ParticipantsOG0007
ParticipantsOG0016
ParticipantsOG0025
ParticipantsOG0034
Eosinophils-BELOW-ABOVE
ParticipantsOG0007
ParticipantsOG0016
ParticipantsOG0025
ParticipantsOG0034
Eosinophils-WITHIN-UNKNOWN
ParticipantsOG00090
ParticipantsOG00189
ParticipantsOG00290
ParticipantsOG00394
Eosinophils-WITHIN-BELOW
ParticipantsOG00090
ParticipantsOG00189
ParticipantsOG00290
ParticipantsOG00394
Eosinophils-WITHIN-WITHIN
ParticipantsOG00090
ParticipantsOG00189
ParticipantsOG00290
ParticipantsOG00394
Eosinophils-WITHIN-ABOVE
ParticipantsOG00090
ParticipantsOG00189
ParticipantsOG00290
ParticipantsOG00394
Eosinophils-ABOVE-WITHIN
ParticipantsOG0004
ParticipantsOG0012
ParticipantsOG0024
ParticipantsOG0032
Eosinophils-ABOVE-ABOVE
ParticipantsOG0004
ParticipantsOG0012
ParticipantsOG0024
ParticipantsOG0032
Erythrocytes-BELOW-BELOW
ParticipantsOG0005
ParticipantsOG0014
ParticipantsOG0021
ParticipantsOG0031
Erythrocytes-BELOW-WITHIN
ParticipantsOG0005
ParticipantsOG0014
ParticipantsOG0021
ParticipantsOG0031
Erythrocytes-WITHIN-UNKNOWN
ParticipantsOG00095
ParticipantsOG00191
ParticipantsOG00296
ParticipantsOG00399
Erythrocytes-WITHIN-BELOW
ParticipantsOG00095
ParticipantsOG00191
ParticipantsOG00296
ParticipantsOG00399
Erythrocytes-WITHIN-WITHIN
ParticipantsOG00095
ParticipantsOG00191
ParticipantsOG00296
ParticipantsOG00399
Erythrocytes-WITHIN-ABOVE
ParticipantsOG00095
ParticipantsOG00191
ParticipantsOG00296
ParticipantsOG00399
Erythrocytes-ABOVE-WITHIN
ParticipantsOG0001
ParticipantsOG0012
ParticipantsOG0022
ParticipantsOG0030
Erythrocytes-ABOVE-ABOVE
ParticipantsOG0001
ParticipantsOG0012
ParticipantsOG0022
ParticipantsOG0030
Hemoglobin-BELOW-UNKNOWN
ParticipantsOG00010
ParticipantsOG0018
ParticipantsOG0021
ParticipantsOG0035
Hemoglobin-BELOW-BELOW
ParticipantsOG00010
ParticipantsOG0018
ParticipantsOG0021
ParticipantsOG0035
Hemoglobin-BELOW-WITHIN
ParticipantsOG00010
ParticipantsOG0018
ParticipantsOG0021
ParticipantsOG0035
Hemoglobin-WITHIN-UNKNOWN
ParticipantsOG00091
ParticipantsOG00186
ParticipantsOG00297
ParticipantsOG00393
Hemoglobin-WITHIN-BELOW
ParticipantsOG00091
ParticipantsOG00186
ParticipantsOG00297
ParticipantsOG00393
Hemoglobin-WITHIN-WITHIN
ParticipantsOG00091
ParticipantsOG00186
ParticipantsOG00297
ParticipantsOG00393
Hemoglobin-WITHIN-ABOVE
ParticipantsOG00091
ParticipantsOG00186
ParticipantsOG00297
ParticipantsOG00393
Hemoglobin-ABOVE-WITHIN
ParticipantsOG0000
ParticipantsOG0013
ParticipantsOG0021
ParticipantsOG0032
Hemoglobin-ABOVE-ABOVE
ParticipantsOG0000
ParticipantsOG0013
ParticipantsOG0021
ParticipantsOG0032
Lymphocytes-BELOW-BELOW
ParticipantsOG0002
ParticipantsOG0012
ParticipantsOG0020
ParticipantsOG0033
Lymphocytes-BELOW-WITHIN
ParticipantsOG0002
ParticipantsOG0012
ParticipantsOG0020
ParticipantsOG0033
Lymphocytes-WITHIN-UNKNOWN
ParticipantsOG00099
ParticipantsOG00194
ParticipantsOG00299
ParticipantsOG00397
Lymphocytes-WITHIN-BELOW
ParticipantsOG00099
ParticipantsOG00194
ParticipantsOG00299
ParticipantsOG00397
Lymphocytes-WITHIN-WITHIN
ParticipantsOG00099
ParticipantsOG00194
ParticipantsOG00299
ParticipantsOG00397
Lymphocytes-WITHIN-ABOVE
ParticipantsOG00099
ParticipantsOG00194
ParticipantsOG00299
ParticipantsOG00397
Lymphocytes-ABOVE-WITHIN
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0030
Lymphocytes-ABOVE-ABOVE
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0030
Monocytes-BELOW-UNKNOWN
ParticipantsOG0004
ParticipantsOG0012
ParticipantsOG0023
ParticipantsOG0032
Monocytes-BELOW-BELOW
ParticipantsOG0004
ParticipantsOG0012
ParticipantsOG0023
ParticipantsOG0032
Monocytes-BELOW-WITHIN
ParticipantsOG0004
ParticipantsOG0012
ParticipantsOG0023
ParticipantsOG0032
Monocytes-WITHIN-UNKNOWN
ParticipantsOG00097
ParticipantsOG00195
ParticipantsOG00296
ParticipantsOG00398
Monocytes-WITHIN-BELOW
ParticipantsOG00097
ParticipantsOG00195
ParticipantsOG00296
ParticipantsOG00398
Monocytes-WITHIN-WITHIN
ParticipantsOG00097
ParticipantsOG00195
ParticipantsOG00296
ParticipantsOG00398
Monocytes-WITHIN-ABOVE
ParticipantsOG00097
ParticipantsOG00195
ParticipantsOG00296
ParticipantsOG00398
Neutrophils-BELOW-BELOW
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0023
ParticipantsOG0034
Neutrophils-BELOW-WITHIN
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0023
ParticipantsOG0034
Neutrophils-WITHIN-UNKNOWN
ParticipantsOG000100
ParticipantsOG00196
ParticipantsOG00296
ParticipantsOG00393
Neutrophils-WITHIN-BELOW
ParticipantsOG000100
ParticipantsOG00196
ParticipantsOG00296
ParticipantsOG00393
Neutrophils-WITHIN-WITHIN
ParticipantsOG000100
ParticipantsOG00196
ParticipantsOG00296
ParticipantsOG00393
Neutrophils-WITHIN-ABOVE
ParticipantsOG000100
ParticipantsOG00196
ParticipantsOG00296
ParticipantsOG00393
Neutrophils-ABOVE-WITHIN
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0033
Neutrophils-ABOVE-ABOVE
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0033
Platelets-UNKNOWN-UNKNOWN
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0030
Platelets-BELOW-BELOW
ParticipantsOG0003
ParticipantsOG0011
ParticipantsOG0023
ParticipantsOG0031
Platelets-BELOW-WITHIN
ParticipantsOG0003
ParticipantsOG0011
ParticipantsOG0023
ParticipantsOG0031
Platelets-WITHIN-UNKNOWN
ParticipantsOG00097
ParticipantsOG00196
ParticipantsOG00295
ParticipantsOG00397
Platelets-WITHIN-BELOW
ParticipantsOG00097
ParticipantsOG00196
ParticipantsOG00295
ParticipantsOG00397
Platelets-WITHIN-WITHIN
ParticipantsOG00097
ParticipantsOG00196
ParticipantsOG00295
ParticipantsOG00397
Platelets-WITHIN-ABOVE
ParticipantsOG00097
ParticipantsOG00196
ParticipantsOG00295
ParticipantsOG00397
Platelets-ABOVE-WITHIN
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0032
Platelets-ABOVE-ABOVE
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0032
Urea Nitrogen-BELOW-BELOW
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0031
Urea Nitrogen-WITHIN-UNKNOWN
ParticipantsOG00098
ParticipantsOG00197
ParticipantsOG00298
ParticipantsOG00398
Urea Nitrogen-WITHIN-BELOW
ParticipantsOG00098
ParticipantsOG00197
ParticipantsOG00298
ParticipantsOG00398
Urea Nitrogen-WITHIN-WITHIN
ParticipantsOG00098
ParticipantsOG00197
ParticipantsOG00298
ParticipantsOG00398
Urea Nitrogen-WITHIN-ABOVE
ParticipantsOG00098
ParticipantsOG00197
ParticipantsOG00298
ParticipantsOG00398
Urea Nitrogen-ABOVE-WITHIN
ParticipantsOG0003
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0031
Urea Nitrogen-ABOVE-ABOVE
ParticipantsOG0003
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0031
Uric Acid-BELOW-BELOW
ParticipantsOG0001
ParticipantsOG0012
ParticipantsOG0020
ParticipantsOG0033
Uric Acid-BELOW-WITHIN
ParticipantsOG0001
ParticipantsOG0012
ParticipantsOG0020
ParticipantsOG0033
Uric Acid-WITHIN-UNKNOWN
ParticipantsOG00095
ParticipantsOG00194
ParticipantsOG00296
ParticipantsOG00396
Uric Acid-WITHIN-BELOW
ParticipantsOG00095
ParticipantsOG00194
ParticipantsOG00296
ParticipantsOG00396
Uric Acid-WITHIN-WITHIN
ParticipantsOG00095
ParticipantsOG00194
ParticipantsOG00296
ParticipantsOG00396
Uric Acid-WITHIN-ABOVE
ParticipantsOG00095
ParticipantsOG00194
ParticipantsOG00296
ParticipantsOG00396
Uric Acid-ABOVE-WITHIN
ParticipantsOG0005
ParticipantsOG0011
ParticipantsOG0023
ParticipantsOG0031
Uric Acid-ABOVE-ABOVE
ParticipantsOG0005
ParticipantsOG0011
ParticipantsOG0023
ParticipantsOG0031
White Blood Cells-BELOW-UNKNOWN
ParticipantsOG0003
ParticipantsOG0011
ParticipantsOG0024
ParticipantsOG0036
White Blood Cells-BELOW-BELOW
ParticipantsOG0003
ParticipantsOG0011
ParticipantsOG0024
ParticipantsOG0036
White Blood Cells-BELOW-WITHIN
ParticipantsOG0003
ParticipantsOG0011
ParticipantsOG0024
ParticipantsOG0036
White Blood Cells-WITHIN-UNKNOWN
ParticipantsOG00096
ParticipantsOG00195
ParticipantsOG00295
ParticipantsOG00391
White Blood Cells-WITHIN-BELOW
ParticipantsOG00096
ParticipantsOG00195
ParticipantsOG00295
ParticipantsOG00391
White Blood Cells-WITHIN-WITHIN
ParticipantsOG00096
ParticipantsOG00195
ParticipantsOG00295
ParticipantsOG00391
White Blood Cells-WITHIN-ABOVE
ParticipantsOG00096
ParticipantsOG00195
ParticipantsOG00295
ParticipantsOG00391
White Blood Cells-ABOVE-WITHIN
ParticipantsOG0002
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0033
White Blood Cells-ABOVE-ABOVE
ParticipantsOG0002
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0033
OG002
High Dose_PLAIN_A Group
Subjects in Part A aged 18-40 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted high dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG003
Placebo_A Group
Subjects in Part A aged 18-40 years, receiving 2 doses of placebo (Saline solution) control, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
Units
Counts
Participants
OG00012
OG00110
OG00211
OG00312
Title
Denominators
Categories
ALT-WITHIN-WITHIN
ParticipantsOG00012
ParticipantsOG00110
ParticipantsOG00210
ParticipantsOG00312
Title
Measurements
OG00011
OG00110
OG00210
OG003
ALT-WITHIN-ABOVE
ParticipantsOG00012
ParticipantsOG00110
ParticipantsOG00210
ParticipantsOG00312
ALT-ABOVE-WITHIN
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0030
AST-WITHIN-WITHIN
ParticipantsOG00011
ParticipantsOG00110
ParticipantsOG00211
ParticipantsOG00312
AST-WITHIN-ABOVE
ParticipantsOG00011
ParticipantsOG00110
ParticipantsOG00211
ParticipantsOG00312
AST-ABOVE-ABOVE
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Basophils-UNKNOWN-WITHIN
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Basophils-WITHIN-WITHIN
ParticipantsOG00011
ParticipantsOG00110
ParticipantsOG00211
ParticipantsOG00312
Creatinine-BELOW-BELOW
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0031
Creatinine-WITHIN-WITHIN
ParticipantsOG00012
ParticipantsOG0019
ParticipantsOG00211
ParticipantsOG00310
Creatinine-WITHIN-ABOVE
ParticipantsOG00012
ParticipantsOG0019
ParticipantsOG00211
ParticipantsOG00310
Creatinine-ABOVE-WITHIN
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0031
Creatinine-ABOVE-ABOVE
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0031
Eosinophils-UNKNOWN-WITHIN
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Eosinophils-BELOW-BELOW
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0021
ParticipantsOG0030
Eosinophils-BELOW-WITHIN
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0021
ParticipantsOG0030
Eosinophils-WITHIN-BELOW
ParticipantsOG00011
ParticipantsOG0019
ParticipantsOG00210
ParticipantsOG00312
Eosinophils-WITHIN-WITHIN
ParticipantsOG00011
ParticipantsOG0019
ParticipantsOG00210
ParticipantsOG00312
Eosinophils-WITHIN-ABOVE
ParticipantsOG00011
ParticipantsOG0019
ParticipantsOG00210
ParticipantsOG00312
Erythrocytes-UNKNOWN-BELOW
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Erythrocytes-WITHIN-BELOW
ParticipantsOG00011
ParticipantsOG0019
ParticipantsOG00211
ParticipantsOG00312
Erythrocytes-WITHIN-WITHIN
ParticipantsOG00011
ParticipantsOG0019
ParticipantsOG00211
ParticipantsOG00312
Erythrocytes-WITHIN-ABOVE
ParticipantsOG00011
ParticipantsOG0019
ParticipantsOG00211
ParticipantsOG00312
Erythrocytes-ABOVE-ABOVE
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0030
Hemoglobin-UNKNOWN-BELOW
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Hemoglobin-BELOW-WITHIN
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0030
Hemoglobin-WITHIN-WITHIN
ParticipantsOG00011
ParticipantsOG00110
ParticipantsOG00210
ParticipantsOG00312
Hemoglobin-WITHIN-ABOVE
ParticipantsOG00011
ParticipantsOG00110
ParticipantsOG00210
ParticipantsOG00312
Lymphocytes-UNKNOWN-WITHIN
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Lymphocytes-BELOW-WITHIN
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0031
Lymphocytes-WITHIN-WITHIN
ParticipantsOG00011
ParticipantsOG00110
ParticipantsOG00211
ParticipantsOG00311
Monocytes-UNKNOWN-WITHIN
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Monocytes-BELOW-WITHIN
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0030
Monocytes-WITHIN-WITHIN
ParticipantsOG00011
ParticipantsOG00110
ParticipantsOG00210
ParticipantsOG00312
Neutrophils-UNKNOWN-WITHIN
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Neutrophils-BELOW-BELOW
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0030
Neutrophils-BELOW-WITHIN
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0030
Neutrophils-WITHIN-BELOW
ParticipantsOG00010
ParticipantsOG00110
ParticipantsOG00210
ParticipantsOG00312
Neutrophils-WITHIN-WITHIN
ParticipantsOG00010
ParticipantsOG00110
ParticipantsOG00210
ParticipantsOG00312
Platelets-UNKNOWN-WITHIN
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0030
Platelets-WITHIN-WITHIN
ParticipantsOG00011
ParticipantsOG0018
ParticipantsOG00211
ParticipantsOG00312
Platelets-ABOVE-WITHIN
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0030
Urea Nitrogen-WITHIN-WITHIN
ParticipantsOG00012
ParticipantsOG00110
ParticipantsOG00211
ParticipantsOG00312
Uric Acid-BELOW-WITHIN
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Uric Acid-WITHIN-WITHIN
ParticipantsOG00011
ParticipantsOG00110
ParticipantsOG00211
ParticipantsOG00312
White Blood Cells-UNKNOWN-WITHIN
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
White Blood Cells-BELOW-BELOW
ParticipantsOG0002
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0030
White Blood Cells-BELOW-WITHIN
ParticipantsOG0002
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0030
White Blood Cells-WITHIN-BELOW
ParticipantsOG0008
ParticipantsOG00110
ParticipantsOG00210
ParticipantsOG00312
White Blood Cells-WITHIN-WITHIN
ParticipantsOG0008
ParticipantsOG00110
ParticipantsOG00210
ParticipantsOG00312
White Blood Cells-ABOVE-WITHIN
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
OG002
High Dose_PLAIN_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted high dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG003
Low Dose_AS01E_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) low dose adjuvanted with AS01E, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG004
Medium Dose_AS01E_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) medium dose adjuvanted with AS01E, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG005
High Dose_AS01E_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01E, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG006
Low Dose_AS01B_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) low dose adjuvanted with AS01B, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG007
Medium Dose_AS01B_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) medium dose adjuvanted with AS01B, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG008
High Dose_AS01B_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01B, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG009
Placebo_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of placebo (Saline solution) control, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
Units
Counts
Participants
OG00097
OG00194
OG00295
OG00396
OG00498
OG00597
OG00698
OG00797
OG00897
OG00999
Title
Denominators
Categories
ALT-UNKNOWN-WITHIN
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0031
ParticipantsOG0040
ParticipantsOG0051
ParticipantsOG0061
ParticipantsOG0071
ParticipantsOG0082
ParticipantsOG0090
Title
Measurements
OG0001
OG0010
OG0020
OG003
ALT-WITHIN-UNKNOWN
ParticipantsOG00095
ParticipantsOG00194
ParticipantsOG00295
ParticipantsOG00393
ALT-WITHIN-WITHIN
ParticipantsOG00095
ParticipantsOG00194
ParticipantsOG00295
ParticipantsOG00393
ALT-WITHIN-ABOVE
ParticipantsOG00095
ParticipantsOG00194
ParticipantsOG00295
ParticipantsOG00393
ALT-ABOVE-WITHIN
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0032
ALT-ABOVE-ABOVE
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0032
AST-UNKNOWN-WITHIN
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0031
AST-WITHIN-UNKNOWN
ParticipantsOG00096
ParticipantsOG00193
ParticipantsOG00295
ParticipantsOG00394
AST-WITHIN-WITHIN
ParticipantsOG00096
ParticipantsOG00193
ParticipantsOG00295
ParticipantsOG00394
AST-WITHIN-ABOVE
ParticipantsOG00096
ParticipantsOG00193
ParticipantsOG00295
ParticipantsOG00394
AST-ABOVE-WITHIN
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0031
AST-ABOVE-ABOVE
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0031
Basophils-UNKNOWN-WITHIN
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0030
Basophils-WITHIN-UNKNOWN
ParticipantsOG00096
ParticipantsOG00194
ParticipantsOG00294
ParticipantsOG00396
Basophils-WITHIN-WITHIN
ParticipantsOG00096
ParticipantsOG00194
ParticipantsOG00294
ParticipantsOG00396
Creatinine-UNKNOWN-BELOW
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0031
Creatinine-UNKNOWN-WITHIN
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0031
Creatinine-UNKNOWN-ABOVE
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0031
Creatinine-BELOW-UNKNOWN
ParticipantsOG0003
ParticipantsOG0016
ParticipantsOG0023
ParticipantsOG0033
Creatinine-BELOW-BELOW
ParticipantsOG0003
ParticipantsOG0016
ParticipantsOG0023
ParticipantsOG0033
Creatinine-BELOW-WITHIN
ParticipantsOG0003
ParticipantsOG0016
ParticipantsOG0023
ParticipantsOG0033
Creatinine-WITHIN-BELOW
ParticipantsOG00087
ParticipantsOG00183
ParticipantsOG00290
ParticipantsOG00389
Creatinine-WITHIN-WITHIN
ParticipantsOG00087
ParticipantsOG00183
ParticipantsOG00290
ParticipantsOG00389
Creatinine-WITHIN-ABOVE
ParticipantsOG00087
ParticipantsOG00183
ParticipantsOG00290
ParticipantsOG00389
Creatinine-ABOVE-WITHIN
ParticipantsOG0006
ParticipantsOG0015
ParticipantsOG0022
ParticipantsOG0033
Creatinine-ABOVE-ABOVE
ParticipantsOG0006
ParticipantsOG0015
ParticipantsOG0022
ParticipantsOG0033
Eosinophils-UNKNOWN-WITHIN
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0030
Eosinophils-UNKNOWN-ABOVE
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0030
Eosinophils-BELOW-UNKNOWN
ParticipantsOG0007
ParticipantsOG0015
ParticipantsOG0029
ParticipantsOG0036
Eosinophils-BELOW-BELOW
ParticipantsOG0007
ParticipantsOG0015
ParticipantsOG0029
ParticipantsOG0036
Eosinophils-BELOW-WITHIN
ParticipantsOG0007
ParticipantsOG0015
ParticipantsOG0029
ParticipantsOG0036
Eosinophils-WITHIN-UNKNOWN
ParticipantsOG00086
ParticipantsOG00187
ParticipantsOG00282
ParticipantsOG00387
Eosinophils-WITHIN-BELOW
ParticipantsOG00086
ParticipantsOG00187
ParticipantsOG00282
ParticipantsOG00387
Eosinophils-WITHIN-WITHIN
ParticipantsOG00086
ParticipantsOG00187
ParticipantsOG00282
ParticipantsOG00387
Eosinophils-WITHIN-ABOVE
ParticipantsOG00086
ParticipantsOG00187
ParticipantsOG00282
ParticipantsOG00387
Eosinophils-ABOVE-WITHIN
ParticipantsOG0003
ParticipantsOG0012
ParticipantsOG0023
ParticipantsOG0033
Eosinophils-ABOVE-ABOVE
ParticipantsOG0003
ParticipantsOG0012
ParticipantsOG0023
ParticipantsOG0033
Erythrocytes-UNKNOWN-BELOW
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0030
Erythrocytes-UNKNOWN-WITHIN
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0030
Erythrocytes-UNKNOWN-ABOVE
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0030
Erythrocytes-BELOW-BELOW
ParticipantsOG0007
ParticipantsOG0012
ParticipantsOG0020
ParticipantsOG0032
Erythrocytes-BELOW-WITHIN
ParticipantsOG0007
ParticipantsOG0012
ParticipantsOG0020
ParticipantsOG0032
Erythrocytes-WITHIN-UNKNOWN
ParticipantsOG00087
ParticipantsOG00191
ParticipantsOG00291
ParticipantsOG00393
Erythrocytes-WITHIN-BELOW
ParticipantsOG00087
ParticipantsOG00191
ParticipantsOG00291
ParticipantsOG00393
Erythrocytes-WITHIN-WITHIN
ParticipantsOG00087
ParticipantsOG00191
ParticipantsOG00291
ParticipantsOG00393
Erythrocytes-WITHIN-ABOVE
ParticipantsOG00087
ParticipantsOG00191
ParticipantsOG00291
ParticipantsOG00393
Erythrocytes-ABOVE-WITHIN
ParticipantsOG0002
ParticipantsOG0011
ParticipantsOG0023
ParticipantsOG0031
Erythrocytes-ABOVE-ABOVE
ParticipantsOG0002
ParticipantsOG0011
ParticipantsOG0023
ParticipantsOG0031
Hemoglobin-UNKNOWN-BELOW
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0030
Hemoglobin-UNKNOWN-WITHIN
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0030
Hemoglobin-BELOW-BELOW
ParticipantsOG0008
ParticipantsOG0018
ParticipantsOG0023
ParticipantsOG0037
Hemoglobin-BELOW-WITHIN
ParticipantsOG0008
ParticipantsOG0018
ParticipantsOG0023
ParticipantsOG0037
Hemoglobin-WITHIN-UNKNOWN
ParticipantsOG00087
ParticipantsOG00185
ParticipantsOG00290
ParticipantsOG00386
Hemoglobin-WITHIN-BELOW
ParticipantsOG00087
ParticipantsOG00185
ParticipantsOG00290
ParticipantsOG00386
Hemoglobin-WITHIN-WITHIN
ParticipantsOG00087
ParticipantsOG00185
ParticipantsOG00290
ParticipantsOG00386
Hemoglobin-WITHIN-ABOVE
ParticipantsOG00087
ParticipantsOG00185
ParticipantsOG00290
ParticipantsOG00386
Hemoglobin-ABOVE-WITHIN
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0021
ParticipantsOG0033
Hemoglobin-ABOVE-ABOVE
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0021
ParticipantsOG0033
Lymphocytes-UNKNOWN-WITHIN
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0030
Lymphocytes-BELOW-BELOW
ParticipantsOG0002
ParticipantsOG0011
ParticipantsOG0024
ParticipantsOG0034
Lymphocytes-BELOW-WITHIN
ParticipantsOG0002
ParticipantsOG0011
ParticipantsOG0024
ParticipantsOG0034
Lymphocytes-WITHIN-UNKNOWN
ParticipantsOG00093
ParticipantsOG00192
ParticipantsOG00290
ParticipantsOG00391
Lymphocytes-WITHIN-BELOW
ParticipantsOG00093
ParticipantsOG00192
ParticipantsOG00290
ParticipantsOG00391
Lymphocytes-WITHIN-WITHIN
ParticipantsOG00093
ParticipantsOG00192
ParticipantsOG00290
ParticipantsOG00391
Lymphocytes-WITHIN-ABOVE
ParticipantsOG00093
ParticipantsOG00192
ParticipantsOG00290
ParticipantsOG00391
Lymphocytes-ABOVE-WITHIN
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0031
Lymphocytes-ABOVE-ABOVE
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0031
Monocytes-UNKNOWN-BELOW
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0030
Monocytes-UNKNOWN-WITHIN
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0030
Monocytes-BELOW-BELOW
ParticipantsOG0005
ParticipantsOG0010
ParticipantsOG0024
ParticipantsOG0033
Monocytes-BELOW-WITHIN
ParticipantsOG0005
ParticipantsOG0010
ParticipantsOG0024
ParticipantsOG0033
Monocytes-WITHIN-UNKNOWN
ParticipantsOG00089
ParticipantsOG00194
ParticipantsOG00290
ParticipantsOG00393
Monocytes-WITHIN-BELOW
ParticipantsOG00089
ParticipantsOG00194
ParticipantsOG00290
ParticipantsOG00393
Monocytes-WITHIN-WITHIN
ParticipantsOG00089
ParticipantsOG00194
ParticipantsOG00290
ParticipantsOG00393
Monocytes-ABOVE-WITHIN
ParticipantsOG0002
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Monocytes-ABOVE-ABOVE
ParticipantsOG0002
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Neutrophils-UNKNOWN-WITHIN
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0030
Neutrophils-BELOW-BELOW
ParticipantsOG0002
ParticipantsOG0011
ParticipantsOG0021
ParticipantsOG0033
Neutrophils-BELOW-WITHIN
ParticipantsOG0002
ParticipantsOG0011
ParticipantsOG0021
ParticipantsOG0033
Neutrophils-WITHIN-UNKNOWN
ParticipantsOG00094
ParticipantsOG00192
ParticipantsOG00293
ParticipantsOG00392
Neutrophils-WITHIN-BELOW
ParticipantsOG00094
ParticipantsOG00192
ParticipantsOG00293
ParticipantsOG00392
Neutrophils-WITHIN-WITHIN
ParticipantsOG00094
ParticipantsOG00192
ParticipantsOG00293
ParticipantsOG00392
Neutrophils-WITHIN-ABOVE
ParticipantsOG00094
ParticipantsOG00192
ParticipantsOG00293
ParticipantsOG00392
Neutrophils-ABOVE-WITHIN
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0031
Neutrophils-ABOVE-ABOVE
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0031
Platelets-UNKNOWN-UNKNOWN
ParticipantsOG0003
ParticipantsOG0012
ParticipantsOG0022
ParticipantsOG0030
Platelets-UNKNOWN-WITHIN
ParticipantsOG0003
ParticipantsOG0012
ParticipantsOG0022
ParticipantsOG0030
Platelets-BELOW-UNKNOWN
ParticipantsOG0003
ParticipantsOG0011
ParticipantsOG0023
ParticipantsOG0031
Platelets-BELOW-BELOW
ParticipantsOG0003
ParticipantsOG0011
ParticipantsOG0023
ParticipantsOG0031
Platelets-BELOW-WITHIN
ParticipantsOG0003
ParticipantsOG0011
ParticipantsOG0023
ParticipantsOG0031
Platelets-WITHIN-UNKNOWN
ParticipantsOG00089
ParticipantsOG00191
ParticipantsOG00289
ParticipantsOG00393
Platelets-WITHIN-BELOW
ParticipantsOG00089
ParticipantsOG00191
ParticipantsOG00289
ParticipantsOG00393
Platelets-WITHIN-WITHIN
ParticipantsOG00089
ParticipantsOG00191
ParticipantsOG00289
ParticipantsOG00393
Platelets-WITHIN-ABOVE
ParticipantsOG00089
ParticipantsOG00191
ParticipantsOG00289
ParticipantsOG00393
Platelets-ABOVE-WITHIN
ParticipantsOG0002
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0032
Platelets-ABOVE-ABOVE
ParticipantsOG0002
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0032
Urea Nitrogen-UNKNOWN-WITHIN
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0031
Urea Nitrogen-UNKNOWN-ABOVE
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0031
Urea Nitrogen-BELOW-BELOW
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0031
Urea Nitrogen-BELOW-WITHIN
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0031
Urea Nitrogen-WITHIN-UNKNOWN
ParticipantsOG00092
ParticipantsOG00194
ParticipantsOG00293
ParticipantsOG00392
Urea Nitrogen-WITHIN-WITHIN
ParticipantsOG00092
ParticipantsOG00194
ParticipantsOG00293
ParticipantsOG00392
Urea Nitrogen-WITHIN-ABOVE
ParticipantsOG00092
ParticipantsOG00194
ParticipantsOG00293
ParticipantsOG00392
Urea Nitrogen-ABOVE-WITHIN
ParticipantsOG0004
ParticipantsOG0010
ParticipantsOG0022
ParticipantsOG0032
Urea Nitrogen-ABOVE-ABOVE
ParticipantsOG0004
ParticipantsOG0010
ParticipantsOG0022
ParticipantsOG0032
Uric Acid-UNKNOWN-BELOW
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0031
Uric Acid-UNKNOWN-WITHIN
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0031
Uric Acid-UNKNOWN-ABOVE
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0031
Uric Acid-BELOW-BELOW
ParticipantsOG0002
ParticipantsOG0012
ParticipantsOG0021
ParticipantsOG0033
Uric Acid-BELOW-WITHIN
ParticipantsOG0002
ParticipantsOG0012
ParticipantsOG0021
ParticipantsOG0033
Uric Acid-WITHIN-UNKNOWN
ParticipantsOG00091
ParticipantsOG00187
ParticipantsOG00292
ParticipantsOG00390
Uric Acid-WITHIN-BELOW
ParticipantsOG00091
ParticipantsOG00187
ParticipantsOG00292
ParticipantsOG00390
Uric Acid-WITHIN-WITHIN
ParticipantsOG00091
ParticipantsOG00187
ParticipantsOG00292
ParticipantsOG00390
Uric Acid-WITHIN-ABOVE
ParticipantsOG00091
ParticipantsOG00187
ParticipantsOG00292
ParticipantsOG00390
Uric Acid-ABOVE-WITHIN
ParticipantsOG0003
ParticipantsOG0015
ParticipantsOG0022
ParticipantsOG0032
Uric Acid-ABOVE-ABOVE
ParticipantsOG0003
ParticipantsOG0015
ParticipantsOG0022
ParticipantsOG0032
White Blood Cells-UNKNOWN-WITHIN
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0030
White Blood Cells-BELOW-BELOW
ParticipantsOG0004
ParticipantsOG0010
ParticipantsOG0023
ParticipantsOG0034
White Blood Cells-BELOW-WITHIN
ParticipantsOG0004
ParticipantsOG0010
ParticipantsOG0023
ParticipantsOG0034
White Blood Cells-WITHIN-UNKNOWN
ParticipantsOG00091
ParticipantsOG00192
ParticipantsOG00291
ParticipantsOG00390
White Blood Cells-WITHIN-BELOW
ParticipantsOG00091
ParticipantsOG00192
ParticipantsOG00291
ParticipantsOG00390
White Blood Cells-WITHIN-WITHIN
ParticipantsOG00091
ParticipantsOG00192
ParticipantsOG00291
ParticipantsOG00390
White Blood Cells-WITHIN-ABOVE
ParticipantsOG00091
ParticipantsOG00192
ParticipantsOG00291
ParticipantsOG00390
White Blood Cells-ABOVE-WITHIN
ParticipantsOG0001
ParticipantsOG0012
ParticipantsOG0020
ParticipantsOG0032
White Blood Cells-ABOVE-ABOVE
ParticipantsOG0001
ParticipantsOG0012
ParticipantsOG0020
ParticipantsOG0032
OG003
Placebo_A Group
Subjects in Part A aged 18-40 years, receiving 2 doses of placebo (Saline solution) control, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG004
Low Dose_PLAIN_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted low dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG005
Medium Dose_PLAIN_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted medium dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG006
High Dose_PLAIN_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted high dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG007
Low Dose_AS01E_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) low dose adjuvanted with AS01E, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG008
Medium Dose_AS01E_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) medium dose adjuvanted with AS01E, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG009
High Dose_AS01E_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01E, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG010
Low Dose_AS01B_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) low dose adjuvanted with AS01B, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG011
Medium Dose_AS01B_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) medium dose adjuvanted with AS01B, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG012
High Dose_AS01B_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01B, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG013
Placebo_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of placebo (Saline solution) control, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
Units
Counts
Participants
OG00012
OG00112
OG00212
OG00312
OG004101
OG00597
OG006100
OG007101
OG008101
OG009100
OG010103
OG011100
OG012101
OG013101
Title
Denominators
Categories
Any adverse event
Title
Measurements
OG0001
OG0010
OG0020
OG0030
OG0041
OG0051
OG0064
OG0073
OG0087
OG0091
OG0107
OG0116
OG0128
OG0134
General adverse event
Title
Measurements
OG0001
OG0010
OG0020
OG003
Local adverse event
Title
Measurements
OG0000
OG0010
OG0020
OG003
OG003
Placebo_A Group
Subjects in Part A aged 18-40 years, receiving 2 doses of placebo (Saline solution) control, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG004
Low Dose_PLAIN_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted low dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG005
Medium Dose_PLAIN_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted medium dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG006
High Dose_PLAIN_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted high dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG007
Low Dose_AS01E_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) low dose adjuvanted with AS01E, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG008
Medium Dose_AS01E_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) medium dose adjuvanted with AS01E, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG009
High Dose_AS01E_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01E, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG010
Low Dose_AS01B_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) low dose adjuvanted with AS01B, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG011
Medium Dose_AS01B_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) medium dose adjuvanted with AS01B, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG012
High Dose_AS01B_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01B, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG013
Placebo_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of placebo (Saline solution) control, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
Units
Counts
Participants
OG00012
OG00110
OG00211
OG00312
OG00498
OG00595
OG00695
OG00796
OG00898
OG00997
OG01098
OG01197
OG01297
OG01399
Title
Denominators
Categories
Any adverse event
Title
Measurements
OG0001
OG0010
OG0020
OG0030
OG0041
OG0050
OG0062
OG0075
OG0083
OG0095
OG0108
OG0117
OG0123
OG0130
General adverse event
Title
Measurements
OG0001
OG0010
OG0020
OG003
Local adverse event
Title
Measurements
OG0000
OG0010
OG0020
OG003
OG003
Placebo_A Group
Subjects in Part A aged 18-40 years, receiving 2 doses of placebo (Saline solution) control, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG004
Low Dose_PLAIN_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted low dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG005
Medium Dose_PLAIN_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted medium dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG006
High Dose_PLAIN_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted high dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG007
Low Dose_AS01E_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) low dose adjuvanted with AS01E, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG008
Medium Dose_AS01E_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) medium dose adjuvanted with AS01E, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG009
High Dose_AS01E_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01E, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG010
Low Dose_AS01B_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) low dose adjuvanted with AS01B, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG011
Medium Dose_AS01B_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) medium dose adjuvanted with AS01B, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG012
High Dose_AS01B_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01B, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG013
Placebo_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of placebo (Saline solution) control, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
Units
Counts
Participants
OG00012
OG00112
OG00212
OG00312
OG004101
OG00597
OG006100
OG007101
OG008101
OG009100
OG010103
OG011100
OG012101
OG013101
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0046
OG0050
OG0061
OG0074
OG0082
OG0091
OG0101
OG0113
OG0125
OG0131
OG003
Low Dose_AS01E_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) low dose adjuvanted with AS01E, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG004
Medium Dose_AS01E_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) medium dose adjuvanted with AS01E, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG005
High Dose_AS01E_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01E, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG006
Low Dose_AS01B_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) low dose adjuvanted with AS01B, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG007
Medium Dose_AS01B_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) medium dose adjuvanted with AS01B, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG008
High Dose_AS01B_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01B, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG009
Placebo_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of placebo (Saline solution) control, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
Units
Counts
Participants
OG000101
OG00197
OG002100
OG003101
OG004101
OG005100
OG006103
OG007100
OG008101
OG009101
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG003
Low Dose_AS01E_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) low dose adjuvanted with AS01E, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG004
Medium Dose_AS01E_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) medium dose adjuvanted with AS01E, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG005
High Dose_AS01E_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01E, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG006
Low Dose_AS01B_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) low dose adjuvanted with AS01B, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG007
Medium Dose_AS01B_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) medium dose adjuvanted with AS01B, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG008
High Dose_AS01B_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01B, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG009
Placebo_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of placebo (Saline solution) control, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
Units
Counts
Participants
OG000101
OG00197
OG002100
OG003101
OG004101
OG005100
OG006103
OG007100
OG008101
OG009101
Title
Denominators
Categories
Title
Measurements
OG00013
OG0013
OG0025
OG0038
OG0046
OG00511
OG0069
OG0075
OG0089
OG0099
OG003
Low Dose_AS01E_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) low dose adjuvanted with AS01E, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG004
Medium Dose_AS01E_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) medium dose adjuvanted with AS01E, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG005
High Dose_AS01E_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01E, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG006
Low Dose_AS01B_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) low dose adjuvanted with AS01B, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG007
Medium Dose_AS01B_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) medium dose adjuvanted with AS01B, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG008
High Dose_AS01B_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01B, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG009
Placebo_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of placebo (Saline solution) control, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
Units
Counts
Participants
OG000101
OG00197
OG002100
OG003101
OG004101
OG005100
OG006103
OG007100
OG008101
OG009101
Title
Denominators
Categories
Title
Measurements
OG0001
OG0010
OG0020
OG0030
OG0041
OG0051
OG0060
OG0070
OG0080
OG0091
Subjects in Part B aged 60-80 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted high dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG003
Low Dose_AS01E_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) low dose adjuvanted with AS01E, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG004
Medium Dose_AS01E_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) medium dose adjuvanted with AS01E, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG005
High Dose_AS01E_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01E, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG006
Low Dose_AS01B_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) low dose adjuvanted with AS01B, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG007
Medium Dose_AS01B_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) medium dose adjuvanted with AS01B, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG008
High Dose_AS01B_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01B, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG009
Placebo_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of placebo (Saline solution) control, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
Units
Counts
Participants
OG000101
OG00197
OG002100
OG003101
OG004101
OG005100
OG006103
OG007100
OG008101
OG009101
Title
Denominators
Categories
RSV+
Title
Measurements
OG0001
OG0012
OG0020
OG0030
OG0040
OG0050
OG0060
OG0072
OG0080
OG0093
RSV-
Title
Measurements
OG00019
OG00112
OG00220
OG003
OG002
High Dose_PLAIN_A Group
Subjects in Part A aged 18-40 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted high dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG003
Placebo_A Group
Subjects in Part A aged 18-40 years, receiving 2 doses of placebo (Saline solution) control, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG004
Low Dose_PLAIN_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted low dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG005
Medium Dose_PLAIN_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted medium dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG006
High Dose_PLAIN_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted high dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG007
Low Dose_AS01E_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) low dose adjuvanted with AS01E, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG008
Medium Dose_AS01E_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) medium dose adjuvanted with AS01E, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG009
High Dose_AS01E_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01E, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG010
Low Dose_AS01B_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) low dose adjuvanted with AS01B, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG011
Medium Dose_AS01B_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) medium dose adjuvanted with AS01B, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG012
High Dose_AS01B_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01B, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG013
Placebo_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of placebo (Saline solution) control, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
Units
Counts
Participants
OG00011
OG00111
OG00212
OG00312
OG004101
OG00596
OG00699
OG007100
OG008101
OG009100
OG010102
OG011100
OG012101
OG013100
Title
Denominators
Categories
Day 1
ParticipantsOG00011
ParticipantsOG00111
ParticipantsOG00212
ParticipantsOG00312
ParticipantsOG004101
ParticipantsOG00596
ParticipantsOG00699
ParticipantsOG007100
ParticipantsOG008101
ParticipantsOG009100
ParticipantsOG010102
ParticipantsOG011100
ParticipantsOG012101
ParticipantsOG013100
Title
Measurements
OG0001019(634.6 to 1636.1)
OG001846.2(481.7 to 1486.4)
OG002673.6(325.3 to 1394.7)
OG003
Day 31
ParticipantsOG00011
ParticipantsOG0018
ParticipantsOG00211
ParticipantsOG00312
Day 61
ParticipantsOG00011
ParticipantsOG0019
ParticipantsOG00211
ParticipantsOG00312
Day 91
ParticipantsOG00011
ParticipantsOG0018
ParticipantsOG00211
ParticipantsOG00312
OG002
High Dose_PLAIN_A Group
Subjects in Part A aged 18-40 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted high dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG003
Placebo_A Group
Subjects in Part A aged 18-40 years, receiving 2 doses of placebo (Saline solution) control, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG004
Low Dose_PLAIN_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted low dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG005
Medium Dose_PLAIN_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted medium dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG006
High Dose_PLAIN_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted high dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG007
Low Dose_AS01E_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) low dose adjuvanted with AS01E, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG008
Medium Dose_AS01E_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) medium dose adjuvanted with AS01E, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG009
High Dose_AS01E_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01E, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG010
Low Dose_AS01B_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) low dose adjuvanted with AS01B, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG011
Medium Dose_AS01B_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) medium dose adjuvanted with AS01B, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG012
High Dose_AS01B_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01B, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG013
Placebo_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of placebo (Saline solution) control, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
Units
Counts
Participants
OG00011
OG00111
OG00212
OG00312
OG004101
OG00596
OG00699
OG007100
OG008101
OG009100
OG010102
OG011100
OG012101
OG013100
Title
Denominators
Categories
Day 1
ParticipantsOG00011
ParticipantsOG00111
ParticipantsOG00212
ParticipantsOG00312
ParticipantsOG004101
ParticipantsOG00596
ParticipantsOG00699
ParticipantsOG007100
ParticipantsOG008101
ParticipantsOG009100
ParticipantsOG010102
ParticipantsOG011100
ParticipantsOG012101
ParticipantsOG013100
Title
Measurements
OG0008330.7(5561.5 to 12478.9)
OG0017699.5(5326 to 11130.8)
OG0027439.1(5808.6 to 9527.2)
OG003
Day 31
ParticipantsOG00011
ParticipantsOG0018
ParticipantsOG00211
ParticipantsOG00312
Day 61
ParticipantsOG00011
ParticipantsOG0019
ParticipantsOG00211
ParticipantsOG00312
Day 91
ParticipantsOG00011
ParticipantsOG0019
ParticipantsOG00211
ParticipantsOG00312
OG002
High Dose_PLAIN_A Group
Subjects in Part A aged 18-40 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted high dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG003
Placebo_A Group
Subjects in Part A aged 18-40 years, receiving 2 doses of placebo (Saline solution) control, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG004
Low Dose_PLAIN_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted low dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG005
Medium Dose_PLAIN_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted medium dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG006
High Dose_PLAIN_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted high dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG007
Low Dose_AS01E_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) low dose adjuvanted with AS01E, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG008
Medium Dose_AS01E_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) medium dose adjuvanted with AS01E, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG009
High Dose_AS01E_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01E, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG010
Low Dose_AS01B_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) low dose adjuvanted with AS01B, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG011
Medium Dose_AS01B_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) medium dose adjuvanted with AS01B, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG012
High Dose_AS01B_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01B, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
OG013
Placebo_B Group
Subjects in Part B aged 60-80 years, receiving 2 doses of placebo (Saline solution) control, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.