Safety, Immunogenicity and Efficacy of GSK S. Aureus Cand... | NCT04420221 | Trialant
NCT04420221
Sponsor
GlaxoSmithKline
Status
Completed
Last Update Posted
May 8, 2025Actual
Enrollment
226Actual
Phase
Phase 2
Conditions
Infections, Soft Tissue
Interventions
Sa-5Ag half dose non-adjuvanted
Sa-5Ag full dose non-adjuvanted
Sa-5Ag half dose adjuvanted
Sa-5Ag full dose adjuvanted
Placebo
Countries
Not provided
Protocol Section
Identification Module
NCT ID
NCT04420221
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
208833
Secondary IDs
ID
Type
Description
Link
2021-006215-29
EudraCT Number
Brief Title
Safety, Immunogenicity and Efficacy of GSK S. Aureus Candidate Vaccine (GSK3878858A) When Administered to Healthy Adults (Dose-escalation) and to Adults 18 to 64 Years of Age With a Recent S. Aureus Skin and Soft Tissue Infection (SSTI)
Official Title
A Phase I/II, Observer-blind, Randomised, Placebo-controlled Study to Assess Safety, Immunogenicity and Efficacy of GSK S. Aureus Candidate Vaccine When Administered to Healthy Adults (Dose-escalation) and to Adults 18 to 64 Years of Age With a Recent S. Aureus Skin and Soft Tissue Infection (SSTI)
Acronym
Not provided
Organization
GlaxoSmithKlineINDUSTRY
Status Module
Record Verification Date
Apr 2025
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
Nov 16, 2022Actual
Primary Completion Date
Mar 12, 2024Actual
Completion Date
Mar 12, 2024Actual
First Submitted Date
Jun 4, 2020
First Submission Date that Met QC Criteria
Jun 4, 2020
First Posted Date
Jun 9, 2020Actual
Results Waived
Not provided
Results First Submitted Date
Mar 12, 2025
Results First Submitted that Met QC Criteria
Apr 25, 2025
Results First Posted Date
May 8, 2025Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Apr 25, 2025
Last Update Posted Date
May 8, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
GlaxoSmithKlineINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
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
No
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The study evaluates the safety, immunogenicity, and efficacy of the GSK S. aureus candidate vaccine (GSK3878858A) when administered to two groups: healthy adults (dose-escalation phase) and adults aged 18 to 64 years with a recent S. aureus skin and soft tissue infection (SSTI). In the dose-escalation safety lead-in phase, the safety and immunogenicity of four different vaccine compositions are assessed in healthy adults. Once safety has been established in this phase, the second phase, known as the proof of principle (PoP) phase, will assess the safety, immunogenicity, and efficacy of the final vaccine composition in adults with a recent SSTI.
Detailed Description
Not provided
Conditions Module
Conditions
Infections, Soft Tissue
Keywords
S. aureus
skin and soft tissue infection
first time in human
S. aureus vaccine
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 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
226Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Group 1 Dose-escalation Safety Lead-in Epoch: Half dose Non-Adjuvant (Non-Adj)
Experimental
Participants received 1 dose of the half dose formulation of the vaccine on Day 1.
Biological: Sa-5Ag half dose non-adjuvanted
Group 2 Dose-escalation Safety Lead-in Epoch: Full dose Non-Adj
Experimental
Participants received 1 dose of the full dose formulation of the vaccine on Day 1.
Biological: Sa-5Ag full dose non-adjuvanted
Group 3 Dose-escalation Safety Lead-in Epoch: Half dose Adj
Experimental
Participants received 1 dose of the half dose formulation of the vaccine with adjuvant on Day 1.
Biological: Sa-5Ag half dose adjuvanted
Group 4 Dose-escalation Safety Lead-in Epoch: Full dose Adj
Experimental
Participants received 2 doses of the full dose formulation of the vaccine with adjuvant on Day 1 and Day 61.
Biological: Sa-5Ag full dose adjuvanted
Dose-escalation Safety Lead-in Epoch: Placebo
Placebo Comparator
Participants received matching placebo on Day 1 for Group 1, Group 2 and Group 3, and on Day 1 and Day 61 for Group 4 of the escalation epoch.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Sa-5Ag half dose non-adjuvanted
Biological
1 dose of Sa-5Ag (5 antigens of S. aureus) half dose, non-adjuvanted at Day 1, administered intramuscularly.
Group 1 Dose-escalation Safety Lead-in Epoch: Half dose Non-Adjuvant (Non-Adj)
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Dose-escalation Safety lead-in: Number of Participants With Any and Grade 3 Solicited Administration Site Adverse Events (AEs) After Each Vaccination
The solicited administration site AE(s) assessed are pain, redness and swelling. Any = any solicited administration site AE, regardless of intensity; Grade 3 Pain at injection site = Severe, significant pain at rest, that prevents normal everyday activities; Grade 3 redness/swelling = greater than (>)100 millimeter (mm) diameter.
Within 7 days post vaccination (day of administration and 6 subsequent days post-each vaccination; Vaccination 1 on Day 1 and Vaccination 2 on Day 61)
PoP: Number of Participants With Any and Grade 3 Solicited Administration Site AEs After Each Vaccination
The solicited administration site AEs assessed are pain, redness and swelling. Any = any solicited administration site AE, regardless of intensity; Grade 3 Pain at injection site = Severe, significant pain at rest, that prevents normal everyday activities; Grade 3 redness/swelling = greater than (>)100 millimeter (mm) diameter.
Within 7 days post vaccination (day of administration and 6 subsequent days post-each vaccination; Vaccination 1 on Day 1 and Vaccination 2 on Day 61)
Dose-escalation Safety lead-in: Number of Participants With Any and Grade 3 Solicited Systemic AEs After Each Vaccination
The solicited systemic AE(s) assessed are headache, fatigue, nausea, vomiting, diarrhea, abdominal pain, myalgia, shivering and fever. Any = any solicited systemic AE regardless of intensity; Grade 3 headache/fatigue/nausea/abdominal pain/myalgia/shivering = Severe: Prevents daily activity. Grade 3 vomiting = Severe: 6 or more times in 24 hours or requires intravenous hydration. Grade 3 diarrhea = Severe: 6 or more loose stools in 24 hours or requires intravenous hydration. Grade 3 fever = body temperature greater than (>) 40.0°C/104°F.
Within 7 days post vaccination (day of administration and 6 subsequent days post-each vaccination; Vaccination 1 on Day 1 and Vaccination 2 on Day 61)
PoP: Number of Participants With Any and Grade 3 Solicited Systemic AEs After Each Vaccination
Secondary Outcomes
Measure
Description
Time Frame
Number of Participants With at Least One Culture Confirmed Case of Recurrent Staphylococcus Aureus (S. Aureus) Skin and Soft Tissue Infection (SSTI) - Interim Analysis
An interim analysis was performed after 13 cases of recurrent SA-SSTI were reported following 14 days from the study intervention dose 2.
From Day 75 to Day 426
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
All participants must satisfy all the following criteria at study entry:
Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits).
Written or witnessed informed consent obtained from the participant prior to performance of any study specific procedure.
Participant satisfying screening requirements.
Participants who, after the nature of the study has been explained to them, have shown adequate comprehension of the study procedures and knowledge of study.
A male or female
Dose escalation and safety lead-in phase: Aged between 18 and 50 years of age, inclusive, at the time of first vaccination.
PoP phase: Aged between 18 and 64 years of age, inclusive, at the time of first vaccination.
Female participants of non-childbearing potential may be enrolled in the study. Non-childbearing potential is defined as pre-menarche, current bilateral tubal ligation or occlusion, hysterectomy, bilateral ovariectomy or post-menopause.
Female participants of childbearing potential may be enrolled in the study, if the participant:
has practiced adequate contraception for 30 days prior to vaccination,
has a negative pregnancy test on the day of enrolment, and
has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series.
Additional inclusion criteria only for participants to be enrolled in the dose-escalation safety lead-in screening epoch:
- Healthy participants as established by medical history, clinical examination and laboratory assessment.
Additional inclusion criteria only for participants to be enrolled in the PoP screening epoch:
- Healthy participants as established by medical history and clinical examination before entering into the study with an ongoing SSTI suspected to be caused by S. aureus, as diagnosed by investigator (before randomization participants have to be treated until clinical resolution of culture confirmed SSTI caused by S. aureus). SSTI must be amenable to microbiological culturing per standard clinical practice (i.e. recovery of drainage sample from abscess or suppurative cellulitis).
OR
- Healthy participants as established by medical history and clinical examination before entering into the study with an ongoing S. aureus SSTI (i.e. S. aureus is the most likely cause), as confirmed by a S. aureus positive culture performed outside the study procedures and not earlier than 30 days prior to Informed Consent Form signature. Before randomisation participants have to be treated until clinical resolution of the culture confirmed SSTI caused by S. aureus. These participants will be enrolled whether they have or have not already started specific treatment of the infection. In case they have not started the treatment, this will be then given in compliance with the standard medical practice for the management of S. aureus SSTIs and the choice and judgment of the most appropriate treatment will be applied by the investigator, outside the study procedures.
Exclusion Criteria:
All participants at study entry
Body mass index (BMI) >40 kg/m2
History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine
Hypersensitivity to latex
Recurrent history of uncontrolled neurological disorders or seizures
History of potential immune-mediated disease (pIMD)
Clinical conditions that in the investigator's opinion represent a contraindication to intramuscular vaccination and blood draws
Known bleeding diathesis or any condition that may be associated with a prolonged bleeding time
Use of any investigational or non-registered product (drug, vaccine or medical device) other than the study vaccine(s) within 30 days before the first dose of study vaccine(s)/placebo (Day -29 to Day 1), or during the study period
Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs during the period starting 3 months prior to the first vaccine/placebo dose
Cytotoxic therapy (e.g., medications used during cancer chemotherapy)
Administration of long-acting immune-modifying drugs at any time during the study period (e.g. infliximab)
Administration of immunoglobulins and/or any blood products or plasma derivatives within 3 months before the first dose of study vaccine or during the study period
Planned administration/administration of a vaccine not foreseen by the study protocol in the period starting 15 days before the first dose and ending 15 days after the last dose of vaccine(s) administration with the exception of any non-adjuvanted influenza vaccine which may be administered ≥7 days before or after each study vaccination
*In case an emergency mass vaccination for an unforeseen public health threat (e.g.: a pandemic) is organised by the public health authorities, outside the routine immunisation program, the time period described above can be reduced if necessary for that vaccine provided it is licensed and used according to its Product Information.
Concurrently participating in another clinical study, in which the participant has been or will be exposed to an investigational or a non-investigational vaccine/product (drug or medical device)
Received a vaccine against S. aureus
Pregnant or lactating female
Female planning to become pregnant or planning to discontinue contraceptive precautions before 2 months after completion of the vaccination series
History of chronic alcohol consumption and/or drug abuse
Any study personnel or immediate dependents, family, or household member
All participants at the time of vaccination
Any clinically significant hematological (hemoglobin level, white blood cell, lymphocyte, neutrophil, eosinophil, platelet count and red blood cell count) and/or biochemical (alanine aminotransferase [ALT], aspartate aminotransferase [AST], creatinine) laboratory abnormality
Additional exclusion criteria applied only for dose-escalation safety lead-in
Any active or ongoing illness at screening or time of injection
History of any serious chronic or progressive disease according to the judgment of the investigator
Additional exclusion criteria applied only for PoP at study entry
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
Major congenital defects, as assessed by the investigator
Acute or chronic, clinically significant pulmonary, cardiovascular*, hepatic or renal functional abnormality, neoplasm, diabetes type 1 and uncontrolled diabetes type 2*, as determined by physical examination or laboratory screening tests * Note: Well-controlled type 2 diabetes mellitus (HbA1c <7%) and well-controlled arterial hypertension (blood pressure <140/90 mmHg) can be considered for inclusion in the study.
Any behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, may interfere with the participant's ability to participate in the study
Individuals at risk for severe or life-threatening SSTIs (e.g., lymphatic or venous insufficiency, liver and kidney disease, IV drug use, etc.)
Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study
Additional exclusion criteria applied only for PoP at vaccination
- Microbiological test results of drainage suggest that the SSTI etiology could be other than infection with S. aureus
Athan E, Greenberg RN, Baker DA, Shah R, Dubhashi S, Badat A, Thurlow C, Schlessinger J, Wronski A, Zakrzewski M, Turner D, Bindi I, Basile V, Galletti B, Spensieri F, Brazzoli M, Zigon G, Cilio GL, Ranzato G, Lattanzi M, Pellegrini M; Staph aureus 208833 study group. Safety, Efficacy, and Immunogenicity of a Multivalent Adjuvanted S. aureus Vaccine in Adults with Recent Skin And Soft Tissue Infections: An Observer-blind, Randomized, Placebo-controlled, Multinational Phase 1/2 Trial. Clin Infect Dis. 2026 Mar 9:ciag162. doi: 10.1093/cid/ciag162. Online ahead of print.
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.
Participants were randomized to receive 2 doses of the full dose formulation of the vaccine with adjuvant on Day 1 and Day 61.
Biological: Sa-5Ag full dose adjuvanted
PoP: Placebo
Placebo Comparator
Participants were randomized to receive 2 doses of placebo on Day 1 and Day 61.
Biological: Placebo
Sa-5Ag full dose non-adjuvanted
Biological
1 dose of Sa-5Ag (5 antigens of S. aureus) full dose, non-adjuvanted at Day 1, administered intramuscularly.
Group 2 Dose-escalation Safety Lead-in Epoch: Full dose Non-Adj
Sa-5Ag half dose adjuvanted
Biological
1 dose of Sa-5Ag (5 antigens of S. aureus) half dose, adjuvanted at Day 1, administered intramuscularly.
Group 3 Dose-escalation Safety Lead-in Epoch: Half dose Adj
Sa-5Ag full dose adjuvanted
Biological
A series of 2 doses of S. aureus candidate vaccine (Sa-5Ag full dose adjuvanted) given approximately 2 months apart (Days 1 and 61), administered intramuscularly.
Group 4 Dose-escalation Safety Lead-in Epoch: Full dose Adj
Proof of Principle (PoP): Full dose Adj
Placebo
Biological
One dose of placebo (saline solution for injection/ vial or prefilled syringe) at Day 1 for placebo Groups 1 to 3 (Dose-escalation epoch) and a series of 2 doses of placebo given approximately 2 months apart (Days 1 and 61) for placebo Group 4 (Dose-escalation epoch) and Group PoP: Placebo, administered intramuscularly.
Dose-escalation Safety Lead-in Epoch: Placebo
PoP: Placebo
The solicited systemic AE(s) assessed are headache, fatigue, nausea, vomiting, diarrhea, abdominal pain, myalgia, shivering and fever were assessed. Any = any solicited systemic AE regardless of intensity; Grade 3 headache/fatigue/nausea/abdominal pain/myalgia/shivering = Severe: Prevents daily activity. Grade 3 vomiting = Severe: 6 or more times in 24 hours or requires intravenous hydration. Grade 3 diarrhea = Severe: 6 or more loose stools in 24 hours or requires intravenous hydration. Grade 3 fever = body temperature greater than (>) 40.0°C/104°F.
Within 7 days post vaccination (day of administration and 6 subsequent days post-each vaccination; Vaccination 1 on Day 1 and Vaccination 2 on Day 61)
Dose-escalation Safety lead-in: Number of Participants With Unsolicited AEs (Any, Grade 3, Related, Related Grade 3) After Each Vaccination
An unsolicited adverse event is defined as an adverse event that was not solicited using a Subject Diary and that was spontaneously communicated by a subject who has signed the informed consent. Any unsolicited AE, Grade 3 unsolicited AE, unsolicited AE causally related to the vaccination and Grade 3 unsolicited AE causally related to the vaccination were assessed. A grade 3 AE is an AE that prevents normal, everyday activities.
During 30 days after each vaccination (day of administration and 29 subsequent days post-each vaccination; Vaccination 1 on Day 1 and Vaccination 2 on Day 61)
PoP: Number of Participants With Unsolicited AEs (Any, Grade 3, Related, Related Grade 3) After Each Vaccination
An unsolicited adverse event is defined as an adverse event that was not solicited using a Subject Diary and that was spontaneously communicated by a subject who has signed the informed consent. Any unsolicited AE, Grade 3 unsolicited AE, unsolicited AE causally related to the vaccination and Grade 3 unsolicited AE causally related to the vaccination were assessed. A grade 3 AE is an AE that prevents normal, everyday activities.
During 30 days after each vaccination (day of administration and 29 subsequent days post-each vaccination; Vaccination 1 on Day 1 and Vaccination 2 on Day 61)
Dose-escalation Safety lead-in: Number of Participants With Serious AEs (SAEs) up to 1 Year Post First Vaccination
A SAE is defined as any untoward medical occurrence that, at any dose: resulted in death, was life threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment. A grade 3 SAE is a SAE that prevents normal, everyday activities.
From Day 1 to Day 366
Dose-escalation Safety lead-in: Number of Participants With SAEs up to 1 Year Post Second Vaccination
A SAE is defined as any untoward medical occurrence that, at any dose: resulted in death, was life threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment. A grade 3 SAE is a SAE that prevents normal, everyday activities.
From Day 61 to Day 426 (post vaccination at Day 61)
PoP: Number of Participants With SAEs
A SAE is defined as any untoward medical occurrence that, at any dose: resulted in death, was life threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment. A grade 3 SAE is a SAE that prevents normal, everyday activities.
From Day 1 to Day 426
Dose-escalation Safety lead-in: Number of Participants With Potential Immune-mediated Diseases (pIMDs) up to 1 Year Post First Vaccination
pIMDs are defined as a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.
From Day 1 to Day 366
Dose-escalation Safety lead-in: Number of Participants With pIMDs up to 1 Year Post Second Vaccination
pIMDs are defined as a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.
From Day 61 to Day 426 (post vaccination at Day 61)
PoP: Number of Participants With Potential Immune-mediated Diseases (pIMDs)
pIMDs are defined as a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.
From Day 1 to Day 426
Number of Participants With Maximum Toxicity Grade Increase From Baseline for Haematological and Biochemical Laboratory Parameters
The Biochemical parameters assessed were: Creatinine, Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and the Haematological parameters assessed were: Haemoglobin, white blood cells (WBC) decrease, WBC increase, Neutrophils decrease, Platelets decrease, Lymphocytes decrease, Eosinophils increase. Hematological and biochemical laboratory results are defined as follows: <parameter>,<grade at baseline>,<grade at visit> (e.g. ALT, Grade 0, Grade 0), where Grade 0 = a non-missing parameter value for which grade could not be derived according to the grading scale and does not belong to Grade 1-4; Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Potentially Life-Threatening. Grading following the FDA Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (September 2007). Unknown = parameter value missing for the specified parameter.
On Day 8 compared to Baseline (Day 1)
Number of Participants With Maximum Toxicity Grade Increase From Baseline for Haematological and Biochemical Laboratory Parameters
The Biochemical parameters assessed were: Creatinine, AST, ALT and the Haematological parameters assessed were: Haemoglobin, WBC decrease, WBC increase, Neutrophils decrease, Platelets decrease, Lymphocytes decrease, Eosinophils increase. Hematological and biochemical laboratory results are defined as follows: <parameter>,<grade at baseline>,<grade at visit> (e.g. ALT, Grade 0, Grade 0), where Grade 0 = a non-missing parameter value for which grade could not be derived according to the grading scale and does not belong to Grade 1-4; Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Potentially Life-Threatening. Grading following the FDA Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (September 2007). Unknown = parameter value missing for the specified parameter.
On Day 68 compared to Baseline (Day 61)
Number of Participants With Haematological and Biochemical Laboratory Change From Baseline Values
The Biochemical parameters assessed were: Creatinine, AST, ALT and the Haematological parameters assessed were: Haemoglobin, WBC decrease, WBC increase, Neutrophils decrease, Platelets decrease, Lymphocytes decrease, Eosinophils increase. Hematological and biochemical laboratory results are defined as follows: <parameter>,<any grade at baseline>,<grade at visit> (e.g. ALT, Any, Grade 0), where Grade 0 = a non-missing parameter value for which grade could not be derived according to the grading scale and does not belong to Grade 1-4; Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Potentially Life-Threatening. Grading following the FDA Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (September 2007). Unknown = parameter value missing for the specified parameter.
On Day 8
Number of Participants With Haematological and Biochemical Laboratory Change From Baseline Values
The Biochemical parameters assessed were: Creatinine, AST, ALT and the Haematological parameters assessed were: Haemoglobin, WBC decrease, WBC increase, Neutrophils decrease, Platelets decrease, Lymphocytes decrease, Eosinophils increase. Hematological and biochemical laboratory results are defined as follows: <parameter>,<any grade at baseline>,<grade at visit> (e.g. ALT, Any, Grade 0), where Grade 0 = a non-missing parameter value for which grade could not be derived according to the grading scale and does not belong to Grade 1-4; Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Potentially Life-Threatening. Grading following the FDA Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (September 2007). Unknown = parameter value missing for the specified parameter.
On Day 68
Number of Participants With at Least One Culture Confirmed Case of Recurrent S. Aureus SSTI - Final Analysis
After encountering futility at the interim analysis, an EOS analysis was conducted when at least one culture-confirmed case of recurrent SA-SSTI was identified 14 days after the second dose of the vaccine. For the final analysis, all the data collected by End of Study (EoS; Last Participant Last Visit) were analyzed for descriptive purposes.
From Day 75 to Day 426
Number of Participants With at Least One Culture Confirmed Case of Recurrent S. Aureus SSTI - Final Analysis
An EOS analysis was conducted when at least one culture-confirmed case of recurrent SA-SSTI was identified 14 days after the first dose of the vaccine. For the final analysis, all the data collected by End of Study (EoS; Last Participant Last Visit) were analyzed for descriptive purposes.
From Day 15 to Day 426
Participants received 1 dose of the full dose formulation of the vaccine on Day 1.
FG002
Group 3 Dose-escalation Safety Lead-in Epoch: Half Dose Adj
Participants received 1 dose of the half dose formulation of the vaccine with adjuvant on Day 1.
FG003
Group 4 Dose-escalation Safety Lead-in Epoch: Full Dose Adj
Participants received 2 doses of the full dose formulation of the vaccine with adjuvant on Day 1 and Day 61.
FG004
Dose-escalation Safety Lead-in Epoch: Placebo
Participants received matching placebo on Day 1 for Group 1, Group 2 and Group 3, and on Day 1 and Day 61 for Group 4 of the escalation epoch.
FG005
Proof of Principle (PoP): Full Dose Adj
Participants were randomized to receive 2 doses of the full dose formulation of the vaccine with adjuvant on Day 1 and Day 61.
FG006
PoP: Placebo
Participants were randomized to receive 2 doses of placebo on Day 1 and Day 61.
FG0006 subjects
FG0016 subjects
FG0026 subjects
FG0036 subjects
FG0048 subjects
FG005105 subjects
FG00689 subjects
Exposed Set
Participants who received at least 1 dose of the study treatment.
FG0006 subjects
FG0016 subjects
FG0026 subjects
FG0036 subjects
FG0048 subjects
FG005103 subjects
FG00689 subjects
COMPLETED
FG0006 subjects
FG0016 subjects
FG0026 subjects
FG0036 subjects
FG0048 subjects
FG00580 subjects
FG00679 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG00525 subjects
FG00610 subjects
Type
Comment
Reasons
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG00520 subjects
FG0065 subjects
Other
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Migrated / Moved from the Study Area
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Group 1 Dose-escalation Safety Lead-in Epoch: Half Dose Non-Adjuvant (Non-Adj)
Participants received 1 dose of the half dose formulation of the vaccine on Day 1.
BG001
Group 2 Dose-escalation Safety Lead-in Epoch: Full Dose Non-Adj
Participants received 1 dose of the full dose formulation of the vaccine on Day 1.
BG002
Group 3 Dose-escalation Safety Lead-in Epoch: Half Dose Adj
Participants received 1 dose of the half dose formulation of the vaccine with adjuvant on Day 1.
BG003
Group 4 Dose-escalation Safety Lead-in Epoch: Full Dose Adj
Participants received 2 doses of the full dose formulation of the vaccine with adjuvant on Day 1 and Day 61.
BG004
Dose-escalation Safety Lead-in Epoch: Placebo
Participants received matching placebo on Day 1 for Group 1, Group 2 and Group 3, and on Day 1 and Day 61 for Group 4 of the escalation epoch.
BG005
Proof of Principle (PoP): Full Dose Adj
Participants were randomized to receive 2 doses of the full dose formulation of the vaccine with adjuvant on Day 1 and Day 61.
BG006
PoP: Placebo
Participants were randomized to receive 2 doses of placebo on Day 1 and Day 61.
BG007
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0006
BG0016
BG0026
BG0036
BG0048
BG005105
BG00689
BG007226
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Customized
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
18 - 64 years
BG0006
BG0016
BG0026
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0003
BG0015
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Hispanic or Latino
Title
Measurements
BG0001
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
Dose-escalation Safety lead-in: Number of Participants With Any and Grade 3 Solicited Administration Site Adverse Events (AEs) After Each Vaccination
The solicited administration site AE(s) assessed are pain, redness and swelling. Any = any solicited administration site AE, regardless of intensity; Grade 3 Pain at injection site = Severe, significant pain at rest, that prevents normal everyday activities; Grade 3 redness/swelling = greater than (>)100 millimeter (mm) diameter.
The analysis was performed on Solicited Safety Set (SSS) which included all subjects who received at least 1 dose of the study treatment (Exposed Set) who have solicited safety data. Analysis is presented for Dose-escalation safety lead-in participants.
Posted
Count of Participants
Participants
Within 7 days post vaccination (day of administration and 6 subsequent days post-each vaccination; Vaccination 1 on Day 1 and Vaccination 2 on Day 61)
ID
Title
Description
OG000
Group 1 Dose-escalation Safety Lead-in Epoch: Half Dose Non-Adjuvant (Non-Adj)
Participants received 1 dose of the half dose formulation of the vaccine on Day 1.
OG001
Group 2 Dose-escalation Safety Lead-in Epoch: Full Dose Non-Adj
Participants received 1 dose of the full dose formulation of the vaccine on Day 1.
OG002
Group 3 Dose-escalation Safety Lead-in Epoch: Half Dose Adj
Participants received 1 dose of the half dose formulation of the vaccine with adjuvant on Day 1.
OG003
Group 4 Dose-escalation Safety Lead-in Epoch: Full Dose Adj
Participants received 2 doses of the full dose formulation of the vaccine with adjuvant on Day 1 and Day 61.
OG004
Dose-escalation Safety Lead-in Epoch: Placebo
Participants received matching placebo on Day 1 for Group 1, Group 2 and Group 3, and on Day 1 and Day 61 for Group 4 of the escalation epoch.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
Vaccination 1, Pain at injection site, Any
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG003
Primary
PoP: Number of Participants With Any and Grade 3 Solicited Administration Site AEs After Each Vaccination
The solicited administration site AEs assessed are pain, redness and swelling. Any = any solicited administration site AE, regardless of intensity; Grade 3 Pain at injection site = Severe, significant pain at rest, that prevents normal everyday activities; Grade 3 redness/swelling = greater than (>)100 millimeter (mm) diameter.
The analysis was performed on Solicited Safety Set (SSS). Analysis is presented for PoP participants.
Posted
Count of Participants
Participants
Within 7 days post vaccination (day of administration and 6 subsequent days post-each vaccination; Vaccination 1 on Day 1 and Vaccination 2 on Day 61)
ID
Title
Description
OG000
Proof of Principle (PoP): Full Dose Adj
Participants were randomized to receive 2 doses of the full dose formulation of the vaccine with adjuvant on Day 1 and Day 61.
OG001
PoP: Placebo
Participants were randomized to receive 2 doses of placebo on Day 1 and Day 61.
Units
Counts
Participants
Primary
Dose-escalation Safety lead-in: Number of Participants With Any and Grade 3 Solicited Systemic AEs After Each Vaccination
The solicited systemic AE(s) assessed are headache, fatigue, nausea, vomiting, diarrhea, abdominal pain, myalgia, shivering and fever. Any = any solicited systemic AE regardless of intensity; Grade 3 headache/fatigue/nausea/abdominal pain/myalgia/shivering = Severe: Prevents daily activity. Grade 3 vomiting = Severe: 6 or more times in 24 hours or requires intravenous hydration. Grade 3 diarrhea = Severe: 6 or more loose stools in 24 hours or requires intravenous hydration. Grade 3 fever = body temperature greater than (>) 40.0°C/104°F.
The analysis was performed on Solicited Safety Set (SSS). Analysis is presented for Dose-escalation safety lead-in participants.
Posted
Count of Participants
Participants
Within 7 days post vaccination (day of administration and 6 subsequent days post-each vaccination; Vaccination 1 on Day 1 and Vaccination 2 on Day 61)
ID
Title
Description
OG000
Group 1 Dose-escalation Safety Lead-in Epoch: Half Dose Non-Adjuvant (Non-Adj)
Participants received 1 dose of the half dose formulation of the vaccine on Day 1.
OG001
Group 2 Dose-escalation Safety Lead-in Epoch: Full Dose Non-Adj
Participants received 1 dose of the full dose formulation of the vaccine on Day 1.
OG002
Primary
PoP: Number of Participants With Any and Grade 3 Solicited Systemic AEs After Each Vaccination
The solicited systemic AE(s) assessed are headache, fatigue, nausea, vomiting, diarrhea, abdominal pain, myalgia, shivering and fever were assessed. Any = any solicited systemic AE regardless of intensity; Grade 3 headache/fatigue/nausea/abdominal pain/myalgia/shivering = Severe: Prevents daily activity. Grade 3 vomiting = Severe: 6 or more times in 24 hours or requires intravenous hydration. Grade 3 diarrhea = Severe: 6 or more loose stools in 24 hours or requires intravenous hydration. Grade 3 fever = body temperature greater than (>) 40.0°C/104°F.
The analysis was performed on Solicited Safety Set (SSS). Analysis is presented for PoP participants.
Posted
Count of Participants
Participants
Within 7 days post vaccination (day of administration and 6 subsequent days post-each vaccination; Vaccination 1 on Day 1 and Vaccination 2 on Day 61)
ID
Title
Description
OG000
Proof of Principle (PoP): Full Dose Adj
Participants were randomized to receive 2 doses of the full dose formulation of the vaccine with adjuvant on Day 1 and Day 61.
OG001
PoP: Placebo
Participants were randomized to receive 2 doses of placebo on Day 1 and Day 61.
Primary
Dose-escalation Safety lead-in: Number of Participants With Unsolicited AEs (Any, Grade 3, Related, Related Grade 3) After Each Vaccination
An unsolicited adverse event is defined as an adverse event that was not solicited using a Subject Diary and that was spontaneously communicated by a subject who has signed the informed consent. Any unsolicited AE, Grade 3 unsolicited AE, unsolicited AE causally related to the vaccination and Grade 3 unsolicited AE causally related to the vaccination were assessed. A grade 3 AE is an AE that prevents normal, everyday activities.
The analysis was performed on the Unsolicited Safety Set (USS) which included all subjects who received at least 1 dose of the study treatment (Exposed Set) that report unsolicited AEs/report not having unsolicited AEs.
Posted
Count of Participants
Participants
During 30 days after each vaccination (day of administration and 29 subsequent days post-each vaccination; Vaccination 1 on Day 1 and Vaccination 2 on Day 61)
ID
Title
Description
OG000
Group 1 Dose-escalation Safety Lead-in Epoch: Half Dose Non-Adjuvant (Non-Adj)
Participants received 1 dose of the half dose formulation of the vaccine on Day 1.
OG001
Group 2 Dose-escalation Safety Lead-in Epoch: Full Dose Non-Adj
Participants received 1 dose of the full dose formulation of the vaccine on Day 1.
OG002
Primary
PoP: Number of Participants With Unsolicited AEs (Any, Grade 3, Related, Related Grade 3) After Each Vaccination
An unsolicited adverse event is defined as an adverse event that was not solicited using a Subject Diary and that was spontaneously communicated by a subject who has signed the informed consent. Any unsolicited AE, Grade 3 unsolicited AE, unsolicited AE causally related to the vaccination and Grade 3 unsolicited AE causally related to the vaccination were assessed. A grade 3 AE is an AE that prevents normal, everyday activities.
The analysis was performed on USS.
Posted
Count of Participants
Participants
During 30 days after each vaccination (day of administration and 29 subsequent days post-each vaccination; Vaccination 1 on Day 1 and Vaccination 2 on Day 61)
ID
Title
Description
OG000
Proof of Principle (PoP): Full Dose Adj
Participants were randomized to receive 2 doses of the full dose formulation of the vaccine with adjuvant on Day 1 and Day 61.
OG001
PoP: Placebo
Participants were randomized to receive 2 doses of placebo on Day 1 and Day 61.
Units
Counts
Participants
Primary
Dose-escalation Safety lead-in: Number of Participants With Serious AEs (SAEs) up to 1 Year Post First Vaccination
A SAE is defined as any untoward medical occurrence that, at any dose: resulted in death, was life threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment. A grade 3 SAE is a SAE that prevents normal, everyday activities.
The analysis was performed on the Exposed Set (ES) that included all subjects who received at least 1 dose of the study treatment. The allocation in a group is done in function of the administered treatment.
Posted
Count of Participants
Participants
From Day 1 to Day 366
ID
Title
Description
OG000
Group 1 Dose-escalation Safety Lead-in Epoch: Half Dose Non-Adjuvant (Non-Adj)
Participants received 1 dose of the half dose formulation of the vaccine on Day 1.
OG001
Group 2 Dose-escalation Safety Lead-in Epoch: Full Dose Non-Adj
Participants received 1 dose of the full dose formulation of the vaccine on Day 1.
OG002
Group 3 Dose-escalation Safety Lead-in Epoch: Half Dose Adj
Participants received 1 dose of the half dose formulation of the vaccine with adjuvant on Day 1.
Primary
Dose-escalation Safety lead-in: Number of Participants With SAEs up to 1 Year Post Second Vaccination
A SAE is defined as any untoward medical occurrence that, at any dose: resulted in death, was life threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment. A grade 3 SAE is a SAE that prevents normal, everyday activities.
The analysis was performed on ES. Only participants that received a second vaccination on Day 61 were included in this analysis.
Posted
Count of Participants
Participants
From Day 61 to Day 426 (post vaccination at Day 61)
ID
Title
Description
OG000
Group 4 Dose-escalation Safety Lead-in Epoch: Full Dose Adj
Participants received 2 doses of the full dose formulation of the vaccine with adjuvant on Day 1 and Day 61.
OG001
Dose-escalation Safety Lead-in Epoch: Placebo
Participants received matching placebo on Day 1 for Group 1, Group 2 and Group 3, and on Day 1 and Day 61 for Group 4 of the escalation epoch.
Units
Counts
Primary
PoP: Number of Participants With SAEs
A SAE is defined as any untoward medical occurrence that, at any dose: resulted in death, was life threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment. A grade 3 SAE is a SAE that prevents normal, everyday activities.
The analysis was performed on ES. The allocation in a group is done in function of the administered treatment.
Posted
Count of Participants
Participants
From Day 1 to Day 426
ID
Title
Description
OG000
Proof of Principle (PoP): Full Dose Adj
Participants were randomized to receive 2 doses of the full dose formulation of the vaccine with adjuvant on Day 1 and Day 61.
OG001
PoP: Placebo
Participants were randomized to receive 2 doses of placebo on Day 1 and Day 61.
Units
Counts
Participants
Primary
Dose-escalation Safety lead-in: Number of Participants With Potential Immune-mediated Diseases (pIMDs) up to 1 Year Post First Vaccination
pIMDs are defined as a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.
The analysis was performed on ES.
Posted
Count of Participants
Participants
From Day 1 to Day 366
ID
Title
Description
OG000
Group 1 Dose-escalation Safety Lead-in Epoch: Half Dose Non-Adjuvant (Non-Adj)
Participants received 1 dose of the half dose formulation of the vaccine on Day 1.
OG001
Group 2 Dose-escalation Safety Lead-in Epoch: Full Dose Non-Adj
Participants received 1 dose of the full dose formulation of the vaccine on Day 1.
OG002
Group 3 Dose-escalation Safety Lead-in Epoch: Half Dose Adj
Participants received 1 dose of the half dose formulation of the vaccine with adjuvant on Day 1.
OG003
Group 4 Dose-escalation Safety Lead-in Epoch: Full Dose Adj
Primary
Dose-escalation Safety lead-in: Number of Participants With pIMDs up to 1 Year Post Second Vaccination
pIMDs are defined as a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.
The analysis was performed on ES. Only participants that received a second vaccination on Day 61 were included in this analysis.
Posted
Count of Participants
Participants
From Day 61 to Day 426 (post vaccination at Day 61)
ID
Title
Description
OG000
Group 4 Dose-escalation Safety Lead-in Epoch: Full Dose Adj
Participants received 2 doses of the full dose formulation of the vaccine with adjuvant on Day 1 and Day 61.
OG001
Dose-escalation Safety Lead-in Epoch: Placebo
Participants received matching placebo on Day 1 for Group 1, Group 2 and Group 3, and on Day 1 and Day 61 for Group 4 of the escalation epoch.
Units
Counts
Participants
Primary
PoP: Number of Participants With Potential Immune-mediated Diseases (pIMDs)
pIMDs are defined as a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.
The analysis was performed on ES.
Posted
Count of Participants
Participants
From Day 1 to Day 426
ID
Title
Description
OG000
Proof of Principle (PoP): Full Dose Adj
Participants were randomized to receive 2 doses of the full dose formulation of the vaccine with adjuvant on Day 1 and Day 61.
OG001
PoP: Placebo
Participants were randomized to receive 2 doses of placebo on Day 1 and Day 61.
Units
Counts
Participants
OG000
Primary
Number of Participants With Maximum Toxicity Grade Increase From Baseline for Haematological and Biochemical Laboratory Parameters
The Biochemical parameters assessed were: Creatinine, Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and the Haematological parameters assessed were: Haemoglobin, white blood cells (WBC) decrease, WBC increase, Neutrophils decrease, Platelets decrease, Lymphocytes decrease, Eosinophils increase. Hematological and biochemical laboratory results are defined as follows: <parameter>,<grade at baseline>,<grade at visit> (e.g. ALT, Grade 0, Grade 0), where Grade 0 = a non-missing parameter value for which grade could not be derived according to the grading scale and does not belong to Grade 1-4; Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Potentially Life-Threatening. Grading following the FDA Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (September 2007). Unknown = parameter value missing for the specified parameter.
The analysis was performed on the Laboratory Safety Set that was a subset of the Unsolicited Safety Set. Only participants that had available data as per pre-assigned timepoints were included in this analysis.
Posted
Count of Participants
Participants
On Day 8 compared to Baseline (Day 1)
ID
Title
Description
OG000
Group 1 Dose-escalation Safety Lead-in Epoch: Half Dose Non-Adjuvant (Non-Adj)
Participants received 1 dose of the half dose formulation of the vaccine on Day 1.
OG001
Primary
Number of Participants With Maximum Toxicity Grade Increase From Baseline for Haematological and Biochemical Laboratory Parameters
The Biochemical parameters assessed were: Creatinine, AST, ALT and the Haematological parameters assessed were: Haemoglobin, WBC decrease, WBC increase, Neutrophils decrease, Platelets decrease, Lymphocytes decrease, Eosinophils increase. Hematological and biochemical laboratory results are defined as follows: <parameter>,<grade at baseline>,<grade at visit> (e.g. ALT, Grade 0, Grade 0), where Grade 0 = a non-missing parameter value for which grade could not be derived according to the grading scale and does not belong to Grade 1-4; Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Potentially Life-Threatening. Grading following the FDA Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (September 2007). Unknown = parameter value missing for the specified parameter.
The analysis was performed on the Laboratory Safety Set. Only participants that had available data as per pre-assigned timepoints were included in this analysis.
Posted
Count of Participants
Participants
On Day 68 compared to Baseline (Day 61)
ID
Title
Description
OG000
Group 4 Dose-escalation Safety Lead-in Epoch: Full Dose Adj
Participants received 2 doses of the full dose formulation of the vaccine with adjuvant on Day 1 and Day 61.
OG001
Dose-escalation Safety Lead-in Epoch: Placebo
Primary
Number of Participants With Haematological and Biochemical Laboratory Change From Baseline Values
The Biochemical parameters assessed were: Creatinine, AST, ALT and the Haematological parameters assessed were: Haemoglobin, WBC decrease, WBC increase, Neutrophils decrease, Platelets decrease, Lymphocytes decrease, Eosinophils increase. Hematological and biochemical laboratory results are defined as follows: <parameter>,<any grade at baseline>,<grade at visit> (e.g. ALT, Any, Grade 0), where Grade 0 = a non-missing parameter value for which grade could not be derived according to the grading scale and does not belong to Grade 1-4; Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Potentially Life-Threatening. Grading following the FDA Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (September 2007). Unknown = parameter value missing for the specified parameter.
The analysis was performed on the Laboratory Safety Set. Only participants that had available data as per pre-assigned timepoints were included in this analysis.
Posted
Count of Participants
Participants
On Day 8
ID
Title
Description
OG000
Group 1 Dose-escalation Safety Lead-in Epoch: Half Dose Non-Adjuvant (Non-Adj)
Participants received 1 dose of the half dose formulation of the vaccine on Day 1.
OG001
Group 2 Dose-escalation Safety Lead-in Epoch: Full Dose Non-Adj
Primary
Number of Participants With Haematological and Biochemical Laboratory Change From Baseline Values
The Biochemical parameters assessed were: Creatinine, AST, ALT and the Haematological parameters assessed were: Haemoglobin, WBC decrease, WBC increase, Neutrophils decrease, Platelets decrease, Lymphocytes decrease, Eosinophils increase. Hematological and biochemical laboratory results are defined as follows: <parameter>,<any grade at baseline>,<grade at visit> (e.g. ALT, Any, Grade 0), where Grade 0 = a non-missing parameter value for which grade could not be derived according to the grading scale and does not belong to Grade 1-4; Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Potentially Life-Threatening. Grading following the FDA Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (September 2007). Unknown = parameter value missing for the specified parameter.
The analysis was performed on the Laboratory Safety Set. Only participants that had available data as per pre-assigned timepoints were included in this analysis.
Posted
Count of Participants
Participants
On Day 68
ID
Title
Description
OG000
Group 4 Dose-escalation Safety Lead-in Epoch: Full Dose Adj
Participants received 2 doses of the full dose formulation of the vaccine with adjuvant on Day 1 and Day 61.
OG001
Dose-escalation Safety Lead-in Epoch: Placebo
Participants received matching placebo on Day 1 for Group 1, Group 2 and Group 3, and on Day 1 and Day 61 for Group 4 of the escalation epoch.
Secondary
Number of Participants With at Least One Culture Confirmed Case of Recurrent Staphylococcus Aureus (S. Aureus) Skin and Soft Tissue Infection (SSTI) - Interim Analysis
An interim analysis was performed after 13 cases of recurrent SA-SSTI were reported following 14 days from the study intervention dose 2.
The analysis was performed on Interim analysis Proof of Principle (PoP) - modified Full Analysis Set (mFAS) which included all subjects who received full study treatment course to which they are randomised and have post-vaccination efficacy data.
Posted
Count of Participants
Participants
From Day 75 to Day 426
ID
Title
Description
OG000
Proof of Principle (PoP): Full Dose Adj
Participants were randomized to receive 2 doses of the full dose formulation of the vaccine with adjuvant on Day 1 and Day 61.
OG001
PoP: Placebo
Participants were randomized to receive 2 doses of placebo on Day 1 and Day 61.
Units
Counts
Participants
Secondary
Number of Participants With at Least One Culture Confirmed Case of Recurrent S. Aureus SSTI - Final Analysis
After encountering futility at the interim analysis, an EOS analysis was conducted when at least one culture-confirmed case of recurrent SA-SSTI was identified 14 days after the second dose of the vaccine. For the final analysis, all the data collected by End of Study (EoS; Last Participant Last Visit) were analyzed for descriptive purposes.
The analysis was performed on EoS analysis PoP mFAS.
Posted
Count of Participants
Participants
From Day 75 to Day 426
ID
Title
Description
OG000
Proof of Principle (PoP): Full Dose Adj
Participants were randomized to receive 2 doses of the full dose formulation of the vaccine with adjuvant on Day 1 and Day 61.
OG001
PoP: Placebo
Participants were randomized to receive 2 doses of placebo on Day 1 and Day 61.
Units
Counts
Participants
OG000
Secondary
Number of Participants With at Least One Culture Confirmed Case of Recurrent S. Aureus SSTI - Final Analysis
An EOS analysis was conducted when at least one culture-confirmed case of recurrent SA-SSTI was identified 14 days after the first dose of the vaccine. For the final analysis, all the data collected by End of Study (EoS; Last Participant Last Visit) were analyzed for descriptive purposes.
The analysis was performed on the EOS PoP: Full Analysis Set (FAS) which included all subjects who received at least 1 dose of the study treatment and have post-vaccination efficacy data.
Posted
Count of Participants
Participants
From Day 15 to Day 426
ID
Title
Description
OG000
Proof of Principle (PoP): Full Dose Adj
Participants were randomized to receive 2 doses of the full dose formulation of the vaccine with adjuvant on Day 1 and Day 61.
OG001
PoP: Placebo
Participants were randomized to receive 2 doses of placebo on Day 1 and Day 61.
Units
Counts
Participants
Time Frame
Solicited AEs were collected from Day 1 to Day 7 (post vaccination 1) and from Day 61 to Day 67 (post Vaccination 2 only for Group 4 and PoP epoch). Unsolicited AEs were collected from Day 1 to Day 30 (post vaccination 1) and from Day 61 to Day 90 (post vaccination 2 only for Group 4 and PoP epoch). SAEs and pIMDs were collected from Day 1 to Day 366 (post vaccination 1, dose escalation), Day 61 to Day 426 (post vaccination 2, only for Group 4), from Day 1 to Day 426 for PoP epoch
Description
Adverse events are reported on the Exposed Set, who received at least 1 dose of the study treatment.
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
Group 1 Dose-escalation Safety Lead-in Epoch: Half Dose Non-Adjuvant (Non-Adj)
Participants received 1 dose of the half dose formulation of the vaccine on Day 1.
0
6
0
6
3
6
EG001
Group 2 Dose-escalation Safety Lead-in Epoch: Full Dose Non-Adj
Participants received 1 dose of the full dose formulation of the vaccine on Day 1.
0
6
0
6
6
6
EG002
Group 3 Dose-escalation Safety Lead-in Epoch: Half Dose Adj
Participants received 1 dose of the half dose formulation of the vaccine with adjuvant on Day 1.
0
6
0
6
5
6
EG003
Group 4 Dose-escalation Safety Lead-in Epoch: Full Dose Adj
Participants received 2 doses of the full dose formulation of the vaccine with adjuvant on Day 1 and Day 61.
0
6
0
6
6
6
EG004
Dose-escalation Safety Lead-in Epoch: Placebo
Participants received matching placebo on Day 1 for Group 1, Group 2 and Group 3, and on Day 1 and Day 61 for Group 4 of the escalation epoch.
0
8
0
8
5
8
EG005
Proof of Principle (PoP): Full Dose Adj
Participants were randomized to receive 2 doses of the full dose formulation of the vaccine with adjuvant on Day 1 and Day 61.
0
103
5
103
82
103
EG006
PoP: Placebo
Participants were randomized to receive 2 doses of placebo on Day 1 and Day 61.
0
89
5
89
60
89
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Abscess limb
Infections and infestations
v22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected8 at risk
EG0051 events1 affected103 at risk
EG0060 events0 affected89 at risk
Cellulitis
Infections and infestations
v22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Erysipelas
Infections and infestations
v22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Furuncle
Infections and infestations
v22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Subcutaneous abscess
Infections and infestations
v22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Concussion
Injury, poisoning and procedural complications
v22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Limb injury
Injury, poisoning and procedural complications
v22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Thermal burn
Injury, poisoning and procedural complications
v22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Large intestine benign neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
v22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Transient ischaemic attack
Nervous system disorders
v22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Suicidal ideation
Psychiatric disorders
v22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Lymphadenopathy
Blood and lymphatic system disorders
v22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected8 at risk
EG0054 events4 affected103 at risk
EG0060 events0 affected89 at risk
Neutropenia
Blood and lymphatic system disorders
v22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Eye inflammation
Eye disorders
v22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
v22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Abdominal pain
Gastrointestinal disorders
v22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
v22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Angular cheilitis
Gastrointestinal disorders
v22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Constipation
Gastrointestinal disorders
v22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Diarrhoea
Gastrointestinal disorders
v22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected6 at risk
EG0021 events1 affected6 at risk
EG003
Dyspepsia
Gastrointestinal disorders
v22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Mouth ulceration
Gastrointestinal disorders
v22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Nausea
Gastrointestinal disorders
v22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected6 at risk
EG0022 events2 affected6 at risk
EG003
Toothache
Gastrointestinal disorders
v22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Vomiting
Gastrointestinal disorders
v22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Chills
General disorders
v22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Fatigue
General disorders
v22.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0012 events2 affected6 at risk
EG0023 events3 affected6 at risk
EG003
Feeling hot
General disorders
v22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Injection site erythema
General disorders
v22.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Injection site induration
General disorders
v22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Injection site macule
General disorders
v22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Injection site mass
General disorders
v22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Injection site pain
General disorders
v22.1
Systematic Assessment
EG0002 events2 affected6 at risk
EG0014 events4 affected6 at risk
EG0025 events5 affected6 at risk
EG003
Injection site rash
General disorders
v22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Injection site reaction
General disorders
v22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Injection site swelling
General disorders
v22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Pain
General disorders
v22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Pyrexia
General disorders
v22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Vaccination site erythema
General disorders
v22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
COVID-19
Infections and infestations
v22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Candida infection
Infections and infestations
v22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Ear infection staphylococcal
Infections and infestations
v22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Eye infection
Infections and infestations
v22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Furuncle
Infections and infestations
v22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Herpes simplex
Infections and infestations
v22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Hordeolum
Infections and infestations
v22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Impetigo
Infections and infestations
v22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Laryngitis
Infections and infestations
v22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Nasopharyngitis
Infections and infestations
v22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Oral herpes
Infections and infestations
v22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Otitis externa
Infections and infestations
v22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Pharyngitis
Infections and infestations
v22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Pharyngitis streptococcal
Infections and infestations
v22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Skin infection
Infections and infestations
v22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Staphylococcal skin infection
Infections and infestations
v22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Upper respiratory tract infection
Infections and infestations
v22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Viral infection
Infections and infestations
v22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Vulvovaginal candidiasis
Infections and infestations
v22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Arthropod sting
Injury, poisoning and procedural complications
v22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Fall
Injury, poisoning and procedural complications
v22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Limb injury
Injury, poisoning and procedural complications
v22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Muscle rupture
Injury, poisoning and procedural complications
v22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Muscle strain
Injury, poisoning and procedural complications
v22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
v22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Skin graft failure
Injury, poisoning and procedural complications
v22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Skin laceration
Injury, poisoning and procedural complications
v22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Blood creatinine increased
Investigations
v22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Haemoglobin decreased
Investigations
v22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Dehydration
Metabolism and nutrition disorders
v22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Type 2 diabetes mellitus
Metabolism and nutrition disorders
v22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Vitamin B12 deficiency
Metabolism and nutrition disorders
v22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
v22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected6 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
v22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Exostosis
Musculoskeletal and connective tissue disorders
v22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Fibromyalgia
Musculoskeletal and connective tissue disorders
v22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
v22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
v22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Musculoskeletal discomfort
Musculoskeletal and connective tissue disorders
v22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
v22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
v22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Rotator cuff syndrome
Musculoskeletal and connective tissue disorders
v22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Acrochordon
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
v22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Dizziness
Nervous system disorders
v22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Headache
Nervous system disorders
v22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0013 events3 affected6 at risk
EG0022 events2 affected6 at risk
EG003
Lethargy
Nervous system disorders
v22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Migraine
Nervous system disorders
v22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Sciatica
Nervous system disorders
v22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Syncope
Nervous system disorders
v22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Anxiety disorder
Psychiatric disorders
v22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Insomnia
Psychiatric disorders
v22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Renal impairment
Renal and urinary disorders
v22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Menstruation irregular
Reproductive system and breast disorders
v22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
v22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
v22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
v22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
v22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Tonsillar hypertrophy
Respiratory, thoracic and mediastinal disorders
v22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Acne
Skin and subcutaneous tissue disorders
v22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Blister
Skin and subcutaneous tissue disorders
v22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Dermatitis
Skin and subcutaneous tissue disorders
v22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Dermatitis atopic
Skin and subcutaneous tissue disorders
v22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
v22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
v22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Pain of skin
Skin and subcutaneous tissue disorders
v22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Photodermatosis
Skin and subcutaneous tissue disorders
v22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
v22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
v22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
v22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Hot flush
Vascular disorders
v22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Hypertension
Vascular disorders
v22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 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.