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)

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)

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). In the dose-escalation safety lead-in phase in healthy adults safety and immunogenicity of 4 different compositions is assessed. After safety has been shown in this phase, in the second phase, proof of principle (PoP) phase of the study in adults with a recent SSTI safety, immunogenicity and efficacy of the final composition of the vaccine is assessed.

Study Overview

• Status: Active, not recruiting
• Conditions: Infections, Soft Tissue
• Intervention / Treatment: Biological: Sa-5Ag half dose non-adjuvanted; Biological: Placebo; Biological: Sa-5Ag full dose non-adjuvanted; Biological: Sa-5Ag half dose adjuvanted; Biological: Sa-5Ag full dose adjuvanted

• Study Type: Interventional
• Enrollment (Estimated): 632
• Phase: Phase 2

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Coffs Harbour, New South Wales, Australia, 2450
      • GSK Investigational Site
    • Darlinghurst, Sydney, New South Wales, Australia, 2010
      • GSK Investigational Site
    • Sydney, New South Wales, Australia, 2010
      • GSK Investigational Site
  • Queensland
    • Fortitude Valley, Queensland, Australia, 4006
      • GSK Investigational Site
    • Southport, Queensland, Australia, 4215
      • GSK Investigational Site
  • Victoria
    • Geelong, Victoria, Australia, 3220
      • GSK Investigational Site
• India
  • Lucknow, India, 226000
    • GSK Investigational Site
  • Nagpur, India, 440003
    • GSK Investigational Site
  • Nagpur, India, 441108
    • GSK Investigational Site
  • Pune, India, 411001
    • GSK Investigational Site
  • Gujarat
    • Ahmedabad, Gujarat, India, 380006
      • GSK Investigational Site
    • Ahmedabad, Gujarat, India, 380015
      • GSK Investigational Site
    • Ahmedabad, Gujarat, India, 380054
      • GSK Investigational Site
    • Ahmedabad, Gujarat, India, 380061
      • GSK Investigational Site
  • Maharashtra
    • Shivajinagar,Pune, Maharashtra, India, 411005
      • GSK Investigational Site
    • Thane, Maharashtra, India, 400606
      • GSK Investigational Site
  • Uttar Pradesh
    • Kanpur, Uttar Pradesh, India, 208002
      • GSK Investigational Site
    • Varanasi, Uttar Pradesh, India, 221007
      • GSK Investigational Site
  • West Bengal
    • Kolkata, West Bengal, India, 700016
      • GSK Investigational Site
• New Zealand
  • Auckland, New Zealand, 1010
    • GSK Investigational Site
  • Christchurch, New Zealand, 8013
    • GSK Investigational Site
  • Nawton, New Zealand, 3200
    • GSK Investigational Site
  • Nelson, New Zealand, 7011
    • GSK Investigational Site
  • New Lynn, New Zealand, 0600
    • GSK Investigational Site
  • Otahuhu, New Zealand, 1640
    • GSK Investigational Site
• Poland
  • Bialystok, Poland, 15-453
    • GSK Investigational Site
  • Katowice, Poland, 40-851
    • GSK Investigational Site
  • Lodz, Poland, 91-363
    • GSK Investigational Site
  • Lublin, Poland, 20-078
    • GSK Investigational Site
  • Szczecin, Poland, 70-332
    • GSK Investigational Site
  • Warszawa, Poland, 00-215
    • GSK Investigational Site
  • Warszawa, Poland, 01-142
    • GSK Investigational Site
• South Africa
  • Cape Town, South Africa, 7708
    • GSK Investigational Site
  • Gauteng
    • Johannesburg, Gauteng, South Africa, 2013
      • GSK Investigational Site
  • KwaZulu- Natal
    • Durban, KwaZulu- Natal, South Africa, 4052
      • GSK Investigational Site
• United Kingdom
  • Nottingham, United Kingdom, NG7 2QW
    • GSK Investigational Site
  • West Midlands, United Kingdom, B9 5SS
    • GSK Investigational Site
• United States
  • California
    • La Mesa, California, United States, 91942
      • GSK Investigational Site
    • Torrance, California, United States, 90502
      • GSK Investigational Site
  • Illinois
    • Evanston, Illinois, United States, 60201
      • GSK Investigational Site
  • Kentucky
    • Lexington, Kentucky, United States, 40503
      • GSK Investigational Site
    • Lexington, Kentucky, United States, 40536
      • GSK Investigational Site
  • Louisiana
    • Metairie, Louisiana, United States, 70006
      • GSK Investigational Site
    • Slidell, Louisiana, United States, 70458
      • GSK Investigational Site
  • Nebraska
    • Omaha, Nebraska, United States, 68144
      • GSK Investigational Site
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • GSK Investigational Site
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

All subjects must satisfy all the following criteria at study entry:

• Subjects 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 subject prior to performance of any study specific procedure.
• Subject satisfying screening requirements.
• Subjects 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 subjects 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 subjects of childbearing potential may be enrolled in the study, if the subject:
• 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 subjects to be enrolled in the dose-escalation safety lead-in screening epoch:

- Healthy subjects as established by medical history, clinical examination and laboratory assessment.

Additional inclusion criteria only for subjects to be enrolled in the PoP screening epoch:

- Healthy subjects 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 subjects 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 subjects 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 subjects have to be treated until clinical resolution of the culture confirmed SSTI caused by S. aureus. These subjects 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 subjects at study entry

• 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 subject 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 subjects 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 subject'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 subject 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Quadruple

Number of Arms

10

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Half dose non-adj Group 1a; Subjects aged 18 to 50 at the time of first vaccination who receive 1 dose of Sa-5Ag (5 antigens of S. aureus) half dose, non-adjuvanted at Day 1.	Biological: Sa-5Ag half dose non-adjuvanted; 1 dose of Sa-5Ag (5 antigens of S. aureus) half dose, non-adjuvanted at Day 1, administered intramuscularly.
Placebo Comparator: Placebo Group 1b; Subjects aged 18 to 50 at the time of first vaccination who receive 1 dose of placebo (saline) at Day 1.	Biological: Placebo; One dose of placebo (saline solution for injection/ vial or prefilled syringe) at Day 1 for placebo groups 1 to 3 and a series of 2 doses of placebo given approximately 2 months apart (Days 1 and 61) for placebo groups 4 and 5, administered intramuscularly.
Experimental: Full dose non-adj Group 2a; Subjects aged 18 to 50 at the time of first vaccination who receive 1 dose of Sa-5Ag (5 antigens of S. aureus) full dose, non-adjuvanted at Day 1	Biological: Sa-5Ag full dose non-adjuvanted; 1 dose of Sa-5Ag (5 antigens of S. aureus) full dose, non-adjuvanted at Day 1, administered intramuscularly.
Placebo Comparator: Placebo Group 2b; Subjects aged 18 to 50 at the time of first vaccination who receive 1 dose of placebo (saline) at Day 1.	Biological: Placebo; One dose of placebo (saline solution for injection/ vial or prefilled syringe) at Day 1 for placebo groups 1 to 3 and a series of 2 doses of placebo given approximately 2 months apart (Days 1 and 61) for placebo groups 4 and 5, administered intramuscularly.
Experimental: Half dose adj Group 3a; Subjects aged 18 to 50 at the time of first vaccination who receive 1 dose of Sa-5Ag (5 antigens of S. aureus) half dose, adjuvanted at Day 1.	Biological: Sa-5Ag half dose adjuvanted; 1 dose of Sa-5Ag (5 antigens of S. aureus) half dose, adjuvanted at Day 1, administered intramuscularly.
Placebo Comparator: Placebo Group 3b; Subjects aged 18 to 50 at the time of first vaccination who receive 1 dose of placebo (saline) at Day 1.	Biological: Placebo; One dose of placebo (saline solution for injection/ vial or prefilled syringe) at Day 1 for placebo groups 1 to 3 and a series of 2 doses of placebo given approximately 2 months apart (Days 1 and 61) for placebo groups 4 and 5, administered intramuscularly.
Experimental: Full dose adj Group 4a; Subjects aged 18 to 50 at the time of first vaccination who receive a series of 2 doses of S. aureus candidate vaccine (Sa-5Ag full dose adjuvanted) given approximately 2 months apart (Days 1 and 61)	Biological: Sa-5Ag full dose adjuvanted; 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.
Placebo Comparator: Placebo Group 4b; Subjects aged 18 to 50 at the time of first vaccination who receive a series of 2 doses of placebo (saline) given approximately 2 months apart (Days 1 and 61).	Biological: Placebo; One dose of placebo (saline solution for injection/ vial or prefilled syringe) at Day 1 for placebo groups 1 to 3 and a series of 2 doses of placebo given approximately 2 months apart (Days 1 and 61) for placebo groups 4 and 5, administered intramuscularly.
Experimental: Vaccine Group 5a; Subjects aged 18 to 64 at the time of first vaccination who receive a series of 2 doses of S. aureus candidate vaccine (Sa-5Ag full dose adjuvanted) given approximately 2 months apart (Days 1 and 61).	Biological: Sa-5Ag full dose adjuvanted; 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.
Placebo Comparator: Placebo Group 5b; Subjects aged 18 to 64 at the time of first vaccination who receive a series of 2 doses of placebo (saline) given approximately 2 months apart (Days 1 and 61).	Biological: Placebo; One dose of placebo (saline solution for injection/ vial or prefilled syringe) at Day 1 for placebo groups 1 to 3 and a series of 2 doses of placebo given approximately 2 months apart (Days 1 and 61) for placebo groups 4 and 5, administered intramuscularly.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with solicited local adverse events (AEs) (any, grade 3)	The solicited local AE(s) assessed are pain, redness and swelling. Any = any solicited local AE, regardless of intensity; Grade 3 pain = Significant pain at rest, that prevents normal every day activities; Grade 3 redness/swelling = greater than or equal to (≥)100 mm diameter (greatest surface diameter in millimetres [mm]).	During 7 days after the first dose (Days 1 to 8)
Number of participants with solicited local adverse events (AEs) (any, grade 3)	The solicited local AE(s) assessed are pain, redness and swelling. Any = any solicited local AE, regardless of intensity; Grade 3 pain = Significant pain at rest, that prevents normal every day activities; Grade 3 redness/swelling = greater than or equal to (≥)100 mm diameter (greatest surface diameter in millimeters [mm]).	During 7 days after the second dose (Days 61 to 68)
Number of participants with solicited general AEs (any, grade 3)	The solicited general AE(s) assessed are headache, fatigue, nausea, vomiting, diarrhea, abdominal pain, myalgia, shivering and fever (temperature ≥ 38.0 degrees Celsius (°C)/100.4 degrees Fahrenheit (°F). Any = any solicited general 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.	During 7 days after the first dose (Days 1 to 8)
Number of participants with solicited general AEs (any, grade 3)	The solicited general AE(s) assessed are headache, fatigue, nausea, vomiting, diarrhea, abdominal pain, myalgia, shivering and fever (temperature ≥ 38.0 degrees Celsius (°C)/100.4 degrees Fahrenheit (°F). Any = any solicited general 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.	During 7 days after the second dose (Days 61 to 68)
Number of participants with unsolicited AEs (any, grade 3, related, related grade 3)	Any (independent from causality) unsolicited AEs regardless of intensity; Grade 3 unsolicited AEs = An AE which prevents normal, everyday activities. Such an AE would, for example, prevent attendance at work/school and would necessitate the administration of corrective therapy. Related unsolicited AEs = AEs assessed by the investigator to be causally related to vaccination. Grade 3 related unsolicited AEs = An AE which prevents normal, everyday activities. Such an AE would, for example, prevent attendance at work/school and would necessitate the administration of corrective therapy.	During 30 days after the first dose (Days 1 to 31)
Number of participants with unsolicited AEs (any, grade 3, related, related grade 3)	Any (independent from causality) unsolicited AEs regardless of intensity; Grade 3 unsolicited AEs = An AE which prevents normal, everyday activities. Such an AE would, for example, prevent attendance at work/school and would necessitate the administration of corrective therapy. Related unsolicited AEs = AEs assessed by the investigator to be causally related to vaccination. Grade 3 related unsolicited AEs = An AE which prevents normal, everyday activities. Such an AE would, for example, prevent attendance at work/school and would necessitate the administration of corrective therapy.	During 30 days after the second dose (Days 61 to 91)
Number of participants with serious AEs (SAEs) (any, grade 3, related, related grade 3)	Any (independent from causality) SAEs regardless of intensity; Grade 3 SAEs = SAE which prevents normal, everyday activities. Such an SAE would, for example, prevent attendance at work/school and would necessitate the administration of corrective therapy. Related SAEs = SAEs assessed by the investigator to be causally related to vaccination. Grade 3 related SAEs = SAE which prevents normal, everyday activities. Such an SAE would, for example, prevent attendance at work/school and would necessitate the administration of corrective therapy.	Throughout the study period [from Day 1 (day of vaccination) until Day 366
Number of participants with serious AEs (SAEs) (any, grade 3, related, related grade 3)	Any (independent from causality) SAEs regardless of intensity; Grade 3 SAEs = SAE which prevents normal, everyday activities. Such an SAE would, for example, prevent attendance at work/school and would necessitate the administration of corrective therapy. Related SAEs = SAEs assessed by the investigator to be causally related to vaccination. Grade 3 related SAEs = SAE which prevents normal, everyday activities. Such an SAE would, for example, prevent attendance at work/school and would necessitate the administration of corrective therapy.	Throughout the study period [from Day 1 (day of vaccination) until Day 426
Number of participants with potential immune-mediated diseases (PIMDs) (any, grade 3, related, related grade 3)	Any (independent from causality) PIMDs regardless of intensity; Grade 3 PIMDs = PIMD which prevents normal, everyday activities. Such an PIMD would, for example, prevent attendance at work/school and would necessitate the administration of corrective therapy. Related PIMDs = PIMDs assessed by the investigator to be causally related to vaccination. Grade 3 related PIMDs = PIMD which prevents normal, everyday activities. Such an PIMD would, for example, prevent attendance at work/school and would necessitate the administration of corrective therapy.	Throughout the study period [from Day 1 (day of vaccination) until Day 366
Number of participants with potential immune-mediated diseases (PIMDs) (any, grade 3, related, related grade 3)	Any (independent from causality) PIMDs regardless of intensity; Grade 3 PIMDs = PIMD which prevents normal, everyday activities. Such an PIMD would, for example, prevent attendance at work/school and would necessitate the administration of corrective therapy. Related PIMDs = PIMDs assessed by the investigator to be causally related to vaccination. Grade 3 related PIMDs = PIMD which prevents normal, everyday activities. Such an PIMD would, for example, prevent attendance at work/school and would necessitate the administration of corrective therapy.	Throughout the study period [from Day 1 (day of vaccination) until Day 426
Number of participants with haematological and biochemical laboratory abnormalities and changes from the baseline values	The number of participants having hematology and biochemistry results below, within or above the normal laboratory ranges, compared to baseline range indicator.	At Day 8 (7 days after the first dose)
Number of participants with haematological and biochemical laboratory abnormalities and changes from the baseline values	The number of participants having hematology and biochemistry results below, within or above the normal laboratory ranges, compared to baseline range indicator.	At Day 68 (7 days after the second dose)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with at least one culture confirmed case of recurrent S. aureus SSTI	This key secondary outcome measure is to evaluate efficacy in terms of number of participants with at least one culture confirmed case of recurrent S. aureus SSTI starting 14 days after the second dose.	Starting from Day 75 (i.e.14 days after the second dose) up to Day 426 (12 months after the second dose).
Number of participants with at least one culture confirmed case of recurrent S. aureus SSTI	This co-secondary outcome measure is to evaluate efficacy in terms of number of participants with at least one culture confirmed case of recurrent S. aureus SSTI starting 14 days after the first dose.	Starting from Day 15 (i.e. 14 days after the first dose) up to Day 426 (12 months after the second dose).

Collaborators and Investigators

• Sponsor: GlaxoSmithKline
• Investigators: Study Director: GSK Clinical Trials, GlaxoSmithKlline

Study record dates

Study Major Dates

• Study Start (Actual): June 29, 2020
• Primary Completion (Estimated): March 14, 2024
• Study Completion (Estimated): March 14, 2024

Study Registration Dates

• First Submitted: June 4, 2020
• First Submitted That Met QC Criteria: June 4, 2020
• First Posted (Actual): June 9, 2020

Study Record Updates

• Last Update Posted (Estimated): February 22, 2024
• Last Update Submitted That Met QC Criteria: February 21, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: first time in human; S. aureus; skin and soft tissue infection; S. aureus vaccine
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases; Soft Tissue Infections
• Other Study ID Numbers: 208833; 2021-006215-29 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: IPD for this study will be made available via the Clinical Study Data Request site.
• IPD Sharing 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
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No