Study to Assess the Safety and Immunogenicity of GSK Meningococcal Group B Vaccine When Administered Concomitantly With GSK Meningococcal MenACWY Conjugate Vaccine in Healthy Subjects of 16-18 Years of Age

NCT04318548 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: 2054192016-003722-16
• Study Type: interventional
• Target: 945
• Locations: 2 countries
• Sites: 53

Brief Summary

The purpose of this study is to evaluate the immunogenicity, safety and tolerability of rMenB+OMV NZ and MenACWY vaccines when concomitantly administered to healthy subjects 16-18 years of age.

Conditions

Infections, Meningococcal

Keywords

Meningitis; Invasive meningococcal disease; Bexsero; Menveo

Outcome Measures

Primary Outcomes (26)

• Number of Participants With Solicited Local Adverse Events (AEs) After the Vaccination With rMenB+OMV NZ

  Solicited local adverse events assessed are injection site pain, erythema, swelling, induration. Any solicited local AEs = occurrence of the symptom regardless of intensity grade.

  During 7 days after the rMenB+OMV NZ vaccination at Day 1

• Number of Participants With Solicited Local Adverse Events (AEs) After the Vaccination With rMenB+OMV NZ

  Solicited local adverse events assessed are injection site pain, erythema, swelling, induration. Any solicited local AEs = occurrence of the symptom regardless of intensity grade.

  During 7 days after the rMenB+OMV NZ vaccination at Day 61

• Number of Participants With Solicited Local Adverse Events (AEs) After the Vaccination With rMenB+OMV NZ

  Solicited local adverse events assessed are injection site pain, erythema, swelling, induration. Any solicited local AEs = occurrence of the symptom regardless of intensity grade.

  During 7 days after the rMenB+OMV NZ vaccination at Day 91

• Number of Participants With Solicited Local AEs After the Vaccination With MenACWY

  Solicited local adverse events assessed are injection site pain, erythema, swelling, induration. Any solicited local AEs= occurrence of the symptom regardless of intensity grade.

  During 7 days after the MenACWY vaccination at Day 1

• Number of Participants With Solicited Local AEs After the Vaccination With MenACWY

  Solicited local adverse events assessed are injection site pain, erythema, swelling, induration. Any solicited local AEs= occurrence of the symptom regardless of intensity grade.

  During 7 days after the MenACWY vaccination at Day 61

• Number of Participants With Solicited Local AEs After the Vaccination With MenACWY

  Solicited local adverse events assessed are injection site pain, erythema, swelling, induration. Any solicited local AEs= occurrence of the symptom regardless of intensity grade.

  During 7 days after the MenACWY vaccination at Day 91

• Number of Participants With Solicited Local AEs After the Vaccination With Placebo

  Solicited local adverse events assessed are injection site pain, erythema, swelling, induration. Any solicited local AEs = occurrence of the symptom regardless of intensity grade.

  During 7 days after the Placebo vaccination at Day 1

• Number of Participants With Solicited Local AEs After the Vaccination With Placebo

  Solicited local adverse events assessed are injection site pain, erythema, swelling, induration. Any solicited local AEs = occurrence of the symptom regardless of intensity grade.

  During 7 days after the Placebo vaccination at Day 91

• Number of Participants With Solicited Systemic AEs

  Solicited systemic adverse events assessed are fever \[temperature \>= 38.0°C\], nausea, fatigue, myalgia, arthralgia, and headache.

  During 7 days after the first study intervention administration occurring at Day 1

• Number of Participants With Solicited Systemic AEs

  Solicited systemic adverse events assessed are fever \[temperature \>= 38.0°C\], nausea, fatigue, myalgia, arthralgia, and headache.

  During 7 days after the second study intervention administration occurring at Day 61

• Number of Participants With Solicited Systemic AEs

  Solicited systemic adverse events assessed are fever \[temperature \>= 38.0°C\], nausea, fatigue, myalgia, arthralgia, and headache.

  During 7 days after the third study intervention administration occurring at Day 91

• Number of Participants With Any Unsolicited AEs (Including All Serious Adverse Events)

  Unsolicited adverse events are defined as any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms are reported as an unsolicited adverse event. Any solicited AE that has not resolved within 30 days post vaccination and is reported during clinic visits or safety follow-up calls is entered into the subject's electronic Case Report Form (eCRF) as an unsolicited AE. Serious Adverse Events (SAEs) are any untoward medical occurrence that result in death, are life-threatening, require hospitalization or prolongation of existing hospitalization, result in disability/incapacity and is a congenital anomaly/birth defect in the offspring of a study subject.

  During 30 days after the first study intervention administration occurring at Day 1

• Number of Participants With Any Unsolicited AEs (Including All Serious Adverse Events)

  Unsolicited adverse events are defined as any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms are reported as an unsolicited adverse event. Any solicited AE that has not resolved within 30 days post vaccination and is reported during clinic visits or safety follow-up calls is entered into the subject's electronic Case Report Form (eCRF) as an unsolicited AE. Serious Adverse Events (SAEs) are any untoward medical occurrence that result in death, are life-threatening, require hospitalization or prolongation of existing hospitalization, result in disability/incapacity and is a congenital anomaly/birth defect in the offspring of a study subject.

  During 30 days after the second study intervention administration occurring at Day 61

• Number of Participants With Any Unsolicited AEs (Including All Serious Adverse Events)

  Unsolicited adverse events are defined as any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms are reported as an unsolicited adverse event. Any solicited AE that has not resolved within 30 days post vaccination and is reported during clinic visits or safety follow-up calls is entered into the subject's electronic Case Report Form (eCRF) as an unsolicited AE. Serious Adverse Events (SAEs) are any untoward medical occurrence that result in death, are life-threatening, require hospitalization or prolongation of existing hospitalization, result in disability/incapacity and is a congenital anomaly/birth defect in the offspring of a study subject.

  During 30 days after the third study intervention administration occurring at Day 91

• Number of Participants With Any AEs/SAEs Leading to Withdrawal

  Unsolicited AEs are defined as any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms are reported as an unsolicited adverse event. Any solicited AE that has not resolved within 30 days post vaccination and is reported during clinic visits or safety follow-up calls is entered into the subject's electronic Case Report Form (eCRF) as an unsolicited AE. SAEs are any untoward medical occurrence that result in death, are life-threatening, require hospitalization or prolongation of existing hospitalization, result in disability/incapacity and is a congenital anomaly/birth defect in the offspring of a study subject. A participant was considered a 'withdrawal' from the study when no study procedure has occurred, no follow-up has been performed and no further information has been collected for this participant from the date of withdrawal/last contact.

  During 30 days after the first study intervention administration occurring at Day 1

• Number of Participants With Any AEs/SAEs Leading to Withdrawal

  Unsolicited AEs are defined as any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms are reported as an unsolicited adverse event. Any solicited AE that has not resolved within 30 days post vaccination and is reported during clinic visits or safety follow-up calls is entered into the subject's electronic Case Report Form (eCRF) as an unsolicited AE. SAEs are any untoward medical occurrence that result in death, are life-threatening, require hospitalization or prolongation of existing hospitalization, result in disability/incapacity and is a congenital anomaly/birth defect in the offspring of a study subject. A participant was considered a 'withdrawal' from the study when no study procedure has occurred, no follow-up has been performed and no further information has been collected for this participant from the date of withdrawal/last contact.

  During 30 days after the second study intervention administration occurring at Day 61

• Number of Participants With Any AEs/SAEs Leading to Withdrawal

  Unsolicited AEs are defined as any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms are reported as an unsolicited adverse event. Any solicited AE that has not resolved within 30 days post vaccination and is reported during clinic visits or safety follow-up calls is entered into the subject's electronic Case Report Form (eCRF) as an unsolicited AE. SAEs are any untoward medical occurrence that result in death, are life-threatening, require hospitalization or prolongation of existing hospitalization, result in disability/incapacity and is a congenital anomaly/birth defect in the offspring of a study subject. A participant was considered a 'withdrawal' from the study when no study procedure has occurred, no follow-up has been performed and no further information has been collected for this participant from the date of withdrawal/last contact.

  During 30 days after the third study intervention administration occurring at Day 91

• Number of Participants With Any Medically Attended AEs

  Medically attended AEs are symptoms or illnesses requiring hospitalization, or emergency room visit, or visit to/by a health care provider.

  During 30 days after the first study intervention administration occurring at Day 1

• Number of Participants With Any Medically Attended AEs

  Medically attended AEs are symptoms or illnesses requiring hospitalization, or emergency room visit, or visit to/by a health care provider.

  During 30 days after the second study intervention administration occurring at Day 61

• Number of Participants With Any Medically Attended AEs

  Medically attended AEs are symptoms or illnesses requiring hospitalization, or emergency room visit, or visit to/by a health care provider.

  During 30 days after the third study intervention administration occurring at Day 91

• Number of Participants With Any SAEs, AEs Leading to Withdrawal and Medically Attended AEs

  SAEs, AEs leading to withdrawal and medically attended AEs were assessed throughout the study period are reported in this outcome measure.

  Throughout the study period (Day 1 to Day 271)

• Number of Participants Who Received rMenB+OMV NZ With Adverse Events of Special Interest (AESI)

  AESIs are predefined (serious or non-serious) adverse events of scientific and medical concern specific to the product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor can be appropriate, because such an event might warrant further investigation in order to characterize and understand it.

  Throughout the study period (Day 1 to Day 271)

• Number of Participants With Any SAEs and AEs Leading to Withdrawal

  Unsolicited AEs are defined as any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms are reported as an unsolicited adverse event. Any solicited AE that has not resolved within 30 days post vaccination and is reported during clinic visits or safety follow-up calls is entered into the subject's electronic Case Report Form (eCRF) as an unsolicited AE. SAEs are any untoward medical occurrence that result in death, are life-threatening, require hospitalization or prolongation of existing hospitalization, result in disability/incapacity and is a congenital anomaly/birth defect in the offspring of a study subject. A participant was considered a 'withdrawal' from the study when no study procedure has occurred, no follow-up has been performed and no further information has been collected for this participant from the date of withdrawal/last contact.

  During safety follow-up (Day 271 to Day 451)

• Number of Participants Who Received rMenB+OMV NZ With AESI

  AESIs are predefined (serious or non-serious) adverse events of scientific and medical concern specific to the product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor can be appropriate, because such an event might warrant further investigation in order to characterize and understand it.

  During safety follow-up (Day 271 to Day 451)

• Human Serum Bactericidal Assay (hSBA) Geometric Mean Titers (GMTs) Against Each of the N. Meningitidis Serogroup B Strains at 1 Month After the Second Vaccination With rMenB+OMV NZ (Groups MenB+MenACWY and MenB), and Between-group GMT Ratios

  hSBA titers were measured by serum bactericidal assay and expressed as Geometric Mean Titers (GMTs) against N. meningitidis serogroup B indicator strains (M14459 \[fHbp\], 96217 \[NadA\], NZ98/254 \[PorA\] and M13520 \[NHBA\]).

  At Day 91 (1 month after the second vaccination with rMenB+OMV NZ in MenB+MenACWY and MenB groups)

• hSBA GMTs Against Each of the N. Meningitidis Serogroups A, C, W and Y After Vaccination With MenACWY (Groups MenB+MenACWY and MenACWY), and Between-group GMT Ratios

  hSBA titers were measured by serum bactericidal assay and expressed as GMTs against each of the 4 serogroups Men A, Men C, Men W and Men Y.

  At Day 31 (1 month after the vaccination with MenACWY in MenACWY and MenB+MenACWY groups)

Secondary Outcomes (11)

• hSBA Geometric Mean Concentrations (GMCs) Measured by ECL Against Each of the N. Meningitidis Serogroups After MenACWY Vaccination

  At Day 31 (1 month after the vaccination of MenACWY in MenACWY and MenB+MenACWY groups)

• hSBA GMTs Against Each of the Serogroup B Strains in Both MenB+MenACWY and MenB Groups After First rMenB+OMV NZ Vaccination and Between-group GMT Ratios

  At Day 31 (1 month after first vaccination with rMenB+OMV NZ)

• Geometric Mean Ratios (GMRs) Against Each of the N. Meningitidis Serogroup B Strains in Both MenB+MenACWY and MenB Groups After the First rMenB+OMV NZ Vaccination

  At Dya 31 (1 month after first rMenB+OMV NZ vaccination) compared to the baseline (Day 1)

• GMRs Against Each of the N. Meningitidis Serogroup B Strains in Both MenB+MenACWY and MenB Groups After the Second rMenB+OMV NZ Vaccination

  At Day 91 (1 month after the second rMenB+OMV NZ vaccination) compared to the baseline (Day 1)

• Percentage of Participants With hSBA Titers >= Lower Limit of Quantitation (LLOQ) for Each and All Serogroup B Test Strains in Both MenB+MenACWY and MenB Groups After the First rMenB+OMV NZ Vaccination

  At Day 31 (one month after the first rMenB+OMV NZ vaccination)

Study Arms (3)

MenB+MenACWY Group

EXPERIMENTAL

Participants received 1 dose of rMenB+OMV NZ vaccine administered concomitantly with 1 dose of MenACWY vaccine, as separate injections in each arm at Day 1, 1 dose of rMenB+OMV NZ vaccine at Day 61 and 1 dose of placebo at Day 91.

Combination Product: Meningococcal Group B Vaccine (GSK3536829A) (rMenB+OMV NZ); Biological: Meningococcal MenACWY Conjugate Vaccine (GSK3536820A) (MenA lyo + MenCWY liquid); Combination Product: Placebo

MenB Group

EXPERIMENTAL

Participants received 1 dose of rMenB+OMV NZ vaccine administered concomitantly with 1 dose of placebo, as separate injections in each arm at Day 1, 1 dose of rMenB+OMV NZ vaccine at Day 61 and 1 dose of MenACWY at Day 91.

Combination Product: Meningococcal Group B Vaccine (GSK3536829A) (rMenB+OMV NZ); Biological: Meningococcal MenACWY Conjugate Vaccine (GSK3536820A) (MenA lyo + MenCWY liquid); Combination Product: Placebo

MenACWY Group

EXPERIMENTAL

Participants received 1 dose of MenACWY vaccine administered concomitantly with 1 dose of placebo, as separate injections in each arm at Day1, 1 dose of rMenB+OMV NZ vaccine each administered at Day 61 and at Day 91.

Combination Product: Meningococcal Group B Vaccine (GSK3536829A) (rMenB+OMV NZ); Biological: Meningococcal MenACWY Conjugate Vaccine (GSK3536820A) (MenA lyo + MenCWY liquid); Combination Product: Placebo

Interventions

Meningococcal Group B Vaccine (GSK3536829A) (rMenB+OMV NZ) COMBINATION_PRODUCT

1 dose of rMenB+OMV administered intramuscularly at day 1 and 61 to participants in MenB+MenACWY group and MenB group and as 1 dose at day 91 to participants in MenACWY group.

Also known as: Bexsero

MenACWY Group; MenB Group; MenB+MenACWY Group

Meningococcal MenACWY Conjugate Vaccine (GSK3536820A) (MenA lyo + MenCWY liquid) BIOLOGICAL

1 dose of MenACWY administered intramuscularly at day 1 to participants in MenB+MenACWY group and MenACWY group, 1 dose at day 91 to participants for MenB group.

Also known as: Menveo

MenACWY Group; MenB Group; MenB+MenACWY Group

Placebo COMBINATION_PRODUCT

1 dose of Placebo administered intramuscularly at 1 to participants in MenB group and MenACWY group and as 1 dose at day 91 to participants in MenB+MenACWY group.

Also known as: NaCl, saline solution

MenACWY Group; MenB Group; MenB+MenACWY Group

Eligibility Criteria

• Age: 16 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol or/and participants' parent(s)/Legally Acceptable Representative(s) \[LAR(s)\] who, in the opinion of the investigator, can and will comply, with the requirements of the protocol.
• Previous vaccination with 1 dose of quadrivalent meningococcal conjugate vaccine (MenACWY, Menveo or Menactra) at least 4 years prior to informed consent and assent as applicable.
• Written or /witnessed/thumb printed informed consent obtained from the participant/parent(s)/LAR(s) of the participant prior to performance of any study specific procedure.
• Written informed assent obtained from the participant (if applicable) along with informed consent from the participant's parent(s)/LAR(s) prior to performing any study specific procedure.
• A male or female between, and including, 16 and 18 years of age at the time of the first vaccination.
• Healthy participants as established by medical history and clinical examination before entering the study.
• 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, and
• has a negative pregnancy test on the day of vaccination, and
• has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series.

You may not qualify if:

• Medical conditions
• Progressive, unstable, or uncontrolled clinical conditions.
• Clinical conditions representing a contraindication to intramuscular vaccination and blood draws.
• Abnormal function of the immune system resulting from:
• Clinical conditions.
• Systemic administration of corticosteroids (PO/IV/IM) for more than 14 consecutive days within 90 days prior to study vaccination. This will mean prednisone ≥ 20 mg/day (for adult participants) or ≥ 0.5 mg/kg/day or 20 mg/day whichever is the maximum dose for pediatric participants, or equivalent. Inhaled and topical steroids are allowed.
• Administration of antineoplastic or immunomodulating agents or radiotherapy within 90 days prior to informed consent.
• Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study.
• History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
• History of any reaction or hypersensitivity likely to be exacerbated by any medicinal products or medical equipment whose use is foreseen in this study.
• Current or previous, confirmed, or suspected disease caused by N. meningitidis.
• Known contact to an individual with any laboratory-confirmed N. meningitidis infection within 60 days, prior to enrolment.
• History of neuroinflammatory or autoimmune condition.
• Recurrent history or un-controlled neurological disorders or seizures.
• Prior/Concomitant therapy

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (53)

GSK Investigational Site

Phoenix, Arizona, 85238, United States

Location

GSK Investigational Site

Bell Gardens, California, 90201, United States

Location

GSK Investigational Site

Los Angeles, California, 90027, United States

Location

GSK Investigational Site

Oakland, California, 94611, United States

Location

GSK Investigational Site

Roseville, California, 95661, United States

Location

GSK Investigational Site

Sacramento, California, 95815, United States

Location

GSK Investigational Site

San Jose, California, 95119, United States

Location

GSK Investigational Site

Santa Clara, California, 95051, United States

Location

GSK Investigational Site

Walnut Creek, California, 94596, United States

Location

GSK Investigational Site

Wellington, Florida, 33470, United States

Location

GSK Investigational Site

Boise, Idaho, 83702, United States

Location

GSK Investigational Site

Nampa, Idaho, 83686, United States

Location

GSK Investigational Site

Nampa, Idaho, 83687, United States

Location

GSK Investigational Site

Evansville, Indiana, 47715, United States

Location

GSK Investigational Site

Bardstown, Kentucky, 40004, United States

Location

GSK Investigational Site

Louisville, Kentucky, 40291, United States

Location

GSK Investigational Site

Lafayette, Louisiana, 70508, United States

Location

GSK Investigational Site

Lincoln, Nebraska, 68504, United States

Location

GSK Investigational Site

Lincoln, Nebraska, 68505, United States

Location

GSK Investigational Site

Lincoln, Nebraska, 68516, United States

Location

GSK Investigational Site

Lincoln, Nebraska, 68526, United States

Location

GSK Investigational Site

Cortland, New York, 13045, United States

Location

GSK Investigational Site

Charlotte, North Carolina, 28226, United States

Location

GSK Investigational Site

Winston-Salem, North Carolina, 27103, United States

Location

GSK Investigational Site

Corvallis, Oregon, 97330, United States

Location

GSK Investigational Site

Erie, Pennsylvania, 16508, United States

Location

GSK Investigational Site

Hermitage, Pennsylvania, 16148, United States

Location

GSK Investigational Site

Pittsburgh, Pennsylvania, 15025, United States

Location

GSK Investigational Site

Pittsburgh, Pennsylvania, 15213, United States

Location

GSK Investigational Site

Pittsburgh, Pennsylvania, 15217, United States

Location

GSK Investigational Site

Pittsburgh, Pennsylvania, 15234, United States

Location

GSK Investigational Site

Charleston, South Carolina, 29414, United States

Location

GSK Investigational Site

Sioux Falls, South Dakota, 57108, United States

Location

GSK Investigational Site

Austin, Texas, 75010, United States

Location

GSK Investigational Site

Austin, Texas, 78613, United States

Location

GSK Investigational Site

Austin, Texas, 78726, United States

Location

GSK Investigational Site

Dallas, Texas, 75230-2571, United States

Location

GSK Investigational Site

Dallas, Texas, 75251, United States

Location

GSK Investigational Site

Houston, Texas, 77584, United States

Location

GSK Investigational Site

Plano, Texas, 75024, United States

Location

GSK Investigational Site

Plano, Texas, 75093, United States

Location

GSK Investigational Site

Victoria, Texas, 77901, United States

Location

GSK Investigational Site

Waxahachie, Texas, 75165, United States

Location

GSK Investigational Site

Orem, Utah, 84057, United States

Location

GSK Investigational Site

Salt Lake City, Utah, 84107, United States

Location

GSK Investigational Site

South Jordan, Utah, 84095, United States

Location

GSK Investigational Site

Syracuse, Utah, 84075, United States

Location

GSK Investigational Site

Falls Church, Virginia, 22044, United States

Location

GSK Investigational Site

Richmond, Virginia, 23294, United States

Location

GSK Investigational Site

Chiavari GE, 16043, Italy

Location

GSK Investigational Site

Foggia, 71122, Italy

Location

GSK Investigational Site

Milan, 20122, Italy

Location

GSK Investigational Site

Milan, 20162, Italy

Location

MeSH Terms

Conditions

Meningococcal Infections; Meningitis

Interventions

4CMenB vaccine; Meningococcal Vaccines; Saline Solution

Condition Hierarchy (Ancestors)

Neisseriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Neuroinflammatory Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Bacterial Vaccines; Vaccines; Biological Products; Complex Mixtures; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

GSKClinicalSupportHD@gsk.com

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This is an Observer-blinded study. Recipients \& study evaluators were unaware of vaccine administered.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2020
• First Posted: March 24, 2020
• Study Start: August 25, 2020
• Primary Completion: November 21, 2023
• Study Completion: November 21, 2023
• Last Updated: March 4, 2025
• Results First Posted: March 4, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, 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.

Locations

US (49); IT (4)