NCT_ID: NCT05921903
Clinical Trial Link
Brief Summaries
Sequence: | 30521137 |
Description | The purpose of this study is to evaluate the immunogenicity, safety, and reactogenicity of the RSVPreF3 OA investigational vaccine in an immunocompromised (lung and renal transplant recipients) population and assess whether a second dose of the vaccine increases the immune response. The aim of the study is to prevent severe Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Disease (LRTD). |
Studies
Study First Submitted Date | 2023-06-16 |
Study First Posted Date | 2023-06-27 |
Last Update Posted Date | 2023-06-27 |
Start Month Year | July 31, 2023 |
Primary Completion Month Year | September 9, 2024 |
Verification Month Year | June 2023 |
Verification Date | 2023-06-30 |
Last Update Posted Date | 2023-06-27 |
Facilities
Sequence: | 198477541 | Sequence: | 198477542 | Sequence: | 198477543 | Sequence: | 198477544 | Sequence: | 198477545 | Sequence: | 198477546 | Sequence: | 198477547 | Sequence: | 198477548 | Sequence: | 198477549 | Sequence: | 198477550 | Sequence: | 198477551 | Sequence: | 198477552 | Sequence: | 198477553 | Sequence: | 198477554 | Sequence: | 198477555 | Sequence: | 198477556 | Sequence: | 198477557 | Sequence: | 198477558 | Sequence: | 198477559 | Sequence: | 198477560 | Sequence: | 198477561 | Sequence: | 198477562 | Sequence: | 198477563 | Sequence: | 198477564 | Sequence: | 198477565 | Sequence: | 198477566 | Sequence: | 198477567 | Sequence: | 198477568 | Sequence: | 198477569 | Sequence: | 198477570 | Sequence: | 198477571 | Sequence: | 198477572 | Sequence: | 198477573 | Sequence: | 198477574 | Sequence: | 198477575 | Sequence: | 198477576 | Sequence: | 198477577 | Sequence: | 198477578 | Sequence: | 198477579 | Sequence: | 198477580 | Sequence: | 198477581 | Sequence: | 198477582 | Sequence: | 198477583 | Sequence: | 198477584 | Sequence: | 198477585 | Sequence: | 198477586 | Sequence: | 198477587 | Sequence: | 198477588 | Sequence: | 198477589 | Sequence: | 198477590 | Sequence: | 198477591 | Sequence: | 198477592 | Sequence: | 198477593 |
Name | GSK Investigational Site | Name | GSK Investigational Site | Name | GSK Investigational Site | Name | GSK Investigational Site | Name | GSK investigational Site | Name | GSK Investigational Site | Name | GSK Investigational Site | Name | GSK Investigational Site | Name | GSK Investigational Site | Name | GSK Investigational Site | Name | GSK Investigational Site | Name | GSK Investigational Site | Name | GSK Investigational Site | Name | GSK Investigational Site | Name | GSK Investigational Site | Name | GSK Investigational Site | Name | GSK Investigational Site | Name | GSK Investigational Site | Name | GSK Investigational Site | Name | GSK Investigational Site | Name | GSK Investigational Site | Name | GSK Investigational Site | Name | GSK Investigational Site | Name | GSK Investigational Site | Name | GSK Investigational Site | Name | GSK Investigational Site | Name | GSK Investigational Site | Name | GSK Investigational Site | Name | GSK Investigational Site | Name | GSK Investigational Site | Name | GSK Investigational Site | Name | GSK Investigational Site | Name | GSK Investigational Site | Name | GSK investigational Site | Name | GSK Investigational Site | Name | GSK Investigational Site | Name | GSK Investigational Site | Name | GSK Investigational Site | Name | GSK Investigational Site | Name | GSK Investigational Site | Name | GSK Investigational Site | Name | GSK Investigational Site | Name | GSK Investigational Site | Name | GSK Investigational Site | Name | GSK Investigational Site | Name | GSK Investigational Site | Name | GSK Investigational Site | Name | GSK Investigational Site | Name | GSK Investigational Site | Name | GSK Investigational Site | Name | GSK Investigational Site | Name | GSK Investigational Site | Name | GSK investigational Site |
City | Phoenix | City | Chicago | City | Iowa City | City | Lexington | City | Minneapolis | City | Saint Louis | City | Omaha | City | New York | City | New York | City | Pittsburgh | City | Dallas | City | Birtinya | City | Herston | City | Woolloongabba | City | Adelaide | City | Nedlands | City | Edmonton | City | Vancouver | City | London | City | Toronto | City | Montreal | City | Sherbrooke | City | Heidelberg | City | Giessen | City | Kaiserslautern | City | Milano | City | Milano | City | Pavia | City | Palermo | City | Siena | City | Aichi | City | Aichi | City | Fukuoka | City | Hyogo | City | Kumamoto | City | Kyoto | City | Okayama | City | Tokyo | City | Tokyo | City | Seoul | City | Seoul | City | Seoul | City | Santander | City | Barcelona | City | A Coruna | City | Majadahonda | City | Barcelona | City | Córdoba | City | Madrid | City | Madrid | City | Madrid | City | Madrid | City | Sevilla |
State | Arizona | State | Illinois | State | Iowa | State | Kentucky | State | Minnesota | State | Missouri | State | Nebraska | State | New York | State | New York | State | Pennsylvania | State | Texas | State | Queensland | State | Queensland | State | Queensland | State | South Australia | State | Western Australia | State | Alberta | State | British Columbia | State | Ontario | State | Ontario | State | Quebec | State | Quebec | State | Baden-Wuerttemberg | State | Hessen | State | Rheinland-Pfalz | State | Lombardia | State | Lombardia | State | Lombardia | State | Sicilia | State | Toscana | State | Korea | State | Korea | State | Korea | State | Cantabria | State | Catalonia | State | Coruna | State | Madrid | ||||||||||||||||||||||||||||||||
Zip | 85013 | Zip | 60612 | Zip | 52242 | Zip | 40536 | Zip | 55455 | Zip | 63110 | Zip | 68198 | Zip | 10032 | Zip | 10065 | Zip | 15213 | Zip | 76502 | Zip | 4556 | Zip | 4029 | Zip | 4102 | Zip | 5000 | Zip | 6009 | Zip | T6G 2B7 | Zip | V5Z 1M9 | Zip | N6A 5A5 | Zip | M5G 2N2 | Zip | H2X 3H9 | Zip | J1J 2G2 | Zip | 69120 | Zip | 35392 | Zip | 67655 | Zip | 20122 | Zip | 20132 | Zip | 27100 | Zip | 90127 | Zip | 53100 | Zip | 466-8650 | Zip | 470-1192 | Zip | 814-0180 | Zip | 662-0918 | Zip | 861-8520 | Zip | 606-8507 | Zip | 700-8558 | Zip | 160-0017 | Zip | 193-0998 | Zip | 03722 | Zip | 110-774 | Zip | 138-736 | Zip | 39011 | Zip | 08907 | Zip | 15006 | Zip | 28222 | Zip | 08036 | Zip | 14004 | Zip | 28007 | Zip | 28034 | Zip | 28040 | Zip | 28041 | Zip | 41013 |
Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | Australia | Country | Australia | Country | Australia | Country | Australia | Country | Australia | Country | Canada | Country | Canada | Country | Canada | Country | Canada | Country | Canada | Country | Canada | Country | Germany | Country | Germany | Country | Germany | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Italy | Country | Japan | Country | Japan | Country | Japan | Country | Japan | Country | Japan | Country | Japan | Country | Japan | Country | Japan | Country | Japan | Country | Korea, Republic of | Country | Korea, Republic of | Country | Korea, Republic of | Country | Spain | Country | Spain | Country | Spain | Country | Spain | Country | Spain | Country | Spain | Country | Spain | Country | Spain | Country | Spain | Country | Spain | Country | Spain |
Conditions
Sequence: | 51750754 |
Name | Respiratory Syncytial Virus Infections |
Downcase Name | respiratory syncytial virus infections |
Id Information
Sequence: | 39823073 | Sequence: | 39823074 |
Id Source | org_study_id | Id Source | secondary_id |
Id Value | 219900 | Id Value | 2023-503951-81-00 |
Id Type | Other Identifier | ||
Id Type Description | EU CT number | ||
Countries
Sequence: | 42222259 | Sequence: | 42222260 | Sequence: | 42222261 | Sequence: | 42222262 | Sequence: | 42222263 | Sequence: | 42222264 | Sequence: | 42222265 | Sequence: | 42222266 |
Name | United States | Name | Australia | Name | Canada | Name | Germany | Name | Italy | Name | Japan | Name | Korea, Republic of | Name | Spain |
Removed | False | Removed | False | Removed | False | Removed | False | Removed | False | Removed | False | Removed | False | Removed | False |
Design Groups
Sequence: | 55172032 | Sequence: | 55172033 | Sequence: | 55172034 |
Group Type | Experimental | Group Type | Experimental | Group Type | Active Comparator |
Title | RSV_IC_1 group | Title | RSV_IC_2 group | Title | RSV_HA group |
Description | Immunocompromised (IC) patients receiving 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1). | Description | Immunocompromised (IC) patients receiving 2 doses of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1) and Visit 3 (Visit 1 + 30-60 days). | Description | Healthy participants receiving 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1). |
Interventions
Sequence: | 52072421 |
Intervention Type | Biological |
Name | RSVPreF3 OA Investigational Vaccine |
Description | The investigational vaccine will be administered intramuscularly as 1 dose to RSV_IC_1 and RSV_HA groups, and 2 doses to RSV_IC_2 group). |
Keywords
Sequence: | 79178900 | Sequence: | 79178901 | Sequence: | 79178902 | Sequence: | 79178903 |
Name | Respiratory syncytial virus | Name | Vaccine | Name | Immunogenicity | Name | Safety |
Downcase Name | respiratory syncytial virus | Downcase Name | vaccine | Downcase Name | immunogenicity | Downcase Name | safety |
Design Outcomes
Sequence: | 176020149 | Sequence: | 176020150 | Sequence: | 176020151 | Sequence: | 176020152 | Sequence: | 176020153 | Sequence: | 176020154 | Sequence: | 176020155 | Sequence: | 176020156 | Sequence: | 176020157 | Sequence: | 176020158 | Sequence: | 176020159 | Sequence: | 176020160 |
Outcome Type | primary | Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | RSV-A serum neutralizing titers expressed as mean geometric increase (MGI) post Dose 2 over post-Dose 1 | Measure | RSV-B serum neutralizing titers expressed as MGI post-Dose 2 over post-Dose 1 | Measure | RSV-A serum neutralizing titers expressed as geometric mean titers (GMT) | Measure | RSV-B serum neutralizing titers expressed as geometric mean titers (GMT) | Measure | Cell Mediated Immunity (CMI) response in a subset of participants | Measure | Percentage of participants with solicited administration site events | Measure | Percentage of participants with solicited administration site events and solicited systemic events | Measure | Percentage of participants with unsolicited adverse events (AEs) | Measure | Percentage of participants with serious adverse events (SAEs) | Measure | Percentage of participants with any serious adverse events (SAEs), SAEs related to study intervention and fatal SAEs | Measure | Percentage of participants with any potential immune-mediated disease (pIMDs) and pIMDs related to study intervention | Measure | Percentage of participants with any AESIs |
Time Frame | At Visit 4 (Visit 3 + 30-42 days) versus Visit 3 (Day 30-60) | Time Frame | At Visit 4 (Visit 3 + 30-42 days) versus Visit 3 (Day 30-60) | Time Frame | At Day 1 (dose 1), at Visit 2 (7-14 days post-dose 1), Visit 3 (30-60 days post dose-1, dose 2 for the RSV_IC_2 group), Visit 4 (Visit 3+30-42 days), Visit 5 (180-210 days post last-dose) and at Visit 6 (350-380 days post last dose) | Time Frame | At Day 1 (dose 1), at Visit 2 (7-14 days post-dose 1), Visit 3 (30-60 days post dose-1, dose 2 for the RSV_IC_2 group), Visit 4 (Visit 3+30-42 days), Visit 5 (180-210 days post last-dose) and at Visit 6 (350-380 days post last dose) | Time Frame | At Day 1 (dose 1), at Visit 2 (7-14 days post-dose 1), Visit 3 (30-60 days post dose-1, dose 2 for the RSV_IC_2 group), Visit 4 (Visit 3+30-42 days), Visit 5 (180-210 days post last-dose) and at Visit 6 (350-380 days post last dose) | Time Frame | Within 7 days post-study intervention administration (i.e., the day of vaccination and 6 subsequent days, vaccine administered on Day 1 for all groups and Day 30-60 for RSV_IC_2) | Time Frame | Within 7 days post-study intervention administration (i.e., the day of vaccination and 6 subsequent days, vaccine administered on Day 1 for all groups and Day 30-60 for RSV_IC_2) | Time Frame | Within 30 days post-study intervention administration (i.e., the day of vaccination and 29 subsequent days, vaccine administered on Day 1 for all groups and Day 30-60 for RSV_IC_2) | Time Frame | From Day 1 up to study end (Day 350-380 post last dose, vaccine administered on Day 1 for all groups and Day 30-60 for RSV_IC_2) | Time Frame | From Day 1 up to study end (Day 350-380 post last dose, vaccine administered on Day 1 for all groups and Day 30-60 for RSV_IC_2) | Time Frame | From Day 1 up to study end (Day 350-380 post last dose, vaccine administered on Day 1 for all groups and Day 30-60 for RSV_IC_2) | Time Frame | From Day 1 up to study end (Day 350-380 post last dose, vaccine administered on Day 1 for all groups and Day 30-60 for RSV_IC_2) |
Description | The analysis is performed on the renal and lung SOT patients in the 2-dose group. | Description | The analysis is performed on the renal and lung SOT patients in the 2-dose group. | Description | RSV-A serum neutralizing titers expressed as group GMT ratio RSV_HA group over RSV_IC group (pooled RSV_IC_1 and RSV_IC_2 groups) is assessed at Visit 2 (in a subset of participants) and Visit 3, and RSV_IC_2 over RSV_IC_1, RSV_HA over RSV_IC_1, and RSV_HA over RSV_IC_2) at Visit 4, Visit 5 and Visit 6. | Description | RSV-B serum neutralizing titers expressed as group GMT ratio RSV_HA group over RSV_IC group (pooled RSV_IC_1 and RSV_IC_2 groups) is assessed at Visit 2 (in a subset of participants) and Visit 3, and RSV_IC_2 over RSV_IC_1, RSV_HA over RSV_IC_1, and RSV_HA over RSV_IC_2) at Visit 4, Visit 5 and Visit 6. | Description | CMI response is expressed as group geometric mean of the frequency of RSVPreF3-specific CD4+ and/or CD8+ T cells expressing at least 2 activation markers including at least one cytokine among CD40L, 4-1BB, IL-2, TNF-α, IFN-γ, IL- 13 and IL-17. The CMI is measured in a subgroup consisting of participants with renal and lung SOT (from 1-dose group and 2-dose group) and healthy participants. | Description | Assessed solicited administration site events included pain, redness and swelling, at the injection site. | Description | Assessed solicited systemic events included fever, myalgia, arthralgia, headache, and fatigue. | Description | An unsolicited AE is an AE that was not included in the list of solicited events. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms is to be reported as an unsolicited AE. | Description | A SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study participant. | Description | A SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study participant. | Description | Potential immune-mediated diseases (pIMDs) are a subset of AEs of special interest (AESIs) that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology. | Description | AESIs are AEs of special interest. Along with pIMDs, they include also the acute rejection (specific to renal and lung SOT patients) and Atrial fibrillation (AF). |
Browse Conditions
Sequence: | 191792689 | Sequence: | 191792690 | Sequence: | 191792691 | Sequence: | 191792692 | Sequence: | 191792693 | Sequence: | 191792694 | Sequence: | 191792695 |
Mesh Term | Respiratory Syncytial Virus Infections | Mesh Term | Virus Diseases | Mesh Term | Infections | Mesh Term | Pneumovirus Infections | Mesh Term | Paramyxoviridae Infections | Mesh Term | Mononegavirales Infections | Mesh Term | RNA Virus Infections |
Downcase Mesh Term | respiratory syncytial virus infections | Downcase Mesh Term | virus diseases | Downcase Mesh Term | infections | Downcase Mesh Term | pneumovirus infections | Downcase Mesh Term | paramyxoviridae infections | Downcase Mesh Term | mononegavirales infections | Downcase Mesh Term | rna virus infections |
Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
Sequence: | 47928674 |
Agency Class | INDUSTRY |
Lead Or Collaborator | lead |
Name | GlaxoSmithKline |
Central Contacts
Sequence: | 11924074 | Sequence: | 11924075 |
Contact Type | primary | Contact Type | backup |
Name | US GSK Clinical Trials Call Center | Name | EU GSK Clinical Trials Call Center |
Phone | 877-379-3718 | Phone | +44 (0) 20 89904466 |
GSKClinicalSupportHD@gsk.com | GSKClinicalSupportHD@gsk.com | ||
Role | Contact | Role | Contact |
Design Group Interventions
Sequence: | 67639068 | Sequence: | 67639069 | Sequence: | 67639070 |
Design Group Id | 55172034 | Design Group Id | 55172032 | Design Group Id | 55172033 |
Intervention Id | 52072421 | Intervention Id | 52072421 | Intervention Id | 52072421 |
Eligibilities
Sequence: | 30519918 |
Gender | All |
Minimum Age | 50 Years |
Maximum Age | N/A |
Healthy Volunteers | Accepts Healthy Volunteers |
Criteria | Inclusion Criteria: Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol Participants living in the general community or in an assisted-living facility that provides minimal assistance can be enrolled, such that the participant is primarily responsible for self-care and activities of daily living. Written or witnessed informed consent obtained from the participant prior to performance of any study-specific procedure. A male or female, ≥50 YoA at the time of signing the Informed consent form (ICF). Female participants of nonchildbearing potential may be enrolled in the study. Non-childbearing potential is defined as hysterectomy, bilateral oophorectomy, bilateral salpingectomy, and post-menopause. Female participants of childbearing potential may be enrolled in the study if the participant has practiced adequate contraception from 1 month prior to study intervention administration and agreed to continue adequate contraception until study end for this study, and has a negative pregnancy test on the day of and prior to study intervention administration. Specific inclusion criteria for renal/lung transplant patients: Participant who has received an ABO compatible allogeneic renal or lung transplant (allograft) more than 12 months (365 days) prior to the first study intervention administration. Participant receiving maintenance immunosuppressive therapy for the prevention of allograft rejection. Specific inclusion criteria for renal transplant (RTx) patients: • Participant with stable renal function, stability defined as less than 20% variability between last two results of eGFR or in the opinion of the investigator after investigator review of more than the last two results of eGFRs and based on medical history. Specific inclusion criteria for lung transplant (LTx) patients: • Participant with stable lung function, with stability defined as the stability in the FEV1 compared to post-transplant baseline FEV1 and based on medical history of the last 3 months, in the opinion of the investigator. Specific inclusion criteria for healthy participants: Healthy participants as established by medical history and clinical examination before entering the study. Participants who are medically stable in the opinion of the investigator at the time of first study intervention administration. Participants with chronic stable medical conditions with or without specific treatment, such as diabetes mellitus, hypertension, or cardiac disease, are allowed to participate in this study if considered by the investigator as medically stable. Exclusion Criteria: Medical conditions: History of any reaction/ hypersensitivity likely to be exacerbated by any component of the study intervention. Acute or chronic clinically significant cardiovascular or hepatic functional abnormality as determined by physical examination or laboratory screening tests. Recurrent/uncontrolled neurological disorders or seizures. Participants with medically controlled chronic neurological diseases can be enrolled in the study if their condition will allow them to comply with the requirements of the protocol, with the help of a caregiver if needed. Any history of dementia or any medical condition that moderately or severely impairs cognition. Significant underlying illness that would prevent completion of the study). Acute disease and/or fever at the time of study intervention administration (≥ 38°C /100.4°F, oral or axillary). However, participants with a minor illness without fever may be enrolled at the discretion of the investigator. Bedridden participants. Prior/Concomitant therapy: Use of any other investigational or non-registered product (drug, vaccine, or medical device) up to 30 days before the first dose administration (Day -30 to Day 1), or their planned use during the study period (up to Visit 6). Previous vaccination with the study antigen (RSV), including investigational RSV vaccines. Unexpected vaccine administration during a study should not occur 30 days prior to the first dose or 30 days after the last dose. For COVID-19 and inactivated/subunit/split influenza vaccines, this window is shortened to 14 days. Prior/Concurrent clinical study experience: • Concurrently participating in another active clinical study Other exclusion criteria: Pregnant or lactating female participant. Female participant planning to become pregnant or planning to discontinue contraceptive precautions. History of chronic alcohol consumption and/or drug abuse Participation of any study personnel or their immediate dependents. Planned move during the study period that will prohibit participating in the study until study end. Specific exclusion criteria for renal/lung transplant patients: More than one organ transplanted. Dual organ is allowed (double kidney or double lung). History of events that may put the participant at increased risk for chronic allograft dysfunction. Participant with an episode of allograft rejection over the previous 90 days prior to the first study intervention administration. Histologic evidence of chronic allograft injury. Active treatment for acute rejection. Current diagnosis of malignancy (except non-melanoma skin cancer that does not require systemic therapy). Any autoimmune conditions or pIMDs that may put the participant at increased risk. Any confirmed or suspected HIV infection, primary immunodeficiency disease or ongoing CMV infection with a viremia > 200 IU/mL. Use of anti-CD20 or other B-cell monoclonal antibody agents for the prevention of allograft rejection within 274 days of first dose of study. Use of investigational and non-registered immunosuppressants at the local/country level, unless specifically prescribed for the prevention of allograft rejection, and which are in process of approval, approved in other countries and locally available. Evidence/high suspicion of noncompliance/nonadherence to use of induction and/or maintenance immunosuppressive therapies. Any clinically significant hematologic and/or biochemical laboratory abnormality. Specific exclusion criteria for renal transplant (RTx) patients: Previous allograft loss secondary to recurrent primary kidney disease. Multiple consecutive kidney transplants are allowed if the reason is not recurrent primary kidney disease. Evidence of significant proteinuria/albuminuria. Specific exclusion criteria for lung transplant (LTx) patients: At study intervention administration visit, diagnosis of documented acute pulmonary infection within the 2 prior weeks. Patients with diagnosis of chronic lung allograft dysfunction (decrement of 20% or more in FEV1 compared to post-transplant baseline FEV1). Specific exclusion criteria for healthy participants: Any confirmed/suspected immunosuppressive/immunodeficient condition resulting from disease or immunosuppressive/cytotoxic therapy, based on medical history and physical examination. Unstable serious chronic illness. Chronic administration of immune-modifying drugs (>14 days in total) and/or administration of long-acting immune-modifying treatments or planned administration at any time up to the end of the study. Up to 3 months prior to the study intervention administration: For corticosteroids -prednisone equivalent ≥20 mg/day, or equivalent. Inhaled, topical and intra-articular steroids are allowed. Administration of immunoglobulins and/or any blood products or plasma derivatives. Up to 6 months prior to study intervention administration: long-acting immune-modifying drugs. |
Adult | True |
Child | False |
Older Adult | True |
Calculated Values
Sequence: | 254077522 |
Number Of Facilities | 53 |
Registered In Calendar Year | 2023 |
Were Results Reported | False |
Has Us Facility | True |
Has Single Facility | False |
Minimum Age Num | 50 |
Minimum Age Unit | Years |
Number Of Primary Outcomes To Measure | 2 |
Number Of Secondary Outcomes To Measure | 10 |
Designs
Sequence: | 30268937 |
Allocation | Randomized |
Intervention Model | Parallel Assignment |
Observational Model | |
Primary Purpose | Prevention |
Time Perspective | |
Masking | None (Open Label) |
Masking Description | This study is an open label study. Potential bias will be reduced by central randomization. |
Responsible Parties
Sequence: | 28649089 |
Responsible Party Type | Sponsor |
Ipd Information Types
Sequence: | 3310748 | Sequence: | 3310749 | Sequence: | 3310750 | Sequence: | 3310751 |
Name | Study Protocol | Name | Statistical Analysis Plan (SAP) | Name | Informed Consent Form (ICF) | Name | Clinical Study Report (CSR) |