chufangao/CTO huggingface dataset:
Clinical trial NCT04431453: Study of Remdesivir in Participants Below 18 Years Old With COVID-19
Official title: A Phase 2/3 Single-Arm, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of Remdesivir (GS-5734™) in Participants From Birth to < 18 Years of Age With COVID-19
Acronym: CARAVAN
Sponsor: Gilead Sciences (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: COMPLETED 
Enrollment: 59.0 (ACTUAL)
Number of arms: 8.0
Start date: 2020-07-21
Primary completion date: 2023-02-10
Completion date: 2023-02-10
Baseline population: The Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.
Plan to share individual participant data: YES
IPD sharing description: Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gileadclinicaltrials.com/transparency-policy#Commitment
IPD time frame: 18 months after study completion
IPD access criteria: A secured external environment with username, password, and RSA code.
Clinical trial NCT03855865: Study of Rapastinel as Monotherapy in Major Depressive Disorder (MDD)
Official title: A Randomized, Double-blind, Placebo- and Active- Controlled, Multicenter Study of Rapastinel as Monotherapy in Major Depressive Disorder
Sponsor: Naurex, Inc, an affiliate of Allergan plc (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: WITHDRAWN 
Why stopped: Business decision to stop the program.
Enrollment: 0.0 (ACTUAL)
Number of arms: 3.0
Start date: 2019-07-01
Primary completion date: 2020-12-31
Completion date: 2020-12-31
Plan to share individual participant data: YES
IPD sharing description: Allergan will share de-identified patient-level data and study-level data including protocols and clinical study reports for phase 2 - 4 trials completed after 2008 that are registered to ClinicalTrials.gov or EudraCT, have received regulatory approval in the United States and/or the European Union in a given indication and the primary manuscript from the trial has been published. To request access to the data, the researcher must sign a data use agreement and any shared data is to be used for non-commercial purposes. More information can be found on http://www.allerganclinicaltrials.com/.
IPD time frame: After having received regulatory approval in the United States and/or the European Union in a given indication and the primary manuscript from the trial has been published.
IPD access criteria: To request access to the data, the researcher must sign a data use agreement and any shared data is to be used for non-commercial purposes.
Clinical trial NCT04285268: Rituximab, Venetoclax, and Bortezomib for the Treatment of Relapsed or Refractory Diffuse Large B-Cell Lymphoma
Official title: A Phase 2 Study of Rituximab, Venetoclax (ABT 199) and Bortezomib in Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL)
Sponsor: Rutgers, The State University of New Jersey (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: funding available
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-05-06
Primary completion date: 2024-09-30
Completion date: 2024-09-30
Clinical trial NCT03680560: Study of ACTR T Cell Product in Combination With Trastuzumab in Subjects With HER2-Positive Advanced Solid Tumor Cancers
Official title: A Phase 1 Study of an Autologous ACTR T Cell Product in Combination With Trastuzumab, a Monoclonal Antibody, in Subjects With HER2-Positive Advanced Malignancies
Sponsor: Cogent Biosciences, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Business Reasons
Enrollment: 6.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-03-13
Primary completion date: 2020-03-12
Completion date: 2020-03-12
Clinical trial NCT03669133: Vitamin E for NASH Treatment in HIV Infected Individuals
Official title: Vitamin E for NASH Treatment in HIV Infected Individuals
Sponsor: Indiana University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: lack of coordinator resources and lack of access to study resources during and due to the COVID pandemic
Enrollment: 3.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-10-01
Primary completion date: 2021-03-08
Completion date: 2021-03-08
Baseline population: Three people consented to enroll in this study; one participant screen failed and two completed the study
Plan to share individual participant data: NO
Clinical trial NCT03401749: Preadmission Skin Wipe Use for Surgical Site Infection Prophylaxis in Adult Orthopaedic Surgery Patients
Official title: Efficacy of Preadmission Theraworx Wipe Use for Surgical Site Infection Prophylaxis in Adult Orthopaedic Surgery Patients: A Randomized Controlled Trial
Sponsor: University of Alabama at Birmingham (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Funding issues, poor recruiting and compliance of the patients.
Enrollment: 203.0 (ACTUAL)
Number of arms: 3.0
Start date: 2018-11-01
Primary completion date: 2020-12-01
Completion date: 2020-12-01
Plan to share individual participant data: NO
Clinical trial NCT03599362: Study of Nivolumab, Cabiralizumab, and Stereotactic Body Radiotherapy (SBRT) for Locally Advanced Unresectable Pancreatic Cancer
Official title: Nivolumab, Cabiralizumab, and Stereotactic Body Radiotherapy (SBRT) for Locally Advanced Unresectable Pancreatic Cancer
Sponsor: NYU Langone Health (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: PI departure from institution
Enrollment: 7.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-07-31
Primary completion date: 2020-06-15
Completion date: 2020-06-15
Clinical trial NCT00549848: Total Therapy Study XVI for Newly Diagnosed Patients With Acute Lymphoblastic Leukemia
Official title: Total Therapy Study XVI for Newly Diagnosed Patients With Acute Lymphoblastic Leukemia
Sponsor: St. Jude Children's Research Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 600.0 (ACTUAL)
Number of arms: 2.0
Start date: 2007-10-29
Primary completion date: 2020-09-26
Completion date: 2022-03-26
Clinical trial NCT04386239: Study on the Use of Sarilumab in Patients With COVID-19 Infection
Official title: Pilot Study on the Use of Sarilumab in Patients With COVID-19 Infection
Sponsor: ASST Fatebenefratelli Sacco (OTHER)
Study type: INTERVENTIONAL
Phase: EARLY_PHASE1
Status: WITHDRAWN 
Why stopped: Technical impasse from IRB
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-01-01
Primary completion date: 2023-01-01
Completion date: 2023-01-01
Plan to share individual participant data: NO
Clinical trial NCT01496118: Study of the Combination of Panobinostat and Carfilzomib in Patients With Relapsed/Refractory Multiple Myeloma
Official title: Phase I/II Study of the Combination of Panobinostat and Carfilzomib in Patients With Relapsed/Refractory Multiple Myeloma
Sponsor: SCRI Development Innovations, LLC (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: COMPLETED 
Enrollment: 80.0 (ACTUAL)
Number of arms: 1.0
Start date: 2011-12-31
Primary completion date: 2020-12-31
Completion date: 2020-12-31
Baseline population: Participants with a Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 are included in this study. Performance status (PS) measures how well patients are able to perform their daily activities and care for themselves and has a scale of 0-5, where PS 0 being normal activity and PS 5 being dead.
Clinical trial NCT05996744: Study of Obeldesivir in Children and Adolescents With COVID-19
Official title: A Phase 2/3 Single-Arm, Open-label Study to Evaluate the Safety, Pharmacokinetics and Efficacy of Obeldesivir in Pediatric Participants With COVID-19
Sponsor: Gilead Sciences (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: TERMINATED 
Why stopped: Study was terminated by Sponsor and the decision was not due to any safety or efficacy reasons.
Enrollment: 3.0 (ACTUAL)
Number of arms: 1.0
Start date: 2023-12-26
Primary completion date: 2024-02-23
Completion date: 2024-02-23
Plan to share individual participant data: NO
Clinical trial NCT03167619: Phase II Multicenter Study of Durvalumab and Olaparib in Platinum tReated Advanced Triple Negative Breast Cancer (DORA)
Official title: Phase II Multicenter Study of Durvalumab and Olaparib in Platinum tReated Advanced Triple Negative Breast Cancer
Acronym: DORA
Sponsor: Duke University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 45.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-10-04
Primary completion date: 2021-06-30
Completion date: 2022-06-30
Plan to share individual participant data: NO
Clinical trial NCT05004077: Repeated Amiodarone Dosing In Cardiac surgicaL Procedures
Official title: Repeated Amiodarone Dosing In Cardiac surgicaL Procedures
Acronym: RADICAL
Sponsor: University of Kentucky (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: limited enrollment
Enrollment: 3.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-11-02
Primary completion date: 2022-10-10
Completion date: 2022-10-10
Plan to share individual participant data: NO
Clinical trial NCT04358549: Study of the Use of Favipiravir in Hospitalized Subjects With COVID-19
Official title: Open Label, Randomized, Controlled Phase 2 Proof-of-Concept Study of the Use of Favipiravir Compared to Standard of Care in Hospitalized Subjects With COVID-19
Sponsor: Fujifilm Pharmaceuticals U.S.A., Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 50.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-04-17
Primary completion date: 2020-09-30
Completion date: 2020-10-30
Baseline population: Intent-to-Treat (ITT) population
Plan to share individual participant data: NO
Clinical trial NCT03618134: Stereotactic Body Radiation Therapy and Durvalumab With or Without Tremelimumab Before Surgery in Treating Participants With Human Papillomavirus Positive Oropharyngeal Squamous Cell Caner
Official title: Phase Ib/II Trial of Stereotactic Body Radiotherapy (SBRT) in Cominbation With Immunotherapy Prior to Transoral Robotic Surgery (TORS) for Human Papillomavirus Positive (HPV+) Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Sponsor: Jonsson Comprehensive Cancer Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: slow accrual
Enrollment: 19.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-10-04
Primary completion date: 2023-06-30
Completion date: 2023-06-30
Clinical trial NCT03641703: A Long-Term Follow-Up Study of Haemophilia B Patients Who Have Undergone Gene Therapy
Official title: An Open-Label, Multicentre, Long-Term Follow-Up Study to Investigate the Safety and Durability of Response Following Dosing of a Novel Adeno-Associated Viral Vector (FLT180a) in Patients With Haemophilia B
Sponsor: Freeline Therapeutics (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Freeline has decided to pause development of FLT180a for business priorities
Enrollment: 10.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-07-10
Primary completion date: 2023-05-24
Completion date: 2023-05-24
Plan to share individual participant data: NO
Clinical trial NCT03333551: Cardiac Uptake of 18F Florbetapir in Patients Undergoing Chemotherapy
Official title: A Pilot Study to Evaluate 18F Florbetapir Binding to Cardiac Amyloid in Patients Undergoing Chemotherapy
Sponsor: Medical College of Wisconsin (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: slow recruitment.
Enrollment: 3.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-10-01
Primary completion date: 2023-05-08
Completion date: 2023-05-08
Plan to share individual participant data: UNDECIDED
Clinical trial NCT05532163: A Study to Investigate the Radiological Onset of Action After Treatment Initiation With Subcutaneous (SC) Natalizumab in Participants With Relapsing-Remitting Multiple Sclerosis (RRMS)
Official title: A Prospective, Multicenter, Interventional, Open-Label, Single-arm Phase IV Study Over 24 Weeks to Investigate the Radiological Onset of Action After Treatment Initiation With Subcutaneous Natalizumab in Patients With Relapsing-Remitting Multiple Sclerosis (TYS-ON)
Sponsor: Biogen (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Sponsor's decision
Enrollment: 1.0 (ACTUAL)
Number of arms: 1.0
Start date: 2023-01-23
Primary completion date: 2023-10-09
Completion date: 2023-10-09
Plan to share individual participant data: YES
IPD sharing description: In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/
Clinical trial NCT04840667: A Study of Replagal in Treatment-naïve Adults With Fabry Disease
Official title: A Phase 3, Open-label Study to Evaluate the Efficacy and Safety of REPLAGAL® in Treatment-naïve Subjects With Fabry Disease
Sponsor: Takeda (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Study closed due to enrolment challenges, not for any safety issues
Enrollment: 17.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-12-28
Primary completion date: 2022-12-16
Completion date: 2022-12-16
Baseline population: A total of 17 participants were screened and signed informed consent but none of the participants received any treatment due to screen failures. The study was terminated by the sponsor due to enrolment challenges and no participants were treated, therefore no data were evaluated and collected to be reported in this study.
Limitations and caveats: The study was terminated by the Sponsor due to enrolment challenges. No participants were evaluated, and no data were collected to be reported in this study.
Plan to share individual participant data: NO
IPD sharing description: The study was terminated by the Sponsor due to enrolment challenges. No participants were evaluated, and no data were collected.
Clinical trial NCT04359329: Estrogen Patch for COVID-19 Symptoms
Official title: Phase II Clinical Trial of Estradiol to Reduce Severity of COVID19 Infection in COVID19+ and Presumptive COVID19+ Patients
Sponsor: Stony Brook University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Poor accrual
Enrollment: 2.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-04-20
Primary completion date: 2020-07-30
Completion date: 2020-07-30
Plan to share individual participant data: NO
Clinical trial NCT01554410: Intensity Modulated Radiation Therapy With Cisplatin and Gemcitabine to Treat Locally Advanced Cervical Carcinoma
Official title: A Phase I Trial of Intensity Modulated Radiation Therapy With Concurrent Cisplatin and Escalating Gemcitabine for Locally Advanced Cervical Carcinoma
Sponsor: University of California, San Diego (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 35.0 (ACTUAL)
Number of arms: 1.0
Start date: 2010-08-31
Primary completion date: 2019-07-16
Completion date: 2020-08-01
Clinical trial NCT05392959: Effect of the Antidiabetic Drug Dapagliflozin on the Coronary Macrovascular and Microvascular Function in Type 2 Diabetic Patients
Official title: Effect of the Antidiabetic Drug DAPAgliflozin on the Coronary Macrovascular and MICROvascular Function in Type 2 Diabetic Patients
Acronym: DAPAMICRO
Sponsor: Centre Hospitalier Universitaire Saint Pierre (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: recruitment too slow
Enrollment: 4.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-06-06
Primary completion date: 2023-07-17
Completion date: 2023-07-17
Plan to share individual participant data: NO
Clinical trial NCT03946462: Nitric Oxide During CPB to Reduce AKI in Neonates
Official title: A Prospective Randomized Controlled Trial of Supplemental Nitric Oxide During Cardiopulmonary Bypass to Reduce Acute Kidney Injury After Cardiac Surgery
Sponsor: Baylor College of Medicine (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: This study could not be started because of some technical issues.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-10-31
Primary completion date: 2022-10-31
Completion date: 2023-03-31
Plan to share individual participant data: NO
Clinical trial NCT05761041: Silver Diamine Fluoride Versus Sodium Fluoride Varnish With Parental Behavior Modification in Arresting Early Childhood Caries
Official title: Effectiveness of Silver Diamine Fluoride Versus Sodium Fluoride Varnish With Parental Behavior Modification for Arresting Early Childhood Caries: A Randomized Clinical Trial
Sponsor: Alexandria University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 140.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-03-28
Primary completion date: 2023-03-30
Completion date: 2023-04-15
Plan to share individual participant data: NO
Clinical trial NCT04246554: Ketorolac as an Adjuvant Agent for Postoperative Pain Control Following Arthroscopic ACL Surgery
Official title: Ketorolac as an Adjuvant Agent for Postoperative Pain Control Following Arthroscopic ACL Surgery
Sponsor: University Hospitals Cleveland Medical Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 49.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-05-21
Primary completion date: 2020-10-09
Completion date: 2021-01-01
Limitations and caveats: This is a single-institution study involving only five surgeons, so patient demographics and outcomes may not reflect a broader population. Neither surgeons nor patients were blinded with regards to medication use. Therefore, subjective pain scores may have been influenced by perceptions of greater pain control in patients who received ketorolac in addition to oxycodone-acetaminophen. The study may be underpowered with regards to functional outcome scores and medication side effects profiles.
Clinical trial NCT02248701: Testosterone Plus Finasteride Treatment After Spinal Cord Injury
Official title: Higher-Than-Replacement Testosterone Plus Finasteride Treatment After SCI
Sponsor: VA Office of Research and Development (FED)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Enrollment difficulties
Enrollment: 33.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-04-27
Primary completion date: 2021-08-13
Completion date: 2021-08-13
Limitations and caveats: This trial was terminated early due to enrollment and retention difficulties that persisted during the severe acute respiratory syndrome (SARS)-Cov19 pandemic. This resulted in a smaller number of subjects being enrolled and undergoing testing than was originally planned in our a priori analysis.
Plan to share individual participant data: YES
IPD sharing description: Data will be shared according to the requirements described by the Department of Veterans Affairs, Office of Research \& Development.
IPD time frame: Data will be shared according to the requirements described by the Department of Veterans Affairs, Office of Research \& Development.
IPD access criteria: Data will be shared according to the requirements described by the Department of Veterans Affairs, Office of Research \& Development.
Clinical trial NCT04134143: Multiple Applications of ExpressGraft-C9T1 Skin Tissue as a Treatment for Diabetic Foot Ulcers
Official title: An Open-Label, Prospective, Safety, and Tolerability Study of ExpressGraft- C9T1 Skin Tissue in the Treatment of Diabetic Foot Ulcers
Sponsor: Mallinckrodt (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Business decision - not related to product quality or safety concerns
Enrollment: 6.0 (ACTUAL)
Number of arms: 3.0
Start date: 2019-11-07
Primary completion date: 2020-11-25
Completion date: 2020-12-30
Plan to share individual participant data: NO
Clinical trial NCT03602495: A Phase 3 Study of Donafenib in Patients With Radioiodine-refractory Differentiated Thyroid Cancer
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 3 Study of Donafenib in Patients With Radioiodine-Refractory Differentiated Thyroid Cancer
Acronym: DTC
Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Based on IDMC's recommendations during the interim analysisthe trial has reached the goal of early termination of the trial. the sponsor communicating with CDE, CDE agreed to unblind the trial and submit a NDA.
Enrollment: 204.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-08-29
Primary completion date: 2021-02-28
Completion date: 2021-07-15
Clinical trial NCT03329508: A Phase 3 Study With P2B001 in Subjects With Early Parkinson's
Official title: A Phase 3, Twelve-week Study to Determine the Efficacy, Safety and Tolerability of P2B001 Once Daily Compared to Its Individual Components in Subjects With Early Parkinson's Disease and to a Calibration Arm of Pramipexole ER.
Sponsor: Pharma Two B Ltd. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 544.0 (ACTUAL)
Number of arms: 4.0
Start date: 2018-01-19
Primary completion date: 2021-08-23
Completion date: 2021-10-31
Baseline population: The dispensing of the investigational product was based on a just-in-time shipping strategy per subject. Randomization was done at the end of the Screening period and before the Baseline Visit to allow for shipping of the kit to the site. Twenty-five (25) subjects were enrolled and randomized into treatment groups, but withdrew from study prior to first dose. They did not came to baseline visit , receive study drug nor did they receive a post-randomization evaluation.
Clinical trial NCT03040024: Delirium Prevention With Ketamine in Ear, Nose, and Throat (ENT) Patients
Official title: A Randomized Placebo-controlled Pilot Study of Single-dose Intraoperative Ketamine for the Prevention of Delirium in Otolaryngeal Cancer Surgery Patients
Sponsor: Emory University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Halted due to COVID 19; we believe we have adequate data for analysis
Enrollment: 71.0 (ACTUAL)
Number of arms: 3.0
Start date: 2017-03-17
Primary completion date: 2020-02-24
Completion date: 2020-04-24
Plan to share individual participant data: NO
Clinical trial NCT05047770: A Study on the Immune Response and Safety of the Shingles Vaccine and the Influenza Vaccine When Either is Given to Healthy Adults at the Same Time or Following a COVID-19 Booster Vaccine
Official title: A Phase III, Randomized, Open-label, Controlled, Multicenter Study to Evaluate the Immune Response and Safety of Both Herpes Zoster Subunit Vaccine in Healthy Adults Aged 50 Years and Older AND the Influenza Virus Vaccine in Healthy Adults Aged 18 Years and Older When Administered Sequentially or Coadministered With mRNA-1273 Booster Vaccination
Sponsor: GlaxoSmithKline (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 2013.0 (ACTUAL)
Number of arms: 4.0
Start date: 2021-10-07
Primary completion date: 2022-08-29
Completion date: 2022-08-31
Plan to share individual participant data: YES
IPD sharing description: Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/
IPD time frame: Anonymized IPD is made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
IPD access criteria: Anonymized IPD is shared with researchers whose proposals are approved by an 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 may be granted, when justified, for up to 6 months.