chufangao/CTO huggingface dataset:
Clinical trial NCT04031729: Aspirin for the Treatment of Nonalcoholic Fatty Liver Disease
Official title: Aspirin in Adults With Nonalcoholic Fatty Liver Disease
Sponsor: Massachusetts General Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: COMPLETED 
Enrollment: 80.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-09-12
Primary completion date: 2023-02-23
Completion date: 2023-02-23
Plan to share individual participant data: NO
Clinical trial NCT02311920: Ipilimumab and/or Nivolumab in Combination With Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma or Gliosarcoma
Official title: Phase I Study of Ipilimumab, Nivolumab, and the Combination in Patients With Newly Diagnosed Glioblastoma
Sponsor: National Cancer Institute (NCI) (NIH)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 32.0 (ACTUAL)
Number of arms: 3.0
Start date: 2015-04-16
Primary completion date: 2017-12-31
Completion date: 2022-12-22
Clinical trial NCT03655236: PROSEEK: A Phase 2 Study In Early Parkinson's Disease Patients Evaluating The Safety And Efficacy Of Abl Tyrosine Kinase Inhibition Using K0706
Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of K0706 in Subjects With Early Parkinson's Disease
Sponsor: Sun Pharma Advanced Research Company Limited (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Terminated based on study outcomes
Enrollment: 513.0 (ACTUAL)
Number of arms: 3.0
Start date: 2019-02-18
Primary completion date: 2024-04-08
Completion date: 2024-06-06
Plan to share individual participant data: NO
Clinical trial NCT01700946: Therapy for Pediatric Relapsed or Refractory Precursor B-Cell Acute Lymphoblastic Leukemia and Lymphoma
Official title: A Phase II Study of Therapy for Pediatric Relapsed or Refractory Precursor B-Cell Acute Lymphoblastic Leukemia and Lymphoma
Sponsor: St. Jude Children's Research Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 80.0 (ACTUAL)
Number of arms: 2.0
Start date: 2013-04-15
Primary completion date: 2021-07-24
Completion date: 2021-07-24
Baseline population: All participants enrolled on study.
Clinical trial NCT03095118: Daratumumab in Treatment of PGNMID and C3 GN
Official title: Single-center Phase 2 Open-label Trial Evaluating Efficacy and Safety of Daratumumab in Treatment of Patients With Proliferative Glomerulonephritis With Monoclonal Immune Deposits and C3 Glomerulopathy Associated With Monoclonal Gammopathy
Sponsor: Mayo Clinic (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 12.0 (ACTUAL)
Number of arms: 1.0
Start date: 2017-09-07
Primary completion date: 2019-10-14
Completion date: 2020-05-12
Clinical trial NCT03760614: A Study of Entinostat and FOLFOX in Subjects With Pancreatic Adenocarcinoma
Official title: A Phase Ib Study of Entinostat and FOLFOX in Subjects With Pancreatic Adenocarcinoma
Sponsor: Abramson Cancer Center at Penn Medicine (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: Lack of Funding
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-01-31
Primary completion date: 2022-07-31
Completion date: 2022-11-30
Plan to share individual participant data: UNDECIDED
Clinical trial NCT05445882: N-803 Alone or in Combination With BN-Brachyury Vaccine or Bintrafusp Alfa (M7824) for Participants With Castration Resistant Prostate Cancer
Official title: A Phase II Study of N-803 Alone or in Combination With BN-Brachyury Vaccine or Bintrafusp Alfa (M7824) for Participants With Castration Resistant Prostate Cancer
Sponsor: National Institutes of Health Clinical Center (CC) (NIH)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Closed by study team, no subjects enrolled.
Enrollment: 0.0 (ACTUAL)
Number of arms: 3.0
Start date: 2024-04-01
Primary completion date: 2024-04-01
Completion date: 2024-04-01
Plan to share individual participant data: YES
IPD sharing description: .All IPD recorded in the medical record will be shared with intramural investigators upon request. In addition, all large scale genomic sequencing data will be shared with subscribers to dbGaP.
IPD time frame: Clinical data available during the study and indefinitely. Genomic data are available once genomic data are uploaded per protocol GDS plan for as long as database is active.
IPD access criteria: Clinical data will be made available via subscription to BTRIS and with the permission of the study PI. Genomic data are made available via dbGaP through requests to the data custodians.
Clinical trial NCT04252248: Decitabine Treatment in HPV-Induced Anogenital and Head and Neck Cancer Patients After Radiotherapy or as Novel Late Salvage
Official title: Decitabine Treatment in HPV-Induced Anogenital and Head and Neck Cancer Patients After Radiotherapy or as Novel Late Salvage (DERANO)
Acronym: DERANO
Sponsor: University Hospital Heidelberg (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Organizational reasons
Enrollment: 3.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-10-11
Primary completion date: 2021-06-15
Completion date: 2021-06-15
Plan to share individual participant data: YES
Clinical trial NCT03456882: The Effect of RNS60 on ALS Biomarkers
Official title: The Effect of RNS60 on ALS Biomarkers
Acronym: RNS60
Sponsor: Mario Negri Institute for Pharmacological Research (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 147.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-05-30
Primary completion date: 2020-11-23
Completion date: 2021-05-30
Limitations and caveats: The study was limited by the COVID-19 outbreak that started in Italy in February 2020. The pandemic caused restrictions in terms of participant access to trial sites and limitations in the performance of respiratory function tests. This context led to missing visits and missing data.~Also, the drug administration route that required weekly visits to the participating center, with significant discomfort for disabled patients.
Plan to share individual participant data: NO
Clinical trial NCT03625141: A Study Evaluating the Safety and Efficacy of Cobimetinib Plus Atezolizumab in BRAFV600 Wild-type Melanoma With Central Nervous System Metastases and Cobimetinib Plus Atezolizumab and Vemurafenib in BRAFV600 Mutation-positive Melanoma With Central Nervous System Metastases
Official title: A Phase II Two Cohort Study Evaluating the Safety and Efficacy of Cobimetinib Plus Atezolizumab in BRAFV600 Wild-type Melanoma With Central Nervous System Metastases and Cobimetinib Plus Atezolizumab and Vemurafenib in BRAFV600 Mutation-positive Melanoma With Central Nervous System Metastases
Sponsor: Hoffmann-La Roche (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 80.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-12-13
Primary completion date: 2021-06-07
Completion date: 2023-04-13
Limitations and caveats: The Sponsor decided to discontinue enrollment into Cohort 1, which was communicated in a Dear Investigator Letter dated 9 July 2019.
Clinical trial NCT02558231: The Efficacy and Safety of Initial Triple Versus Initial Dual Oral Combination Therapy in Patients With Newly Diagnosed Pulmonary Arterial Hypertension
Official title: The Efficacy and Safety of Initial Triple Versus Initial Dual Oral Combination Therapy in Patients With Newly Diagnosed Pulmonary Arterial Hypertension: A Multi-center, Double-blind, Placebo-controlled, Phase 3b Study
Acronym: TRITON
Sponsor: Actelion (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 247.0 (ACTUAL)
Number of arms: 2.0
Start date: 2016-05-01
Primary completion date: 2019-08-29
Completion date: 2020-04-20
Baseline population: Full Analysis Set (FAS) includes all randomized participants.
Limitations and caveats: The main limitation of the sponsor's findings was that analyses of disease progression and mortality were exploratory due to the testing hierarchy and the post hoc nature of the analyses. The study was not powered to show significant differences for the disease progression related endpoint. Another limitation was the availability of hemodynamic assessments only for Week 26 timepoint.
Clinical trial NCT05071313: A Study of an Ad26.RSV.preF-based Vaccine and High-dose Seasonal Influenza Vaccine, With and Without Coadministration, in Adults Aged 65 Years and Older
Official title: A Randomized, Double-blind, Placebo-controlled Phase 3 Study to Evaluate the Immunogenicity and Safety of Ad26.RSV.preF-based Vaccine and High-dose Seasonal Influenza Vaccine, With and Without Coadministration, in Adults Aged 65 Years and Older
Sponsor: Janssen Vaccines & Prevention B.V. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 777.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-10-04
Primary completion date: 2022-04-20
Completion date: 2022-10-11
Baseline population: The full analysis set (FAS) included all participants who received at least 1 study vaccination, regardless of the occurrence of protocol deviations and vaccine type (seasonal influenza, Ad26/protein preF RSV vaccine, or placebo).
Plan to share individual participant data: YES
IPD sharing description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
Clinical trial NCT04258683: A Study of Pembrolizumab Added to the Standard First-Line Therapy of Cyclophosphamide, Bortezomib, and Dexamethasone (CyBorD) for NDMM NTE
Official title: A Phase 2A Multi Centre, Open Label, Pilot Study Of Pembrolizumab Added to The Standard First-Line Therapy Of Cyclophosphamide, Bortezomib And Dexamethasone (CyBorD) In Newly Diagnosed Multiple Myeloma Patients Not Eligible For Autologous Stem Cell Transplantation
Sponsor: Canadian Myeloma Research Group (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Study terminated due to changing treatment landscape
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-02-17
Primary completion date: 2022-10-31
Completion date: 2022-10-31
Plan to share individual participant data: NO
Clinical trial NCT05832775: Study to Assess the Safety of MRx0029 or MRx0005 Compared to Placebo, in People With Parkinson's
Official title: A First-in-human, Double-blind, Placebo-controlled, Multicentre, Cross-over, Phase I Study to Assess Safety and Tolerability of Repeat Oral Administrations of MRx0029 OR MRx0005 in Adult Participants With Idiopathic Parkinson's Disease
Sponsor: 4D pharma plc (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: Sponsor insolvency
Enrollment: 0.0 (ACTUAL)
Number of arms: 4.0
Start date: 2022-05-31
Primary completion date: 2023-04-30
Completion date: 2023-04-30
Plan to share individual participant data: NO
Clinical trial NCT03516084: A Study of Niraparib as Maintenance Therapy Following First-Line Platinum-Based Chemotherapy in Patients With Extensive Stage Small Cell Lung Cancer
Official title: A Randomized, Double-blind, Placebo-controlled, Multi-center Phase 3 Study of ZL-2306 (Niraparib) as Maintenance Therapy Following First-line Platinum-based Chemotherapy in Patients With Extensive-stage Disease Small Cell Lung Cancer (ED-SCLC) to Evaluate the Efficacy and Safety
Sponsor: Zai Lab (Hong Kong), Ltd. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: As the treatment model of extensive-stage small cell lung cancer changed rapidly and the enrollment speed significantly lower than expected, ZaiLab decided to terminate this study
Enrollment: 185.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-08-20
Primary completion date: 2020-02-21
Completion date: 2020-03-20
Clinical trial NCT02953509: Trial of Magrolimab (Hu5F9-G4) in Combination With Rituximab or Rituximab + Chemotherapy in Participants With Relapsed/Refractory B-cell Non-Hodgkin's Lymphoma
Official title: A Phase 1b/2 Trial of Hu5F9-G4 in Combination With Rituximab or Rituximab + Chemotherapy in Patients With Relapsed/Refractory B-cell Non-Hodgkin's Lymphoma
Sponsor: Gilead Sciences (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Study terminated early due to the magrolimab program discontinuation.
Enrollment: 178.0 (ACTUAL)
Number of arms: 5.0
Start date: 2016-11-21
Primary completion date: 2024-03-25
Completion date: 2024-03-25
Plan to share individual participant data: NO
Clinical trial NCT00047008: Chemotherapy and Radiation Therapy With or Without Surgery in Treating Patients With Head and Neck Cancer
Official title: A Phase III Trial of Concurrent Radiation and Chemotherapy for Advanced Head and Neck Carcinomas
Sponsor: Radiation Therapy Oncology Group (NETWORK)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 743.0 (ACTUAL)
Number of arms: 2.0
Start date: 2002-07-31
Primary completion date: 2010-06-30
Completion date: 2022-05-20
Baseline population: Eligible patients who did not withdraw consent.
Limitations and caveats: Local-regional failure and disease-free survival were additionally analyzed with the definition of failure used in the Meta-Analysis of Radiotherapy in Carcinomas of Head and Neck (MARCH) Collaborative Group and the Meta-Analysis of Chemotherapy in Head and Neck Cancer (MACH-NC) Collaborative Group publications. These modified outcome measures are labeled Alternate Definition.
Plan to share individual participant data: NO
Clinical trial NCT03494114: Imaging Activated Macrophages in the Lungs
Official title: Imaging Activated Macrophages in the Lungs
Sponsor: Vanderbilt University Medical Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Funding has ended and unable to recruit due to COVID 19
Enrollment: 13.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-11-29
Primary completion date: 2019-11-20
Completion date: 2021-01-13
Plan to share individual participant data: NO
Clinical trial NCT03280277: Ferumoxytol-Enhanced MRI in Imaging Lymph Nodes in Patients With Locally Advanced Rectal Cancer
Official title: Novel Imaging of Lymph Nodes in Patients With Rectal Cancer Using Ferumoxytol Enhanced MRI
Sponsor: OHSU Knight Cancer Institute (OTHER)
Study type: INTERVENTIONAL
Phase: EARLY_PHASE1
Status: TERMINATED 
Why stopped: low accrual
Enrollment: 2.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-04-27
Primary completion date: 2021-08-26
Completion date: 2021-08-26
Clinical trial NCT03250299: Microtubule-Targeted Agent BAL101553 and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma
Official title: Phase I Study to Determine the Safety and Tolerability of the Oral Microtubule Destabilizer BAL101553 in Combination With Standard Radiation in Patients With MGMT Promoter Unmethylated Newly Diagnosed Glioblastoma
Sponsor: Basilea Pharmaceutica (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Due to the National Cancer Institute's (NCI)-mandated termination of the Adult Brain Tumor Consortium which was conducting the study
Enrollment: 26.0 (ACTUAL)
Number of arms: 1.0
Start date: 2017-12-15
Primary completion date: 2022-06-03
Completion date: 2022-08-24
Plan to share individual participant data: NO
Clinical trial NCT04654689: Impact of the Combined Treatment of Liposomed Polyphenols With G04CB02 on the ALS Patients
Official title: Impact of the Combined Treatment of Curcumin and Resveratrol Liposomed Polyphenols With G04CB02 on the Clinical Improvement of ALS Patients
Sponsor: Fundación Universidad Católica de Valencia San Vicente Mártir (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 90.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-11-20
Primary completion date: 2022-11-12
Completion date: 2023-02-04
Plan to share individual participant data: YES
IPD sharing description: Variables related to inflammation and oxidation:~* Quantitative measurement of plasma IL-6 and TNF-alpha.~* Quantitative measurement of plasma PCR.~* Quantitative measurement of plasma haptoglobin.~* Quantitative measurement of TEAC (oxidation).~* Quantitative measurement of plasma 8-oxoG.~* Quantitative measurement of plasma MDA.~Variables for cognitive and behavioural assessment:~* Edinburgh Cognitive and Behavioral ALS Screen~* Frontal Assessment Battery (FAB)
Clinical trial NCT03503968: TCR Modified T Cells MDG1011 in High Risk Myeloid and Lymphoid Neoplasms
Official title: A Phase I/II, Open-Label, Non-Randomized, Multicentre, Dose-Escalation Clinical Trial With Control Group to Evaluate the Safety, Feasibility and Preliminary Efficacy of PRAME TCR Modified T Cells, MDG1011, in Subjects With High Risk Myeloid and Lymphoid Neoplasms
Sponsor: Medigene AG (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: The clinical trial is terminated after the completion of phase I without moving to Phase II.
Enrollment: 9.0 (ACTUAL)
Number of arms: 5.0
Start date: 2018-03-27
Primary completion date: 2022-06-28
Completion date: 2022-07-15
Clinical trial NCT04348474: Efficacy and Safety of Hydroxychloroquine and Azithromycin for the Treatment of Ambulatory Patients With Mild COVID-19
Official title: Open Label, Multicentric, Non Randomized, Exploratory Clinical Trial to Assess the Efficacy and Safety of Hydroxychloroquine and Azithromycin for the Treatment of Mild Acute Respiratory Syndrome (COVID-19) Caused by SARS-CoV-2 Virus
Sponsor: Azidus Brasil (INDUSTRY)
Study type: INTERVENTIONAL
Phase: EARLY_PHASE1
Status: SUSPENDED 
Why stopped: Azidus, the CRO hired for this study by Prevent Senior has lost the interest to conduct this study.
Enrollment: 200.0 (ESTIMATED)
Number of arms: 1.0
Start date: 2020-04-20
Primary completion date: 2020-06-30
Completion date: 2023-07-31
Plan to share individual participant data: NO
IPD sharing description: It is believed that after the data analysis and presentation to the National Commission on Research Ethics, all data of the study will become public.
Clinical trial NCT04396847: Laboratory Screening of Lorcaserin for Alcohol Use Disorder
Official title: Human Laboratory Screening of Lorcaserin in Smokers With Alcohol Use Disorder
Sponsor: The Mind Research Network (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Medication removed from the U.S. market by the The Food and Drug Administration
Enrollment: 5.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-10-25
Primary completion date: 2020-02-26
Completion date: 2020-02-26
Baseline population: 5 participants provided informed consent. Due to participant no-shows and the cancelation of the study, only one participant started study medication.
Plan to share individual participant data: NO
Clinical trial NCT03965871: Efficacy, Safety and Pharmacokinetic Study of Inhaled Esketamine in Treatment-resistant Bipolar Depression
Official title: A Multicentre, Double-blind, Randomised, Placebo - Controlled Phase II Study to Assess Efficacy, Safety and Pharmacokinetics of Inhaled Esketamine in Subject With Treatment-resistant Bipolar Depression
Sponsor: Celon Pharma SA (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 88.0 (ACTUAL)
Number of arms: 4.0
Start date: 2019-03-28
Primary completion date: 2021-01-03
Completion date: 2021-02-19
Clinical trial NCT04174677: Safety and Tolerability of Inebilizumab, VIB4920, or the Combination in Highly Sensitized Candidates Awaiting Kidney Transplantation From a Deceased Donor
Official title: A Phase 2 Open-label, Prospective, Randomized Study of Inebilizumab, VIB4920, or the Combination to Evaluate Safety and Tolerability in Highly Sensitized Candidates Awaiting Kidney Transplantation From a Deceased Donor
Sponsor: Amgen (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Stopped due to no enrollment
Enrollment: 0.0 (ACTUAL)
Number of arms: 3.0
Start date: 2019-12-27
Primary completion date: 2021-12-31
Completion date: 2022-04-30
Plan to share individual participant data: YES
IPD sharing description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
IPD time frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
IPD access criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
Clinical trial NCT03828448: Study to Assess Umbralisib Plus Ublituximab in Participants With Treatment Naïve Follicular Lymphoma
Official title: A Phase II Study Evaluating the Safety and Efficacy of Umbralisib (TGR-1202) in Combination With Ublituximab in Patients With Treatment Naïve Follicular Lymphoma and Small Lymphocytic Lymphoma
Sponsor: TG Therapeutics, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Strategic/Business Decision
Enrollment: 34.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-07-10
Primary completion date: 2022-05-16
Completion date: 2022-05-31
Limitations and caveats: Due to sponsor's business decision, the clinical trial was terminated by the sponsor prematurely. No analysis was done at the termination of the trial, therefore, outcome, and safety data are not available and the numbers of participants analyzed are reported as 0.
Clinical trial NCT03326245: Dopaminergic Modulation of Brain Activation Using Simultaneous PET/Pharmacological MRI
Official title: Dopaminergic Modulation of Brain Activation Using Simultaneous PET/Pharmacological MRI
Sponsor: National Institutes of Health Clinical Center (CC) (NIH)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 25.0 (ACTUAL)
Number of arms: 3.0
Start date: 2018-01-29
Primary completion date: 2021-12-13
Completion date: 2024-02-08
Plan to share individual participant data: NO
IPD sharing description: .Data is analyzed by subject group and not on an individual basis.
Clinical trial NCT03893448: Safety, Tolerability, and Immunogenicity of V114 in Healthy Infants (V114-029)
Official title: A Phase 3, Multicenter, Randomized, Double-blind, Active-Comparator-controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of a 4-dose Regimen of V114 in Healthy Infants (PNEU-PED)
Acronym: PNEU-PED
Sponsor: Merck Sharp & Dohme LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 1720.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-06-19
Primary completion date: 2021-05-24
Completion date: 2021-05-24
Plan to share individual participant data: YES
IPD sharing description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf