chufangao/CTO huggingface dataset:
Clinical trial NCT04549363: Characterization of Corneal Epithelial Changes in Participants Treated With Belantamab Mafodotin
Official title: Characterization of Corneal Epithelial Changes in Participants Treated With Belantamab Mafodotin (GSK2857916)
Sponsor: GlaxoSmithKline (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: The study has been terminated for reasons pertaining to feasibility
Enrollment: 16.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-12-21
Primary completion date: 2022-11-21
Completion date: 2022-11-21
Plan to share individual participant data: YES
IPD sharing description: IPD for this study will be made available via the Clinical Study Data Request site.
IPD time frame: IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.
IPD 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.
Clinical trial NCT04563871: Efficacy and Safety of 80mg Osimertinib in Patients With Non-small Cell Lung Cancer(NSCLC)
Official title: A Phase II, Open-label, Single-arm, Multicenter, Efficacy and Safety of 80mg Osimertinib in Patients With Leptomeningeal Metastases(LM) Associated With EGFR Mutation-positive Non-small Cell Lung Cancer(NSCLC)
Acronym: BLOSSOM
Sponsor: Samsung Medical Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 73.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-11-17
Primary completion date: 2023-10-25
Completion date: 2023-10-25
Plan to share individual participant data: NO
Clinical trial NCT03077698: An Endometrial Cancer Study for Women With Recurrent or Persistent Endometrial Cancer
Official title: A Phase 2, Single Arm, Two Period Study of Sodium Cridanimod in Conjunction With Progestin Therapy in Patients With Endometrial Carcinoma
Sponsor: Xenetic Biosciences, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: The study was discontinued due to a change in development strategy and not due safety concern.
Enrollment: 25.0 (ACTUAL)
Number of arms: 1.0
Start date: 2017-06-14
Primary completion date: 2020-07-17
Completion date: 2020-07-17
Limitations and caveats: The study was discontinued early due to a change in development strategy and not due safety concern. No safety concerns were noted during the trial. This change in development strategy was the determining factor in the decision to discontinue the study. Because the study was terminated early, the planned analysis was not conducted, as full enrollment was not met.
Plan to share individual participant data: NO
Clinical trial NCT02394028: A Study to Assess Whether Etrolizumab is a Safe and Efficacious Treatment for Participants With Moderately to Severely Active Crohn's Disease
Official title: A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Etrolizumab as an Induction And Maintenance Treatment For Patients With Moderately to Severely Active Crohn's Disease
Acronym: BERGAMOT
Sponsor: Hoffmann-La Roche (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 1035.0 (ACTUAL)
Number of arms: 11.0
Start date: 2015-03-20
Primary completion date: 2021-09-07
Completion date: 2021-09-07
Baseline population: Safety Population: All participants randomized who received at least one dose of study treatment, grouped under the treatment arm received.
Clinical trial NCT04229095: Medication Development in Alcoholism: Suvorexant Versus Placebo
Official title: Medication Development for Protracted Abstinence in Alcoholism: Suvorexant Versus Placebo
Sponsor: The Scripps Research Institute (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 26.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-11-17
Primary completion date: 2022-11-08
Completion date: 2022-11-08
Limitations and caveats: The actual enrollment was 26 subjects, relative to the planned enrollment of 50 subjects, due to chronic staffing problems for overnight studies at the Altman Clinical and Translational Research Institute (ACTRI) at the University of California-San Diego (UCSD) that resulted in multiple pre-randomization visit cancellations. Alternative inpatient beds were not available at general hospitals due to the prioritization of their facilities for COVID-19 patients.
Plan to share individual participant data: NO
Clinical trial NCT04562597: A Pilot Trial to Determine the Effective N-acetylcysteine Dose for Opioid Reduction for Spine Surgery.
Official title: A Pilot Trial to Determine the Effective Dose of N-acetylcysteine for Opioid Reduction in Patients Undergoing Spine Surgery.
Sponsor: Medical University of South Carolina (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: COMPLETED 
Enrollment: 50.0 (ACTUAL)
Number of arms: 6.0
Start date: 2021-01-20
Primary completion date: 2022-05-20
Completion date: 2022-05-21
Limitations and caveats: * Opioid consumption was highly variable. This is likely due to the small sample size.~* Data only collected up to 48 hours postoperative, and this limits our ability to comment more on the usefulness of NAC as an agent for patients with chronic pain.
Plan to share individual participant data: NO
Clinical trial NCT03615144: TCR Alpha Beta T-cell and CD19 B-cell Depleted Peripheral Blood Stem Cell Transplantation Using the CliniMACS System for Patients With Non-Malignant Hematologic Disorders From Matched or Mismatched, Related or Unrelated Donors
Official title: A Phase II Trial of Alpha Beta T-cell and CD19 B-cell Depleted Peripheral Blood Stem Cell Transplantation Using the CliniMACS System for Patients With Non-Malignant Hematologic Disorders From Matched or Mismatched, Related or Unrelated Donors
Sponsor: Memorial Sloan Kettering Cancer Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Participant accrual low and the study was closed
Enrollment: 1.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-07-23
Primary completion date: 2020-11-13
Completion date: 2020-11-13
Baseline population: Participant accrual low and the study was closed.
Clinical trial NCT04306692: Myo-inositol Versus Clomiphene Citrate in PCOS
Official title: Myo-inositol Versus Clomiphene Citrate as First Line Treatment for Ovulation Induction in PCOS
Sponsor: University Hospital, Ghent (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: clomiphene citrate is no longer being considered as standard treatment for polycystic ovary syndrome
Enrollment: 12.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-07-02
Primary completion date: 2021-04-20
Completion date: 2022-01-31
Clinical trial NCT04016779: Evaluation of SPN-812 (Viloxazine Extended-release Capsule) in Adults With ADHD
Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel-Group Flexible-Dose Study of the Efficacy and Safety of SPN-812 in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)
Sponsor: Supernus Pharmaceuticals, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 374.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-11-20
Primary completion date: 2020-10-10
Completion date: 2020-10-10
Baseline population: Full analysis set (FAS) Population: The FAS population includes subjects who were randomized, took at least one dose of study medication, have a baseline Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Investigator Symptom Rating Scale (AISRS) assessment and have at least one post-baseline AISRS assessment.
Clinical trial NCT02231879: Plerixafor Versus G-CSF in the Treatment of People With WHIM Syndrome
Official title: A Phase III Double-Blind Randomized Crossover Study of Plerixafor Versus G-CSF in the Treatment of Patients With WHIM Syndrome.
Sponsor: National Institutes of Health Clinical Center (CC) (NIH)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: COMPLETED 
Enrollment: 20.0 (ACTUAL)
Number of arms: 2.0
Start date: 2014-10-14
Primary completion date: 2020-10-08
Completion date: 2021-02-24
Limitations and caveats: 1. Highly variable disease phenotypic expression made crossover design optimal but a placebo arm was not included due to infection risk of severe neutropenia~2. Prophylactic supplemental immunoglobulin and antibiotics were allowed~3. Tolerance of G-CSF was insured prior to randomization but plerixafor was never used before randomization in 17/19 patients,~4. Non-inferiority analysis of primary endpoint was not planned because there were no defined equivalence margins
Plan to share individual participant data: NO
Clinical trial NCT03396315: Bisphosphonates for Prevention of Post-Denosumab Bone Loss
Official title: Bisphosphonates for Prevention of Post-Denosumab Bone Loss in Premenopausal Women With Idiopathic Osteoporosis
Sponsor: Columbia University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 24.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-01-29
Primary completion date: 2023-06-09
Completion date: 2023-06-09
Plan to share individual participant data: UNDECIDED
Clinical trial NCT04438902: Osimertinib Combined With Anlotinib in EGFR T790M Mutated NSCLC Patients With Progression on Osimertinib Treatment
Official title: A Prospective, Multi-center, Interventional Study of Osimertinib Combined With Anlotinib in Acquired EGFR T790M Mutated NSCLC Patients With Gradual Progression on Osimertinib Treatment
Sponsor: First Affiliated Hospital of Zhejiang University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Many patients can't tolerate the combination treatment due to adverse events.
Enrollment: 3.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-12-12
Primary completion date: 2022-12-08
Completion date: 2023-02-16
Plan to share individual participant data: NO
IPD sharing description: No plan to share participant data of the trial.
Clinical trial NCT05007808: Efficacy and Safety of G001 in Patients With Osteoarthritis (OA) of the Knee
Official title: Phase 2 Multicenter, Double-blind, Randomized, Parallel-Group, Vehicle-Controlled Study to Evaluate the Efficacy, Safety, and Local Tolerability of G001 in Patients With Osteoarthritis (OA) of the Knee
Sponsor: BUZZZ Pharmaceuticals Limited (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 210.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-01-06
Primary completion date: 2023-01-04
Completion date: 2023-01-10
Plan to share individual participant data: NO
Clinical trial NCT05216055: Transverse Abdominus Plane Block Study
Official title: Effect of Laparoscopic-Guided Transversus Abdominus Plane (TAP) Block on Opioid Consumption Using Dual-Adjunct Therapy With Dexmedetomidine and Dexamethasone Versus Liposomal Bupivacaine (Exparel®) Following Minimally Invasive Colorectal Surgery: A Single-Blinded Randomized Clinical Trial.
Acronym: TAP
Sponsor: University of Colorado, Denver (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: No Accrual. PI left Institution
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-04-19
Primary completion date: 2022-12-16
Completion date: 2022-12-27
Plan to share individual participant data: NO
Clinical trial NCT04250597: Study of GNX102 in Patients With Advanced Solid Tumors
Official title: A Phase I Study of GNX102 in Patients With Advanced Solid Tumors
Sponsor: GlycoNex, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Maximum tolerated dose reached; expansion phase not performed per Sponsor business decision.
Enrollment: 46.0 (ACTUAL)
Number of arms: 3.0
Start date: 2020-07-29
Primary completion date: 2023-07-26
Completion date: 2023-07-26
Plan to share individual participant data: NO
Clinical trial NCT03929757: A Study of 2-dose Vaccination Regimen of Ad26.ZEBOV and MVA-BN-Filo in Infants
Official title: A Phase 2 Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of a Heterologous 2-dose Vaccination Regimen Using Ad26.ZEBOV and MVA-BN®-Filo in Infants Aged 4-11 Months in Guinea and Sierra Leone
Sponsor: Janssen Vaccines & Prevention B.V. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 108.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-08-19
Primary completion date: 2022-08-22
Completion date: 2022-09-28
Clinical trial NCT03737474: A Long-Term Study of Brexpiprazole in Patients With Major Depressive Disorder
Official title: A Multi-center, Open-label Trial to Assess the Long-term Safety and Efficacy of Brexpiprazole as Adjunctive Therapy in Patients With Major Depressive Disorder
Sponsor: Otsuka Pharmaceutical Co., Ltd. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 248.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-10-04
Primary completion date: 2021-03-17
Completion date: 2021-04-13
Baseline population: This trial was conducted in 248 participants in Japan. Of the 248 subjects who were administered investigational medicinal product, the efficacy analysis set and the safety analysis set comprised 247 subjects (216 rollover subjects, 31 newly enrolled subjects) of the total brexpiprazole population.
Plan to share individual participant data: YES
IPD sharing description: Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal.
IPD time frame: Data will be available after marketing approval in global markets, or beginning 1-3 years following article Publication. There is no end date to the availability of the data.
IPD access criteria: Otsuka will share data on an Otsuka-owned remotely accessible data sharing platform with Python and R analytical software. Research requests should be directed to clinicaltransparency@Otsuka-us.com.
Clinical trial NCT03541187: Cockroach Immunotherapy in Children and Adolescents
Official title: Cockroach Immunotherapy in Children and Adolescents
Acronym: CRITICAL
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) (NIH)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 82.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-07-16
Primary completion date: 2022-06-02
Completion date: 2022-06-03
Baseline population: Intent-to-treat population with available data
Plan to share individual participant data: YES
IPD sharing description: Participant level data access will be made available to the public at some point in the future via the mechanism of the Immunology Database and Analysis Portal (ImmPort), a long-term archive of clinical and mechanistic data from DAIT-funded grants and contracts.
IPD time frame: The aim is to share data with the public within 24 months upon completion of the study.
IPD access criteria: ImmPort public data access.
Clinical trial NCT05268744: Micronutrient Supplementation in Children With ASD
Official title: Micronutrient Supplementation in Children With Autism Spectrum Disorder (ASD): A Clinical Trial Examining Mechanism of Action
Sponsor: University of California, San Francisco (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 16.0 (ACTUAL)
Number of arms: 1.0
Start date: 2022-11-14
Primary completion date: 2023-01-14
Completion date: 2023-01-30
Limitations and caveats: The limited sample size (N=11) has indeed constrained the statistical power of the analysis.~The absence of a control group prevents direct comparisons between treated participants and untreated individuals, limiting our ability to isolate the effects of the micronutrient supplement from other confounding factors.~We do not have information regarding the types of diets the participants were on which could have influenced their response to the micronutrient supplementation.
Plan to share individual participant data: NO
Clinical trial NCT01945775: A Study Evaluating Talazoparib (BMN 673), a PARP Inhibitor, in Advanced and/or Metastatic Breast Cancer Patients With BRCA Mutation (EMBRACA Study)
Official title: A PHASE 3, OPEN-LABEL, RANDOMIZED PARALLEL,2-ARM,MULTI-CENTER STUDY OF TALAZOPARIB(BMN 673) VERSUS PHYSICIAN'S CHOICE IN GERMLINE BRCA MUTATION SUBJECTS WITH LOCALLY ADVANCED AND/OR METASTATIC BREAST CANCER, WHO HAVE RECEIVED PRIOR CHEMOTHERAPY REGIMENS FOR METASTATIC DISEASE
Acronym: EMBRACA
Sponsor: Pfizer (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 431.0 (ACTUAL)
Number of arms: 2.0
Start date: 2013-10-14
Primary completion date: 2017-09-15
Completion date: 2021-03-05
Baseline population: Intent-to-treat (ITT) analysis population included all randomized participants.
Plan to share individual participant data: YES
IPD sharing description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Clinical trial NCT04988997: VIBRANT Study of Vurolenatide in Adult Patients With Short Bowel Syndrome.
Official title: A Phase 2, Double-Blind, Double-Dummy, Placebo-Controlled, Multicenter Study of the Efficacy, Safety, and Tolerability of Vurolenatide in Adult Patients With Short Bowel Syndrome
Sponsor: 9 Meters Biopharma, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Trial terminated by Sponsor
Enrollment: 12.0 (ACTUAL)
Number of arms: 4.0
Start date: 2021-06-14
Primary completion date: 2022-08-05
Completion date: 2022-08-24
Plan to share individual participant data: NO
Clinical trial NCT03164083: The Effects of Stromal Vascular Fraction and Mesenchymal Stem Cells as Intra-articular Injection in Knee Joint Osteoarthritis
Official title: Evaluation the Effects of Intra-articular Injection of Mesenchymal Stem Cells and Stromal Vascular Fraction Patients With Knee Joint Osteoarthritis, Triple Blind Randomized Clinical Trial
Sponsor: SCARM Institute, Tabriz, Iran (OTHER_GOV)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: not approved by sponsor
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-11-10
Primary completion date: 2020-08-21
Completion date: 2020-12-05
Plan to share individual participant data: NO
Clinical trial NCT02533141: Effect of Simvastatin Withdrawal on Ocular Endothelial Function
Official title: Effect of Simvastatin Withdrawal on Ocular Endothelial Function
Sponsor: Medical University of Vienna (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: WITHDRAWN 
Why stopped: no funding
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-10-31
Primary completion date: 2020-09-30
Completion date: 2020-12-31
Clinical trial NCT03393702: Pain Control in Children and Adolescent After Thoracic Surgery: The Effect of Gabapentin
Official title: Efficacy of Gabapentin as Adjuvant for Postoperative Pain in Pediatric Thoracic Surgery - a Randomized Quadruple Blind Study
Sponsor: National Institute for Tuberculosis and Lung Diseases, Poland (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 104.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-05-09
Primary completion date: 2019-12-30
Completion date: 2020-12-03
Clinical trial NCT04241744: Prospective Trial of Oral Vancomycin Therapy vs. Placebo for Prevention of CDI
Official title: Prospective, Randomized, Double-Blind, Trial of Oral Vancomycin Therapy Compared to Placebo As Primary Prevention for C. Difficile-associated Infection (CDI)
Sponsor: Creighton University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: WITHDRAWN 
Why stopped: difficulty enrolling patients
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-10-29
Primary completion date: 2020-01-13
Completion date: 2020-01-13
Plan to share individual participant data: NO
Clinical trial NCT01366612: PRO#1278: Fludarabine and Busulfan vs. Fludarabine, Busulfan and Total Body Irradiation
Official title: PRO#1278: A Phase III Study of Fludarabine and Busulfan Versus Fludarabine, Busulfan and Low Dose Total Body Irradiation in Patients Receiving an Allogeneic Hematopoietic Stem Cell Transplant
Acronym: FLUBUTBI
Sponsor: Hackensack Meridian Health (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Lack of Accrual
Enrollment: 53.0 (ACTUAL)
Number of arms: 2.0
Start date: 2010-06-16
Primary completion date: 2020-08-17
Completion date: 2020-08-18
Baseline population: Of the 53 consented, Forty-Seven patients with myeloid diseases were randomized into Flu/Bu4 (25 patients) or Flu/Bu4/TBI (22 patients)
Clinical trial NCT03831945: Combination Therapy With VRC01 and 10-1074 in HIV-Infected Individuals Undergoing Sequential Treatment Interruptions
Official title: An Exploratory Study of Combination Therapy With VRC-HIVMAB060-00-AB (VRC01) and 10-1074 in HIVInfected Individuals Undergoing Sequential Treatment Interruptions
Sponsor: National Institutes of Health Clinical Center (CC) (NIH)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: unable to recruit due to COVID pandemic
Enrollment: 27.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-04-04
Primary completion date: 2020-12-08
Completion date: 2020-12-08
Clinical trial NCT02066285: Trial of Pazopanib in Patients With Solitary Fibrous Tumor and Extraskeletal Myxoid Chondrosarcoma
Official title: A Phase II Open-Label Trial of Pazopanib Administered as a Single Agent in Patients With Unresectable or Metastatic Solitary Fibrous Tumor (SFT) and Extraskeletal Myxoid Chondrosarcoma (EMC)
Sponsor: Grupo Espanol de Investigacion en Sarcomas (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 96.0 (ACTUAL)
Number of arms: 1.0
Start date: 2014-06-30
Primary completion date: 2019-12-31
Completion date: 2023-03-24
Clinical trial NCT00316888: Cetuximab, Cisplatin, Fluorouracil, and Radiation Therapy in Treating Patients With Anal Cancer
Official title: Phase II Trial of Cetuximab Plus Cisplatin, 5- Fluorouracil and Radiation in Immunocompetent Patients With Anal Carcinoma
Sponsor: Eastern Cooperative Oncology Group (NETWORK)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 63.0 (ACTUAL)
Number of arms: 2.0
Start date: 2007-02-28
Primary completion date: 2015-11-30
Completion date: 2021-08-17
Baseline population: all eligible and treated patients
Plan to share individual participant data: YES
IPD sharing description: Individual participant data may be made available upon request as per the ECOG-ACRIN Data Sharing Policy.
Clinical trial NCT04384107: Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 in Healthy Japanese Infants (V114-033)
Official title: A Phase 3, Multicenter, Randomized, Double-blind, Active-Comparator-controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 in Healthy Japanese Infants
Sponsor: Merck Sharp & Dohme LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 694.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-07-01
Primary completion date: 2021-12-01
Completion date: 2021-12-01
Plan to share individual participant data: YES
IPD sharing description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf