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20〜45歳の男性における9価ヒトパピローマウイルスワクチン（9vHPV）の経口持続感染、免疫原性および安全性に対する有効性（V503-049）

2026年10月17日 更新者：Merck Sharp & Dohme LLC

第3相、国際、多施設、無作為化、二重盲検、プラセボ対照臨床試験で、経口持続性の予防における多価L1ウイルス様粒子ワクチンである9vHPVワクチンの有効性、免疫原性、および安全性を研究する20～45歳の成人男性におけるHPV 16、18、31、33、45、52、または58型による感染

The purpose of this study is to evaluate the efficacy, immunogenicity and safety of the 9vHPV vaccine in men 20 to 45 years of age. The primary hypothesis tested after the primary database lock is that administration of a 3-dose regimen of 9vHPV vaccine will reduce the incidence of human papillomavirus (HPV) 16/18/31/33/45/52/58-related oral persistent infection (6 months or longer) compared with placebo.

There will also be an Extension Study to offer an opportunity to complete the 3 dose regimen of 9vHPV vaccine for participants who received placebo in the Base Study, or received less than 3 doses of 9vHPV vaccine in the Base Study.

調査の概要

状態

積極的、募集していない

条件

介入・治療

研究の種類

介入

入学 (実際)

6033

段階

  • フェーズ 3

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

  • アメリカ
    • California
      • Northridge、California、アメリカ、91325
        • Valley Clinical Trials Inc. ( Site 0002)
      • Rialto、California、アメリカ、92377
        • Inland Empire Clinical Trials, LLC ( Site 0025)
      • Simi Valley、California、アメリカ、93065
        • Alta California Medical Group ( Site 0031)
      • Spring Valley、California、アメリカ、91978
        • Encompass Clinical Research ( Site 0028)
      • Walnut Creek、California、アメリカ、94598
        • Diablo Clinical Research, Inc ( Site 0042)
    • Florida
      • Coral Gables、Florida、アメリカ、33134
        • Clinical Research of South Florida ( Site 0036)
      • Miami、Florida、アメリカ、33142
        • Acevedo Clinical Research Associates ( Site 0001)
      • Tampa、Florida、アメリカ、33617
        • Moffitt Cancer Center ( Site 0017)
    • Georgia
      • Augusta、Georgia、アメリカ、30912
        • Augusta University ( Site 0010)
    • Idaho
      • Meridian、Idaho、アメリカ、83646
        • Solaris Clinical Research, LLC ( Site 0003)
    • Kansas
      • Topeka、Kansas、アメリカ、66606
        • Cotton-O'Neil Clinical Research Center ( Site 0044)
      • Wichita、Kansas、アメリカ、67207
        • Heartland Research Associates, LLC ( Site 0034)
    • Kentucky
      • Bardstown、Kentucky、アメリカ、40004
        • Kentucky Pediatric/Adult Research Inc ( Site 0011)
    • Missouri
      • Hazelwood、Missouri、アメリカ、63042
        • Healthcare Research Network LLC ( Site 0035)
    • Nevada
      • Las Vegas、Nevada、アメリカ、89119
        • Alliance for Multispecialty Reseach, LLC ( Site 0021)
    • New York
      • Cortland、New York、アメリカ、13045
        • Certified Research Associates ( Site 0041)
      • New York、New York、アメリカ、10011
        • Laser Surgery Care ( Site 0018)
      • New York、New York、アメリカ、10065
        • Weill Cornell Medicine ( Site 0046)
      • Rochester、New York、アメリカ、14609
        • Rochester Clinical Research, Inc. ( Site 0008)
    • North Carolina
      • Salisbury、North Carolina、アメリカ、28144
        • PMG Research of Salisbury ( Site 0009)
    • Ohio
      • Cleveland、Ohio、アメリカ、44122
        • Rapid Medical Research, Inc. ( Site 0037)
    • Pennsylvania
      • Pittsburgh、Pennsylvania、アメリカ、15236
        • Preferred Primary Care Physicians ( Site 0032)
    • South Carolina
      • North Charleston、South Carolina、アメリカ、29405
        • Coastal Carolina Research Center ( Site 0043)
    • Tennessee
      • Kingsport、Tennessee、アメリカ、37660
        • Holston Medical Group ( Site 0030)
    • Texas
      • Galveston、Texas、アメリカ、77555-1115
        • University of Texas Medical Branch at Galveston ( Site 0038)
      • Houston、Texas、アメリカ、77081
        • Texas Center For Drug Development ( Site 0013)
      • Victoria、Texas、アメリカ、77901
        • Crossroads Clinical Research LLC ( Site 0027)
    • Utah
      • Salt Lake City、Utah、アメリカ、84121
        • J Lewis Research Inc/Foothill Family Clinic South ( Site 0006)
      • South Jordan、Utah、アメリカ、84095
        • J Lewis Research Inc/Jordan River Family Medicine ( Site 0023)
    • Virginia
      • Charlottesville、Virginia、アメリカ、22911
        • Charlottesville Medical Research Center, LLC ( Site 0007)
      • Newport News、Virginia、アメリカ、23606
        • Health Research of Hampton Roads, Inc. ( Site 0015)
      • Richmond、Virginia、アメリカ、23226
        • Clinical Research Partners, LLC. ( Site 0004)
  • イスラエル
      • Haifa、イスラエル、3525408
        • Rambam Medical Center ( Site 0601)
      • Jerusalem、イスラエル、9112001
        • Hadassah Medical Center. Ein Kerem ( Site 0600)
    • Central District
      • Kfar Saba、Central District、イスラエル、4428164
        • Meir Medical Center ( Site 0602)
      • Tel Aviv、Central District、イスラエル、6789140
        • Maccabi Health Services Medical Center ( Site 0604)
  • イタリア
      • Bari、イタリア、70124
        • Azienda Ospedaliera Policlinico di Bari ( Site 0550)
      • Catania、イタリア、95123
        • AOU Policlinico Vittorio Emanuele ( Site 0552)
      • Roma、イタリア、00161
        • Universita di Roma "La Sapienza" ( Site 0553)
    • Roma
      • Rome、Roma、イタリア、00144
        • Istittuto Nazionale dei Tumori Regina Elena IRCCS - IFO ( Site 0551)
    • Veneto
      • Padova、Veneto、イタリア、35128
        • Azienda Ospedaliera - Universita di Padova ( Site 0555)
  • コロンビア
    • Antioquia
      • Medellín、Antioquia、コロンビア、050021
        • Fundacion Centro de Investigacion Clinica CIC ( Site 0153)
    • Atlántico
      • Barranquilla、Atlántico、コロンビア、080020
        • Clinica de la Costa Ltda. ( Site 0152)
    • Cundinamarca
      • Chía、Cundinamarca、コロンビア、250001
        • Centro de Atención e Investigación Médica SAS - CAIMED CHIA ( Site 0156)
  • スペイン
    • Barcelona
      • Badalona、Barcelona、スペイン、08916
        • Institut Catala d Oncologia Hospital Germans Trias i Pujol ( Site 0755)
      • Centelles、Barcelona、スペイン、08540
        • CAP Centelles ( Site 0751)
      • L'Hospitalet de Llobregat、Barcelona、スペイン、08090
        • ICO L Hospitalet ( Site 0754)
  • タイ
      • Chiang Mai、タイ、50200
        • Research Institute for Health Sciences ( Site 1053)
    • Bangkok
      • Bangkok、Bangkok、タイ、10400
        • Armed Forces Research Institute of Medical Sciences ( Site 1051)
      • Bangkok、Bangkok、タイ、10400
        • Vaccine Trial Center Faculty of Tropical Medicine ( Site 1052)
      • Bangkok、Bangkok、タイ、10700
        • Faculty of Medicine Siriraj Hospital ( Site 1050)
  • チェコ
      • Olomouc、チェコ、772 00
        • G-CENTRUM Olomouc s.r.o. ( Site 0400)
      • Prague、チェコ、120 00
        • MediStar s.r.o. ( Site 0403)
      • Prague、チェコ、150 06
        • FN Motol ( Site 0402)
    • Brno-mesto
      • Brno、Brno-mesto、チェコ、602 00
        • Centrum ambulantni gynekologie a primarni pece ( Site 0401)
  • ドイツ
      • Berlin、ドイツ、10787
        • Epimed GmbH ( Site 0450)
      • Berlin、ドイツ、10787
        • Klinische Forschung Berlin ( Site 0454)
      • Hamburg、ドイツ、20246
        • Universitatsklinikum Hamburg-Eppendorf ( Site 0451)
    • Hesse
      • Frankfurt am Main、Hesse、ドイツ、60596
        • Infektiologikum Frankfurt-Sachsenhausen ( Site 0456)
  • フランス
    • Cote-d Or
      • Dijon、Cote-d Or、フランス、21079
        • CHU Dijon Bourgogne - Hopital F. Mitterrand ( Site 0223)
    • Herault
      • Montpellier、Herault、フランス、34295
        • Hopital Saint Eloi ( Site 0504)
    • Ille-et-Vilaine
      • Rennes、Ille-et-Vilaine、フランス、35033
        • C.H.R.U. de Rennes. Hopital de Pontchaillou ( Site 0507)
    • Loire-Atlantique
      • Nantes、Loire-Atlantique、フランス、44093
        • CHU Nantes - Hopital Hotel Dieu ( Site 0510)
    • Île-de-France Region
      • Paris、Île-de-France Region、フランス、75014
        • Hopital Cochin ( Site 0506)
  • ブラジル
      • São Paulo、ブラジル、05402-000
        • Centro de Pesquisa Clinica II - ICHC - FMUSP ( Site 0102)
    • Estado de Bahia
      • Salvador、Estado de Bahia、ブラジル、40415-006
        • Hospital Santo Antonio - Obras Sociais Irma Dulce ( Site 0101)
    • Rio Grande do Norte
      • Natal、Rio Grande do Norte、ブラジル、59025-050
        • CPCLIN ( Site 0100)
  • ベルギー
    • Antwerpen
      • Wilrijk、Antwerpen、ベルギー、2610
        • University of Antwerp ( Site 0352)
    • Vlaams-Brabant
      • Leuven、Vlaams-Brabant、ベルギー、3000
        • Universitair Ziekenhuis Gasthuisberg ( Site 0353)
      • Tienen、Vlaams-Brabant、ベルギー、3300
        • Femicare VZW ( Site 0350)
  • ペルー
      • Lima、ペルー、07006
        • Policlinico Universidad Nacional Mayor de San Marcos ( Site 0257)
      • Lima、ペルー、15046
        • Investigaciones Medicas en Salud - INMENSA ( Site 0255)
      • Lima、ペルー、15423
        • Instituto de Investigacion Nutricional - Anexo Huascar ( Site 0251)
      • Lima、ペルー、LIMA 01
        • Asociacion Via Libre ( Site 0250)
    • Loreto
      • Iquitos、Loreto、ペルー、16000
        • Asociacion Civil Selva Amazonica ( Site 0252)
  • メキシコ
      • Chihuahua City、メキシコ、31000
        • Icaro Investigaciones en Medicina S.A. de C.V. ( Site 0200)
      • Veracruz、メキシコ、91910
        • ARKE Estudios Clinicos S.A de C.V ( Site 0211)
    • Mexico City
      • Mexico City、Mexico City、メキシコ、06700
        • Arke Estudios Clinicos S.A. de C.V. ( Site 0203)
    • Morelos
      • Cuernavaca、Morelos、メキシコ、62100
        • Instituto Nacional de Salud Publica ( Site 0202)
  • 台湾
      • Kaohsiung City、台湾、833
        • Chang Gung Medical Foundation. Kaohsiung Branch ( Site 1003)
      • Tainan、台湾、70403
        • National Cheng Kung University Hospital ( Site 1002)
      • Taipei、台湾、100
        • National Taiwan University Hospital ( Site 1000)
      • Taoyuan、台湾、333
        • Chang Gung Medical Foundation.Linkou Branch ( Site 1001)
  • 日本
      • Fukuoka、日本、810-0001
        • Sagiyama Urology Clinic ( Site 1116)
      • Fukuoka、日本、812-0025
        • Souseikai PS Clinic ( Site 1103)
      • Kumamoto、日本、861-4157
        • Souseikai Nishikumamoto Hospital ( Site 1104)
      • Osaka、日本、532-0003
        • Medical Corporation Heishinkai OPHAC Hospital ( Site 1105)
      • Osaka、日本、542-0076
        • Nomura Clinic Namba ( Site 1114)
      • Osaka、日本、542-0086
        • Medical Corporation Seiwakai Hayakawa Clinic ( Site 1113)
      • Tokyo、日本、101-0041
        • Doujin Memorial Medical Foundation, Meiwa Hospital ( Site 1111)
      • Tokyo、日本、107-0052
        • Taisei Clinic ( Site 1109)
      • Tokyo、日本、144-0051
        • Medical Corporation Mori to Umi Tokyo Tokyo Kamata Hospital ( Site 1112)
      • Tokyo、日本、158-0097
        • Naoko Dermatology Clinic ( Site 1107)
      • Tokyo、日本、160-0017
        • Medical Corporation Shinanokai Shinanozaka Clinic ( Site 1106)
      • Tokyo、日本、160-0022
        • Medical Corporation Iseikai My City Clinic ( Site 1108)
      • Tokyo、日本、171-0014
        • Medical Corporation Houeikai Sekino Clinical Pharmacology Clinic ( Site 1102)
      • Tokyo、日本、175-0092
        • Kusunoki Clinic ( Site 1110)
    • Tokyo
      • Hachiōji、Tokyo、日本、192-0071
        • P-One Clinic, Keikokai Medical Corp. ( Site 1101)
  • 韓国
      • Seoul、韓国、03312
        • The Catholic University of Korea Eunpyeong St Mary s Hospital ( Site 0954)
      • Seoul、韓国、03722
        • Severance Hospital ( Site 0953)
      • Seoul、韓国、07441
        • Hallym University Kangnam Sacred Heart Hospital ( Site 0951)
      • Seoul、韓国、08308
        • Korea University Guro Hospital ( Site 0950)
    • Kyonggi-do
      • Ansan-si、Kyonggi-do、韓国、15355
        • Korea University Ansan Hospital ( Site 0952)

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

20年～45年 (大人)

健康ボランティアの受け入れ

はい

受講資格のある性別

男

説明

Inclusion Criteria:

Base Study:

  • Is healthy and is judged to be in good physical health based on medical history and physical examination
  • Has provided written informed consent for the study. The participant may also provide consent for future biomedical research. However, the participant may participate in the main study without participating in future biomedical research
  • Agrees to provide study personnel with a primary telephone number as well as an alternate means of contact, if available (such as an alternate telephone number or email) for follow-up purposes
  • Can read, understand, and complete the electronic vaccination report card (eVRC)
  • Has had at least 1 lifetime sexual partner

Extension Study:

  • Participants may continue in the Extension Study if Inclusion Criteria #1 and #4 are still met, and the participants was in either the placebo group in the Base Study or the vaccine group in the Base Study but did not complete the vaccination series
  • Provides documented consent for the Extension Study

Exclusion Criteria:

Base Study:

  • Has a history of HPV-related anal lesion (anal intraepithelial neoplasia or anal cancer) or HPV related head and neck cancer
  • Has a history of or clinical evidence at the Day 1 external genital examination of HPV-related external lesion
  • Has clinical evidence at the Day 1 external genital examination of gross genital lesion suggesting sexually transmitted disease
  • Has a fever (defined as oral temperature ≥100.0°F or ≥37.8°C) within a 24-hour period prior to Day 1 visit
  • Has a history of severe allergic reaction (e.g., swelling of the mouth and throat, difficulty breathing, hypotension, or shock) that required medical intervention
  • Is allergic to any vaccine component, including aluminum, yeast, or BENZONASE®
  • Has known thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections
  • Is currently immunocompromised or has been diagnosed as having congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia, systemic lupus erythematosus, rheumatoid arthritis, juvenile rheumatoid arthritis, inflammatory bowel disease, or other autoimmune condition
  • Has a history of splenectomy
  • Has a history or current evidence of any condition, therapy, laboratory abnormality or other circumstance that might confound the results of the study, or interfere with the participant's participation for the full duration of the study, such that it is not in the best interest of the participant to participate by judgment of investigator
  • Is, at the time of signing informed consent, a user of recreational or illicit drugs or has had a recent history (within the last year) of drug or alcohol abuse or dependence at the discretion of the investigator. Alcohol abusers are defined as those who drink despite recurrent social, interpersonal, and/or legal problems because of alcohol use
  • Has received within 12 months prior to enrollment, is receiving, or plans to receive during the study, the following immunosuppressive therapies: radiation therapy, cyclophosphamide, azathioprine, methotrexate, any chemotherapy, cyclosporin, leflunomide (ARAVA®), TNF-α antagonists, monoclonal antibody therapies (including rituximab [RITUXAN®]), intravenous immunoglobulin (IVIG), anti-lymphocyte sera, or other therapy known to interfere with the immune response. Regarding systemic corticosteroids, a participant will be excluded if he is currently receiving steroid therapy, has recently received such therapy, or has received 2 or more courses of high-dose corticosteroids (≥20 mg/day of prednisone [or equivalent] orally or parenterally) lasting at least 1 week in duration in the year prior. Participants using inhaled, nasal, or topical steroids are considered eligible for the study
  • Has received within the 3 months prior to vaccination, is receiving, or plans to receive during the study, any immune globulin product (including RhoGAM™) or blood-derived product other than IVIG
  • Has received inactivated or recombinant vaccines within 14 days prior to vaccination or receipt of live vaccines within 21 days prior to vaccination
  • Is concurrently enrolled in other clinical studies of investigational agents
  • Has previously received a marketed HPV vaccine, or has participated in a clinical trial for any HPV vaccine (receiving either active agent or placebo)
  • Has engaged in sexual activity 48 hours prior to vaccination. Sexual activity is defined as: penile penetrative vaginal intercourse with female partner; penile penetrative or receptive anal intercourse with male or female partner; or oral sex involving any contact between participant's mouth with a female partner's vagina, genital or anal area or male partner's penis or genital or anal area. This also includes any contact between participant's partner's mouth with participant's penis, genital or anal area
  • Is unlikely to adhere to the study procedures, keep appointments, or is planning to permanently relocate from the area prior to the completion of the study or to leave for an extended period when study visits would need to be scheduled
  • Is or has an immediate family member (e.g., spouse, parent/legal guardian, sibling, or child) who is investigational site or Sponsor staff directly involved with this study

Extension Study:

- Participants must be excluded from the Extension Study if Base Study Exclusion Criteria #4, 5, 6, 7, 10, 16, or 18 are met

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：防止
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：トリプル

武器と介入

参加者グループ / アーム
介入・治療
実験的：9vHPV vaccine

Single 0.5-mL intramuscular injection at Day 1, Month 2, and Month 6
生物学的：9vHPV Vaccine

9vHPV is an aluminum-adjuvanted recombinant protein vaccine prepared from the highly purified virus-like particles of the recombinant major capsid (L1) protein of HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 given as a 0.5 mL intramuscular injection.

他の名前：
  • ガーダシル®9
  • V503
プラセボコンパレーター：Placebo

Single 0.5-mL intramuscular injection at Day 1, Month 2, and Month 6
他の：Placebo (Saline for Injection)

0.9% sodium chloride given as a 0.5-mL intramuscular injection

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Incidence of HPV 16/18/31/33/45/52/58-related 6-month Persistent Oral Infection
時間枠：Up to Month 90

A 6-month persistent infection is defined to have occurred if a participant, after completion of the Month 7 visit, is positive for the same HPV type by the HPV polymerase chain reaction (PCR) assay to at least 1 common gene in Oral Rinse and Gargle (ORG) samples obtained at 2 or more consecutive visits at 6 months (+/-1 month visit window) apart.
Up to Month 90

二次結果の測定

結果測定
メジャーの説明
時間枠
Incidence of HPV 6/11-related 6-month Persistent Oral Infection
時間枠：Up to Month 90

A 6-month persistent infection is defined to have occurred if a participant, after completion of the Month 7 visit, is positive for the same HPV type by the HPV PCR assay to at least 1 common gene in ORG samples obtained at 2 or more consecutive visits at 6 months (+/-1 month visit window) apart.
Up to Month 90
Geometric Mean Titers to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 Antibodies
時間枠：1 month postdose 3 (Month 7)

Serum antibodies to HPV types are measured with competitive Luminex immunoassay (cLIA). Geometric mean titers of antibodies to HPV types will be calculated by exponentiating the mean estimates of natural logarithm of the anti-HPV titers.
1 month postdose 3 (Month 7)
Percentage of Participants who Seroconvert to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58
時間枠：1 month postdose 3 (Month 7)

Seroconversion is defined as changing a participant's serostatus from seronegative at Day 1 to seropositive by 4 weeks postdose 3. A participant with anti-HPV cLIA titer at or above the serostatus cutoff of the cLIA for a given HPV type is considered seropositive for that HPV type.
1 month postdose 3 (Month 7)
Percentage of Participants with at Least 1 Solicited Injection-site Adverse Event (AE)
時間枠：Up to 5 days after any vaccination

An AE is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with the study vaccine. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or a protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the study vaccine or protocol-specified procedure is also an AE. Solicited injection-site AEs such as redness/erythema, swelling, and tenderness/pain at the injection site will be recorded.
Up to 5 days after any vaccination
Percentage of Participants with Elevated Temperature (Fever)
時間枠：Up to 5 days after any vaccination

Participants are asked to record oral body temperatures. The percentage of participants with elevated temperature (≥37.8°C or 100.0°F) will be assessed.
Up to 5 days after any vaccination
Percentage of Participants Who Report at Least 1 Systemic AE
時間枠：Up to 15 days after any vaccination

An AE is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with the study vaccine. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or a protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the study vaccine or protocol-specified procedure is also an AE. Systemic AEs are those not categorized as injection-site AEs.
Up to 15 days after any vaccination
Percentage of Participants Who Experience at Least 1 Serious Adverse Event (SAE)
時間枠：Up to 15 days after any vaccination

A SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly/birth defect, or is another important medical event deemed such by medical or scientific judgment.
Up to 15 days after any vaccination
Percentage of Participants who Experience at Least 1 Serious Vaccine-Related AE
時間枠：Up to Month 90

A SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly/birth defect, or is another important medical event deemed such by medical or scientific judgment. An SAE that is considered by an investigator (a qualified physician) to be vaccine-related will be reported during entire study period.
Up to Month 90

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Merck Sharp & Dohme LLC

捜査官

  • スタディディレクター：Medical Director、Merck Sharp & Dohme LLC

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

便利なリンク

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2020年2月27日

一次修了 (推定)

2027年1月15日

研究の完了 (推定)

2027年8月13日

試験登録日

最初に提出

2019年12月12日

QC基準を満たした最初の提出物

2019年12月12日

最初の投稿 (実際)

2019年12月16日

学習記録の更新

投稿された最後の更新 (実際)

2026年10月20日

QC基準を満たした最後の更新が送信されました

2026年10月17日

最終確認日

2026年10月1日

詳しくは

本研究に関する用語

追加の関連 MeSH 用語

その他の研究ID番号

  • V503-049
  • V503-049 (その他の識別子：MSD)
  • 205346 (レジストリ識別子：JAPIC-CTI)
  • U1111-1275-8682 (レジストリ識別子：UTN)
  • 2019 (米国 NIH グラント/契約)
  • 2022-501974-21-00 (レジストリ識別子：EU CT)
  • 2019-003236-23 (EudraCT番号)

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

IPD プランの説明

https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

はい

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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