A Study to Evaluate the Safety and Efficacy of MK-1406/CD388 for Prevention of Influenza (MK-1406-005/CD388.SQ.3.06)
ANCHOR
A Phase 3 Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of CD388, a Novel Long-Acting Antiviral Conjugate, for the Prevention of Influenza in Adults and Adolescents at Higher Risk of Developing Influenza Complications
3 other identifiers
interventional
10,000
5 countries
362
Brief Summary
Approximately one billion cases of seasonal influenza occur annually. Of these, 3 to 5 million illnesses are severe and responsible for up to 650,000 deaths per year (WHO 2025). Yearly administration of an influenza vaccine for the prevention of influenza is currently recommended. However, the real-world vaccine effectiveness varied from 10% to 60% in the general population across the years of 2004 to 2024, with effectiveness in most years below 50% (CDC 2025) and decreasing to as low as 5% in immunocompromised individuals (Hughes 2021). The goal of this study is to learn whether MK-1406 (CD388) can help prevent the flu in people who are at higher risk of becoming seriously ill from influenza. Researchers want to find out if MK-1406 dosed at a single study visit can provide protection against influenza compared with placebo. The study will include adolescents and adults who may be more vulnerable to complications from influenza because of their age, health conditions, or weakened immune systems. Researchers will also evaluate the safety of MK-1406 and how well participants tolerate the study medicine.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Sep 2025
362 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 29, 2025
CompletedFirst Posted
Study publicly available on registry
September 8, 2025
CompletedStudy Start
First participant enrolled
September 25, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2027
September 17, 2026
September 1, 2026
1.8 years
August 29, 2025
September 15, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants Experiencing Protocol-defined Influenza-like Illness (ILI) Occurring ≥7 Days after and up to 24 Weeks after Administration of Study Drug
Protocol-defined ILI includes: 1) Influenza infection confirmed by a reverse transcriptase-polymerase chain reaction positive (RT-PCR +) result from nasopharyngeal (NP) swab assayed at a central laboratory AND 2) New onset or worsening of ≥ 2 respiratory symptoms (nasal congestion, sore throat, or cough) OR New onset or worsening of 1 respiratory symptom (nasal congestion, sore throat, or cough) AND new onset of ≥ 1 systemic symptom (headache, feeling feverish or chills, body aches/pains, or fatigue). Number of participants experiencing protocol-defined ILI occurring after administration of MK-1406 (CD388), with influenza infection confirmed by an RT-PCR+ result based on a NP swab assayed at a central laboratory (first occurrence only), as compared to placebo will be assessed.
Up to approximately 24 weeks post dose
Secondary Outcomes (9)
Number of participants with ≥1 Adverse Event (AE)
Up to approximately Day 197
Number of Participants Who Discontinued from the Study Due to an AE
Up to approximately Day 197
Number of Participants with Injection Site Reactions (ISRs)
Up to approximately Day 8 post dose
Number of Stratum B Participants Experiencing Protocol-defined Influenza-like Illness (ILI) Occurring ≥7 Days after and up to 24 Weeks after Administration of Study Drug
Up to approximately 24 weeks post dose
Number of Participants with All-cause Hospitalization within 30 Days after the Onset of Symptomatic Laboratory-Confirmed Influenza
Up to 30 days after onset of symptomatic laboratory-confirmed influenza
- +4 more secondary outcomes
Study Arms (2)
MK-1406
EXPERIMENTALParticipants will receive 450 milligrams (mg) dose of MK-1406 (CD388) by subcutaneous (SC) injection.
Placebo
PLACEBO COMPARATORParticipants will receive placebo by SC injection.
Interventions
Eligibility Criteria
You may qualify if:
- Primary Stratum A (non-immunocompromised participants who have chronic stable medical conditions) and Primary Stratum B (participants who are immunocompromised either due to underlying disease or receipt of immunosuppressive medications)
- Has negative rapid antigen tests for influenza and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) prior to dosing at Day 1
- Weight is ≥ 40 kg
- Primary Stratum A only
- Has a history of pulmonary disease
- Has moderate to severe asthma, as defined by the Global Initiative for Asthma (GINA 2025)
- Has existing cardiac disease
- Has insulin-dependent diabetes
- Has moderate renal impairment
- Is ≥ 65 years of age at the time of randomization but does not meet any of the above criteria for Primary Stratum A, and is otherwise healthy
- Primary Stratum B only
- Has a solid tumor diagnosis AND has received chemotherapy and/or immunotherapy within 1 year of screening
- Has a diagnosis of a hematologic malignancy within 5 years of screening AND has received any chemotherapy or biologic therapy within 1 year of screening
- Participants who have had a solid organ transplant (SOT) must satisfy all of the following:
- Has received a kidney, liver, heart, or lung transplant more than 6 months prior to screening
- +9 more criteria
You may not qualify if:
- Known or suspected allergy or history of anaphylaxis or other serious adverse reactions to zanamivir (following administration of inhaled or intravenous formulations), monoclonal antibody (mAbs (including Fc domains)), or any of the components of CD388 or placebo
- Has an acute (time-limited) or febrile (temperature ≥ 38.0°C \[≥ 100.4°F\]) illness within 7 days prior to planned dosing on Day 1
- Has severe chronic kidney disease (CKD) or is receiving hemodialysis
- Receipt within the past 30 days or 5 half-lives (whichever is longer) or anticipated receipt of any drug or other biologic agent (e.g., mAbs) administered for the prevention or treatment of influenza
- Has a clinically significant bleeding disorder (e.g., factor deficiency, coagulopathy, or platelet disorder) or medical history of significant bleeding or bruising following intramuscular or subcutaneous (SC) injections or venipuncture
- Has previously enrolled in this study (CD388.SQ.3.06)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (362)
Pinnacle Research Group ( Site 0505)
Anniston, Alabama, 36207, United States
Pinnacle Research Group, LLC
Anniston, Alabama, 36207, United States
Cullman Clinical Trials ( Site 0538)
Cullman, Alabama, 35055, United States
Cullman Clinical Trials
Cullman, Alabama, 35055, United States
Hope Research Institute ( Site 0575)
Glendale, Arizona, 85308, United States
HOPE Research Institute
Glendale, Arizona, 85308, United States
Desert Clinical Research, LLC / Avacare
Mesa, Arizona, 85213, United States
Desert Clinical Research/ CCT Research ( Site 0612)
Mesa, Arizona, 85213, United States
Foothills Research Center ( Site 0591)
Phoenix, Arizona, 85044, United States
Foothills Research Center / Avacare
Phoenix, Arizona, 85044, United States
Fiel Family and Sports Medicine / Avacare
Tempe, Arizona, 85283, United States
Fiel Family and Sports Medicine, PC/CCT Research ( Site 0529)
Tempe, Arizona, 85283, United States
Hope Research Institute ( Site 0587)
Tempe, Arizona, 85284, United States
HOPE Research Institute
Tempe, Arizona, 85284, United States
Arizona Clinical Trials
Tucson, Arizona, 85711, United States
Arizona Liver Health ( Site 0516)
Tucson, Arizona, 85712, United States
Del Sol Research Management, LLC ( Site 0515)
Tucson, Arizona, 85715, United States
Del Sol Research Management, LLC
Tucson, Arizona, 85715, United States
Triallogix Medical Corporation ( Site 0615)
Fullerton, California, 92835, United States
Triallogix Medical Corporation
Fullerton, California, 92835, United States
National Institute of Clinical Research ( Site 0582)
Garden Grove, California, 92844, United States
National Institute of Clinical Research, Inc.
Garden Grove, California, 92844, United States
Eximia Clinical Research ( Site 0571)
La Mesa, California, 91942, United States
Eximia Research-CA, LLC
La Mesa, California, 91942, United States
Kinetic Clinical Research, LLC dba Long Beach Clinical Trials
Long Beach, California, 90806, United States
Long Beach Clinical Trials, LLC ( Site 0607)
Long Beach, California, 90806, United States
Profound Research LLC ( Site 0533)
Oceanside, California, 92058, United States
Seaside Medical Group
Oceanside, California, 92058, United States
Profound Research LLC ( Site 0574)
Pasadena, California, 91105, United States
Profound Research, LLC
Pasadena, California, 91105, United States
Paradigm Clinical Research Centers, Inc ( Site 0518)
Redding, California, 96001, United States
Paradigm Clinical Research
Redding, California, 96001, United States
Artemis Institute for Clinical Research ( Site 0617)
San Diego, California, 92103, United States
Artemis Institute for Clinical Research
San Diego, California, 92103, United States
Acclaim Clinical Research ( Site 0506)
San Diego, California, 92120, United States
Acclaim Clinical Research
San Diego, California, 92120, United States
Diablo Clinical Research, Inc. ( Site 0572)
Walnut Creek, California, 94598, United States
Diablo Clinical Research, Inc.
Walnut Creek, California, 94598, United States
Tekton Research ( Site 0611)
Denver, Colorado, 80238, United States
Tekton Research, LLC
Denver, Colorado, 80238, United States
Tekton Research, LLC
Fort Collins, Colorado, 80525, United States
Tekton Research ( Site 0613)
Fort Collins, Colorado, 80528, United States
Critical Care Pulmonary & Sleep Associates - CCT Research ( Site 0525)
Lakewood, Colorado, 80228, United States
Critical Care, Pulmonary and Sleep Associates PLLP / Avacare
Lakewood, Colorado, 80228, United States
Tekton Research, LLC. ( Site 0616)
Longmont, Colorado, 80501, United States
Tekton Research, LLC
Longmont, Colorado, 80501, United States
New England Research Associates, LLC ( Site 0558)
Bridgeport, Connecticut, 06606, United States
New England Research Associates
Bridgeport, Connecticut, 06606, United States
Stamford Therapeutics Consortium ( Site 0539)
Stamford, Connecticut, 06905, United States
Stamford Therapeutics Consortium
Stamford, Connecticut, 06905, United States
Emerson Clinical Research Institute ( Site 0547)
Washington D.C., District of Columbia, 20009, United States
Emerson Clinical Research Institute
Washington D.C., District of Columbia, 20009, United States
Imagine Research - Palm Beach County
Boynton Beach, Florida, 33435, United States
Imagine Research of Palm Beach County ( Site 0509)
Boynton Beach, Florida, 33435, United States
Innovative Research of West Florida ( Site 0596)
Clearwater, Florida, 33756, United States
Innovative Research of West Florida, Inc.
Clearwater, Florida, 33756, United States
Hillcrest Medical Research ( Site 0563)
DeLand, Florida, 32720, United States
Hillcrest Medical Research, LLC
DeLand, Florida, 32720, United States
Health Awareness, Inc. ( Site 0524)
Jupiter, Florida, 33458, United States
Health Awareness, Inc.
Jupiter, Florida, 33458, United States
Columbus Clinical Services ( Site 0588)
Miami, Florida, 33125, United States
Columbus Clinical Services, LLC
Miami, Florida, 33125, United States
Flourish Research - Miami, LLC DBA Flourish Research
Miami, Florida, 33135, United States
South Florida Research Center, Inc ( Site 0507)
Miami, Florida, 33135, United States
South Florida Research Center, Inc.
Miami, Florida, 33135, United States
Clinical Site Partners, LLC d/b/a CSP Miami ( Site 0521)
Miami, Florida, 33186, United States
Floridian Clinical Research, LLC ( Site 0534)
Miami Lakes, Florida, 33016, United States
Floridian Clinical Research, LLC
Miami Lakes, Florida, 33016, United States
Behavioral Clinical Research, Inc. ( Site 0508)
North Miami, Florida, 33161, United States
Healthcare Clinical Data, Inc.
North Miami, Florida, 33161, United States
Clinical Neuroscience Solutions ( Site 0623)
Orlando, Florida, 32806, United States
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, 32806, United States
Progressive Medical Research ( Site 0579)
Port Orange, Florida, 32127, United States
Progressive Medical Research
Port Orange, Florida, 32127, United States
Health Awareness, Inc. ( Site 0541)
Port Saint Lucie, Florida, 34952, United States
Health Awareness, Inc.
Port Saint Lucie, Florida, 34952, United States
Global Clinical Professionals
St. Petersburg, Florida, 33705, United States
GCP- Global Clinical Research Professionals, LLC ( Site 0595)
St. Petersburg, Florida, 33714, United States
Clinical Site Partners, LLC dba Flourish Research ( Site 0540)
Winter Park, Florida, 32789, United States
Clinical Site Partners, LLC dba Flourish Research
Winter Park, Florida, 32789, United States
Agile Clinical Research Trials, LLC ( Site 0600)
Atlanta, Georgia, 30328, United States
Agile Clinical Research Trials, LLC
Atlanta, Georgia, 30328, United States
DelRicht Research ( Site 0583)
Atlanta, Georgia, 30329, United States
DelRicht Research
Atlanta, Georgia, 30329, United States
Clinical Research Atlanta ( Site 0531)
Stockbridge, Georgia, 30281, United States
Clinical Research Atlanta
Stockbridge, Georgia, 30281, United States
Paradigm Clinical Research - Boise ( Site 0614)
Boise, Idaho, 83709, United States
Paradigm Clinical Research
Boise, Idaho, 83709, United States
Velocity Clinical Research - Boise
Meridian, Idaho, 83642, United States
Velocity Clinical Research, Boise ( Site 0535)
Meridian, Idaho, 83642, United States
Great Lakes Clinical Trials - Ravenswood ( Site 0564)
Chicago, Illinois, 60640, United States
Great Lakes Clinical Trials, LLC dba Flourish Research
Chicago, Illinois, 60640, United States
DM Clinical Research ( Site 0502)
Palos Heights, Illinois, 60463, United States
Velocity Clinical Research ( Site 0528)
Valparaiso, Indiana, 46383, United States
Velocity Clinical Research - Valparaiso
Valparaiso, Indiana, 46383, United States
Integrated Clinical Trial Services, Inc ( Site 0576)
West Des Moines, Iowa, 50265, United States
Integrated Clinical Trial Services, LLC
West Des Moines, Iowa, 50265, United States
Johnson County Clin-Trials ( Site 0530)
Lenexa, Kansas, 66219-1376, United States
Johnson County Clin-Trials, LLC
Lenexa, Kansas, 66219, United States
Alliance for Multispecialty Research, LLC ( Site 0561)
Newton, Kansas, 67114, United States
AMR Clinical
Newton, Kansas, 67114, United States
DelRicht Research ( Site 0585)
Louisville, Kentucky, 40205, United States
DelRicht Research
Louisville, Kentucky, 40205, United States
Elevate Clinical Research ( Site 0565)
Lake Charles, Louisiana, 70605, United States
Elevate Clinical Research
Lake Charles, Louisiana, 70605, United States
DelRicht Research ( Site 0510)
New Orleans, Louisiana, 70115, United States
DelRicht Research
New Orleans, Louisiana, 70115, United States
DelRicht Research ( Site 0594)
Prairieville, Louisiana, 70769-4212, United States
DelRicht Research
Prairieville, Louisiana, 70769, United States
Annapolis Internal Medicine - CCT Research ( Site 0580)
Annapolis, Maryland, 21401, United States
Annapolis Internal Medicine / Avacare
Annapolis, Maryland, 21401, United States
Jadestone Clinical Research, LLC ( Site 0555)
Silver Spring, Maryland, 20904, United States
Jadestone Clinical Research, LLC
Silver Spring, Maryland, 20904, United States
Skylight Health Research, Inc ( Site 0609)
Burlington, Massachusetts, 01803, United States
Skylight Health Research
Burlington, Massachusetts, 01803, United States
Profound Research LLC ( Site 0536)
Clarkston, Michigan, 48346, United States
Profound Research, LLC
Clarkston, Michigan, 48346, United States
Michigan Hematology & Oncology Consultants ( Site 0610)
Dearborn, Michigan, 48126, United States
Profound Research, LLC
Dearborn, Michigan, 48126, United States
Michigan Heathcare Professionals- TRIATRIA ( Site 0513)
Farmington Hills, Michigan, 48334, United States
Profound Research, LLC
Farmington Hills, Michigan, 48334, United States
Javara, Inc.
Mankato, Minnesota, 56001, United States
Mankato Clinic ( Site 0573)
Mankato, Minnesota, 56001, United States
DelRicht Research ( Site 0584)
Gulfport, Mississippi, 39503, United States
DelRicht Research
Gulfport, Mississippi, 39503, United States
Clay Platte Family Medicine, PC / Avacare
Kansas City, Missouri, 64151, United States
Clay- Platte Family Medicine, P.C.-CCT Research ( Site 0517)
Kansas City, Missouri, 64151, United States
DelRicht Research ( Site 0586)
Springfield, Missouri, 65807, United States
DelRicht Research
Springfield, Missouri, 65807, United States
Sundance Clinical Research LLC ( Site 0526)
St Louis, Missouri, 63141, United States
Sundance Clinical Research, LLC
St Louis, Missouri, 63141, United States
Montana Medical Research, Inc. ( Site 0570)
Missoula, Montana, 59808, United States
Montana Medical Research, Inc.
Missoula, Montana, 59808, United States
Methodist Physicians Clinic / Avacare
Fremont, Nebraska, 68025, United States
Methodist Physicians Clinic/CCT Research ( Site 0598)
Fremont, Nebraska, 68025, United States
Velocity Clinical Research - Omaha
Omaha, Nebraska, 68134, United States
Velocity Clinical Research, Omaha ( Site 0512)
Omaha, Nebraska, 68134, United States
Midwest Regional Health Services, LLC / Avacare ( Site 0603)
Omaha, Nebraska, 68144, United States
Midwest Regional Health Services, LLC / Avacare
Omaha, Nebraska, 68144, United States
Henderson Clinical Trials ( Site 0522)
Henderson, Nevada, 89052, United States
Henderson Clinical Trials
Henderson, Nevada, 89052, United States
Excel Clinical Research, LLC ( Site 0566)
Las Vegas, Nevada, 89109, United States
Excel Clinical Research
Las Vegas, Nevada, 89109, United States
Santa Rosa Medical Centers of Nevada / Avacare
Las Vegas, Nevada, 89119, United States
Santa Rosa Medical Centers of Nevada / CCT Research ( Site 0605)
Las Vegas, Nevada, 89119, United States
Las Vegas Clinical Trials ( Site 0527)
North Las Vegas, Nevada, 89030, United States
Las Vegas Clinical Trials, LLC
North Las Vegas, Nevada, 89030, United States
IMA Clinical Research ( Site 0599)
Warren Township, New Jersey, 07059, United States
IMA Clinical Research
Warren Township, New Jersey, 07059, United States
Brooklyn Clinical Research
Brooklyn, New York, 11226, United States
DM Clinical Research - Brooklyn ( Site 0550)
Brooklyn, New York, 11226, United States
Certified Research Associates ( Site 0552)
Cortland, New York, 13045, United States
Finger Lakes Medical Research, PLLC dba Certified Research Associates
Cortland, New York, 13045, United States
Drug Trials America ( Site 0553)
Hartsdale, New York, 10530, United States
Drug Trials America
Hartsdale, New York, 10530, United States
Rochester Clinical Research, Inc. ( Site 0557)
Rochester, New York, 14609, United States
Rochester Clinical Research
Rochester, New York, 14609, United States
CHEAR Center LLC ( Site 0543)
The Bronx, New York, 10455, United States
CHEAR Center, LLC
The Bronx, New York, 10455, United States
DelRicht Research
Charlotte, North Carolina, 28205, United States
DelRicht Research ( Site 0593)
Charlotte, North Carolina, 28210, United States
Eximia EquiHealth Research ( Site 0590)
Durham, North Carolina, 27704, United States
Eximia EquiHealth Research, LLC
Durham, North Carolina, 27704, United States
Monroe Biomedical Research ( Site 0549)
Monroe, North Carolina, 28112, United States
Monroe Biomedical Research
Monroe, North Carolina, 28112, United States
West Clinical Research ( Site 0542)
Morehead City, North Carolina, 28557, United States
West Clinical Research, Inc.
Morehead City, North Carolina, 28557, United States
OnSite Clinical Solutions ( Site 0608)
Salisbury, North Carolina, 28144, United States
OnSite Clinical Solutions, LLC
Salisbury, North Carolina, 28144, United States
Wilmington Health Associates ( Site 0548)
Wilmington, North Carolina, 28401, United States
Wilmington Health
Wilmington, North Carolina, 28412, United States
Wake Forest University Health Sciences ( Site 0569)
Winston-Salem, North Carolina, 27157, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157, United States
Velocity Clinical Research - Cleveland
Beachwood, Ohio, 44122, United States
Velocity Clinical Research - Springdale
Cincinnati, Ohio, 45246, United States
Velocity Clinical Research, Springdale ( Site 0511)
Cincinnati, Ohio, 45246, United States
Velocity Clinical Research- Cleveland ( Site 0520)
Cleveland, Ohio, 44122, United States
Centricity Research Columbus Ohio Multispecialty ( Site 0562)
Columbus, Ohio, 43213, United States
Centricity Research Columbus Ohio Multispecialty
Columbus, Ohio, 43213, United States
PriMED Clinical Research ( Site 0560)
Dayton, Ohio, 45429, United States
PriMed Clinical Research
Dayton, Ohio, 45429, United States
Tekton Research, LLC. ( Site 0601)
Edmond, Oklahoma, 73013, United States
Tekton Research, LLC
Edmond, Oklahoma, 73013, United States
Lynn Health Science Institute - East (OKC) ( Site 0544)
Oklahoma City, Oklahoma, 73111, United States
Lynn Health Science Institute East
Oklahoma City, Oklahoma, 73111, United States
DelRicht Research ( Site 0618)
Tulsa, Oklahoma, 74133, United States
DelRicht Research
Tulsa, Oklahoma, 74133, United States
Tekton Research, Inc. ( Site 0597)
Yukon, Oklahoma, 73099, United States
Tekton Research, LLC
Yukon, Oklahoma, 73099, United States
Altoona Center for Clinical Research ( Site 0545)
Duncansville, Pennsylvania, 16635, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635, United States
Central Erie Primary Care
Erie, Pennsylvania, 16508, United States
Liberty Family Practice ( Site 0546)
Erie, Pennsylvania, 16508, United States
Hatboro Medical Associates ( Site 0551)
Horsham, Pennsylvania, 19044, United States
Hatboro Medical Associates / Avacare
Horsham, Pennsylvania, 19044, United States
DM Clinical Research
Philadelphia, Pennsylvania, 19107, United States
DelRicht Research ( Site 0619)
Charleston, South Carolina, 29407, United States
DelRicht Research
Charleston, South Carolina, 29407, United States
Tribe Clinical Research, LLC ( Site 0577)
Greenville, South Carolina, 29607, United States
Tribe Clinical Research, LLC
Greenville, South Carolina, 29607, United States
Spartanburg Medical Research ( Site 0514)
Spartanburg, South Carolina, 29303, United States
Spartanburg Medical Research
Spartanburg, South Carolina, 29303, United States
Velocity Clinical Research - Spartanburg
Spartanburg, South Carolina, 29303, United States
Velocity Clinical Research, Spartanburg ( Site 0523)
Spartanburg, South Carolina, 29303, United States
DelRicht Research ( Site 0620)
Hendersonville, Tennessee, 37075, United States
DelRicht Research
Hendersonville, Tennessee, 37075, United States
DCT-HCWC, LLC dba Discovery Clinical Trials ( Site 0606)
Dallas, Texas, 75230, United States
DCT-HCWC, LLC dba Discovery Clinical Trials
Dallas, Texas, 75230, United States
Zenos Clinical Research ( Site 0537)
Dallas, Texas, 75230, United States
Zenos Clinical Research
Dallas, Texas, 75230, United States
Lonestar Clinical Research - Dallas ( Site 0501)
Dallas, Texas, 75243, United States
Lonestar Clinical Research, LLC
Dallas, Texas, 75243, United States
Elevate Clinical Research - Houston ( Site 0589)
Houston, Texas, 77058, United States
DM Clinical Research ( Site 0503)
Houston, Texas, 77065, United States
Laguna Clinical Research Associates LLC ( Site 0581)
Laredo, Texas, 78041, United States
Laguna Clinical Research Associates, LLC
Laredo, Texas, 78041, United States
Epic Clinical Research ( Site 0578)
Lewisville, Texas, 75057, United States
Epic Clinical Research
Lewisville, Texas, 75057, United States
Elevate Clinical Research - McAllen ( Site 0621)
McAllen, Texas, 78504, United States
Elevate Clinical Research
McAllen, Texas, 78504, United States
Pearland Physicians ( Site 0592)
Pearland, Texas, 77581, United States
Pearland Physicians
Pearland, Texas, 77581, United States
Javara - Privia Medical Group North Texas - Dallas ( Site 0519)
Plano, Texas, 75093, United States
Research Your Health ( Site 0567)
Plano, Texas, 75093, United States
Research Your Health
Plano, Texas, 75093, United States
Clinical Trials of Texas, LLC ( Site 0532)
San Antonio, Texas, 78229, United States
Clinical Trials of Texas, LLC dba Flourish Research
San Antonio, Texas, 78229, United States
Elevate Clinical Research
Seabrook, Texas, 77586, United States
Javara, Inc.
Stephenville, Texas, 76401, United States
DM Clinical Research
Tomball, Texas, 77375, United States
Cope Family Medicine / Avacare
Bountiful, Utah, 84010, United States
Cope Family Medicine / CCT Research ( Site 0602)
Bountiful, Utah, 84010, United States
Olympus Family Medicine / Avacare
Salt Lake City, Utah, 84117, United States
Olympus Family Medicine/CCT Research ( Site 0604)
Salt Lake City, Utah, 84117, United States
Charlottesville Medical Research ( Site 0559)
Charlottesville, Virginia, 22911, United States
Charlottesville Medical Research Center, LLC
Charlottesville, Virginia, 22911, United States
Clinical Research Partners, LLC. ( Site 0504)
Richmond, Virginia, 23226, United States
Clinical Research Partners, LLC
Richmond, Virginia, 23226, United States
Rainier Clinical Research Center ( Site 0556)
Renton, Washington, 98057, United States
Rainier Clinical Research Center
Renton, Washington, 98057, United States
Centro de Estudios InfectolĂ³gicos S.A. ( Site 0002)
CABA, Buenos Aires, C1002ABN, Argentina
Equipo Ciencia ( Site 0008)
Ciudad Autonoma de Buenos Aires, Buenos Aires, C1428BNF, Argentina
Centro Medico de Enfermedades Respiratorias ( Site 0005)
Florida, Buenos Aires, B1602DQD, Argentina
CINME - Centro de Investigaciones MetabĂ³licas ( Site 0007)
Buenos Aires, Buenos Aires F.D., C1056ABJ, Argentina
Sanatorio Mayo Privado S.A ( Site 0003)
CĂ³rdoba, CĂ³rdoba Province, X5000FAL, Argentina
CEMER Centro MĂ©dico Enfermedades Respiratorias
Buenos Aires, B1602DQD, Argentina
Centro de Estudios InfectolĂ³gicos
Buenos Aires, C1002ABJ, Argentina
CINME - Centro de Investigaciones Metabolicas
Buenos Aires, C1027AAP, Argentina
Equipo Ciencia
Buenos Aires, C1428BNF, Argentina
Sanatorio Mayo Privado S.A.
CĂ³rdoba, X5000FAL, Argentina
Instituto del Buen Aire ( Site 0006)
Santa Fe, S3000ASF, Argentina
Instituto IBAMEDICA
Santa Fe, S3000ASF, Argentina
Emeritus Research ( Site 0106)
Botany, New South Wales, 2019, Australia
Emeritus Research Sydney
Botany, New South Wales, 2019, Australia
Australian Clinical Research Network ( Site 0103)
Maroubra, New South Wales, 2035, Australia
Australian Clinical Research Network Pty Ltd
Maroubra, New South Wales, 2035, Australia
AIM Research
Merewether, New South Wales, 2291, Australia
The AIM Centre Hunter Diabetes Centre ( Site 0105)
Newcastle, New South Wales, 2291, Australia
Momentum Clinical Research St Leonards
Saint Leonards, New South Wales, 2065, Australia
Momentum St Leonards ( Site 0107)
St Leonards, New South Wales, 2065, Australia
Core Research Group ( Site 0102)
Brisbane, Queensland, 4064, Australia
Core Research Group Pty Ltd
Milton, Queensland, 4064, Australia
Momentum Clinical Research Taringa
Taringa, Queensland, 4062, Australia
Momentum Clinical Research Taringa ( Site 0104)
Taringa, Queensland, 4068, Australia
Emeritus Research ( Site 0101)
Camberwell, Victoria, 3124, Australia
Emeritus Research Camberwell
Camberwell, Victoria, 3124, Australia
Synergy Biomed Research Institute ( Site 0218)
East London, Eastern Cape, 5201, South Africa
Jose Pearson TB Hospital ( Site 0202)
Port Elizabeth, Eastern Cape, 6003, South Africa
Josha Research
Bloemfontein, Free State, 9300, South Africa
Josha Research ( Site 0216)
Bloemfontein, Free State, 9301, South Africa
Welkom Clinical Trial Centre ( Site 0219)
Welkom, Free State, 9460, South Africa
Ubuntu Clinical Research Center ( Site 0208)
Johannesburg, Gauteng, 1821, South Africa
Helen Joseph Hospital-Clinical HIV Research Unit ( Site 0205)
Johannesburg, Gauteng, 2000, South Africa
University of Witwatersrand, Clinical HIV Research Unit (CHRU), Helen Joseph Hospital
Johannesburg, Gauteng, 2092, South Africa
Ubuntu Clinical Research
Lenasia, Gauteng, 1827, South Africa
Newtown Clinical Research Centre ( Site 0207)
Newtown, Gauteng, 2001, South Africa
Emmed Research Incorporating ( Site 0209)
Pretoria, Gauteng, 0084, South Africa
Global Clinical Trials ( Site 0212)
Pretoria, Gauteng, 0157, South Africa
Jongaie Research ( Site 0214)
Pretoria West, Gauteng, 0183, South Africa
Centre for the Aids Programme of Research in South Africa. CAPRISA ( Site 0220)
Durban, KwaZulu-Natal, 4013, South Africa
Qhakaza Mbokodo Research Clinic ( Site 0215)
Ladysmith, KwaZulu-Natal, 3370, South Africa
Qhakaza Mbokodo Research Clinic
Ladysmith, KwaZulu-Natal, 3370, South Africa
Madibeng Centre for Research ( Site 0201)
Brits, North West, 0250, South Africa
Madibeng Centre for Research
Brits, North West, 0250, South Africa
Aurum Institute - Rustenburg ( Site 0203)
Rustenburg, North West, 0299, South Africa
TASK Applied Science - Headquarter ( Site 0211)
Cape Town, Western Cape, 7500, South Africa
TREAD Research ( Site 0206)
Cape Town, Western Cape, 7500, South Africa
Tiervlei Trial Centre ( Site 0204)
Cape Town, Western Cape, 7530, South Africa
Paarl Research Centre ( Site 0213)
Paarl, Western Cape, 7646, South Africa
Tiervlei Trial Centre
Bellville, 7530, South Africa
TREAD Research (Pty) Ltd
Bellville, 7530, South Africa
TASK Applied Science, Central
Cape Town, 7530, South Africa
Paarl Research Centre
Cape Town, 7646, South Africa
CAPRISA eThekwini Clinical Research Site
Durban, 4001, South Africa
Synergy Biomed Research Institute
East London, 5201, South Africa
Newtown Clinical Research Centre
Johannesburg, 2001, South Africa
Isango Lethemba TB Research Unit
Port Elizabeth, 6003, South Africa
Emmed Research
Pretoria, 0002, South Africa
Global Clinical Trials (Pty) Ltd
Pretoria, 0157, South Africa
Jongaie Research
Pretoria, 0183, South Africa
The Aurum Institute
Rustenburg, 0299, South Africa
Welkom Clinical Trial Centre
Welkom, 9460, South Africa
Aberdeen Royal Infirmary ( Site 0423)
Aberdeen, Aberdeen City, AB252ZN, United Kingdom
Southmead Hospital ( Site 0409)
Bristol, Bristol, City of, BS10 5NB, United Kingdom
Velocity Clinical Research, Bristol ( Site 0428)
Bristol, Bristol, City of, BS8 2RA, United Kingdom
Velocity Clinical Research High Wycombe ( Site 0406)
High Wycombe, Buckinghamshire, HP11 2QW, United Kingdom
Wansford Research ( Site 0429)
Peterborough, Cambridgeshire, PE8 6PL, United Kingdom
Royal Cornwall Hospitals NHS Trust ( Site 0410)
Truro, Cornwall, TR1 3LJ, United Kingdom
Western General Hospital ( Site 0421)
Edinburgh, Edinburgh, City of, EH4 2XU, United Kingdom
Queen Elizabeth Hospital, University Hospitals Birmingham NHS Foundation Trust
Birmingham, England, B15 2TH, United Kingdom
Fylde Coast Clinical Research at Layton Medical Centre
Blackpool, England, FY3 7EN, United Kingdom
Southmead Hospital, North Bristol NHS Trust - Clinical Research Centre
Bristol, England, BS10 5NB, United Kingdom
Velocity Clinical Research - Bristol
Bristol, England, BS8 2RA, United Kingdom
Eynsham Medical Centre
Eynsham, England, OX29 4QB, United Kingdom
Velocity Clinical Research - High Wycombe
High Wycombe, England, HP11 2QW, United Kingdom
HMC Health, The Meadows Centre for Health, The Great West Surgery
Hounslow, England, TW4 7NR, United Kingdom
Leeds Teaching Hospitals NHS Trust - St. James's University Hospital
Leeds, England, LS9 7TF, United Kingdom
University Hospitals of Leicester NHS Trust - Leicester Royal Infirmary
Leicester, England, LE1 5WW, United Kingdom
hVIVO Services Limited
London, England, E1 1EQ, United Kingdom
Panthera Enfield
London, England, EN3 4GS, United Kingdom
Velocity Clinical Research - North London
London, England, N12 8BU, United Kingdom
North Manchester General Hospital
Manchester, England, M8 5RB, United Kingdom
The University of Nottingham Health Service
Nottingham, England, NG7 2QW, United Kingdom
Wansford Research LTD
Peterborough, England, PE8 6PL, United Kingdom
University Hospitals Plymouth NHS Trust
Plymouth, England, PL6 8DH, United Kingdom
Panthera Preston
Preston, England, PR2 9QB, United Kingdom
Panthera Rochdale
Rochdale, England, OL11 4AU, United Kingdom
Velocity Clinical Research - Romford
Romford, England, RM1 3PJ, United Kingdom
Warrington and Halton Teaching Hospitals NHS Foundation Trust
Runcorn, England, WA7 2DA, United Kingdom
Salford Royal Hospital
Salford, England, M6 8HD, United Kingdom
Panthera Sheffield
Sheffield, England, S2 5FX, United Kingdom
University Hospital Southampton NHS Foundation Trust, NIHR Southampton Clinical Research Facility
Southampton, England, SO16 6YD, United Kingdom
Royal Cornwall Hospitals NHS Trust
Truro, England, TR1 3LJ, United Kingdom
Windrush Medical Practice
Witney, England, OX28 6JS, United Kingdom
Panthera York
York, England, YO24 4LJ, United Kingdom
Queen Elizabeth University Hospital ( Site 0422)
Glasgow, Glasgow City, G51 4TF, United Kingdom
Southampton General Hospital ( Site 0418)
Southampton, Hampshire, SO16 0YD, United Kingdom
Velocity Clinical Research Romford ( Site 0427)
London, Havering, +441708200585, United Kingdom
Layton Medical Centre ( Site 0405)
Blackpool, Lancashire, FY3 7EN, United Kingdom
Panthera Biopartners ( Site 0408)
Preston, Lancashire, PR2 9QB, United Kingdom
Panthera Biopartners ( Site 0407)
Enfield, London, City of, EN3 4GS, United Kingdom
The Great West Surgery ( Site 0415)
Hounslow, London, City of, TW4 7NJ, United Kingdom
hVIVO ( Site 0404)
London, London, City of, E1 1EQ, United Kingdom
Velocity Clinical Research North London ( Site 0430)
North Finchley, London, City of, N12 8BU, United Kingdom
Panthera Biopartners ( Site 0414)
Rochdale, Manchester, OL11 4AU, United Kingdom
Cripps Health Centre ( Site 0424)
Nottingham, Nottinghamshire, NG7 2QW, United Kingdom
Eynsham Medical Centre ( Site 0401)
Eynsham, Oxfordshire, OX29 4QB, United Kingdom
Windrush Medical Centre ( Site 0416)
Witney, Oxfordshire, OX28 6JS, United Kingdom
Aberdeen Royal Infirmary
Aberdeen, Scotland, AB25 2ZD, United Kingdom
NHS Lothian - Western General Hospital
Edinburgh, Scotland, EH4 2XU, United Kingdom
Queen Elizabeth University Hospital, Glasgow Clinical Research Facility
Glasgow, Scotland, G51 4TF, United Kingdom
Cardiff and Vale UHB - University Hospital of Wales
Cardiff, Wales, CF14 4XW, United Kingdom
University Hospital of Wales ( Site 0420)
Cardiff, Wales, CF14 4XW, United Kingdom
Queen Elizabeth Hospital ( Site 0411)
Birmingham, B15 2TH, United Kingdom
St James's University Hospital ( Site 0425)
Leeds, LS9 7TF, United Kingdom
Leicester Royal Infirmary ( Site 0426)
Leicester, LE1 5WW, United Kingdom
North Manchester General Hospital ( Site 0413)
Manchester, M8 5RB, United Kingdom
Derriford Hospital ( Site 0417)
Plymouth, PL6 8DH, United Kingdom
Salford Royal Hospital ( Site 0419)
Salford, M6 8HD, United Kingdom
Panthera Biopartners ( Site 0402)
Sheffield, S2 5FX, United Kingdom
Warrington Hospital ( Site 0412)
Warrington, WA5 1QG, United Kingdom
Panthera Biopartners ( Site 0403)
York, YO24 4LJ, United Kingdom
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Merck Sharp & Dohme LLC
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 29, 2025
First Posted
September 8, 2025
Study Start
September 25, 2025
Primary Completion (Estimated)
June 30, 2027
Study Completion (Estimated)
June 30, 2027
Last Updated
September 17, 2026
Record last verified: 2026-09
Data Sharing
- IPD Sharing
- Will share
https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf