AzTrials
AzTrials

InfluenzaPhase 3ANCHORNCT07159763

A Study to Evaluate the Safety and Efficacy of MK-1406/CD388 for Prevention of Influenza (MK-1406-005/CD388.SQ.3.06)

A Phase 3 study testing MK-1406 in people with Influenza, run by Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) at 211 sites in 6 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 12 years and older
Conditions the study is for
Influenza
What is being tested?
MK-1406
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
10,000 participants
Where
211 sitesin 6 countries
Study dates
25 Sep 2025to 30 Jun 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • The main inclusion criteria include but are not limited to the following:
  • 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
Show all 25Show fewer
  • 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
  • Is currently receiving at least two immunosuppressive medications
  • Participants who have had a hematopoietic stem cell transplant (HSCT) must satisfy at least one of the following:
  • Has a history of hematopoietic stem cell transplantation (HSCT) (i.e., autologous, allogeneic, bone marrow, peripheral blood stem cell, tandem [peripheral blood and marrow]) within 1 year of screening
  • Has a history of non-autologous HSCT with graft-versus-host disease (GvHD) requiring active treatment with immunosuppressants (e.g., systemic corticosteroids ≥1 mg/kg at screening), regardless of the duration of time since HSCT
  • Is receiving immunosuppressive medicines
  • Has received chimeric antigen receptor-modified T-cell therapy
  • Has received B-cell depleting therapies (e.g., rituximab, ocrelizumab, ofatumumab, alemtuzumab) within the 12 months prior to screening
  • Has a diagnosis of any primary immunodeficiency except immunoglobulin A (IgA) deficiency
  • Has advanced or untreated human immunodeficiency virus (HIV) infection

Who cannot join

  • The main exclusion criteria include but are not limited to the following:
  • 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)

Trial locations and contacts

211 sites in 6 countries. Contact the study team or a site near you to ask about taking part.

Toll Free Number contact

1-888-577-8839

Trialsites@msd.com

211 sites in 6 countries

United States135 sites, 66 recruiting

  • DM Clinical Research ( Site 0731)

    Albuquerque, New Mexico, 87106

    Study Coordinator, 505-348-9500

    Recruiting

  • Michigan Institute of Research (MIR) ( Site 0734)

    Allen Park, Michigan, 29406

    Study Coordinator, 313-220-6681

    Recruiting

  • Annapolis Internal Medicine - CCT Research ( Site 0580)

    Annapolis, Maryland, 21401

    Study Coordinator, 410-897-9841

    Recruiting

  • Pinnacle Research Group ( Site 0505)

    Anniston, Alabama, 36207

    Study Coordinator, 256-452-1160

    Recruiting

  • Agile Clinical Research Trials, LLC ( Site 0600)

    Atlanta, Georgia, 30328

    Study Coordinator, 404-400-2255

    Recruiting

  • DelRicht Research ( Site 0583)

    Atlanta, Georgia, 30329

    Study Coordinator, 504-336-2667

    Recruiting

  • Paradigm Clinical Research - Boise ( Site 0614)

    Boise, Idaho, 83709

    Study Coordinator, 208-801-7438

    Recruiting

  • Cope Family Medicine / CCT Research ( Site 0602)

    Bountiful, Utah, 84010

    Active, not recruiting

  • Imagine Research of Palm Beach County ( Site 0509)

    Boynton Beach, Florida, 33435

    Active, not recruiting

  • New England Research Associates, LLC ( Site 0558)

    Bridgeport, Connecticut, 06606

    Study Coordinator, 203-374-9816

    Recruiting

  • DM Clinical Research - Brooklyn ( Site 0550)

    Brooklyn, New York, 11226

    Study Coordinator, 929-552-2442

    Recruiting

  • Skylight Health Research, Inc ( Site 0609)

    Burlington, Massachusetts, 01803

    Study Coordinator, 781-328-2491

    Recruiting

  • Profound Research LLC ( Site 0743)

    Carlsbad, California, 92011

    Study Coordinator, 858-248-1245

    Recruiting

  • DelRicht Research ( Site 0619)

    Charleston, South Carolina, 29407

    Active, not recruiting

  • DelRicht Research ( Site 0593)

    Charlotte, North Carolina, 28210

    Active, not recruiting

  • Charlottesville Medical Research ( Site 0559)

    Charlottesville, Virginia, 22911

    Study Coordinator, 434-817-2442

    Recruiting

  • Great Lakes Clinical Trials - Ravenswood ( Site 0564)

    Chicago, Illinois, 60640

    Study Coordinator, 773-769-3500

    Recruiting

  • Velocity Clinical Research, Springdale ( Site 0511)

    Cincinnati, Ohio, 45246

    Active, not recruiting

  • Profound Research LLC ( Site 0536)

    Clarkston, Michigan, 48346

    Active, not recruiting

  • Innovative Research of West Florida ( Site 0596)

    Clearwater, Florida, 33756

    Active, not recruiting

  • Velocity Clinical Research- Cleveland ( Site 0520)

    Cleveland, Ohio, 44122

    Active, not recruiting

  • Centricity Research Columbus Ohio Multispecialty ( Site 0562)

    Columbus, Ohio, 43213

    Active, not recruiting

  • Certified Research Associates ( Site 0552)

    Cortland, New York, 13045

    Active, not recruiting

  • Cullman Clinical Trials ( Site 0538)

    Cullman, Alabama, 35055

    Study Coordinator, 256-708-2826

    Recruiting

  • DCT-HCWC, LLC dba Discovery Clinical Trials ( Site 0606)

    Dallas, Texas, 75230

    Study Coordinator, 817-378-0855

    Recruiting

  • Zenos Clinical Research ( Site 0537)

    Dallas, Texas, 75230

    Active, not recruiting

  • Lonestar Clinical Research - Dallas ( Site 0501)

    Dallas, Texas, 75243

    Active, not recruiting

  • PriMED Clinical Research ( Site 0560)

    Dayton, Ohio, 45429

    Study Coordinator, 937-534-4201

    Recruiting

  • Michigan Hematology & Oncology Consultants ( Site 0610)

    Dearborn, Michigan, 48126

    Study Coordinator, 313-816-1600

    Recruiting

  • Hillcrest Medical Research ( Site 0563)

    DeLand, Florida, 32720

    Active, not recruiting

  • Tekton Research ( Site 0611)

    Denver, Colorado, 80238

    Study Coordinator, 303-345-6994

    Recruiting

  • Altoona Center for Clinical Research ( Site 0545)

    Duncansville, Pennsylvania, 16635

    Active, not recruiting

  • Eximia EquiHealth Research ( Site 0590)

    Durham, North Carolina, 27704

    Active, not recruiting

  • Tekton Research, LLC. ( Site 0601)

    Edmond, Oklahoma, 73013

    Study Coordinator, 405-534-5609

    Recruiting

  • Liberty Family Practice ( Site 0546)

    Erie, Pennsylvania, 16508

    Study Coordinator, 814-868-9828

    Recruiting

  • Michigan Heathcare Professionals- TRIATRIA ( Site 0513)

    Farmington Hills, Michigan, 48334

    Active, not recruiting

  • Tekton Research ( Site 0613)

    Fort Collins, Colorado, 80528

    Active, not recruiting

  • The Oncology Institute of Hope and Innovation - Fort Lauderdale ( Site 0728)

    Fort Lauderdale, Florida, 33316

    Study Coordinator, 561-955-6400

    Recruiting

  • Methodist Physicians Clinic/CCT Research ( Site 0598)

    Fremont, Nebraska, 68025

    Study Coordinator, 402-753-6034

    Recruiting

  • Triallogix Medical Corporation ( Site 0615)

    Fullerton, California, 92835

    Study Coordinator, 281-772-4450

    Recruiting

  • National Institute of Clinical Research ( Site 0582)

    Garden Grove, California, 92844

    Active, not recruiting

  • Hope Research Institute ( Site 0575)

    Glendale, Arizona, 85308

    Study Coordinator, 602-288-4673

    Recruiting

  • Tribe Clinical Research, LLC ( Site 0577)

    Greenville, South Carolina, 29607

    Study Coordinator, 864-334-0141

    Recruiting

  • DelRicht Research ( Site 0584)

    Gulfport, Mississippi, 39503

    Active, not recruiting

  • Drug Trials America ( Site 0553)

    Hartsdale, New York, 10530

    Active, not recruiting

  • Henderson Clinical Trials ( Site 0522)

    Henderson, Nevada, 89052

    Active, not recruiting

  • DelRicht Research ( Site 0620)

    Hendersonville, Tennessee, 37075

    Active, not recruiting

  • Hatboro Medical Associates ( Site 0551)

    Horsham, Pennsylvania, 19044

    Active, not recruiting

  • Elevate Clinical Research - Houston ( Site 0589)

    Houston, Texas, 77058

    Study Coordinator, 281-282-0808

    Recruiting

  • DM Clinical Research ( Site 0503)

    Houston, Texas, 77065

    Active, not recruiting

  • Hutchinson Clinic, P.A. ( Site 0729)

    Hutchinson, Kansas, 67502

    Study Coordinator, 620-694-2141

    Recruiting

  • Health Awareness, Inc. ( Site 0524)

    Jupiter, Florida, 33458

    Study Coordinator, 561-741-2033

    Recruiting

  • Clay- Platte Family Medicine, P.C.-CCT Research ( Site 0517)

    Kansas City, Missouri, 64151

    Active, not recruiting

  • Eximia Clinical Research ( Site 0571)

    La Mesa, California, 91942

    Active, not recruiting

  • Elevate Clinical Research ( Site 0565)

    Lake Charles, Louisiana, 70605

    Active, not recruiting

  • Critical Care Pulmonary & Sleep Associates - CCT Research ( Site 0525)

    Lakewood, Colorado, 80228

    Study Coordinator, 303-951-0600

    Recruiting

  • Laguna Clinical Research Associates LLC ( Site 0581)

    Laredo, Texas, 78041

    Active, not recruiting

  • Excel Clinical Research, LLC ( Site 0566)

    Las Vegas, Nevada, 89109

    Study Coordinator, 702-680-1500

    Recruiting

  • Santa Rosa Medical Centers of Nevada / CCT Research ( Site 0605)

    Las Vegas, Nevada, 89119

    Study Coordinator, 725-237-2605

    Recruiting

  • Johnson County Clin-Trials ( Site 0530)

    Lenexa, Kansas, 66219-1376

    Study Coordinator, 913-825-4400

    Recruiting

  • Epic Clinical Research ( Site 0578)

    Lewisville, Texas, 75057

    Active, not recruiting

  • Long Beach Clinical Trials, LLC ( Site 0607)

    Long Beach, California, 90806

    Active, not recruiting

  • Tekton Research, LLC. ( Site 0616)

    Longmont, Colorado, 80501

    Active, not recruiting

  • DelRicht Research ( Site 0585)

    Louisville, Kentucky, 40205

    Active, not recruiting

  • Mankato Clinic ( Site 0573)

    Mankato, Minnesota, 56001

    Study Coordinator, 507-216-0972

    Recruiting

  • Elevate Clinical Research - McAllen ( Site 0621)

    McAllen, Texas, 78504

    Active, not recruiting

  • DM Clinical Research ( Site 0736)

    Melrose Park, Illinois, 33016

    Study Coordinator, 312-761-4252

    Recruiting

  • Velocity Clinical Research, Boise ( Site 0535)

    Meridian, Idaho, 83642

    Study Coordinator, 208-377-8653

    Recruiting

  • Desert Clinical Research/ CCT Research ( Site 0612)

    Mesa, Arizona, 85213

    Active, not recruiting

  • Columbus Clinical Services ( Site 0588)

    Miami, Florida, 33125

    Active, not recruiting

  • South Florida Research Center, Inc ( Site 0507)

    Miami, Florida, 33135

    Active, not recruiting

  • Hope Research Network-Miami ( Site 0742)

    Miami, Florida, 33166

    Study Coordinator, 786-803-8692

    Recruiting

  • Clinical Site Partners, LLC d/b/a CSP Miami ( Site 0521)

    Miami, Florida, 33186

    Active, not recruiting

  • Floridian Clinical Research, LLC ( Site 0534)

    Miami Lakes, Florida, 33016

    Study Coordinator, 305-330-9977

    Recruiting

  • Indago Research and Health Center Inc ( Site 0725)

    Miami Lakes, Florida, 33016

    Study Coordinator, 305-825-6588

    Recruiting

  • Helios Clinical Research - CLE ( Site 0740)

    Middleburg Heights, Ohio, 44130

    Study Coordinator, 440-340-9010

    Recruiting

  • Montana Medical Research, Inc. ( Site 0570)

    Missoula, Montana, 59808

    Active, not recruiting

  • Paradigm Clinical Research, LLC ( Site 0733)

    Modesto, California, 95355

    Study Coordinator, 530-247-7049

    Recruiting

  • Monroe Biomedical Research ( Site 0549)

    Monroe, North Carolina, 28112

    Active, not recruiting

  • West Clinical Research ( Site 0542)

    Morehead City, North Carolina, 28557

    Active, not recruiting

  • DelRicht Research ( Site 0510)

    New Orleans, Louisiana, 70115

    Active, not recruiting

  • Suncoast Clinical Research ( Site 0724)

    New Port Richey, Florida, 34652

    Study Coordinator, 727-849-4131

    Recruiting

  • Alliance for Multispecialty Research, LLC ( Site 0561)

    Newton, Kansas, 67114

    Study Coordinator, 316-283-0828

    Recruiting

  • Las Vegas Clinical Trials ( Site 0527)

    North Las Vegas, Nevada, 89030

    Active, not recruiting

  • Behavioral Clinical Research, Inc. ( Site 0508)

    North Miami, Florida, 33161

    Active, not recruiting

  • Valley Clinical Trials Inc. ( Site 0741)

    Northridge, California, 91325

    Study Coordinator, 818-280-4220

    Recruiting

  • Profound Research LLC ( Site 0533)

    Oceanside, California, 92058

    Active, not recruiting

  • Lynn Health Science Institute - East (OKC) ( Site 0544)

    Oklahoma City, Oklahoma, 73111

    Active, not recruiting

  • Velocity Clinical Research, Omaha ( Site 0512)

    Omaha, Nebraska, 68134

    Active, not recruiting

  • Midwest Regional Health Services, LLC / Avacare ( Site 0603)

    Omaha, Nebraska, 68144

    Study Coordinator, 402-778-5490

    Recruiting

  • Clinical Neuroscience Solutions ( Site 0623)

    Orlando, Florida, 32806

    Active, not recruiting

  • DM Clinical Research ( Site 0502)

    Palos Heights, Illinois, 60463

    Study Coordinator, 445-300-9011

    Recruiting

  • Profound Research LLC ( Site 0574)

    Pasadena, California, 91105

    Study Coordinator, 62679312270

    Recruiting

  • Pearland Physicians ( Site 0592)

    Pearland, Texas, 77581

    Active, not recruiting

  • Foothills Research Center ( Site 0591)

    Phoenix, Arizona, 85044

    Active, not recruiting

  • Javara - Privia Medical Group North Texas - Dallas ( Site 0519)

    Plano, Texas, 75093

    Active, not recruiting

  • Research Your Health ( Site 0567)

    Plano, Texas, 75093

    Study Coordinator, 972-999-1155

    Recruiting

  • Progressive Medical Research ( Site 0579)

    Port Orange, Florida, 32127

    Study Coordinator, 386-304-7070

    Recruiting

  • Health Awareness, Inc. ( Site 0541)

    Port Saint Lucie, Florida, 34952

    Study Coordinator, 561-741-2033

    Recruiting

  • DelRicht Research ( Site 0594)

    Prairieville, Louisiana, 70769-4212

    Study Coordinator, 225-412-0316

    Recruiting

  • Paradigm Clinical Research Centers, Inc ( Site 0518)

    Redding, California, 96001

    Study Coordinator, 530-232-3000

    Recruiting

  • Rainier Clinical Research Center ( Site 0556)

    Renton, Washington, 98057

    Active, not recruiting

  • Clinical Research Partners, LLC. ( Site 0504)

    Richmond, Virginia, 23226

    Study Coordinator, 804-477-3045

    Recruiting

  • Rochester Clinical Research, Inc. ( Site 0557)

    Rochester, New York, 14609

    Active, not recruiting

  • OnSite Clinical Solutions ( Site 0608)

    Salisbury, North Carolina, 28144

    Active, not recruiting

  • Olympus Family Medicine/CCT Research ( Site 0604)

    Salt Lake City, Utah, 84117

    Active, not recruiting

  • Clinical Trials of Texas, LLC ( Site 0532)

    San Antonio, Texas, 78229

    Active, not recruiting

  • Artemis Institute for Clinical Research ( Site 0617)

    San Diego, California, 92103

    Active, not recruiting

  • Acclaim Clinical Research ( Site 0506)

    San Diego, California, 92120

    Active, not recruiting

  • Profound Research LLC ( Site 0744)

    San Diego, California, 92120

    Study Coordinator, 619-229-3909

    Recruiting

  • Jadestone Clinical Research, LLC ( Site 0555)

    Silver Spring, Maryland, 20904

    Active, not recruiting

  • DM Clinical Research ( Site 0739)

    Southfield, Michigan, 98105

    Study Coordinator, 248-585-8265

    Recruiting

  • Spartanburg Medical Research ( Site 0514)

    Spartanburg, South Carolina, 29303

    Study Coordinator, 864-583-1556

    Recruiting

  • Velocity Clinical Research, Spartanburg ( Site 0523)

    Spartanburg, South Carolina, 29303

    Active, not recruiting

  • DelRicht Research ( Site 0586)

    Springfield, Missouri, 65807

    Active, not recruiting

  • Sundance Clinical Research LLC ( Site 0526)

    St Louis, Missouri, 63141

    Study Coordinator, 314-567-3377

    Recruiting

  • GCP- Global Clinical Research Professionals, LLC ( Site 0595)

    St. Petersburg, Florida, 33714

    Study Coordinator, 208-346-8900

    Recruiting

  • Stamford Therapeutics Consortium ( Site 0539)

    Stamford, Connecticut, 06905

    Active, not recruiting

  • Clinical Research Atlanta ( Site 0531)

    Stockbridge, Georgia, 30281

    Study Coordinator, 770-507-6867

    Recruiting

  • Fiel Family and Sports Medicine, PC/CCT Research ( Site 0529)

    Tempe, Arizona, 85283

    Active, not recruiting

  • Hope Research Institute ( Site 0587)

    Tempe, Arizona, 85284

    Study Coordinator, 480-786-6655

    Recruiting

  • CHEAR Center LLC ( Site 0543)

    The Bronx, New York, 10455

    Active, not recruiting

  • Arizona Liver Health ( Site 0516)

    Tucson, Arizona, 85712

    Active, not recruiting

  • Del Sol Research Management, LLC ( Site 0515)

    Tucson, Arizona, 85715

    Study Coordinator, 520-647-9926

    Recruiting

  • DelRicht Research ( Site 0618)

    Tulsa, Oklahoma, 74133

    Study Coordinator, 918-932-2276

    Recruiting

  • Velocity Clinical Research ( Site 0528)

    Valparaiso, Indiana, 46383

    Active, not recruiting

  • Diablo Clinical Research, Inc. ( Site 0572)

    Walnut Creek, California, 94598

    Active, not recruiting

  • IMA Clinical Research ( Site 0599)

    Warren Township, New Jersey, 07059

    Active, not recruiting

  • Emerson Clinical Research Institute ( Site 0547)

    Washington D.C., District of Columbia, 20009

    Active, not recruiting

  • Integrated Clinical Trial Services, Inc ( Site 0576)

    West Des Moines, Iowa, 50265

    Study Coordinator, 515-223-2300

    Recruiting

  • Triple O Research Institute, P.A ( Site 0727)

    West Palm Beach, Florida, 33407

    Study Coordinator, 561-855-7871

    Recruiting

  • Wilmington Health Associates ( Site 0548)

    Wilmington, North Carolina, 28401

    Study Coordinator, 910-815-3262

    Recruiting

  • Wake Forest University Health Sciences ( Site 0569)

    Winston-Salem, North Carolina, 27157

    Study Coordinator, 336-716-4584

    Recruiting

  • Clinical Site Partners, LLC dba Flourish Research ( Site 0540)

    Winter Park, Florida, 32789

    Study Coordinator, 667-210-5368

    Recruiting

  • Tekton Research, Inc. ( Site 0597)

    Yukon, Oklahoma, 73099

    Active, not recruiting

Other trials in United States

United Kingdom35 sites, 17 recruiting

  • Aberdeen Royal Infirmary ( Site 0423)

    Aberdeen, Aberdeen City, AB252ZN

    Study Coordinator, 441224558109

    Recruiting

  • Queen Elizabeth Hospital ( Site 0411)

    Birmingham, B15 2TH

    Active, not recruiting

  • Birmingham Heartlands Hospital ( Site 0440)

    Birmingham, B9 5SS

    Study Coordinator, +441213713178

    Recruiting

  • Layton Medical Centre ( Site 0405)

    Blackpool, Lancashire, FY3 7EN

    Study Coordinator, 01253204084

    Recruiting

  • Bradford Royal Infirmary ( Site 0444)

    Bradford, BD9 6RJ

    Study Coordinator, +441274383383

    Recruiting

  • Royal Sussex County Hospital ( Site 0443)

    Brighton, Brighton And Hove, BN2 5BE

    Study Coordinator, +441273696955

    Recruiting

  • Southmead Hospital ( Site 0409)

    Bristol, Bristol, City of, BS10 5NB

    Active, not recruiting

  • Velocity Clinical Research, Bristol ( Site 0428)

    Bristol, Bristol, City of, BS8 2RA

    Study Coordinator, 4401174611208

    Recruiting

  • University Hospital of Wales ( Site 0420)

    Cardiff, Wales, CF14 4XW

    Active, not recruiting

  • Lakeside Healthcare ( Site 0445)

    Corby, Northamptonshire, NN17 2UR

    Study Coordinator, +441536748282

    Recruiting

  • Western General Hospital ( Site 0421)

    Edinburgh, Edinburgh, City of, EH4 2XU

    Study Coordinator, 01315372840

    Recruiting

  • Panthera Biopartners ( Site 0407)

    Enfield, London, City of, EN3 4GS

    Active, not recruiting

  • Eynsham Medical Centre ( Site 0401)

    Eynsham, Oxfordshire, OX29 4QB

    Study Coordinator, 4407738683874

    Recruiting

  • Queen Elizabeth University Hospital ( Site 0422)

    Glasgow, Glasgow City, G51 4TF

    Study Coordinator, 1422327600

    Recruiting

  • Velocity Clinical Research High Wycombe ( Site 0406)

    High Wycombe, Buckinghamshire, HP11 2QW

    Active, not recruiting

  • The Great West Surgery ( Site 0415)

    Hounslow, London, City of, TW4 7NJ

    Study Coordinator, 02086303414

    Recruiting

  • St James's University Hospital ( Site 0425)

    Leeds, LS9 7TF

    Active, not recruiting

  • Leicester Royal Infirmary ( Site 0426)

    Leicester, LE1 5WW

    Active, not recruiting

  • Velocity Clinical Research Romford ( Site 0427)

    London, Havering, +441708200585

    Active, not recruiting

  • hVIVO ( Site 0404)

    London, London, City of, E1 1EQ

    Study Coordinator, 02077561414

    Recruiting

  • North Manchester General Hospital ( Site 0413)

    Manchester, M8 5RB

    Active, not recruiting

  • Bioluminux Ltd ( Site 0446)

    Milton Keynes, Buckinghamshire, MK15 0DU

    Study Coordinator, 442033012990

    Recruiting

  • Velocity Clinical Research North London ( Site 0430)

    North Finchley, London, City of, N12 8BU

    Active, not recruiting

  • Cripps Health Centre ( Site 0424)

    Nottingham, Nottinghamshire, NG7 2QW

    Study Coordinator, 01158227979

    Recruiting

  • Wansford Research ( Site 0429)

    Peterborough, Cambridgeshire, PE8 6PL

    Active, not recruiting

  • Derriford Hospital ( Site 0417)

    Plymouth, PL6 8DH

    Study Coordinator, 01752439123

    Recruiting

  • Panthera Biopartners ( Site 0408)

    Preston, Lancashire, PR2 9QB

    Active, not recruiting

  • Panthera Biopartners ( Site 0414)

    Rochdale, Manchester, OL11 4AU

    Active, not recruiting

  • Salford Royal Hospital ( Site 0419)

    Salford, M6 8HD

    Active, not recruiting

  • Panthera Biopartners ( Site 0402)

    Sheffield, S2 5FX

    Active, not recruiting

  • Southampton General Hospital ( Site 0418)

    Southampton, Hampshire, SO16 0YD

    Study Coordinator, 02381204939

    Recruiting

  • Royal Cornwall Hospitals NHS Trust ( Site 0410)

    Truro, Cornwall, TR1 3LJ

    Active, not recruiting

  • Warrington Hospital ( Site 0412)

    Warrington, WA5 1QG

    Study Coordinator, 01925662213

    Recruiting

  • Windrush Medical Centre ( Site 0416)

    Witney, Oxfordshire, OX28 6JS

    Active, not recruiting

  • Panthera Biopartners ( Site 0403)

    York, YO24 4LJ

    Active, not recruiting

Other trials in United Kingdom

South Africa18 sites

  • Josha Research ( Site 0216)

    Bloemfontein, Free State, 9301

    Active, not recruiting

  • Madibeng Centre for Research ( Site 0201)

    Brits, North West, 0250

    Active, not recruiting

  • TASK Applied Science - Headquarter ( Site 0211)

    Cape Town, Western Cape, 7500

    Active, not recruiting

  • TREAD Research ( Site 0206)

    Cape Town, Western Cape, 7500

    Active, not recruiting

  • Tiervlei Trial Centre ( Site 0204)

    Cape Town, Western Cape, 7530

    Active, not recruiting

  • Centre for the Aids Programme of Research in South Africa. CAPRISA ( Site 0220)

    Durban, KwaZulu-Natal, 4013

    Active, not recruiting

  • Synergy Biomed Research Institute ( Site 0218)

    East London, Eastern Cape, 5201

    Active, not recruiting

  • Ubuntu Clinical Research Center ( Site 0208)

    Johannesburg, Gauteng, 1821

    Active, not recruiting

  • Helen Joseph Hospital-Clinical HIV Research Unit ( Site 0205)

    Johannesburg, Gauteng, 2000

    Active, not recruiting

  • Qhakaza Mbokodo Research Clinic ( Site 0215)

    Ladysmith, KwaZulu-Natal, 3370

    Active, not recruiting

  • Newtown Clinical Research Centre ( Site 0207)

    Newtown, Gauteng, 2001

    Active, not recruiting

  • Paarl Research Centre ( Site 0213)

    Paarl, Western Cape, 7646

    Active, not recruiting

  • Jose Pearson TB Hospital ( Site 0202)

    Port Elizabeth, Eastern Cape, 6003

    Active, not recruiting

  • Emmed Research Incorporating ( Site 0209)

    Pretoria, Gauteng, 0084

    Active, not recruiting

  • Global Clinical Trials ( Site 0212)

    Pretoria, Gauteng, 0157

    Active, not recruiting

  • Jongaie Research ( Site 0214)

    Pretoria West, Gauteng, 0183

    Active, not recruiting

  • Aurum Institute - Rustenburg ( Site 0203)

    Rustenburg, North West, 0299

    Active, not recruiting

  • Welkom Clinical Trial Centre ( Site 0219)

    Welkom, Free State, 9460

    Active, not recruiting

Other trials in South Africa

Japan10 sites, 10 recruiting

  • Takeuchi Hospital ( Site 0818)

    Arakawa City, Tokyo, 116-0002

    Study Coordinator, +810338927771

    Recruiting

  • Ishikawa Prefectural Central Hospital ( Site 0814)

    Kanazawa, Ishikawa-ken, 920-8530

    Study Coordinator, +81762378211

    Recruiting

  • Medical Corporation Chiyukai Shin Komonji Hospital ( Site 0820)

    Kitakyushu, Fukuoka, 800-0057

    Study Coordinator, +81933911001

    Recruiting

  • National Hospital Organization Tokyo National Hospital ( Site 0802)

    Kiyose, Tokyo, 204-8585

    Study Coordinator, +81424912111

    Recruiting

  • National Hospital Organization Kumamoto Medical Center ( Site 0801)

    Kumamoto, 860-0008

    Study Coordinator, 81963536501

    Recruiting

  • Maebashi Hirosegawa Clinic ( Site 0804)

    Maebashi, Gunma, 371-0022

    Study Coordinator, +81272314101

    Recruiting

  • Jobu Hospital for Respiratory Diseases ( Site 0821)

    Maebashi, Gunma, 371-0048

    Study Coordinator, +81272325000

    Recruiting

  • National Hospital Organization Tokyo Medical Center ( Site 0807)

    Meguro City, Tokyo, 152-8902

    Study Coordinator, +81333531211

    Recruiting

  • Association of Healthcare Corporation Oyama East Clinic ( Site 0823)

    Oyama, Tochigi, 323-0022

    Study Coordinator, +81285242200

    Recruiting

  • NewHeart Watanabe Institute ( Site 0811)

    Suginami, Tokyo, 168-0065

    Study Coordinator, +81762652355

    Recruiting

Other trials in Japan

Australia7 sites

  • Emeritus Research ( Site 0106)

    Botany, New South Wales, 2019

    Active, not recruiting

  • Core Research Group ( Site 0102)

    Brisbane, Queensland, 4064

    Active, not recruiting

  • Emeritus Research ( Site 0101)

    Camberwell, Victoria, 3124

    Active, not recruiting

  • Australian Clinical Research Network ( Site 0103)

    Maroubra, New South Wales, 2035

    Active, not recruiting

  • The AIM Centre Hunter Diabetes Centre ( Site 0105)

    Newcastle, New South Wales, 2291

    Active, not recruiting

  • Momentum St Leonards ( Site 0107)

    St Leonards, New South Wales, 2065

    Active, not recruiting

  • Momentum Clinical Research Taringa ( Site 0104)

    Taringa, Queensland, 4068

    Active, not recruiting

Other trials in Australia

Argentina6 sites

  • CINME - Centro de Investigaciones Metabólicas ( Site 0007)

    Buenos Aires, Buenos Aires F.D., C1056ABJ

    Active, not recruiting

  • Centro de Estudios Infectológicos S.A. ( Site 0002)

    CABA, Buenos Aires, C1002ABN

    Active, not recruiting

  • Equipo Ciencia ( Site 0008)

    Ciudad Autonoma de Buenos Aires, Buenos Aires, C1428BNF

    Active, not recruiting

  • Sanatorio Mayo Privado S.A ( Site 0003)

    Córdoba, Córdoba Province, X5000FAL

    Active, not recruiting

  • Centro Medico de Enfermedades Respiratorias ( Site 0005)

    Florida, Buenos Aires, B1602DQD

    Active, not recruiting

  • Instituto del Buen Aire ( Site 0006)

    Santa Fe, S3000ASF

    Active, not recruiting

Other trials in Argentina

About this study

Official title: 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

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.

Read the detailed description

This is a Phase 3, randomized, double-blind, placebo-controlled, parallel-group, multicenter study to evaluate the efficacy, safety, and tolerability of MK-1406 (CD388) administered as a single dose via 3 subcutaneous (SC) injections in adult and adolescent participants who are at higher risk of developing complications from influenza.

Conditions
Influenza
Being tested
MK-1406, Placebo
Keywords
Influenza, Antiviral Agents
Medical subject headings
Influenza, Human

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MK-1406Combination product

    Also called CD388

    MK-1406 liquid for injection administered subcutaneously (SC)

  • PlaceboCombination product

    MK-1406 matched liquid for SC injection

Study groups in NCT07159763
Study groupRoleWhat they receive
MK-1406ExperimentalParticipants will receive 450 milligrams (mg) dose of MK-1406 (CD388) by subcutaneous (SC) injection.
Receives: Combination Product: MK-1406
PlaceboPlacebo comparatorParticipants will receive placebo by SC injection.
Receives: Combination Product: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Up to approximately 24 weeks post dose

Secondary outcomes (9)

  1. Number of participants with ≥1 Adverse Event (AE)

    An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants with ≥1 AE will be assessed.

    Measured: Up to approximately Day 197

  2. Number of Participants Who Discontinued from the Study Due to an AE

    An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinued the study because of an AE will be assessed.

    Measured: Up to approximately Day 197

  3. Number of Participants with Injection Site Reactions (ISRs)

    Participants will complete the injection site reaction questionnaire in the eDiary Day 1 through Day 8 following the study intervention administration to assess for reactogenicity, based on the US Food and Drug Administration (FDA) toxicity grading scale used for vaccine trials. Injection site reactions are graded on a scale from 1 to 5 where Grade 1 is mild, Grade 2 is moderate, Grade 3 is severe and Grade 4 is potentially life threatening. The injection-site reactions assessed are pain, tenderness, erythema/redness, and induration/swelling.

    Measured: Up to approximately Day 8 post dose

  4. 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

    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 Stratum B ((immunocompromised participants) experiencing protocol-defined ILI occurring after administration of CD388, with influenza infection confirmed by an RT-PCR+ result based on an NP swab assayed at a central laboratory (first occurrence only), as compared to placebo will be assessed.

    Measured: Up to approximately 24 weeks post dose

  5. Number of Participants with All-cause Hospitalization within 30 Days after the Onset of Symptomatic Laboratory-Confirmed Influenza

    Hospitalizations are defined as an overnight admission in a hospital or similar acute care facility, including emergency rooms due to any cause within 30 days after the onset of symptomatic laboratory-confirmed influenza infection which occurred from ≥ 7 days after and up to 24 weeks after study intervention administration. Number of participants with all-cause hospitalization within 30 days after the onset of symptomatic influenza will be assessed.

    Measured: Up to 30 days after onset of symptomatic laboratory-confirmed influenza

  6. Number of Participants with All-cause Mortality within 30 Days after the Onset of Symptomatic Laboratory-Confirmed Influenza

    Number of participants with mortality due to any cause within 30 days after the onset of symptomatic laboratory-confirmed influenza infection which occurred from ≥ 7 days after and up to 24 weeks after study intervention administration will be determined.

    Measured: Up to 30 days after onset of symptomatic laboratory-confirmed influenza

  7. Plasma Concentrations Following Administration of MK-1406 (CD388)

    Blood samples will be collected at multiple time points to assess the plasma concentrations of MK-1406.

    Measured: Day 1 (pre-dose), Day 29, and Day 197 post dose

  8. Number of Participants with Treatment Emergent Anti-Drug Antibodies (ADAs)

    The number of participants with confirmed anti MK-1406 antibodies post-baseline (i.e. treatment-emergent ADAs) will be determined via evaluation of blood samples collected at multiple time points.

    Measured: Day 1 (pre-dose), Day 29, and Day 197 post dose

  9. Number of Participants with Treatment Boosted ADAs

    The number of participants with an increase in ADA titer over an initial positive baseline titer (i.e., treatment-boosted ADAs) will be determined will be determined via evaluation of blood samples collected at multiple time points.

    Measured: Day 1 (pre-dose), Day 29, and Day 197 post dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Sep 2025
  2. Study start25 Sep 2025
  3. Primary completion30 Jun 2027 (estimated)
  4. Study completion30 Jun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
10,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07159763
Sponsor's protocol ID
1406-005
Other IDs
CD388.SQ.3.06, MK-1406-005, ANCHOR
Acronym
ANCHOR
Status last verified
Nov 2026
First submitted
29 Aug 2025
Last updated
6 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing MK-1406 in people with Influenza, run by Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) at 211 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 25 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 211 sites in United States, United Kingdom, South Africa, Japan, Australia and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Toll Free Number (1-888-577-8839, Trialsites@msd.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Experiencing Protocol-defined Influenza-like Illness (ILI) Occurring ≥7 Days after and up to 24 Weeks after Administration of Study Drug (time frame: Up to approximately 24 weeks post dose). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07159763.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.

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