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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

Status: Recruiting
Location: See all (185) locations...
Intervention Type: Combination product
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Healthy Volunteers: f
View:

∙ 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

• 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

Locations
United States
Alabama
Pinnacle Research Group ( Site 0505)
RECRUITING
Anniston
Cullman Clinical Trials ( Site 0538)
RECRUITING
Cullman
Arizona
Hope Research Institute ( Site 0575)
RECRUITING
Glendale
Desert Clinical Research/ CCT Research ( Site 0612)
ACTIVE_NOT_RECRUITING
Mesa
Foothills Research Center ( Site 0591)
ACTIVE_NOT_RECRUITING
Phoenix
Fiel Family and Sports Medicine, PC/CCT Research ( Site 0529)
ACTIVE_NOT_RECRUITING
Tempe
Hope Research Institute ( Site 0587)
RECRUITING
Tempe
Arizona Liver Health ( Site 0516)
ACTIVE_NOT_RECRUITING
Tucson
Del Sol Research Management, LLC ( Site 0515)
RECRUITING
Tucson
California
Triallogix Medical Corporation ( Site 0615)
RECRUITING
Fullerton
National Institute of Clinical Research ( Site 0582)
ACTIVE_NOT_RECRUITING
Garden Grove
Eximia Clinical Research ( Site 0571)
ACTIVE_NOT_RECRUITING
La Mesa
Long Beach Clinical Trials, LLC ( Site 0607)
ACTIVE_NOT_RECRUITING
Long Beach
Profound Research LLC ( Site 0533)
ACTIVE_NOT_RECRUITING
Oceanside
Profound Research LLC ( Site 0574)
RECRUITING
Pasadena
Paradigm Clinical Research Centers, Inc ( Site 0518)
RECRUITING
Redding
Acclaim Clinical Research ( Site 0506)
ACTIVE_NOT_RECRUITING
San Diego
Artemis Institute for Clinical Research ( Site 0617)
ACTIVE_NOT_RECRUITING
San Diego
Diablo Clinical Research, Inc. ( Site 0572)
ACTIVE_NOT_RECRUITING
Walnut Creek
Colorado
Tekton Research ( Site 0611)
RECRUITING
Denver
Tekton Research ( Site 0613)
ACTIVE_NOT_RECRUITING
Fort Collins
Critical Care Pulmonary & Sleep Associates - CCT Research ( Site 0525)
RECRUITING
Lakewood
Tekton Research, LLC. ( Site 0616)
ACTIVE_NOT_RECRUITING
Longmont
Connecticut
New England Research Associates, LLC ( Site 0558)
RECRUITING
Bridgeport
Stamford Therapeutics Consortium ( Site 0539)
ACTIVE_NOT_RECRUITING
Stamford
Washington, D.c.
Emerson Clinical Research Institute ( Site 0547)
ACTIVE_NOT_RECRUITING
Washington D.c.
Florida
Imagine Research of Palm Beach County ( Site 0509)
ACTIVE_NOT_RECRUITING
Boynton Beach
Innovative Research of West Florida ( Site 0596)
ACTIVE_NOT_RECRUITING
Clearwater
Hillcrest Medical Research ( Site 0563)
ACTIVE_NOT_RECRUITING
Deland
The Oncology Institute of Hope and Innovation - Fort Lauderdale ( Site 0728)
RECRUITING
Fort Lauderdale
Health Awareness, Inc. ( Site 0524)
RECRUITING
Jupiter
Clinical Site Partners, LLC d/b/a CSP Miami ( Site 0521)
ACTIVE_NOT_RECRUITING
Miami
Columbus Clinical Services ( Site 0588)
ACTIVE_NOT_RECRUITING
Miami
South Florida Research Center, Inc ( Site 0507)
ACTIVE_NOT_RECRUITING
Miami
Floridian Clinical Research, LLC ( Site 0534)
RECRUITING
Miami Lakes
Suncoast Clinical Research ( Site 0724)
RECRUITING
New Port Richey
Behavioral Clinical Research, Inc. ( Site 0508)
ACTIVE_NOT_RECRUITING
North Miami
Clinical Neuroscience Solutions ( Site 0623)
ACTIVE_NOT_RECRUITING
Orlando
Progressive Medical Research ( Site 0579)
RECRUITING
Port Orange
Health Awareness, Inc. ( Site 0541)
RECRUITING
Port Saint Lucie
GCP- Global Clinical Research Professionals, LLC ( Site 0595)
RECRUITING
St. Petersburg
Clinical Site Partners, LLC dba Flourish Research ( Site 0540)
RECRUITING
Winter Park
Georgia
Agile Clinical Research Trials, LLC ( Site 0600)
RECRUITING
Atlanta
DelRicht Research ( Site 0583)
RECRUITING
Atlanta
Clinical Research Atlanta ( Site 0531)
RECRUITING
Stockbridge
Iowa
Integrated Clinical Trial Services, Inc ( Site 0576)
RECRUITING
West Des Moines
Idaho
Paradigm Clinical Research - Boise ( Site 0614)
RECRUITING
Boise
Velocity Clinical Research, Boise ( Site 0535)
RECRUITING
Meridian
Illinois
Great Lakes Clinical Trials - Ravenswood ( Site 0564)
RECRUITING
Chicago
DM Clinical Research ( Site 0736)
RECRUITING
Melrose Park
DM Clinical Research ( Site 0502)
RECRUITING
Palos Heights
Indiana
Velocity Clinical Research ( Site 0528)
ACTIVE_NOT_RECRUITING
Valparaiso
Kansas
Johnson County Clin-Trials ( Site 0530)
RECRUITING
Lenexa
Alliance for Multispecialty Research, LLC ( Site 0561)
RECRUITING
Newton
Kentucky
DelRicht Research ( Site 0585)
ACTIVE_NOT_RECRUITING
Louisville
Louisiana
Elevate Clinical Research ( Site 0565)
ACTIVE_NOT_RECRUITING
Lake Charles
DelRicht Research ( Site 0510)
ACTIVE_NOT_RECRUITING
New Orleans
DelRicht Research ( Site 0594)
RECRUITING
Prairieville
Massachusetts
Skylight Health Research, Inc ( Site 0609)
RECRUITING
Burlington
Maryland
Annapolis Internal Medicine - CCT Research ( Site 0580)
RECRUITING
Annapolis
Jadestone Clinical Research, LLC ( Site 0555)
ACTIVE_NOT_RECRUITING
Silver Spring
Michigan
Profound Research LLC ( Site 0536)
ACTIVE_NOT_RECRUITING
Clarkston
Michigan Hematology & Oncology Consultants ( Site 0610)
RECRUITING
Dearborn
Michigan Heathcare Professionals- TRIATRIA ( Site 0513)
ACTIVE_NOT_RECRUITING
Farmington Hills
Minnesota
Mankato Clinic ( Site 0573)
RECRUITING
Mankato
Missouri
Clay- Platte Family Medicine, P.C.-CCT Research ( Site 0517)
ACTIVE_NOT_RECRUITING
Kansas City
DelRicht Research ( Site 0586)
ACTIVE_NOT_RECRUITING
Springfield
Sundance Clinical Research LLC ( Site 0526)
RECRUITING
St Louis
Mississippi
DelRicht Research ( Site 0584)
ACTIVE_NOT_RECRUITING
Gulfport
Montana
Montana Medical Research, Inc. ( Site 0570)
ACTIVE_NOT_RECRUITING
Missoula
North Carolina
DelRicht Research ( Site 0593)
ACTIVE_NOT_RECRUITING
Charlotte
Eximia EquiHealth Research ( Site 0590)
ACTIVE_NOT_RECRUITING
Durham
Monroe Biomedical Research ( Site 0549)
ACTIVE_NOT_RECRUITING
Monroe
West Clinical Research ( Site 0542)
ACTIVE_NOT_RECRUITING
Morehead City
OnSite Clinical Solutions ( Site 0608)
ACTIVE_NOT_RECRUITING
Salisbury
Wilmington Health Associates ( Site 0548)
RECRUITING
Wilmington
Wake Forest University Health Sciences ( Site 0569)
RECRUITING
Winston-salem
Nebraska
Methodist Physicians Clinic/CCT Research ( Site 0598)
RECRUITING
Fremont
Midwest Regional Health Services, LLC / Avacare ( Site 0603)
RECRUITING
Omaha
Velocity Clinical Research, Omaha ( Site 0512)
ACTIVE_NOT_RECRUITING
Omaha
New Jersey
IMA Clinical Research ( Site 0599)
ACTIVE_NOT_RECRUITING
Warren Township
Nevada
Henderson Clinical Trials ( Site 0522)
ACTIVE_NOT_RECRUITING
Henderson
Excel Clinical Research, LLC ( Site 0566)
RECRUITING
Las Vegas
Santa Rosa Medical Centers of Nevada / CCT Research ( Site 0605)
RECRUITING
Las Vegas
Las Vegas Clinical Trials ( Site 0527)
ACTIVE_NOT_RECRUITING
North Las Vegas
New York
DM Clinical Research - Brooklyn ( Site 0550)
RECRUITING
Brooklyn
Certified Research Associates ( Site 0552)
ACTIVE_NOT_RECRUITING
Cortland
Drug Trials America ( Site 0553)
ACTIVE_NOT_RECRUITING
Hartsdale
Rochester Clinical Research, Inc. ( Site 0557)
ACTIVE_NOT_RECRUITING
Rochester
CHEAR Center LLC ( Site 0543)
ACTIVE_NOT_RECRUITING
The Bronx
Ohio
Velocity Clinical Research, Springdale ( Site 0511)
ACTIVE_NOT_RECRUITING
Cincinnati
Velocity Clinical Research- Cleveland ( Site 0520)
ACTIVE_NOT_RECRUITING
Cleveland
Centricity Research Columbus Ohio Multispecialty ( Site 0562)
ACTIVE_NOT_RECRUITING
Columbus
PriMED Clinical Research ( Site 0560)
RECRUITING
Dayton
Oklahoma
Tekton Research, LLC. ( Site 0601)
RECRUITING
Edmond
Lynn Health Science Institute - East (OKC) ( Site 0544)
ACTIVE_NOT_RECRUITING
Oklahoma City
DelRicht Research ( Site 0618)
RECRUITING
Tulsa
Tekton Research, Inc. ( Site 0597)
ACTIVE_NOT_RECRUITING
Yukon
Pennsylvania
Altoona Center for Clinical Research ( Site 0545)
ACTIVE_NOT_RECRUITING
Duncansville
Liberty Family Practice ( Site 0546)
RECRUITING
Erie
Hatboro Medical Associates ( Site 0551)
ACTIVE_NOT_RECRUITING
Horsham
South Carolina
DelRicht Research ( Site 0619)
ACTIVE_NOT_RECRUITING
Charleston
Tribe Clinical Research, LLC ( Site 0577)
RECRUITING
Greenville
Spartanburg Medical Research ( Site 0514)
RECRUITING
Spartanburg
Velocity Clinical Research, Spartanburg ( Site 0523)
ACTIVE_NOT_RECRUITING
Spartanburg
Tennessee
DelRicht Research ( Site 0620)
ACTIVE_NOT_RECRUITING
Hendersonville
Texas
DCT-HCWC, LLC dba Discovery Clinical Trials ( Site 0606)
RECRUITING
Dallas
Lonestar Clinical Research - Dallas ( Site 0501)
ACTIVE_NOT_RECRUITING
Dallas
Zenos Clinical Research ( Site 0537)
ACTIVE_NOT_RECRUITING
Dallas
DM Clinical Research ( Site 0503)
ACTIVE_NOT_RECRUITING
Houston
Elevate Clinical Research - Houston ( Site 0589)
RECRUITING
Houston
Laguna Clinical Research Associates LLC ( Site 0581)
ACTIVE_NOT_RECRUITING
Laredo
Epic Clinical Research ( Site 0578)
ACTIVE_NOT_RECRUITING
Lewisville
Elevate Clinical Research - McAllen ( Site 0621)
ACTIVE_NOT_RECRUITING
Mcallen
Pearland Physicians ( Site 0592)
ACTIVE_NOT_RECRUITING
Pearland
Javara - Privia Medical Group North Texas - Dallas ( Site 0519)
ACTIVE_NOT_RECRUITING
Plano
Research Your Health ( Site 0567)
RECRUITING
Plano
Clinical Trials of Texas, LLC ( Site 0532)
ACTIVE_NOT_RECRUITING
San Antonio
Utah
Cope Family Medicine / CCT Research ( Site 0602)
ACTIVE_NOT_RECRUITING
Bountiful
Olympus Family Medicine/CCT Research ( Site 0604)
ACTIVE_NOT_RECRUITING
Salt Lake City
Virginia
Charlottesville Medical Research ( Site 0559)
RECRUITING
Charlottesville
Clinical Research Partners, LLC. ( Site 0504)
RECRUITING
Richmond
Washington
Rainier Clinical Research Center ( Site 0556)
ACTIVE_NOT_RECRUITING
Renton
Other Locations
Argentina
CINME - Centro de Investigaciones Metabólicas ( Site 0007)
ACTIVE_NOT_RECRUITING
Buenos Aires
Centro de Estudios Infectológicos S.A. ( Site 0002)
ACTIVE_NOT_RECRUITING
Caba
Equipo Ciencia ( Site 0008)
ACTIVE_NOT_RECRUITING
Ciudad Autonoma De Buenos Aires
Sanatorio Mayo Privado S.A ( Site 0003)
ACTIVE_NOT_RECRUITING
Córdoba
Centro Medico de Enfermedades Respiratorias ( Site 0005)
ACTIVE_NOT_RECRUITING
Florida
Instituto del Buen Aire ( Site 0006)
ACTIVE_NOT_RECRUITING
Santa Fe
Australia
Emeritus Research ( Site 0106)
ACTIVE_NOT_RECRUITING
Botany
Core Research Group ( Site 0102)
ACTIVE_NOT_RECRUITING
Brisbane
Emeritus Research ( Site 0101)
ACTIVE_NOT_RECRUITING
Camberwell
Australian Clinical Research Network ( Site 0103)
ACTIVE_NOT_RECRUITING
Maroubra
The AIM Centre Hunter Diabetes Centre ( Site 0105)
ACTIVE_NOT_RECRUITING
Newcastle
Momentum St Leonards ( Site 0107)
ACTIVE_NOT_RECRUITING
St Leonards
Momentum Clinical Research Taringa ( Site 0104)
ACTIVE_NOT_RECRUITING
Taringa
Japan
Ishikawa Prefectural Central Hospital ( Site 0814)
RECRUITING
Kanazawa
South Africa
Josha Research ( Site 0216)
ACTIVE_NOT_RECRUITING
Bloemfontein
Madibeng Centre for Research ( Site 0201)
ACTIVE_NOT_RECRUITING
Brits
TASK Applied Science - Headquarter ( Site 0211)
ACTIVE_NOT_RECRUITING
Cape Town
Tiervlei Trial Centre ( Site 0204)
ACTIVE_NOT_RECRUITING
Cape Town
TREAD Research ( Site 0206)
ACTIVE_NOT_RECRUITING
Cape Town
Centre for the Aids Programme of Research in South Africa. CAPRISA ( Site 0220)
ACTIVE_NOT_RECRUITING
Durban
Synergy Biomed Research Institute ( Site 0218)
ACTIVE_NOT_RECRUITING
East London
Helen Joseph Hospital-Clinical HIV Research Unit ( Site 0205)
ACTIVE_NOT_RECRUITING
Johannesburg
Ubuntu Clinical Research Center ( Site 0208)
ACTIVE_NOT_RECRUITING
Johannesburg
Qhakaza Mbokodo Research Clinic ( Site 0215)
ACTIVE_NOT_RECRUITING
Ladysmith
Newtown Clinical Research Centre ( Site 0207)
ACTIVE_NOT_RECRUITING
Newtown
Paarl Research Centre ( Site 0213)
ACTIVE_NOT_RECRUITING
Paarl
Jose Pearson TB Hospital ( Site 0202)
ACTIVE_NOT_RECRUITING
Port Elizabeth
Emmed Research Incorporating ( Site 0209)
ACTIVE_NOT_RECRUITING
Pretoria
Global Clinical Trials ( Site 0212)
ACTIVE_NOT_RECRUITING
Pretoria
Jongaie Research ( Site 0214)
ACTIVE_NOT_RECRUITING
Pretoria West
Aurum Institute - Rustenburg ( Site 0203)
ACTIVE_NOT_RECRUITING
Rustenburg
Welkom Clinical Trial Centre ( Site 0219)
ACTIVE_NOT_RECRUITING
Welkom
United Kingdom
Aberdeen Royal Infirmary ( Site 0423)
RECRUITING
Aberdeen
Queen Elizabeth Hospital ( Site 0411)
ACTIVE_NOT_RECRUITING
Birmingham
Layton Medical Centre ( Site 0405)
RECRUITING
Blackpool
Southmead Hospital ( Site 0409)
ACTIVE_NOT_RECRUITING
Bristol
Velocity Clinical Research, Bristol ( Site 0428)
RECRUITING
Bristol
University Hospital of Wales ( Site 0420)
ACTIVE_NOT_RECRUITING
Cardiff
Western General Hospital ( Site 0421)
RECRUITING
Edinburgh
Panthera Biopartners ( Site 0407)
ACTIVE_NOT_RECRUITING
Enfield
Eynsham Medical Centre ( Site 0401)
RECRUITING
Eynsham
Queen Elizabeth University Hospital ( Site 0422)
RECRUITING
Glasgow
Velocity Clinical Research High Wycombe ( Site 0406)
ACTIVE_NOT_RECRUITING
High Wycombe
The Great West Surgery ( Site 0415)
RECRUITING
Hounslow
St James's University Hospital ( Site 0425)
ACTIVE_NOT_RECRUITING
Leeds
Leicester Royal Infirmary ( Site 0426)
ACTIVE_NOT_RECRUITING
Leicester
hVIVO ( Site 0404)
RECRUITING
London
Velocity Clinical Research Romford ( Site 0427)
ACTIVE_NOT_RECRUITING
London
North Manchester General Hospital ( Site 0413)
ACTIVE_NOT_RECRUITING
Manchester
Velocity Clinical Research North London ( Site 0430)
ACTIVE_NOT_RECRUITING
North Finchley
Cripps Health Centre ( Site 0424)
RECRUITING
Nottingham
Wansford Research ( Site 0429)
ACTIVE_NOT_RECRUITING
Peterborough
Derriford Hospital ( Site 0417)
RECRUITING
Plymouth
Panthera Biopartners ( Site 0408)
ACTIVE_NOT_RECRUITING
Preston
Panthera Biopartners ( Site 0414)
ACTIVE_NOT_RECRUITING
Rochdale
Salford Royal Hospital ( Site 0419)
ACTIVE_NOT_RECRUITING
Salford
Panthera Biopartners ( Site 0402)
ACTIVE_NOT_RECRUITING
Sheffield
Southampton General Hospital ( Site 0418)
RECRUITING
Southampton
Royal Cornwall Hospitals NHS Trust ( Site 0410)
ACTIVE_NOT_RECRUITING
Truro
Warrington Hospital ( Site 0412)
RECRUITING
Warrington
Windrush Medical Centre ( Site 0416)
ACTIVE_NOT_RECRUITING
Witney
Panthera Biopartners ( Site 0403)
ACTIVE_NOT_RECRUITING
York
Contact Information
Primary
Toll Free Number
Trialsites@msd.com
1-888-577-8839
Time Frame
Start Date: 2025-09-25
Estimated Completion Date: 2027-06-30
Participants
Target number of participants: 10000
Treatments
Experimental: MK-1406
Participants will receive 450 milligrams (mg) dose of MK-1406 (CD388) by subcutaneous (SC) injection.
Placebo_comparator: Placebo
Participants will receive placebo by SC injection.
Related Therapeutic Areas
Sponsors
Leads: Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

This content was sourced from clinicaltrials.gov