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RECRUITING

NCT07159763

PHASE3

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

Sponsor: Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

12 Years - Any

Study Type

INTERVENTIONAL

Enrollment

10000

Start Date

2025-09-25

Completion Date

2027-06-30

Last Updated

2026-10-27

Healthy Volunteers

Conditions

Influenza

Interventions

COMBINATION_PRODUCT

MK-1406

MK-1406 liquid for injection administered subcutaneously (SC)

COMBINATION_PRODUCT

Placebo

MK-1406 matched liquid for SC injection

Inclusion Criteria: 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 Exclusion Criteria: 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)

Locations (185)

Pinnacle Research Group ( Site 0505)

Anniston, Alabama, United States

Cullman Clinical Trials ( Site 0538)

Cullman, Alabama, United States

Hope Research Institute ( Site 0575)

Glendale, Arizona, United States

Desert Clinical Research/ CCT Research ( Site 0612)

Mesa, Arizona, United States

Foothills Research Center ( Site 0591)

Phoenix, Arizona, United States

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

Tempe, Arizona, United States

Hope Research Institute ( Site 0587)

Tempe, Arizona, United States

Arizona Liver Health ( Site 0516)

Tucson, Arizona, United States

Del Sol Research Management, LLC ( Site 0515)

Tucson, Arizona, United States

Triallogix Medical Corporation ( Site 0615)

Fullerton, California, United States

National Institute of Clinical Research ( Site 0582)

Garden Grove, California, United States

Eximia Clinical Research ( Site 0571)

La Mesa, California, United States

Long Beach Clinical Trials, LLC ( Site 0607)

Long Beach, California, United States

Profound Research LLC ( Site 0533)

Oceanside, California, United States

Profound Research LLC ( Site 0574)

Pasadena, California, United States

Paradigm Clinical Research Centers, Inc ( Site 0518)

Redding, California, United States

Artemis Institute for Clinical Research ( Site 0617)

San Diego, California, United States

Acclaim Clinical Research ( Site 0506)

San Diego, California, United States

Diablo Clinical Research, Inc. ( Site 0572)

Walnut Creek, California, United States

Tekton Research ( Site 0611)

Denver, Colorado, United States

Tekton Research ( Site 0613)

Fort Collins, Colorado, United States

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

Lakewood, Colorado, United States

Tekton Research, LLC. ( Site 0616)

Longmont, Colorado, United States

New England Research Associates, LLC ( Site 0558)

Bridgeport, Connecticut, United States

Stamford Therapeutics Consortium ( Site 0539)

Stamford, Connecticut, United States

Emerson Clinical Research Institute ( Site 0547)

Washington D.C., District of Columbia, United States

Imagine Research of Palm Beach County ( Site 0509)

Boynton Beach, Florida, United States

Innovative Research of West Florida ( Site 0596)

Clearwater, Florida, United States

Hillcrest Medical Research ( Site 0563)

DeLand, Florida, United States

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

Fort Lauderdale, Florida, United States

Health Awareness, Inc. ( Site 0524)

Jupiter, Florida, United States

Columbus Clinical Services ( Site 0588)

Miami, Florida, United States

South Florida Research Center, Inc ( Site 0507)

Miami, Florida, United States

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

Miami, Florida, United States

Floridian Clinical Research, LLC ( Site 0534)

Miami Lakes, Florida, United States

Suncoast Clinical Research ( Site 0724)

New Port Richey, Florida, United States

Behavioral Clinical Research, Inc. ( Site 0508)

North Miami, Florida, United States

Clinical Neuroscience Solutions ( Site 0623)

Orlando, Florida, United States

Progressive Medical Research ( Site 0579)

Port Orange, Florida, United States

Health Awareness, Inc. ( Site 0541)

Port Saint Lucie, Florida, United States

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

St. Petersburg, Florida, United States

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

Winter Park, Florida, United States

Agile Clinical Research Trials, LLC ( Site 0600)

Atlanta, Georgia, United States

DelRicht Research ( Site 0583)

Atlanta, Georgia, United States

Clinical Research Atlanta ( Site 0531)

Stockbridge, Georgia, United States

Paradigm Clinical Research - Boise ( Site 0614)

Boise, Idaho, United States

Velocity Clinical Research, Boise ( Site 0535)

Meridian, Idaho, United States

Great Lakes Clinical Trials - Ravenswood ( Site 0564)

Chicago, Illinois, United States

DM Clinical Research ( Site 0736)

Melrose Park, Illinois, United States

DM Clinical Research ( Site 0502)

Palos Heights, Illinois, United States

Velocity Clinical Research ( Site 0528)

Valparaiso, Indiana, United States

Integrated Clinical Trial Services, Inc ( Site 0576)

West Des Moines, Iowa, United States

Johnson County Clin-Trials ( Site 0530)

Lenexa, Kansas, United States

Alliance for Multispecialty Research, LLC ( Site 0561)

Newton, Kansas, United States

DelRicht Research ( Site 0585)

Louisville, Kentucky, United States

Elevate Clinical Research ( Site 0565)

Lake Charles, Louisiana, United States

DelRicht Research ( Site 0510)

New Orleans, Louisiana, United States

DelRicht Research ( Site 0594)

Prairieville, Louisiana, United States

Annapolis Internal Medicine - CCT Research ( Site 0580)

Annapolis, Maryland, United States

Jadestone Clinical Research, LLC ( Site 0555)

Silver Spring, Maryland, United States

Skylight Health Research, Inc ( Site 0609)

Burlington, Massachusetts, United States

Profound Research LLC ( Site 0536)

Clarkston, Michigan, United States

Michigan Hematology & Oncology Consultants ( Site 0610)

Dearborn, Michigan, United States

Michigan Heathcare Professionals- TRIATRIA ( Site 0513)

Farmington Hills, Michigan, United States

Mankato Clinic ( Site 0573)

Mankato, Minnesota, United States

DelRicht Research ( Site 0584)

Gulfport, Mississippi, United States

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

Kansas City, Missouri, United States

DelRicht Research ( Site 0586)

Springfield, Missouri, United States

Sundance Clinical Research LLC ( Site 0526)

St Louis, Missouri, United States

Montana Medical Research, Inc. ( Site 0570)

Missoula, Montana, United States

Methodist Physicians Clinic/CCT Research ( Site 0598)

Fremont, Nebraska, United States

Velocity Clinical Research, Omaha ( Site 0512)

Omaha, Nebraska, United States

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

Omaha, Nebraska, United States

Henderson Clinical Trials ( Site 0522)

Henderson, Nevada, United States

Excel Clinical Research, LLC ( Site 0566)

Las Vegas, Nevada, United States

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

Las Vegas, Nevada, United States

Las Vegas Clinical Trials ( Site 0527)

North Las Vegas, Nevada, United States

IMA Clinical Research ( Site 0599)

Warren Township, New Jersey, United States

DM Clinical Research - Brooklyn ( Site 0550)

Brooklyn, New York, United States

Certified Research Associates ( Site 0552)

Cortland, New York, United States

Drug Trials America ( Site 0553)

Hartsdale, New York, United States

Rochester Clinical Research, Inc. ( Site 0557)

Rochester, New York, United States

CHEAR Center LLC ( Site 0543)

The Bronx, New York, United States

DelRicht Research ( Site 0593)

Charlotte, North Carolina, United States

Eximia EquiHealth Research ( Site 0590)

Durham, North Carolina, United States

Monroe Biomedical Research ( Site 0549)

Monroe, North Carolina, United States

West Clinical Research ( Site 0542)

Morehead City, North Carolina, United States

OnSite Clinical Solutions ( Site 0608)

Salisbury, North Carolina, United States

Wilmington Health Associates ( Site 0548)

Wilmington, North Carolina, United States

Wake Forest University Health Sciences ( Site 0569)

Winston-Salem, North Carolina, United States

Velocity Clinical Research, Springdale ( Site 0511)

Cincinnati, Ohio, United States

Velocity Clinical Research- Cleveland ( Site 0520)

Cleveland, Ohio, United States

Centricity Research Columbus Ohio Multispecialty ( Site 0562)

Columbus, Ohio, United States

PriMED Clinical Research ( Site 0560)

Dayton, Ohio, United States

Tekton Research, LLC. ( Site 0601)

Edmond, Oklahoma, United States

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

Oklahoma City, Oklahoma, United States

DelRicht Research ( Site 0618)

Tulsa, Oklahoma, United States

Tekton Research, Inc. ( Site 0597)

Yukon, Oklahoma, United States

Altoona Center for Clinical Research ( Site 0545)

Duncansville, Pennsylvania, United States

Liberty Family Practice ( Site 0546)

Erie, Pennsylvania, United States

And 85 more locations on ClinicalTrials.gov

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (185)