Ireland
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Recruiting Phase 3

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

NCT07159763 · tracked via the Priya Life Science USA tracker
Phase
Phase 3
Started
2025-09-25
Last updated
2026-10-27

Condition(s) studied

Influenza

Investigational drug(s) / intervention(s)

MK-1406Placebo

MK-1406: MK-1406 liquid for injection administered subcutaneously (SC)

Placebo: MK-1406 matched liquid for SC injection

Study 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

Sex
ALL
Min age
12 Years
Max age
—
Healthy volunteers
No
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)

Primary outcome measure(s)

  • Number of 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
    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.

Trial sites (185)

FacilityCityRegionStatus
Pinnacle Research Group ( Site 0505) Anniston Alabama Recruiting
Cullman Clinical Trials ( Site 0538) Cullman Alabama Recruiting
Hope Research Institute ( Site 0575) Glendale Arizona Recruiting
Desert Clinical Research/ CCT Research ( Site 0612) Mesa Arizona Active Not Recruiting
Foothills Research Center ( Site 0591) Phoenix Arizona Active Not Recruiting
Fiel Family and Sports Medicine, PC/CCT Research ( Site 0529) Tempe Arizona Active Not Recruiting
Hope Research Institute ( Site 0587) Tempe Arizona Recruiting
Arizona Liver Health ( Site 0516) Tucson Arizona Active Not Recruiting
Del Sol Research Management, LLC ( Site 0515) Tucson Arizona Recruiting
Triallogix Medical Corporation ( Site 0615) Fullerton California Recruiting
National Institute of Clinical Research ( Site 0582) Garden Grove California Active Not Recruiting
Eximia Clinical Research ( Site 0571) La Mesa California Active Not Recruiting
Long Beach Clinical Trials, LLC ( Site 0607) Long Beach California Active Not Recruiting
Profound Research LLC ( Site 0533) Oceanside California Active Not Recruiting
Profound Research LLC ( Site 0574) Pasadena California Recruiting
Paradigm Clinical Research Centers, Inc ( Site 0518) Redding California Recruiting
Artemis Institute for Clinical Research ( Site 0617) San Diego California Active Not Recruiting
Acclaim Clinical Research ( Site 0506) San Diego California Active Not Recruiting
Diablo Clinical Research, Inc. ( Site 0572) Walnut Creek California Active Not Recruiting
Tekton Research ( Site 0611) Denver Colorado Recruiting
Tekton Research ( Site 0613) Fort Collins Colorado Active Not Recruiting
Critical Care Pulmonary & Sleep Associates - CCT Research ( Site 0525) Lakewood Colorado Recruiting
Tekton Research, LLC. ( Site 0616) Longmont Colorado Active Not Recruiting
New England Research Associates, LLC ( Site 0558) Bridgeport Connecticut Recruiting
Stamford Therapeutics Consortium ( Site 0539) Stamford Connecticut Active Not Recruiting
Emerson Clinical Research Institute ( Site 0547) Washington D.C. District of Columbia Active Not Recruiting
Imagine Research of Palm Beach County ( Site 0509) Boynton Beach Florida Active Not Recruiting
Innovative Research of West Florida ( Site 0596) Clearwater Florida Active Not Recruiting
Hillcrest Medical Research ( Site 0563) DeLand Florida Active Not Recruiting
The Oncology Institute of Hope and Innovation - Fort Lauderdale ( Site 0728) Fort Lauderdale Florida Recruiting
Health Awareness, Inc. ( Site 0524) Jupiter Florida Recruiting
Columbus Clinical Services ( Site 0588) Miami Florida Active Not Recruiting
South Florida Research Center, Inc ( Site 0507) Miami Florida Active Not Recruiting
Clinical Site Partners, LLC d/b/a CSP Miami ( Site 0521) Miami Florida Active Not Recruiting
Floridian Clinical Research, LLC ( Site 0534) Miami Lakes Florida Recruiting
Suncoast Clinical Research ( Site 0724) New Port Richey Florida Recruiting
Behavioral Clinical Research, Inc. ( Site 0508) North Miami Florida Active Not Recruiting
Clinical Neuroscience Solutions ( Site 0623) Orlando Florida Active Not Recruiting
Progressive Medical Research ( Site 0579) Port Orange Florida Recruiting
Health Awareness, Inc. ( Site 0541) Port Saint Lucie Florida Recruiting

+ 145 more sites — see the full list on the official registry below.

More Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) trials in the USA

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07159763 on ClinicalTrials.gov ↗ ← All trials in the USA