A Study to Evaluate the Safety and Efficacy of MK-1406/CD388 for Prevention of Influenza (MK-1406-005/CD388.SQ.3.06)
Condition(s) studied
Investigational drug(s) / intervention(s)
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
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)
| Facility | City | Region | Status |
|---|---|---|---|
| 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
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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