A Study to Evaluate the Safety and Efficacy of MK-1406/CD388 for Prevention of Influenza (MK-1406-005/CD388.SQ.3.06) (NCT07159763)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (22 items) and avoid the listed exclusions (7 items).
Location: Pinnacle Research Group ( Site 0505) — Anniston, Alabama
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- 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)
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (181 Sites)
- Pinnacle Research Group ( Site 0505) — Anniston, Alabama
- Cullman Clinical Trials ( Site 0538) — Cullman, Alabama
- Hope Research Institute ( Site 0575) — Glendale, Arizona
- Desert Clinical Research/ CCT Research ( Site 0612) — Mesa, Arizona
- Foothills Research Center ( Site 0591) — Phoenix, Arizona
- Fiel Family and Sports Medicine, PC/CCT Research ( Site 0529) — Tempe, Arizona
- Hope Research Institute ( Site 0587) — Tempe, Arizona
- Arizona Liver Health ( Site 0516) — Tucson, Arizona
- Del Sol Research Management, LLC ( Site 0515) — Tucson, Arizona
- Triallogix Medical Corporation ( Site 0615) — Fullerton, California
- National Institute of Clinical Research ( Site 0582) — Garden Grove, California
- Eximia Clinical Research ( Site 0571) — La Mesa, California
- Long Beach Clinical Trials, LLC ( Site 0607) — Long Beach, California
- Profound Research LLC ( Site 0533) — Oceanside, California
- Profound Research LLC ( Site 0574) — Pasadena, California
- Paradigm Clinical Research Centers, Inc ( Site 0518) — Redding, California
- Artemis Institute for Clinical Research ( Site 0617) — San Diego, California
- Acclaim Clinical Research ( Site 0506) — San Diego, California
- Diablo Clinical Research, Inc. ( Site 0572) — Walnut Creek, California
- Tekton Research ( Site 0611) — Denver, Colorado
- Tekton Research ( Site 0613) — Fort Collins, Colorado
- Critical Care Pulmonary & Sleep Associates - CCT Research ( Site 0525) — Lakewood, Colorado
- Tekton Research, LLC. ( Site 0616) — Longmont, Colorado
- New England Research Associates, LLC ( Site 0558) — Bridgeport, Connecticut
- Stamford Therapeutics Consortium ( Site 0539) — Stamford, Connecticut
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.