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RecruitingPhase 3

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

Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) · NCT07159763

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 12+ · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 3
Target enrollment
10000
US sites recruiting
52
Study start
September 25, 2025
Record last updated
October 15, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: MK-1406; Placebo

Conditions: Influenza

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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)

Recruiting US locations

  • Pinnacle Research Group ( Site 0505)

    Anniston, AL 36207

    Site contact: Study Coordinator · 256-452-1160

  • Cullman Clinical Trials ( Site 0538)

    Cullman, AL 35055

    Site contact: Study Coordinator · 256-708-2826

  • Hope Research Institute ( Site 0575)

    Glendale, AZ 85308

    Site contact: Study Coordinator · 602-288-4673

  • Hope Research Institute ( Site 0587)

    Tempe, AZ 85284

    Site contact: Study Coordinator · 480-786-6655

  • Del Sol Research Management, LLC ( Site 0515)

    Tucson, AZ 85715

    Site contact: Study Coordinator · 520-647-9926

  • Triallogix Medical Corporation ( Site 0615)

    Fullerton, CA 92835

    Site contact: Study Coordinator · 281-772-4450

  • Profound Research LLC ( Site 0574)

    Pasadena, CA 91105

    Site contact: Study Coordinator · 62679312270

  • Paradigm Clinical Research Centers, Inc ( Site 0518)

    Redding, CA 96001

    Site contact: Study Coordinator · 530-232-3000

  • Tekton Research ( Site 0611)

    Denver, CO 80238

    Site contact: Study Coordinator · 303-345-6994

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

    Lakewood, CO 80228

    Site contact: Study Coordinator · 303-951-0600

  • New England Research Associates, LLC ( Site 0558)

    Bridgeport, CT 06606

    Site contact: Study Coordinator · 203-374-9816

  • Health Awareness, Inc. ( Site 0524)

    Jupiter, FL 33458

    Site contact: Study Coordinator · 561-741-2033

  • Floridian Clinical Research, LLC ( Site 0534)

    Miami Lakes, FL 33016

    Site contact: Study Coordinator · 305-330-9977

  • Progressive Medical Research ( Site 0579)

    Port Orange, FL 32127

    Site contact: Study Coordinator · 386-304-7070

  • Health Awareness, Inc. ( Site 0541)

    Port Saint Lucie, FL 34952

    Site contact: Study Coordinator · 561-741-2033

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

    St. Petersburg, FL 33714

    Site contact: Study Coordinator · 208-346-8900

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

    Winter Park, FL 32789

    Site contact: Study Coordinator · 667-210-5368

  • Agile Clinical Research Trials, LLC ( Site 0600)

    Atlanta, GA 30328

    Site contact: Study Coordinator · 404-400-2255

  • DelRicht Research ( Site 0583)

    Atlanta, GA 30329

    Site contact: Study Coordinator · 504-336-2667

  • Clinical Research Atlanta ( Site 0531)

    Stockbridge, GA 30281

    Site contact: Study Coordinator · 770-507-6867

  • Paradigm Clinical Research - Boise ( Site 0614)

    Boise, ID 83709

    Site contact: Study Coordinator · 208-801-7438

  • Velocity Clinical Research, Boise ( Site 0535)

    Meridian, ID 83642

    Site contact: Study Coordinator · 208-377-8653

  • Great Lakes Clinical Trials - Ravenswood ( Site 0564)

    Chicago, IL 60640

    Site contact: Study Coordinator · 773-769-3500

  • DM Clinical Research ( Site 0502)

    Palos Heights, IL 60463

    Site contact: Study Coordinator · 445-300-9011

  • Integrated Clinical Trial Services, Inc ( Site 0576)

    West Des Moines, IA 50265

    Site contact: Study Coordinator · 515-223-2300

  • Johnson County Clin-Trials ( Site 0530)

    Lenexa, KS 66219-1376

    Site contact: Study Coordinator · 913-825-4400

  • Alliance for Multispecialty Research, LLC ( Site 0561)

    Newton, KS 67114

    Site contact: Study Coordinator · 316-283-0828

  • DelRicht Research ( Site 0594)

    Prairieville, LA 70769-4212

    Site contact: Study Coordinator · 225-412-0316

  • Annapolis Internal Medicine - CCT Research ( Site 0580)

    Annapolis, MD 21401

    Site contact: Study Coordinator · 410-897-9841

  • Skylight Health Research, Inc ( Site 0609)

    Burlington, MA 01803

    Site contact: Study Coordinator · 781-328-2491

  • Michigan Hematology & Oncology Consultants ( Site 0610)

    Dearborn, MI 48126

    Site contact: Study Coordinator · 313-816-1600

  • Mankato Clinic ( Site 0573)

    Mankato, MN 56001

    Site contact: Study Coordinator · 507-216-0972

  • DelRicht Research ( Site 0584)

    Gulfport, MS 39503

    Site contact: Study Coordinator · 504-336-2667

  • Sundance Clinical Research LLC ( Site 0526)

    St Louis, MO 63141

    Site contact: Study Coordinator · 314-567-3377

  • Methodist Physicians Clinic/CCT Research ( Site 0598)

    Fremont, NE 68025

    Site contact: Study Coordinator · 402-753-6034

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

    Omaha, NE 68144

    Site contact: Study Coordinator · 402-778-5490

  • Excel Clinical Research, LLC ( Site 0566)

    Las Vegas, NV 89109

    Site contact: Study Coordinator · 702-680-1500

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

    Las Vegas, NV 89119

    Site contact: Study Coordinator · 725-237-2605

  • DM Clinical Research - Brooklyn ( Site 0550)

    Brooklyn, NY 11226

    Site contact: Study Coordinator · 929-552-2442

  • Wilmington Health Associates ( Site 0548)

    Wilmington, NC 28401

    Site contact: Study Coordinator · 910-815-3262

  • Wake Forest University Health Sciences ( Site 0569)

    Winston-Salem, NC 27157

    Site contact: Study Coordinator · 336-716-4584

  • PriMED Clinical Research ( Site 0560)

    Dayton, OH 45429

    Site contact: Study Coordinator · 937-534-4201

  • Tekton Research, LLC. ( Site 0601)

    Edmond, OK 73013

    Site contact: Study Coordinator · 405-534-5609

  • DelRicht Research ( Site 0618)

    Tulsa, OK 74133

    Site contact: Study Coordinator · 918-932-2276

  • Liberty Family Practice ( Site 0546)

    Erie, PA 16508

    Site contact: Study Coordinator · 814-868-9828

  • Tribe Clinical Research, LLC ( Site 0577)

    Greenville, SC 29607

    Site contact: Study Coordinator · 864-334-0141

  • Spartanburg Medical Research ( Site 0514)

    Spartanburg, SC 29303

    Site contact: Study Coordinator · 864-583-1556

  • DCT-HCWC, LLC dba Discovery Clinical Trials ( Site 0606)

    Dallas, TX 75230

    Site contact: Study Coordinator · 817-378-0855

  • Elevate Clinical Research - Houston ( Site 0589)

    Houston, TX 77058

    Site contact: Study Coordinator · 281-282-0808

  • Research Your Health ( Site 0567)

    Plano, TX 75093

    Site contact: Study Coordinator · 972-999-1155

  • Charlottesville Medical Research ( Site 0559)

    Charlottesville, VA 22911

    Site contact: Study Coordinator · 434-817-2442

  • Clinical Research Partners, LLC. ( Site 0504)

    Richmond, VA 23226

    Site contact: Study Coordinator · 804-477-3045

Study contacts (from the official record)

  • Toll Free Number · 1-888-577-8839 · Trialsites@msd.com
A Study to Evaluate the Safety and Efficacy of MK-1406/CD388 for… (NCT07159763) | Bored Studies