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

RecruitingPhase 3

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

Who can join

Ages 12 and older · All sexes

Full eligibility 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)

About the study

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.

What is being tested

Sponsor: Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) · Participants: 10,000 · Started: Sep 25, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT07159763

Locations in the U.S.

AlabamaPinnacle Research Group ( Site 0505), Anniston
Cullman Clinical Trials ( Site 0538), Cullman
ArizonaHope Research Institute ( Site 0575), Glendale
Hope Research Institute ( Site 0587), Tempe
Del Sol Research Management, LLC ( Site 0515), Tucson
CaliforniaProfound Research LLC ( Site 0743), Carlsbad
Triallogix Medical Corporation ( Site 0615), Fullerton
Paradigm Clinical Research, LLC ( Site 0733), Modesto
Valley Clinical Trials Inc. ( Site 0741), Northridge
Profound Research LLC ( Site 0574), Pasadena
Paradigm Clinical Research Centers, Inc ( Site 0518), Redding
Profound Research LLC ( Site 0744), San Diego
ColoradoTekton Research ( Site 0611), Denver
Critical Care Pulmonary & Sleep Associates - CCT Research ( Site 0525), Lakewood
ConnecticutNew England Research Associates, LLC ( Site 0558), Bridgeport
FloridaThe Oncology Institute of Hope and Innovation - Fort Lauderdale ( Site 0728), Fort Lauderdale
Health Awareness, Inc. ( Site 0524), Jupiter
Hope Research Network-Miami ( Site 0742), Miami
Floridian Clinical Research, LLC ( Site 0534), Miami Lakes
Indago Research and Health Center Inc ( Site 0725), Miami Lakes
Suncoast Clinical Research ( Site 0724), New Port Richey
Progressive Medical Research ( Site 0579), Port Orange
Health Awareness, Inc. ( Site 0541), Port Saint Lucie
GCP- Global Clinical Research Professionals, LLC ( Site 0595), St. Petersburg
Triple O Research Institute, P.A ( Site 0727), West Palm Beach
Clinical Site Partners, LLC dba Flourish Research ( Site 0540), Winter Park
GeorgiaAgile Clinical Research Trials, LLC ( Site 0600), Atlanta
DelRicht Research ( Site 0583), Atlanta
Clinical Research Atlanta ( Site 0531), Stockbridge
IdahoParadigm Clinical Research - Boise ( Site 0614), Boise
Velocity Clinical Research, Boise ( Site 0535), Meridian
IllinoisGreat Lakes Clinical Trials - Ravenswood ( Site 0564), Chicago
DM Clinical Research ( Site 0736), Melrose Park
DM Clinical Research ( Site 0502), Palos Heights
IowaIntegrated Clinical Trial Services, Inc ( Site 0576), West Des Moines
KansasHutchinson Clinic, P.A. ( Site 0729), Hutchinson
Johnson County Clin-Trials ( Site 0530), Lenexa
Alliance for Multispecialty Research, LLC ( Site 0561), Newton
LouisianaDelRicht Research ( Site 0594), Prairieville
MarylandAnnapolis Internal Medicine - CCT Research ( Site 0580), Annapolis
MassachusettsSkylight Health Research, Inc ( Site 0609), Burlington
MichiganMichigan Institute of Research (MIR) ( Site 0734), Allen Park
Michigan Hematology & Oncology Consultants ( Site 0610), Dearborn
DM Clinical Research ( Site 0739), Southfield
MinnesotaMankato Clinic ( Site 0573), Mankato
MissouriSundance Clinical Research LLC ( Site 0526), St Louis
NebraskaMethodist Physicians Clinic/CCT Research ( Site 0598), Fremont
Midwest Regional Health Services, LLC / Avacare ( Site 0603), Omaha
NevadaExcel Clinical Research, LLC ( Site 0566), Las Vegas
Santa Rosa Medical Centers of Nevada / CCT Research ( Site 0605), Las Vegas
New MexicoDM Clinical Research ( Site 0731), Albuquerque
New YorkDM Clinical Research - Brooklyn ( Site 0550), Brooklyn
North CarolinaWilmington Health Associates ( Site 0548), Wilmington
Wake Forest University Health Sciences ( Site 0569), Winston-Salem
OhioPriMED Clinical Research ( Site 0560), Dayton
Helios Clinical Research - CLE ( Site 0740), Middleburg Heights
OklahomaTekton Research, LLC. ( Site 0601), Edmond
DelRicht Research ( Site 0618), Tulsa
PennsylvaniaLiberty Family Practice ( Site 0546), Erie
South CarolinaTribe Clinical Research, LLC ( Site 0577), Greenville
Spartanburg Medical Research ( Site 0514), Spartanburg
TexasDCT-HCWC, LLC dba Discovery Clinical Trials ( Site 0606), Dallas
Elevate Clinical Research - Houston ( Site 0589), Houston
Research Your Health ( Site 0567), Plano
VirginiaCharlottesville Medical Research ( Site 0559), Charlottesville
Clinical Research Partners, LLC. ( Site 0504), Richmond

Conditions

From ClinicalTrials.gov, data retrieved Nov 15, 2026. Each study sets its own eligibility; the study team decides who can join.