Active, not 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)
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
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 (362)
| Facility | City | Region | Status |
| Pinnacle Research Group ( Site 0505) |
Anniston |
Alabama |
|
| Pinnacle Research Group, LLC |
Anniston |
Alabama |
|
| Cullman Clinical Trials ( Site 0538) |
Cullman |
Alabama |
|
| Cullman Clinical Trials |
Cullman |
Alabama |
|
| Hope Research Institute ( Site 0575) |
Glendale |
Arizona |
|
| HOPE Research Institute |
Glendale |
Arizona |
|
| Desert Clinical Research, LLC / Avacare |
Mesa |
Arizona |
|
| Desert Clinical Research/ CCT Research ( Site 0612) |
Mesa |
Arizona |
|
| Foothills Research Center ( Site 0591) |
Phoenix |
Arizona |
|
| Foothills Research Center / Avacare |
Phoenix |
Arizona |
|
| Fiel Family and Sports Medicine / Avacare |
Tempe |
Arizona |
|
| Fiel Family and Sports Medicine, PC/CCT Research ( Site 0529) |
Tempe |
Arizona |
|
| Hope Research Institute ( Site 0587) |
Tempe |
Arizona |
|
| HOPE Research Institute |
Tempe |
Arizona |
|
| Arizona Clinical Trials |
Tucson |
Arizona |
|
| Arizona Liver Health ( Site 0516) |
Tucson |
Arizona |
|
| Del Sol Research Management, LLC ( Site 0515) |
Tucson |
Arizona |
|
| Del Sol Research Management, LLC |
Tucson |
Arizona |
|
| Triallogix Medical Corporation ( Site 0615) |
Fullerton |
California |
|
| Triallogix Medical Corporation |
Fullerton |
California |
|
| National Institute of Clinical Research ( Site 0582) |
Garden Grove |
California |
|
| National Institute of Clinical Research, Inc. |
Garden Grove |
California |
|
| Eximia Clinical Research ( Site 0571) |
La Mesa |
California |
|
| Eximia Research-CA, LLC |
La Mesa |
California |
|
| Kinetic Clinical Research, LLC dba Long Beach Clinical Trials |
Long Beach |
California |
|
| Long Beach Clinical Trials, LLC ( Site 0607) |
Long Beach |
California |
|
| Profound Research LLC ( Site 0533) |
Oceanside |
California |
|
| Seaside Medical Group |
Oceanside |
California |
|
| Profound Research LLC ( Site 0574) |
Pasadena |
California |
|
| Profound Research, LLC |
Pasadena |
California |
|
| Paradigm Clinical Research Centers, Inc ( Site 0518) |
Redding |
California |
|
| Paradigm Clinical Research |
Redding |
California |
|
| Artemis Institute for Clinical Research ( Site 0617) |
San Diego |
California |
|
| Artemis Institute for Clinical Research |
San Diego |
California |
|
| Acclaim Clinical Research ( Site 0506) |
San Diego |
California |
|
| Acclaim Clinical Research |
San Diego |
California |
|
| Diablo Clinical Research, Inc. ( Site 0572) |
Walnut Creek |
California |
|
| Diablo Clinical Research, Inc. |
Walnut Creek |
California |
|
| Tekton Research ( Site 0611) |
Denver |
Colorado |
|
| Tekton Research, LLC |
Denver |
Colorado |
|
+ 322 more sites — see the full list on the official registry below.
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