Influenza study: MK-1406
Official title A Study to Evaluate the Safety and Efficacy of MK-1406/CD388 for Prevention of Influenza (MK-1406-005/CD388.SQ.3.06)
ClinicalTrials.gov ID: NCT07159763
What this study is testing
What is MK-1406?
An investigational once‑dose injectable medicine being studied to help prevent influenza in people at higher risk of serious illness.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to find out if a single dose of MK‑1406 can protect against influenza and how safe it is.
- Who it's for
- It is looking for adolescents and adults who are at higher risk of serious flu illness because of age, health conditions, or weakened immune systems.
- What's involved
- Participants will receive either MK‑1406 or a placebo at one study visit and will be monitored for flu infection and any side effects.
- Time commitment
- The study lasts about a year, with a few visits for screening, the single dose, and follow‑up checks for flu symptoms and safety.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 and older
You may be able to join if
- The main include but are not limited to the following: Primary Stratum A (non-immunocompromised participants who have chronic stable medical...
- 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)
You likely can't join if
- Known or suspected allergy or history of anaphylaxis or other serious adverse reactions to zanamivir (following administration of inhaled or...
- 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)...
- Has a clinically significant bleeding disorder (e.g., factor deficiency, coagulopathy, or platelet disorder) or medical history of significant...
- Has previously enrolled in this study (CD388.SQ.3.06)
See the full eligibility criteria
- The main 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...
- 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
- Has received a kidney, liver, heart, or lung transplant more than 6 months prior to screening
- Is currently receiving at least two immunosuppressive medications
- 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...
- 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
- 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))...
- 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...
- Has previously enrolled in this study (CD388.SQ.3.06)
The study team makes the final eligibility decision.
Where it is enrolling
- Anniston, Alabama, United States
- Cullman, Alabama, United States
- Glendale, Arizona, United States
- Tempe, Arizona, United States
- Tucson, Arizona, United States
- Carlsbad, California, United States
- Fullerton, California, United States
- Modesto, California, United States
- Northridge, California, United States
- Pasadena, California, United States
- Redding, California, United States
- San Diego, California, United States
- Denver, Colorado, United States
- Lakewood, Colorado, United States
- Bridgeport, Connecticut, United States
- Fort Lauderdale, Florida, United States
- Jupiter, Florida, United States
- Miami, Florida, United States
- Miami Lakes, Florida, United States
- New Port Richey, Florida, United States
+ 69 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Anniston, Alabama, United States; Cullman, Alabama, United States; Glendale, Arizona, United States; Tempe, Arizona, United States; Tucson, Arizona, United States; Carlsbad, California, United States and 83 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.