Study of CD388 for Influenza Prevention
This study is testing CD388 Injection to see how well it prevents the flu (influenza) compared to a placebo (an inactive substance that looks like the study drug). We are looking for 10,000 participants aged 12 and older. The main goal is to see if fewer people who receive CD388 Injection get flu-like illness within 24 weeks after getting the study drug. The study is also checking the safety of CD388 Injection. The current status of this study is unclear.
- Study design
- This is a Phase 3, randomized (participants are assigned to groups by chance), double-blind (neither you nor your doctor will know if you're getting the study drug or placebo), placebo-controlled study involving about 10,000 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be monitored for flu-like illness for up to 24 weeks after receiving the study drug.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT07159763
A Study to Evaluate the Safety and Efficacy of CD388 for Prevention of Influenza
Active, Not Recruiting
PHASE3Ages 12+InterventionalPreventionCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
~10,000 participants
Updated 2026-06-22 on ClinicalTrials.gov
What's tested:CD388 InjectionPlacebo
At a glance
Recruiting sites
0 of 181 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percentage of Participants Experiencing Protocol-defined Influenza-like Illness (ILI) Occurring ≥7 Days after and up to 24 Weeks after Administration of Study Drug
Measured over From Day 8 up to 24 weeks after study drug dosing
Conditions
Where it's being run
181 sites across 48 statesEngland26
Florida14
South Africa13
Texas12
California10
Arizona7
North Carolina7
Argentina6
Study leadership
- Barbara Haber, MD · STUDY_DIRECTOR · Merck Sharp & Dohme LLC
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema, graded as follows using the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Categories A, B, and E (ABE) (i.e., GOLD ABE) assessment tool:
Gold Grade 2 (moderate) or Grade 3 (severe) with following exacerbation history, within 1 year of screening
At least 2 moderate exacerbations (i.e., not leading to hospitalization), or
At least 1 exacerbation leading to hospitalization OR
Gold Grade 4 regardless of exacerbation history
Bronchiectasis, cystic fibrosis, interstitial lung disease, pneumoconiosis, or past or active bronchopulmonary dysplasia. 2. Has moderate to severe asthma, as defined by the Global Initiative for Asthma (GINA) Treatment Steps 3-5. 3. Has existing cardiac disease; specifically:
Congenital heart disease
Congestive heart failure New York Heart Association (NYHA) Class II-IV
Coronary artery disease requiring regular medication and/or follow-up for ischemic heart disease (i.e., participants who, through interventional procedure\[s\] and/or active medical treatment, have attained an established state of chronic stability of a duration of no less than 6 months)
Hypertension with cardiac complications (NOTE: Hypertension alone without cardiac complications will be excluded). Acceptable cardiac complications of hypertension include, but are not limited to, heart failure, cardiac arrhythmias (e.g., atrial fibrillation), ischemic heart disease, coronary artery disease, enlarged left heart, metabolic syndrome, left ventricular hypertrophy, systolic or diastolic myocardial dysfunction, angina, and myocardial infarction. 4. Has insulin-dependent diabetes. 5. Has moderate renal impairment (Stage 3 Chronic Kidney Disease \[CKD\], equivalent to an estimated glomerular filtration rate \[eGFR\] 30 to 59 milliliter per minute \[mL/min\] per 1.73 m\^2 as calculated by the Chronic Kidney Disease Epidemiology Collaboration \[CKD-EPI\] equation for adults or the Chronic Kidney Disease in Children under 25 \[CKiD U25\] equation for adolescents) with or without micro-macroproteinuria and within 3 months prior to screening; examples include, but are not limited to, any history of glomerulosclerosis, diabetic nephropathy, lupus nephritis, glomerular nephritis, immunoglobulin A (IgA) nephropathy, and Goodpasture syndrome. NOTE: Participants with chronic renal disease who meet the criteria for immune compromised (immunosuppressive therapy) should be enrolled in Stratum B. 6. Is ≥ 65 years of age at the time of randomization but does not meet any of criteria 11a through 11e, and is otherwise healthy as determined by the Investigator or designee.
Has received a kidney, liver, heart, or lung transplant more than 6 months prior to screening
Is currently receiving at least two immunosuppressive medications 4. Participants who have had a hematopoietic stem cell transplant (HSCT) must satisfy at least one of the following:
Has a history of 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 5. Is receiving immunosuppressive medicines (e.g., corticosteroids \[i.e., at least 20 mg prednisone or equivalent per day\], alkylating agents, antimetabolites, transplant-related immunosuppressive drugs, cancer chemotherapeutic agents classified as severely immunosuppressive \[e.g., Bruton's tyrosine kinase inhibitors\], tumor- necrosis blockers, or other immunosuppressive biologic agents \[e.g., for rheumatic diseases\]). NOTE: The regimen must be stable (same agents and doses, or clinically equivalent doses) for ≥2 months prior to Screening to ensure clinical stability (see Inclusion Criterion 7). 6. Has received chimeric antigen receptor-modified T-cell therapy. 7. Has received B-cell depleting therapies (e.g., rituximab, ocrelizumab, ofatumumab, alemtuzumab) within the 12 months prior to screening. 8. Has a diagnosis of any primary or secondary immunodeficiency except IgA deficiency. 9. Has advanced or untreated human immunodeficiency virus (HIV) infection manifested by a cluster of differentiation 4 (CD4) cell count less than 350/cubic millimeter (mm\^3) within 6 months of screening.
What this trial measures
- Percentage of Participants Experiencing Protocol-defined Influenza-like Illness (ILI) Occurring ≥7 Days after and up to 24 Weeks after Administration of Study DrugFrom Day 8 up to 24 weeks after study drug dosing
Percentage of participants experiencing protocol-defined ILI occurring after administration of CD388, with influenza infection confirmed by a reverse-transcriptase polymerase chain reaction positive (RT-PCR+) result based on a nasopharyngeal (NP) swab assayed at a central laboratory (first occurrence only), as compared to placebo.