A Study to Evaluate the Safety and Efficacy of CD388 for Prevention of Influenza

NCT07159763 | Active Not Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: CD388.SQ.3.06MK-1406-005
• Study Type: interventional
• Target: 10,000
• Locations: 5 countries
• Sites: 181

Brief Summary

The purpose of this study is to evaluate how well CD388 works in preventing symptomatic laboratory-confirmed influenza infections, as compared to placebo, when given as a single dose via 3 subcutaneous (SQ) injections to adult and adolescent participants who are at higher risk of developing influenza complications, and to evaluate the safety and tolerability of CD388, as compared to placebo.

Conditions

Influenza

Keywords

Influenza; Antiviral Agents

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Experiencing Protocol-defined Influenza-like Illness (ILI) Occurring ≥7 Days after and up to 24 Weeks after Administration of Study Drug

  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.

  From Day 8 up to 24 weeks after study drug dosing

Secondary Outcomes (9)

• Incidence and Severity of Treatment-Emergent Adverse Events (TEAEs) after Administration of Study Drug

  From Day 1 through Day 197/End of Study (EOS) after study drug dosing

• Percentage of Stratum B Participants Experiencing Protocol-defined Influenza-like Illness (ILI) Occurring ≥7 Days after and up to 24 Weeks after Administration of Study Drug

  From Day 8 up to 24 weeks after study drug dosing

• All-cause Hospitalization within 30 Days after the Onset of Symptomatic Influenza

  From Day 8 up to 24 weeks after study drug dosing

• All-cause Mortality within 30 Days after the Onset of Symptomatic Influenza

  From Day 8 up to 24 weeks after study drug dosing

• Trough Plasma Concentration at 24 Weeks (C[trough24w]) Following Administration of CD388

  Based on sampling done on Day 1 (pre-dose baseline) and at onsite visits on Day 8 (±3 days), Day 29 (±3 days), and Day 197/EOS (±7 days)

Study Arms (2)

CD388 (also known as MK-1406)

EXPERIMENTAL

Participants are randomized to receive 450 milligrams (mg) CD388 by SQ injection. Participants are randomized at a 1:1 ratio between the 2 arms.

Combination Product: CD388 Injection

Placebo

PLACEBO COMPARATOR

Participants are randomized to receive placebo by SQ injection. Participants are randomized at a 1:1 ratio between the 2 arms.

Combination Product: Placebo

Interventions

CD388 Injection COMBINATION_PRODUCT

CD388 liquid for injection

CD388 (also known as MK-1406)

Placebo COMBINATION_PRODUCT

Placebo to match

Placebo

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Must be 12 years of age or older at the time of signing the informed consent.
• Written informed consent and any locally required authorization (e.g., Health Insurance Portability and Accountability Act \[HIPAA\] in the US) obtained from the participant before performing any protocol-related procedures, including screening evaluations. For participants under the legal age of consent as defined by local regulations, the parent(s) or legal guardian(s) may be required to give their signed written informed consent and participants may sign an assent form as specified by local law.
• 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 kilograms (kg) at screening.
• Body Mass Index (BMI; calculated as weight in kg divided by height in meters \[m\] squared)) is ≥ 18 kg/m\^2 at screening.
• In the opinion of the Investigator or designee, must be able to comply with the requirements of the protocol and be able to read, understand, and complete questionnaires in the electronic diary (eDiary), work with smartphones/tablets/computers (if applicable, with assistance by a caregiver, surrogate, or legally authorized representative), and be willing and able to adhere to the prohibitions and restrictions specified in this protocol. If an appropriate language version is not available for the eDiary assessments, the participant should not be enrolled.
• Must be assessed by the Investigator or designee as medically stable and not requiring significant change in maintenance therapy and has not been hospitalized for worsening disease or any significant medical event during the 2 months before screening
• Female participants must agree to the following contraception requirements:
• a. Females of childbearing potential must use a highly effective, preferably user-independent, method of contraception (failure rate of less than 1 percent per year when used consistently and correctly) from ≥2 weeks prior to randomization and agree to remain on a highly effective method from Day 1 until 32 weeks after study intervention administration, the end of relevant systemic exposure. Note: A woman is considered of childbearing potential (i.e., fertile) following menarche and until becoming postmenopausal, unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy. However, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient.
• Note: Contraceptive (birth control) use by participants should be consistent with local regulations regarding the acceptable methods of contraception for those participating in clinical studies.
• Must agree not to donate blood or blood products from Day 1 until 32 weeks after study intervention administration.
• Must be willing to provide verifiable identification, has means to be contacted, and is able to contact the Investigator or designee/study site and communicate reliably during participation in the study.
• Has a history of pulmonary disease; specifically:
• 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

You may not qualify if:

• A female who is pregnant or lactating.
• Known or suspected allergy or history of anaphylaxis or other serious adverse reactions to zanamivir (following administration of inhaled or intravenous formulations), monoclonal antibodies (including crystallizable fragment \[Fc\] domains), or any of the components of CD388 or placebo.
• Has been diagnosed with influenza (i.e., with medical history \[including verbal\] of influenza) within 6 months prior to randomization.
• Has received the current seasonal inactivated influenza vaccine or live attenuated influenza vaccine within the 14 days prior to dosing on Day 1. (NOTE: Participant may have received recombinant influenza vaccine up to the day of dosing on Day 1.)
• Has an acute (time-limited) or febrile (temperature ≥38.0 degrees Celsius \[ºC\] \[≥100.4 degrees Fahrenheit {ºF}\]) illness within 7 days prior to planned dosing on Day 1.
• Has had close contact (including household contact) with someone with laboratory-confirmed influenza or SARS-CoV-2 or with someone who has been treated with antiviral therapies for influenza or SARS-CoV-2 within the 7 days prior to randomization.
• Has a clinically unstable condition including, but not limited to, a psychiatric condition, including recent (within the past year) or active suicidal ideation/behavior, or any other condition for which, in the opinion of the Investigator or designee, may lead to hospitalization or death within the study period and that suggests that study enrollment would not be in the participant's best interest and/or that could prevent, confound, or limit the protocol-specified assessments.
• Has any history of alcohol or drug abuse that, in the opinion of the Investigator or designee, would adversely impact the conduct of the study.
• Had major surgery (e.g., major cardiac, pulmonary or abdominal operation) within 4 weeks prior to randomization, or will not have fully recovered from surgery, or has major surgery planned during the time the participant is expected to participate in the study.
• Has severe CKD (equivalent to an eGFR less than 30 mL/min/1.73 m\^2 as calculated by CKD-EPI equation for adults or the CKiD U25 equation for adolescents), or is receiving hemodialysis.
• Current or planned participation in another clinical study in which study intervention is being administered during participation in the current study. NOTE: Concurrent enrollment is allowed during the follow-up phase of the other clinical study or in case the study intervention in the other clinical study is a marketed product already approved for another indication - exception being if the other study requires study interventions that could affect the safety assessments of the present study (e.g., clinical laboratory tests).
• 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., monoclonal antibodies) administered for the prevention or treatment of influenza.
• Receipt of any formulation of immunoglobulin within 14 days prior to planned study intervention administration.
• Receipt of any experimental drug, vaccine, or biologic agent within the 90 days or 5 half-lives (whichever is longer) prior to study intervention administration.
• 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 SQ injections or venipuncture. NOTE: Participants receiving apixaban or warfarin may be enrolled if the Investigator or designee determines risk of SQ treatment with study intervention on Day 1 is minimal.

Sponsors & Collaborators

• Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA): lead

Study Sites (181)

Pinnacle Research Group, LLC

Anniston, Alabama, 36207, United States

Location

Cullman Clinical Trials

Cullman, Alabama, 35055, United States

Location

HOPE Research Institute

Glendale, Arizona, 85308, United States

Location

Desert Clinical Research, LLC / Avacare

Mesa, Arizona, 85213, United States

Location

Foothills Research Center / Avacare

Phoenix, Arizona, 85044, United States

Location

Fiel Family and Sports Medicine / Avacare

Tempe, Arizona, 85283, United States

Location

HOPE Research Institute

Tempe, Arizona, 85284, United States

Location

Arizona Clinical Trials

Tucson, Arizona, 85711, United States

Location

Del Sol Research Management, LLC

Tucson, Arizona, 85715, United States

Location

Triallogix Medical Corporation

Fullerton, California, 92835, United States

Location

National Institute of Clinical Research, Inc.

Garden Grove, California, 92844, United States

Location

Eximia Research-CA, LLC

La Mesa, California, 91942, United States

Location

Kinetic Clinical Research, LLC dba Long Beach Clinical Trials

Long Beach, California, 90806, United States

Location

Seaside Medical Group

Oceanside, California, 92058, United States

Location

Profound Research, LLC

Pasadena, California, 91105, United States

Location

Paradigm Clinical Research

Redding, California, 96001, United States

Location

Artemis Institute for Clinical Research

San Diego, California, 92103, United States

Location

Acclaim Clinical Research

San Diego, California, 92120, United States

Location

Diablo Clinical Research, Inc.

Walnut Creek, California, 94598, United States

Location

Tekton Research, LLC

Denver, Colorado, 80238, United States

Location

Tekton Research, LLC

Fort Collins, Colorado, 80525, United States

Location

Critical Care, Pulmonary and Sleep Associates PLLP / Avacare

Lakewood, Colorado, 80228, United States

Location

Tekton Research, LLC

Longmont, Colorado, 80501, United States

Location

New England Research Associates

Bridgeport, Connecticut, 06606, United States

Location

Stamford Therapeutics Consortium

Stamford, Connecticut, 06905, United States

Location

Emerson Clinical Research Institute

Washington D.C., District of Columbia, 20009, United States

Location

Imagine Research - Palm Beach County

Boynton Beach, Florida, 33435, United States

Location

Innovative Research of West Florida, Inc.

Clearwater, Florida, 33756, United States

Location

Hillcrest Medical Research, LLC

DeLand, Florida, 32720, United States

Location

Health Awareness, Inc.

Jupiter, Florida, 33458, United States

Location

Columbus Clinical Services, LLC

Miami, Florida, 33125, United States

Location

Flourish Research - Miami, LLC DBA Flourish Research

Miami, Florida, 33135, United States

Location

South Florida Research Center, Inc.

Miami, Florida, 33135, United States

Location

Floridian Clinical Research, LLC

Miami Lakes, Florida, 33016, United States

Location

Healthcare Clinical Data, Inc.

North Miami, Florida, 33161, United States

Location

Clinical Neuroscience Solutions, Inc.

Orlando, Florida, 32806, United States

Location

Progressive Medical Research

Port Orange, Florida, 32127, United States

Location

Health Awareness, Inc.

Port Saint Lucie, Florida, 34952, United States

Location

Global Clinical Professionals

St. Petersburg, Florida, 33705, United States

Location

Clinical Site Partners, LLC dba Flourish Research

Winter Park, Florida, 32789, United States

Location

Agile Clinical Research Trials, LLC

Atlanta, Georgia, 30328, United States

Location

DelRicht Research

Atlanta, Georgia, 30329, United States

Location

Clinical Research Atlanta

Stockbridge, Georgia, 30281, United States

Location

Paradigm Clinical Research

Boise, Idaho, 83709, United States

Location

Velocity Clinical Research - Boise

Meridian, Idaho, 83642, United States

Location

Great Lakes Clinical Trials, LLC dba Flourish Research

Chicago, Illinois, 60640, United States

Location

Velocity Clinical Research - Valparaiso

Valparaiso, Indiana, 46383, United States

Location

Integrated Clinical Trial Services, LLC

West Des Moines, Iowa, 50265, United States

Location

Johnson County Clin-Trials, LLC

Lenexa, Kansas, 66219, United States

Location

AMR Clinical

Newton, Kansas, 67114, United States

Location

DelRicht Research

Louisville, Kentucky, 40205, United States

Location

Elevate Clinical Research

Lake Charles, Louisiana, 70605, United States

Location

DelRicht Research

New Orleans, Louisiana, 70115, United States

Location

DelRicht Research

Prairieville, Louisiana, 70769, United States

Location

Annapolis Internal Medicine / Avacare

Annapolis, Maryland, 21401, United States

Location

Jadestone Clinical Research, LLC

Silver Spring, Maryland, 20904, United States

Location

Skylight Health Research

Burlington, Massachusetts, 01803, United States

Location

Profound Research, LLC

Clarkston, Michigan, 48346, United States

Location

Profound Research, LLC

Dearborn, Michigan, 48126, United States

Location

Profound Research, LLC

Farmington Hills, Michigan, 48334, United States

Location

Javara, Inc.

Mankato, Minnesota, 56001, United States

Location

DelRicht Research

Gulfport, Mississippi, 39503, United States

Location

Clay Platte Family Medicine, PC / Avacare

Kansas City, Missouri, 64151, United States

Location

DelRicht Research

Springfield, Missouri, 65807, United States

Location

Sundance Clinical Research, LLC

St Louis, Missouri, 63141, United States

Location

Montana Medical Research, Inc.

Missoula, Montana, 59808, United States

Location

Methodist Physicians Clinic / Avacare

Fremont, Nebraska, 68025, United States

Location

Velocity Clinical Research - Omaha

Omaha, Nebraska, 68134, United States

Location

Midwest Regional Health Services, LLC / Avacare

Omaha, Nebraska, 68144, United States

Location

Henderson Clinical Trials

Henderson, Nevada, 89052, United States

Location

Excel Clinical Research

Las Vegas, Nevada, 89109, United States

Location

Santa Rosa Medical Centers of Nevada / Avacare

Las Vegas, Nevada, 89119, United States

Location

Las Vegas Clinical Trials, LLC

North Las Vegas, Nevada, 89030, United States

Location

IMA Clinical Research

Warren Township, New Jersey, 07059, United States

Location

Brooklyn Clinical Research

Brooklyn, New York, 11226, United States

Location

Finger Lakes Medical Research, PLLC dba Certified Research Associates

Cortland, New York, 13045, United States

Location

Drug Trials America

Hartsdale, New York, 10530, United States

Location

Rochester Clinical Research

Rochester, New York, 14609, United States

Location

CHEAR Center, LLC

The Bronx, New York, 10455, United States

Location

DelRicht Research

Charlotte, North Carolina, 28205, United States

Location

Eximia EquiHealth Research, LLC

Durham, North Carolina, 27704, United States

Location

Monroe Biomedical Research

Monroe, North Carolina, 28112, United States

Location

West Clinical Research, Inc.

Morehead City, North Carolina, 28557, United States

Location

OnSite Clinical Solutions, LLC

Salisbury, North Carolina, 28144, United States

Location

Wilmington Health

Wilmington, North Carolina, 28412, United States

Location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

Velocity Clinical Research - Cleveland

Beachwood, Ohio, 44122, United States

Location

Velocity Clinical Research - Springdale

Cincinnati, Ohio, 45246, United States

Location

Centricity Research Columbus Ohio Multispecialty

Columbus, Ohio, 43213, United States

Location

PriMed Clinical Research

Dayton, Ohio, 45429, United States

Location

Tekton Research, LLC

Edmond, Oklahoma, 73013, United States

Location

Lynn Health Science Institute East

Oklahoma City, Oklahoma, 73111, United States

Location

DelRicht Research

Tulsa, Oklahoma, 74133, United States

Location

Tekton Research, LLC

Yukon, Oklahoma, 73099, United States

Location

Altoona Center for Clinical Research

Duncansville, Pennsylvania, 16635, United States

Location

Central Erie Primary Care

Erie, Pennsylvania, 16508, United States

Location

Hatboro Medical Associates / Avacare

Horsham, Pennsylvania, 19044, United States

Location

DM Clinical Research

Philadelphia, Pennsylvania, 19107, United States

Location

DelRicht Research

Charleston, South Carolina, 29407, United States

Location

Tribe Clinical Research, LLC

Greenville, South Carolina, 29607, United States

Location

Spartanburg Medical Research

Spartanburg, South Carolina, 29303, United States

Location

Velocity Clinical Research - Spartanburg

Spartanburg, South Carolina, 29303, United States

Location

DelRicht Research

Hendersonville, Tennessee, 37075, United States

Location

DCT-HCWC, LLC dba Discovery Clinical Trials

Dallas, Texas, 75230, United States

Location

Zenos Clinical Research

Dallas, Texas, 75230, United States

Location

Lonestar Clinical Research, LLC

Dallas, Texas, 75243, United States

Location

Laguna Clinical Research Associates, LLC

Laredo, Texas, 78041, United States

Location

Epic Clinical Research

Lewisville, Texas, 75057, United States

Location

Elevate Clinical Research

McAllen, Texas, 78504, United States

Location

Pearland Physicians

Pearland, Texas, 77581, United States

Location

Research Your Health

Plano, Texas, 75093, United States

Location

Clinical Trials of Texas, LLC dba Flourish Research

San Antonio, Texas, 78229, United States

Location

Elevate Clinical Research

Seabrook, Texas, 77586, United States

Location

Javara, Inc.

Stephenville, Texas, 76401, United States

Location

DM Clinical Research

Tomball, Texas, 77375, United States

Location

Cope Family Medicine / Avacare

Bountiful, Utah, 84010, United States

Location

Olympus Family Medicine / Avacare

Salt Lake City, Utah, 84117, United States

Location

Charlottesville Medical Research Center, LLC

Charlottesville, Virginia, 22911, United States

Location

Clinical Research Partners, LLC

Richmond, Virginia, 23226, United States

Location

Rainier Clinical Research Center

Renton, Washington, 98057, United States

Location

CEMER Centro Médico Enfermedades Respiratorias

Buenos Aires, B1602DQD, Argentina

Location

Centro de Estudios Infectológicos

Buenos Aires, C1002ABJ, Argentina

Location

CINME - Centro de Investigaciones Metabolicas

Buenos Aires, C1027AAP, Argentina

Location

Equipo Ciencia

Buenos Aires, C1428BNF, Argentina

Location

Sanatorio Mayo Privado S.A.

Córdoba, X5000FAL, Argentina

Location

Instituto IBAMEDICA

Santa Fe, S3000ASF, Argentina

Location

Emeritus Research Sydney

Botany, New South Wales, 2019, Australia

Location

Australian Clinical Research Network Pty Ltd

Maroubra, New South Wales, 2035, Australia

Location

AIM Research

Merewether, New South Wales, 2291, Australia

Location

Momentum Clinical Research St Leonards

Saint Leonards, New South Wales, 2065, Australia

Location

Core Research Group Pty Ltd

Milton, Queensland, 4064, Australia

Location

Momentum Clinical Research Taringa

Taringa, Queensland, 4062, Australia

Location

Emeritus Research Camberwell

Camberwell, Victoria, 3124, Australia

Location

Josha Research

Bloemfontein, Free State, 9300, South Africa

Location

University of Witwatersrand, Clinical HIV Research Unit (CHRU), Helen Joseph Hospital

Johannesburg, Gauteng, 2092, South Africa

Location

Ubuntu Clinical Research

Lenasia, Gauteng, 1827, South Africa

Location

Qhakaza Mbokodo Research Clinic

Ladysmith, KwaZulu-Natal, 3370, South Africa

Location

Madibeng Centre for Research

Brits, North West, 0250, South Africa

Location

Tiervlei Trial Centre

Bellville, 7530, South Africa

Location

TREAD Research (Pty) Ltd

Bellville, 7530, South Africa

Location

TASK Applied Science, Central

Cape Town, 7530, South Africa

Location

Paarl Research Centre

Cape Town, 7646, South Africa

Location

CAPRISA eThekwini Clinical Research Site

Durban, 4001, South Africa

Location

Synergy Biomed Research Institute

East London, 5201, South Africa

Location

Newtown Clinical Research Centre

Johannesburg, 2001, South Africa

Location

Isango Lethemba TB Research Unit

Port Elizabeth, 6003, South Africa

Location

Emmed Research

Pretoria, 0002, South Africa

Location

Global Clinical Trials (Pty) Ltd

Pretoria, 0157, South Africa

Location

Jongaie Research

Pretoria, 0183, South Africa

Location

The Aurum Institute

Rustenburg, 0299, South Africa

Location

Welkom Clinical Trial Centre

Welkom, 9460, South Africa

Location

Queen Elizabeth Hospital, University Hospitals Birmingham NHS Foundation Trust

Birmingham, England, B15 2TH, United Kingdom

Location

Fylde Coast Clinical Research at Layton Medical Centre

Blackpool, England, FY3 7EN, United Kingdom

Location

Southmead Hospital, North Bristol NHS Trust - Clinical Research Centre

Bristol, England, BS10 5NB, United Kingdom

Location

Velocity Clinical Research - Bristol

Bristol, England, BS8 2RA, United Kingdom

Location

Eynsham Medical Centre

Eynsham, England, OX29 4QB, United Kingdom

Location

Velocity Clinical Research - High Wycombe

High Wycombe, England, HP11 2QW, United Kingdom

Location

HMC Health, The Meadows Centre for Health, The Great West Surgery

Hounslow, England, TW4 7NR, United Kingdom

Location

Leeds Teaching Hospitals NHS Trust - St. James's University Hospital

Leeds, England, LS9 7TF, United Kingdom

Location

University Hospitals of Leicester NHS Trust - Leicester Royal Infirmary

Leicester, England, LE1 5WW, United Kingdom

Location

hVIVO Services Limited

London, England, E1 1EQ, United Kingdom

Location

Panthera Enfield

London, England, EN3 4GS, United Kingdom

Location

Velocity Clinical Research - North London

London, England, N12 8BU, United Kingdom

Location

North Manchester General Hospital

Manchester, England, M8 5RB, United Kingdom

Location

The University of Nottingham Health Service

Nottingham, England, NG7 2QW, United Kingdom

Location

Wansford Research LTD

Peterborough, England, PE8 6PL, United Kingdom

Location

University Hospitals Plymouth NHS Trust

Plymouth, England, PL6 8DH, United Kingdom

Location

Panthera Preston

Preston, England, PR2 9QB, United Kingdom

Location

Panthera Rochdale

Rochdale, England, OL11 4AU, United Kingdom

Location

Velocity Clinical Research - Romford

Romford, England, RM1 3PJ, United Kingdom

Location

Warrington and Halton Teaching Hospitals NHS Foundation Trust

Runcorn, England, WA7 2DA, United Kingdom

Location

Salford Royal Hospital

Salford, England, M6 8HD, United Kingdom

Location

Panthera Sheffield

Sheffield, England, S2 5FX, United Kingdom

Location

University Hospital Southampton NHS Foundation Trust, NIHR Southampton Clinical Research Facility

Southampton, England, SO16 6YD, United Kingdom

Location

Royal Cornwall Hospitals NHS Trust

Truro, England, TR1 3LJ, United Kingdom

Location

Windrush Medical Practice

Witney, England, OX28 6JS, United Kingdom

Location

Panthera York

York, England, YO24 4LJ, United Kingdom

Location

Aberdeen Royal Infirmary

Aberdeen, Scotland, AB25 2ZD, United Kingdom

Location

NHS Lothian - Western General Hospital

Edinburgh, Scotland, EH4 2XU, United Kingdom

Location

Queen Elizabeth University Hospital, Glasgow Clinical Research Facility

Glasgow, Scotland, G51 4TF, United Kingdom

Location

Cardiff and Vale UHB - University Hospital of Wales

Cardiff, Wales, CF14 4XW, United Kingdom

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• Barbara Haber, MD

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2025
• First Posted: September 8, 2025
• Study Start: September 25, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: June 22, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (30); US (120); AR (6); AU (7); ZA (18)