A Study of mRNA-1345 Vaccine Targeting Respiratory Syncytial Virus in Pregnant Women and in Infants Born to Vaccinated Mothers
NCT ID: NCT06143046
Last Updated: 2026-02-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
360 participants
INTERVENTIONAL
2023-11-15
2026-05-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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mRNA-1345 Dose A
Participants will be vaccinated in the period from 28 weeks to 36 weeks of gestation with a single intramuscular (IM) injection of mRNA-1345 Dose A.
mRNA-1345
Sterile liquid for injection
mRNA-1345 Dose B
Participants will be vaccinated in the period from 28 weeks to 36 weeks of gestation with a single IM injection of mRNA-1345 Dose B.
mRNA-1345
Sterile liquid for injection
mRNA-1345 Dose C
Participants will be vaccinated in the period from 28 weeks to 36 weeks of gestation with a single IM injection of mRNA-1345 Dose C.
mRNA-1345
Sterile liquid for injection
Placebo
Participants will receive single IM injection of mRNA-1345 vaccine matching placebo in the period from 28 weeks to 36 weeks of gestation.
Placebo
0.9% sodium chloride (normal saline) injection
Interventions
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mRNA-1345
Sterile liquid for injection
Placebo
0.9% sodium chloride (normal saline) injection
Eligibility Criteria
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Inclusion Criteria
* Are adults ≥18 years to \<40 years of age inclusive, at the time of signing the informed consent.
* Will be 28 to 36 weeks pregnant at the time of vaccination (confirmed by an obstetric ultrasound report).
* Intend to deliver at a maternity unit where study procedures can be performed.
* Are willing and able to attend all study visits, to undergo all study procedures/or have their infant undergo all study procedures, and to comply with study requirements, including a means of communication (for example, phone, text message or email) with study site staff.
* Have engaged with local antenatal care and will continue to do so through the remainder of their pregnancy.
* Have had an antenatal obstetric ultrasound at ≥18 weeks of pregnancy or be willing to have an antenatal obstetric ultrasound at Screening if not already conducted.
* Japanese participants are defined as individuals born in Japan, with both parents and 4 grandparents who were born in Japan.
Infant Participants
* Have consent from infant participant's parent(s)/legally authorized representative (LAR) if required by local regulations.
Exclusion Criteria
* Acutely ill or febrile (temperature ≥38.0 degrees Celsius \[℃\]/100.4 degrees Fahrenheit \[°F\]) within 72 hours prior to or at the Screening Visit or Day 1.
* Reported history of anaphylaxis or severe hypersensitivity reaction after receipt of any mRNA vaccine or therapeutic or any components of an mRNA-1345 vaccine.
* Any medical, psychiatric, or occupational condition, including reported history of drug or alcohol abuse, that, in the opinion of the Investigator, might pose additional risk due to participation in the study or could interfere with the interpretation of study results.
* Have conditions in the current pregnancy or in previous pregnancies that may affect participant safety, assessment of safety endpoints, assessment of immune response, or adherence to study procedures.
* Received or plans to receive any mRNA vaccine or COVID-19 vaccine within 4 weeks before or after Day 1 and/or any other nonstudy vaccine within 2 weeks before or after Day 1.
* Previous vaccination with any licensed or investigational RSV vaccine or planned receipt during study participation.
* Intend for their infant to receive RSV monoclonal antibodies after delivery.
Infant Participants
* Is a child who has been placed under the control or protection of an agency, organization, institution, or entity by the courts, the government, or a government body acting in accordance with powers conferred on them by laws and regulation (for example, foster care). This does not include a child who is adopted or has an appointed LAR.
0 Years
40 Years
ALL
Yes
Sponsors
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ModernaTX, Inc.
INDUSTRY
Responsible Party
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Locations
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SEC Clinical Research LLC - Dothan 2 - ClinEdge - PPDS
Dothan, Alabama, United States
Abby's Research Institute
Phoenix, Arizona, United States
Watching Over Mothers & Babies
Tucson, Arizona, United States
Applied Research Center of Arkansas - ClinEdge - PPDS
Little Rock, Arkansas, United States
Matrix Clinical Research - Gardena
Gardena, California, United States
Matrix Clinical Research - Huntington Park
Huntington Park, California, United States
Matrix Clinical Research, Inc - Corporate Office
Los Angeles, California, United States
Clinical Research Prime - ClinEdge - PPDS
Idaho Falls, Idaho, United States
Bingham Memorial Hospital
Pocatello, Idaho, United States
Clinical Research Prime - ClinEdge - Rexburg - PPDS
Rexburg, Idaho, United States
Velocity Clinical Research - Covington - PPDS
Covington, Louisiana, United States
Saginaw Valley Medical Research Group LLC
Saginaw, Michigan, United States
Boeson Research GTF - Great Falls - ERN - PPDS
Great Falls, Montana, United States
Boeson Research KAL - Kalispell - ERN - PPDS
Kalispell, Montana, United States
Boeson Research MSO - Missoula - ERN - PPDS
Missoula, Montana, United States
Velocity Clinical Research (Grand Island - Nebraska) - PPDS
Grand Island, Nebraska, United States
Velocity Clinical Research (Hastings - Nebraska) - PPDS
Hastings, Nebraska, United States
Velocity Clinical Research (Norfolk - Nebraska) - PPDS
Norfolk, Nebraska, United States
DM Clinical Research - Bellaire - ERN - PPDS
Houston, Texas, United States
Maximos OB/GYN
League City, Texas, United States
SMS Clinical Research
Mesquite, Texas, United States
Maternal Fetal Diagnostics Center
Salt Lake City, Utah, United States
Dalhousie University - 5820 University Ave
Halifax, Nova Scotia, Canada
Ottawa Hospital
Ottawa, Ontario, Canada
Sainte Justine Hospital
Montreal, Quebec, Canada
Centre Hospitalier de l'Université Laval
Québec, , Canada
Clínica Universidad de los Andes
Las Condes, Región-MetropolitanadeSantiago, Chile
Centro Internacional de Estudios Clínicos
Recoleta, Región-MetropolitanadeSantiago, Chile
Red Hospital Clinico de la Universidad de Chile
Santiago, , Chile
Hvidovre Hospital
Hvidovre, Capital, Denmark
Aarhus Universitetshospital
Aarhus, Central Jutland, Denmark
Regionshospitalet Gødstrup
Herning, Central Jutland, Denmark
Shonan Kamakura General Hospital
Kamakura-Shi, Kanagawa, Japan
Saiseikai Yokohamashi Nanbu Hospital
Yokohama, Kanagawa, Japan
Saitama City Hospital
Saitama-Shi, Saitama, Japan
Center Hospital of the National Center for Global Health and Medicine
Shinjuku-Ku, Tokyo, Japan
Centro De Vacunacion Internacional, S.A. (Cevaxin) - David
David, Chiriquí Province, Panama
Centro De Vacunacion Internacional, S.A. (Cevaxin) Sede La Chorrera
Panama City, , Panama
Centro De Vacunacion Internacional, S.A. (Cevaxin)
Panama City, , Panama
CEVAXIN 24 de diciembre
Panama City, , Panama
Instituto de Investigaciones Científicas Y Servicios de Alta Tecnología Asociación de Interés Panama
Pueblo Nuevo, , Panama
Josha Research
Bloemfontein, Free State, South Africa
Drs. YAK Vahed & Partners
Welkom, Free State, South Africa
Ubuntu Clinical Research
Krugersdorp, Gauteng, South Africa
Bothe ke Bontle Health Services-316 Kuit st
Pretoria, Gauteng, South Africa
Setshaba Research Centre
Soshanguve, Gauteng, South Africa
WITS Clinical Research Site - PPDS
Soweto, Gauteng, South Africa
Merclinico Middelburg
Middelburg, Mpumalanga, South Africa
FAM-CRU
Cape Town, Western Cape, South Africa
Royal Bournemouth Hospital
Bournemouth, Dorset, United Kingdom
Southampton General Hospital
Southampton, Hampshire, United Kingdom
The Royal London Hospital
London, London, City of, United Kingdom
The Royal Free Hospital
London, Middlesex, United Kingdom
Cardiff & Vale University Health Board-PPDS
Cardiff, South Glamorgan, United Kingdom
St George's Hospital
London, Surrey, United Kingdom
Glasgow Clinical Research Facility - PPDS
Glasgow, , United Kingdom
Countries
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Other Identifiers
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2023-505359-37-00
Identifier Type: OTHER
Identifier Source: secondary_id
mRNA-1345-P201
Identifier Type: -
Identifier Source: org_study_id
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