Phase
Condition
N/ATreatment
mRNA-1345
Placebo
Clinical Study ID
Ages 18-40 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Key Inclusion Criteria:
Maternal Participants
Are adults ≥18 years to <40 years of age inclusive, at the time of signing theinformed consent.
Will be 28 to 36 weeks pregnant at the time of vaccination (confirmed by anobstetric 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/orhave their infant undergo all study procedures, and to comply with studyrequirements, including a means of communication (for example, phone, text messageor email) with study site staff.
Have engaged with local antenatal care and will continue to do so through theremainder of their pregnancy.
Have had an antenatal obstetric ultrasound at ≥18 weeks of pregnancy or be willingto have an antenatal obstetric ultrasound at Screening if not already conducted.
Specific inclusion criteria for Japanese pregnant women:
- Japanese participants are defined as individuals born in Japan, with both parentsand 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
Key Exclusion Criteria:
Maternal Participants
Acutely ill or febrile (temperature ≥38.0 degrees Celsius [℃]/100.4 degreesFahrenheit [°F]) within 72 hours prior to or at the Screening Visit or Day 1.
Reported history of anaphylaxis or severe hypersensitivity reaction after receipt ofany mRNA vaccine or therapeutic or any components of an mRNA-1345 vaccine.
Any medical, psychiatric, or occupational condition, including reported history ofdrug or alcohol abuse, that, in the opinion of the Investigator, might poseadditional risk due to participation in the study or could interfere with theinterpretation of study results.
Have conditions in the current pregnancy or in previous pregnancies that may affectparticipant 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 weeksbefore or after Day 1 and/or any other nonstudy vaccine within 2 weeks before orafter Day 1.
Previous vaccination with any licensed or investigational RSV vaccine or plannedreceipt 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 governmentbody acting in accordance with powers conferred on them by laws and regulation (forexample, foster care). This does not include a child who is adopted or has anappointed LAR.
Other inclusion and exclusion criteria may apply.
Study Design
Connect with a study center
Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich
Ciudad Autónoma de Buenos Aires, Buenos Aires C1426
ArgentinaSite Not Available
Clinica Privada Independencia
Munro, Buenos Aires B1605
ArgentinaSite Not Available
Instituto Médico de la Fundación Estudios Clínicos
Rosario, Santa Fe S2000DEJ
ArgentinaSite Not Available
Expertia S.A- Mautalen Salud e Investigacion
Ciudad Autónoma de Buenos Aires, C1128AAF
ArgentinaSite Not Available
Clinica Mayo de U.M.C.B. S.R.L
San Miguel De Tucumán, T4000IHE
ArgentinaSite Not Available
Instituto de Maternidad Nuestra Señora de La Merced
San Miguel de Tucumán, T4000CPC
ArgentinaSite Not Available
BC Women's Hospital and Health Centre
Vancouver, British Columbia V6H 3N1
CanadaSite Not Available
Dalhousie University - 5820 University Ave
Halifax, Nova Scotia B3H 1
CanadaSite Not Available
Ottawa Hospital
Ottawa, Ontario K1H 8L6
CanadaSite Not Available
Ottawa Hospital Civic Campus
Ottawa, Ontario K1H 8L6
CanadaSite Not Available
Sainte Justine Hospital
Montréal, Quebec H3T 1C5
CanadaSite Not Available
Centre Hospitalier de l'Université Laval
Quebec, G1V 4G2
CanadaSite Not Available
Clínica Universidad de los Andes
Las Condes, Región-MetropolitanadeSantiago 7550000
ChileSite Not Available
Centro Internacional de Estudios Clínicos
Recoleta, Región-MetropolitanadeSantiago 8420000
ChileSite Not Available
Red Hospital Clinico de la Universidad de Chile
Santiago, 8380453
ChileSite Not Available
Hvidovre Hospital
Hvidovre, Capital DK-2650
DenmarkSite Not Available
Aarhus Universitetshospital
Aarhus, Central Jutland 8200
DenmarkSite Not Available
Regionshospitalet Gødstrup
Herning, Central Jutland 7400
DenmarkSite Not Available
Sygehus Lillebaelt, Kolding
Kolding, South Denmark 6000
DenmarkSite Not Available
Shonan Kamakura General Hospital
Kamakura-Shi, Kanagawa 247-8533
JapanSite Not Available
Saiseikai Yokohamashi Nanbu Hospital
Yokohama, Kanagawa 234-0054
JapanSite Not Available
Saitama City Hospital
Saitama-Shi, Saitama 336-0911
JapanSite Not Available
Center Hospital of the National Center for Global Health and Medicine
Shinjuku-Ku, Tokyo 162-8655
JapanSite Not Available
Centro De Vacunacion Internacional, S.A. (Cevaxin) - David
David, Chiriquí
PanamaSite Not Available
Centro De Vacunacion Internacional, S.A. (Cevaxin)
Ciudad De Panamá,
PanamaSite Not Available
Centro De Vacunacion Internacional, S.A. (Cevaxin) Sede La Chorrera
Ciudad De Panamá,
PanamaSite Not Available
CEVAXIN 24 de diciembre
Panamá,
PanamaSite Not Available
Instituto de Investigaciones Científicas Y Servicios de Alta Tecnología Asociación de Interés Panama
Pueblo Nuevo,
PanamaSite Not Available
Josha Research
Bloemfontein, Free State 9300
South AfricaSite Not Available
Drs. YAK Vahed & Partners
Welkom, Free State 9459
South AfricaSite Not Available
Ubuntu Clinical Research
Krugersdorp, Gauteng 1739
South AfricaSite Not Available
Bothe ke Bontle Health Services-316 Kuit st
Pretoria, Gauteng 0184
South AfricaSite Not Available
Setshaba Research Centre
Soshanguve, Gauteng 152
South AfricaSite Not Available
WITS Clinical Research Site - PPDS
Soweto, Gauteng 2013
South AfricaSite Not Available
Limpopo Clinical Research Initiative
Thabazimbi, Limpopo 387
South AfricaSite Not Available
Merclinico Middelburg
Middelburg, Mpumalanga 1050
South AfricaSite Not Available
FAM-CRU
Cape Town, Western Cape 7505
South AfricaSite Not Available
Royal Bournemouth Hospital
Bournemouth, Dorset BH7 7DW
United KingdomSite Not Available
Southampton General Hospital
Southampton, Hampshire
United KingdomSite Not Available
The Royal London Hospital
London, London, City Of E1 1FR
United KingdomSite Not Available
The Royal Free Hospital
London, Middlesex NW3 2QG
United KingdomSite Not Available
Cardiff & Vale University Health Board-PPDS
Cardiff, South Glamorgan CF14 4XN
United KingdomSite Not Available
St George's Hospital
London, Surrey SW17 0QT
United KingdomSite Not Available
Glasgow Clinical Research Facility - PPDS
Glasgow, G51 4TF
United KingdomSite Not Available
Central Research Associates - Flourish - PPDS
Birmingham, Alabama 35205-1605
United StatesSite Not Available
SEC Clinical Research LLC - Dothan 2 - ClinEdge - PPDS
Dothan, Alabama 36305-7376
United StatesSite Not Available
Abby's Research Institute
Phoenix, Arizona 85031-3878
United StatesSite Not Available
Watching Over Mothers & Babies
Tucson, Arizona 85712
United StatesSite Not Available
Applied Research Center of Arkansas - ClinEdge - PPDS
Little Rock, Arkansas 72212-4169
United StatesSite Not Available
Matrix Clinical Research - Gardena
Gardena, California 90247-4956
United StatesSite Not Available
Matrix Clinical Research - Huntington Park
Huntington Park, California 90255-2913
United StatesSite Not Available
Matrix Clinical Research, Inc - Corporate Office
Los Angeles, California 90057-4103
United StatesSite Not Available
ARS - Fetal Diagnostic Center of Orlando - ERN - PPDS
Orlando, Florida 32803-1465
United StatesSite Not Available
Clinical Research Prime - ClinEdge - PPDS
Idaho Falls, Idaho 83404-5305
United StatesSite Not Available
Bingham Memorial Hospital
Pocatello, Idaho 83201
United StatesSite Not Available
Clinical Research Prime - ClinEdge - Rexburg - PPDS
Rexburg, Idaho 83440-5390
United StatesSite Not Available
Velocity Clinical Research - Covington - PPDS
Covington, Louisiana 70433-7237
United StatesSite Not Available
Saginaw Valley Medical Research Group LLC
Saginaw, Michigan 48604-9533
United StatesSite Not Available
Boeson Research GTF - Great Falls - ERN - PPDS
Great Falls, Montana 59405-5316
United StatesSite Not Available
Boeson Research KAL - Kalispell - ERN - PPDS
Kalispell, Montana 59901-2158
United StatesSite Not Available
Boeson Research MSO - Missoula - ERN - PPDS
Missoula, Montana 59804-7401
United StatesSite Not Available
Velocity Clinical Research (Grand Island - Nebraska) - PPDS
Grand Island, Nebraska 68803-4327
United StatesSite Not Available
Velocity Clinical Research (Hastings - Nebraska) - PPDS
Hastings, Nebraska 68901-2615
United StatesSite Not Available
Velocity Clinical Research (Norfolk - Nebraska) - PPDS
Norfolk, Nebraska 68701-7701
United StatesSite Not Available
DM Clinical Research - Birthing Center of New York - ERN - PPDS
Brooklyn, New York 11220-5203
United StatesSite Not Available
DM Clinical Research - Bellaire - ERN - PPDS
Houston, Texas 77081
United StatesSite Not Available
Maximos OB/GYN
League City, Texas 77573-2681
United StatesSite Not Available
SMS Clinical Research
Mesquite, Texas 75149
United StatesSite Not Available
Maternal Fetal Diagnostics Center
Salt Lake City, Utah 84132-0001
United StatesSite Not Available
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