A Study of mRNA-1345 Vaccine Targeting Respiratory Syncytial Virus in Pregnant Women and in Infants Born to Vaccinated Mothers

Last updated: March 12, 2025
Sponsor: ModernaTX, Inc.
Overall Status: Active - Not Recruiting

Phase

2

Condition

N/A

Treatment

mRNA-1345

Placebo

Clinical Study ID

NCT06143046
mRNA-1345-P201
2023-505359-37-00
  • Ages 18-40
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The purpose of the study is to evaluate the reactogenicity, safety, and immunogenicity of an investigational respiratory syncytial virus (RSV) vaccine, mRNA-1345, in pregnant women, and safety and immunogenicity in infants born to vaccinated mothers.

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

Total Participants: 360
Treatment Group(s): 2
Primary Treatment: mRNA-1345
Phase: 2
Study Start date:
November 15, 2023
Estimated Completion Date:
February 18, 2026

Connect with a study center

  • Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich

    Ciudad Autónoma de Buenos Aires, Buenos Aires C1426
    Argentina

    Site Not Available

  • Clinica Privada Independencia

    Munro, Buenos Aires B1605
    Argentina

    Site Not Available

  • Instituto Médico de la Fundación Estudios Clínicos

    Rosario, Santa Fe S2000DEJ
    Argentina

    Site Not Available

  • Expertia S.A- Mautalen Salud e Investigacion

    Ciudad Autónoma de Buenos Aires, C1128AAF
    Argentina

    Site Not Available

  • Clinica Mayo de U.M.C.B. S.R.L

    San Miguel De Tucumán, T4000IHE
    Argentina

    Site Not Available

  • Instituto de Maternidad Nuestra Señora de La Merced

    San Miguel de Tucumán, T4000CPC
    Argentina

    Site Not Available

  • BC Women's Hospital and Health Centre

    Vancouver, British Columbia V6H 3N1
    Canada

    Site Not Available

  • Dalhousie University - 5820 University Ave

    Halifax, Nova Scotia B3H 1
    Canada

    Site Not Available

  • Ottawa Hospital

    Ottawa, Ontario K1H 8L6
    Canada

    Site Not Available

  • Ottawa Hospital Civic Campus

    Ottawa, Ontario K1H 8L6
    Canada

    Site Not Available

  • Sainte Justine Hospital

    Montréal, Quebec H3T 1C5
    Canada

    Site Not Available

  • Centre Hospitalier de l'Université Laval

    Quebec, G1V 4G2
    Canada

    Site Not Available

  • Clínica Universidad de los Andes

    Las Condes, Región-MetropolitanadeSantiago 7550000
    Chile

    Site Not Available

  • Centro Internacional de Estudios Clínicos

    Recoleta, Región-MetropolitanadeSantiago 8420000
    Chile

    Site Not Available

  • Red Hospital Clinico de la Universidad de Chile

    Santiago, 8380453
    Chile

    Site Not Available

  • Hvidovre Hospital

    Hvidovre, Capital DK-2650
    Denmark

    Site Not Available

  • Aarhus Universitetshospital

    Aarhus, Central Jutland 8200
    Denmark

    Site Not Available

  • Regionshospitalet Gødstrup

    Herning, Central Jutland 7400
    Denmark

    Site Not Available

  • Sygehus Lillebaelt, Kolding

    Kolding, South Denmark 6000
    Denmark

    Site Not Available

  • Shonan Kamakura General Hospital

    Kamakura-Shi, Kanagawa 247-8533
    Japan

    Site Not Available

  • Saiseikai Yokohamashi Nanbu Hospital

    Yokohama, Kanagawa 234-0054
    Japan

    Site Not Available

  • Saitama City Hospital

    Saitama-Shi, Saitama 336-0911
    Japan

    Site Not Available

  • Center Hospital of the National Center for Global Health and Medicine

    Shinjuku-Ku, Tokyo 162-8655
    Japan

    Site Not Available

  • Centro De Vacunacion Internacional, S.A. (Cevaxin) - David

    David, Chiriquí
    Panama

    Site Not Available

  • Centro De Vacunacion Internacional, S.A. (Cevaxin)

    Ciudad De Panamá,
    Panama

    Site Not Available

  • Centro De Vacunacion Internacional, S.A. (Cevaxin) Sede La Chorrera

    Ciudad De Panamá,
    Panama

    Site Not Available

  • CEVAXIN 24 de diciembre

    Panamá,
    Panama

    Site Not Available

  • Instituto de Investigaciones Científicas Y Servicios de Alta Tecnología Asociación de Interés Panama

    Pueblo Nuevo,
    Panama

    Site Not Available

  • Josha Research

    Bloemfontein, Free State 9300
    South Africa

    Site Not Available

  • Drs. YAK Vahed & Partners

    Welkom, Free State 9459
    South Africa

    Site Not Available

  • Ubuntu Clinical Research

    Krugersdorp, Gauteng 1739
    South Africa

    Site Not Available

  • Bothe ke Bontle Health Services-316 Kuit st

    Pretoria, Gauteng 0184
    South Africa

    Site Not Available

  • Setshaba Research Centre

    Soshanguve, Gauteng 152
    South Africa

    Site Not Available

  • WITS Clinical Research Site - PPDS

    Soweto, Gauteng 2013
    South Africa

    Site Not Available

  • Limpopo Clinical Research Initiative

    Thabazimbi, Limpopo 387
    South Africa

    Site Not Available

  • Merclinico Middelburg

    Middelburg, Mpumalanga 1050
    South Africa

    Site Not Available

  • FAM-CRU

    Cape Town, Western Cape 7505
    South Africa

    Site Not Available

  • Royal Bournemouth Hospital

    Bournemouth, Dorset BH7 7DW
    United Kingdom

    Site Not Available

  • Southampton General Hospital

    Southampton, Hampshire
    United Kingdom

    Site Not Available

  • The Royal London Hospital

    London, London, City Of E1 1FR
    United Kingdom

    Site Not Available

  • The Royal Free Hospital

    London, Middlesex NW3 2QG
    United Kingdom

    Site Not Available

  • Cardiff & Vale University Health Board-PPDS

    Cardiff, South Glamorgan CF14 4XN
    United Kingdom

    Site Not Available

  • St George's Hospital

    London, Surrey SW17 0QT
    United Kingdom

    Site Not Available

  • Glasgow Clinical Research Facility - PPDS

    Glasgow, G51 4TF
    United Kingdom

    Site Not Available

  • Central Research Associates - Flourish - PPDS

    Birmingham, Alabama 35205-1605
    United States

    Site Not Available

  • SEC Clinical Research LLC - Dothan 2 - ClinEdge - PPDS

    Dothan, Alabama 36305-7376
    United States

    Site Not Available

  • Abby's Research Institute

    Phoenix, Arizona 85031-3878
    United States

    Site Not Available

  • Watching Over Mothers & Babies

    Tucson, Arizona 85712
    United States

    Site Not Available

  • Applied Research Center of Arkansas - ClinEdge - PPDS

    Little Rock, Arkansas 72212-4169
    United States

    Site Not Available

  • Matrix Clinical Research - Gardena

    Gardena, California 90247-4956
    United States

    Site Not Available

  • Matrix Clinical Research - Huntington Park

    Huntington Park, California 90255-2913
    United States

    Site Not Available

  • Matrix Clinical Research, Inc - Corporate Office

    Los Angeles, California 90057-4103
    United States

    Site Not Available

  • ARS - Fetal Diagnostic Center of Orlando - ERN - PPDS

    Orlando, Florida 32803-1465
    United States

    Site Not Available

  • Clinical Research Prime - ClinEdge - PPDS

    Idaho Falls, Idaho 83404-5305
    United States

    Site Not Available

  • Bingham Memorial Hospital

    Pocatello, Idaho 83201
    United States

    Site Not Available

  • Clinical Research Prime - ClinEdge - Rexburg - PPDS

    Rexburg, Idaho 83440-5390
    United States

    Site Not Available

  • Velocity Clinical Research - Covington - PPDS

    Covington, Louisiana 70433-7237
    United States

    Site Not Available

  • Saginaw Valley Medical Research Group LLC

    Saginaw, Michigan 48604-9533
    United States

    Site Not Available

  • Boeson Research GTF - Great Falls - ERN - PPDS

    Great Falls, Montana 59405-5316
    United States

    Site Not Available

  • Boeson Research KAL - Kalispell - ERN - PPDS

    Kalispell, Montana 59901-2158
    United States

    Site Not Available

  • Boeson Research MSO - Missoula - ERN - PPDS

    Missoula, Montana 59804-7401
    United States

    Site Not Available

  • Velocity Clinical Research (Grand Island - Nebraska) - PPDS

    Grand Island, Nebraska 68803-4327
    United States

    Site Not Available

  • Velocity Clinical Research (Hastings - Nebraska) - PPDS

    Hastings, Nebraska 68901-2615
    United States

    Site Not Available

  • Velocity Clinical Research (Norfolk - Nebraska) - PPDS

    Norfolk, Nebraska 68701-7701
    United States

    Site Not Available

  • DM Clinical Research - Birthing Center of New York - ERN - PPDS

    Brooklyn, New York 11220-5203
    United States

    Site Not Available

  • DM Clinical Research - Bellaire - ERN - PPDS

    Houston, Texas 77081
    United States

    Site Not Available

  • Maximos OB/GYN

    League City, Texas 77573-2681
    United States

    Site Not Available

  • SMS Clinical Research

    Mesquite, Texas 75149
    United States

    Site Not Available

  • Maternal Fetal Diagnostics Center

    Salt Lake City, Utah 84132-0001
    United States

    Site Not Available

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