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ACTIVE NOT RECRUITING

NCT06143046

PHASE2

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

Sponsor: ModernaTX, Inc.

View on ClinicalTrials.gov

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.

Official title: A Phase 2, Randomized, Observer-Blind, Placebo-Controlled, Dose-Escalation Study to Evaluate the Reactogenicity, Safety, and Immunogenicity of mRNA-1345, an mRNA Vaccine Targeting Respiratory Syncytial Virus, in Pregnant Women, and Safety and Immunogenicity in Infants Born to Vaccinated Mothers

Key Details

Gender

All

Age Range

0 Years - 40 Years

Study Type

INTERVENTIONAL

Enrollment

360

Start Date

2023-11-15

Completion Date

2026-05-27

Last Updated

2026-02-05

Healthy Volunteers

Yes

Conditions

Respiratory Syncytial Virus

Interventions

BIOLOGICAL

mRNA-1345

Sterile liquid for injection

BIOLOGICAL

Placebo

0.9% sodium chloride (normal saline) injection

Key Inclusion Criteria: Maternal Participants * 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. Specific inclusion criteria for Japanese pregnant women: * 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. Key Exclusion Criteria: Maternal Participants * 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. Other inclusion and exclusion criteria may apply.

Locations (56)

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

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (56)