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

NCT06143046 | Active Not Recruiting Phase 2 FDA Drug

• 2 other identifiers: mRNA-1345-P2012023-505359-37-00
• Study Type: interventional
• Target: 360
• Locations: 8 countries
• Sites: 56

Brief 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.

Conditions

Respiratory Syncytial Virus

Keywords

mRNA-1345; RSV vaccine; Viral Diseases; Messenger RNA; Moderna

Outcome Measures

Primary Outcomes (11)

• Number of Maternal Participants with Solicited Local and Systemic Adverse Reactions (ARs)

  Up to Day 7 (7 days post vaccination)

• Number of Maternal Participants with Unsolicited Adverse Events (AEs)

  Up to Day 28 (28 days post vaccination)

• Number of Maternal Participants with Medically-Attended AEs (MAAEs)

  Day 1 to Month 6 (6 months postdelivery)

• Number of Maternal Participants with Adverse Events of Special Interest (AESIs)

  Day 1 to Month 12 (12 months postdelivery)

• Number of Maternal Participants with Serious Adverse Events (SAEs)

  Day 1 to Month 12 (12 months postdelivery)

• Number of Maternal Participants with AEs Leading to Discontinuation

  Day 1 to Month 12 (12 months postdelivery)

• Number of Maternal Participants With Pregnancy Outcomes

  Pregnancy outcomes will include stillbirth, live birth, vaginal delivery, and cesarean section delivery.

  Day 1 to Month 12 (12 months postdelivery)

• Number of Infant Participants with MAAEs

  Day 1 (birth) to Month 12

• Number of Infant Participants with AESIs

  Day 1 (birth) to Month 12

• Number of Infant Participants with SAEs

  Day 1 (birth) to Month 12

• Number of Infant Participants With Birth Outcomes

  Birth outcomes will include gestational age and anthropometric measurements.

  Day 1 (birth) to Month 12

Secondary Outcomes (6)

• Geometric Mean Titer (GMT) of Serum RSV-A and RSV-B Neutralizing Antibodies in Maternal Participants

  Day 1, Day 29, delivery, and Month 6 (6 months postdelivery)

• Geometric Mean Concentration (GMC) of Serum RSV-F Binding Antibodies in Maternal Participants

  Day 1, Day 29, delivery, and Month 6 (6 months postdelivery)

• Geometric Mean Fold-Rise (GMFR) of Postbaseline/Baseline Neutralizing Antibody Titers and Binding Antibody Concentrations in Maternal Participants

  Day 29, delivery, and Month 6 (6 months postdelivery)

• Percentage of Maternal Participants With ≥4-fold Increase From Baseline in Neutralizing Antibody Titers and Binding Antibody Concentrations

  Baseline up to Month 6 (6 months postdelivery)

• GMT of Serum RSV-A and RSV-B Neutralizing Antibodies in Infant Participants

  Day 1 (birth), and Months 2, 6, and 12

Study Arms (4)

mRNA-1345 Dose A

EXPERIMENTAL

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.

Biological: mRNA-1345

mRNA-1345 Dose B

EXPERIMENTAL

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.

Biological: mRNA-1345

mRNA-1345 Dose C

EXPERIMENTAL

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.

Biological: mRNA-1345

Placebo

PLACEBO COMPARATOR

Participants will receive single IM injection of mRNA-1345 vaccine matching placebo in the period from 28 weeks to 36 weeks of gestation.

Biological: Placebo

Interventions

Placebo BIOLOGICAL

0.9% sodium chloride (normal saline) injection

Placebo

mRNA-1345 BIOLOGICAL

Sterile liquid for injection

mRNA-1345 Dose A; mRNA-1345 Dose B; mRNA-1345 Dose C

Eligibility Criteria

• Age: 0 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• ModernaTX, Inc.: lead

Study Sites (56)

SEC Clinical Research LLC - Dothan 2 - ClinEdge - PPDS

Dothan, Alabama, 36305-7376, United States

Location

Abby's Research Institute

Phoenix, Arizona, 85031-3878, United States

Location

Watching Over Mothers & Babies

Tucson, Arizona, 85712, United States

Location

Applied Research Center of Arkansas - ClinEdge - PPDS

Little Rock, Arkansas, 72212-4169, United States

Location

Matrix Clinical Research - Gardena

Gardena, California, 90247-4956, United States

Location

Matrix Clinical Research - Huntington Park

Huntington Park, California, 90255-2913, United States

Location

Matrix Clinical Research, Inc - Corporate Office

Los Angeles, California, 90057-4103, United States

Location

Clinical Research Prime - ClinEdge - PPDS

Idaho Falls, Idaho, 83404-5305, United States

Location

Bingham Memorial Hospital

Pocatello, Idaho, 83201, United States

Location

Clinical Research Prime - ClinEdge - Rexburg - PPDS

Rexburg, Idaho, 83440-5390, United States

Location

Velocity Clinical Research - Covington - PPDS

Covington, Louisiana, 70433-7237, United States

Location

Saginaw Valley Medical Research Group LLC

Saginaw, Michigan, 48604-9533, United States

Location

Boeson Research GTF - Great Falls - ERN - PPDS

Great Falls, Montana, 59405-5316, United States

Location

Boeson Research KAL - Kalispell - ERN - PPDS

Kalispell, Montana, 59901-2158, United States

Location

Boeson Research MSO - Missoula - ERN - PPDS

Missoula, Montana, 59804-7401, United States

Location

Velocity Clinical Research (Grand Island - Nebraska) - PPDS

Grand Island, Nebraska, 68803-4327, United States

Location

Velocity Clinical Research (Hastings - Nebraska) - PPDS

Hastings, Nebraska, 68901-2615, United States

Location

Velocity Clinical Research (Norfolk - Nebraska) - PPDS

Norfolk, Nebraska, 68701-7701, United States

Location

DM Clinical Research - Bellaire - ERN - PPDS

Houston, Texas, 77081, United States

Location

Maximos OB/GYN

League City, Texas, 77573-2681, United States

Location

SMS Clinical Research

Mesquite, Texas, 75149, United States

Location

Maternal Fetal Diagnostics Center

Salt Lake City, Utah, 84132-0001, United States

Location

Dalhousie University - 5820 University Ave

Halifax, Nova Scotia, B3H 1, Canada

Location

Ottawa Hospital

Ottawa, Ontario, K1H 8L6, Canada

Location

Sainte Justine Hospital

Montreal, Quebec, H3T 1C5, Canada

Location

Centre Hospitalier de l'Université Laval

Québec, G1V 4G2, Canada

Location

Clínica Universidad de los Andes

Las Condes, Región-MetropolitanadeSantiago, 7550000, Chile

Location

Centro Internacional de Estudios Clínicos

Recoleta, Región-MetropolitanadeSantiago, 8420000, Chile

Location

Red Hospital Clinico de la Universidad de Chile

Santiago, 8380453, Chile

Location

Hvidovre Hospital

Hvidovre, Capital, DK-2650, Denmark

Location

Aarhus Universitetshospital

Aarhus, Central Jutland, 8200, Denmark

Location

Regionshospitalet Gødstrup

Herning, Central Jutland, 7400, Denmark

Location

Shonan Kamakura General Hospital

Kamakura-Shi, Kanagawa, 247-8533, Japan

Location

Saiseikai Yokohamashi Nanbu Hospital

Yokohama, Kanagawa, 234-0054, Japan

Location

Saitama City Hospital

Saitama-Shi, Saitama, 336-0911, Japan

Location

Center Hospital of the National Center for Global Health and Medicine

Shinjuku-Ku, Tokyo, 162-8655, Japan

Location

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

David, Chiriquí Province, Panama

Location

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

Panama City, Panama

Location

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

Panama City, Panama

Location

CEVAXIN 24 de diciembre

Panama City, Panama

Location

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

Pueblo Nuevo, Panama

Location

Josha Research

Bloemfontein, Free State, 9300, South Africa

Location

Drs. YAK Vahed & Partners

Welkom, Free State, 9459, South Africa

Location

Ubuntu Clinical Research

Krugersdorp, Gauteng, 1739, South Africa

Location

Bothe ke Bontle Health Services-316 Kuit st

Pretoria, Gauteng, 0184, South Africa

Location

Setshaba Research Centre

Soshanguve, Gauteng, 152, South Africa

Location

WITS Clinical Research Site - PPDS

Soweto, Gauteng, 2013, South Africa

Location

Merclinico Middelburg

Middelburg, Mpumalanga, 1050, South Africa

Location

FAM-CRU

Cape Town, Western Cape, 7505, South Africa

Location

Royal Bournemouth Hospital

Bournemouth, Dorset, BH7 7DW, United Kingdom

Location

Southampton General Hospital

Southampton, Hampshire, United Kingdom

Location

The Royal London Hospital

London, London, City of, E1 1FR, United Kingdom

Location

The Royal Free Hospital

London, Middlesex, NW3 2QG, United Kingdom

Location

Cardiff & Vale University Health Board-PPDS

Cardiff, South Glamorgan, CF14 4XN, United Kingdom

Location

St George's Hospital

London, Surrey, SW17 0QT, United Kingdom

Location

Glasgow Clinical Research Facility - PPDS

Glasgow, G51 4TF, United Kingdom

Location

MeSH Terms

Conditions

Virus Diseases

Interventions

mRNA-1345 respiratory syncytial virus vaccine

Condition Hierarchy (Ancestors)

Infections

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Observer-blind study
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2023
• First Posted: November 22, 2023
• Study Start: November 15, 2023
• Primary Completion (Estimated): May 27, 2026
• Study Completion (Estimated): May 27, 2026
• Last Updated: February 5, 2026

Record last verified: 2026-01

Locations

DK (3); CL (3); PA (5); US (22); CA (4); GB (7); ZA (8); JP (4)