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Could a shot during pregnancy shield babies from RSV?

NCT ID NCT06143046

Vaccine Sponsor: ModernaTX, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested an mRNA vaccine (mRNA-1345) against respiratory syncytial virus (RSV) in 360 pregnant women. The goal was to see if the vaccine is safe for mothers and their babies, and whether it triggers an immune response that could protect infants after birth. Participants received either the vaccine or a placebo during their third trimester.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
mRNA-1345 (an mRNA vaccine against respiratory syncytial virus)
What this could lead to
If successful, this vaccine could protect newborns from severe RSV disease by passing immunity from vaccinated mothers.
What could go wrong
This is an early phase 2 trial with only 360 participants, so results may not confirm safety or effectiveness. Side effects or lack of immune response in infants are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

360 people

The number who actually took part.

Started

Nov 2023

Finished

May 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

0 to 40 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

viral infectious disease respiratory syncytial virus infectious disease prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Respiratory syncytial virus

Contacts and locations

Locations

  • Aarhus Universitetshospital

    Aarhus, Central Jutland, 8200, Denmark

  • Abby's Research Institute

    Phoenix, Arizona, 85031-3878, United States

  • Applied Research Center of Arkansas - ClinEdge - PPDS

    Little Rock, Arkansas, 72212-4169, United States

  • Bingham Memorial Hospital

    Pocatello, Idaho, 83201, United States

  • Boeson Research GTF - Great Falls - ERN - PPDS

    Great Falls, Montana, 59405-5316, United States

  • Boeson Research KAL - Kalispell - ERN - PPDS

    Kalispell, Montana, 59901-2158, United States

  • Boeson Research MSO - Missoula - ERN - PPDS

    Missoula, Montana, 59804-7401, United States

  • Bothe ke Bontle Health Services-316 Kuit st

    Pretoria, Gauteng, 0184, South Africa

  • CEVAXIN 24 de diciembre

    Panama City, Panama

  • Cardiff & Vale University Health Board-PPDS

    Cardiff, South Glamorgan, CF14 4XN, United Kingdom

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

    Shinjuku-Ku, Tokyo, 162-8655, Japan

  • Centre Hospitalier de l'Université Laval

    Québec, G1V 4G2, Canada

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

    Panama City, Panama

  • 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 Internacional de Estudios Clínicos

    Recoleta, Región-MetropolitanadeSantiago, 8420000, Chile

  • Clinical Research Prime - ClinEdge - PPDS

    Idaho Falls, Idaho, 83404-5305, United States

  • Clinical Research Prime - ClinEdge - Rexburg - PPDS

    Rexburg, Idaho, 83440-5390, United States

  • Clínica Universidad de los Andes

    Las Condes, Región-MetropolitanadeSantiago, 7550000, Chile

  • DM Clinical Research - Bellaire - ERN - PPDS

    Houston, Texas, 77081, United States

  • Dalhousie University - 5820 University Ave

    Halifax, Nova Scotia, B3H 1, Canada

  • Drs. YAK Vahed & Partners

    Welkom, Free State, 9459, South Africa

  • FAM-CRU

    Cape Town, Western Cape, 7505, South Africa

  • Glasgow Clinical Research Facility - PPDS

    Glasgow, G51 4TF, United Kingdom

  • Hvidovre Hospital

    Hvidovre, Capital, DK-2650, Denmark

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

    Pueblo Nuevo, Panama

  • Josha Research

    Bloemfontein, Free State, 9300, South Africa

  • Maternal Fetal Diagnostics Center

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

  • Matrix Clinical Research - Gardena

    Gardena, California, 90247-4956, United States

  • Matrix Clinical Research - Huntington Park

    Huntington Park, California, 90255-2913, United States

  • Matrix Clinical Research, Inc - Corporate Office

    Los Angeles, California, 90057-4103, United States

  • Maximos OB/GYN

    League City, Texas, 77573-2681, United States

  • Merclinico Middelburg

    Middelburg, Mpumalanga, 1050, South Africa

  • Ottawa Hospital

    Ottawa, Ontario, K1H 8L6, Canada

  • Red Hospital Clinico de la Universidad de Chile

    Santiago, 8380453, Chile

  • Regionshospitalet Gødstrup

    Herning, Central Jutland, 7400, Denmark

  • Royal Bournemouth Hospital

    Bournemouth, Dorset, BH7 7DW, United Kingdom

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

    Dothan, Alabama, 36305-7376, United States

  • SMS Clinical Research

    Mesquite, Texas, 75149, United States

  • Saginaw Valley Medical Research Group LLC

    Saginaw, Michigan, 48604-9533, United States

  • Sainte Justine Hospital

    Montreal, Quebec, H3T 1C5, Canada

  • Saiseikai Yokohamashi Nanbu Hospital

    Yokohama, Kanagawa, 234-0054, Japan

  • Saitama City Hospital

    Saitama-Shi, Saitama, 336-0911, Japan

  • Setshaba Research Centre

    Soshanguve, Gauteng, 152, South Africa

  • Shonan Kamakura General Hospital

    Kamakura-Shi, Kanagawa, 247-8533, Japan

  • Southampton General Hospital

    Southampton, Hampshire, United Kingdom

  • St George's Hospital

    London, Surrey, SW17 0QT, United Kingdom

  • The Royal Free Hospital

    London, Middlesex, NW3 2QG, United Kingdom

  • The Royal London Hospital

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

  • Ubuntu Clinical Research

    Krugersdorp, Gauteng, 1739, South Africa

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

    Grand Island, Nebraska, 68803-4327, United States

  • Velocity Clinical Research (Hastings - Nebraska) - PPDS

    Hastings, Nebraska, 68901-2615, United States

  • Velocity Clinical Research (Norfolk - Nebraska) - PPDS

    Norfolk, Nebraska, 68701-7701, United States

  • Velocity Clinical Research - Covington - PPDS

    Covington, Louisiana, 70433-7237, United States

  • WITS Clinical Research Site - PPDS

    Soweto, Gauteng, 2013, South Africa

  • Watching Over Mothers & Babies

    Tucson, Arizona, 85712, United States

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Other studies related to the condition(s) this trial covers.