AzTrials
AzTrials

Respiratory Syncytial VirusPhase 2/3NCT05127434

A Study to Evaluate the Safety and Efficacy of mRNA-1345 Vaccine Targeting Respiratory Syncytial Virus (RSV) in Adults ≥60 Years of Age

A Phase 2/3 study testing mRNA-1345 in people with Respiratory Syncytial Virus, run by ModernaTX, Inc. at 269 sites in 23 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The main purpose of Part A of this study is to evaluate the safety and tolerability of mRNA-1345 vaccine and to demonstrate the efficacy of a single dose of mRNA-1345 vaccine in the prevention of a first episode of RSV-associated lower respiratory tract disease (RSV-LRTD) as compared with placebo from 14 days… Read more about this study

Who is it for?
Ages 60 years and olderHealthy volunteers can take part
Conditions the study is for
Respiratory Syncytial Virus
What is being tested?
mRNA-1345
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
36,814 participants
Where
269 sitesin 23 countries
Study dates
17 Nov 2021to 28 Jul 2025
Phase
Phase 2/3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Adults ≥ 60 years of age who are primarily responsible for self-care and activities of daily living. Participants may have one or more chronic medical diagnoses (including chronic heart failure [CHF] and chronic obstructive pulmonary disease [COPD]), but should be medically stable
  • Body mass index from ≥18 kilograms (kg)/square meter (m^2) to ≤35 kg/m^2
  • Randomized to and were subsequently vaccinated with the mRNA-1345 study injection in Part A at least 21 months prior to Screening.

Who cannot join

  • Participation in another clinical research study where participant has received an investigational product (drug/biologic/device) within 6 months before the planned date of the Day 1 study injection.
  • Current participation in research involving receipt of any investigational RSV product
  • History of a serious reaction to any prior vaccination or Guillain-Barré syndrome within 6 weeks of any prior influenza immunization.
  • Received or plans to receive any non-study vaccine within 28 days before or after the Day 1 study injection.
  • Participation in another clinical research study where participant has received an investigational product (drug/biologic/device) within 6 months before the planned date of BD study injection (BD Day 1).
  • History of a serious reaction to any prior vaccination, or Guillain-Barré syndrome within 6 weeks of any prior influenza immunization.
Show all 9Show fewer
  • Received or plans to receive any non-study vaccine (including authorized or approved vaccines for the prevention of coronavirus disease 2019 (COVID-19) regardless of type of vaccine) within 14 days before or after the BD Day 1 study injection.
  • Received or plans to receive any commercial RSV vaccination at any time prior to BD study injection (BD Day 1) or during the substudy.
  • Other inclusion and/or exclusion criteria may apply.

Trial locations and contacts

269 sites in 23 countries.

269 sites in 23 countries

United States133 sites

  • Privia Medical Group, LLC - Annapolis - Javara - PPDS

    Annapolis, Maryland, 21401

  • Mount Vernon Clinical Research, LLC - M3 WR

    Atlanta, Georgia, 30328

  • Masters of Clinical Research Inc

    Augusta, Georgia, 30909

  • Lynn Institute of Denver

    Aurora, Colorado, 80012

  • Premier Family Physicians - Austin - Hunt - PPDS

    Austin, Texas, 78735

  • Tekton Research

    Austin, Texas, 78745

  • Velocity Clinical Research, Banning

    Banning, California, 92220

  • Velocity Clinical Research (Baton Rouge - Louisiana) - PPDS

    Baton Rouge, Louisiana, 70809

  • AES - DRS - Synexus Clinical Research US, Inc. - Birmingham

    Birmingham, Alabama, 35211

  • Accel Research Site - Achieve - Birmingham

    Birmingham, Alabama, 35216

  • Cope Family Medicine - CCT - PPDS

    Bountiful, Utah, 84010

  • PanAmerican Clinical Research LLC

    Brownsville, Texas, 78520

  • Hope Clinical Research, LLC

    Canoga Park, California, 91303

  • ACRC Trials - Carrollton - Hunt - PPDS

    Carrollton, Texas, 75010

  • AES - DRS - Synexus Clinical Research US, Inc. - Chicago

    Chicago, Illinois, 60602

  • Velocity Clinical Research - Chula Vista - PPDS

    Chula Vista, California, 91911

  • CTI Clinical Research

    Cincinnati, Ohio, 45212

  • Velocity Clinical Research (Cincinnati - Ohio) - PPDS

    Cincinnati, Ohio, 45219

  • Velocity Clinical Research - Cincinnati - PPDS

    Cincinnati, Ohio, 45219

  • AES - DRS - Synexus Clinical Research US, Inc. - Cincinnati

    Cincinnati, Ohio, 45236

  • Alpine Research Organization, Inc

    Clinton, Utah, 84015

  • Centricity Research - Roswell - HyperCore - PPDS

    Columbus, Georgia, 31904

  • Benchmark Research - Covington - HyperCore - PPDS

    Covington, Louisiana, 70433

  • AES - DRS - Synexus Clinical Research US, Inc. - St. Louis

    Creve Coeur, Missouri, 63141

  • PPD Virtual - Science 37, Inc

    Culver City, California, 90230

  • Velocity Clinical Research (Dakota Dunes - South Dakota) - PPDS

    Dakota Dunes, South Dakota, 57049

  • iResearch Atlanta

    Decatur, Georgia, 30030

  • Velocity Clinical Research - East Syracuse - PPDS

    East Syracuse, New York, 13057

  • Velocity Clinical Research, New Smyrna Beach

    Edgewater, Florida, 32132

  • Tekton Research - Oklahoma - PPDS

    Edmond, Oklahoma, 73013

  • Skyline Medical Center, PC - CCT Research

    Elkhorn, Nebraska, 68022

  • Velocity Clinical Research (Endwell - New York) - PPDS

    Endwell, New York, 13760

  • AES - DRS - Synexus Clinical Research US, Inc. - Evansville

    Evansville, Indiana, 47714

  • Javara, Inc./Privia Medical Group Georgia, LLC

    Fayetteville, Georgia, 30214

  • Carolina Institute for Clinical Research - M3 WR

    Fayetteville, North Carolina, 28303

  • Fleming Island Clinical Research Center

    Fleming Island, Florida, 32003

  • Tekton Research - Fort Collins - PPDS

    Fort Collins, Colorado, 80525

  • Privia Medical Group- North Texas - West Parker Road - Fort Worth - Javara - PPDS

    Fort Worth, Texas, 76132

  • Methodist Physicians Clinic - CCT Research - PPDS

    Fremont, Nebraska, 68025

  • Allure Health LLC

    Friendswood, Texas, 77546

  • Olympus Family Medicine- CCT

    Friendswood, Texas, 77546

  • Village Health Partners Frisco Medical Village

    Frisco, Texas, 75033

  • CBH Health - CenExel CBH - PPDS

    Gaithersburg, Maryland, 20877

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

    Grand Island, Nebraska, 68803

  • Triad Clinical Trials

    Greensboro, North Carolina, 27410

  • Lakeview Clinical Research

    Guntersville, Alabama, 35976

  • Velocity Clinical Research - Hallandale Beach - PPDS

    Hallandale, Florida, 33009

  • Drug Trials America

    Hartsdale, New York, 10530

  • Hatboro Medical Associates - CCT - PPDS

    Hatboro, Pennsylvania, 19040

  • East West Medical Research Institute

    Honolulu, Hawaii, 96814

  • West Houston Clinical Research - Hunt - PPDS

    Houston, Texas, 77055

  • DM Clinical Research - Bellaire - ERN - PPDS

    Houston, Texas, 77081

  • DM Clinical-TCDD

    Humble, Texas, 77338

  • Hope Research Institute LLC - Hunt - PPDS

    Hunt, Arizona, 85023

  • Hope Research Institute LLC - Hunt - PPDS

    Hunt, Arizona, 85284

  • AES - DRS - Optimal Research Alabama - Huntsville

    Huntsville, Alabama, 35802

  • Jacksonville Center for Clinical Research

    Jacksonville, Florida, 32216

  • Helios CR, Inc. - Houston - PPDS

    Keller, Texas, 76248

  • Velocity Clinical Research, San Diego

    La Mesa, California, 91942

  • Multi-Specialty Research Associates, Inc. M3 WR

    Lake City, Florida, 32055

  • HEALOR Primary Care - Physicians Las Vegas - CCT

    Las Vegas, Nevada, 89102

  • Excel Clinical Research - Las Vegas

    Las Vegas, Nevada, 89109

  • Johnson County Clin-Trials

    Lenexa, Kansas, 66219

  • Velocity Clinical Research (Lincoln - Nebraska) - PPDS

    Lincoln, Nebraska, 68510

  • Baptist Health Center for Clinical Research

    Little Rock, Arkansas, 72205

  • Tekton Research - Longmont - PPDS

    Longmont, Colorado, 80501

  • PRI, LLC - Los Alamitos - M3 WR

    Los Alamitos, California, 90720

  • Accel Research Sites - Maitland - ERN - PPDS

    Maitland, Florida, 32751

  • Drug Studies America - ClinEdge - PPDS

    Marietta, Georgia, 30060

  • Velocity Clinical Research - Boise - PPDS

    Meridian, Idaho, 83642

  • Desert Clinical Research, LLC - CCT

    Mesa, Arizona, 85213

  • Benchmark Research - Metairie - HyperCore - PPDS

    Metairie, Louisiana, 70006

  • Spotlight Research Center, LLC

    Miami, Florida, 33176

  • IMA Clinical Research - Manhattan - PPDS

    Miami Beach, Florida, 33140

  • Clinical Research Consultants LLC - ClinEdge - PPDS

    Milford, Connecticut, 06460

  • Clinical Research Institute, Inc - CRN - PPDS

    Minneapolis, Minnesota, 55402

  • Montana Medical Research

    Missoula, Montana, 59804

  • Boeson Research MSO - Missoula - ERN - PPDS

    Missoula, Montana, 59808

  • IMA Clinical Research - Monroe, LA - PPDS

    Monroe, Louisiana, 71259

  • Affinity Health - Nashville

    Nashville, Tennessee, 37203

  • DelRicht Clinical Research, LLC - Internal - Covington - PPDS

    New Orleans, Louisiana, 70115

  • AES - DRS - Synexus Clinical Research US, Inc. - New York

    New York, New York, 10017

  • PRI, LLC - Newport Beach - M3 WR

    Newport Beach, California, 92660

  • Health Research of Hampton Roads Inc.

    Newport News, Virginia, 23606

  • Affinity Health (Oak Brook)

    Oak Brook, Illinois, 60523

  • Velocity Clinical Research (Omaha - Nebraska) - PPDS

    Omaha, Nebraska, 68134

  • AES - DRS - Synexus Clinical Research US, Inc. - The Villages

    Orlando, Florida, 32162

  • FOMAT Medical Research - FOMAT - HyperCore - PPDS

    Oxnard, California, 93030

  • CCT Research

    Papillion, Nebraska, 68046

  • Randomize Now -Commerce Dr

    Peachtree City, Georgia, 30269

  • DM Clinical Research - Philadelphia - ERN - PPDS

    Philadelphia, Pennsylvania, 19107

  • Hope Research Institute LLC - Phoenix - Hunt - PPDS

    Phoenix, Arizona, 85018

  • AES - DRS - Synexus Clinical Research US, Inc. - Phoenix Central

    Phoenix, Arizona, 85020

  • Synexus Clinical Research US, Inc. - Phoenix Southeast

    Phoenix, Arizona, 85224

  • AIM Trials

    Plano, Texas, 75093

  • Reddy Care Medical

    Pomona, California, 91768

  • Health Awareness Inc

    Port Saint Lucie, Florida, 33458

  • Summit Research Network, Inc. - Portland - Headlands - PPDS

    Portland, Oregon, 97210

  • Velocity Clinical Research - Family Practice - Portsmouth - PPDS

    Portsmouth, Virginia, 23703

  • American Indian Clinical Trials Research Network

    Rapid City, South Dakota, 57701

  • IMA Clinical Research - Raritan - PPDS

    Raritan, New Jersey, 08869

  • Paradigm Clinical Research Institute Inc - ClinEdge - PPDS

    Redding, California, 96001

  • Rainier Clinical Research Center

    Renton, Washington, 98057

  • AES - DRS - Synexus Clinical Research US, Inc. - Minneapolis

    Richfield, Minnesota, 55423

  • DM Clinical - Chicago

    River Forest, Illinois, 60305

  • Rochester Clinical Research, Inc

    Rochester, New York, 14609

  • Velocity Clinical Research (Rockville - Maryland) - PPDS

    Rockville, Maryland, 20854

  • AES - DRS - Synexus Clinical Research US, Inc. - San Antonio

    San Antonio, Texas, 78229

  • Clinical Trials of Texas, LLC - HyperCore - PPDS

    San Antonio, Texas, 78229

  • Medical Center For Clinical Research - M3 WR

    San Diego, California, 92660

  • Velocity Clinical Research (Savannah - Georgia) - PPDS

    Savannah, Georgia, 31406

  • Seattle Clinical Research Center

    Seattle, Washington, 98105

  • Riverside Medical Group - Circuit - PPDS

    Secaucus, New Jersey, 07094

  • South Ogden Family Medicine - CCT

    South Ogden, Utah, 84405

  • Great Lakes Research Institute

    Southfield, Michigan, 48075

  • DM Clinical Research - Southfield - ERN - PPDS

    Southfield, Michigan, 48076

  • IMA Clinical Research - Saint Petersburg - PPDS

    St. Petersburg, Florida, 33709

  • AES - DRS - Synexus Clinical Research US, Inc. - St. Petersburg

    St. Petersburg, Florida, 33781

  • Privia Medical Group- North Texas - Stephenville - Javara - PPDS

    Stephenville, Texas, 76401

  • Clinical Research Atlanta - ERN-PPDS

    Stockbridge, Georgia, 30281

  • DM Clinical Research - Sugarland - ERN - PPDS

    Sugar Land, Texas, 77338

  • Clinical Trials of Tampa

    Tampa, Florida, 33614

  • DM Clinical Research - ERN - PPDS

    Tomball, Texas, 77375

  • DM Clinical Research - ERN

    Tomball, Texas, 77375

  • Tucson Neuroscience Research - M3 WR

    Tucson, Arizona, 85710

  • Velocity Clinical Research - Valparaiso - PPDS

    Valparaiso, Indiana, 46383

  • Versailles Family Medicine - CCT - PPDS

    Versailles, Kentucky, 40383

  • Washington Health Institute

    Washington D.C., District of Columbia, 20017

  • Palm Beach Research - ClinEdge - PPDS

    West Palm Beach, Florida, 33409

  • Paradigm Clinical Research Institute Inc - ClinEdge - PPDS

    Wheat Ridge, Colorado, 80033

  • Trial Management Associates, LLC

    Wilmington, North Carolina, 28403

  • Clinical Site Partners - Winter Park - HyperCore -PPDS

    Winter Park, Florida, 32789

  • Tekton Research

    Yukon, Oklahoma, 73099

Other trials in United States

South Korea11 sites

  • Dong-A University Hospital

    Busan, 49201

  • Chungnam National University Hospital

    Daejeon, 35015

  • Samsung Medical Center - PPDS

    Gangnam-gu, Seoul, 06351

  • Ewha Womans University Seoul Hospital

    Gangseo-gu, Seoul, 07804

  • Soon Chun Hyang University Hospital Bucheon

    Gyeonggi-do, 14584

  • Catholic Kwandong University International St. Mar

    Incheon, 22711

  • Inha University Hospital

    Jung-gu, Incheon, 22332

  • Severance Hospital Yonsei University Health System

    Seoul, 03722

  • Gangnam Severance Hospital, Yonsei University Health System

    Seoul, 06273

  • Hallym University Kangnam Sacred Heart Hospital

    Seoul, 07441

  • Yonsei University Wonju Severance Christian Hospital

    Wŏnju, Gangwon-do, 26426

Other trials in South Korea

United Kingdom11 sites

  • AES - DRS - Synexus Scotland Clinical Research Centre

    Bellshill, ML4 3NJ

  • AES - DRS - Synexus Midlands Clinical Research Centre

    Birmingham, B15 2SQ

  • Layton Medical Centre

    Blackpool, FY3 7EN

  • Bristol Royal Infirmary

    Bristol, Avon, BS2 8HW

  • AES - DRS - Synexus Wales Clinical Research Centre

    Cardiff, CF15 9SS

  • AES - DRS - NW Consortium Lancashire

    Chorley, Lancashire, PR7 7NA

  • AES - DRS - Synexus Hexham Clinical Research Centre

    Hexham, Northumberland, NE46 1QJ

  • AES - DRS - NW Consortium Merseyside

    Liverpool, L22 0LG

  • AES - DRS - NW Consortium Manchester

    Manchester, M15 6SE

  • Royal Victoria Infirmary

    Newcastle upon Tyne, Tyne and Wear, NE1 4LP

  • Cheadle Hospital

    Stoke-on-Trent, Staffordshire, ST10 1NS

Other trials in United Kingdom

Canada10 sites

  • Centricity Research - Toronto - HyperCore - PPDS

    Etobicoke, Ontario, M9W 4L6

  • Dr. Steven Z. Zizzo Medicine Professional Corporation

    Hamilton, Ontario, L8J OB6

  • Okanagan Clinical Trials - Headlands - PPDS

    Kelowna, British Columbia, V1Y 1Z9

  • Centricity Research - Quebec - HyperCore - PPDS

    Lévis, Quebec, G6W OM5

  • Diex Recherche - Québec - PPDS

    Québec, J6E 2B4

  • CARe Clinic

    Red Deer, Alberta, T4P 1K4

  • Diex Recherche - Joilette - PPDS

    Saint-Charles-Borromée, Quebec, J6E 2B4

  • Diex Recherche - Sherbrooke - PPDS

    Sherbrooke, Quebec, J1L 0H8

  • LMC Clinical Research Inc (Bayview)

    Toronto, Ontario, M4G 3E8

  • Diex Recherche - Trois Rivieres - PPDS

    Trois-Rivières, Quebec, G9A 4P3

Other trials in Canada

Colombia10 sites

  • Centro de Atención e Investigación Médica S.A. - CAIMED - Aguazul

    Aguazul, Casanare Department, 856010

  • Institucion Clinica de la Costa SAS

    Barranquilla, Atlántico, 80020

  • Solano & Terront Servicios Médicos LTDA (UNIENDO) Bogota

    Bogota, Cundinamarca, 110221

  • Centro de Atención e Investigación Médica S.A. - CAIMED - Bogota

    Bogota, Cundinamarca, 111611

  • Centro Medico Imbanaco de Cali S.A.

    Cali, Valle de Cuaca, 760042

  • Centro de Atención e Investigación Médica S.A. - CAIMED - Chia

    Chía, Cundinamarca, 250001

  • Fundacion Oftalmologica de Santander Foscal

    Floridablanca, Santandar, 681002

  • Centro de Atención e Investigación Médica S.A. - CAIMED - Girardot

    Girardot City, Cundinamarca, 252431

  • Centro de Atención e Investigación Médica S.A. - CAIMED - Ibague

    Ibague, Tolima Department, 730001

  • IPS Centro de Investigacion Clinicas Cardiomet

    Pereira, Risaralda Department, 660003

Other trials in Colombia

Finland10 sites

  • Espoo Vaccine Research Clinic

    Espoo, 02230

  • Helsinki South Vaccine Research Clinic

    Helsinki, 00100

  • Helsinki East Vaccine Research Clinic

    Helsinki, 00930

  • Järvenpää Vaccine Research Clinic

    Jarvenpaa, 04400

  • KokkolaVaccine Research Clinic

    Kokkola, 67100

  • Oulu Vaccine Research Clinic

    Oulu, 90220

  • Pori Vaccine Research Clinic

    Pori, 28100

  • Seinäjoki Vaccine Research Clinic

    Seinäjoki, 60100

  • Tampere Vaccine Research Clinic

    Tampere, 33100

  • Turku Vaccine Research Clinic

    Turku, 20520

Other trials in Finland

Japan10 sites

  • Medical Corporation Asbo Tokyo Asbo Clinic

    Chuo-ku, Tokyo, 104-0031

  • Fukui General Clinic

    Fukui-shi, Fukui, 910-0067

  • Tenjin Sogo Clinic

    Fukuoka, Fukuoka, 810-0021

  • SOUSEIKAI PS Clinic

    Fukuoka, 812-0025

  • Boocs Clinic Fukuoka

    Hakata-ku, Fukuoka, 812-0025

  • Motomachi Takatsuka Naika Clinic

    Naka-ku, Yokohama-ku, Kanagawa, 231-0023

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

    Shinjuku-ku, Tokyo, 162-8655

  • Higashi Shinjuku Clinic

    Shinjuku-ku, Tokyo, 169-0072

  • NewHeart Watanabe Institute

    Suginami-ku, Tokyo, 168-0065

  • Sekino Hospital

    Toshima-ku, Tokyo, 171-0014

Other trials in Japan

Mexico7 sites

  • Investigacion en Salud y Metabolismo S.C.

    Chihuahua City, 31110

  • AES - AS - RM Pharma Specialists Mexico City

    Ciudad de Mexcio, Ciudad de Mexcio, 03100

  • AES - AS - CEMDEC Mexico City

    Ciudad de Mexcio, Ciudad de Mexcio, 06100

  • Hospital General 450

    Durango, 34217

  • Maria del rayo morfin otero

    Guadalajara, Jalisco, 44280

  • Accelerium, S. de R.L. de C.V.

    Monterrey, Nuevo León, 64000

  • PanAmerican Clinical Research-Avenida

    Querétaro, 76100

Other trials in Mexico

Australia6 sites

  • Paratus Clinical Research - Western Sydney - PPDS

    Blacktown, New South Wales, 2148

  • Northern Beaches Clinical Research

    Brookvale, New South Wales, 2100

  • Paratus Clinical Research - Canberra - PPDS

    Bruce, Australian Capital Territory, 2617

  • Emeritus Research - PPDS

    Camberwell, Victoria, 3124

  • Northside Health

    Coffs Harbour, New South Wales, 2450

  • Holdsworth House Medical Brisbane

    Fortitude Valley, Queensland, 4006

Other trials in Australia

Germany6 sites

  • AES - DRS - Synexus Berlin Research Centre

    Berlin, 12627

  • Medizentrum Essen Borbeck

    Essen, North Rhine-Westphalia, 45355

  • AES - DRS - Synexus Frankfurt Research Centre

    Frankfurt am Main, Hesse, 60313

  • Infektioresearch GmbH & Co. KG

    Frankfurt am Main, Hesse, 60569

  • Klinische Forschung Hannover-Mitte GmbH

    Hanover, Lower Saxony, 30159

  • Klinische Forschung, Schwerin GmbH (KFGN)

    Schwerin, Mecklenburg-West Pomerania, 19055

Other trials in Germany

New Zealand6 sites

  • Southern Clinical Trials Waitemata

    Auckland, 0626

  • New Zealand Clinical Research - Auckland

    Auckland, 1010

  • Optimal Clinical Trials Ltd

    Auckland, 1010

  • Southern Clinical Trials Limited

    Christchurch, Canterbury, 8023

  • Southern Clinical Trials - Tasman

    Nelson, 7011

  • Lakeland Clinical Trials

    Rotorua, Canterbury, 3010

Other trials in New Zealand

Poland6 sites

  • AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Gdansku

    Gdansk, Pomeranian Voivodeship, 80-382

  • AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Katowicach

    Katowice, Silesian Voivodeship, 40-040

  • Ostrowieckie Centrum Medyczne Spólka Cywilna Anna Olech-Cudzik, Krzysztof Cudzik

    Ostrowiec Świętokrzyski, Świętokrzyskie Voivodeship, 27-400

  • AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Poznaniu

    Poznan, Greater Poland Voivodeship, 60-702

  • AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Warszawie

    Warsaw, Masovian Voivodeship, 02-672

  • AES - DRS - Synexus Polska Sp. z o.o. Oddzial we Wroclawiu

    Wroclaw, Lower Silesian Voivodeship, 50-381

Other trials in Poland

South Africa6 sites

  • Worthwhile Clinical Trials

    Benoni, Gauteng, 1500

  • Aliwal Shoal Medical Center

    eMkhomazi, KwaZulu-Natal, 4170

  • Dr. J Breedt

    Pretoria, Gauteng, 0002

  • AES - DRS - Synexus - Stanza Clinical Research Centre

    Pretoria, Gauteng, 0184

  • AES - DRS - Synexus Watermeyer Clinical Research Centre

    Pretoria, Gauteng, 0184

  • AES - DRS - Synexus - Helderberg Clinical Research Centre

    Somerset West, Western Cape, 7130

Other trials in South Africa

Argentina5 sites

  • Instituto Medico Platense

    Buenos Aires, Provincial de Buenos Aires, B1900AVG

  • Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich

    Ciudad Autónoma de BuenosAires, 1426

  • Fundación Dr. Mario Socolinsky - Centro de Vacunación Proteger

    Ciudad Autónoma de BuenosAires, C1023

  • Centro Medico Barrio Parque

    Ciudad Autónoma de BuenosAires, C1425

  • Consultorios Médicos Dr. Doreski

    Ciudad Autónoma de BuenosAires, C1426ABP

Other trials in Argentina

Chile5 sites

  • Hospital Base de Osorno

    Osorno, Los Lagos Region, 5311523

  • Centro Respiratorio Integral LTDA. (CENRESIN)

    Quillota, Valparaiso, 2260734

  • Biomedica Research Group

    Santiago, Santiago Metropolitan, 7500710

  • BIOCINETIC SpA

    Santiago, Santiago Metropolitan, 8320000

  • Centro de Investigacion del Maule

    Talca, Maule Region, 3465586

Other trials in Chile

Spain5 sites

  • ABS Centelles

    Centelles, Barcelona, 08540

  • Hospital Universitario de La Princesa

    Madrid, 28006

  • Hospital Universitario La Paz - PPDS

    Madrid, 28046

  • Hospital Son Llatzer

    Son Ferriol, Palma de Mallorca, 07198

  • FISABIO Oftalmología Médica (FOM)

    Valencia, 46025

Other trials in Spain

Bangladesh4 sites

  • icddr,b Matlab Health Research Center

    Chāndpur, 3640

  • Icddr,b Kamalapur Field Site

    Dhaka, 1204

  • JHU-Projahnmo Sylhet site

    Sylhet, 3100

  • JHU-Projahnmo Zakiganj site

    Zakiganj, Sylhet Division, 3190

Other trials in Bangladesh

Belgium4 sites

  • ANIMA Research Center

    Diepenbeek, 3590

  • Vaccinopolis

    Edegem, 2650

  • Private Practice Dr Jean Benoit Martinot

    Erpent, 5101

  • Ziekenhuis Oost-Limburg

    Genk, 3600

Other trials in Belgium

Costa Rica4 sites

  • Campus Universidad EARTH, finca La Flor

    Liberia, Guanacaste Province, 50101

  • Instituto de Investigación en Ciencias Médicas S.A.

    San José, 10108

  • Hospital CIMA San Jose

    San José, 10203

  • Hospital Clínica Bíblica Sede Santa Ana

    San José, 10903

Other trials in Costa Rica

Taiwan4 sites

  • China Medical University Hospital - PPDS

    Taichung, 404

  • Taichung Veterans General Hospital

    Taichung, 40705

  • Taipei Veterans General Hospital

    Taipei, 112

  • Chang Gung Memorial Hospital, Linkou

    Taoyuan City, 333

Other trials in Taiwan

Puerto Rico3 sites

  • BRCR Global Puerto Rico (Ponce)

    Ponce, 00717

  • Caribbean Medical Research Center

    San Juan, 00918

  • Proyecto ACTU

    San Juan, 00935

Other trials in Puerto Rico

Panama2 sites

  • CEVAXIN Avenida México

    Panama City, Calidonia, 07093

  • CEVAXIN 24 de diciembre

    Panama City, 07113

Other trials in Panama

Singapore1 site

  • Singapore General Hospital (SGH)

    Singapore, 169608

Other trials in Singapore

About this study

Official title: A Phase 2/3, Randomized, Observer-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of mRNA-1345, an mRNA Vaccine Targeting Respiratory Syncytial Virus (RSV), in Adults ≥60 Years of Age

The main purpose of Part A of this study is to evaluate the safety and tolerability of mRNA-1345 vaccine and to demonstrate the efficacy of a single dose of mRNA-1345 vaccine in the prevention of a first episode of RSV-associated lower respiratory tract disease (RSV-LRTD) as compared with placebo from 14 days postinjection through 12 months.

The main purpose of Part B of this study is to evaluate the safety, tolerability and immunogenicity of a booster dose (BD) of mRNA-1345 administered 24 months after the primary dose.

Read the detailed description

The study will be conducted in 2 phases: Phase 2 and Phase 3. In the Part A Phase 2 segment, up to 2,000 participants will be randomly assigned to receive a single injection of either mRNA-1345 vaccine at the selected dose or placebo in a 1:1 randomization ratio.

In the Part A Phase 3 segment, approximately 35,000 participants will be randomly assigned to receive a single injection of either mRNA-1345 vaccine at the selected dose or placebo in a 1:1 randomization ratio.

In the Part B substudy, 1500 participants who received a dose of mRNA-1345 in Part A Phase 3 will be randomly assigned in a 2:1 randomization ratio to receive a single BD injection of either mRNA-1345 at the selected dose or placebo.

Being tested
Placebo, mRNA-1345
Keywords
Viral Diseases, Messenger RNA, Moderna, mRNA-1345, Respiratory syncytial virus, Safety, Vaccines
Medical subject headings
Virus Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboDrug

    0.9% sodium chloride (normal saline) injection

  • mRNA-1345Drug

    Sterile liquid for injection

Study groups in NCT05127434
Study groupRoleWhat they receive
mRNA-1345ExperimentalSingle injection of mRNA-1345 on Day 1.
Receives: Drug: mRNA-1345
PlaceboExperimentalSingle injection of mRNA-1345 matching-placebo on Day 1.
Receives: Drug: Placebo
mRNA-1345 BDExperimentalSingle injection of mRNA-1345 on BD Day 1.
Receives: Drug: mRNA-1345

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part A: Number of Participants With Any Solicited Adverse Reactions (ARs) (Solicited Local and/or Systemic ARs)

    Solicited ARs were collected in an electronic diary (eDiary). Local ARs: injection site pain, erythema (redness), swelling/induration (hardness); and axillary (underarm) swelling or tenderness ipsilateral to the side of injection. Systemic ARs: fever, headache, fatigue, myalgia, arthralgia, nausea/vomiting, and chills. Note, not all solicited ARs were considered adverse events (AEs). Investigator reviewed whether the solicited AR was also to be recorded as an AE. A summary of serious AEs (SAEs) and nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section.

    Measured: Up to 7 days postinjection

  2. Part B: Number of Participants With Solicited Local and Systemic ARs

    Solicited ARs were recorded daily using electronic diaries (eDiaries). Local ARs: injection site pain, erythema (redness), swelling/induration (hardness); and axillary (underarm) swelling or tenderness ipsilateral to the side of injection. Systemic ARs: fever, headache, fatigue, myalgia, arthralgia, nausea/vomiting, and chills. Note, not all solicited ARs were considered adverse events (AEs). Investigator reviewed whether the solicited AR was also to be recorded as an AE. A summary of all Serious Adverse Events (SAEs) and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.

    Measured: Up to 7 days post-BD injection

  3. Part A: Number of Participants With Unsolicited Adverse Events (AEs)

    An unsolicited AE was defined as any AE reported by the participant that was not specified as a solicited AR in the protocol. An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. A summary of all SAEs and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.

    Measured: Up to 28 days postinjection

  4. Part B: Number of Participants With Unsolicited AEs

    An unsolicited AE was defined as any AE reported by the participant that was not specified as a solicited AR in the protocol. An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. A summary of all SAEs and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.

    Measured: Up to 28 days post-BD injection

  5. Part A: Number of Participants With Medically Attended AEs (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation

    MAAEs were AEs that led to an unscheduled visit to a healthcare provider. AESIs were AEs (serious or nonserious) of scientific and medical concern specific to the Sponsor's product or program for which ongoing monitoring and immediate notification by the investigator to the Sponsor was required. SAEs were AEs that resulted in death, were life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, a congenital anomaly or birth defect, or was a medically important event. A summary of all SAEs and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.

    Measured: Up to 24 months postinjection

  6. Part B: Number of Participants With MAAEs, AESIs, SAEs, and AEs Leading to Study Discontinuation

    MAAEs were AEs that led to an unscheduled visit to a healthcare provider. AESIs were AEs (serious or nonserious) of scientific and medical concern specific to the Sponsor's product or program for which ongoing monitoring and immediate notification by the investigator to the Sponsor was required. SAEs were AEs that resulted in death, were life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, a congenital anomaly or birth defect, or was a medically important event. A summary of all SAEs and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.

    Measured: Up to BD Day 181

  7. Part A: Number of Participants With Respiratory Syncytial Virus- Associated Lower RSV-LRTD With 2 or More Symptoms From 14 Days Postinjection up to 12 Months Postinjection

    RSV-LRTD: Reverse transcriptase polymerase chain reaction (RT PCR) confirmed RSV infection PLUS new or worsening of ≥2 of the following symptoms: shortness of breath, cough and/or fever (≥37.8 degrees Celsius [°C]), wheezing and/or rales and/or rhonchi, sputum production, tachypnea (≥20 breaths/minute or increase of ≥ 2 breaths/minute from baseline measurement in those who had baseline tachypnea), hypoxemia (new oxygen saturation ≤93% or new or increasing use of supplemental oxygen), pleuritic chest pain for ≥24 hours.

    Measured: From 14 days postinjection up to 12 months postinjection

  8. Part A: Number of Participants With RSV-LRTD With 3 or More Symptoms From 14 Days Postinjection up to 12 Months Postinjection

    RSV-LRTD: RT PCR confirmed RSV infection PLUS new or worsening of ≥3 of the following symptoms: shortness of breath, cough and/or fever (≥37.8°C), wheezing and/or rales and/or rhonchi, sputum production, tachypnea (≥20 breaths/minute or increase of ≥ 2 breaths/minute from baseline measurement in those who had baseline tachypnea), hypoxemia (new oxygen saturation ≤93% or new or increasing use of supplemental oxygen), pleuritic chest pain for ≥24 hours.

    Measured: From 14 days postinjection up to 12 months postinjection

  9. Part B: Geometric Mean Titer (GMT) of Serum Respiratory Syncytial Virus Subtype A (RSV-A) and Respiratory Syncytial Virus Subtype B (RSV-B) Neutralizing Antibodies (nAb) at BD Day 29 Compared to Primary Dose Day 29

    Antibody values reported as below lower limit of quantification (LLOQ) replaced by 0.5 * LLOQ. Values greater than upper limit of quantification (ULOQ) replaced by ULOQ. LLOQ = 13 international units (IU)/milliliter (mL), ULOQ = 259061 IU/mL for RSV-A nAb. LLOQ = 10, ULOQ = 112476 for RSV-B nAb. Part B Per-protocol (PP) Set: all Part B randomized participants who received both Parts A and B assigned study intervention doses, had RSV immunogenicity titer results at pre-Primary Dose (baseline), had RSV immunogenicity titer results at Primary Dose Day 29, had at least 1 valid result at Revaccination Day 29, and had no major protocol deviations affecting the primary immunogenicity outcomes as determined prior to database lock and unblinding. Participants were analyzed according to the study intervention group to which they were randomized.

    Measured: Primary Dose Day 29 and BD Day 29

Secondary outcomes (19)

  1. Part A: Number of Participants With RSV-Associated Acute Respiratory Disease (RSV-ARD) From 14 Days Postinjection up to 12 Months Postinjection

    RSV-ARD: RT-PCR-confirmed RSV infection PLUS an acute symptomatic respiratory disease manifesting as new or worsening of 1 or more of cough, stuffy nose, runny nose, sore throat, fever (≥37.8°C), shortness of breath, observed tachypnea (≥20 breaths/minute or increase of ≥2 breaths/minute from baseline in those who have baseline tachypnea), hypoxemia (new oxygen saturation ≤ 93%, or new or increasing use of supplemental oxygen), wheezing, sputum production, hoarseness, sinus pain, chills, pleuritic chest pain for at least 24 hours.

    Measured: From 14 days postinjection up to 12 months postinjection

  2. Part A: Number of Participants With Hospitalization Associated With Protocol-defined RSV-ARD or RSV-LRTD From 14 Days Postinjection up to 12 Months Postinjection

    A case of first hospitalization associated with protocol-defined RSV-ARD or RSV-LRTD was defined if: (a) The investigator assessed that an event was a confirmed diagnosis of RSV-LRTD or RSV-ARD and that required inpatient or prolongation of existing hospitalization; (b) a protocol-defined RSV-LRTD/RSV-ARD occurred; (c) date of protocol-defined RSV-LRTD/RSV-ARD was within 14 days prior or during hospitalization. RSV-ARD defined in Outcome Measure #10 and RSV-LRTD defined in Outcome Measure #7 above.

    Measured: From 14 days postinjection up to 12 months postinjection

  3. Part A: Number of Participants With All-Cause Hospitalizations From 14 Days Postinjection up to 12 Months Postinjection

    An all-cause hospitalization was defined as any reported hospitalization which was collected as inpatient or prolongation of existing hospitalization in the electronic case report form (eCRF) AE form.

    Measured: From 14 days postinjection up to 12 months postinjection

  4. Part A: Number of Participants With All-Cause LRTD From 14 Days Postinjection up to 12 Months Postinjection

    All-cause LRTD: New or worsening of ≥2 of following symptoms: shortness of breath, cough and/or fever (≥37.8°C), wheezing and/or rales and/or rhonchi, sputum production, tachypnea (≥20 breaths/minute or increase of ≥2 breaths/minute from baseline measurement in those who had baseline tachypnea), hypoxemia (new oxygen saturation ≤93% or new or increasing use of supplemental oxygen), pleuritic chest pain for ≥24 hours with any or no RT-PCR result. All-cause LRTD was derived based on eligible LRTD symptoms onset within a respiratory illness episode.

    Measured: From 14 days postinjection up to 12 months postinjection

  5. Part A: Number of Participants With RSV-LRTD With 3 or More Symptoms From 14 Days Postinjection up to 24 Months Postinjection

    RSV-LRTD: RT PCR confirmed RSV infection PLUS new or worsening of ≥3 of the following symptoms: shortness of breath, cough and/or fever (≥37.8°C), wheezing and/or rales and/or rhonchi, sputum production, tachypnea (≥20 breaths/minute or increase of ≥ 2 breaths/minute from baseline measurement in those who had baseline tachypnea), hypoxemia (new oxygen saturation ≤93% or new or increasing use of supplemental oxygen), pleuritic chest pain for ≥24 hours.

    Measured: From 14 days postinjection up to 24 months postinjection

  6. Part A: Number of Participants With RSV-LRTD With 2 or More Symptoms From 14 Days Postinjection up to 24 Months Postinjection

    RSV-LRTD: RT PCR confirmed RSV infection PLUS new or worsening of ≥2 of the following symptoms: shortness of breath, cough and/or fever (≥37.8°C), wheezing and/or rales and/or rhonchi, sputum production, tachypnea (≥20 breaths/minute or increase of ≥ 2 breaths/minute from baseline measurement in those who had baseline tachypnea), hypoxemia (new oxygen saturation ≤93% or new or increasing use of supplemental oxygen), pleuritic chest pain for ≥24 hours.

    Measured: From 14 days postinjection up to 24 months postinjection

  7. Part A: Number of Participants With RSV-LRTD With 2 or More Symptoms by RSV Subtype A and RSV Subtype B From 14 Days Postinjection up to 12 Months Postinjection

    RSV-LRTD: RT PCR confirmed RSV infection PLUS new or worsening of ≥2 of the following symptoms: shortness of breath, cough and/or fever (≥37.8°C), wheezing and/or rales and/or rhonchi, sputum production, tachypnea (≥20 breaths/minute or increase of ≥ 2 breaths/minute from baseline measurement in those who had baseline tachypnea), hypoxemia (new oxygen saturation ≤93% or new or increasing use of supplemental oxygen), pleuritic chest pain for ≥24 hours.

    Measured: From 14 days postinjection up to 12 months postinjection

  8. Part A: Number of Participants With RSV-LRTD With 3 or More Symptoms by RSV Subtype A and RSV Subtype B From 14 Days Postinjection up to 12 Months Postinjection

    RSV-LRTD: RT PCR confirmed RSV infection PLUS new or worsening of ≥3 of the following symptoms: shortness of breath, cough and/or fever (≥37.8°C), wheezing and/or rales and/or rhonchi, sputum production, tachypnea (≥20 breaths/minute or increase of ≥ 2 breaths/minute from baseline measurement in those who had baseline tachypnea), hypoxemia (new oxygen saturation ≤93% or new or increasing use of supplemental oxygen), pleuritic chest pain for ≥24 hours.

    Measured: From 14 days postinjection up to 12 months postinjection

  9. Part A: Number of Participants With First Hospitalization Associated With Protocol-defined RSV-ARD or RSV-LRTD From 14 Days Postinjection up to 24 Months Postinjection

    A case of first hospitalization associated with protocol-defined RSV-ARD or RSV-LRTD was defined if: (a) The investigator assessed that an event was a confirmed diagnosis of RSV-LRTD or RSV-ARD and that required inpatient or prolongation of existing hospitalization; (b) a protocol-defined RSV-LRTD/RSV-ARD occurred; (c) date of protocol-defined RSV-LRTD/RSV-ARD was within 14 days prior or during hospitalization. RSV-ARD defined in Outcome Measure #10 and RSV-LRTD defined in Outcome Measure #7 above.

    Measured: From 14 days postinjection up to 24 months postinjection

  10. Part A: Change in Total Frailty Score From Baseline to 12 Months and 24 Months Postinjection, Using the Edmonton Frail Scale (EFS)

    The total frail score is the sum of individual scores from the 11 questions representing 9 domains included in EFS, which is a multidimensional frail assessment scale that assesses domains related to frailty including cognition, general health status, functional independence, social support, medication use, nutrition, mood, continence, and functional performance. The total frail score ranges between 0 and 17. Higher scores suggest more frailty, and the total frail score can be interpreted as: 0-3=fit, 4-5=vulnerable, 6-7=mild frail, 8-9=moderate frail, 10 or more=severe frail.

    Measured: Baseline, 12 months and 24 months postinjection

  11. Part A: GMT of Serum RSV nAb

    Antibody values reported as below LLOQ replaced by 0.5 * LLOQ. Values greater than ULOQ replaced by ULOQ. LLOQ = 13 IU/mL, ULOQ = 259061 IU/mL for RSV-A nAb. LLOQ = 10, ULOQ = 112476 for RSV-B nAb. Part A Per-protocol Immunogenicity (PPI) Set: a randomly selected subset of participants who: a) received the assigned study drug, b) had RSV immunogenicity titer results at baseline (prior to study drug administration) and at least 1 valid result after the study drug administration at timepoint of interest, and c) had no major protocol deviation affecting the primary immunogenicity outcomes as determined prior to database lock and unblinding.

    Measured: Baseline (Day 1), Days 29, 181, 365, and 730

  12. Part A: Geometric Mean Concentration (GMC) of Serum RSV Binding Antibodies

    Antibody values reported as below LLOQ replaced by 0.5 * LLOQ. Values greater than ULOQ replaced by ULOQ. LLOQ = 35 arbitrary unit (AU)/mL, ULOQ = 580553 AU/mL for RSV Pre-F immunoglobulin G (IgG) antibody (Ab). LLOQ = 57, ULOQ = 847551 for RSV Post-F IgG Ab. Part A PPI Set: a randomly selected subset of participants who: a) received the assigned study drug, b) had RSV immunogenicity titer results at baseline (prior to study drug administration) and at least 1 valid result after the study drug administration at timepoint of interest, and c) had no major protocol deviation affecting the primary immunogenicity outcomes as determined prior to database lock and unblinding.

    Measured: Baseline (Day 1), Days 29, 181, 365, and 730

  13. Part A: Percentage of Participants With Seroresponse in RSV nAb

    Seroresponse was defined as a change from below the LLOQ to equal or above 4 * LLOQ, or at least a 4-fold increase if baseline was equal to or above the LLOQ. Part A PPI Set: a randomly selected subset of participants who: a) received the assigned study drug, b) had RSV immunogenicity titer results at baseline (prior to study drug administration) and at least 1 valid result after the study drug administration at timepoint of interest, and c) had no major protocol deviation affecting the primary immunogenicity outcomes as determined prior to database lock and unblinding.

    Measured: Days 29, 181, 365, and 730

  14. Part A: Geometric Mean Fold-Rise (GMFR) of Postbaseline/Baseline Antibody Titers

    Antibody values reported as below LLOQ replaced by 0.5 * LLOQ. Values greater than ULOQ replaced by ULOQ. LLOQ = 13 IU/mL, ULOQ = 259061 IU/mL for RSV-A nAb. LLOQ = 10, ULOQ = 112476 for RSV-B nAb. Part A PPI Set: a randomly selected subset of participants who: a) received the assigned study drug, b) had RSV immunogenicity titer results at baseline (prior to study drug administration) and at least 1 valid result after the study drug administration at timepoint of interest, and c) had no major protocol deviation affecting the primary immunogenicity outcomes as determined prior to database lock and unblinding.

    Measured: Days 29, 181, 365, and 730

  15. Part A: Percentage of Participants With ≥2-fold Increases in Antibody Titers From Baseline

    A ≥2-fold increase from baseline was defined as a change from below the LLOQ to equal or above 2 * LLOQ, or at least a 2-fold increase if baseline was equal to or above the LLOQ. Part A PPI Set: a randomly selected subset of participants who: a) received the assigned study drug, b) had RSV immunogenicity titer results at baseline (prior to study drug administration) and at least 1 valid result after the study drug administration at timepoint of interest, and c) had no major protocol deviation affecting the primary immunogenicity outcomes as determined prior to database lock and unblinding.

    Measured: Days 29, 181, 365, and 730

  16. Part B: Percentage of Participants With Seroresponse of Serum RSV-A and RSV-B nAb at BD Day 29 Compared to Primary Dose Day 29

    Seroresponse was defined as a post-primary dose or post-revaccination titer ≥4 * LLOQ if Baseline was <LLOQ or a ≥4-fold increase from baseline if baseline was ≥LLOQ. Part B PP Set: all Part B randomized participants who received both Parts A and B assigned study intervention doses, had RSV immunogenicity titer results at pre-Primary Dose (baseline), had RSV immunogenicity titer results at Primary Dose Day 29, had at least 1 valid result at Revaccination Day 29, and had no major protocol deviations affecting the primary immunogenicity outcomes as determined prior to database lock and unblinding. Participants were analyzed according to the study intervention group to which they were randomized.

    Measured: Primary Dose Day 29 and BD Day 29

  17. Part B: GMT of Serum RSV-A and RSV-B nAb at BD Day 1 and BD Day 181

    Antibody values reported as below LLOQ replaced by 0.5 * LLOQ. Values greater than ULOQ replaced by ULOQ. LLOQ = 13 IU/mL, ULOQ = 259061 IU/mL for RSV-A nAb. LLOQ = 10, ULOQ = 112476 for RSV-B nAb. Part B PP Set: all Part B randomized participants who received both Parts A and B assigned study intervention doses, had RSV immunogenicity titer results at pre-Primary Dose (baseline), had RSV immunogenicity titer results at Primary Dose Day 29, had at least 1 valid result at Revaccination Day 29, and had no major protocol deviations affecting the primary immunogenicity outcomes as determined prior to database lock and unblinding. Participants were analyzed according to the study intervention group to which they were randomized.

    Measured: BD Day 1 and BD Day 181

  18. Part B: GMFR of Serum RSV-A and RSV-B NAb From Pre-primary Dose (Baseline)

    Antibody values reported as below LLOQ replaced by 0.5 * LLOQ. Values greater than ULOQ replaced by ULOQ. LLOQ = 13 IU/mL, ULOQ = 259061 IU/mL for RSV-A nAb. LLOQ = 10, ULOQ = 112476 for RSV-B nAb. Part B PP Set: all Part B randomized participants who received both Parts A and B assigned study intervention doses, had RSV immunogenicity titer results at pre-Primary Dose (baseline), had RSV immunogenicity titer results at Primary Dose Day 29, had at least 1 valid result at Revaccination Day 29, and had no major protocol deviations affecting the primary immunogenicity outcomes as determined prior to database lock and unblinding. Participants were analyzed according to the study intervention group to which they were randomized.

    Measured: BD Day 1, BD Day 29, and BD Day 181

  19. Part B: Percentage of Participants With Seroresponse of Serum RSV-A and RSV-B Neutralizing Antibodies From Pre-primary Dose (Baseline)

    Seroresponse was defined as a post-primary dose or post-revaccination titer ≥4 * LLOQ if Baseline was <LLOQ or a ≥4-fold increase from baseline if baseline was ≥LLOQ. Part B PP Set: all Part B randomized participants who received both Parts A and B assigned study intervention doses, had RSV immunogenicity titer results at pre-Primary Dose (baseline), had RSV immunogenicity titer results at Primary Dose Day 29, had at least 1 valid result at Revaccination Day 29, and had no major protocol deviations affecting the primary immunogenicity outcomes as determined prior to database lock and unblinding. Participants were analyzed according to the study intervention group to which they were randomized.

    Measured: BD Day 1, BD Day 29, and BD Day 181

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Nov 2021
  2. Study start17 Nov 2021
  3. Primary completion28 Jul 2025
  4. Study completion28 Jul 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
36,814 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05127434
Sponsor's protocol ID
mRNA-1345-P301
Other IDs
2021-005026-20
Status last verified
Aug 2026
First submitted
9 Nov 2021
Last updated
29 Sep 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Desai M, Jimenez G, Wijewardane P, Lan L, Wilson L, Mehta S, Priddy F. Safety, Tolerability, and Immunogenicity of Revaccination With mRNA-1345 RSV Vaccine Administered 24 Months Following a Primary Dose in Adults >/=60 Years of Age. J Infect Dis. 2026 Jul 9:jiag350. doi: 10.1093/infdis/jiag350. Online ahead of print.

    PubMed 42419724

  • Goswami J, Baqui AH, Doreski PA, Perez Marc G, Jimenez G, Ahmed S, Zaman K, Duncan CJA, Ujiie M, Ramet M, Perez-Breva L, Lan L, Du J, Kapoor A, Mehta S, Tomassini JE, Huang W, Zhou H, Stoszek SK, Priddy F, Lin N, Le Cam N, Shaw CA, Slobod K, Wilson E, Miller JM, Das R. Humoral Immunogenicity of mRNA-1345 RSV Vaccine in Older Adults. J Infect Dis. 2024 Nov 15;230(5):e996-e1006. doi: 10.1093/infdis/jiae316.

    PubMed 38889247

  • Wilson E, Goswami J, Baqui AH, Doreski PA, Perez-Marc G, Zaman K, Monroy J, Duncan CJA, Ujiie M, Ramet M, Perez-Breva L, Falsey AR, Walsh EE, Dhar R, Wilson L, Du J, Ghaswalla P, Kapoor A, Lan L, Mehta S, Mithani R, Panozzo CA, Simorellis AK, Kuter BJ, Schodel F, Huang W, Reuter C, Slobod K, Stoszek SK, Shaw CA, Miller JM, Das R, Chen GL; ConquerRSV Study Group. Efficacy and Safety of an mRNA-Based RSV PreF Vaccine in Older Adults. N Engl J Med. 2023 Dec 14;389(24):2233-2244. doi: 10.1056/NEJMoa2307079.

    PubMed 38091530

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing mRNA-1345 in people with Respiratory Syncytial Virus, run by ModernaTX, Inc. at 269 sites in 23 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 269 sites in United States, South Korea, United Kingdom, Canada, Colombia and 18 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part A: Number of Participants With Any Solicited Adverse Reactions (ARs) (Solicited Local and/or Systemic ARs) (time frame: Up to 7 days postinjection). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05127434, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.

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