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

February 8, 2024 updated by: ModernaTX, Inc.

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.

Study Overview

Status

Active, not recruiting

Conditions

Respiratory Syncytial Virus

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

36557

Phase

Phase 2
Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Argentina
- - Ciudad Autónoma de BuenosAires, Argentina, C1426ABP
    - Consultorios Médicos Dr. Doreski
  - Ciudad Autónoma de BuenosAires, Argentina, 1426
    - Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich
  - Ciudad Autónoma de BuenosAires, Argentina, C1023
    - Fundación Dr. Mario Socolinsky - Centro de Vacunación Proteger
  - Ciudad Autónoma de BuenosAires, Argentina, C1425
    - Centro Medico Barrio Parque
- Provincial De Buenos Aires
  - Buenos Aires, Provincial De Buenos Aires, Argentina, B1900AVG
    - Instituto Medico Platense
Australia
- Australian Capital Territory
  - Bruce, Australian Capital Territory, Australia, 2617
    - Paratus Clinical Research - Canberra - PPDS
- New South Wales
  - Blacktown, New South Wales, Australia, 2148
    - Paratus Clinical Research - Western Sydney - PPDS
  - Brookvale, New South Wales, Australia, 2100
    - Northern Beaches Clinical Research
  - Coffs Harbour, New South Wales, Australia, 2450
    - Northside Health
- Queensland
  - Fortitude Valley, Queensland, Australia, 4006
    - Holdsworth House Medical Brisbane
- Victoria
  - Camberwell, Victoria, Australia, 3124
    - Emeritus Research - PPDS
Bangladesh
- - Chandpur, Bangladesh, 3640
    - icddr,b Matlab Health Research Center
  - Dhaka, Bangladesh, 1204
    - Icddr,b Kamalapur Field Site
  - Sylhet, Bangladesh, 3100
    - JHU-Projahnmo Sylhet site
- Sylhet
  - Zakiganj, Sylhet, Bangladesh, 3190
    - JHU-Projahnmo Zakiganj site
Belgium
- - Diepenbeek, Belgium, 3590
    - Anima Research Center
  - Edegem, Belgium, 2650
    - Vaccinopolis
  - Erpent, Belgium, 5101
    - Private Practice Dr Jean Benoit Martinot
  - Genk, Belgium, 3600
    - Ziekenhuis Oost-Limburg
Canada
- - Québec, Canada, J6E 2B4
    - Diex Recherche - Québec - PPDS
- Alberta
  - Red Deer, Alberta, Canada, T4P 1K4
    - Care Clinic
- British Columbia
  - Kelowna, British Columbia, Canada, V1Y 1Z9
    - Okanagan Clinical Trials - Headlands - PPDS
- Ontario
  - Etobicoke, Ontario, Canada, M9W 4L6
    - Centricity Research - Toronto - HyperCore - PPDS
  - Hamilton, Ontario, Canada, L8J OB6
    - Dr. Steven Z. Zizzo Medicine Professional Corporation
  - Toronto, Ontario, Canada, M4G 3E8
    - LMC Clinical Research Inc (Bayview)
- Quebec
  - Levis, Quebec, Canada, G6W OM5
    - Centricity Research - Quebec - HyperCore - PPDS
  - Sherbrooke, Quebec, Canada, J1L 0H8
    - Diex Recherche - Sherbrooke - PPDS
  - St-Charles-Borromee, Quebec, Canada, J6E 2B4
    - Diex Recherche - Joilette - PPDS
  - Trois-Rivieres, Quebec, Canada, G9A 4P3
    - Diex Recherche - Trois Rivieres - PPDS
Chile
- Region De Los Lagos
  - Osorno, Region De Los Lagos, Chile, 5311523
    - Hospital Base de Osorno
- Region De Valparaiso
  - Quillota, Region De Valparaiso, Chile, 2260734
    - Centro Respiratorio Integral LTDA. (CENRESIN)
- Region Del Maule
  - Talca, Region Del Maule, Chile, 3465586
    - Centro de Investigación del Maule
- Region Metropolitana
  - Santiago, Region Metropolitana, Chile, 7500710
    - BioMedica Research Group
  - Santiago, Region Metropolitana, Chile, 8320000
    - BIOCINETIC SpA
Colombia
- Atlantico
  - Barranquilla, Atlantico, Colombia, 80020
    - Institucion Clinica de la Costa SAS
- Casanare
  - Aguazul, Casanare, Colombia, 856010
    - Centro de Atención e Investigación Médica S.A. - CAIMED - Aguazul
- Cundinamarca
  - Bogota, Cundinamarca, Colombia, 110221
    - Solano & Terront Servicios Médicos LTDA (UNIENDO) Bogota
  - Bogota, Cundinamarca, Colombia, 111611
    - Centro de Atención e Investigación Médica S.A. - CAIMED - Bogota
  - Chia, Cundinamarca, Colombia, 250001
    - Centro de Atención e Investigación Médica S.A. - CAIMED - Chia
  - Girardot, Cundinamarca, Colombia, 252431
    - Centro de Atención e Investigación Médica S.A. - CAIMED - Girardot
- Risaralda
  - Pereira, Risaralda, Colombia, 660003
    - IPS Centro de Investigacion Clinicas Cardiomet
- Santandar
  - Floridablanca, Santandar, Colombia, 681002
    - Fundación Oftalmológica de Santander FOSCAL
- Tolima
  - Ibague, Tolima, Colombia, 730001
    - Centro de Atención e Investigación Médica S.A. - CAIMED - Ibague
- Valle De Cuaca
  - Cali, Valle De Cuaca, Colombia, 760042
    - Centro Medico Imbanaco de Cali S.A.
Costa Rica
- - San José, Costa Rica, 10203
    - Hospital CIMA San Jose
  - San José, Costa Rica, 10108
    - Instituto de Investigación en Ciencias Médicas S.A.
  - San José, Costa Rica, 10903
    - Hospital Clínica Bíblica Sede Santa Ana
- Guanacaste
  - Liberia, Guanacaste, Costa Rica, 50101
    - Campus Universidad EARTH, finca La Flor
Finland
- - Espoo, Finland, 02230
    - Espoo Vaccine Research Clinic
  - Helsinki, Finland, 00100
    - Helsinki South Vaccine Research Clinic
  - Helsinki, Finland, 00930
    - Helsinki East Vaccine Research Clinic
  - Järvenpää, Finland, 04400
    - Järvenpää Vaccine Research Clinic
  - Kokkola, Finland, 67100
    - KokkolaVaccine Research Clinic
  - Oulu, Finland, 90220
    - Oulu Vaccine Research Clinic
  - Pori, Finland, 28100
    - Pori Vaccine Research Clinic
  - Seinäjoki, Finland, 60100
    - Seinäjoki Vaccine Research Clinic
  - Tampere, Finland, 33100
    - Tampere Vaccine Research Clinic
  - Turku, Finland, 20520
    - Turku Vaccine Research Clinic
Germany
- - Berlin, Germany, 12627
    - AES - DRS - Synexus Berlin Research Centre
- Hesse
  - Frankfurt, Hesse, Germany, 60313
    - AES - DRS - Synexus Frankfurt Research Centre
  - Frankfurt, Hesse, Germany, 60569
    - Infektioresearch GmbH & Co. KG
- Lower Saxony
  - Hannover, Lower Saxony, Germany, 30159
    - Klinische Forschung Hannover-Mitte GmbH
- Mecklenburg-West Pomerania
  - Schwerin, Mecklenburg-West Pomerania, Germany, 19055
    - Klinische Forschung, Schwerin GmbH (KFGN)
- North Rhine-Westphalia
  - Essen, North Rhine-Westphalia, Germany, 45355
    - Medizentrum Essen Borbeck
Japan
- - Fukuoka, Japan, 812-0025
    - SOUSEIKAI PS Clinic
- Fukui
  - Fukui-shi, Fukui, Japan, 910-0067
    - Fukui General Clinic
- Fukuoka
  - Fukuoka-shi, Fukuoka, Japan, 810-0021
    - Tenjin Sogo Clinic
  - Hakata-ku, Fukuoka, Japan, 812-0025
    - Boocs Clinic Fukuoka
- Kanagawa
  - Naka-ku, Yokohama-ku, Kanagawa, Japan, 231-0023
    - Motomachi Takatsuka Naika Clinic
- Tokyo
  - Chuo-ku, Tokyo, Japan, 104-0031
    - Medical Corporation Asbo Tokyo Asbo Clinic
  - Shinjuku-ku, Tokyo, Japan, 162-8655
    - Center Hospital of the National Center for Global Health and Medicine
  - Shinjuku-ku, Tokyo, Japan, 169-0072
    - Higashi Shinjuku Clinic
  - Suginami-ku, Tokyo, Japan, 168-0065
    - NewHeart Watanabe Institute
  - Toshima-ku, Tokyo, Japan, 171-0014
    - Sekino Hospital
Korea, Republic of
- - Busan, Korea, Republic of, 49201
    - Dong-A University Hospital
  - Daejeon, Korea, Republic of, 35015
    - Chungnam National University Hospital
  - Gyeonggi-do, Korea, Republic of, 14584
    - Soon Chun Hyang University Hospital Bucheon
  - Incheon, Korea, Republic of, 22711
    - Catholic Kwandong University International St. Mar
  - Seoul, Korea, Republic of, 07441
    - Hallym University Kangnam Sacred Heart Hospital
  - Seoul, Korea, Republic of, 06273
    - Gangnam Severance Hospital, Yonsei University Health System
  - Seoul, Korea, Republic of, 03722
    - Severance Hospital Yonsei University Health System
- Gangwon-do
  - Wonju-si, Gangwon-do, Korea, Republic of, 26426
    - Yonsei University Wonju Severance Christian Hospital
- Incheon
  - Jung-gu, Incheon, Korea, Republic of, 22332
    - Inha University Hospital
- Seoul
  - Gangnam-gu, Seoul, Korea, Republic of, 06351
    - Samsung Medical Center - PPDS
  - Gangseo-gu, Seoul, Korea, Republic of, 07804
    - Ewha Womans University Seoul Hospital
Mexico
- - Chihuahua, Mexico, 31110
    - Investigación en Salud y Metabolismo S.C.
  - Ciudad De Mexcio, Mexico, 03100
    - AES - AS - RM Pharma Specialists Mexico City
  - Ciudad De Mexcio, Mexico, 06100
    - AES - AS - CEMDEC Mexico City
  - Durango, Mexico, 34217
    - Hospital General 450
  - Querétaro, Mexico, 76100
    - PanAmerican Clinical Research-Avenida
- Jalisco
  - Guadalajara, Jalisco, Mexico, 44280
    - Maria del rayo morfin otero
- Nuevo Leon
  - Monterrey, Nuevo Leon, Mexico, 64000
    - Accelerium, S. de R.L. de C.V.
New Zealand
- - Auckland, New Zealand, 1010
    - Optimal Clinical Trials Ltd
  - Auckland, New Zealand, 0626
    - Southern Clinical Trials Waitemata
  - Auckland, New Zealand, 1010
    - New Zealand Clinical Research - Auckland
  - Nelson, New Zealand, 7011
    - Southern Clinical Trials - Tasman
- Canterbury
  - Christchurch, Canterbury, New Zealand, 8023
    - Southern Clinical Trials Limited
  - Rotorua, Canterbury, New Zealand, 3010
    - Lakeland Clinical Trials
Panama
- - Panamá, Panama, 07113
    - Cevaxin 24 de diciembre
- Calidonia
  - Panamá, Calidonia, Panama, 07093
    - Cevaxin Avenida Mexico
Poland
- Dolnoslaskie
  - Wroclaw, Dolnoslaskie, Poland, 50-381
    - AES - DRS - Synexus Polska Sp. z o.o. Oddzial we Wroclawiu
- Mazowieckie
  - Warszawa, Mazowieckie, Poland, 02-672
    - AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Warszawie
- Pomorskie
  - Gdansk, Pomorskie, Poland, 80-382
    - AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Gdansku
- Slaskie
  - Katowice, Slaskie, Poland, 40-040
    - AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Katowicach
- Swietokrzyskie
  - Ostrowiec Swietokrzyski, Swietokrzyskie, Poland, 27-400
    - Ostrowieckie Centrum Medyczne Spolka Cywilna Anna Olech-Cudzik, Krzysztof Cudzik
- Wielkopolskie
  - Poznan, Wielkopolskie, Poland, 60-702
    - AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Poznaniu
Puerto Rico
- - Ponce, Puerto Rico, 00717
    - BRCR Global Puerto Rico (Ponce)
  - San Juan, Puerto Rico, 00935
    - Proyecto ACTU
  - San Juan, Puerto Rico, 00918
    - Caribbean Medical Research Center
Singapore
- - Singapore, Singapore, 169608
    - Singapore General Hospital (SGH)
South Africa
- Gauteng
  - Benoni, Gauteng, South Africa, 1500
    - Worthwhile Clinical Trials
  - Pretoria, Gauteng, South Africa, 0002
    - Dr. J Breedt
  - Pretoria, Gauteng, South Africa, 0184
    - AES - DRS - Synexus - Stanza Clinical Research Centre
  - Pretoria, Gauteng, South Africa, 0184
    - AES - DRS - Synexus Watermeyer Clinical Research Centre
- Kwazulu - Natal
  - Umkomaas, Kwazulu - Natal, South Africa, 4170
    - Aliwal Shoal Medical Center
- Western Cape
  - Somerset West, Western Cape, South Africa, 7130
    - AES - DRS - Synexus - Helderberg Clinical Research Centre
Spain
- - Madrid, Spain, 28006
    - Hospital Universitario de la Princesa
  - Madrid, Spain, 28046
    - Hospital Universitario La Paz - PPDS
  - Valencia, Spain, 46025
    - FISABIO Oftalmología Médica (FOM)
- Barcelona
  - Centelles, Barcelona, Spain, 08540
    - ABS Centelles
- Palma De Mallorca
  - Son Ferriol, Palma De Mallorca, Spain, 07198
    - Hospital Son Llatzer
Taiwan
- - Taichung, Taiwan, 40705
    - Taichung Veterans General Hospital
  - Taichung City, Taiwan, 404
    - China Medical University Hospital - PPDS
  - Taipei City, Taiwan, 112
    - Taipei Veterans General Hospital
  - Taoyuan City, Taiwan, 333
    - Chang Gung Memorial Hospital, Linkou
United Kingdom
- - Bellshill, United Kingdom, ML4 3NJ
    - AES - DRS - Synexus Scotland Clinical Research Centre
  - Birmingham, United Kingdom, B15 2SQ
    - AES - DRS - Synexus Midlands Clinical Research Centre
  - Blackpool, United Kingdom, FY3 7EN
    - Layton Medical Centre
  - Cardiff, United Kingdom, CF15 9SS
    - AES - DRS - Synexus Wales Clinical Research Centre
  - Liverpool, United Kingdom, L22 0LG
    - AES - DRS - NW Consortium Merseyside
  - Manchester, United Kingdom, M15 6SE
    - AES - DRS - NW Consortium Manchester
- Avon
  - Bristol, Avon, United Kingdom, BS2 8HW
    - Bristol Royal Infirmary
- Lancashire
  - Chorley, Lancashire, United Kingdom, PR7 7NA
    - AES - DRS - NW Consortium Lancashire
- Northumberland
  - Hexham, Northumberland, United Kingdom, NE46 1QJ
    - AES - DRS - Synexus Hexham Clinical Research Centre
- Staffordshire
  - Stoke-On-Trent, Staffordshire, United Kingdom, ST10 1NS
    - Cheadle Hospital
- Tyne And Wear
  - Newcastle Upon Tyne, Tyne And Wear, United Kingdom, NE1 4LP
    - Royal Victoria Infirmary
United States
- Alabama
  - Birmingham, Alabama, United States, 35216
    - Accel Research Site - Achieve - Birmingham
  - Birmingham, Alabama, United States, 35211
    - AES - DRS - Synexus Clinical Research US, Inc. - Birmingham
  - Guntersville, Alabama, United States, 35976
    - Lakeview Clinical Research
  - Huntsville, Alabama, United States, 35802
    - AES - DRS - Optimal Research Alabama - Huntsville
- Arizona
  - Hunt, Arizona, United States, 85023
    - Hope Research Institute LLC - Hunt - PPDS
  - Hunt, Arizona, United States, 85284
    - Hope Research Institute LLC - Hunt - PPDS
  - Mesa, Arizona, United States, 85213
    - Desert Clinical Research, LLC - CCT
  - Phoenix, Arizona, United States, 85018
    - Hope Research Institute LLC - Phoenix - Hunt - PPDS
  - Phoenix, Arizona, United States, 85224
    - Synexus Clinical Research US, Inc. - Phoenix Southeast
  - Phoenix, Arizona, United States, 85020
    - AES - DRS - Synexus Clinical Research US, Inc. - Phoenix Central
  - Tucson, Arizona, United States, 85710
    - Tucson Neuroscience Research - M3 WR
- Arkansas
  - Little Rock, Arkansas, United States, 72205
    - Baptist Health Center for Clinical Research
- California
  - Banning, California, United States, 92220
    - Velocity Clinical Research, Banning
  - Canoga Park, California, United States, 91303
    - Hope Clinical Research, LLC
  - Chula Vista, California, United States, 91911
    - Velocity Clinical Research - Chula Vista - PPDS
  - Culver City, California, United States, 90230
    - PPD Virtual - Science 37, Inc
  - La Mesa, California, United States, 91942
    - Velocity Clinical Research, San Diego
  - Los Alamitos, California, United States, 90720
    - PRI, LLC - Los Alamitos - M3 WR
  - Newport Beach, California, United States, 92660
    - PRI, LLC - Newport Beach - M3 WR
  - Oxnard, California, United States, 93030
    - FOMAT Medical Research - FOMAT - HyperCore - PPDS
  - Pomona, California, United States, 91768
    - Reddy Care Medical
  - Redding, California, United States, 96001
    - Paradigm Clinical Research Institute Inc - ClinEdge - PPDS
  - San Diego, California, United States, 92660
    - Medical Center For Clinical Research - M3 WR
- Colorado
  - Aurora, Colorado, United States, 80012
    - Lynn Institute of Denver
  - Fort Collins, Colorado, United States, 80525
    - Tekton Research - Fort Collins - PPDS
  - Longmont, Colorado, United States, 80501
    - Tekton Research - Longmont - PPDS
  - Wheat Ridge, Colorado, United States, 80033
    - Paradigm Clinical Research Institute Inc - ClinEdge - PPDS
- Connecticut
  - Milford, Connecticut, United States, 06460
    - Clinical Research Consultants LLC - ClinEdge - PPDS
- District of Columbia
  - Washington, District of Columbia, United States, 20017
    - Washington Health Institute
- Florida
  - Edgewater, Florida, United States, 32132
    - Velocity Clinical Research, New Smyrna Beach
  - Fleming Island, Florida, United States, 32003
    - Fleming Island Clinical Research Center
  - Hallandale Beach, Florida, United States, 33009
    - Velocity Clinical Research - Hallandale Beach - PPDS
  - Jacksonville, Florida, United States, 32216
    - Jacksonville Center for Clinical Research
  - Lake City, Florida, United States, 32055
    - Multi-Specialty Research Associates, Inc. M3 WR
  - Maitland, Florida, United States, 32751
    - Accel Research Sites - Maitland - ERN - PPDS
  - Miami, Florida, United States, 33176
    - Spotlight Research Center, LLC
  - Miami Beach, Florida, United States, 33140
    - IMA Clinical Research - Manhattan - PPDS
  - Orlando, Florida, United States, 32162
    - AES - DRS - Synexus Clinical Research US, Inc. - The Villages
  - Port Saint Lucie, Florida, United States, 33458
    - Health Awareness INC
  - Saint Petersburg, Florida, United States, 33709
    - IMA Clinical Research - Saint Petersburg - PPDS
  - Saint Petersburg, Florida, United States, 33781
    - AES - DRS - Synexus Clinical Research US, Inc. - St. Petersburg
  - Tampa, Florida, United States, 33614
    - Clinical Trials of Tampa
  - West Palm Beach, Florida, United States, 33409
    - Palm Beach Research - ClinEdge - PPDS
  - Winter Park, Florida, United States, 32789
    - Clinical Site Partners - Winter Park - HyperCore -PPDS
- Georgia
  - Atlanta, Georgia, United States, 30328
    - Mount Vernon Clinical Research, LLC - M3 WR
  - Augusta, Georgia, United States, 30909
    - Masters of Clinical Research Inc
  - Columbus, Georgia, United States, 31904
    - Centricity Research - Roswell - HyperCore - PPDS
  - Decatur, Georgia, United States, 30030
    - iResearch Atlanta
  - Fayetteville, Georgia, United States, 30214
    - Javara, Inc./Privia Medical Group Georgia, LLC
  - Marietta, Georgia, United States, 30060
    - Drug Studies America - ClinEdge - PPDS
  - Peachtree City, Georgia, United States, 30269
    - Randomize Now -Commerce Dr
  - Savannah, Georgia, United States, 31406
    - Velocity Clinical Research (Savannah - Georgia) - PPDS
  - Stockbridge, Georgia, United States, 30281
    - Clinical Research Atlanta - ERN-PPDS
- Hawaii
  - Honolulu, Hawaii, United States, 96814
    - East West Medical Research Institute
- Idaho
  - Meridian, Idaho, United States, 83642
    - Velocity Clinical Research - Boise - PPDS
- Illinois
  - Chicago, Illinois, United States, 60602
    - AES - DRS - Synexus Clinical Research US, Inc. - Chicago
  - Oak Brook, Illinois, United States, 60523
    - Affinity Health (Oak Brook)
  - River Forest, Illinois, United States, 60305
    - DM Clinical - Chicago
- Indiana
  - Evansville, Indiana, United States, 47714
    - AES - DRS - Synexus Clinical Research US, Inc. - Evansville
  - Valparaiso, Indiana, United States, 46383
    - Velocity Clinical Research - Valparaiso - PPDS
- Kansas
  - Lenexa, Kansas, United States, 66219
    - Johnson County Clin-Trials
- Kentucky
  - Versailles, Kentucky, United States, 40383
    - Versailles Family Medicine - CCT - PPDS
- Louisiana
  - Baton Rouge, Louisiana, United States, 70809
    - Velocity Clinical Research (Baton Rouge - Louisiana) - PPDS
  - Covington, Louisiana, United States, 70433
    - Benchmark Research - Covington - HyperCore - PPDS
  - Metairie, Louisiana, United States, 70006
    - Benchmark Research - Metairie - HyperCore - PPDS
  - Monroe, Louisiana, United States, 71259
    - IMA Clinical Research - Monroe, LA - PPDS
  - New Orleans, Louisiana, United States, 70115
    - DelRicht Clinical Research, LLC - Internal - Covington - PPDS
- Maryland
  - Annapolis, Maryland, United States, 21401
    - Privia Medical Group, LLC - Annapolis - Javara - PPDS
  - Gaithersburg, Maryland, United States, 20877
    - CBH Health - CenExel CBH - PPDS
  - Rockville, Maryland, United States, 20854
    - Velocity Clinical Research (Rockville - Maryland) - PPDS
- Michigan
  - Southfield, Michigan, United States, 48075
    - Great Lakes Research Institute
  - Southfield, Michigan, United States, 48076
    - DM Clinical Research - Southfield - ERN - PPDS
- Minnesota
  - Minneapolis, Minnesota, United States, 55402
    - Clinical Research Institute, Inc - CRN - PPDS
  - Richfield, Minnesota, United States, 55423
    - AES - DRS - Synexus Clinical Research US, Inc. - Minneapolis
- Missouri
  - Creve Coeur, Missouri, United States, 63141
    - AES - DRS - Synexus Clinical Research US, Inc. - St. Louis
- Montana
  - Missoula, Montana, United States, 59804
    - Montana Medical Research
  - Missoula, Montana, United States, 59808
    - Boeson Research MSO - Missoula - ERN - PPDS
- Nebraska
  - Elkhorn, Nebraska, United States, 68022
    - Skyline Medical Center, PC - CCT Research
  - Fremont, Nebraska, United States, 68025
    - Methodist Physicians Clinic - CCT Research - PPDS
  - Grand Island, Nebraska, United States, 68803
    - Velocity Clinical Research (Grand Island - Nebraska) - PPDS
  - Lincoln, Nebraska, United States, 68510
    - Velocity Clinical Research (Lincoln - Nebraska) - PPDS
  - Omaha, Nebraska, United States, 68134
    - Velocity Clinical Research (Omaha - Nebraska) - PPDS
  - Papillion, Nebraska, United States, 68046
    - CCT Research
- Nevada
  - Las Vegas, Nevada, United States, 89102
    - HEALOR Primary Care - Physicians Las Vegas - CCT
  - Las Vegas, Nevada, United States, 89109
    - Excel Clinical Research - Las Vegas
- New Jersey
  - Raritan, New Jersey, United States, 08869
    - IMA Clinical Research - Raritan - PPDS
  - Secaucus, New Jersey, United States, 07094
    - Riverside Medical Group - Circuit - PPDS
- New York
  - East Syracuse, New York, United States, 13057
    - Velocity Clinical Research - East Syracuse - PPDS
  - Endwell, New York, United States, 13760
    - Velocity Clinical Research (Endwell - New York) - PPDS
  - Hartsdale, New York, United States, 10530
    - Drug Trials America
  - New York, New York, United States, 10017
    - AES - DRS - Synexus Clinical Research US, Inc. - New York
  - Rochester, New York, United States, 14609
    - Rochester Clinical Research, Inc
- North Carolina
  - Fayetteville, North Carolina, United States, 28303
    - Carolina Institute for Clinical Research - M3 WR
  - Greensboro, North Carolina, United States, 27410
    - Triad Clinical Trials
  - Wilmington, North Carolina, United States, 28403
    - Trial Management Associates, LLC
- Ohio
  - Cincinnati, Ohio, United States, 45212
    - CTI Clinical Research
  - Cincinnati, Ohio, United States, 45219
    - Velocity Clinical Research - Cincinnati - PPDS
  - Cincinnati, Ohio, United States, 45236
    - AES - DRS - Synexus Clinical Research US, Inc. - Cincinnati
  - Cincinnati, Ohio, United States, 45219
    - Velocity Clinical Research (Cincinnati - Ohio) - PPDS
- Oklahoma
  - Edmond, Oklahoma, United States, 73013
    - Tekton Research - Oklahoma - PPDS
  - Yukon, Oklahoma, United States, 73099
    - Tekton Research
- Oregon
  - Portland, Oregon, United States, 97210
    - Summit Research Network, Inc. - Portland - Headlands - PPDS
- Pennsylvania
  - Hatboro, Pennsylvania, United States, 19040
    - Hatboro Medical Associates - CCT - PPDS
  - Philadelphia, Pennsylvania, United States, 19107
    - DM Clinical Research - Philadelphia - ERN - PPDS
- South Dakota
  - Dakota Dunes, South Dakota, United States, 57049
    - Velocity Clinical Research (Dakota Dunes - South Dakota) - PPDS
  - Rapid City, South Dakota, United States, 57701
    - American Indian Clinical Trials Research Network
- Tennessee
  - Nashville, Tennessee, United States, 37203
    - Affinity Health - Nashville
- Texas
  - Austin, Texas, United States, 78745
    - Tekton Research
  - Austin, Texas, United States, 78735
    - Premier Family Physicians - Austin - Hunt - PPDS
  - Brownsville, Texas, United States, 78520
    - PanAmerican Clinical Research LLC
  - Carrollton, Texas, United States, 75010
    - ACRC Trials - Carrollton - Hunt - PPDS
  - Fort Worth, Texas, United States, 76132
    - Privia Medical Group- North Texas - West Parker Road - Fort Worth - Javara - PPDS
  - Friendswood, Texas, United States, 77546
    - Allure Health LLC
  - Friendswood, Texas, United States, 77546
    - Olympus Family Medicine- CCT
  - Frisco, Texas, United States, 75033
    - Village Health Partners Frisco Medical Village
  - Houston, Texas, United States, 77055
    - West Houston Clinical Research - Hunt - PPDS
  - Houston, Texas, United States, 77081
    - DM Clinical Research - Bellaire - ERN - PPDS
  - Humble, Texas, United States, 77338
    - DM Clinical-TCDD
  - Keller, Texas, United States, 76248
    - Helios CR, Inc. - Houston - PPDS
  - Plano, Texas, United States, 75093
    - AIM Trials
  - San Antonio, Texas, United States, 78229
    - AES - DRS - Synexus Clinical Research US, Inc. - San Antonio
  - San Antonio, Texas, United States, 78229
    - Clinical Trials of Texas, LLC - HyperCore - PPDS
  - Stephenville, Texas, United States, 76401
    - Privia Medical Group- North Texas - Stephenville - Javara - PPDS
  - Sugar Land, Texas, United States, 77338
    - DM Clinical Research - Sugarland - ERN - PPDS
  - Tomball, Texas, United States, 77375
    - DM Clinical Research - ERN - PPDS
  - Tomball, Texas, United States, 77375
    - DM Clinical Research - ERN
- Utah
  - Bountiful, Utah, United States, 84010
    - Cope Family Medicine - CCT - PPDS
  - Clinton, Utah, United States, 84015
    - Alpine Research Organization, Inc
  - South Ogden, Utah, United States, 84405
    - South Ogden Family Medicine - CCT
- Virginia
  - Newport News, Virginia, United States, 23606
    - Health Research of Hampton Roads Inc.
  - Portsmouth, Virginia, United States, 23703
    - Velocity Clinical Research - Family Practice - Portsmouth - PPDS
- Washington
  - Renton, Washington, United States, 98057
    - Rainier Clinical Research Center
  - Seattle, Washington, United States, 98105
    - Seattle Clinical Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Key Inclusion Criteria (Part A):

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

Key Inclusion Criteria (Part B):

Randomized to and were subsequently vaccinated with the mRNA-1345 study injection in Part A at least 21 months prior to Screening.

Key Exclusion Criteria (Part A):

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.

Key Exclusion Criteria (Part B):

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.
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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Quadruple

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: mRNA-1345 Single injection of mRNA-1345 on Day 1.	Drug: mRNA-1345 Sterile liquid for injection
Experimental: Placebo Single injection of mRNA-1345 matching-placebo on Day 1.	Drug: Placebo 0.9% sodium chloride (normal saline) injection
Experimental: mRNA-1345 BD Single injection of mRNA-1345 on BD Day 1.	Drug: mRNA-1345 Sterile liquid for injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs) Time Frame: Up to 7 days after each injection		Up to 7 days after each injection
Number of Participants with Unsolicited Adverse Events (AEs) Time Frame: Up to 28 days after each injection		Up to 28 days after each injection
Number of Participants With Medically Attended AEs (MAAEs), Adverse Events of Special Interests (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Withdrawal Time Frame: Up to BD Day 181		Up to BD Day 181
Vaccine Efficacy (VE) of mRNA-1345 to Prevent a First Episode of RSV-LRTD with 2 or More Symptoms Time Frame: From 14 days postinjection up to 12 months postinjection	VE of mRNA-1345 to prevent reverse transcription polymerase chain reaction (RT-PCR) confirmed protocol-defined RSV-LRTD, defined as 100*(1-HR ratio), where HR is the hazard ratio (mRNA-1345 versus placebo).	From 14 days postinjection up to 12 months postinjection
VE of mRNA-1345 to Prevent a First Episode of RSV-LRTD with 3 or More Symptoms Time Frame: From 14 days postinjection up to 12 months postinjection	VE of mRNA-1345 to prevent reverse transcription polymerase chain reaction (RT-PCR) confirmed protocol-defined RSV-LRTD, defined as 100*(1-HR ratio), where HR is the hazard ratio (mRNA-1345 versus placebo).	From 14 days postinjection up to 12 months postinjection
Geometric Mean Titer (GMT) of Serum Respiratory Syncytial Virus Subtype A (RSV-A) and Respiratory Syncytial Virus Subtype B (RSV-B) Neutralizing Antibodies Time Frame: BD Day 29		BD Day 29
Geometric Mean Ratio (GMR) of Serum RSV-A and RSV-B Neutralizing Antibodies After BD Compared to After Initial Dose Time Frame: BD Day 29		BD Day 29

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
VE of mRNA-1345 to Prevent a First Episode of RSV-Associated Acute Respiratory Disease (RSV-ARD) Time Frame: From 14 days postinjection up to 12 months postinjection	VE of mRNA-1345 to prevent RT-PCR confirmed protocol-defined RSV-ARD, defined as 100*(1-HR ratio), where HR is the hazard ratio (mRNA-1345 versus placebo).	From 14 days postinjection up to 12 months postinjection
VE of mRNA-1345 to Prevent First Hospitalization Associated with RSV-ARD or RSV-LRTD Time Frame: From 14 days postinjection up to 12 months postinjection	VE of mRNA-1345 to prevent first hospitalization associated with RSV-ARD or RSV-LRTD, defined as 100*(1-HR ratio), where HR is the hazard ratio (mRNA-1345 versus placebo).	From 14 days postinjection up to 12 months postinjection
GMT of Serum RSV Neutralizing Antibodies Time Frame: Baseline through up to 24 months postinjection		Baseline through up to 24 months postinjection
Geometric Mean Concentration (GMC) of Serum RSV Binding Antibodies Time Frame: Baseline through up to 24 months postinjection		Baseline through up to 24 months postinjection
Seroresponse Rate in RSV Neutralizing Antibodies Time Frame: Baseline through up to 24 months postinjection		Baseline through up to 24 months postinjection
Geometric Mean Fold-Rise (GMFR) of Postbaseline/Baseline Antibody Titers Time Frame: Baseline through up to 24 months postinjection		Baseline through up to 24 months postinjection
Proportion of Participants with ≥4-fold Increases in Antibody Titers from Baseline Time Frame: Baseline through up to 24 months postinjection		Baseline through up to 24 months postinjection
Seroresponse Rate (SRR) Difference Between Serum RSV-A and RSV-B Neutralizing Antibodies After BD Compared to After Initial Dose Time Frame: BD Day 29		BD Day 29
GMT of Serum RSV-A and RSV-B Neutralizing Antibodies Time Frame: BD Day 1 and Day 181		BD Day 1 and Day 181
GMFR of Serum RSV-A and RSV-B Neutralizing Antibodies from Pre-primary Dose (Baseline) Time Frame: Baseline, BD Day 1, Day 29 and Day 181		Baseline, BD Day 1, Day 29 and Day 181
SRR of Serum RSV-A and RSV-B Neutralizing Antibodies from Pre-primary Dose (Baseline) Time Frame: Baseline, BD Day 1, Day 29 and Day 181		Baseline, BD Day 1, Day 29 and Day 181

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ModernaTX, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 17, 2021

Primary Completion (Estimated)

August 25, 2025

Study Completion (Estimated)

August 25, 2025

Study Registration Dates

First Submitted

November 9, 2021

First Submitted That Met QC Criteria

November 9, 2021

First Posted (Actual)

November 19, 2021

Study Record Updates

Last Update Posted (Estimated)

February 9, 2024

Last Update Submitted That Met QC Criteria

February 8, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

mRNA-1345-P301

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Study Overview

Status

Conditions

Intervention / Treatment

Detailed Description

Study Type

Enrollment (Actual)

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Estimated)

Study Completion (Estimated)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Estimated)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

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