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, 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
2 other identifiers
interventional
36,814
22 countries
259
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2021
Typical duration for phase_2
259 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 9, 2021
CompletedStudy Start
First participant enrolled
November 17, 2021
CompletedFirst Posted
Study publicly available on registry
November 19, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 28, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
July 28, 2025
CompletedAugust 19, 2025
August 1, 2025
3.7 years
November 9, 2021
August 18, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (7)
Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs)
Up to 7 days after each injection
Number of Participants with Unsolicited Adverse Events (AEs)
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
Up to BD Day 181
Vaccine Efficacy (VE) of mRNA-1345 to Prevent a First Episode of RSV-LRTD with 2 or More Symptoms
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
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
BD Day 29
Geometric Mean Ratio (GMR) of Serum RSV-A and RSV-B Neutralizing Antibodies After BD Compared to After Initial Dose
BD Day 29
Secondary Outcomes (11)
VE of mRNA-1345 to Prevent a First Episode of RSV-Associated Acute Respiratory Disease (RSV-ARD)
From 14 days postinjection up to 12 months postinjection
VE of mRNA-1345 to Prevent First Hospitalization Associated with RSV-ARD or RSV-LRTD
From 14 days postinjection up to 12 months postinjection
GMT of Serum RSV Neutralizing Antibodies
Baseline through up to 24 months postinjection
Geometric Mean Concentration (GMC) of Serum RSV Binding Antibodies
Baseline through up to 24 months postinjection
Seroresponse Rate in RSV Neutralizing Antibodies
Baseline through up to 24 months postinjection
- +6 more secondary outcomes
Study Arms (3)
mRNA-1345
EXPERIMENTALSingle injection of mRNA-1345 on Day 1.
Placebo
EXPERIMENTALSingle injection of mRNA-1345 matching-placebo on Day 1.
mRNA-1345 BD
EXPERIMENTALSingle injection of mRNA-1345 on BD Day 1.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ModernaTX, Inc.lead
Study Sites (269)
AES - DRS - Synexus Clinical Research US, Inc. - Birmingham
Birmingham, Alabama, 35211, United States
Accel Research Site - Achieve - Birmingham
Birmingham, Alabama, 35216, United States
Lakeview Clinical Research
Guntersville, Alabama, 35976, United States
AES - DRS - Optimal Research Alabama - Huntsville
Huntsville, Alabama, 35802, United States
Hope Research Institute LLC - Hunt - PPDS
Hunt, Arizona, 85023, United States
Hope Research Institute LLC - Hunt - PPDS
Hunt, Arizona, 85284, United States
Desert Clinical Research, LLC - CCT
Mesa, Arizona, 85213, United States
Hope Research Institute LLC - Phoenix - Hunt - PPDS
Phoenix, Arizona, 85018, United States
AES - DRS - Synexus Clinical Research US, Inc. - Phoenix Central
Phoenix, Arizona, 85020, United States
Synexus Clinical Research US, Inc. - Phoenix Southeast
Phoenix, Arizona, 85224, United States
Tucson Neuroscience Research - M3 WR
Tucson, Arizona, 85710, United States
Baptist Health Center for Clinical Research
Little Rock, Arkansas, 72205, United States
Velocity Clinical Research, Banning
Banning, California, 92220, United States
Hope Clinical Research, LLC
Canoga Park, California, 91303, United States
Velocity Clinical Research - Chula Vista - PPDS
Chula Vista, California, 91911, United States
PPD Virtual - Science 37, Inc
Culver City, California, 90230, United States
Velocity Clinical Research, San Diego
La Mesa, California, 91942, United States
PRI, LLC - Los Alamitos - M3 WR
Los Alamitos, California, 90720, United States
PRI, LLC - Newport Beach - M3 WR
Newport Beach, California, 92660, United States
FOMAT Medical Research - FOMAT - HyperCore - PPDS
Oxnard, California, 93030, United States
Reddy Care Medical
Pomona, California, 91768, United States
Paradigm Clinical Research Institute Inc - ClinEdge - PPDS
Redding, California, 96001, United States
Medical Center For Clinical Research - M3 WR
San Diego, California, 92660, United States
Lynn Institute of Denver
Aurora, Colorado, 80012, United States
Tekton Research - Fort Collins - PPDS
Fort Collins, Colorado, 80525, United States
Tekton Research - Longmont - PPDS
Longmont, Colorado, 80501, United States
Paradigm Clinical Research Institute Inc - ClinEdge - PPDS
Wheat Ridge, Colorado, 80033, United States
Clinical Research Consultants LLC - ClinEdge - PPDS
Milford, Connecticut, 06460, United States
Washington Health Institute
Washington D.C., District of Columbia, 20017, United States
Velocity Clinical Research, New Smyrna Beach
Edgewater, Florida, 32132, United States
Fleming Island Clinical Research Center
Fleming Island, Florida, 32003, United States
Velocity Clinical Research - Hallandale Beach - PPDS
Hallandale, Florida, 33009, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, 32216, United States
Multi-Specialty Research Associates, Inc. M3 WR
Lake City, Florida, 32055, United States
Accel Research Sites - Maitland - ERN - PPDS
Maitland, Florida, 32751, United States
Spotlight Research Center, LLC
Miami, Florida, 33176, United States
IMA Clinical Research - Manhattan - PPDS
Miami Beach, Florida, 33140, United States
AES - DRS - Synexus Clinical Research US, Inc. - The Villages
Orlando, Florida, 32162, United States
Health Awareness Inc
Port Saint Lucie, Florida, 33458, United States
IMA Clinical Research - Saint Petersburg - PPDS
St. Petersburg, Florida, 33709, United States
AES - DRS - Synexus Clinical Research US, Inc. - St. Petersburg
St. Petersburg, Florida, 33781, United States
Clinical Trials of Tampa
Tampa, Florida, 33614, United States
Palm Beach Research - ClinEdge - PPDS
West Palm Beach, Florida, 33409, United States
Clinical Site Partners - Winter Park - HyperCore -PPDS
Winter Park, Florida, 32789, United States
Mount Vernon Clinical Research, LLC - M3 WR
Atlanta, Georgia, 30328, United States
Masters of Clinical Research Inc
Augusta, Georgia, 30909, United States
Centricity Research - Roswell - HyperCore - PPDS
Columbus, Georgia, 31904, United States
iResearch Atlanta
Decatur, Georgia, 30030, United States
Javara, Inc./Privia Medical Group Georgia, LLC
Fayetteville, Georgia, 30214, United States
Drug Studies America - ClinEdge - PPDS
Marietta, Georgia, 30060, United States
Randomize Now -Commerce Dr
Peachtree City, Georgia, 30269, United States
Velocity Clinical Research (Savannah - Georgia) - PPDS
Savannah, Georgia, 31406, United States
Clinical Research Atlanta - ERN-PPDS
Stockbridge, Georgia, 30281, United States
East West Medical Research Institute
Honolulu, Hawaii, 96814, United States
Velocity Clinical Research - Boise - PPDS
Meridian, Idaho, 83642, United States
AES - DRS - Synexus Clinical Research US, Inc. - Chicago
Chicago, Illinois, 60602, United States
Affinity Health (Oak Brook)
Oak Brook, Illinois, 60523, United States
DM Clinical - Chicago
River Forest, Illinois, 60305, United States
AES - DRS - Synexus Clinical Research US, Inc. - Evansville
Evansville, Indiana, 47714, United States
Velocity Clinical Research - Valparaiso - PPDS
Valparaiso, Indiana, 46383, United States
Johnson County Clin-Trials
Lenexa, Kansas, 66219, United States
Versailles Family Medicine - CCT - PPDS
Versailles, Kentucky, 40383, United States
Velocity Clinical Research (Baton Rouge - Louisiana) - PPDS
Baton Rouge, Louisiana, 70809, United States
Benchmark Research - Covington - HyperCore - PPDS
Covington, Louisiana, 70433, United States
Benchmark Research - Metairie - HyperCore - PPDS
Metairie, Louisiana, 70006, United States
IMA Clinical Research - Monroe, LA - PPDS
Monroe, Louisiana, 71259, United States
DelRicht Clinical Research, LLC - Internal - Covington - PPDS
New Orleans, Louisiana, 70115, United States
Privia Medical Group, LLC - Annapolis - Javara - PPDS
Annapolis, Maryland, 21401, United States
CBH Health - CenExel CBH - PPDS
Gaithersburg, Maryland, 20877, United States
Velocity Clinical Research (Rockville - Maryland) - PPDS
Rockville, Maryland, 20854, United States
Great Lakes Research Institute
Southfield, Michigan, 48075, United States
DM Clinical Research - Southfield - ERN - PPDS
Southfield, Michigan, 48076, United States
Clinical Research Institute, Inc - CRN - PPDS
Minneapolis, Minnesota, 55402, United States
AES - DRS - Synexus Clinical Research US, Inc. - Minneapolis
Richfield, Minnesota, 55423, United States
AES - DRS - Synexus Clinical Research US, Inc. - St. Louis
Creve Coeur, Missouri, 63141, United States
Montana Medical Research
Missoula, Montana, 59804, United States
Boeson Research MSO - Missoula - ERN - PPDS
Missoula, Montana, 59808, United States
Skyline Medical Center, PC - CCT Research
Elkhorn, Nebraska, 68022, United States
Methodist Physicians Clinic - CCT Research - PPDS
Fremont, Nebraska, 68025, United States
Velocity Clinical Research (Grand Island - Nebraska) - PPDS
Grand Island, Nebraska, 68803, United States
Velocity Clinical Research (Lincoln - Nebraska) - PPDS
Lincoln, Nebraska, 68510, United States
Velocity Clinical Research (Omaha - Nebraska) - PPDS
Omaha, Nebraska, 68134, United States
CCT Research
Papillion, Nebraska, 68046, United States
HEALOR Primary Care - Physicians Las Vegas - CCT
Las Vegas, Nevada, 89102, United States
Excel Clinical Research - Las Vegas
Las Vegas, Nevada, 89109, United States
IMA Clinical Research - Raritan - PPDS
Raritan, New Jersey, 08869, United States
Riverside Medical Group - Circuit - PPDS
Secaucus, New Jersey, 07094, United States
Velocity Clinical Research - East Syracuse - PPDS
East Syracuse, New York, 13057, United States
Velocity Clinical Research (Endwell - New York) - PPDS
Endwell, New York, 13760, United States
Drug Trials America
Hartsdale, New York, 10530, United States
AES - DRS - Synexus Clinical Research US, Inc. - New York
New York, New York, 10017, United States
Rochester Clinical Research, Inc
Rochester, New York, 14609, United States
Carolina Institute for Clinical Research - M3 WR
Fayetteville, North Carolina, 28303, United States
Triad Clinical Trials
Greensboro, North Carolina, 27410, United States
Trial Management Associates, LLC
Wilmington, North Carolina, 28403, United States
CTI Clinical Research
Cincinnati, Ohio, 45212, United States
Velocity Clinical Research (Cincinnati - Ohio) - PPDS
Cincinnati, Ohio, 45219, United States
Velocity Clinical Research - Cincinnati - PPDS
Cincinnati, Ohio, 45219, United States
AES - DRS - Synexus Clinical Research US, Inc. - Cincinnati
Cincinnati, Ohio, 45236, United States
Tekton Research - Oklahoma - PPDS
Edmond, Oklahoma, 73013, United States
Tekton Research
Yukon, Oklahoma, 73099, United States
Summit Research Network, Inc. - Portland - Headlands - PPDS
Portland, Oregon, 97210, United States
Hatboro Medical Associates - CCT - PPDS
Hatboro, Pennsylvania, 19040, United States
DM Clinical Research - Philadelphia - ERN - PPDS
Philadelphia, Pennsylvania, 19107, United States
Velocity Clinical Research (Dakota Dunes - South Dakota) - PPDS
Dakota Dunes, South Dakota, 57049, United States
American Indian Clinical Trials Research Network
Rapid City, South Dakota, 57701, United States
Affinity Health - Nashville
Nashville, Tennessee, 37203, United States
Premier Family Physicians - Austin - Hunt - PPDS
Austin, Texas, 78735, United States
Tekton Research
Austin, Texas, 78745, United States
PanAmerican Clinical Research LLC
Brownsville, Texas, 78520, United States
ACRC Trials - Carrollton - Hunt - PPDS
Carrollton, Texas, 75010, United States
Privia Medical Group- North Texas - West Parker Road - Fort Worth - Javara - PPDS
Fort Worth, Texas, 76132, United States
Allure Health LLC
Friendswood, Texas, 77546, United States
Olympus Family Medicine- CCT
Friendswood, Texas, 77546, United States
Village Health Partners Frisco Medical Village
Frisco, Texas, 75033, United States
West Houston Clinical Research - Hunt - PPDS
Houston, Texas, 77055, United States
DM Clinical Research - Bellaire - ERN - PPDS
Houston, Texas, 77081, United States
DM Clinical-TCDD
Humble, Texas, 77338, United States
Helios CR, Inc. - Houston - PPDS
Keller, Texas, 76248, United States
AIM Trials
Plano, Texas, 75093, United States
AES - DRS - Synexus Clinical Research US, Inc. - San Antonio
San Antonio, Texas, 78229, United States
Clinical Trials of Texas, LLC - HyperCore - PPDS
San Antonio, Texas, 78229, United States
Privia Medical Group- North Texas - Stephenville - Javara - PPDS
Stephenville, Texas, 76401, United States
DM Clinical Research - Sugarland - ERN - PPDS
Sugar Land, Texas, 77338, United States
DM Clinical Research - ERN - PPDS
Tomball, Texas, 77375, United States
DM Clinical Research - ERN
Tomball, Texas, 77375, United States
Cope Family Medicine - CCT - PPDS
Bountiful, Utah, 84010, United States
Alpine Research Organization, Inc
Clinton, Utah, 84015, United States
South Ogden Family Medicine - CCT
South Ogden, Utah, 84405, United States
Health Research of Hampton Roads Inc.
Newport News, Virginia, 23606, United States
Velocity Clinical Research - Family Practice - Portsmouth - PPDS
Portsmouth, Virginia, 23703, United States
Rainier Clinical Research Center
Renton, Washington, 98057, United States
Seattle Clinical Research Center
Seattle, Washington, 98105, United States
Instituto Medico Platense
Buenos Aires, Provincial de Buenos Aires, B1900AVG, Argentina
Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich
Ciudad Autónoma de BuenosAires, 1426, Argentina
Fundación Dr. Mario Socolinsky - Centro de Vacunación Proteger
Ciudad Autónoma de BuenosAires, C1023, Argentina
Centro Medico Barrio Parque
Ciudad Autónoma de BuenosAires, C1425, Argentina
Consultorios Médicos Dr. Doreski
Ciudad Autónoma de BuenosAires, C1426ABP, Argentina
Paratus Clinical Research - Canberra - PPDS
Bruce, Australian Capital Territory, 2617, Australia
Paratus Clinical Research - Western Sydney - PPDS
Blacktown, New South Wales, 2148, Australia
Northern Beaches Clinical Research
Brookvale, New South Wales, 2100, Australia
Northside Health
Coffs Harbour, New South Wales, 2450, Australia
Holdsworth House Medical Brisbane
Fortitude Valley, Queensland, 4006, Australia
Emeritus Research - PPDS
Camberwell, Victoria, 3124, Australia
JHU-Projahnmo Zakiganj site
Zakiganj, Sylhet Division, 3190, Bangladesh
icddr,b Matlab Health Research Center
Chāndpur, 3640, Bangladesh
Icddr,b Kamalapur Field Site
Dhaka, 1204, Bangladesh
JHU-Projahnmo Sylhet site
Sylhet, 3100, Bangladesh
ANIMA Research Center
Diepenbeek, 3590, Belgium
Vaccinopolis
Edegem, 2650, Belgium
Private Practice Dr Jean Benoit Martinot
Erpent, 5101, Belgium
Ziekenhuis Oost-Limburg
Genk, 3600, Belgium
CARe Clinic
Red Deer, Alberta, T4P 1K4, Canada
Okanagan Clinical Trials - Headlands - PPDS
Kelowna, British Columbia, V1Y 1Z9, Canada
Centricity Research - Toronto - HyperCore - PPDS
Etobicoke, Ontario, M9W 4L6, Canada
Dr. Steven Z. Zizzo Medicine Professional Corporation
Hamilton, Ontario, L8J OB6, Canada
LMC Clinical Research Inc (Bayview)
Toronto, Ontario, M4G 3E8, Canada
Centricity Research - Quebec - HyperCore - PPDS
Lévis, Quebec, G6W OM5, Canada
Diex Recherche - Joilette - PPDS
Saint-Charles-Borromée, Quebec, J6E 2B4, Canada
Diex Recherche - Sherbrooke - PPDS
Sherbrooke, Quebec, J1L 0H8, Canada
Diex Recherche - Trois Rivieres - PPDS
Trois-Rivières, Quebec, G9A 4P3, Canada
Diex Recherche - Québec - PPDS
Québec, J6E 2B4, Canada
Hospital Base de Osorno
Osorno, Los Lagos Region, 5311523, Chile
Centro de Investigacion del Maule
Talca, Maule Region, 3465586, Chile
Centro Respiratorio Integral LTDA. (CENRESIN)
Quillota, Región de Valparaíso, 2260734, Chile
Biomedica Research Group
Santiago, Santiago Metropolitan, 7500710, Chile
BIOCINETIC SpA
Santiago, Santiago Metropolitan, 8320000, Chile
Institucion Clinica de la Costa SAS
Barranquilla, Atlántico, 80020, Colombia
Centro de Atención e Investigación Médica S.A. - CAIMED - Aguazul
Aguazul, Casanare Department, 856010, Colombia
Solano & Terront Servicios Médicos LTDA (UNIENDO) Bogota
Bogota, Cundinamarca, 110221, Colombia
Centro de Atención e Investigación Médica S.A. - CAIMED - Bogota
Bogota, Cundinamarca, 111611, Colombia
Centro de Atención e Investigación Médica S.A. - CAIMED - Chia
Chía, Cundinamarca, 250001, Colombia
Centro de Atención e Investigación Médica S.A. - CAIMED - Girardot
Girardot City, Cundinamarca, 252431, Colombia
IPS Centro de Investigacion Clinicas Cardiomet
Pereira, Risaralda Department, 660003, Colombia
Fundacion Oftalmologica de Santander Foscal
Floridablanca, Santandar, 681002, Colombia
Centro de Atención e Investigación Médica S.A. - CAIMED - Ibague
Ibagué, Tolima Department, 730001, Colombia
Centro Medico Imbanaco de Cali S.A.
Cali, Valle de Cuaca, 760042, Colombia
Campus Universidad EARTH, finca La Flor
Liberia, Guanacaste Province, 50101, Costa Rica
Instituto de Investigación en Ciencias Médicas S.A.
San José, 10108, Costa Rica
Hospital CIMA San Jose
San José, 10203, Costa Rica
Hospital Clínica Bíblica Sede Santa Ana
San José, 10903, Costa Rica
Espoo Vaccine Research Clinic
Espoo, 02230, Finland
Helsinki South Vaccine Research Clinic
Helsinki, 00100, Finland
Helsinki East Vaccine Research Clinic
Helsinki, 00930, Finland
Järvenpää Vaccine Research Clinic
Jarvenpaa, 04400, Finland
KokkolaVaccine Research Clinic
Kokkola, 67100, Finland
Oulu Vaccine Research Clinic
Oulu, 90220, Finland
Pori Vaccine Research Clinic
Pori, 28100, Finland
Seinäjoki Vaccine Research Clinic
Seinäjoki, 60100, Finland
Tampere Vaccine Research Clinic
Tampere, 33100, Finland
Turku Vaccine Research Clinic
Turku, 20520, Finland
AES - DRS - Synexus Frankfurt Research Centre
Frankfurt am Main, Hesse, 60313, Germany
Infektioresearch GmbH & Co. KG
Frankfurt am Main, Hesse, 60569, Germany
Klinische Forschung Hannover-Mitte GmbH
Hanover, Lower Saxony, 30159, Germany
Klinische Forschung, Schwerin GmbH (KFGN)
Schwerin, Mecklenburg-West Pomerania, 19055, Germany
Medizentrum Essen Borbeck
Essen, North Rhine-Westphalia, 45355, Germany
AES - DRS - Synexus Berlin Research Centre
Berlin, 12627, Germany
Fukui General Clinic
Fukui-shi, Fukui, 910-0067, Japan
Tenjin Sogo Clinic
Fukuoka, Fukuoka, 810-0021, Japan
Boocs Clinic Fukuoka
Hakata-ku, Fukuoka, 812-0025, Japan
Motomachi Takatsuka Naika Clinic
Naka-ku, Yokohama-ku, Kanagawa, 231-0023, Japan
Medical Corporation Asbo Tokyo Asbo Clinic
Chuo-ku, Tokyo, 104-0031, Japan
Center Hospital of the National Center for Global Health and Medicine
Shinjuku-ku, Tokyo, 162-8655, Japan
Higashi Shinjuku Clinic
Shinjuku-ku, Tokyo, 169-0072, Japan
NewHeart Watanabe Institute
Suginami-ku, Tokyo, 168-0065, Japan
Sekino Hospital
Toshima-ku, Tokyo, 171-0014, Japan
SOUSEIKAI PS Clinic
Fukuoka, 812-0025, Japan
AES - AS - RM Pharma Specialists Mexico City
Ciudad de Mexcio, Ciudad de Mexcio, 03100, Mexico
AES - AS - CEMDEC Mexico City
Ciudad de Mexcio, Ciudad de Mexcio, 06100, Mexico
Maria del rayo morfin otero
Guadalajara, Jalisco, 44280, Mexico
Accelerium, S. de R.L. de C.V.
Monterrey, Nuevo León, 64000, Mexico
Investigacion en Salud y Metabolismo S.C.
Chihuahua City, 31110, Mexico
Hospital General 450
Durango, 34217, Mexico
PanAmerican Clinical Research-Avenida
Querétaro, 76100, Mexico
Southern Clinical Trials Limited
Christchurch, Canterbury, 8023, New Zealand
Lakeland Clinical Trials
Rotorua, Canterbury, 3010, New Zealand
Southern Clinical Trials Waitemata
Auckland, 0626, New Zealand
New Zealand Clinical Research - Auckland
Auckland, 1010, New Zealand
Optimal Clinical Trials Ltd
Auckland, 1010, New Zealand
Southern Clinical Trials - Tasman
Nelson, 7011, New Zealand
CEVAXIN Avenida México
Panama City, Calidonia, 07093, Panama
CEVAXIN 24 de diciembre
Panama City, 07113, Panama
AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Poznaniu
Poznan, Greater Poland Voivodeship, 60-702, Poland
AES - DRS - Synexus Polska Sp. z o.o. Oddzial we Wroclawiu
Wroclaw, Lower Silesian Voivodeship, 50-381, Poland
AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Warszawie
Warsaw, Masovian Voivodeship, 02-672, Poland
AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Gdansku
Gdansk, Pomeranian Voivodeship, 80-382, Poland
AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Katowicach
Katowice, Silesian Voivodeship, 40-040, Poland
Ostrowieckie Centrum Medyczne Spólka Cywilna Anna Olech-Cudzik, Krzysztof Cudzik
Ostrowiec Świętokrzyski, Świętokrzyskie Voivodeship, 27-400, Poland
BRCR Global Puerto Rico (Ponce)
Ponce, 00717, Puerto Rico
Caribbean Medical Research Center
San Juan, 00918, Puerto Rico
Proyecto ACTU
San Juan, 00935, Puerto Rico
Singapore General Hospital (SGH)
Singapore, 169608, Singapore
Worthwhile Clinical Trials
Benoni, Gauteng, 1500, South Africa
Dr. J Breedt
Pretoria, Gauteng, 0002, South Africa
AES - DRS - Synexus - Stanza Clinical Research Centre
Pretoria, Gauteng, 0184, South Africa
AES - DRS - Synexus Watermeyer Clinical Research Centre
Pretoria, Gauteng, 0184, South Africa
Aliwal Shoal Medical Center
eMkhomazi, KwaZulu-Natal, 4170, South Africa
AES - DRS - Synexus - Helderberg Clinical Research Centre
Somerset West, Western Cape, 7130, South Africa
Yonsei University Wonju Severance Christian Hospital
Wŏnju, Gangwon-do, 26426, South Korea
Inha University Hospital
Jung-gu, Incheon, 22332, South Korea
Samsung Medical Center - PPDS
Gangnam-gu, Seoul, 06351, South Korea
Ewha Womans University Seoul Hospital
Gangseo-gu, Seoul, 07804, South Korea
Dong-A University Hospital
Busan, 49201, South Korea
Chungnam National University Hospital
Daejeon, 35015, South Korea
Soon Chun Hyang University Hospital Bucheon
Gyeonggi-do, 14584, South Korea
Catholic Kwandong University International St. Mar
Incheon, 22711, South Korea
Severance Hospital Yonsei University Health System
Seoul, 03722, South Korea
Gangnam Severance Hospital, Yonsei University Health System
Seoul, 06273, South Korea
Hallym University Kangnam Sacred Heart Hospital
Seoul, 07441, South Korea
ABS Centelles
Centelles, Barcelona, 08540, Spain
Hospital Son Llatzer
Son Ferriol, Palma de Mallorca, 07198, Spain
Hospital Universitario de La Princesa
Madrid, 28006, Spain
Hospital Universitario La Paz - PPDS
Madrid, 28046, Spain
FISABIO Oftalmología Médica (FOM)
Valencia, 46025, Spain
China Medical University Hospital - PPDS
Taichung, 404, Taiwan
Taichung Veterans General Hospital
Taichung, 40705, Taiwan
Taipei Veterans General Hospital
Taipei, 112, Taiwan
Chang Gung Memorial Hospital, Linkou
Taoyuan, 333, Taiwan
Bristol Royal Infirmary
Bristol, Avon, BS2 8HW, United Kingdom
AES - DRS - NW Consortium Lancashire
Chorley, Lancashire, PR7 7NA, United Kingdom
AES - DRS - Synexus Hexham Clinical Research Centre
Hexham, Northumberland, NE46 1QJ, United Kingdom
Cheadle Hospital
Stoke-on-Trent, Staffordshire, ST10 1NS, United Kingdom
Royal Victoria Infirmary
Newcastle upon Tyne, Tyne and Wear, NE1 4LP, United Kingdom
AES - DRS - Synexus Scotland Clinical Research Centre
Bellshill, ML4 3NJ, United Kingdom
AES - DRS - Synexus Midlands Clinical Research Centre
Birmingham, B15 2SQ, United Kingdom
Layton Medical Centre
Blackpool, FY3 7EN, United Kingdom
AES - DRS - Synexus Wales Clinical Research Centre
Cardiff, CF15 9SS, United Kingdom
AES - DRS - NW Consortium Merseyside
Liverpool, L22 0LG, United Kingdom
AES - DRS - NW Consortium Manchester
Manchester, M15 6SE, United Kingdom
Related Publications (2)
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.
PMID: 38889247DERIVEDWilson 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.
PMID: 38091530DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 9, 2021
First Posted
November 19, 2021
Study Start
November 17, 2021
Primary Completion
July 28, 2025
Study Completion
July 28, 2025
Last Updated
August 19, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share