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

NCT ID: NCT05127434

Last Updated: 2025-08-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

36814 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-17

Study Completion Date

2025-07-28

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Respiratory Syncytial Virus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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mRNA-1345

Single injection of mRNA-1345 on Day 1.

Group Type EXPERIMENTAL

mRNA-1345

Intervention Type DRUG

Sterile liquid for injection

Placebo

Single injection of mRNA-1345 matching-placebo on Day 1.

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

0.9% sodium chloride (normal saline) injection

mRNA-1345 BD

Single injection of mRNA-1345 on BD Day 1.

Group Type EXPERIMENTAL

mRNA-1345

Intervention Type DRUG

Sterile liquid for injection

Interventions

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Placebo

0.9% sodium chloride (normal saline) injection

Intervention Type DRUG

mRNA-1345

Sterile liquid for injection

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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ModernaTX, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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

Birmingham, Alabama, United States

Site Status

Accel Research Site - Achieve - Birmingham

Birmingham, Alabama, United States

Site Status

Lakeview Clinical Research

Guntersville, Alabama, United States

Site Status

AES - DRS - Optimal Research Alabama - Huntsville

Huntsville, Alabama, United States

Site Status

Hope Research Institute LLC - Hunt - PPDS

Hunt, Arizona, United States

Site Status

Hope Research Institute LLC - Hunt - PPDS

Hunt, Arizona, United States

Site Status

Desert Clinical Research, LLC - CCT

Mesa, Arizona, United States

Site Status

Hope Research Institute LLC - Phoenix - Hunt - PPDS

Phoenix, Arizona, United States

Site Status

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

Phoenix, Arizona, United States

Site Status

Synexus Clinical Research US, Inc. - Phoenix Southeast

Phoenix, Arizona, United States

Site Status

Tucson Neuroscience Research - M3 WR

Tucson, Arizona, United States

Site Status

Baptist Health Center for Clinical Research

Little Rock, Arkansas, United States

Site Status

Velocity Clinical Research, Banning

Banning, California, United States

Site Status

Hope Clinical Research, LLC

Canoga Park, California, United States

Site Status

Velocity Clinical Research - Chula Vista - PPDS

Chula Vista, California, United States

Site Status

PPD Virtual - Science 37, Inc

Culver City, California, United States

Site Status

Velocity Clinical Research, San Diego

La Mesa, California, United States

Site Status

PRI, LLC - Los Alamitos - M3 WR

Los Alamitos, California, United States

Site Status

PRI, LLC - Newport Beach - M3 WR

Newport Beach, California, United States

Site Status

FOMAT Medical Research - FOMAT - HyperCore - PPDS

Oxnard, California, United States

Site Status

Reddy Care Medical

Pomona, California, United States

Site Status

Paradigm Clinical Research Institute Inc - ClinEdge - PPDS

Redding, California, United States

Site Status

Medical Center For Clinical Research - M3 WR

San Diego, California, United States

Site Status

Lynn Institute of Denver

Aurora, Colorado, United States

Site Status

Tekton Research - Fort Collins - PPDS

Fort Collins, Colorado, United States

Site Status

Tekton Research - Longmont - PPDS

Longmont, Colorado, United States

Site Status

Paradigm Clinical Research Institute Inc - ClinEdge - PPDS

Wheat Ridge, Colorado, United States

Site Status

Clinical Research Consultants LLC - ClinEdge - PPDS

Milford, Connecticut, United States

Site Status

Washington Health Institute

Washington D.C., District of Columbia, United States

Site Status

Velocity Clinical Research, New Smyrna Beach

Edgewater, Florida, United States

Site Status

Fleming Island Clinical Research Center

Fleming Island, Florida, United States

Site Status

Velocity Clinical Research - Hallandale Beach - PPDS

Hallandale, Florida, United States

Site Status

Jacksonville Center for Clinical Research

Jacksonville, Florida, United States

Site Status

Multi-Specialty Research Associates, Inc. M3 WR

Lake City, Florida, United States

Site Status

Accel Research Sites - Maitland - ERN - PPDS

Maitland, Florida, United States

Site Status

Spotlight Research Center, LLC

Miami, Florida, United States

Site Status

IMA Clinical Research - Manhattan - PPDS

Miami Beach, Florida, United States

Site Status

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

Orlando, Florida, United States

Site Status

Health Awareness Inc

Port Saint Lucie, Florida, United States

Site Status

IMA Clinical Research - Saint Petersburg - PPDS

St. Petersburg, Florida, United States

Site Status

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

St. Petersburg, Florida, United States

Site Status

Clinical Trials of Tampa

Tampa, Florida, United States

Site Status

Palm Beach Research - ClinEdge - PPDS

West Palm Beach, Florida, United States

Site Status

Clinical Site Partners - Winter Park - HyperCore -PPDS

Winter Park, Florida, United States

Site Status

Mount Vernon Clinical Research, LLC - M3 WR

Atlanta, Georgia, United States

Site Status

Masters of Clinical Research Inc

Augusta, Georgia, United States

Site Status

Centricity Research - Roswell - HyperCore - PPDS

Columbus, Georgia, United States

Site Status

iResearch Atlanta

Decatur, Georgia, United States

Site Status

Javara, Inc./Privia Medical Group Georgia, LLC

Fayetteville, Georgia, United States

Site Status

Drug Studies America - ClinEdge - PPDS

Marietta, Georgia, United States

Site Status

Randomize Now -Commerce Dr

Peachtree City, Georgia, United States

Site Status

Velocity Clinical Research (Savannah - Georgia) - PPDS

Savannah, Georgia, United States

Site Status

Clinical Research Atlanta - ERN-PPDS

Stockbridge, Georgia, United States

Site Status

East West Medical Research Institute

Honolulu, Hawaii, United States

Site Status

Velocity Clinical Research - Boise - PPDS

Meridian, Idaho, United States

Site Status

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

Chicago, Illinois, United States

Site Status

Affinity Health (Oak Brook)

Oak Brook, Illinois, United States

Site Status

DM Clinical - Chicago

River Forest, Illinois, United States

Site Status

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

Evansville, Indiana, United States

Site Status

Velocity Clinical Research - Valparaiso - PPDS

Valparaiso, Indiana, United States

Site Status

Johnson County Clin-Trials

Lenexa, Kansas, United States

Site Status

Versailles Family Medicine - CCT - PPDS

Versailles, Kentucky, United States

Site Status

Velocity Clinical Research (Baton Rouge - Louisiana) - PPDS

Baton Rouge, Louisiana, United States

Site Status

Benchmark Research - Covington - HyperCore - PPDS

Covington, Louisiana, United States

Site Status

Benchmark Research - Metairie - HyperCore - PPDS

Metairie, Louisiana, United States

Site Status

IMA Clinical Research - Monroe, LA - PPDS

Monroe, Louisiana, United States

Site Status

DelRicht Clinical Research, LLC - Internal - Covington - PPDS

New Orleans, Louisiana, United States

Site Status

Privia Medical Group, LLC - Annapolis - Javara - PPDS

Annapolis, Maryland, United States

Site Status

CBH Health - CenExel CBH - PPDS

Gaithersburg, Maryland, United States

Site Status

Velocity Clinical Research (Rockville - Maryland) - PPDS

Rockville, Maryland, United States

Site Status

Great Lakes Research Institute

Southfield, Michigan, United States

Site Status

DM Clinical Research - Southfield - ERN - PPDS

Southfield, Michigan, United States

Site Status

Clinical Research Institute, Inc - CRN - PPDS

Minneapolis, Minnesota, United States

Site Status

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

Richfield, Minnesota, United States

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

Creve Coeur, Missouri, United States

Site Status

Montana Medical Research

Missoula, Montana, United States

Site Status

Boeson Research MSO - Missoula - ERN - PPDS

Missoula, Montana, United States

Site Status

Skyline Medical Center, PC - CCT Research

Elkhorn, Nebraska, United States

Site Status

Methodist Physicians Clinic - CCT Research - PPDS

Fremont, Nebraska, United States

Site Status

Velocity Clinical Research (Grand Island - Nebraska) - PPDS

Grand Island, Nebraska, United States

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Velocity Clinical Research (Lincoln - Nebraska) - PPDS

Lincoln, Nebraska, United States

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Velocity Clinical Research (Omaha - Nebraska) - PPDS

Omaha, Nebraska, United States

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CCT Research

Papillion, Nebraska, United States

Site Status

HEALOR Primary Care - Physicians Las Vegas - CCT

Las Vegas, Nevada, United States

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Excel Clinical Research - Las Vegas

Las Vegas, Nevada, United States

Site Status

IMA Clinical Research - Raritan - PPDS

Raritan, New Jersey, United States

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Riverside Medical Group - Circuit - PPDS

Secaucus, New Jersey, United States

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Velocity Clinical Research - East Syracuse - PPDS

East Syracuse, New York, United States

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Velocity Clinical Research (Endwell - New York) - PPDS

Endwell, New York, United States

Site Status

Drug Trials America

Hartsdale, New York, United States

Site Status

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

New York, New York, United States

Site Status

Rochester Clinical Research, Inc

Rochester, New York, United States

Site Status

Carolina Institute for Clinical Research - M3 WR

Fayetteville, North Carolina, United States

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Triad Clinical Trials

Greensboro, North Carolina, United States

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Trial Management Associates, LLC

Wilmington, North Carolina, United States

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CTI Clinical Research

Cincinnati, Ohio, United States

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Velocity Clinical Research (Cincinnati - Ohio) - PPDS

Cincinnati, Ohio, United States

Site Status

Velocity Clinical Research - Cincinnati - PPDS

Cincinnati, Ohio, United States

Site Status

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

Cincinnati, Ohio, United States

Site Status

Tekton Research - Oklahoma - PPDS

Edmond, Oklahoma, United States

Site Status

Tekton Research

Yukon, Oklahoma, United States

Site Status

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

Portland, Oregon, United States

Site Status

Hatboro Medical Associates - CCT - PPDS

Hatboro, Pennsylvania, United States

Site Status

DM Clinical Research - Philadelphia - ERN - PPDS

Philadelphia, Pennsylvania, United States

Site Status

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

Dakota Dunes, South Dakota, United States

Site Status

American Indian Clinical Trials Research Network

Rapid City, South Dakota, United States

Site Status

Affinity Health - Nashville

Nashville, Tennessee, United States

Site Status

Premier Family Physicians - Austin - Hunt - PPDS

Austin, Texas, United States

Site Status

Tekton Research

Austin, Texas, United States

Site Status

PanAmerican Clinical Research LLC

Brownsville, Texas, United States

Site Status

ACRC Trials - Carrollton - Hunt - PPDS

Carrollton, Texas, United States

Site Status

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

Fort Worth, Texas, United States

Site Status

Allure Health LLC

Friendswood, Texas, United States

Site Status

Olympus Family Medicine- CCT

Friendswood, Texas, United States

Site Status

Village Health Partners Frisco Medical Village

Frisco, Texas, United States

Site Status

West Houston Clinical Research - Hunt - PPDS

Houston, Texas, United States

Site Status

DM Clinical Research - Bellaire - ERN - PPDS

Houston, Texas, United States

Site Status

DM Clinical-TCDD

Humble, Texas, United States

Site Status

Helios CR, Inc. - Houston - PPDS

Keller, Texas, United States

Site Status

AIM Trials

Plano, Texas, United States

Site Status

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

San Antonio, Texas, United States

Site Status

Clinical Trials of Texas, LLC - HyperCore - PPDS

San Antonio, Texas, United States

Site Status

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

Stephenville, Texas, United States

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DM Clinical Research - Sugarland - ERN - PPDS

Sugar Land, Texas, United States

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DM Clinical Research - ERN - PPDS

Tomball, Texas, United States

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DM Clinical Research - ERN

Tomball, Texas, United States

Site Status

Cope Family Medicine - CCT - PPDS

Bountiful, Utah, United States

Site Status

Alpine Research Organization, Inc

Clinton, Utah, United States

Site Status

South Ogden Family Medicine - CCT

South Ogden, Utah, United States

Site Status

Health Research of Hampton Roads Inc.

Newport News, Virginia, United States

Site Status

Velocity Clinical Research - Family Practice - Portsmouth - PPDS

Portsmouth, Virginia, United States

Site Status

Rainier Clinical Research Center

Renton, Washington, United States

Site Status

Seattle Clinical Research Center

Seattle, Washington, United States

Site Status

Instituto Medico Platense

Buenos Aires, Provincial de Buenos Aires, Argentina

Site Status

Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich

Ciudad Autónoma de BuenosAires, , Argentina

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Fundación Dr. Mario Socolinsky - Centro de Vacunación Proteger

Ciudad Autónoma de BuenosAires, , Argentina

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Centro Medico Barrio Parque

Ciudad Autónoma de BuenosAires, , Argentina

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Consultorios Médicos Dr. Doreski

Ciudad Autónoma de BuenosAires, , Argentina

Site Status

Paratus Clinical Research - Canberra - PPDS

Bruce, Australian Capital Territory, Australia

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Paratus Clinical Research - Western Sydney - PPDS

Blacktown, New South Wales, Australia

Site Status

Northern Beaches Clinical Research

Brookvale, New South Wales, Australia

Site Status

Northside Health

Coffs Harbour, New South Wales, Australia

Site Status

Holdsworth House Medical Brisbane

Fortitude Valley, Queensland, Australia

Site Status

Emeritus Research - PPDS

Camberwell, Victoria, Australia

Site Status

JHU-Projahnmo Zakiganj site

Zakiganj, Sylhet Division, Bangladesh

Site Status

icddr,b Matlab Health Research Center

Chāndpur, , Bangladesh

Site Status

Icddr,b Kamalapur Field Site

Dhaka, , Bangladesh

Site Status

JHU-Projahnmo Sylhet site

Sylhet, , Bangladesh

Site Status

ANIMA Research Center

Diepenbeek, , Belgium

Site Status

Vaccinopolis

Edegem, , Belgium

Site Status

Private Practice Dr Jean Benoit Martinot

Erpent, , Belgium

Site Status

Ziekenhuis Oost-Limburg

Genk, , Belgium

Site Status

CARe Clinic

Red Deer, Alberta, Canada

Site Status

Okanagan Clinical Trials - Headlands - PPDS

Kelowna, British Columbia, Canada

Site Status

Centricity Research - Toronto - HyperCore - PPDS

Etobicoke, Ontario, Canada

Site Status

Dr. Steven Z. Zizzo Medicine Professional Corporation

Hamilton, Ontario, Canada

Site Status

LMC Clinical Research Inc (Bayview)

Toronto, Ontario, Canada

Site Status

Centricity Research - Quebec - HyperCore - PPDS

Lévis, Quebec, Canada

Site Status

Diex Recherche - Joilette - PPDS

Saint-Charles-Borromée, Quebec, Canada

Site Status

Diex Recherche - Sherbrooke - PPDS

Sherbrooke, Quebec, Canada

Site Status

Diex Recherche - Trois Rivieres - PPDS

Trois-Rivières, Quebec, Canada

Site Status

Diex Recherche - Québec - PPDS

Québec, , Canada

Site Status

Hospital Base de Osorno

Osorno, Los Lagos Region, Chile

Site Status

Centro de Investigacion del Maule

Talca, Maule Region, Chile

Site Status

Centro Respiratorio Integral LTDA. (CENRESIN)

Quillota, Región de Valparaíso, Chile

Site Status

Biomedica Research Group

Santiago, Santiago Metropolitan, Chile

Site Status

BIOCINETIC SpA

Santiago, Santiago Metropolitan, Chile

Site Status

Institucion Clinica de la Costa SAS

Barranquilla, Atlántico, Colombia

Site Status

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

Aguazul, Casanare Department, Colombia

Site Status

Solano & Terront Servicios Médicos LTDA (UNIENDO) Bogota

Bogota, Cundinamarca, Colombia

Site Status

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

Bogota, Cundinamarca, Colombia

Site Status

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

Chía, Cundinamarca, Colombia

Site Status

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

Girardot City, Cundinamarca, Colombia

Site Status

IPS Centro de Investigacion Clinicas Cardiomet

Pereira, Risaralda Department, Colombia

Site Status

Fundacion Oftalmologica de Santander Foscal

Floridablanca, Santandar, Colombia

Site Status

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

Ibagué, Tolima Department, Colombia

Site Status

Centro Medico Imbanaco de Cali S.A.

Cali, Valle de Cuaca, Colombia

Site Status

Campus Universidad EARTH, finca La Flor

Liberia, Guanacaste Province, Costa Rica

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Instituto de Investigación en Ciencias Médicas S.A.

San José, , Costa Rica

Site Status

Hospital CIMA San Jose

San José, , Costa Rica

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Hospital Clínica Bíblica Sede Santa Ana

San José, , Costa Rica

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Espoo Vaccine Research Clinic

Espoo, , Finland

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Helsinki South Vaccine Research Clinic

Helsinki, , Finland

Site Status

Helsinki East Vaccine Research Clinic

Helsinki, , Finland

Site Status

Järvenpää Vaccine Research Clinic

Järvenpää, , Finland

Site Status

KokkolaVaccine Research Clinic

Kokkola, , Finland

Site Status

Oulu Vaccine Research Clinic

Oulu, , Finland

Site Status

Pori Vaccine Research Clinic

Pori, , Finland

Site Status

Seinäjoki Vaccine Research Clinic

Seinäjoki, , Finland

Site Status

Tampere Vaccine Research Clinic

Tampere, , Finland

Site Status

Turku Vaccine Research Clinic

Turku, , Finland

Site Status

AES - DRS - Synexus Frankfurt Research Centre

Frankfurt am Main, Hesse, Germany

Site Status

Infektioresearch GmbH & Co. KG

Frankfurt am Main, Hesse, Germany

Site Status

Klinische Forschung Hannover-Mitte GmbH

Hanover, Lower Saxony, Germany

Site Status

Klinische Forschung, Schwerin GmbH (KFGN)

Schwerin, Mecklenburg-West Pomerania, Germany

Site Status

Medizentrum Essen Borbeck

Essen, North Rhine-Westphalia, Germany

Site Status

AES - DRS - Synexus Berlin Research Centre

Berlin, , Germany

Site Status

Fukui General Clinic

Fukui-shi, Fukui, Japan

Site Status

Tenjin Sogo Clinic

Fukuoka, Fukuoka, Japan

Site Status

Boocs Clinic Fukuoka

Hakata-ku, Fukuoka, Japan

Site Status

Motomachi Takatsuka Naika Clinic

Naka-ku, Yokohama-ku, Kanagawa, Japan

Site Status

Medical Corporation Asbo Tokyo Asbo Clinic

Chuo-ku, Tokyo, Japan

Site Status

Center Hospital of the National Center for Global Health and Medicine

Shinjuku-ku, Tokyo, Japan

Site Status

Higashi Shinjuku Clinic

Shinjuku-ku, Tokyo, Japan

Site Status

NewHeart Watanabe Institute

Suginami-ku, Tokyo, Japan

Site Status

Sekino Hospital

Toshima-ku, Tokyo, Japan

Site Status

SOUSEIKAI PS Clinic

Fukuoka, , Japan

Site Status

AES - AS - RM Pharma Specialists Mexico City

Ciudad de Mexcio, Ciudad de Mexcio, Mexico

Site Status

AES - AS - CEMDEC Mexico City

Ciudad de Mexcio, Ciudad de Mexcio, Mexico

Site Status

Maria del rayo morfin otero

Guadalajara, Jalisco, Mexico

Site Status

Accelerium, S. de R.L. de C.V.

Monterrey, Nuevo León, Mexico

Site Status

Investigacion en Salud y Metabolismo S.C.

Chihuahua City, , Mexico

Site Status

Hospital General 450

Durango, , Mexico

Site Status

PanAmerican Clinical Research-Avenida

Querétaro, , Mexico

Site Status

Southern Clinical Trials Limited

Christchurch, Canterbury, New Zealand

Site Status

Lakeland Clinical Trials

Rotorua, Canterbury, New Zealand

Site Status

Southern Clinical Trials Waitemata

Auckland, , New Zealand

Site Status

New Zealand Clinical Research - Auckland

Auckland, , New Zealand

Site Status

Optimal Clinical Trials Ltd

Auckland, , New Zealand

Site Status

Southern Clinical Trials - Tasman

Nelson, , New Zealand

Site Status

CEVAXIN Avenida México

Panama City, Calidonia, Panama

Site Status

CEVAXIN 24 de diciembre

Panama City, , Panama

Site Status

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

Poznan, Greater Poland Voivodeship, Poland

Site Status

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

Wroclaw, Lower Silesian Voivodeship, Poland

Site Status

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

Warsaw, Masovian Voivodeship, Poland

Site Status

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

Gdansk, Pomeranian Voivodeship, Poland

Site Status

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

Katowice, Silesian Voivodeship, Poland

Site Status

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

Ostrowiec Świętokrzyski, Świętokrzyskie Voivodeship, Poland

Site Status

BRCR Global Puerto Rico (Ponce)

Ponce, , Puerto Rico

Site Status

Caribbean Medical Research Center

San Juan, , Puerto Rico

Site Status

Proyecto ACTU

San Juan, , Puerto Rico

Site Status

Singapore General Hospital (SGH)

Singapore, , Singapore

Site Status

Worthwhile Clinical Trials

Benoni, Gauteng, South Africa

Site Status

Dr. J Breedt

Pretoria, Gauteng, South Africa

Site Status

AES - DRS - Synexus - Stanza Clinical Research Centre

Pretoria, Gauteng, South Africa

Site Status

AES - DRS - Synexus Watermeyer Clinical Research Centre

Pretoria, Gauteng, South Africa

Site Status

Aliwal Shoal Medical Center

eMkhomazi, KwaZulu-Natal, South Africa

Site Status

AES - DRS - Synexus - Helderberg Clinical Research Centre

Somerset West, Western Cape, South Africa

Site Status

Yonsei University Wonju Severance Christian Hospital

Wŏnju, Gangwon-do, South Korea

Site Status

Inha University Hospital

Jung-gu, Incheon, South Korea

Site Status

Samsung Medical Center - PPDS

Gangnam-gu, Seoul, South Korea

Site Status

Ewha Womans University Seoul Hospital

Gangseo-gu, Seoul, South Korea

Site Status

Dong-A University Hospital

Busan, , South Korea

Site Status

Chungnam National University Hospital

Daejeon, , South Korea

Site Status

Soon Chun Hyang University Hospital Bucheon

Gyeonggi-do, , South Korea

Site Status

Catholic Kwandong University International St. Mar

Incheon, , South Korea

Site Status

Severance Hospital Yonsei University Health System

Seoul, , South Korea

Site Status

Gangnam Severance Hospital, Yonsei University Health System

Seoul, , South Korea

Site Status

Hallym University Kangnam Sacred Heart Hospital

Seoul, , South Korea

Site Status

ABS Centelles

Centelles, Barcelona, Spain

Site Status

Hospital Son Llatzer

Son Ferriol, Palma de Mallorca, Spain

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Hospital Universitario de La Princesa

Madrid, , Spain

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Hospital Universitario La Paz - PPDS

Madrid, , Spain

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FISABIO Oftalmología Médica (FOM)

Valencia, , Spain

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China Medical University Hospital - PPDS

Taichung, , Taiwan

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Taichung Veterans General Hospital

Taichung, , Taiwan

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Taipei Veterans General Hospital

Taipei, , Taiwan

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Chang Gung Memorial Hospital, Linkou

Taoyuan, , Taiwan

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Bristol Royal Infirmary

Bristol, Avon, United Kingdom

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AES - DRS - NW Consortium Lancashire

Chorley, Lancashire, United Kingdom

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AES - DRS - Synexus Hexham Clinical Research Centre

Hexham, Northumberland, United Kingdom

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Cheadle Hospital

Stoke-on-Trent, Staffordshire, United Kingdom

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Royal Victoria Infirmary

Newcastle upon Tyne, Tyne and Wear, United Kingdom

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AES - DRS - Synexus Scotland Clinical Research Centre

Bellshill, , United Kingdom

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AES - DRS - Synexus Midlands Clinical Research Centre

Birmingham, , United Kingdom

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Layton Medical Centre

Blackpool, , United Kingdom

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AES - DRS - Synexus Wales Clinical Research Centre

Cardiff, , United Kingdom

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AES - DRS - NW Consortium Merseyside

Liverpool, , United Kingdom

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AES - DRS - NW Consortium Manchester

Manchester, , United Kingdom

Site Status

Countries

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United States Argentina Australia Bangladesh Belgium Canada Chile Colombia Costa Rica Finland Germany Japan Mexico New Zealand Panama Poland Puerto Rico Singapore South Africa South Korea Spain Taiwan United Kingdom

References

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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.

Reference Type DERIVED
PMID: 38889247 (View on PubMed)

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.

Reference Type DERIVED
PMID: 38091530 (View on PubMed)

Other Identifiers

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2021-005026-20

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

mRNA-1345-P301

Identifier Type: -

Identifier Source: org_study_id

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