Back to resultsA Study to Evaluate the Safety and Efficacy of mRNA-1345 Vaccine Targeting Respiratory Syncytial Virus (RSV) in Adults ≥60 Years of Age
Primary Purpose
Respiratory Syncytial Virus
Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Placebo
mRNA-1345
Sponsored by
About this trial
This is an interventional prevention trial for Respiratory Syncytial Virus focused on measuring Viral Diseases, Messenger RNA, Moderna, mRNA-1345, Respiratory syncytial virus, Safety, Vaccines
Eligibility Criteria
Key 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 (specifically chronic heart failure [CHF] and chronic obstructive pulmonary disease [COPD]), but should be medically stable as assessed by the following criteria: absence of changes in medical therapy within 1 month due to treatment failure or toxicity; absence of medical events qualifying as SAEs within 1 month of the planned study injection on Day 1; and absence of known, current, and life-limiting diagnoses, which could continue for the duration of the primary efficacy period (12 months from study injection on Day 1) and which, in the opinion of the investigator, would make completion of the protocol unlikely.
- Body mass index from ≥18 kilograms (kg)/square meter (m^2) to ≤35 kg/m^2.
Key Exclusion Criteria:
- Participation in another clinical research study where participant has received an investigational product (drug/biologic/device) within 45 days before the planned date of the Day 1 vaccination.
- Prior participation in research involving receipt of any investigational RSV product (drug/biologic/device).
- 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. The exceptions are seasonal influenza vaccines, pneumococcal vaccines, or authorized or approved vaccines for the prevention of COVID-19 (regardless of type of vaccine), which are not permitted within 14 days before or after the Day 1 study injection. Efforts should be made to space study injection and COVID-19 vaccination by at least 7 and preferably 14 days, but COVID-19 vaccination should not be delayed.
Other inclusion and/or exclusion criteria may apply.
Sites / Locations
- Synexus Clinical Research US, Inc. - Birmingham
- Accel Research Site - Achieve - Birmingham
- Lakeview Clinical Research
- AES - DRS - Optimal Research Alabama - Huntsville
- Hope Research Institute LLC - Hunt - PPDS
- Hope Research Institute LLC - Hunt - PPDS
- Desert Clinical Research, LLC - CCT
- Hope Research Institute LLC - Phoenix - Hunt - PPDS
- Synexus Clinical Research US, Inc. - Phoenix Central
- Synexus Clinical Research US, Inc. - Phoenix Southeast
- Tucson Neuroscience Research
- Baptist Health Center for Clinical Research
- Velocity Clinical Research, Banning
- Hope Clinical Research, LLC
- PPD Virtual - Science 37, Inc
- Paradigm Research
- Velocity Clinical Research, San Diego
- Wr-Pri, Llc
- Wr-Pri, Llc
- FOMAT Medical Research - FOMAT - HyperCore - PPDS
- Reddy Care Medical
- Paradigm Clinical Research Institute Inc - ClinEdge - PPDS
- Wr-McCr, Llc
- Medical Center For Clinical Research - M3 WR
- Lynn Institute of Denver
- Tekton Research
- Tekton Research - Longmont - PPDS
- Paradigm Clinical Research Institute Inc - ClinEdge - PPDS
- Clinical Research Consultants LLC - ClinEdge - PPDS
- Washington Health Institute
- Velocity Clinical Research, New Smyrna Beach
- Fleming Island Clinical Research Center
- Velocity Clinical Research - Hallandale Beach - PPDS
- Jacksonville Center for Clinical Research
- ARS- Maitland
- Spotlight Research Center, LLC
- AES - DRS - Synexus Clinical Research US, Inc. - The Villages
- Flourish Research - Orlando - PPDS
- Health Awareness Inc
- IMA Clinical Research - Saint Petersburg - PPDS
- AES - DRS - Synexus Clinical Research US, Inc. - St. Petersburg
- Clinical Trials of Tampa
- Palm Beach Research - ClinEdge - PPDS
- Clinical Site Partners - Winter Park - HyperCore -PPDS
- Masters of Clinical Research Inc
- IACT Health - Roswell - IACT - HyperCore - PPDS
- iResearch Atlanta
- Javara, Inc./Privia Medical Group Georgia, LLC
- Drug Studies America - ClinEdge - PPDS
- Randomize Now -Commerce Dr
- Centricity Research - Roswell - HyperCore - PPDS
- WR-Mount Vernon Clinical Research, LLC
- Meridian Clinical Research- Savannah, GA
- Clinical Research Atlanta - ERN-PPDS
- East West Medical Research Institute
- AES - DRS - Synexus Clinical Research US, Inc. - Chicago
- Affinity Health (Oak Brook)
- DM Clinical - Chicago
- AES - DRS - Synexus Clinical Research US, Inc. - Evansville
- Velocity Clinical Research - Valparaiso - PPDS
- Meridian Clinical Research - Sioux City
- Johnson County Clin-Trials
- Versailles Family Medicine - CCT - PPDS
- Meridian Clinical Research (Baton Rouge - Louisiana) - PPDS
- Benchmark Research - Covington - HyperCore - PPDS
- Benchmark Research - Metairie - HyperCore - PPDS
- Clinical Trials of America (LA)
- DelRicht Clinical Research, LLC - Internal - Covington - PPDS
- Javara, Inc./Privia Medical Group, LLC
- CBH Health - CenExel CBH - PPDS
- Meridian Clinical Research- Rockville, MD
- Great Lakes Research Institute
- DM Clinical Research - Southfield - ERN - PPDS
- Clinical Research Institute, Inc - CRN - PPDS
- AES - DRS - Synexus Clinical Research US, Inc. - Minneapolis
- AES - DRS - Synexus Clinical Research US, Inc. - St. Louis
- Montana Medical Research
- Boeson Research MSO - Missoula - ERN - PPDS
- Skyline Medical Center, PC - CCT Research
- Methodist Physicians Clinic - CCT Research - PPDS
- Meridian Clinical Research- Grand Island, NE
- Meridian Clinical Research- Lincoln, NE
- Meridian Clinical Research- Omaha, NE
- CCT Research
- HEALOR Primary Care - Physicians Las Vegas - CCT
- Excel Clinical Research - Las Vegas
- IMA Clinical Research - Raritan - PPDS
- Riverside Medical Group - Circuit - PPDS
- Velocity Clinical Research - East Syracuse - PPDS
- Meridian Clinical Research- Endwell, NY
- Drug Trials America
- AES - DRS - Synexus Clinical Research US, Inc. - New York
- Rochester Clinical Research, Inc
- Carolina Institute for Clinical Research - M3 WR
- Carolina Institute for Clinical Research
- Triad Clinical Trials
- Trial Management Associates, LLC
- CTI Clinical Research
- Meridian Clinical Research
- Velocity Clinical Research - Cincinnati - PPDS
- AES - DRS - Synexus Clinical Research US, Inc. - Cincinnati
- Tekton Research
- Tekton Research
- Summit Research Network, Inc. - Portland - Headlands - PPDS
- Hatboro Medical Associates - CCT - PPDS
- DM Clinical Research - Philadelphia - ERN - PPDS
- American Indian Clinical Trials Research Network
- Affinity Health - Nashville
- Premier Family Physicians - Austin - Hunt - PPDS
- Tekton Research
- PanAmerican Clinical Research LLC
- North Texas Family Medicine - Plano - Hunt - PPDS
- Javara, Inc./Texas Health Care, PLLC (d/b/a/ Privia Medical Group - North Texas)
- Allure Health LLC
- Mt. Olympus Medical Research
- Village Health Partners Frisco Medical Village
- West Houston Clinical Research - Hunt - PPDS
- DM Clinical-TCDD
- DM Clinical - Humble
- ACRC Trials - Hunt - PPDS
- AIM Trials
- AES - DRS - Synexus Clinical Research US, Inc. - San Antonio
- Clinical Trials of Texas, LLC - HyperCore - PPDS
- Flourish Research - San Antonio - PPDS
- DM Clinical Research - Sugarland - ERN - PPDS
- DM Clinical - Tomball
- Cope Family Medicine - CCT - PPDS
- Alpine Research Organization, Inc
- Olympus Family Medicine- CCT
- South Ogden Family Medicine - CCT
- Health Research of Hampton Roads Inc.
- Meridian Clinical Research - Family Practice - Portsmouth - PPDS
- Meridian Clinical Research- Portsmouth, VA
- Rainier Clinical Research Center
- Seattle Clinical Research Center
- Fundación Socolinsky Centro de Vacunación Proteger
- Instituto Medico Platense
- Swiss Medical Center Barrio Parque
- Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich
- Consultorios Médicos Dr. Doreski
- Paratus Clinical Research - Canberra - PPDS
- Paratus Clinical Research - Western Sydney - PPDS
- Northern Beaches Clinical Research
- Northside Health
- Holdsworth House Medical Brisbane
- Emeritus Research - PPDS
- icddr,b Matlab Health Research Center
- Icddr,b Kamalapur
- JHU-Projahnmo Sylhet site
- JHU-Projahnmo Zakiganj site
- ANIMA Research Center
- Ziekenhuis Oost-Limburg
- VAXINFECTIO University of Antwerp - Center for the Evaluation of Vaccination - PPDS
- Private Practice Dr Jean Benoit Martinot
- CARe Clinic
- Okanagan Clinical Trials - Headlands - PPDS
- Dr. Steven Z. Zizzo Medicine Professional Corporation
- Centricity Research - Bayview - HyperCore - PPDS
- Centricity Research - Toronto - HyperCore - PPDS
- Diex Recherche - Sherbrooke - PPDS
- Diex Recherche - Joilette - PPDS
- Diex Recherche - Québec - PPDS
- Centricity Research - Quebec - HyperCore - PPDS
- Diex Recherche - Trois Rivieres - PPDS
- Hospital Base de Osorno
- Centro Respiratorio Integral LTDA. (CENRESIN)
- BIOCINETIC SpA
- Centro de Investigacion del Maule
- Biomedica Research Group
- Centro de Atención e Investigación Médica S.A. - CAIMED - Aguazul
- Clinica de la Costa Ltda - PPDS
- Centro de Atención e Investigación Médica S.A. - CAIMED - Bogota
- Solano & Terront Servicios Médicos LTDA (UNIENDO) Bogota
- Centro de Atención e Investigación Médica S.A. - CAIMED - Chia
- Centro de Atención e Investigación Médica S.A. - CAIMED - Girardot
- Fundacion Oftalmologica de Santander Foscal
- Centro de Atención e Investigación Médica S.A. - CAIMED - Ibague
- IPS Centro de Investigacion Clinicas Cardiomet
- Centro Medico Imbanaco de Cali S.A.
- Consultorio Medico La Flor
- Hospital Clínica Bíblica Sede Santa Ana
- Hospital CIMA San Jose
- Instituto de Investigación en Ciencias Médicas S.A.
- FVR/Seinäjoen Rokotetutkimusklinikka
- FVR/Kokkolan Rokotetutkimusklinikka
- FVR/Tampereen Rokotetutkimusklinikka
- FVR/Oulun Rokotetutkimusklinikka
- FVR/Porin Rokotetutkimusklinikka
- FVR/Espoon Rokotetutkimusklinikka
- FVR/Etelä Helsingin Rokotetutkimusklinikka
- FVR/Itä Helsingin Rokotetutkimusklinikka
- FVR/Järvenpään Rokotetutkimusklinikka
- FVR/Turun Rokotetutkimusklinikka
- Klinische Forschung, Schwerin GmbH (KFGN)
- Klinische Forschung Hannover-Mitte GmbH
- Medizentrum Essen Borbeck
- AES - DRS - Synexus Berlin Research Centre
- AES - DRS - Synexus Frankfurt Research Centre
- Infektioresearch GmbH & Co. KG
- Fukui General Hospital
- Boocs Clinic Fukuoka
- SOUSEIKAI PS Clinic
- Tenjin Sogo Clinic
- Higashi Shinjuku Clinic
- Center Hospital of the National Center for Global Health and Medicine
- NewHeart Watanabe Institute
- Medical Corporation Asbo Tokyo Asbo Clinic
- Sekino Hospital
- Institute Medical Corporation Hitomikai Motomachi Takatsuka Naika Clinic
- Soon Chun Hyang University Hospital Bucheon
- Dong-A University Hospital
- Chungnam National University Hospital
- Inha University Hospital
- Catholic Kwandong University International St. Mar
- Samsung Medical Center - PPDS
- Ewha Womans University Seoul Hospital
- Gangnam Severance Hospital, Yonsei University Health System
- Hallym University Kangnam Sacred Heart Hospital
- Yonsei University Wonju Severance Christian Hospital
- Investigacion en Salud y Metabolismo S.C.
- AES - AS - RM Pharma Specialists Mexico City
- Accelerium, S. de R.L. de C.V.
- Hospital General 450
- AES - AS - CEMDEC Mexico City
- Maria del rayo morfin otero
- PanAmerican Clinical Research-Avenida Paseo de la República 13020
- Southern Clinical Trials Waitemata
- New Zealand Clinical Research - Auckland
- Optimal Clinical Trials Ltd
- Southern Clinical Trials Limited
- Southern Clinical Trials - Tasman
- Lakeland Clinical Trials
- CEVAXIN 24 de diciembre
- CEVAXIN Avenida México
- AES - DRS - Synexus Polska Sp. z o.o. Oddzial we Wroclawiu
- AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Poznaniu
- AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Warszawie
- AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Gdansku
- AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Katowicach
- Ostrowieckie Centrum Medyczne Spólka Cywilna Anna Olech-Cudzik, Krzysztof Cudzik
- BRCR Global Puerto Rico (Ponce)
- Caribbean Medical Research Center
- Puerto Rico AIDS Clinical Trials Unit - (CRS)
- Singapore General Hospital (SGH)
- Dr. J Breedt
- AES - DRS - Synexus Watermeyer Clinical Research Centre
- AES - DRS - Synexus - Stanza Clinical Research Centre
- Aliwal Shoal Medical Center
- AES - DRS - Synexus - Helderberg Clinical Research Centre
- Worthwhile Clinical Trials
- ABS Centelles
- Hospital Son Llatzer
- Hospital Universitario La Paz - PPDS
- Hospital Universitario de La Princesa
- FISABIO Oftalmología Médica (FOM)
- China Medical University Hospital - PPDS
- Taichung Veterans General Hospital
- Taipei Veterans General Hospital
- Chang Gung Memorial Hospital, Linkou
- Bristol Royal Infirmary
- AES - DRS - Synexus Scotland Clinical Research Centre
- Layton Medical Centre
- AES - DRS - NW Consortium Lancashire
- AES - DRS - NW Consortium Merseyside
- AES - DRS - Synexus Hexham Clinical Research Centre
- Royal Victoria Infirmary
- Cheadle Hospital
- AES - DRS - Synexus Midlands Clinical Research Centre
- AES - DRS - Synexus Wales Clinical Research Centre
- AES - DRS - NW Consortium Manchester
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
mRNA-1345
Placebo
Arm Description
Single injection of mRNA-1345 on Day 1.
Single injection of mRNA-1345 matching-placebo on Day 1.
Outcomes
Primary Outcome Measures
Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs) up to 7 Days Postinjection
Number of Participants with Unsolicited Adverse Events (AEs) up to 28 Days Postinjection
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 24 Months Postinjection
Vaccine Efficacy (VE) of mRNA-1345 to Prevent a First Episode of RSV-LRTD with 2 or More Symptoms within the Period of 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).
VE of mRNA-1345 to Prevent a First Episode of RSV-LRTD with 3 or More Symptoms within the Period of 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).
Secondary Outcome Measures
VE of mRNA-1345 to Prevent a First Episode of RSV-Associated Acute Respiratory Disease (RSV-ARD) within the Period of 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).
VE of mRNA-1345 to Prevent First Hospitalization Associated with RSV-ARD or RSV-LRTD within the Period of 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).
Geometric Mean Titer (GMT) of Serum RSV Neutralizing Antibodies (Abs)
Geometric Mean Concentration (GMC) of Serum RSV Binding Abs
Seroresponse Rate in RSV Neutralizing Abs
Geometric Mean Fold-Rise of Postbaseline/Baseline Ab Titers
Proportion of Participants with ≥4-fold Increases in Ab Titers from Baseline
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05127434
Brief Title
A Study to Evaluate the Safety and Efficacy of mRNA-1345 Vaccine Targeting Respiratory Syncytial Virus (RSV) in Adults ≥60 Years of Age
Official Title
A Phase 2/3, Randomized, Observer-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of mRNA-1345, an mRNA Vaccine Targeting Respiratory Syncytial Virus (RSV), in Adults ≥60 Years of Age
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 17, 2021 (Actual)
Primary Completion Date
August 25, 2025 (Anticipated)
Study Completion Date
August 25, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ModernaTX, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The main purpose 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.
Detailed Description
The study will be conducted in 2 phases: Phase 2 and Phase 3. In the 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Syncytial Virus
Keywords
Viral Diseases, Messenger RNA, Moderna, mRNA-1345, Respiratory syncytial virus, Safety, Vaccines
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
36557 (Actual)
8. Arms, Groups, and Interventions
Arm Title
mRNA-1345
Arm Type
Experimental
Arm Description
Single injection of mRNA-1345 on Day 1.
Arm Title
Placebo
Arm Type
Experimental
Arm Description
Single injection of mRNA-1345 matching-placebo on Day 1.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
0.9% sodium chloride (normal saline) injection
Intervention Type
Drug
Intervention Name(s)
mRNA-1345
Intervention Description
Sterile liquid for injection
Primary Outcome Measure Information:
Title
Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs) up to 7 Days Postinjection
Time Frame
Up to 7 days postinjection
Title
Number of Participants with Unsolicited Adverse Events (AEs) up to 28 Days Postinjection
Time Frame
Up to 28 days postinjection
Title
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 24 Months Postinjection
Time Frame
Up to 24 months postinjection
Title
Vaccine Efficacy (VE) of mRNA-1345 to Prevent a First Episode of RSV-LRTD with 2 or More Symptoms within the Period of 14 Days Postinjection up to 12 Months Postinjection
Description
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).
Time Frame
14 days postinjection up to 12 months postinjection
Title
VE of mRNA-1345 to Prevent a First Episode of RSV-LRTD with 3 or More Symptoms within the Period of 14 Days Postinjection up to 12 Months Postinjection
Description
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).
Time Frame
14 days postinjection up to 12 months postinjection
Secondary Outcome Measure Information:
Title
VE of mRNA-1345 to Prevent a First Episode of RSV-Associated Acute Respiratory Disease (RSV-ARD) within the Period of 14 Days Postinjection up to 12 Months Postinjection
Description
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).
Time Frame
14 days postinjection up to 12 months postinjection
Title
VE of mRNA-1345 to Prevent First Hospitalization Associated with RSV-ARD or RSV-LRTD within the Period of 14 Days Postinjection up to 12 Months Postinjection
Description
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).
Time Frame
14 days postinjection up to 12 months postinjection
Title
Geometric Mean Titer (GMT) of Serum RSV Neutralizing Antibodies (Abs)
Time Frame
Baseline through up to 24 months postinjection
Title
Geometric Mean Concentration (GMC) of Serum RSV Binding Abs
Time Frame
Baseline through up to 24 months postinjection
Title
Seroresponse Rate in RSV Neutralizing Abs
Time Frame
Baseline through up to 24 months postinjection
Title
Geometric Mean Fold-Rise of Postbaseline/Baseline Ab Titers
Time Frame
Baseline through up to 24 months postinjection
Title
Proportion of Participants with ≥4-fold Increases in Ab Titers from Baseline
Time Frame
Baseline through up to 24 months postinjection
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Key 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
Key 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.
Other inclusion and/or exclusion criteria may apply.
Facility Information:
Facility Name
Synexus Clinical Research US, Inc. - Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35211
Country
United States
Facility Name
Accel Research Site - Achieve - Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35216
Country
United States
Facility Name
Lakeview Clinical Research
City
Guntersville
State/Province
Alabama
ZIP/Postal Code
35976
Country
United States
Facility Name
AES - DRS - Optimal Research Alabama - Huntsville
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35802
Country
United States
Facility Name
Hope Research Institute LLC - Hunt - PPDS
City
Hunt
State/Province
Arizona
ZIP/Postal Code
85023
Country
United States
Facility Name
Hope Research Institute LLC - Hunt - PPDS
City
Hunt
State/Province
Arizona
ZIP/Postal Code
85284
Country
United States
Facility Name
Desert Clinical Research, LLC - CCT
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85213
Country
United States
Facility Name
Hope Research Institute LLC - Phoenix - Hunt - PPDS
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85018
Country
United States
Facility Name
Synexus Clinical Research US, Inc. - Phoenix Central
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85020
Country
United States
Facility Name
Synexus Clinical Research US, Inc. - Phoenix Southeast
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Facility Name
Tucson Neuroscience Research
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85710
Country
United States
Facility Name
Baptist Health Center for Clinical Research
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Velocity Clinical Research, Banning
City
Banning
State/Province
California
ZIP/Postal Code
92220
Country
United States
Facility Name
Hope Clinical Research, LLC
City
Canoga Park
State/Province
California
ZIP/Postal Code
91303
Country
United States
Facility Name
PPD Virtual - Science 37, Inc
City
Culver City
State/Province
California
ZIP/Postal Code
90230
Country
United States
Facility Name
Paradigm Research
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Facility Name
Velocity Clinical Research, San Diego
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Facility Name
Wr-Pri, Llc
City
Los Alamitos
State/Province
California
ZIP/Postal Code
90720
Country
United States
Facility Name
Wr-Pri, Llc
City
Newport Beach
State/Province
California
ZIP/Postal Code
92660
Country
United States
Facility Name
FOMAT Medical Research - FOMAT - HyperCore - PPDS
City
Oxnard
State/Province
California
ZIP/Postal Code
93030
Country
United States
Facility Name
Reddy Care Medical
City
Pomona
State/Province
California
ZIP/Postal Code
91768
Country
United States
Facility Name
Paradigm Clinical Research Institute Inc - ClinEdge - PPDS
City
Redding
State/Province
California
ZIP/Postal Code
96001
Country
United States
Facility Name
Wr-McCr, Llc
City
San Diego
State/Province
California
ZIP/Postal Code
92120
Country
United States
Facility Name
Medical Center For Clinical Research - M3 WR
City
San Diego
State/Province
California
ZIP/Postal Code
92660
Country
United States
Facility Name
Lynn Institute of Denver
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80012
Country
United States
Facility Name
Tekton Research
City
Fort Collins
State/Province
Colorado
ZIP/Postal Code
80525
Country
United States
Facility Name
Tekton Research - Longmont - PPDS
City
Longmont
State/Province
Colorado
ZIP/Postal Code
80501
Country
United States
Facility Name
Paradigm Clinical Research Institute Inc - ClinEdge - PPDS
City
Wheat Ridge
State/Province
Colorado
ZIP/Postal Code
80033
Country
United States
Facility Name
Clinical Research Consultants LLC - ClinEdge - PPDS
City
Milford
State/Province
Connecticut
ZIP/Postal Code
06460
Country
United States
Facility Name
Washington Health Institute
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20017
Country
United States
Facility Name
Velocity Clinical Research, New Smyrna Beach
City
Edgewater
State/Province
Florida
ZIP/Postal Code
32132
Country
United States
Facility Name
Fleming Island Clinical Research Center
City
Fleming Island
State/Province
Florida
ZIP/Postal Code
32003
Country
United States
Facility Name
Velocity Clinical Research - Hallandale Beach - PPDS
City
Hallandale Beach
State/Province
Florida
ZIP/Postal Code
33009
Country
United States
Facility Name
Jacksonville Center for Clinical Research
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
ARS- Maitland
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Facility Name
Spotlight Research Center, LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
AES - DRS - Synexus Clinical Research US, Inc. - The Villages
City
Orlando
State/Province
Florida
ZIP/Postal Code
32162
Country
United States
Facility Name
Flourish Research - Orlando - PPDS
City
Orlando
State/Province
Florida
ZIP/Postal Code
32789
Country
United States
Facility Name
Health Awareness Inc
City
Port Saint Lucie
State/Province
Florida
ZIP/Postal Code
33458
Country
United States
Facility Name
IMA Clinical Research - Saint Petersburg - PPDS
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33709
Country
United States
Facility Name
AES - DRS - Synexus Clinical Research US, Inc. - St. Petersburg
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33781
Country
United States
Facility Name
Clinical Trials of Tampa
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614
Country
United States
Facility Name
Palm Beach Research - ClinEdge - PPDS
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33409
Country
United States
Facility Name
Clinical Site Partners - Winter Park - HyperCore -PPDS
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32789
Country
United States
Facility Name
Masters of Clinical Research Inc
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30909
Country
United States
Facility Name
IACT Health - Roswell - IACT - HyperCore - PPDS
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31904
Country
United States
Facility Name
iResearch Atlanta
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30030
Country
United States
Facility Name
Javara, Inc./Privia Medical Group Georgia, LLC
City
Fayetteville
State/Province
Georgia
ZIP/Postal Code
30214
Country
United States
Facility Name
Drug Studies America - ClinEdge - PPDS
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Randomize Now -Commerce Dr
City
Peachtree City
State/Province
Georgia
ZIP/Postal Code
30269
Country
United States
Facility Name
Centricity Research - Roswell - HyperCore - PPDS
City
Roswell
State/Province
Georgia
ZIP/Postal Code
31904
Country
United States
Facility Name
WR-Mount Vernon Clinical Research, LLC
City
Sandy Springs
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
Meridian Clinical Research- Savannah, GA
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31406
Country
United States
Facility Name
Clinical Research Atlanta - ERN-PPDS
City
Stockbridge
State/Province
Georgia
ZIP/Postal Code
30281
Country
United States
Facility Name
East West Medical Research Institute
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96814
Country
United States
Facility Name
AES - DRS - Synexus Clinical Research US, Inc. - Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60602
Country
United States
Facility Name
Affinity Health (Oak Brook)
City
Oak Brook
State/Province
Illinois
ZIP/Postal Code
60523
Country
United States
Facility Name
DM Clinical - Chicago
City
River Forest
State/Province
Illinois
ZIP/Postal Code
60305
Country
United States
Facility Name
AES - DRS - Synexus Clinical Research US, Inc. - Evansville
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47714
Country
United States
Facility Name
Velocity Clinical Research - Valparaiso - PPDS
City
Valparaiso
State/Province
Indiana
ZIP/Postal Code
46383
Country
United States
Facility Name
Meridian Clinical Research - Sioux City
City
Sioux City
State/Province
Iowa
ZIP/Postal Code
51106
Country
United States
Facility Name
Johnson County Clin-Trials
City
Lenexa
State/Province
Kansas
ZIP/Postal Code
66219
Country
United States
Facility Name
Versailles Family Medicine - CCT - PPDS
City
Versailles
State/Province
Kentucky
ZIP/Postal Code
40383
Country
United States
Facility Name
Meridian Clinical Research (Baton Rouge - Louisiana) - PPDS
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
Country
United States
Facility Name
Benchmark Research - Covington - HyperCore - PPDS
City
Covington
State/Province
Louisiana
ZIP/Postal Code
70433
Country
United States
Facility Name
Benchmark Research - Metairie - HyperCore - PPDS
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
Clinical Trials of America (LA)
City
Monroe
State/Province
Louisiana
ZIP/Postal Code
71259
Country
United States
Facility Name
DelRicht Clinical Research, LLC - Internal - Covington - PPDS
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70115
Country
United States
Facility Name
Javara, Inc./Privia Medical Group, LLC
City
Annapolis
State/Province
Maryland
ZIP/Postal Code
21401
Country
United States
Facility Name
CBH Health - CenExel CBH - PPDS
City
Gaithersburg
State/Province
Maryland
ZIP/Postal Code
20877
Country
United States
Facility Name
Meridian Clinical Research- Rockville, MD
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20854
Country
United States
Facility Name
Great Lakes Research Institute
City
Southfield
State/Province
Michigan
ZIP/Postal Code
48075
Country
United States
Facility Name
DM Clinical Research - Southfield - ERN - PPDS
City
Southfield
State/Province
Michigan
ZIP/Postal Code
48076
Country
United States
Facility Name
Clinical Research Institute, Inc - CRN - PPDS
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55402
Country
United States
Facility Name
AES - DRS - Synexus Clinical Research US, Inc. - Minneapolis
City
Richfield
State/Province
Minnesota
ZIP/Postal Code
55423
Country
United States
Facility Name
AES - DRS - Synexus Clinical Research US, Inc. - St. Louis
City
Creve Coeur
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Montana Medical Research
City
Missoula
State/Province
Montana
ZIP/Postal Code
59804
Country
United States
Facility Name
Boeson Research MSO - Missoula - ERN - PPDS
City
Missoula
State/Province
Montana
ZIP/Postal Code
59808
Country
United States
Facility Name
Skyline Medical Center, PC - CCT Research
City
Elkhorn
State/Province
Nebraska
ZIP/Postal Code
68022
Country
United States
Facility Name
Methodist Physicians Clinic - CCT Research - PPDS
City
Fremont
State/Province
Nebraska
ZIP/Postal Code
68025
Country
United States
Facility Name
Meridian Clinical Research- Grand Island, NE
City
Grand Island
State/Province
Nebraska
ZIP/Postal Code
68803
Country
United States
Facility Name
Meridian Clinical Research- Lincoln, NE
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68510
Country
United States
Facility Name
Meridian Clinical Research- Omaha, NE
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68134
Country
United States
Facility Name
CCT Research
City
Papillion
State/Province
Nebraska
ZIP/Postal Code
68046
Country
United States
Facility Name
HEALOR Primary Care - Physicians Las Vegas - CCT
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
Country
United States
Facility Name
Excel Clinical Research - Las Vegas
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89109
Country
United States
Facility Name
IMA Clinical Research - Raritan - PPDS
City
Raritan
State/Province
New Jersey
ZIP/Postal Code
08869
Country
United States
Facility Name
Riverside Medical Group - Circuit - PPDS
City
Secaucus
State/Province
New Jersey
ZIP/Postal Code
07094
Country
United States
Facility Name
Velocity Clinical Research - East Syracuse - PPDS
City
East Syracuse
State/Province
New York
ZIP/Postal Code
13057
Country
United States
Facility Name
Meridian Clinical Research- Endwell, NY
City
Endwell
State/Province
New York
ZIP/Postal Code
13760
Country
United States
Facility Name
Drug Trials America
City
Hartsdale
State/Province
New York
ZIP/Postal Code
10530
Country
United States
Facility Name
AES - DRS - Synexus Clinical Research US, Inc. - New York
City
New York
State/Province
New York
ZIP/Postal Code
10017
Country
United States
Facility Name
Rochester Clinical Research, Inc
City
Rochester
State/Province
New York
ZIP/Postal Code
14609
Country
United States
Facility Name
Carolina Institute for Clinical Research - M3 WR
City
Fayetteville
State/Province
North Carolina
ZIP/Postal Code
28303
Country
United States
Facility Name
Carolina Institute for Clinical Research
City
Fayetteville
State/Province
North Carolina
ZIP/Postal Code
28303
Country
United States
Facility Name
Triad Clinical Trials
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27410
Country
United States
Facility Name
Trial Management Associates, LLC
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28403
Country
United States
Facility Name
CTI Clinical Research
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45212
Country
United States
Facility Name
Meridian Clinical Research
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Velocity Clinical Research - Cincinnati - PPDS
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
AES - DRS - Synexus Clinical Research US, Inc. - Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45236
Country
United States
Facility Name
Tekton Research
City
Edmond
State/Province
Oklahoma
ZIP/Postal Code
73013
Country
United States
Facility Name
Tekton Research
City
Yukon
State/Province
Oklahoma
ZIP/Postal Code
73099
Country
United States
Facility Name
Summit Research Network, Inc. - Portland - Headlands - PPDS
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Hatboro Medical Associates - CCT - PPDS
City
Hatboro
State/Province
Pennsylvania
ZIP/Postal Code
19040
Country
United States
Facility Name
DM Clinical Research - Philadelphia - ERN - PPDS
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
American Indian Clinical Trials Research Network
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57701
Country
United States
Facility Name
Affinity Health - Nashville
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Premier Family Physicians - Austin - Hunt - PPDS
City
Austin
State/Province
Texas
ZIP/Postal Code
78735
Country
United States
Facility Name
Tekton Research
City
Austin
State/Province
Texas
ZIP/Postal Code
78745
Country
United States
Facility Name
PanAmerican Clinical Research LLC
City
Brownsville
State/Province
Texas
ZIP/Postal Code
78520
Country
United States
Facility Name
North Texas Family Medicine - Plano - Hunt - PPDS
City
Carrollton
State/Province
Texas
ZIP/Postal Code
75010
Country
United States
Facility Name
Javara, Inc./Texas Health Care, PLLC (d/b/a/ Privia Medical Group - North Texas)
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76132
Country
United States
Facility Name
Allure Health LLC
City
Friendswood
State/Province
Texas
ZIP/Postal Code
77546
Country
United States
Facility Name
Mt. Olympus Medical Research
City
Friendswood
State/Province
Texas
ZIP/Postal Code
77546
Country
United States
Facility Name
Village Health Partners Frisco Medical Village
City
Frisco
State/Province
Texas
ZIP/Postal Code
75033
Country
United States
Facility Name
West Houston Clinical Research - Hunt - PPDS
City
Houston
State/Province
Texas
ZIP/Postal Code
77055
Country
United States
Facility Name
DM Clinical-TCDD
City
Houston
State/Province
Texas
ZIP/Postal Code
77081
Country
United States
Facility Name
DM Clinical - Humble
City
Humble
State/Province
Texas
ZIP/Postal Code
77338
Country
United States
Facility Name
ACRC Trials - Hunt - PPDS
City
Plano
State/Province
Texas
ZIP/Postal Code
75024
Country
United States
Facility Name
AIM Trials
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Facility Name
AES - DRS - Synexus Clinical Research US, Inc. - San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Clinical Trials of Texas, LLC - HyperCore - PPDS
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Flourish Research - San Antonio - PPDS
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
DM Clinical Research - Sugarland - ERN - PPDS
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77338
Country
United States
Facility Name
DM Clinical - Tomball
City
Tomball
State/Province
Texas
ZIP/Postal Code
77375
Country
United States
Facility Name
Cope Family Medicine - CCT - PPDS
City
Bountiful
State/Province
Utah
ZIP/Postal Code
84010
Country
United States
Facility Name
Alpine Research Organization, Inc
City
Clinton
State/Province
Utah
ZIP/Postal Code
84015
Country
United States
Facility Name
Olympus Family Medicine- CCT
City
Holladay
State/Province
Utah
ZIP/Postal Code
84117
Country
United States
Facility Name
South Ogden Family Medicine - CCT
City
South Ogden
State/Province
Utah
ZIP/Postal Code
84405
Country
United States
Facility Name
Health Research of Hampton Roads Inc.
City
Newport News
State/Province
Virginia
ZIP/Postal Code
23606-4537
Country
United States
Facility Name
Meridian Clinical Research - Family Practice - Portsmouth - PPDS
City
Portsmouth
State/Province
Virginia
ZIP/Postal Code
23703-3200
Country
United States
Facility Name
Meridian Clinical Research- Portsmouth, VA
City
Portsmouth
State/Province
Virginia
ZIP/Postal Code
23703
Country
United States
Facility Name
Rainier Clinical Research Center
City
Rainier
State/Province
Washington
ZIP/Postal Code
98105-4028
Country
United States
Facility Name
Seattle Clinical Research Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105-4028
Country
United States
Facility Name
Fundación Socolinsky Centro de Vacunación Proteger
City
Buenos Aires
ZIP/Postal Code
C1023AAO
Country
Argentina
Facility Name
Instituto Medico Platense
City
Buenos Aires
Country
Argentina
Facility Name
Swiss Medical Center Barrio Parque
City
Ciudad Autónoma de BuenosAires
ZIP/Postal Code
1426
Country
Argentina
Facility Name
Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich
City
Ciudad Autónoma de BuenosAires
ZIP/Postal Code
1428
Country
Argentina
Facility Name
Consultorios Médicos Dr. Doreski
City
Ciudad Autónoma de BuenosAires
ZIP/Postal Code
C1426ABP
Country
Argentina
Facility Name
Paratus Clinical Research - Canberra - PPDS
City
Bruce
State/Province
Australian Capital Territory
ZIP/Postal Code
2100
Country
Australia
Facility Name
Paratus Clinical Research - Western Sydney - PPDS
City
Blacktown
State/Province
New South Wales
ZIP/Postal Code
2148
Country
Australia
Facility Name
Northern Beaches Clinical Research
City
Brookvale
State/Province
New South Wales
ZIP/Postal Code
4006
Country
Australia
Facility Name
Northside Health
City
Coffs Harbour
State/Province
New South Wales
ZIP/Postal Code
2450
Country
Australia
Facility Name
Holdsworth House Medical Brisbane
City
Fortitude Valley
State/Province
Queensland
ZIP/Postal Code
2617
Country
Australia
Facility Name
Emeritus Research - PPDS
City
Camberwell
State/Province
Victoria
ZIP/Postal Code
3124
Country
Australia
Facility Name
icddr,b Matlab Health Research Center
City
Matlab
State/Province
Chittagong Zila
ZIP/Postal Code
3100
Country
Bangladesh
Facility Name
Icddr,b Kamalapur
City
Dhaka
State/Province
Dhaka Zila
ZIP/Postal Code
3190
Country
Bangladesh
Facility Name
JHU-Projahnmo Sylhet site
City
Sylhet
ZIP/Postal Code
3640
Country
Bangladesh
Facility Name
JHU-Projahnmo Zakiganj site
City
Zakiganj
ZIP/Postal Code
1204
Country
Bangladesh
Facility Name
ANIMA Research Center
City
Diepenbeek
State/Province
Limburg
ZIP/Postal Code
3590
Country
Belgium
Facility Name
Ziekenhuis Oost-Limburg
City
Genk
State/Province
Limburg
ZIP/Postal Code
5101
Country
Belgium
Facility Name
VAXINFECTIO University of Antwerp - Center for the Evaluation of Vaccination - PPDS
City
Antwerpen
ZIP/Postal Code
3600
Country
Belgium
Facility Name
Private Practice Dr Jean Benoit Martinot
City
Erpent
ZIP/Postal Code
2650
Country
Belgium
Facility Name
CARe Clinic
City
Red Deer
State/Province
Alberta
ZIP/Postal Code
L8J 0B6
Country
Canada
Facility Name
Okanagan Clinical Trials - Headlands - PPDS
City
Kelowna
State/Province
British Columbia
ZIP/Postal Code
T4P-1K4
Country
Canada
Facility Name
Dr. Steven Z. Zizzo Medicine Professional Corporation
City
Stoney Creek
State/Province
Ontario
ZIP/Postal Code
V1Y 1Z9
Country
Canada
Facility Name
Centricity Research - Bayview - HyperCore - PPDS
City
Toronto
State/Province
Ontario
ZIP/Postal Code
G9A 4P3
Country
Canada
Facility Name
Centricity Research - Toronto - HyperCore - PPDS
City
Toronto
State/Province
Ontario
ZIP/Postal Code
J1L 0H8
Country
Canada
Facility Name
Diex Recherche - Sherbrooke - PPDS
City
Québec
ZIP/Postal Code
G1V 4T3
Country
Canada
Facility Name
Diex Recherche - Joilette - PPDS
City
Québec
ZIP/Postal Code
G6W 0M5
Country
Canada
Facility Name
Diex Recherche - Québec - PPDS
City
Québec
ZIP/Postal Code
J6E 2B4
Country
Canada
Facility Name
Centricity Research - Quebec - HyperCore - PPDS
City
Québec
ZIP/Postal Code
M4G 3E8
Country
Canada
Facility Name
Diex Recherche - Trois Rivieres - PPDS
City
Québec
ZIP/Postal Code
M9W 4L6
Country
Canada
Facility Name
Hospital Base de Osorno
City
Osorno
State/Province
Los Lagos
ZIP/Postal Code
2260000
Country
Chile
Facility Name
Centro Respiratorio Integral LTDA. (CENRESIN)
City
Los Lagos
ZIP/Postal Code
3480094
Country
Chile
Facility Name
BIOCINETIC SpA
City
Maule
ZIP/Postal Code
7500000
Country
Chile
Facility Name
Centro de Investigacion del Maule
City
Talca
ZIP/Postal Code
8330336
Country
Chile
Facility Name
Biomedica Research Group
City
Valparaíso
ZIP/Postal Code
5311315
Country
Chile
Facility Name
Centro de Atención e Investigación Médica S.A. - CAIMED - Aguazul
City
Aguazul
State/Province
Distrito Capital De Bogotá
ZIP/Postal Code
660003
Country
Colombia
Facility Name
Clinica de la Costa Ltda - PPDS
City
Atlántico
ZIP/Postal Code
252431
Country
Colombia
Facility Name
Centro de Atención e Investigación Médica S.A. - CAIMED - Bogota
City
Bogota
ZIP/Postal Code
681002
Country
Colombia
Facility Name
Solano & Terront Servicios Médicos LTDA (UNIENDO) Bogota
City
Bogota
ZIP/Postal Code
80020
Country
Colombia
Facility Name
Centro de Atención e Investigación Médica S.A. - CAIMED - Chia
City
Cundinamarca
ZIP/Postal Code
111611
Country
Colombia
Facility Name
Centro de Atención e Investigación Médica S.A. - CAIMED - Girardot
City
Cundinamarca
ZIP/Postal Code
856010
Country
Colombia
Facility Name
Fundacion Oftalmologica de Santander Foscal
City
Floridablanca
ZIP/Postal Code
760042
Country
Colombia
Facility Name
Centro de Atención e Investigación Médica S.A. - CAIMED - Ibague
City
Ibague
ZIP/Postal Code
110221
Country
Colombia
Facility Name
IPS Centro de Investigacion Clinicas Cardiomet
City
Risaralda
ZIP/Postal Code
250001
Country
Colombia
Facility Name
Centro Medico Imbanaco de Cali S.A.
City
Santiago De Cali
Country
Colombia
Facility Name
Consultorio Medico La Flor
City
Guanacaste
ZIP/Postal Code
10903
Country
Costa Rica
Facility Name
Hospital Clínica Bíblica Sede Santa Ana
City
San José
ZIP/Postal Code
10108
Country
Costa Rica
Facility Name
Hospital CIMA San Jose
City
San José
ZIP/Postal Code
10203
Country
Costa Rica
Facility Name
Instituto de Investigación en Ciencias Médicas S.A.
City
San José
ZIP/Postal Code
50101
Country
Costa Rica
Facility Name
FVR/Seinäjoen Rokotetutkimusklinikka
City
Seinäjoki
State/Province
Etelä-Pohjanmaa
ZIP/Postal Code
4400
Country
Finland
Facility Name
FVR/Kokkolan Rokotetutkimusklinikka
City
Kokkola
State/Province
Keski-Pohjanmaa
ZIP/Postal Code
2230
Country
Finland
Facility Name
FVR/Tampereen Rokotetutkimusklinikka
City
Tampere
State/Province
Pirkanmaa
ZIP/Postal Code
67100
Country
Finland
Facility Name
FVR/Oulun Rokotetutkimusklinikka
City
Oulu
State/Province
Pohjois-Pohjanmaa
ZIP/Postal Code
20520
Country
Finland
Facility Name
FVR/Porin Rokotetutkimusklinikka
City
Pori
State/Province
Satakunta
ZIP/Postal Code
90220
Country
Finland
Facility Name
FVR/Espoon Rokotetutkimusklinikka
City
Espoo
State/Province
Uusimaa
ZIP/Postal Code
60100
Country
Finland
Facility Name
FVR/Etelä Helsingin Rokotetutkimusklinikka
City
Helsinki
State/Province
Uusimaa
ZIP/Postal Code
100
Country
Finland
Facility Name
FVR/Itä Helsingin Rokotetutkimusklinikka
City
Helsinki
State/Province
Uusimaa
ZIP/Postal Code
28100
Country
Finland
Facility Name
FVR/Järvenpään Rokotetutkimusklinikka
City
Järvenpää
State/Province
Uusimaa
ZIP/Postal Code
930
Country
Finland
Facility Name
FVR/Turun Rokotetutkimusklinikka
City
Turku
State/Province
Varsinais-Suomi
ZIP/Postal Code
33100
Country
Finland
Facility Name
Klinische Forschung, Schwerin GmbH (KFGN)
City
Schwerin
State/Province
Mecklenburg-Vorpommern
ZIP/Postal Code
19055
Country
Germany
Facility Name
Klinische Forschung Hannover-Mitte GmbH
City
Hannover
State/Province
Niedersachsen
ZIP/Postal Code
45355
Country
Germany
Facility Name
Medizentrum Essen Borbeck
City
Essen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
60596
Country
Germany
Facility Name
AES - DRS - Synexus Berlin Research Centre
City
Berlin
ZIP/Postal Code
60313
Country
Germany
Facility Name
AES - DRS - Synexus Frankfurt Research Centre
City
Hessen
ZIP/Postal Code
12627
Country
Germany
Facility Name
Infektioresearch GmbH & Co. KG
City
Hessen
ZIP/Postal Code
30159
Country
Germany
Facility Name
Fukui General Hospital
City
Fukui-Shi
Country
Japan
Facility Name
Boocs Clinic Fukuoka
City
Fukuoka
ZIP/Postal Code
104-0031
Country
Japan
Facility Name
SOUSEIKAI PS Clinic
City
Fukuoka
ZIP/Postal Code
168-0065
Country
Japan
Facility Name
Tenjin Sogo Clinic
City
Fukuoka
ZIP/Postal Code
231-0023
Country
Japan
Facility Name
Higashi Shinjuku Clinic
City
Shinjuku-Ku
ZIP/Postal Code
162-8655
Country
Japan
Facility Name
Center Hospital of the National Center for Global Health and Medicine
City
Shinjuku-Ku
ZIP/Postal Code
812-0025
Country
Japan
Facility Name
NewHeart Watanabe Institute
City
Suginami City
ZIP/Postal Code
910-0067
Country
Japan
Facility Name
Medical Corporation Asbo Tokyo Asbo Clinic
City
Tokyo
ZIP/Postal Code
810-0021
Country
Japan
Facility Name
Sekino Hospital
City
Toshima-Ku
ZIP/Postal Code
171-0014
Country
Japan
Facility Name
Institute Medical Corporation Hitomikai Motomachi Takatsuka Naika Clinic
City
Yokohama
ZIP/Postal Code
812-0025
Country
Japan
Facility Name
Soon Chun Hyang University Hospital Bucheon
City
Bucheon-si,
ZIP/Postal Code
22711
Country
Korea, Republic of
Facility Name
Dong-A University Hospital
City
Busan
ZIP/Postal Code
6273
Country
Korea, Republic of
Facility Name
Chungnam National University Hospital
City
Daejeon
ZIP/Postal Code
14584
Country
Korea, Republic of
Facility Name
Inha University Hospital
City
Incheon
ZIP/Postal Code
26426
Country
Korea, Republic of
Facility Name
Catholic Kwandong University International St. Mar
City
Incheon
ZIP/Postal Code
49201
Country
Korea, Republic of
Facility Name
Samsung Medical Center - PPDS
City
Seoul
ZIP/Postal Code
35015
Country
Korea, Republic of
Facility Name
Ewha Womans University Seoul Hospital
City
Seoul
ZIP/Postal Code
7441
Country
Korea, Republic of
Facility Name
Gangnam Severance Hospital, Yonsei University Health System
City
Seoul
Country
Korea, Republic of
Facility Name
Hallym University Kangnam Sacred Heart Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Yonsei University Wonju Severance Christian Hospital
City
Wonju
ZIP/Postal Code
7804
Country
Korea, Republic of
Facility Name
Investigacion en Salud y Metabolismo S.C.
City
Chiapas
ZIP/Postal Code
3100
Country
Mexico
Facility Name
AES - AS - RM Pharma Specialists Mexico City
City
Chihuahua City
ZIP/Postal Code
31217
Country
Mexico
Facility Name
Accelerium, S. de R.L. de C.V.
City
Durango
ZIP/Postal Code
34217
Country
Mexico
Facility Name
Hospital General 450
City
Durango
Country
Mexico
Facility Name
AES - AS - CEMDEC Mexico City
City
Guadalajara
ZIP/Postal Code
44280
Country
Mexico
Facility Name
Maria del rayo morfin otero
City
Jalisco
ZIP/Postal Code
76230
Country
Mexico
Facility Name
PanAmerican Clinical Research-Avenida Paseo de la República 13020
City
Querétaro
Country
Mexico
Facility Name
Southern Clinical Trials Waitemata
City
Auckland
ZIP/Postal Code
1010
Country
New Zealand
Facility Name
New Zealand Clinical Research - Auckland
City
Auckland
ZIP/Postal Code
3010
Country
New Zealand
Facility Name
Optimal Clinical Trials Ltd
City
Auckland
ZIP/Postal Code
7011
Country
New Zealand
Facility Name
Southern Clinical Trials Limited
City
Christchurch
ZIP/Postal Code
626
Country
New Zealand
Facility Name
Southern Clinical Trials - Tasman
City
Nelson
ZIP/Postal Code
8023
Country
New Zealand
Facility Name
Lakeland Clinical Trials
City
Rotorua
ZIP/Postal Code
1010
Country
New Zealand
Facility Name
CEVAXIN 24 de diciembre
City
Panamá
Country
Panama
Facility Name
CEVAXIN Avenida México
City
Panamá
Country
Panama
Facility Name
AES - DRS - Synexus Polska Sp. z o.o. Oddzial we Wroclawiu
City
Wroclaw
State/Province
Dolnoslaskie
ZIP/Postal Code
50-381
Country
Poland
Facility Name
AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Poznaniu
City
Poznan
State/Province
Wielkopolskie
ZIP/Postal Code
01-192
Country
Poland
Facility Name
AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Warszawie
City
Gdańsk
ZIP/Postal Code
80-382
Country
Poland
Facility Name
AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Gdansku
City
Pomorskie
ZIP/Postal Code
40-040
Country
Poland
Facility Name
AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Katowicach
City
Slaskie
ZIP/Postal Code
27-400
Country
Poland
Facility Name
Ostrowieckie Centrum Medyczne Spólka Cywilna Anna Olech-Cudzik, Krzysztof Cudzik
City
Swietokrzyskie
ZIP/Postal Code
60-702
Country
Poland
Facility Name
BRCR Global Puerto Rico (Ponce)
City
Ponce
ZIP/Postal Code
00935-0001
Country
Puerto Rico
Facility Name
Caribbean Medical Research Center
City
San Juan
ZIP/Postal Code
00918
Country
Puerto Rico
Facility Name
Puerto Rico AIDS Clinical Trials Unit - (CRS)
City
San Juan
Country
Puerto Rico
Facility Name
Singapore General Hospital (SGH)
City
Singapore
ZIP/Postal Code
16908
Country
Singapore
Facility Name
Dr. J Breedt
City
City Of Tshwane
State/Province
Gauteng
ZIP/Postal Code
4170
Country
South Africa
Facility Name
AES - DRS - Synexus Watermeyer Clinical Research Centre
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
122
Country
South Africa
Facility Name
AES - DRS - Synexus - Stanza Clinical Research Centre
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
1500
Country
South Africa
Facility Name
Aliwal Shoal Medical Center
City
Ethekwini
State/Province
Kwazulu - Natal
ZIP/Postal Code
7130
Country
South Africa
Facility Name
AES - DRS - Synexus - Helderberg Clinical Research Centre
City
Somerset West
State/Province
Western Cape
ZIP/Postal Code
184
Country
South Africa
Facility Name
Worthwhile Clinical Trials
City
Benoni
ZIP/Postal Code
84
Country
South Africa
Facility Name
ABS Centelles
City
Barcelona
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hospital Son Llatzer
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Facility Name
Hospital Universitario La Paz - PPDS
City
Madrid
ZIP/Postal Code
7198
Country
Spain
Facility Name
Hospital Universitario de La Princesa
City
Madrid
ZIP/Postal Code
8540
Country
Spain
Facility Name
FISABIO Oftalmología Médica (FOM)
City
Valencia
ZIP/Postal Code
46020
Country
Spain
Facility Name
China Medical University Hospital - PPDS
City
Taichung City
ZIP/Postal Code
112
Country
Taiwan
Facility Name
Taichung Veterans General Hospital
City
Taichung
ZIP/Postal Code
33305
Country
Taiwan
Facility Name
Taipei Veterans General Hospital
City
Taipei
ZIP/Postal Code
40705
Country
Taiwan
Facility Name
Chang Gung Memorial Hospital, Linkou
City
Taoyuan City
ZIP/Postal Code
40447
Country
Taiwan
Facility Name
Bristol Royal Infirmary
City
Bristol
State/Province
Avon
ZIP/Postal Code
ST10 1NS
Country
United Kingdom
Facility Name
AES - DRS - Synexus Scotland Clinical Research Centre
City
Bellshill
State/Province
Lanarkshire
ZIP/Postal Code
B15 2SQ
Country
United Kingdom
Facility Name
Layton Medical Centre
City
Blackpool
State/Province
Lancashire
ZIP/Postal Code
L22 0LG
Country
United Kingdom
Facility Name
AES - DRS - NW Consortium Lancashire
City
Chorley
State/Province
Lancashire
ZIP/Postal Code
NE46 1QJ
Country
United Kingdom
Facility Name
AES - DRS - NW Consortium Merseyside
City
Liverpool
State/Province
Lancashire
ZIP/Postal Code
NE1 4LP
Country
United Kingdom
Facility Name
AES - DRS - Synexus Hexham Clinical Research Centre
City
Hexham
State/Province
Northumberland
ZIP/Postal Code
ML4 3NJ
Country
United Kingdom
Facility Name
Royal Victoria Infirmary
City
Newcastle Upon Tyne
State/Province
Northumberland
ZIP/Postal Code
BS2 8HW
Country
United Kingdom
Facility Name
Cheadle Hospital
City
Stoke-On-Trent
State/Province
Staffordshire
ZIP/Postal Code
CF15 9SS
Country
United Kingdom
Facility Name
AES - DRS - Synexus Midlands Clinical Research Centre
City
Birmingham
State/Province
West Midlands
ZIP/Postal Code
PR7 7NA
Country
United Kingdom
Facility Name
AES - DRS - Synexus Wales Clinical Research Centre
City
Cardiff
ZIP/Postal Code
FY3 7EN
Country
United Kingdom
Facility Name
AES - DRS - NW Consortium Manchester
City
Manchester
ZIP/Postal Code
M15 6SX
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study to Evaluate the Safety and Efficacy of mRNA-1345 Vaccine Targeting Respiratory Syncytial Virus (RSV) in Adults ≥60 Years of Age
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