Clinical trial NCT05127434: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
PHASE3
Conditions: Respiratory Syncytial Virus
Keywords: Viral Diseases
Messenger RNA
Moderna
mRNA-1345
Respiratory syncytial virus
Safety
Vaccines
Lead sponsor: ModernaTX, Inc.
Sponsor class: INDUSTRY
First posted: 2021-11-19
Enrollment: 36814
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

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

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

Eligibility criteria: Key Inclusion Criteria (Part A):

* Adults ≥ 60 years of age who are primarily responsible for self-care and activities of daily living. Participants may have one or more chronic medical diagnoses (including chronic heart failure \[CHF\] and chronic obstructive pulmonary disease \[COPD\]), but should be medically stable
* Body mass index from ≥18 kilograms (kg)/square meter (m\^2) to ≤35 kg/m\^2

Key Inclusion Criteria (Part B):

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

Key Exclusion Criteria (Part A):

* Participation in another clinical research study where participant has received an investigational product (drug/biologic/device) within 6 months before the planned date of the Day 1 study injection.
* Current participation in research involving receipt of any investigational RSV product
* History of a serious reaction to any prior vaccination or Guillain-Barré syndrome within 6 weeks of any prior influenza immunization.
* Received or plans to receive any non-study vaccine within 28 days before or after the Day 1 study injection.

Key Exclusion Criteria (Part B):

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

Other inclusion and/or exclusion criteria may apply.

Primary outcomes:
measure: Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs)
timeFrame: Up to 7 days after each injection
measure: Number of Participants with Unsolicited Adverse Events (AEs)
timeFrame: Up to 28 days after each injection
measure: Number of Participants With Medically Attended AEs (MAAEs), Adverse Events of Special Interests (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Withdrawal
timeFrame: Up to BD Day 181
measure: Vaccine Efficacy (VE) of mRNA-1345 to Prevent a First Episode of RSV-LRTD with 2 or More Symptoms
timeFrame: From 14 days postinjection up to 12 months postinjection
measure: VE of mRNA-1345 to Prevent a First Episode of RSV-LRTD with 3 or More Symptoms
timeFrame: From 14 days postinjection up to 12 months postinjection
measure: Geometric Mean Titer (GMT) of Serum Respiratory Syncytial Virus Subtype A (RSV-A) and Respiratory Syncytial Virus Subtype B (RSV-B) Neutralizing Antibodies
timeFrame: BD Day 29
measure: Geometric Mean Ratio (GMR) of Serum RSV-A and RSV-B Neutralizing Antibodies After BD Compared to After Initial Dose
timeFrame: BD Day 29
Secondary outcomes:
measure: VE of mRNA-1345 to Prevent a First Episode of RSV-Associated Acute Respiratory Disease (RSV-ARD)
timeFrame: From 14 days postinjection up to 12 months postinjection
measure: VE of mRNA-1345 to Prevent First Hospitalization Associated with RSV-ARD or RSV-LRTD
timeFrame: From 14 days postinjection up to 12 months postinjection
measure: GMT of Serum RSV Neutralizing Antibodies
timeFrame: Baseline through up to 24 months postinjection
measure: Geometric Mean Concentration (GMC) of Serum RSV Binding Antibodies
timeFrame: Baseline through up to 24 months postinjection
measure: Seroresponse Rate in RSV Neutralizing Antibodies
timeFrame: Baseline through up to 24 months postinjection
measure: Geometric Mean Fold-Rise (GMFR) of Postbaseline/Baseline Antibody Titers
timeFrame: Baseline through up to 24 months postinjection
measure: Proportion of Participants with ≥4-fold Increases in Antibody Titers from Baseline
timeFrame: Baseline through up to 24 months postinjection
measure: Seroresponse Rate (SRR) Difference Between Serum RSV-A and RSV-B Neutralizing Antibodies After BD Compared to After Initial Dose
timeFrame: BD Day 29
measure: GMT of Serum RSV-A and RSV-B Neutralizing Antibodies
timeFrame: BD Day 1 and Day 181
measure: GMFR of Serum RSV-A and RSV-B Neutralizing Antibodies from Pre-primary Dose (Baseline)
timeFrame: Baseline, BD Day 1, Day 29 and Day 181
measure: SRR of Serum RSV-A and RSV-B Neutralizing Antibodies from Pre-primary Dose (Baseline)
timeFrame: Baseline, BD Day 1, Day 29 and Day 181
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: AES - DRS - Synexus Clinical Research US, Inc. - Birmingham
state: Alabama
city: Birmingham
country: United States
facility: Accel Research Site - Achieve - Birmingham
state: Alabama
city: Guntersville
country: United States
facility: Lakeview Clinical Research
state: Alabama
city: Huntsville
country: United States
facility: AES - DRS - Optimal Research Alabama - Huntsville
state: Alabama
city: Hunt
country: United States
facility: Hope Research Institute LLC - Hunt - PPDS
state: Arizona
city: Hunt
country: United States
facility: Hope Research Institute LLC - Hunt - PPDS
state: Arizona
city: Mesa
country: United States
facility: Desert Clinical Research, LLC - CCT
state: Arizona
city: Phoenix
country: United States
facility: Hope Research Institute LLC - Phoenix - Hunt - PPDS
state: Arizona
city: Phoenix
country: United States
facility: AES - DRS - Synexus Clinical Research US, Inc. - Phoenix Central
state: Arizona
city: Phoenix
country: United States
facility: Synexus Clinical Research US, Inc. - Phoenix Southeast
state: Arizona
city: Tucson
country: United States
facility: Tucson Neuroscience Research - M3 WR
state: Arizona
city: Little Rock
country: United States
facility: Baptist Health Center for Clinical Research
state: Arkansas
city: Banning
country: United States
facility: Velocity Clinical Research, Banning
state: California
city: Canoga Park
country: United States
facility: Hope Clinical Research, LLC
state: California
city: Chula Vista
country: United States
facility: Velocity Clinical Research - Chula Vista - PPDS
state: California
city: Culver City
country: United States
facility: PPD Virtual - Science 37, Inc
state: California
city: La Mesa
country: United States
facility: Velocity Clinical Research, San Diego
state: California
city: Los Alamitos
country: United States
facility: PRI, LLC - Los Alamitos - M3 WR
state: California
city: Newport Beach
country: United States
facility: PRI, LLC - Newport Beach - M3 WR
state: California
city: Oxnard
country: United States
facility: FOMAT Medical Research - FOMAT - HyperCore - PPDS
state: California
city: Pomona
country: United States
facility: Reddy Care Medical
state: California
city: Redding
country: United States
facility: Paradigm Clinical Research Institute Inc - ClinEdge - PPDS
state: California
city: San Diego
country: United States
facility: Medical Center For Clinical Research - M3 WR
state: California
city: Aurora
country: United States
facility: Lynn Institute of Denver
state: Colorado
city: Fort Collins
country: United States
facility: Tekton Research - Fort Collins - PPDS
state: Colorado
city: Longmont
country: United States
facility: Tekton Research - Longmont - PPDS
state: Colorado
city: Wheat Ridge
country: United States
facility: Paradigm Clinical Research Institute Inc - ClinEdge - PPDS
state: Colorado
city: Milford
country: United States
facility: Clinical Research Consultants LLC - ClinEdge - PPDS
state: Connecticut
city: Washington
country: United States
facility: Washington Health Institute
state: District of Columbia
city: Edgewater
country: United States
facility: Velocity Clinical Research, New Smyrna Beach
state: Florida
city: Fleming Island
country: United States
facility: Fleming Island Clinical Research Center
state: Florida
city: Hallandale Beach
country: United States
facility: Velocity Clinical Research - Hallandale Beach - PPDS
state: Florida
city: Jacksonville
country: United States
facility: Jacksonville Center for Clinical Research
state: Florida
city: Lake City
country: United States
facility: Multi-Specialty Research Associates, Inc. M3 WR
state: Florida
city: Maitland
country: United States
facility: Accel Research Sites - Maitland - ERN - PPDS
state: Florida
city: Miami Beach
country: United States
facility: IMA Clinical Research - Manhattan - PPDS
state: Florida
city: Miami
country: United States
facility: Spotlight Research Center, LLC
state: Florida
city: Orlando
country: United States
facility: AES - DRS - Synexus Clinical Research US, Inc. - The Villages
state: Florida
city: Port Saint Lucie
country: United States
facility: Health Awareness Inc
state: Florida
city: Saint Petersburg
country: United States
facility: IMA Clinical Research - Saint Petersburg - PPDS
state: Florida
city: Saint Petersburg
country: United States
facility: AES - DRS - Synexus Clinical Research US, Inc. - St. Petersburg
state: Florida
city: Tampa
country: United States
facility: Clinical Trials of Tampa
state: Florida
city: West Palm Beach
country: United States
facility: Palm Beach Research - ClinEdge - PPDS
state: Florida
city: Winter Park
country: United States
facility: Clinical Site Partners - Winter Park - HyperCore -PPDS
state: Florida
city: Atlanta
country: United States
facility: Mount Vernon Clinical Research, LLC - M3 WR
state: Georgia
city: Augusta
country: United States
facility: Masters of Clinical Research Inc
state: Georgia
city: Columbus
country: United States
facility: Centricity Research - Roswell - HyperCore - PPDS
state: Georgia
city: Decatur
country: United States
facility: iResearch Atlanta
state: Georgia
city: Fayetteville
country: United States
facility: Javara, Inc./Privia Medical Group Georgia, LLC
state: Georgia
city: Marietta
country: United States
facility: Drug Studies America - ClinEdge - PPDS
state: Georgia
city: Peachtree City
country: United States
facility: Randomize Now -Commerce Dr
state: Georgia
city: Savannah
country: United States
facility: Velocity Clinical Research (Savannah - Georgia) - PPDS
state: Georgia
city: Stockbridge
country: United States
facility: Clinical Research Atlanta - ERN-PPDS
state: Georgia
city: Honolulu
country: United States
facility: East West Medical Research Institute
state: Hawaii
city: Meridian
country: United States
facility: Velocity Clinical Research - Boise - PPDS
state: Idaho
city: Chicago
country: United States
facility: AES - DRS - Synexus Clinical Research US, Inc. - Chicago
state: Illinois
city: Oak Brook
country: United States
facility: Affinity Health (Oak Brook)
state: Illinois
city: River Forest
country: United States
facility: DM Clinical - Chicago
state: Illinois
city: Evansville
country: United States
facility: AES - DRS - Synexus Clinical Research US, Inc. - Evansville
state: Indiana
city: Valparaiso
country: United States
facility: Velocity Clinical Research - Valparaiso - PPDS
state: Indiana
city: Lenexa
country: United States
facility: Johnson County Clin-Trials
state: Kansas
city: Versailles
country: United States
facility: Versailles Family Medicine - CCT - PPDS
state: Kentucky
city: Baton Rouge
country: United States
facility: Velocity Clinical Research (Baton Rouge - Louisiana) - PPDS
state: Louisiana
city: Covington
country: United States
facility: Benchmark Research - Covington - HyperCore - PPDS
state: Louisiana
city: Metairie
country: United States
facility: Benchmark Research - Metairie - HyperCore - PPDS
state: Louisiana
city: Monroe
country: United States
facility: IMA Clinical Research - Monroe, LA - PPDS
state: Louisiana
city: New Orleans
country: United States
facility: DelRicht Clinical Research, LLC - Internal - Covington - PPDS
state: Louisiana
city: Annapolis
country: United States
facility: Privia Medical Group, LLC - Annapolis - Javara - PPDS
state: Maryland
city: Gaithersburg
country: United States
facility: CBH Health - CenExel CBH - PPDS
state: Maryland
city: Rockville
country: United States
facility: Velocity Clinical Research (Rockville - Maryland) - PPDS
state: Maryland
city: Southfield
country: United States
facility: Great Lakes Research Institute
state: Michigan
city: Southfield
country: United States
facility: DM Clinical Research - Southfield - ERN - PPDS
state: Michigan
city: Minneapolis
country: United States
facility: Clinical Research Institute, Inc - CRN - PPDS
state: Minnesota
city: Richfield
country: United States
facility: AES - DRS - Synexus Clinical Research US, Inc. - Minneapolis
state: Minnesota
city: Creve Coeur
country: United States
facility: AES - DRS - Synexus Clinical Research US, Inc. - St. Louis
state: Missouri
city: Missoula
country: United States
facility: Montana Medical Research
state: Montana
city: Missoula
country: United States
facility: Boeson Research MSO - Missoula - ERN - PPDS
state: Montana
city: Elkhorn
country: United States
facility: Skyline Medical Center, PC - CCT Research
state: Nebraska
city: Fremont
country: United States
facility: Methodist Physicians Clinic - CCT Research - PPDS
state: Nebraska
city: Grand Island
country: United States
facility: Velocity Clinical Research (Grand Island - Nebraska) - PPDS
state: Nebraska
city: Lincoln
country: United States
facility: Velocity Clinical Research (Lincoln - Nebraska) - PPDS
state: Nebraska
city: Omaha
country: United States
facility: Velocity Clinical Research (Omaha - Nebraska) - PPDS
state: Nebraska
city: Papillion
country: United States
facility: CCT Research
state: Nebraska
city: Las Vegas
country: United States
facility: HEALOR Primary Care - Physicians Las Vegas - CCT
state: Nevada
city: Las Vegas
country: United States
facility: Excel Clinical Research - Las Vegas
state: Nevada
city: Raritan
country: United States
facility: IMA Clinical Research - Raritan - PPDS
state: New Jersey
city: Secaucus
country: United States
facility: Riverside Medical Group - Circuit - PPDS
state: New Jersey
city: East Syracuse
country: United States
facility: Velocity Clinical Research - East Syracuse - PPDS
state: New York
city: Endwell
country: United States
facility: Velocity Clinical Research (Endwell - New York) - PPDS
state: New York
city: Hartsdale
country: United States
facility: Drug Trials America
state: New York
city: New York
country: United States
facility: AES - DRS - Synexus Clinical Research US, Inc. - New York
state: New York
city: Rochester
country: United States
facility: Rochester Clinical Research, Inc
state: New York
city: Fayetteville
country: United States
facility: Carolina Institute for Clinical Research - M3 WR
state: North Carolina
city: Greensboro
country: United States
facility: Triad Clinical Trials
state: North Carolina
city: Wilmington
country: United States
facility: Trial Management Associates, LLC
state: North Carolina
city: Cincinnati
country: United States
facility: CTI Clinical Research
state: Ohio
city: Cincinnati
country: United States
facility: Velocity Clinical Research (Cincinnati - Ohio) - PPDS
state: Ohio
city: Cincinnati
country: United States
facility: Velocity Clinical Research - Cincinnati - PPDS
state: Ohio
city: Cincinnati
country: United States
facility: AES - DRS - Synexus Clinical Research US, Inc. - Cincinnati
state: Ohio
city: Edmond
country: United States
facility: Tekton Research - Oklahoma - PPDS
state: Oklahoma
city: Yukon
country: United States
facility: Tekton Research
state: Oklahoma
city: Portland
country: United States
facility: Summit Research Network, Inc. - Portland - Headlands - PPDS
state: Oregon
city: Hatboro
country: United States
facility: Hatboro Medical Associates - CCT - PPDS
state: Pennsylvania
city: Philadelphia
country: United States
facility: DM Clinical Research - Philadelphia - ERN - PPDS
state: Pennsylvania
city: Dakota Dunes
country: United States
facility: Velocity Clinical Research (Dakota Dunes - South Dakota) - PPDS
state: South Dakota
city: Rapid City
country: United States
facility: American Indian Clinical Trials Research Network
state: South Dakota
city: Nashville
country: United States
facility: Affinity Health - Nashville
state: Tennessee
city: Austin
country: United States
facility: Premier Family Physicians - Austin - Hunt - PPDS
state: Texas
city: Austin
country: United States
facility: Tekton Research
state: Texas
city: Brownsville
country: United States
facility: PanAmerican Clinical Research LLC
state: Texas
city: Carrollton
country: United States
facility: ACRC Trials - Carrollton - Hunt - PPDS
state: Texas
city: Fort Worth
country: United States
facility: Privia Medical Group- North Texas - West Parker Road - Fort Worth - Javara - PPDS
state: Texas
city: Friendswood
country: United States
facility: Allure Health LLC
state: Texas
city: Friendswood
country: United States
facility: Olympus Family Medicine- CCT
state: Texas
city: Frisco
country: United States
facility: Village Health Partners Frisco Medical Village
state: Texas
city: Houston
country: United States
facility: West Houston Clinical Research - Hunt - PPDS
state: Texas
city: Houston
country: United States
facility: DM Clinical Research - Bellaire - ERN - PPDS
state: Texas
city: Humble
country: United States
facility: DM Clinical-TCDD
state: Texas
city: Keller
country: United States
facility: Helios CR, Inc. - Houston - PPDS
state: Texas
city: Plano
country: United States
facility: AIM Trials
state: Texas
city: San Antonio
country: United States
facility: AES - DRS - Synexus Clinical Research US, Inc. - San Antonio
state: Texas
city: San Antonio
country: United States
facility: Clinical Trials of Texas, LLC - HyperCore - PPDS
state: Texas
city: Stephenville
country: United States
facility: Privia Medical Group- North Texas - Stephenville - Javara - PPDS
state: Texas
city: Sugar Land
country: United States
facility: DM Clinical Research - Sugarland - ERN - PPDS
state: Texas
city: Tomball
country: United States
facility: DM Clinical Research - ERN - PPDS
state: Texas
city: Tomball
country: United States
facility: DM Clinical Research - ERN
state: Texas
city: Bountiful
country: United States
facility: Cope Family Medicine - CCT - PPDS
state: Utah
city: Clinton
country: United States
facility: Alpine Research Organization, Inc
state: Utah
city: South Ogden
country: United States
facility: South Ogden Family Medicine - CCT
state: Utah
city: Newport News
country: United States
facility: Health Research of Hampton Roads Inc.
state: Virginia
city: Portsmouth
country: United States
facility: Velocity Clinical Research - Family Practice - Portsmouth - PPDS
state: Virginia
city: Renton
country: United States
facility: Rainier Clinical Research Center
state: Washington
city: Seattle
country: United States
facility: Seattle Clinical Research Center
state: Washington
city: Buenos Aires
country: Argentina
facility: Instituto Medico Platense
state: Provincial De Buenos Aires
city: Ciudad Autónoma de BuenosAires
country: Argentina
facility: Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich
city: Ciudad Autónoma de BuenosAires
country: Argentina
facility: Fundación Dr. Mario Socolinsky - Centro de Vacunación Proteger
city: Ciudad Autónoma de BuenosAires
country: Argentina
facility: Centro Medico Barrio Parque
city: Ciudad Autónoma de BuenosAires
country: Argentina
facility: Consultorios Médicos Dr. Doreski
city: Bruce
country: Australia
facility: Paratus Clinical Research - Canberra - PPDS
state: Australian Capital Territory
city: Blacktown
country: Australia
facility: Paratus Clinical Research - Western Sydney - PPDS
state: New South Wales
city: Brookvale
country: Australia
facility: Northern Beaches Clinical Research
state: New South Wales
city: Coffs Harbour
country: Australia
facility: Northside Health
state: New South Wales
city: Fortitude Valley
country: Australia
facility: Holdsworth House Medical Brisbane
state: Queensland
city: Camberwell
country: Australia
facility: Emeritus Research - PPDS
state: Victoria
city: Zakiganj
country: Bangladesh
facility: JHU-Projahnmo Zakiganj site
state: Sylhet
city: Chandpur
country: Bangladesh
facility: icddr,b Matlab Health Research Center
city: Dhaka
country: Bangladesh
facility: Icddr,b Kamalapur Field Site
city: Sylhet
country: Bangladesh
facility: JHU-Projahnmo Sylhet site
city: Diepenbeek
country: Belgium
facility: ANIMA Research Center
city: Edegem
country: Belgium
facility: Vaccinopolis
city: Erpent
country: Belgium
facility: Private Practice Dr Jean Benoit Martinot
city: Genk
country: Belgium
facility: Ziekenhuis Oost-Limburg
city: Red Deer
country: Canada
facility: CARe Clinic
state: Alberta
city: Kelowna
country: Canada
facility: Okanagan Clinical Trials - Headlands - PPDS
state: British Columbia
city: Etobicoke
country: Canada
facility: Centricity Research - Toronto - HyperCore - PPDS
state: Ontario
city: Hamilton
country: Canada
facility: Dr. Steven Z. Zizzo Medicine Professional Corporation
state: Ontario
city: Toronto
country: Canada
facility: LMC Clinical Research Inc (Bayview)
state: Ontario
city: Levis
country: Canada
facility: Centricity Research - Quebec - HyperCore - PPDS
state: Quebec
city: Sherbrooke
country: Canada
facility: Diex Recherche - Sherbrooke - PPDS
state: Quebec
city: St-Charles-Borromee
country: Canada
facility: Diex Recherche - Joilette - PPDS
state: Quebec
city: Trois-Rivieres
country: Canada
facility: Diex Recherche - Trois Rivieres - PPDS
state: Quebec
city: Québec
country: Canada
facility: Diex Recherche - Québec - PPDS
city: Osorno
country: Chile
facility: Hospital Base de Osorno
state: Region De Los Lagos
city: Quillota
country: Chile
facility: Centro Respiratorio Integral LTDA. (CENRESIN)
state: Region De Valparaiso
city: Talca
country: Chile
facility: Centro de Investigacion del Maule
state: Region Del Maule
city: Santiago
country: Chile
facility: Biomedica Research Group
state: Region Metropolitana
city: Santiago
country: Chile
facility: BIOCINETIC SpA
state: Region Metropolitana
city: Barranquilla
country: Colombia
facility: Institucion Clinica de la Costa SAS
state: Atlantico
city: Aguazul
country: Colombia
facility: Centro de Atención e Investigación Médica S.A. - CAIMED - Aguazul
state: Casanare
city: Bogota
country: Colombia
facility: Solano & Terront Servicios Médicos LTDA (UNIENDO) Bogota
state: Cundinamarca
city: Bogota
country: Colombia
facility: Centro de Atención e Investigación Médica S.A. - CAIMED - Bogota
state: Cundinamarca
city: Chia
country: Colombia
facility: Centro de Atención e Investigación Médica S.A. - CAIMED - Chia
state: Cundinamarca
city: Girardot
country: Colombia
facility: Centro de Atención e Investigación Médica S.A. - CAIMED - Girardot
state: Cundinamarca
city: Pereira
country: Colombia
facility: IPS Centro de Investigacion Clinicas Cardiomet
state: Risaralda
city: Floridablanca
country: Colombia
facility: Fundacion Oftalmologica de Santander Foscal
state: Santandar
city: Ibague
country: Colombia
facility: Centro de Atención e Investigación Médica S.A. - CAIMED - Ibague
state: Tolima
city: Cali
country: Colombia
facility: Centro Medico Imbanaco de Cali S.A.
state: Valle De Cuaca
city: Liberia
country: Costa Rica
facility: Campus Universidad EARTH, finca La Flor
state: Guanacaste
city: San José
country: Costa Rica
facility: Instituto de Investigación en Ciencias Médicas S.A.
city: San José
country: Costa Rica
facility: Hospital CIMA San Jose
city: San José
country: Costa Rica
facility: Hospital Clínica Bíblica Sede Santa Ana
city: Espoo
country: Finland
facility: Espoo Vaccine Research Clinic
city: Helsinki
country: Finland
facility: Helsinki South Vaccine Research Clinic
city: Helsinki
country: Finland
facility: Helsinki East Vaccine Research Clinic
city: Järvenpää
country: Finland
facility: Järvenpää Vaccine Research Clinic
city: Kokkola
country: Finland
facility: KokkolaVaccine Research Clinic
city: Oulu
country: Finland
facility: Oulu Vaccine Research Clinic
city: Pori
country: Finland
facility: Pori Vaccine Research Clinic
city: Seinäjoki
country: Finland
facility: Seinäjoki Vaccine Research Clinic
city: Tampere
country: Finland
facility: Tampere Vaccine Research Clinic
city: Turku
country: Finland
facility: Turku Vaccine Research Clinic
city: Frankfurt
country: Germany
facility: AES - DRS - Synexus Frankfurt Research Centre
state: Hesse
city: Frankfurt
country: Germany
facility: Infektioresearch GmbH & Co. KG
state: Hesse
city: Hannover
country: Germany
facility: Klinische Forschung Hannover-Mitte GmbH
state: Lower Saxony
city: Schwerin
country: Germany
facility: Klinische Forschung, Schwerin GmbH (KFGN)
state: Mecklenburg-West Pomerania
city: Essen
country: Germany
facility: Medizentrum Essen Borbeck
state: North Rhine-Westphalia
city: Berlin
country: Germany
facility: AES - DRS - Synexus Berlin Research Centre
city: Fukui-shi
country: Japan
facility: Fukui General Clinic
state: Fukui
city: Fukuoka-shi
country: Japan
facility: Tenjin Sogo Clinic
state: Fukuoka
city: Hakata-ku
country: Japan
facility: Boocs Clinic Fukuoka
state: Fukuoka
city: Naka-ku, Yokohama-ku
country: Japan
facility: Motomachi Takatsuka Naika Clinic
state: Kanagawa
city: Chuo-ku
country: Japan
facility: Medical Corporation Asbo Tokyo Asbo Clinic
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Center Hospital of the National Center for Global Health and Medicine
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Higashi Shinjuku Clinic
state: Tokyo
city: Suginami-ku
country: Japan
facility: NewHeart Watanabe Institute
state: Tokyo
city: Toshima-ku
country: Japan
facility: Sekino Hospital
state: Tokyo
city: Fukuoka
country: Japan
facility: SOUSEIKAI PS Clinic
city: Wonju-si
country: Korea, Republic of
facility: Yonsei University Wonju Severance Christian Hospital
state: Gangwon-do
city: Jung-gu
country: Korea, Republic of
facility: Inha University Hospital
state: Incheon
city: Gangnam-gu
country: Korea, Republic of
facility: Samsung Medical Center - PPDS
state: Seoul
city: Gangseo-gu
country: Korea, Republic of
facility: Ewha Womans University Seoul Hospital
state: Seoul
city: Busan
country: Korea, Republic of
facility: Dong-A University Hospital
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: Soon Chun Hyang University Hospital Bucheon
city: Incheon
country: Korea, Republic of
facility: Catholic Kwandong University International St. Mar
city: Seoul
country: Korea, Republic of
facility: Severance Hospital Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital, Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Hallym University Kangnam Sacred Heart Hospital
city: Guadalajara
country: Mexico
facility: Maria del rayo morfin otero
state: Jalisco
city: Monterrey
country: Mexico
facility: Accelerium, S. de R.L. de C.V.
state: Nuevo Leon
city: Chihuahua
country: Mexico
facility: Investigacion en Salud y Metabolismo S.C.
city: Ciudad De Mexcio
country: Mexico
facility: AES - AS - RM Pharma Specialists Mexico City
city: Ciudad De Mexcio
country: Mexico
facility: AES - AS - CEMDEC Mexico City
city: Durango
country: Mexico
facility: Hospital General 450
city: Querétaro
country: Mexico
facility: PanAmerican Clinical Research-Avenida
city: Christchurch
country: New Zealand
facility: Southern Clinical Trials Limited
state: Canterbury
city: Rotorua
country: New Zealand
facility: Lakeland Clinical Trials
state: Canterbury
city: Auckland
country: New Zealand
facility: Southern Clinical Trials Waitemata
city: Auckland
country: New Zealand
facility: New Zealand Clinical Research - Auckland
city: Auckland
country: New Zealand
facility: Optimal Clinical Trials Ltd
city: Nelson
country: New Zealand
facility: Southern Clinical Trials - Tasman
city: Panamá
country: Panama
facility: CEVAXIN Avenida México
state: Calidonia
city: Panamá
country: Panama
facility: CEVAXIN 24 de diciembre
city: Wroclaw
country: Poland
facility: AES - DRS - Synexus Polska Sp. z o.o. Oddzial we Wroclawiu
state: Dolnoslaskie
city: Warszawa
country: Poland
facility: AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Warszawie
state: Mazowieckie
city: Gdansk
country: Poland
facility: AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Gdansku
state: Pomorskie
city: Katowice
country: Poland
facility: AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Katowicach
state: Slaskie
city: Ostrowiec Swietokrzyski
country: Poland
facility: Ostrowieckie Centrum Medyczne Spólka Cywilna Anna Olech-Cudzik, Krzysztof Cudzik
state: Swietokrzyskie
city: Poznan
country: Poland
facility: AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Poznaniu
state: Wielkopolskie
city: Ponce
country: Puerto Rico
facility: BRCR Global Puerto Rico (Ponce)
city: San Juan
country: Puerto Rico
facility: Caribbean Medical Research Center
city: San Juan
country: Puerto Rico
facility: Proyecto ACTU
city: Singapore
country: Singapore
facility: Singapore General Hospital (SGH)
city: Benoni
country: South Africa
facility: Worthwhile Clinical Trials
state: Gauteng
city: Pretoria
country: South Africa
facility: Dr. J Breedt
state: Gauteng
city: Pretoria
country: South Africa
facility: AES - DRS - Synexus - Stanza Clinical Research Centre
state: Gauteng
city: Pretoria
country: South Africa
facility: AES - DRS - Synexus Watermeyer Clinical Research Centre
state: Gauteng
city: Umkomaas
country: South Africa
facility: Aliwal Shoal Medical Center
state: Kwazulu - Natal
city: Somerset West
country: South Africa
facility: AES - DRS - Synexus - Helderberg Clinical Research Centre
state: Western Cape
city: Centelles
country: Spain
facility: ABS Centelles
state: Barcelona
city: Son Ferriol
country: Spain
facility: Hospital Son Llatzer
state: Palma De Mallorca
city: Madrid
country: Spain
facility: Hospital Universitario de La Princesa
city: Madrid
country: Spain
facility: Hospital Universitario La Paz - PPDS
city: Valencia
country: Spain
facility: FISABIO Oftalmología Médica (FOM)
city: Taichung City
country: Taiwan
facility: China Medical University Hospital - PPDS
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
city: Taipei City
country: Taiwan
facility: Taipei Veterans General Hospital
city: Taoyuan City
country: Taiwan
facility: Chang Gung Memorial Hospital, Linkou
city: Bristol
country: United Kingdom
facility: Bristol Royal Infirmary
state: Avon
city: Chorley
country: United Kingdom
facility: AES - DRS - NW Consortium Lancashire
state: Lancashire
city: Hexham
country: United Kingdom
facility: AES - DRS - Synexus Hexham Clinical Research Centre
state: Northumberland
city: Stoke-On-Trent
country: United Kingdom
facility: Cheadle Hospital
state: Staffordshire
city: Newcastle Upon Tyne
country: United Kingdom
facility: Royal Victoria Infirmary
state: Tyne And Wear
city: Bellshill
country: United Kingdom
facility: AES - DRS - Synexus Scotland Clinical Research Centre
city: Birmingham
country: United Kingdom
facility: AES - DRS - Synexus Midlands Clinical Research Centre
city: Blackpool
country: United Kingdom
facility: Layton Medical Centre
city: Cardiff
country: United Kingdom
facility: AES - DRS - Synexus Wales Clinical Research Centre
city: Liverpool
country: United Kingdom
facility: AES - DRS - NW Consortium Merseyside
city: Manchester
country: United Kingdom
facility: AES - DRS - NW Consortium Manchester
Study officials:
References: