Clinical trial NCT04908683: A Study of an Adenovirus Serotype 26 Pre-fusion Conformation-stabilized F Protein (Ad26. RSV. preF) Based Respiratory Syncytial Virus (RSV) Vaccine in the Prevention of Lower Respiratory Tract Disease in Adults Aged 60 Years and Older
Official title: A Randomized, Double-blind, Placebo-controlled Phase 3 Efficacy Study of an Ad26.RSV.preF-based Vaccine in the Prevention of Lower Respiratory Tract Disease Caused by RSV in Adults Aged 60 Years and Older
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Respiratory Syncytial Viruses
Lower Respiratory Tract Disease
Keywords: Acute Respiratory Infections
Vaccine
Ad26.RSV.preF-based Vaccine
Lead sponsor: Janssen Vaccines & Prevention B.V.
Sponsor class: INDUSTRY
First posted: 2021-06-01
Enrollment: 25236
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 study will enroll up to 27,200 participants in order to demonstrate the efficacy of the active Ad26.RSV.preF-based study vaccine in the prevention of Reverse Transcription Polymerase Chain Reaction (RT-PCR) confirmed Respiratory Syncytial Virus (RSV)-mediated Lower Respiratory Tract Disease (LRTD) when compared to placebo in adults aged 60 years and above.


Eligibility criteria: Inclusion Criteria:

* Must be able to work with smartphones/tablets/computers
* From the time of vaccination through 3 months after vaccination, participant agrees not to donate blood
* Must be willing to provide verifiable identification, has means to be contacted and to contact the investigator during the study
* Before randomization, a participant must be: a. postmenopausal (postmenopausal state is defined as no menses for 12 months without an alternative medical cause); and b. not intending to conceive by any methods
* Participants must sign an Inform Consent Form (ICF) indicating that the participant understands the purpose, procedures and potential risks and benefits of the study, and is willing to participate in the study

Exclusion Criteria:

* Has a serious clinically unstable condition, (example, end-stage renal disease with or without dialysis, clinically unstable cardiac disease), Alzheimer's disease, or any other condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (example, compromise well-being) or that could prevent, confound, or limit the protocol specified assessments
* History of malignancy within 5 years before screening not in the following categories: a. Participants with squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix may be enrolled at the discretion of the investigator; b. Participants with a history of malignancy within 5 years, which is considered cured with minimal risk of recurrence per investigator's judgement, can be enrolled
* Had major surgery (example, major cardiopulmonary or abdominal operations) as per the investigator's judgment within 4 weeks before vaccination, or will not have fully recovered from surgery, or has major surgery planned during the time the participant is expected to participate in the study
* Employee of the investigator or study site, with direct involvement in the proposed study or other studies under the direction of that investigator or study site, as well as family members of the employees or the investigator, or an employee of the sponsor
* Contraindication to Intramuscular (IM) injections and blood draws (example, bleeding disorders)
* Known or suspected allergy or history of anaphylaxis or other serious adverse reactions to vaccines or vaccine components (including any of the constituents of the study vaccine)

Primary outcomes:
measure: Number of Participants With First Occurrence of Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)-Confirmed Respiratory Syncytial Virus (RSV) Mediated Lower Respiratory Tract Disease (LRTD)
timeFrame: From Baseline (Day 1) up to 12 months
Secondary outcomes:
measure: Number of Participants With First Occurrence of Any RT-PCR-Confirmed RSV-mediated Acute Respiratory Infection (ARI)
timeFrame: From Baseline (Day 1) up to 12 months
measure: Number of Participants With First Occurrence of RT-PCR-Confirmed RSV Mediated LRTD During the Second Year
timeFrame: From Month 12 up to Month 24
measure: Number of Participants With First Occurrence of Any RT-PCR-Confirmed RSV Mediated ARI During the Second Year
timeFrame: From Month 12 up to Month 24
measure: Number of Participants With First Occurrence of Predefined Clinically Relevant Disease Associated With RT-PCR-Confirmed RSV-Mediated ARI Over the Whole Study
timeFrame: Baseline (Day 1) up to 24 months
measure: Number of Participants With Serious Adverse Events (SAEs)
timeFrame: 28 days post vaccination on Day 1 (Day 29); First year follow-up (from Day 29 up to 6 months, that is, up to Day 154)
measure: Number of Participants With Potential Adverse Events of Special Interest (AESIs)
timeFrame: 28 days post vaccination on Day 1 (Day 29); First year follow-up (from Day 29 up to 6 months, that is, up to Day 154)
measure: Number of Participants With Solicited Local Adverse Events (AEs) up to 7 Days After Vaccination
timeFrame: Up to Day 7 post vaccination on Day 1 (up to Day 8)
measure: Number of Participants With Solicited Systemic AEs up to 7 Days After Vaccination
timeFrame: Up to Day 7 post vaccination on Day 1 (up to Day 8)
measure: Number of Participants With Unsolicited AEs up to 28 Days After Vaccination
timeFrame: Up to 28 days post vaccination on Day 1 (up to Day 29)
measure: Respiratory Syncytial Virus (RSV) A2 Strain Neutralization Antibody Titers at 14 Days Post Vaccination
timeFrame: At 14 Days post vaccination on Day 1 (Day 15)
measure: Geometric Mean Titers (GMTs) of Prefusion F-protein (Pre-F) Antibodies Immunoglobulin G (IgG) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at 14 Days Post Vaccination
timeFrame: At 14 days post vaccination on Day 1 (Day 15)
measure: T-cell Interferon (IFN) Gamma Responses to Respiratory Syncytial Virus (RSV) F Protein Peptides Analyzed by Enzyme-linked Immunospot Assay (ELISpot)
timeFrame: 14 days post vaccination on Day 1 (Day 15)
measure: Area Under the Curve (AUC) of the Change From Baseline in Respiratory Infection Intensity and Impact Questionnaire (RiiQ) Total Symptom Scale Score
timeFrame: Baseline (Day 1) up to 24 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Central Research Associates, Inc.
state: Alabama
city: Birmingham
country: United States
facility: Synexus Clinical Research US Inc
state: Alabama
city: Birmingham
country: United States
facility: Achieve Clinical Research, LLC
state: Alabama
city: Huntsville
country: United States
facility: Optimal Research
state: Alabama
city: Mobile
country: United States
facility: Coastal Clinical Research, Inc
state: Alabama
city: Chandler
country: United States
facility: Synexus Clinical Research US Inc
state: Arizona
city: Peoria
country: United States
facility: Hope Research Institute
state: Arizona
city: Phoenix
country: United States
facility: Central Phoenix Medical Clinic
state: Arizona
city: Phoenix
country: United States
facility: Medpharmics, LLC
state: Arizona
city: Tempe
country: United States
facility: Clinical Research Consortium Arizona
state: Arizona
city: Tucson
country: United States
facility: Synexus Clinical Research US Inc
state: Arizona
city: Little Rock
country: United States
facility: Baptist Health Center For Clinical Research
state: Arkansas
city: Banning
country: United States
facility: Rancho Paseo Medical Group
state: California
city: Canoga Park
country: United States
facility: Hope clinical Research LLC
state: California
city: Cerritos
country: United States
facility: Synexus Clinical Research US Inc
state: California
city: Chula Vista
country: United States
facility: eStudySite
state: California
city: La Mesa
country: United States
facility: Velocity Clinical Research, San Diego
state: California
city: Redding
country: United States
facility: Paradigm Clinical Research Centers, Inc.
state: California
city: San Diego
country: United States
facility: Optimal Research
state: California
city: Spring Valley
country: United States
facility: Encompass Clinical Research
state: California
city: Vista
country: United States
facility: Synexus Clinical Research US Inc
state: California
city: Aurora
country: United States
facility: Synexus Clinical Research US Inc
state: Colorado
city: Fort Collins
country: United States
facility: Tekton Research Inc.
state: Colorado
city: Longmont
country: United States
facility: Tekton Research Inc.
state: Colorado
city: Wheat Ridge
country: United States
facility: Paradigm Clinical Research Centers, Inc.
state: Colorado
city: Atlantis
country: United States
facility: JEM Research LLC
state: Florida
city: Coral Gables
country: United States
facility: Clinical Research of South Florida, an AMR Company
state: Florida
city: Coral Gables
country: United States
facility: Prestige Clinical Research Center, Inc.
state: Florida
city: DeLand
country: United States
facility: Avail Clinical Research, LLC
state: Florida
city: Edgewater
country: United States
facility: Velocity Clinical Research, Inc.
state: Florida
city: Fort Myers
country: United States
facility: AMR Fort Myers Clinical Physiology Associates, an AMR company
state: Florida
city: Hallandale Beach
country: United States
facility: Velocity Clinical Research, Hallandale Beach
state: Florida
city: Jacksonville
country: United States
facility: Westside Center for Clinical Research
state: Florida
city: Jacksonville
country: United States
facility: Jacksonville Center For Clinical Research
state: Florida
city: Lake Worth
country: United States
facility: Altus Research, Inc
state: Florida
city: Lakeland
country: United States
facility: Accel Research Sites
state: Florida
city: Leesburg
country: United States
facility: Compass Research LLC
state: Florida
city: Melbourne
country: United States
facility: Optimal Research
state: Florida
city: Miami
country: United States
facility: Suncoast Research Group
state: Florida
city: Miami
country: United States
facility: New Horizon Research Center
state: Florida
city: Miami
country: United States
facility: Suncoast Research Associates, LLC
state: Florida
city: Miami
country: United States
facility: Clinical Site Partners, LLC
state: Florida
city: North Miami Beach
country: United States
facility: Harmony Clinical Research Inc
state: Florida
city: North Miami
country: United States
facility: Healthcare Clinical Data Inc.
state: Florida
city: Orlando
country: United States
facility: Clinical NeuroScience Solutions Inc
state: Florida
city: Orlando
country: United States
facility: Headlands Research Orlando
state: Florida
city: Orlando
country: United States
facility: Synexus Clinical Research US Inc
state: Florida
city: Pinellas Park
country: United States
facility: Synexus Clinical Research US Inc
state: Florida
city: Port Orange
country: United States
facility: Progressive Medical Research
state: Florida
city: Saint Petersburg
country: United States
facility: Sandhill Research
state: Florida
city: Tamarac
country: United States
facility: DBC Research
state: Florida
city: West Palm Beach
country: United States
facility: Palm Beach Research Center
state: Florida
city: Atlanta
country: United States
facility: Synexus Clinical Research US Inc
state: Georgia
city: Atlanta
country: United States
facility: Atlanta Center for Medical Research
state: Georgia
city: Eatonton
country: United States
facility: Accel Research Sites
state: Georgia
city: Savannah
country: United States
facility: Meridian Clinical Research, LLC
state: Georgia
city: Stockbridge
country: United States
facility: Clinical Research Atlanta
state: Georgia
city: Boise
country: United States
facility: Advanced Clinical Research
state: Idaho
city: Champaign
country: United States
facility: Christie Clinic
state: Illinois
city: Chicago
country: United States
facility: Synexus Clinical Research US Inc
state: Illinois
city: Peoria
country: United States
facility: Optimal Research
state: Illinois
city: Evansville
country: United States
facility: Medisphere Medical Research Center, Llc
state: Indiana
city: South Bend
country: United States
facility: The South Bend Clinic Center for Research
state: Indiana
city: Valparaiso
country: United States
facility: Buynak Clinical Research
state: Indiana
city: West Des Moines
country: United States
facility: The Iowa Clinic, P.C.
state: Iowa
city: Augusta
country: United States
facility: Heartland Research Associates, LLC
state: Kansas
city: Lenexa
country: United States
facility: Johnson County Clin-Trials
state: Kansas
city: Newton
country: United States
facility: Heartland Research Associates, LLC
state: Kansas
city: Wichita
country: United States
facility: Heartland Clinical Research
state: Kansas
city: Lexington
country: United States
facility: Central Kentucky Research Associates, Inc.
state: Kentucky
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
city: Kenner
country: United States
facility: Medpharmics, LLC
state: Louisiana
city: Lafayette
country: United States
facility: Medpharmics, LLC
state: Louisiana
city: Lake Charles
country: United States
facility: Centex Studies, Inc.
state: Louisiana
city: Monroe
country: United States
facility: Clinical Trials of America
state: Louisiana
city: New Orleans
country: United States
facility: Tulane University School of Medicine
state: Louisiana
city: New Orleans
country: United States
facility: AMR New Orleans, Formerly New Orleans Center for Clinical Research - New Orleans, an AMR company
state: Louisiana
city: Lewiston
country: United States
facility: Central Maine Medical Center
state: Maine
city: Elkridge
country: United States
facility: Centennial Medical Group
state: Maryland
city: Rockville
country: United States
facility: Optimal Research
state: Maryland
city: Richfield
country: United States
facility: Synexus Clinical Research US Inc
state: Minnesota
city: Biloxi
country: United States
facility: MedPharmics - Biloxi
state: Mississippi
city: Jefferson City
country: United States
facility: Jefferson City Medical Group Family
state: Missouri
city: Kansas City
country: United States
facility: The Center for Pharmaceutical Research (CPR)
state: Missouri
city: Saint Louis
country: United States
facility: Sundance Clinical Research
state: Missouri
city: Saint Louis
country: United States
facility: Synexus Clinical Research US Inc
state: Missouri
city: Butte
country: United States
facility: Mercury Street Medical Group, PLLC
state: Montana
city: Norfolk
country: United States
facility: Meridian Clinical Research, LLC
state: Nebraska
city: Omaha
country: United States
facility: Meridian Clinical Research - Omaha
state: Nebraska
city: Omaha
country: United States
facility: Synexus Clinical Research US Inc
state: Nebraska
city: Henderson
country: United States
facility: Synexus Clinical Research US Inc
state: Nevada
city: Las Vegas
country: United States
facility: Clinical Research Consortium, an AMR company
state: Nevada
city: Albuquerque
country: United States
facility: Medpharmics, LLC
state: New Mexico
city: Bronx
country: United States
facility: CHEAR Center, LLC
state: New York
city: Endwell
country: United States
facility: Meridian Clinical Research, LLC
state: New York
city: Endwell
country: United States
facility: Regional Clinical Research, Inc.
state: New York
city: Manhattan
country: United States
facility: Synexus Clinical Research US Inc
state: New York
city: New York
country: United States
facility: Harlem Hospital Center
state: New York
city: Rochester
country: United States
facility: Finger Lakes Clinical Research
state: New York
city: Staten Island
country: United States
facility: Richmond Behavioral Associates
state: New York
city: Cary
country: United States
facility: Accellacare Research of Cary
state: North Carolina
city: Charlotte
country: United States
facility: American Health Network, LLC
state: North Carolina
city: Durham
country: United States
facility: M3-Emerging Medical Research
state: North Carolina
city: Greensboro
country: United States
facility: Medication Management LLC
state: North Carolina
city: Monroe
country: United States
facility: Monroe Biomedical Research
state: North Carolina
city: Raleigh
country: United States
facility: Accellacare Research of Cary
state: North Carolina
city: Raleigh
country: United States
facility: Wake Research Associates
state: North Carolina
city: Wilmington
country: United States
facility: PMG Research of Wilmington, LLC
state: North Carolina
city: Wilmington
country: United States
facility: Trial Management Associates, LLC
state: North Carolina
city: Winston-Salem
country: United States
facility: Accellacare Research of Cary
state: North Carolina
city: Akron
country: United States
facility: Synexus Clinical Research US Inc
state: Ohio
city: Cincinnati
country: United States
facility: Synexus Clinical Research US Inc
state: Ohio
city: Cincinnati
country: United States
facility: Velocity Clinical Research
state: Ohio
city: Cleveland
country: United States
facility: Rapid Medical Research
state: Ohio
city: Columbus
country: United States
facility: Synexus Clinical Research US Inc
state: Ohio
city: Norman
country: United States
facility: Lynn Institute of Norman
state: Oklahoma
city: Oklahoma City
country: United States
facility: Lynn Health Science Institute
state: Oklahoma
city: Yukon
country: United States
facility: Tekton Research Inc.
state: Oklahoma
city: Grants Pass
country: United States
facility: Clinical Research Institute of Southern Oregon, P.C.
state: Oregon
city: Medford
country: United States
facility: Clinical Research Institute of Southern Oregon, P.C.
state: Oregon
city: Pittsburgh
country: United States
facility: Preferred Primary Care Physicians Research
state: Pennsylvania
city: Uniontown
country: United States
facility: Preferred Primary Care Physicians Research
state: Pennsylvania
city: Warwick
country: United States
facility: Omega Medical Research
state: Rhode Island
city: Anderson
country: United States
facility: Synexus Clinical Research US Inc
state: South Carolina
city: Gaffney
country: United States
facility: Velocity Clinical Research, Inc.
state: South Carolina
city: Mount Pleasant
country: United States
facility: Coastal Carolina Research Center
state: South Carolina
city: Mount Pleasant
country: United States
facility: PMG Research of Charleston, LLC
state: South Carolina
city: Spartanburg
country: United States
facility: Spartanburg Medical Research
state: South Carolina
city: Spartanburg
country: United States
facility: VitaLink Research Spartanburg
state: South Carolina
city: Dakota Dunes
country: United States
facility: Meridian Clinical Research - Dakota Dunes
state: South Dakota
city: Bristol
country: United States
facility: PMG Research of Bristol
state: Tennessee
city: Knoxville
country: United States
facility: VGR & NOCCR - Knoxville
state: Tennessee
city: Nashville
country: United States
facility: Clinical Research Associates Inc
state: Tennessee
city: Austin
country: United States
facility: Central Texas Clinical Research
state: Texas
city: Austin
country: United States
facility: Optimal Research
state: Texas
city: Austin
country: United States
facility: Tekton Research Inc.
state: Texas
city: Beaumont
country: United States
facility: Tekton Research Inc.
state: Texas
city: Cedar Park
country: United States
facility: Advanced Clinical Research
state: Texas
city: Dallas
country: United States
facility: Synexus Clinical Research US Inc
state: Texas
city: Dallas
country: United States
facility: North Texas Infectious Diseases Consultants
state: Texas
city: Houston
country: United States
facility: Vilo Research Group Inc
state: Texas
city: Houston
country: United States
facility: Texas Center for Drug Development Inc
state: Texas
city: Plano
country: United States
facility: Research Your Health
state: Texas
city: San Antonio
country: United States
facility: Clinical Trials of Texas Inc
state: Texas
city: San Antonio
country: United States
facility: Synexus Clinical Research US Inc
state: Texas
city: San Antonio
country: United States
facility: Tekton Research Inc.
state: Texas
city: Tomball
country: United States
facility: DM Clinical Research
state: Texas
city: Tomball
country: United States
facility: Martine Diagnostic Clinic
state: Texas
city: Layton
country: United States
facility: Synexus Clinical Research US Inc
state: Utah
city: Murray
country: United States
facility: Synexus Clinical Research US Inc
state: Utah
city: West Jordan
country: United States
facility: Advanced Clinical Research
state: Utah
city: Charlottesville
country: United States
facility: Charlottesville Medical Research Center, LLC
state: Virginia
city: Danville
country: United States
facility: Spectrum Medical, Inc
state: Virginia
city: Newport News
country: United States
facility: Health Research of Hampton Roads, Inc
state: Virginia
city: Norfolk
country: United States
facility: Clinical Research Associates of Tidewater
state: Virginia
city: Winchester
country: United States
facility: Amherst Family Practice, PC
state: Virginia
city: Bruce
country: Australia
facility: Paratus Clinical Canberra Clinic
city: Coffs Harbour
country: Australia
facility: Northside Health
city: Kanwal
country: Australia
facility: Paratus Clinical Kanwal Clinic
city: South Brisbane
country: Australia
facility: Mater Hospital Brisbane
city: Boa Vista
country: Brazil
facility: UFRR - Universidade Federal de Roraima
city: Juiz de Fora
country: Brazil
facility: CMIP - Centro Mineiro de Pesquisa Ltda
city: Porto Alegre
country: Brazil
facility: Hospital das Clinicas de Porto Alegre
city: Sao Jose do Rio Preto
country: Brazil
facility: Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto Hospital de Base
city: São Paulo
country: Brazil
facility: CPQuali Pesquisa Clinica LTDA ME
city: Kelowna
country: Canada
facility: Okanagan Clinical Trials
state: British Columbia
city: Burlington
country: Canada
facility: LMC Clinical Research dba Manna Research Inc. Burlington
state: Ontario
city: Toronto
country: Canada
facility: LMC Clinical Research Inc. (Bayview)
state: Ontario
city: Toronto
country: Canada
facility: LMC Clinical Research dba Manna Research Inc. Toronto
state: Ontario
city: Levis
country: Canada
facility: LMC Clinical Research dba Manna Research Inc. Quebec City
state: Quebec
city: Pointe Claire
country: Canada
facility: LMC Clinical Research dba Manna Research Inc. Montreal
state: Quebec
city: Saint-Charles-Borromee
country: Canada
facility: DIEX Recherche Joliette Inc.
state: Quebec
city: Sherbrooke
country: Canada
facility: DIEX Recherche Sherbrooke Inc
state: Quebec
city: Victoriaville
country: Canada
facility: DIEX Recherche Victoriaville Inc.
state: Quebec
city: Quebec
country: Canada
facility: DIEX Recherche Quebec Inc.
city: Quilota
country: Chile
facility: CENRESIN
city: Santiago
country: Chile
facility: Centro de Estudios Clínicos e Investigación Médica (CeCim)
city: Talca
country: Chile
facility: Centro de Investigacion del Maule
city: Lianyungang
country: China
facility: Donghai County Center for Disease prevention and Control
city: Yancheng
country: China
facility: Funing County Center for Disease Control and Prevention
city: Yancheng
country: China
facility: Binhai County Center for Disease Control and Prevention
city: Tallinn
country: Estonia
facility: OU Innomedica
city: Tallinn
country: Estonia
facility: Center for Clinical and Basic Research
city: Tartu
country: Estonia
facility: Clinical Research Centre
city: Espoo
country: Finland
facility: Espoon rokotetutkimusklinikka
city: Helsinki
country: Finland
facility: Etelä-Helsingin rokotetutkimusklinikka
city: Helsinki
country: Finland
facility: Itä-Helsingin rokotetutkimusklinikka
city: Järvenpää
country: Finland
facility: Järvenpään rokotetutkimusklinikka
city: Kokkola
country: Finland
facility: Kokkolan rokotetutkimusklinikka
city: Oulu
country: Finland
facility: Oulun rokotetutkimusklinikka
city: Pori
country: Finland
facility: Porin rokotetutkimusklinikka
city: Seinäjoki
country: Finland
facility: Seinäjoen rokotetutkimusklinikka
city: Tampere
country: Finland
facility: Tampereen rokotetutkimusklinikka
city: Turku
country: Finland
facility: Turun rokotetutkimusklinikka
city: Auckland
country: New Zealand
facility: Southern Clinical Trials Totara Clinical Research
city: Auckland
country: New Zealand
facility: Southern Clinical Trials, Waitemata
city: Auckland
country: New Zealand
facility: Optimal Clinical Trials
city: Christchurch
country: New Zealand
facility: Southern Clinical Trials, Christchurch
city: Hamilton
country: New Zealand
facility: Lakeland Clinical Trials
city: Havelock North
country: New Zealand
facility: P3 Research Ltd
city: Main Road Stoke
country: New Zealand
facility: Southern Clinical Trials Tasman
city: Palmerston North
country: New Zealand
facility: P3 Research Ltd
city: Paraparaumu
country: New Zealand
facility: P3 Research Limited Kapiti
city: Rotorua
country: New Zealand
facility: Lakeland Clinical Trials
city: Tauranga
country: New Zealand
facility: P3 Research Ltd
city: Upper Hutt
country: New Zealand
facility: Lakeland Clinical Trials
city: Wellington
country: New Zealand
facility: P3 Reaearch Wellington
city: Czestochowa
country: Poland
facility: Synexus Polska Sp. z o.o. Oddzial w Czestochowie
city: Gdansk
country: Poland
facility: Synexus Polska Sp. z o.o. Oddzial w Gdansku
city: Gdynia
country: Poland
facility: Synexus Scm Sp Z o o Oddzial Gdynia
city: Katowice
country: Poland
facility: Synexus Polska Sp z o o Oddzial w Katowicach
city: Lodz
country: Poland
facility: Synexus Polska Sp z o o
city: Lublin
country: Poland
facility: KO MED Centra Kliniczne LUBLIN
city: Poznan
country: Poland
facility: Synexus Polska Sp. z.o.o. Oddzial w Poznaniu
city: Pulawy
country: Poland
facility: KO MED Centra Kliniczne Pulawy
city: Skorzewo
country: Poland
facility: Centrum Medyczne Pratia Poznan
city: Staszow
country: Poland
facility: KO-MED Centra Kliniczne Staszow
city: Warszawa
country: Poland
facility: Synexus Polska Sp z o o Oddzial w Warszawie
city: Wroclaw
country: Poland
facility: Synexus Polska Sp z o o Oddzial we Wroclawiu
city: Zamosc
country: Poland
facility: KO MED Centra Kliniczne Zamosc
city: Bloemfontein
country: South Africa
facility: Iatros International
city: Bloemfontein
country: South Africa
facility: Josha Research
city: Brits
country: South Africa
facility: Madibeng Centre for Research
city: Cape Town
country: South Africa
facility: Synexus Helderberg Clinical Research Centre
city: Cape Town
country: South Africa
facility: TREAD Research Tygerberg Hospital
city: Cape Town
country: South Africa
facility: TASK Central
city: Cape Town
country: South Africa
facility: Tiervlei Trial Centre
city: Cape Town
country: South Africa
facility: Allergy Immunology Unit
city: East London
country: South Africa
facility: Synergy Biomed Research Institute (SBRI)
city: George
country: South Africa
facility: TASK Central
city: Johannesburg
country: South Africa
facility: CRISMO Bertha Gxowa Research Centre
city: Johannesburg
country: South Africa
facility: Worthwhile Clinical trials
city: Johannesburg
country: South Africa
facility: Clinresco Centres Pty Ltd
city: Krugersdorp
country: South Africa
facility: DJW Research
city: Mamelodi East
country: South Africa
facility: Stanza Clinical Research Centre : Mamelodi
city: Newtown
country: South Africa
facility: Newtown Clinical Research
city: Paarl
country: South Africa
facility: Paarl Research Centre
city: Pretoria
country: South Africa
facility: Global Clin Trials Pretoria
city: Pretoria
country: South Africa
facility: Synexus Watermeyer
city: Rustenburg
country: South Africa
facility: The Aurum Institute Rustenburg Clinical Research Site
city: Vosloorus
country: South Africa
facility: REIMED Vosloorus
city: Welkom
country: South Africa
facility: Welkom Clinical Trial Centre
city: Western Cape
country: South Africa
facility: Be Part Yoluntu Centre
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung Ho Memorial Hospital
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Taipei City
country: Taiwan
facility: Taipei Medical University
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Taipei
country: Taiwan
facility: Tri-Service General Hospital
city: Taipei
country: Taiwan
facility: Taipei Municipal Wanfang Hospital
city: Taoyuan County
country: Taiwan
facility: Chang Gung Memorial Hospital- Linkou
city: Bangkok
country: Thailand
facility: Royal Thai Army, Afrims
city: Bangkok
country: Thailand
facility: The Vaccine Trial Center(VTC), Faculty of Tropical Medicine
city: Bangkok
country: Thailand
facility: Siriraj Hospital
city: Khon Kaen
country: Thailand
facility: Srinagarind Hospital
city: Muang
country: Thailand
facility: Maharaj Nakorn Chiang Mai hospital Faculty of Medicine
city: Pathumwan
country: Thailand
facility: King Chulalongkorn Memorial Hospital
city: Birmingham
country: United Kingdom
facility: Synexus Midlands Clinical Research Centre
city: Birmingham
country: United Kingdom
facility: FutureMeds Soho Health Centre
city: Bradford
country: United Kingdom
facility: Bradford Royal Infirmary
city: Bromborough
country: United Kingdom
facility: FutureMeds Bridle Clinic
city: Cardiff
country: United Kingdom
facility: Synexus Wales Clinical Research Center
city: Chorley
country: United Kingdom
facility: Synexus Lancashire Clinical Research Centre
city: Glasgow
country: United Kingdom
facility: Panthera Biopartners
city: Glasgow
country: United Kingdom
facility: Synexus Scotland Clinical Research Centre
city: Hexham
country: United Kingdom
facility: Synexus Hexham General Hospital
city: Liverpool
country: United Kingdom
facility: Synexus Merseyside Clinical Research Centre
city: Manchester
country: United Kingdom
facility: Synexus Manchester Clinical Research Center
city: Manchester
country: United Kingdom
facility: North Manchester General Hospital
city: Preston
country: United Kingdom
facility: Panthera Biopartners
city: Reading
country: United Kingdom
facility: Panthera Biopartners
city: Stockton on Tees
country: United Kingdom
facility: University Hospital of North Tees
Study officials:
affiliation: Janssen Vaccines & Prevention B.V.
name: Janssen Vaccines & Prevention B.V. Clinical Trial
role: STUDY_DIRECTOR
References: