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 (EVERGREEN)
February 7, 2024 updated by: Janssen Vaccines & Prevention B.V.
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
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.
Study Overview
Status
Completed
Study Type
Interventional
Enrollment (Actual)
25236
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Study Contact
- Phone Number: 844-434-4210
- Email: Participate-In-This-Study@its.jnj.com
Study Locations
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Bruce, Australia, 2617
- Paratus Clinical Canberra Clinic
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Coffs Harbour, Australia, 2450
- Northside Health
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Kanwal, Australia, 2059
- Paratus Clinical Kanwal Clinic
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South Brisbane, Australia, 4101
- Mater Hospital Brisbane
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Boa Vista, Brazil, 69304-000
- UFRR - Universidade Federal de Roraima
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Juiz de Fora, Brazil, 36010-570
- CMIP - Centro Mineiro de Pesquisa Ltda
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Porto Alegre, Brazil, 90035-903
- Hospital das Clinicas de Porto Alegre
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Sao Jose do Rio Preto, Brazil, 15090-000
- Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto - Hospital de Base
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São Paulo, Brazil, 01228-900
- CPQuali Pesquisa Clinica LTDA ME
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Quebec, Canada, G1N 4V3
- Diex Recherche Quebec Inc.
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British Columbia
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Kelowna, British Columbia, Canada, V1Y 1Z9
- Okanagan Clinical Trials
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Ontario
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Burlington, Ontario, Canada, L7R 1E2
- LMC Clinical Research dba Manna Research Inc. Burlington
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Toronto, Ontario, Canada, M4G 3E8
- LMC Clinical Research Inc. (Bayview)
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Toronto, Ontario, Canada, M9W 4L6
- LMC Clinical Research dba Manna Research Inc. Toronto
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Quebec
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Levis, Quebec, Canada, G6W 0M5
- LMC Clinical Research dba Manna Research Inc. Quebec City
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Pointe Claire, Quebec, Canada, H9R 4S3
- LMC Clinical Research dba Manna Research Inc. Montreal
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Saint-Charles-Borromee, Quebec, Canada, J6E 2B4
- Diex Recherche Joliette Inc.
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Sherbrooke, Quebec, Canada, J1L 0H8
- Diex Recherche Sherbrooke Inc.
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Victoriaville, Quebec, Canada, G6P 6P6
- Diex Recherche Victoriaville Inc.
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Quilota, Chile, 2260734
- CENRESIN
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Santiago, Chile, 8331143
- Centro de Estudios Clínicos e Investigación Médica (CeCim)
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Talca, Chile, 3465586
- Centro de Investigación del Maule
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Lianyungang, China, 222200
- Donghai County Center for Disease prevention and Control
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Nanjing, China, 210009
- Jiangsu Provincial Center for Disease Control and Prevention
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Yancheng, China, 224435
- Funing County Center for Disease Control and Prevention
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Yancheng, China, 224554
- Binhai County Center for Disease Control and Prevention
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Tallinn, Estonia, 10117
- OU Innomedica
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Tallinn, Estonia, 10128
- Center for Clinical and Basic Research
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Tartu, Estonia, 50106
- Clinical Research Centre
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Espoo, Finland, 2230
- Espoon rokotetutkimusklinikka
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Helsinki, Finland, 00100
- Etelä-Helsingin rokotetutkimusklinikka
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Helsinki, Finland, 00930
- Itä-Helsingin rokotetutkimusklinikka
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Järvenpää, Finland, 04400
- Järvenpään rokotetutkimusklinikka
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Kokkola, Finland, 67100
- Kokkolan rokotetutkimusklinikka
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Oulu, Finland, 90220
- Oulun rokotetutkimusklinikka
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Pori, Finland, 28100
- Porin rokotetutkimusklinikka
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Seinäjoki, Finland, 60100
- Seinäjoen rokotetutkimusklinikka
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Tampere, Finland, 33100
- Tampereen rokotetutkimusklinikka
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Turku, Finland, 20520
- Turun rokotetutkimusklinikka
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Auckland, New Zealand, 1010
- Optimal Clinical Trials
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Auckland, New Zealand, 0600
- Southern Clinical Trials Totara Clinical Research
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Auckland, New Zealand, 0626
- Southern Clinical Trials, Waitemata
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Christchurch, New Zealand, 8013
- Southern Clinical Trials, Christchurch
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Hamilton, New Zealand, 3200
- Lakeland Clinical Trials
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Havelock North, New Zealand, 3410
- P3 Research Ltd
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Main Road Stoke, New Zealand, 7011
- Southern Clinical Trials Tasman
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Palmerston North, New Zealand, 4414
- P3 Research Ltd
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Paraparaumu, New Zealand, 5032
- P3 Research Limited Kapiti
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Rotorua, New Zealand, 3010
- Lakeland Clinical Trials
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Tauranga, New Zealand, 3110
- P3 Research Ltd
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Upper Hutt, New Zealand, 5018
- Lakeland Clinical Trials
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Wellington, New Zealand, 6021
- P3 Reaearch Wellington
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Czestochowa, Poland, 42-202
- Synexus Polska Sp. z o.o. Oddzial w Czestochowie
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Gdansk, Poland, 80-382
- Synexus Polska Sp. z o.o. Oddzial w Gdansku
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Gdynia, Poland, 81-537
- Synexus Scm Sp. Z o.o. Oddzial Gdynia
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Katowice, Poland, 40-040
- Synexus Polska Sp. Z O.O. Oddzial W Katowicach
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Lodz, Poland, 90-127
- Synexus Polska Sp. z o.o.
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Lublin, Poland, 20-362
- KO-MED Centra Kliniczne LUBLIN
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Poznan, Poland, 60-702
- Synexus Polska Sp. z.o.o. Oddzial w Poznaniu
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Pulawy, Poland, 24-100
- KO-MED Centra Kliniczne Puławy
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Skorzewo, Poland, 60-185
- Centrum Medyczne Pratia Poznan
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Staszow, Poland, 28-200
- KO-MED Centra Kliniczne Staszow
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Warszawa, Poland, 623832
- Synexus Polska Sp. z o.o. Oddzial w Warszawie
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Wrocław, Poland, 50-381
- Synexus Polska Sp. Z O.O. Oddzial We Wroclawiu
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Zamosc, Poland, 22-400
- KO-MED Centra Kliniczne Zamosc
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Bloemfontein, South Africa, 9301
- Iatros International
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Bloemfontein, South Africa, 9301
- Josha Research
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Brits, South Africa, 250
- Madibeng Centre for Research
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Cape Town, South Africa, 7130
- Synexus Helderberg Clinical Research Centre
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Cape Town, South Africa, 7530
- TASK Central
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Cape Town, South Africa, 7500
- TREAD Research Tygerberg Hospital
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Cape Town, South Africa, 7530
- Tiervlei Trial Centre
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Cape Town, South Africa, 7700
- Allergy Immunology Unit
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East London, South Africa, 5241
- Synergy Biomed Research Institute (SBRI)
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George, South Africa, 06530
- TASK Central
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Johannesburg, South Africa, 1619
- Clinresco Centres Pty Ltd
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Johannesburg, South Africa, 1401
- CRISMO Bertha Gxowa Research Centre
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Johannesburg, South Africa, 1501
- Worthwhile Clinical Trials
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Krugersdorp, South Africa, 1739
- DJW Research
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Mamelodi East, South Africa, 0122
- Stanza Clinical Research Centre : Mamelodi
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Newtown, South Africa, 2113
- Newtown Clinical Research
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Paarl, South Africa, 7646
- Paarl Research Centre
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Pretoria, South Africa
- Synexus Watermeyer
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Pretoria, South Africa, 0001
- Global Clin Trials Pretoria
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Rustenburg, South Africa, 300
- The Aurum Institute Rustenburg Clinical Research Site
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Vosloorus, South Africa, 01475
- REIMED Vosloorus
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Welkom, South Africa, 9460
- Welkom Clinical Trial Centre
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Western Cape, South Africa, 7626
- Be Part Yoluntu Centre
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Kaohsiung, Taiwan, 80756
- Kaohsiung Medical University Chung-Ho Memorial Hospital
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Taichung, Taiwan, 40447
- China Medical University Hospital
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Taipei, Taiwan, 10002
- National Taiwan University Hospital
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Taipei, Taiwan, 11217
- Taipei Veterans General Hospital
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Taipei, Taiwan, 11490
- Tri-Service General Hospital
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Taipei, Taiwan, 116
- Taipei Municipal Wanfang Hospital
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Taipei City, Taiwan, 110
- Taipei Medical University
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Taoyuan County, Taiwan, 33305
- Chang Gung Memorial Hospital- Linkou
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Bangkok, Thailand, 10700
- Siriraj Hospital
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Bangkok, Thailand, 10400
- Royal Thai Army, Afrims
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Bangkok, Thailand, 10400
- The Vaccine Trial Center(VTC), Faculty of Tropical Medicine
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Khon Kaen, Thailand, 40002
- Srinagarind Hospital
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Muang, Thailand, 50200
- Maharaj Nakorn Chiang Mai hospital - Faculty of Medicine
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Pathumwan, Thailand, 10330
- King Chulalongkorn Memorial Hospital
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Birmingham, United Kingdom, B15 2SQ
- Synexus Midlands Clinical Research Centre
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Birmingham, United Kingdom, B21 9RY
- FutureMeds Soho Health Centre
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Bradford, United Kingdom, BD9 6RJ
- Bradford Royal Infirmary
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Bromborough, United Kingdom, CH62 6EE
- FutureMeds Bridle Clinic
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Cardiff, United Kingdom, CF15 9SS
- Synexus Wales Clinical Research Center
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Chorley, United Kingdom, PR7 7NA
- Synexus Lancashire Clinical Research Centre
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Glasgow, United Kingdom, G51 4TF
- Panthera Biopartners
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Glasgow, United Kingdom
- Synexus Scotland Clinical Research Centre
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Hexham, United Kingdom, NE46 1QJ
- Synexus Hexham General Hospital
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Liverpool, United Kingdom, L22 0LG
- Synexus Merseyside Clinical Research Centre
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Manchester, United Kingdom, M8 5RB
- North Manchester General Hospital
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Manchester, United Kingdom, M15 6SX
- Synexus Manchester Clinical Research Center
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Preston, United Kingdom, PR2 9RB
- Panthera Biopartners
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Reading, United Kingdom, RG2 9LH
- Panthera Biopartners
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Stockton on Tees, United Kingdom, TS19 8PE
- University Hospital of North Tees
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Alabama
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Birmingham, Alabama, United States, 35216
- Achieve Clinical Research, LLC
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Birmingham, Alabama, United States, 35205
- Central Research Associates, Inc.
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Birmingham, Alabama, United States, 35211
- Synexus Clinical Research US, Inc
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Huntsville, Alabama, United States, 35802
- Optimal Research
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Mobile, Alabama, United States, 36608
- Coastal Clinical Research, Inc
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Arizona
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Chandler, Arizona, United States, 85224
- Synexus Clinical Research US, Inc
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Peoria, Arizona, United States, 85381
- Hope Research Institute
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Phoenix, Arizona, United States, 85020
- Central Phoenix Medical Clinic
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Phoenix, Arizona, United States, 85379
- MedPharmics, LLC
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Tempe, Arizona, United States, 85283
- Clinical Research Consortium Arizona
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Tucson, Arizona, United States, 85741
- Synexus Clinical Research US, Inc
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Arkansas
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Little Rock, Arkansas, United States, 72205
- Baptist Health Center for Clinical Research
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California
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Banning, California, United States, 92220
- Rancho Paseo Medical Group
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Canoga Park, California, United States, 91303
- Hope Clinical Research LLC
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Cerritos, California, United States, 90703
- Synexus Clinical Research US, Inc
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Chula Vista, California, United States, 919111
- eStudySite
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La Mesa, California, United States, 91942
- Velocity Clinical Research, San Diego
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Redding, California, United States, 96001
- Paradigm Clinical Research Centers, Inc.
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San Diego, California, United States, 92108
- Optimal Research
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Spring Valley, California, United States, 91978
- Encompass Clinical Research
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Vista, California, United States, 92083
- Synexus Clinical Research US, Inc
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Colorado
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Aurora, Colorado, United States, 80014
- Synexus Clinical Research US, Inc
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Fort Collins, Colorado, United States, 80528
- Tekton Research Inc.
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Longmont, Colorado, United States, 80501
- Tekton Research Inc.
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Wheat Ridge, Colorado, United States, 80033
- Paradigm Clinical Research Centers, Inc.
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Florida
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Atlantis, Florida, United States, 33462
- JEM Research, LLC
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Coral Gables, Florida, United States, 33134
- Clinical Research of South Florida, an AMR Company
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Coral Gables, Florida, United States, 33134
- Prestige Clinical Research Center, Inc.
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DeLand, Florida, United States, 32720
- Avail Clinical Research, LLC
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Edgewater, Florida, United States, 32132
- Velocity Clinical Research, Inc.
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Fort Myers, Florida, United States, 33912
- AMR Fort Myers Clinical Physiology Associates, an AMR company
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Hallandale Beach, Florida, United States, 33009
- Velocity Clinical Research, Hallandale Beach
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Jacksonville, Florida, United States, 32205
- Westside Center for Clinical Research
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Jacksonville, Florida, United States, 32216
- Jacksonville Center for Clinical Research
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Lake Worth, Florida, United States, 33461
- Altus Research, Inc
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Lakeland, Florida, United States, 33803
- Accel Research Sites
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Leesburg, Florida, United States, 34748
- Compass Research LLC
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Melbourne, Florida, United States, 32934
- Optimal Research
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Miami, Florida, United States, 33165
- New Horizon Research Center
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Miami, Florida, United States, 33135
- Suncoast Research Group
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Miami, Florida, United States, 33173
- Suncoast Research Associates, LLC
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Miami, Florida, United States, 33186
- Clinical Site Partners, LLC
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North Miami, Florida, United States, 33161
- Healthcare Clinical Data Inc.
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North Miami Beach, Florida, United States, 33162
- Harmony Clinical Research Inc
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Orlando, Florida, United States, 32801
- Clinical Neuroscience Solutions, Inc
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Orlando, Florida, United States, 32806
- Synexus Clinical Research US, Inc
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Orlando, Florida, United States, 32806
- Headlands Research Orlando
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Pinellas Park, Florida, United States, 33781
- Synexus Clinical Research US, Inc
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Port Orange, Florida, United States, 32127
- Progressive Medical Research
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Saint Petersburg, Florida, United States, 33709
- Sandhill Research
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Tamarac, Florida, United States, 33321
- DBC Research
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West Palm Beach, Florida, United States, 33409
- Palm Beach Research center
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Georgia
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Atlanta, Georgia, United States, 30331
- Atlanta Center for Medical Research
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Atlanta, Georgia, United States, 30328
- Synexus Clinical Research US, Inc
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Eatonton, Georgia, United States, 31024
- Accel Research Sites
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Savannah, Georgia, United States, 31406
- Meridian Clinical Research, LLC
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Stockbridge, Georgia, United States, 30281
- Clinical Research Atlanta
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Idaho
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Boise, Idaho, United States, 83642
- Advanced Clinical Research
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Illinois
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Champaign, Illinois, United States, 61822
- Christie Clinic
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Chicago, Illinois, United States, 60602
- Synexus Clinical Research US, Inc
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Peoria, Illinois, United States, 61614
- Optimal Research
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Indiana
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Evansville, Indiana, United States, 47714
- MediSphere Medical Research Center, LLC
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South Bend, Indiana, United States, 46617-2808
- The South Bend Clinic Center for Research
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Valparaiso, Indiana, United States, 46383
- Buynak Clinical Research
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Iowa
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West Des Moines, Iowa, United States, 50266
- The Iowa Clinic, P.C.
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Kansas
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Augusta, Kansas, United States, 67010
- Heartland Research Associates, LLC
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Lenexa, Kansas, United States, 66219
- Johnson County Clin-Trials
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Newton, Kansas, United States, 67114
- Heartland Research Associates, LLC
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Wichita, Kansas, United States, 67207
- Heartland Clinical Research
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Kentucky
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Lexington, Kentucky, United States, 40509
- Central Kentucky Research Associates, Inc.
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Louisville, Kentucky, United States, 40202
- University of Louisville
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Louisiana
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Kenner, Louisiana, United States, 70065
- MedPharmics, LLC
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Lafayette, Louisiana, United States, 70508
- MedPharmics, LLC
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Lake Charles, Louisiana, United States, 70601
- Centex Studies, Inc.
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Monroe, Louisiana, United States, 71201
- Clinical Trials Of America
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New Orleans, Louisiana, United States, 70112
- Tulane University School of Medicine
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New Orleans, Louisiana, United States, 70119
- AMR New Orleans, Formerly New Orleans Center for Clinical Research - New Orleans, an AMR company
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Maine
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Lewiston, Maine, United States, 04240
- Central Maine Medical Center
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Maryland
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Elkridge, Maryland, United States, 21075
- Centennial Medical Group
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Rockville, Maryland, United States, 20850
- Optimal Research
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Minnesota
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Richfield, Minnesota, United States, 55423
- Synexus Clinical Research US, Inc
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Mississippi
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Biloxi, Mississippi, United States, 39531
- MedPharmics - Biloxi
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Missouri
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Jefferson City, Missouri, United States, 65109
- Jefferson City Medical Group Family
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Kansas City, Missouri, United States, 64114
- The Center for Pharmaceutical Research (CPR)
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Saint Louis, Missouri, United States, 63141
- Sundance Clinical Research
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Saint Louis, Missouri, United States, 63141
- Synexus Clinical Research US, Inc
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Montana
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Butte, Montana, United States, 59701
- Mercury Street Medical Group, PLLC
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Nebraska
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Norfolk, Nebraska, United States, 68701
- Meridian Clinical Research, LLC
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Omaha, Nebraska, United States, 68144
- Synexus Clinical Research US, Inc
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Omaha, Nebraska, United States, 68134
- Meridian Clinical Research - Omaha
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Nevada
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Henderson, Nevada, United States, 89052
- Synexus Clinical Research US, Inc
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Las Vegas, Nevada, United States, 89119
- Clinical Research Consortium, an AMR company
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New Mexico
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Albuquerque, New Mexico, United States, 87102
- MedPharmics, LLC
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New York
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Bronx, New York, United States, 10455
- CHEAR Center, LLC
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Endwell, New York, United States, 13760
- Regional Clinical Research, Inc.
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Endwell, New York, United States, 13760
- Meridian Clinical Research, LLC
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Manhattan, New York, United States, 10017
- Synexus Clinical Research US, Inc
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New York, New York, United States, 10027
- Harlem Hospital Center
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Rochester, New York, United States, 14618
- Finger Lakes Clinical Research
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Staten Island, New York, United States, 10312
- Richmond Behavioral Associates
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North Carolina
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Cary, North Carolina, United States, 27518
- Accellacare Research of Cary
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Charlotte, North Carolina, United States, 28277
- American Health Network, LLC
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Durham, North Carolina, United States, 27704
- M3-Emerging Medical Research
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Greensboro, North Carolina, United States, 27401
- Medication Management, LLC
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Monroe, North Carolina, United States, 28112
- Monroe Biomedical Research
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Raleigh, North Carolina, United States, 27612
- Wake Research Associates
-
Raleigh, North Carolina, United States, 27609
- Accellacare Research of Cary
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Wilmington, North Carolina, United States, 28401
- PMG Research of Wilmington, LLC
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Wilmington, North Carolina, United States, 28401
- Trial Management Associates, LLC
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Winston-Salem, North Carolina, United States, 27103
- Accellacare Research of Cary
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Ohio
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Akron, Ohio, United States, 44311
- Synexus Clinical Research US, Inc
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Cincinnati, Ohio, United States, 45242
- Velocity Clinical Research
-
Cincinnati, Ohio, United States, 45236
- Synexus Clinical Research US, Inc
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Cleveland, Ohio, United States, 44122
- Rapid Medical Research
-
Columbus, Ohio, United States, 43212
- Synexus Clinical Research US, Inc
-
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Oklahoma
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Norman, Oklahoma, United States, 73072
- Lynn Institute of Norman
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Oklahoma City, Oklahoma, United States, 73112
- Lynn Health Science Institute
-
Yukon, Oklahoma, United States, 73099
- Tekton Research Inc.
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Oregon
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Grants Pass, Oregon, United States, 97527
- Clinical Research Institute of Southern Oregon, P.C.
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Medford, Oregon, United States, 97504
- Clinical Research Institute of Southern Oregon, P.C.
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15243
- Preferred Primary Care Physicians Research
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Uniontown, Pennsylvania, United States, 15401
- Preferred Primary Care Physicians Research
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Rhode Island
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Warwick, Rhode Island, United States, 02886
- Omega Medical Research
-
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South Carolina
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Anderson, South Carolina, United States, 29621-2062
- Synexus Clinical Research US, Inc
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Gaffney, South Carolina, United States, 29340
- Velocity Clinical Research, Inc.
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Mount Pleasant, South Carolina, United States, 29464
- Coastal Carolina Research Center
-
Mount Pleasant, South Carolina, United States, 29464
- PMG Research of Charleston, LLC
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Spartanburg, South Carolina, United States, 29303
- Spartanburg Medical Research
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Spartanburg, South Carolina, United States, 29303
- VitaLink Research Spartanburg
-
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South Dakota
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Dakota Dunes, South Dakota, United States, 57049
- Meridian Clinical Research - Dakota Dunes
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Tennessee
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Bristol, Tennessee, United States, 37620
- PMG Research of Bristol
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Knoxville, Tennessee, United States, 37920
- VGR & NOCCR - Knoxville
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Nashville, Tennessee, United States, 37203
- Clinical Research Associates Inc
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Texas
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Austin, Texas, United States, 78705
- Central Texas Clinical Research
-
Austin, Texas, United States, 78705
- Optimal Research
-
Austin, Texas, United States, 78745
- Tekton Research Inc.
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Beaumont, Texas, United States, 78745
- Tekton Research Inc.
-
Cedar Park, Texas, United States, 78613
- Advanced Clinical Research
-
Dallas, Texas, United States, 75246
- North Texas Infectious Diseases Consultants
-
Dallas, Texas, United States, 75231
- Synexus Clinical Research US, Inc
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Houston, Texas, United States, 77081
- Texas Center for Drug Development Inc
-
Houston, Texas, United States, 77017
- Vilo Research Group Inc
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Plano, Texas, United States, 75093
- Research Your Health
-
San Antonio, Texas, United States, 78229
- Clinical Trials of Texas, Inc
-
San Antonio, Texas, United States, 78229
- Synexus Clinical Research US, Inc
-
San Antonio, Texas, United States, 78240
- Tekton Research Inc.
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Tomball, Texas, United States, 77375
- DM Clinical Research
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Tomball, Texas, United States, 77375
- Martine Diagnostic Clinic
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Utah
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Layton, Utah, United States, 84041
- Synexus Clinical Research US, Inc
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Murray, Utah, United States, 84123
- Synexus Clinical Research US, Inc
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West Jordan, Utah, United States, 84088
- Advanced Clinical Research
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Virginia
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Charlottesville, Virginia, United States, 22911
- Charlottesville Medical Research Center, LLC
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Danville, Virginia, United States, 24541
- Spectrum Medical, Inc
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Newport News, Virginia, United States, 23606
- Health Research of Hampton Roads, Inc
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Norfolk, Virginia, United States, 23507
- Clinical Research Associates of Tidewater
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Winchester, Virginia, United States, 22601
- Amherst Family Practice, PC
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group 1: Respiratory Syncytial Virus (RSV) vaccine
All participants in the active group will receive a single dose intramuscular (IM) injection of study vaccine on Day 1.
|
Participants will receive a single IM injection of an RSV vaccine.
|
|
Placebo Comparator: Group 2: Placebo
All participants in the placebo group will receive a single IM injection of matching placebo on Day 1.
|
Participants will receive a single IM injection of matching placebo.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
Time Frame: From Baseline (Day 1) up to 12 months
|
Number of participants with first occurrence of RT-PCR-confirmed RSV mediated LRTD according to protocol defined criteria were reported.
A participant was considered to have RT-PCR-confirmed RSV-mediated LRTD if the following criteria were met: new onset or worsening from baseline of 3 or more of the symptoms as captured on the respiratory infection intensity and impact questionnaire (RiiQ, version 2) at the same assessment time point: cough, short of breath, coughing up phlegm (sputum), and wheezing and confirmation of RSV by RT-PCR in one or more of the nasal swabs, or in the sputum sample.
RiiQ symptom scale was a 13-item questionnaire rated on a 4-point scale.
Each symptom was rated on a scale of 0 to 3 where 0=None, 1=Mild, 2=Moderate, and 3=Severe.
Higher scores indicated greater severity.
The total LRTD symptom score was calculated as the mean of the 4 lower respiratory scores (cough, short of breath, coughing up phlegm [sputum] and wheezing).
|
From Baseline (Day 1) up to 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Participants With First Occurrence of Any RT-PCR-Confirmed RSV-mediated Acute Respiratory Infection (ARI)
Time Frame: From Baseline (Day 1) up to 12 months
|
A participant was considered to have RT-PCR-confirmed RSV-mediated ARI if the following protocol defined criteria were met: ARI episode initiated by the participant and confirmed by the site with symptoms consistent with an ARI (new symptoms or worsening from baseline of at least one of the symptoms as captured on the RiiQ): sore throat, nasal congestion, cough, short of breath, coughing up phlegm (sputum), wheezing and confirmation of RSV by RT-PCR in one or more of the nasal swabs, or in the sputum sample.
RiiQ symptom scale was a 13-items questionnaire rated on a 4-point scale.
Each symptom was rated on a scale of 0 to 3 where 0=None, 1=Mild, 2=Moderate, and 3=Severe.
Higher scores indicated greater severity.
The total ARI symptom score was calculated as the mean of the 4 lower respiratory scores (cough, short of breath, coughing up phlegm [sputum] and wheezing).
|
From Baseline (Day 1) up to 12 months
|
|
Number of Participants With First Occurrence of RT-PCR-Confirmed RSV Mediated LRTD During the Second Year
Time Frame: From Month 12 up to Month 24
|
Number of participants with first occurrence of any RT-PCR-confirmed RSV mediated LRTD during the second year were reported.
A participant was considered to have RT-PCR-confirmed RSV-mediated LRTD if the following criteria were met: new onset or worsening from baseline of 3 or more of the symptoms as captured on the RiiQ, version 2 at the same assessment time point: cough, short of breath, coughing up phlegm (sputum), and wheezing and confirmation of RSV by RT-PCR in one or more of the nasal swabs, or in the sputum sample.
RiiQ symptom scale was a 13-items questionnaire rated on a 4-point scale.
Each symptom was rated on a scale of 0 to 3 where 0=None, 1=Mild, 2=Moderate, and 3=Severe.
Higher scores indicated greater severity.
The total LRTD symptom score was calculated as the mean of the 4 lower respiratory scores (cough, short of breath, coughing up phlegm [sputum] and wheezing).
|
From Month 12 up to Month 24
|
|
Number of Participants With First Occurrence of Any RT-PCR-Confirmed RSV Mediated ARI During the Second Year
Time Frame: From Month 12 up to Month 24
|
A participant was considered to have RT-PCR-confirmed RSV-mediated ARI according to protocol defined criteria were reported.
A participant was considered to have RT-PCR-confirmed RSV-mediated ARI if the following criteria were met: ARI episode initiated by the participant and confirmed by the site with symptoms consistent with an ARI (new symptoms or worsening from baseline of at least one of the symptoms as captured on the RiiQ): sore throat, nasal congestion, cough, short of breath, coughing up phlegm (sputum), wheezing and confirmation of RSV by RT-PCR in one or more of the nasal swabs, or in the sputum sample.
RiiQ symptom scale was a 13-items questionnaire rated on a 4-point scale.
Each symptom was rated on a scale of 0 to 3 where 0=None, 1=Mild, 2=Moderate, and 3=Severe.
Higher scores indicated greater severity.
The total ARI symptom score was calculated as the mean of the 4 lower respiratory scores (cough, short of breath, coughing up phlegm [sputum] and wheezing).
|
From Month 12 up to Month 24
|
|
Number of Participants With First Occurrence of Predefined Clinically Relevant Disease Associated With RT-PCR-Confirmed RSV-Mediated ARI Over the Whole Study
Time Frame: Baseline (Day 1) up to 24 months
|
A participant was considered to have clinically relevant disease with specific parameters associated with an RT-PCR-confirmed RSV-mediated ARI if the following criteria were met: the participant had an RT-PCR-confirmed RSV-mediated ARI: ARI episode initiated by the participant and confirmed by the site with symptoms consistent with an ARI (new symptoms or worsening from baseline of at least one of the symptoms as captured on the RiiQ): sore throat, nasal congestion, cough, short of breath, coughing up phlegm (sputum), wheezing and confirmation of RSV by RT-PCR in one or more of the nasal swabs, or in the sputum sample; any of the following associated with ARI: hospitalization, emergency department visit, per clinical judgement of complications, decreased oxygen saturation, tachypnea, need of supplemental oxygen, hypotension, pulmonary function test and arterial blood gas result.
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Baseline (Day 1) up to 24 months
|
|
Number of Participants With Serious Adverse Events (SAEs)
Time Frame: 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)
|
Number of participants with SAEs were reported.
An adverse event (AE) is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product.
An AE does not necessarily have a causal relationship with the intervention.
An SAE is any untoward medical occurrence that at any dose may result in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product.
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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)
|
|
Number of Participants With Potential Adverse Events of Special Interest (AESIs)
Time Frame: 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)
|
Number of participants with potential AESIs were reported.
AESIs were significant AEs that were judged to be of special interest because of clinical importance, known or suspected class effects, or based on nonclinical signals.
AESIs were embolic and thrombotic events, hematopoietic thrombocytopenia, and cerebral hemorrhage.
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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)
|
|
Number of Participants With Solicited Local Adverse Events (AEs) up to 7 Days After Vaccination
Time Frame: Up to Day 7 post vaccination on Day 1 (up to Day 8)
|
Number of participants with solicited local AEs 7 days post vaccination were reported.
An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product.
An AE does not necessarily have a causal relationship with the intervention.
Solicited local AEs were precisely defined events that participants were specifically asked about and which were noted by participants in the diary.
Solicited local AEs included erythema, swelling, and pain/tenderness at the study vaccine injection site, were used to assess the reactogenicity of the study vaccine and were pre-defined local (injection site).
All solicited AEs at the injection site (local) were considered related to the study vaccine administration.
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Up to Day 7 post vaccination on Day 1 (up to Day 8)
|
|
Number of Participants With Solicited Systemic AEs up to 7 Days After Vaccination
Time Frame: Up to Day 7 post vaccination on Day 1 (up to Day 8)
|
Number of participants with solicited systemic AEs 7 days post vaccination were reported.
An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product.
An AE does not necessarily have a causal relationship with the intervention.
Solicited systemic AEs included fatigue, headache, myalgia, nausea, pyrexia, for which participants were specifically questioned and which were noted by participants in their participant diary for 7 days post vaccination (day of vaccination and the subsequent 7 days).
|
Up to Day 7 post vaccination on Day 1 (up to Day 8)
|
|
Number of Participants With Unsolicited AEs up to 28 Days After Vaccination
Time Frame: Up to 28 days post vaccination on Day 1 (up to Day 29)
|
Number of participants with unsolicited AEs 28 days post vaccination were reported.
An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product.
An AE does not necessarily have a causal relationship with the intervention.
Unsolicited adverse events included all adverse events for which the participant was not specifically questioned in the subject diary.
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Up to 28 days post vaccination on Day 1 (up to Day 29)
|
|
Respiratory Syncytial Virus (RSV) A2 Strain Neutralization Antibody Titers at 14 Days Post Vaccination
Time Frame: At 14 Days post vaccination on Day 1 (Day 15)
|
RSV A2 strain neutralizing antibody titers of the vaccine-induced immune response was assessed through virus neutralization assay.
|
At 14 Days post vaccination on Day 1 (Day 15)
|
|
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
Time Frame: At 14 days post vaccination on Day 1 (Day 15)
|
GMTs of preF antibodies IgG at 14 days after the administration of Ad26.RSV.preF-based
vaccine as assessed by ELISA were reported.
|
At 14 days post vaccination on Day 1 (Day 15)
|
|
T-cell Interferon (IFN) Gamma Responses to Respiratory Syncytial Virus (RSV) F Protein Peptides Analyzed by Enzyme-linked Immunospot Assay (ELISpot)
Time Frame: 14 days post vaccination on Day 1 (Day 15)
|
T-cell IFN gamma responses to RSV F protein specific peptides at 14 days after vaccination as measured by ELISpot assay were reported.
RSV F specific T-cell IFN gamma ELISpot responses were measured as counts of spot forming cells per million peripheral blood mononuclear cells (SFC/10^6 PBMCs).
|
14 days post vaccination on Day 1 (Day 15)
|
|
Area Under the Curve (AUC) of the Change From Baseline in Respiratory Infection Intensity and Impact Questionnaire (RiiQ) Total Symptom Scale Score
Time Frame: Baseline (Day 1) up to 24 months
|
RiiQ symptom scale was a 13-items questionnaire rated on a 4-point scale.
The respiratory symptoms included 2 upper respiratory tract infection (URTI) symptoms (nasal congestion and sore throat), 4 lower respiratory tract infection (LRTI) symptoms (cough, wheezing, short of breath, and coughing up phlegm/sputum) and 7 systemic symptoms (headache, feeling feverish, neck pain, body aches and pain, fatigue/tiredness, interrupted sleep, and loss of appetite).
Each symptom was rated on a scale of 0 to 3 where 0=None, 1=Mild, 2=Moderate, and 3=Severe.
Higher scores indicated greater severity.
RiiQ total Symptom score was the mean of all scores (based on 13 symptoms).
The AUC of the change from baseline for the RiiQ total symptom score and the RiiQ lower respiratory symptom score during the ARI was calculated.
|
Baseline (Day 1) up to 24 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Janssen Vaccines & Prevention B.V. Clinical Trial, Janssen Vaccines & Prevention B.V.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 21, 2021
Primary Completion (Actual)
July 21, 2023
Study Completion (Actual)
July 21, 2023
Study Registration Dates
First Submitted
May 27, 2021
First Submitted That Met QC Criteria
May 27, 2021
First Posted (Actual)
June 1, 2021
Study Record Updates
Last Update Posted (Actual)
February 8, 2024
Last Update Submitted That Met QC Criteria
February 7, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CR108959
- 2020-005458-97 (EudraCT Number)
- VAC18193RSV3001 (Other Identifier: Janssen Vaccines & Prevention B.V.)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency.
As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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