AzTrials
AzTrials

Respiratory Syncytial VirusesPhase 3EVERGREENNCT04908683

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

A Phase 3 study testing Adenovirus serotype 26 (Ad26)-based respiratory syncytial virus (RSV). preF in people with Respiratory Syncytial Viruses and Lower Respiratory Tract Disease, run by Janssen Vaccines & Prevention B.V. at 272 sites in 14 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 60 years and olderHealthy volunteers can take part
What is being tested?
Adenovirus serotype 26 (Ad26)-based respiratory syncytial virus (RSV). preF
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
25,236 participants
Where
272 sitesin 14 countries
Study dates
21 Jul 2021to 21 Jul 2023
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

272 sites in 14 countries.

272 sites in 14 countries

United States156 sites

  • Synexus Clinical Research US Inc

    Akron, Ohio, 44311

  • Medpharmics, LLC

    Albuquerque, New Mexico, 87102

  • Synexus Clinical Research US Inc

    Anderson, South Carolina, 29621-2062

  • Synexus Clinical Research US Inc

    Atlanta, Georgia, 30328

  • Atlanta Center for Medical Research

    Atlanta, Georgia, 30331

  • JEM Research LLC

    Atlantis, Florida, 33462

  • Heartland Research Associates, LLC

    Augusta, Kansas, 67010

  • Synexus Clinical Research US Inc

    Aurora, Colorado, 80014

  • Central Texas Clinical Research

    Austin, Texas, 78705

  • Optimal Research

    Austin, Texas, 78705

  • Tekton Research Inc.

    Austin, Texas, 78745

  • Rancho Paseo Medical Group

    Banning, California, 92220

  • Tekton Research Inc.

    Beaumont, Texas, 78745

  • MedPharmics - Biloxi

    Biloxi, Mississippi, 39531

  • Central Research Associates, Inc.

    Birmingham, Alabama, 35205

  • Synexus Clinical Research US Inc

    Birmingham, Alabama, 35211

  • Achieve Clinical Research, LLC

    Birmingham, Alabama, 35216

  • Advanced Clinical Research

    Boise, Idaho, 83642

  • PMG Research of Bristol

    Bristol, Tennessee, 37620

  • Mercury Street Medical Group, PLLC

    Butte, Montana, 59701

  • Hope clinical Research LLC

    Canoga Park, California, 91303

  • Accellacare Research of Cary

    Cary, North Carolina, 27518

  • Advanced Clinical Research

    Cedar Park, Texas, 78613

  • Synexus Clinical Research US Inc

    Cerritos, California, 90703

  • Christie Clinic

    Champaign, Illinois, 61822

  • Synexus Clinical Research US Inc

    Chandler, Arizona, 85224

  • American Health Network, LLC

    Charlotte, North Carolina, 28277

  • Charlottesville Medical Research Center, LLC

    Charlottesville, Virginia, 22911

  • Synexus Clinical Research US Inc

    Chicago, Illinois, 60602

  • eStudySite

    Chula Vista, California, 919111

  • Synexus Clinical Research US Inc

    Cincinnati, Ohio, 45236

  • Velocity Clinical Research

    Cincinnati, Ohio, 45242

  • Rapid Medical Research

    Cleveland, Ohio, 44122

  • Synexus Clinical Research US Inc

    Columbus, Ohio, 43212

  • Clinical Research of South Florida, an AMR Company

    Coral Gables, Florida, 33134

  • Prestige Clinical Research Center, Inc.

    Coral Gables, Florida, 33134

  • Meridian Clinical Research - Dakota Dunes

    Dakota Dunes, South Dakota, 57049

  • Synexus Clinical Research US Inc

    Dallas, Texas, 75231

  • North Texas Infectious Diseases Consultants

    Dallas, Texas, 75246

  • Spectrum Medical, Inc

    Danville, Virginia, 24541

  • Avail Clinical Research, LLC

    DeLand, Florida, 32720

  • M3-Emerging Medical Research

    Durham, North Carolina, 27704

  • Accel Research Sites

    Eatonton, Georgia, 31024

  • Velocity Clinical Research, Inc.

    Edgewater, Florida, 32132

  • Centennial Medical Group

    Elkridge, Maryland, 21075

  • Meridian Clinical Research, LLC

    Endwell, New York, 13760

  • Regional Clinical Research, Inc.

    Endwell, New York, 13760

  • Medisphere Medical Research Center, Llc

    Evansville, Indiana, 47714

  • Tekton Research Inc.

    Fort Collins, Colorado, 80528

  • AMR Fort Myers Clinical Physiology Associates, an AMR company

    Fort Myers, Florida, 33912

  • Velocity Clinical Research, Inc.

    Gaffney, South Carolina, 29340

  • Clinical Research Institute of Southern Oregon, P.C.

    Grants Pass, Oregon, 97527

  • Medication Management LLC

    Greensboro, North Carolina, 27401

  • Velocity Clinical Research, Hallandale Beach

    Hallandale, Florida, 33009

  • Synexus Clinical Research US Inc

    Henderson, Nevada, 89052

  • Vilo Research Group Inc

    Houston, Texas, 77017

  • Texas Center for Drug Development Inc

    Houston, Texas, 77081

  • Optimal Research

    Huntsville, Alabama, 35802

  • Westside Center for Clinical Research

    Jacksonville, Florida, 32205

  • Jacksonville Center For Clinical Research

    Jacksonville, Florida, 32216

  • Jefferson City Medical Group Family

    Jefferson City, Missouri, 65109

  • The Center for Pharmaceutical Research (CPR)

    Kansas City, Missouri, 64114

  • Medpharmics, LLC

    Kenner, Louisiana, 70065

  • VGR & NOCCR - Knoxville

    Knoxville, Tennessee, 37920

  • Velocity Clinical Research, San Diego

    La Mesa, California, 91942

  • Medpharmics, LLC

    Lafayette, Louisiana, 70508

  • Centex Studies, Inc.

    Lake Charles, Louisiana, 70601

  • Altus Research, Inc

    Lake Worth, Florida, 33461

  • Accel Research Sites

    Lakeland, Florida, 33803

  • Clinical Research Consortium, an AMR company

    Las Vegas, Nevada, 89119

  • Synexus Clinical Research US Inc

    Layton, Utah, 84041

  • Compass Research LLC

    Leesburg, Florida, 34748

  • Johnson County Clin-Trials

    Lenexa, Kansas, 66219

  • Central Maine Medical Center

    Lewiston, Maine, 04240

  • Central Kentucky Research Associates, Inc.

    Lexington, Kentucky, 40509

  • Baptist Health Center For Clinical Research

    Little Rock, Arkansas, 72205

  • Tekton Research Inc.

    Longmont, Colorado, 80501

  • University of Louisville

    Louisville, Kentucky, 40202

  • Synexus Clinical Research US Inc

    Manhattan, New York, 10017

  • Clinical Research Institute of Southern Oregon, P.C.

    Medford, Oregon, 97504

  • Optimal Research

    Melbourne, Florida, 32934

  • Suncoast Research Group

    Miami, Florida, 33135

  • New Horizon Research Center

    Miami, Florida, 33165

  • Suncoast Research Associates, LLC

    Miami, Florida, 33173

  • Clinical Site Partners, LLC

    Miami, Florida, 33186

  • Coastal Clinical Research, Inc

    Mobile, Alabama, 36608

  • Clinical Trials of America

    Monroe, Louisiana, 71201

  • Monroe Biomedical Research

    Monroe, North Carolina, 28112

  • Coastal Carolina Research Center

    Mt. Pleasant, South Carolina, 29464

  • PMG Research of Charleston, LLC

    Mt. Pleasant, South Carolina, 29464

  • Synexus Clinical Research US Inc

    Murray, Utah, 84123

  • Clinical Research Associates Inc

    Nashville, Tennessee, 37203

  • Tulane University School of Medicine

    New Orleans, Louisiana, 70112

  • AMR New Orleans, Formerly New Orleans Center for Clinical Research - New Orleans, an AMR company

    New Orleans, Louisiana, 70119

  • Harlem Hospital Center

    New York, New York, 10027

  • Health Research of Hampton Roads, Inc

    Newport News, Virginia, 23606

  • Heartland Research Associates, LLC

    Newton, Kansas, 67114

  • Meridian Clinical Research, LLC

    Norfolk, Nebraska, 68701

  • Clinical Research Associates of Tidewater

    Norfolk, Virginia, 23507

  • Lynn Institute of Norman

    Norman, Oklahoma, 73072

  • Healthcare Clinical Data Inc.

    North Miami, Florida, 33161

  • Harmony Clinical Research Inc

    North Miami Beach, Florida, 33162

  • Lynn Health Science Institute

    Oklahoma City, Oklahoma, 73112

  • Meridian Clinical Research - Omaha

    Omaha, Nebraska, 68134

  • Synexus Clinical Research US Inc

    Omaha, Nebraska, 68144

  • Clinical NeuroScience Solutions Inc

    Orlando, Florida, 32801

  • Headlands Research Orlando

    Orlando, Florida, 32806

  • Synexus Clinical Research US Inc

    Orlando, Florida, 32806

  • Hope Research Institute

    Peoria, Arizona, 85381

  • Optimal Research

    Peoria, Illinois, 61614

  • Central Phoenix Medical Clinic

    Phoenix, Arizona, 85020

  • Medpharmics, LLC

    Phoenix, Arizona, 85379

  • Synexus Clinical Research US Inc

    Pinellas Park, Florida, 33781

  • Preferred Primary Care Physicians Research

    Pittsburgh, Pennsylvania, 15243

  • Research Your Health

    Plano, Texas, 75093

  • Progressive Medical Research

    Port Orange, Florida, 32127

  • Accellacare Research of Cary

    Raleigh, North Carolina, 27609

  • Wake Research Associates

    Raleigh, North Carolina, 27612

  • Paradigm Clinical Research Centers, Inc.

    Redding, California, 96001

  • Synexus Clinical Research US Inc

    Richfield, Minnesota, 55423

  • Finger Lakes Clinical Research

    Rochester, New York, 14618

  • Optimal Research

    Rockville, Maryland, 20850

  • Clinical Trials of Texas Inc

    San Antonio, Texas, 78229

  • Synexus Clinical Research US Inc

    San Antonio, Texas, 78229

  • Tekton Research Inc.

    San Antonio, Texas, 78240

  • Optimal Research

    San Diego, California, 92108

  • Meridian Clinical Research, LLC

    Savannah, Georgia, 31406

  • The South Bend Clinic Center for Research

    South Bend, Indiana, 46617-2808

  • Spartanburg Medical Research

    Spartanburg, South Carolina, 29303

  • VitaLink Research Spartanburg

    Spartanburg, South Carolina, 29303

  • Encompass Clinical Research

    Spring Valley, California, 91978

  • Sundance Clinical Research

    St Louis, Missouri, 63141

  • Synexus Clinical Research US Inc

    St Louis, Missouri, 63141

  • Sandhill Research

    St. Petersburg, Florida, 33709

  • Richmond Behavioral Associates

    Staten Island, New York, 10312

  • Clinical Research Atlanta

    Stockbridge, Georgia, 30281

  • DBC Research

    Tamarac, Florida, 33321

  • Clinical Research Consortium Arizona

    Tempe, Arizona, 85283

  • CHEAR Center, LLC

    The Bronx, New York, 10455

  • DM Clinical Research

    Tomball, Texas, 77375

  • Martine Diagnostic Clinic

    Tomball, Texas, 77375

  • Synexus Clinical Research US Inc

    Tucson, Arizona, 85741

  • Preferred Primary Care Physicians Research

    Uniontown, Pennsylvania, 15401

  • Buynak Clinical Research

    Valparaiso, Indiana, 46383

  • Synexus Clinical Research US Inc

    Vista, California, 92083

  • Omega Medical Research

    Warwick, Rhode Island, 02886

  • The Iowa Clinic, P.C.

    West Des Moines, Iowa, 50266

  • Advanced Clinical Research

    West Jordan, Utah, 84088

  • Palm Beach Research Center

    West Palm Beach, Florida, 33409

  • Paradigm Clinical Research Centers, Inc.

    Wheat Ridge, Colorado, 80033

  • Heartland Clinical Research

    Wichita, Kansas, 67207

  • PMG Research of Wilmington, LLC

    Wilmington, North Carolina, 28401

  • Trial Management Associates, LLC

    Wilmington, North Carolina, 28401

  • Amherst Family Practice, PC

    Winchester, Virginia, 22601

  • Accellacare Research of Cary

    Winston-Salem, North Carolina, 27103

  • Tekton Research Inc.

    Yukon, Oklahoma, 73099

Other trials in United States

South Africa23 sites

  • Iatros International

    Bloemfontein, 9301

  • Josha Research

    Bloemfontein, 9301

  • Madibeng Centre for Research

    Brits, 250

  • Synexus Helderberg Clinical Research Centre

    Cape Town, 7130

  • TREAD Research Tygerberg Hospital

    Cape Town, 7500

  • TASK Central

    Cape Town, 7530

  • Tiervlei Trial Centre

    Cape Town, 7530

  • Allergy Immunology Unit

    Cape Town, 7700

  • Synergy Biomed Research Institute (SBRI)

    East London, 5241

  • TASK Central

    George, 06530

  • CRISMO Bertha Gxowa Research Centre

    Johannesburg, 1401

  • Worthwhile Clinical trials

    Johannesburg, 1501

  • Clinresco Centres Pty Ltd

    Johannesburg, 1619

  • DJW Research

    Krugersdorp, 1739

  • Stanza Clinical Research Centre : Mamelodi

    Mamelodi East, 0122

  • Newtown Clinical Research

    Newtown, 2113

  • Paarl Research Centre

    Paarl, 7646

  • Global Clin Trials Pretoria

    Pretoria, 0001

  • Synexus Watermeyer

    Pretoria

  • The Aurum Institute Rustenburg Clinical Research Site

    Rustenburg, 300

  • REIMED Vosloorus

    Vosloorus, 01475

  • Welkom Clinical Trial Centre

    Welkom, 9460

  • Be Part Yoluntu Centre

    Western Cape, 7626

Other trials in South Africa

United Kingdom15 sites

  • Synexus Midlands Clinical Research Centre

    Birmingham, B15 2SQ

  • FutureMeds Soho Health Centre

    Birmingham, B21 9RY

  • Bradford Royal Infirmary

    Bradford, BD9 6RJ

  • FutureMeds Bridle Clinic

    Bromborough, CH62 6EE

  • Synexus Wales Clinical Research Center

    Cardiff, CF15 9SS

  • Synexus Lancashire Clinical Research Centre

    Chorley, PR7 7NA

  • Panthera Biopartners

    Glasgow, G51 4TF

  • Synexus Scotland Clinical Research Centre

    Glasgow

  • Synexus Hexham General Hospital

    Hexham, NE46 1QJ

  • Synexus Merseyside Clinical Research Centre

    Liverpool, L22 0LG

  • Synexus Manchester Clinical Research Center

    Manchester, M15 6SX

  • North Manchester General Hospital

    Manchester, M8 5RB

  • Panthera Biopartners

    Preston, PR2 9RB

  • Panthera Biopartners

    Reading, RG2 9LH

  • University Hospital of North Tees

    Stockton-on-Tees, TS19 8PE

Other trials in United Kingdom

New Zealand13 sites

  • Southern Clinical Trials Totara Clinical Research

    Auckland, 0600

  • Southern Clinical Trials, Waitemata

    Auckland, 0626

  • Optimal Clinical Trials

    Auckland, 1010

  • Southern Clinical Trials, Christchurch

    Christchurch, 8013

  • Lakeland Clinical Trials

    Hamilton, 3200

  • P3 Research Ltd

    Havelock North, 3410

  • Southern Clinical Trials Tasman

    Main Road Stoke, 7011

  • P3 Research Ltd

    Palmerston North, 4414

  • P3 Research Limited Kapiti

    Paraparaumu, 5032

  • Lakeland Clinical Trials

    Rotorua, 3010

  • P3 Research Ltd

    Tauranga, 3110

  • Lakeland Clinical Trials

    Upper Hutt, 5018

  • P3 Reaearch Wellington

    Wellington, 6021

Other trials in New Zealand

Poland13 sites

  • Synexus Polska Sp. z o.o. Oddzial w Czestochowie

    Częstochowa, 42-202

  • Synexus Polska Sp. z o.o. Oddzial w Gdansku

    Gdansk, 80-382

  • Synexus Scm Sp Z o o Oddzial Gdynia

    Gdynia, 81 537

  • Synexus Polska Sp z o o Oddzial w Katowicach

    Katowice, 40 040

  • Synexus Polska Sp z o o

    Lodz, 90 127

  • KO MED Centra Kliniczne LUBLIN

    Lublin, 20 362

  • Synexus Polska Sp. z.o.o. Oddzial w Poznaniu

    Poznan, 60-702

  • KO MED Centra Kliniczne Pulawy

    Puławy, 24-100

  • Centrum Medyczne Pratia Poznan

    Skorzewo, 60 185

  • KO-MED Centra Kliniczne Staszow

    Staszów, 28 200

  • Synexus Polska Sp z o o Oddzial w Warszawie

    Warsaw, 623832

  • Synexus Polska Sp z o o Oddzial we Wroclawiu

    Wroclaw, 50 381

  • KO MED Centra Kliniczne Zamosc

    Zamość, 22 400

Other trials in Poland

Canada10 sites

  • LMC Clinical Research dba Manna Research Inc. Burlington

    Burlington, Ontario, L7R 1E2

  • Okanagan Clinical Trials

    Kelowna, British Columbia, V1Y 1Z9

  • LMC Clinical Research dba Manna Research Inc. Quebec City

    Lévis, Quebec, G6W 0M5

  • LMC Clinical Research dba Manna Research Inc. Montreal

    Pointe-Claire, Quebec, H9R 4S3

  • DIEX Recherche Quebec Inc.

    Québec, Quebec, G1N 4V3

  • DIEX Recherche Joliette Inc.

    Saint-Charles-Borromée, Quebec, J6E 2B4

  • DIEX Recherche Sherbrooke Inc

    Sherbrooke, Quebec, J1L 0H8

  • LMC Clinical Research Inc. (Bayview)

    Toronto, Ontario, M4G 3E8

  • LMC Clinical Research dba Manna Research Inc. Toronto

    Toronto, Ontario, M9W 4L6

  • DIEX Recherche Victoriaville Inc.

    Victoriaville, Quebec, G6P 6P6

Other trials in Canada

Finland10 sites

  • Espoon rokotetutkimusklinikka

    Espoo, 2230

  • Etelä-Helsingin rokotetutkimusklinikka

    Helsinki, 00100

  • Itä-Helsingin rokotetutkimusklinikka

    Helsinki, 00930

  • Järvenpään rokotetutkimusklinikka

    Jarvenpaa, 04400

  • Kokkolan rokotetutkimusklinikka

    Kokkola, 67100

  • Oulun rokotetutkimusklinikka

    Oulu, 90220

  • Porin rokotetutkimusklinikka

    Pori, 28100

  • Seinäjoen rokotetutkimusklinikka

    Seinäjoki, 60100

  • Tampereen rokotetutkimusklinikka

    Tampere, 33100

  • Turun rokotetutkimusklinikka

    Turku, 20520

Other trials in Finland

Taiwan8 sites

  • Kaohsiung Medical University Chung Ho Memorial Hospital

    Kaohsiung City, 80756

  • China Medical University Hospital

    Taichung, 40447

  • National Taiwan University Hospital

    Taipei, 10002

  • Taipei Medical University

    Taipei, 110

  • Taipei Veterans General Hospital

    Taipei, 11217

  • Tri-Service General Hospital

    Taipei, 11490

  • Taipei Municipal Wanfang Hospital

    Taipei, 116

  • Chang Gung Memorial Hospital- Linkou

    Taoyuan County, 33305

Other trials in Taiwan

Thailand6 sites

  • Royal Thai Army, Afrims

    Bangkok, 10400

  • The Vaccine Trial Center(VTC), Faculty of Tropical Medicine

    Bangkok, 10400

  • Siriraj Hospital

    Bangkok, 10700

  • Srinagarind Hospital

    Khon Kaen, 40002

  • Maharaj Nakorn Chiang Mai hospital Faculty of Medicine

    Muang, 50200

  • King Chulalongkorn Memorial Hospital

    Pathumwan, 10330

Other trials in Thailand

Brazil5 sites

  • UFRR - Universidade Federal de Roraima

    Boa Vista, 69304-000

  • CMIP - Centro Mineiro de Pesquisa Ltda

    Juiz de Fora, 36010 570

  • Hospital das Clinicas de Porto Alegre

    Porto Alegre, 90035-903

  • Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto Hospital de Base

    São José do Rio Preto, 15090 000

  • CPQuali Pesquisa Clinica LTDA ME

    São Paulo, 01228-900

Other trials in Brazil

Australia4 sites

  • Paratus Clinical Canberra Clinic

    Bruce, 2617

  • Northside Health

    Coffs Harbour, 2450

  • Paratus Clinical Kanwal Clinic

    Kanwal, 2059

  • Mater Hospital Brisbane

    South Brisbane, 4101

Other trials in Australia

Chile3 sites

  • CENRESIN

    Quilota, 2260734

  • Centro de Estudios Clínicos e Investigación Médica (CeCim)

    Santiago, 8331143

  • Centro de Investigacion del Maule

    Talca, 3465586

Other trials in Chile

China3 sites

  • Donghai County Center for Disease prevention and Control

    Lianyungang, 222200

  • Funing County Center for Disease Control and Prevention

    Yancheng, 224435

  • Binhai County Center for Disease Control and Prevention

    Yancheng, 224554

Other trials in China

Estonia3 sites

  • OU Innomedica

    Tallinn, 10117

  • Center for Clinical and Basic Research

    Tallinn, 10128

  • Clinical Research Centre

    Tartu, 50106

Other trials in Estonia

About this study

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

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.

Being tested
Adenovirus serotype 26 (Ad26)-based respiratory syncytial virus (RSV). preF, Placebo
Keywords
Acute Respiratory Infections, Vaccine, Ad26.RSV.preF-based Vaccine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Adenovirus serotype 26 (Ad26)-based respiratory syncytial virus (RSV). preFBiological

    Participants will receive a single IM injection of an RSV vaccine.

  • PlaceboBiological

    Participants will receive a single IM injection of matching placebo.

Study groups in NCT04908683
Study groupRoleWhat they receive
Group 1: Respiratory Syncytial Virus (RSV) vaccineExperimentalAll participants in the active group will receive a single dose intramuscular (IM) injection of study vaccine on Day 1.
Receives: Biological: Adenovirus serotype 26 (Ad26)-based respiratory syncytial virus (RSV). preF
Group 2: PlaceboPlacebo comparatorAll participants in the placebo group will receive a single IM injection of matching placebo on Day 1.
Receives: Biological: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    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).

    Measured: From Baseline (Day 1) up to 12 months

Secondary outcomes (13)

  1. Number of Participants With First Occurrence of Any RT-PCR-Confirmed RSV-mediated Acute Respiratory Infection (ARI)

    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).

    Measured: From Baseline (Day 1) up to 12 months

  2. Number of Participants With First Occurrence of RT-PCR-Confirmed RSV Mediated LRTD During the Second Year

    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).

    Measured: From Month 12 up to Month 24

  3. Number of Participants With First Occurrence of Any RT-PCR-Confirmed RSV Mediated ARI During the Second Year

    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).

    Measured: From Month 12 up to Month 24

  4. Number of Participants With First Occurrence of Predefined Clinically Relevant Disease Associated With RT-PCR-Confirmed RSV-Mediated ARI Over the Whole Study

    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.

    Measured: Baseline (Day 1) up to 24 months

  5. Number of Participants With Serious Adverse Events (SAEs)

    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.

    Measured: 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)

  6. Number of Participants With Potential Adverse Events of Special Interest (AESIs)

    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.

    Measured: 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)

  7. Number of Participants With Solicited Local Adverse Events (AEs) up to 7 Days After Vaccination

    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.

    Measured: Up to Day 7 post vaccination on Day 1 (up to Day 8)

  8. Number of Participants With Solicited Systemic AEs up to 7 Days After Vaccination

    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).

    Measured: Up to Day 7 post vaccination on Day 1 (up to Day 8)

  9. Number of Participants With Unsolicited AEs up to 28 Days After Vaccination

    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.

    Measured: Up to 28 days post vaccination on Day 1 (up to Day 29)

  10. Respiratory Syncytial Virus (RSV) A2 Strain Neutralization Antibody Titers at 14 Days Post Vaccination

    RSV A2 strain neutralizing antibody titers of the vaccine-induced immune response was assessed through virus neutralization assay.

    Measured: At 14 Days post vaccination on Day 1 (Day 15)

  11. 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

    GMTs of preF antibodies IgG at 14 days after the administration of Ad26.RSV.preF-based vaccine as assessed by ELISA were reported.

    Measured: At 14 days post vaccination on Day 1 (Day 15)

  12. T-cell Interferon (IFN) Gamma Responses to Respiratory Syncytial Virus (RSV) F Protein Peptides Analyzed by Enzyme-linked Immunospot Assay (ELISpot)

    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).

    Measured: 14 days post vaccination on Day 1 (Day 15)

  13. Area Under the Curve (AUC) of the Change From Baseline in Respiratory Infection Intensity and Impact Questionnaire (RiiQ) Total Symptom Scale Score

    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.

    Measured: Baseline (Day 1) up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jun 2021
  2. Study start21 Jul 2021
  3. Primary completion21 Jul 2023
  4. Study completion21 Jul 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
25,236 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04908683
Sponsor's protocol ID
CR108959
Other IDs
2020-005458-97, VAC18193RSV3001
Acronym
EVERGREEN
Status last verified
Nov 2025
First submitted
27 May 2021
Last updated
13 Nov 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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

Publications

  • Comeaux CA, Testa M, Gymnopoulou E, Bastian AR, Nogueira ML, Pan H, Zhu F, Fursenko V, Smith WB, Junquera P, Menten J, Loi M, Effiom EB, Jastorff AM, Weber K, Falsey AR, Callendret B, Heijnen E. A randomised, double-blind, multicentre, placebo-controlled phase 3 efficacy, safety, and immunogenicity study of an Ad26.RSV.preF/RSV prefusion F-protein vaccine for the prevention of respiratory syncytial virus-mediated lower respiratory tract disease in adults aged 60 years and older. EBioMedicine. 2026 Nov 4;133:106513. doi: 10.1016/j.ebiom.2026.106513. Online ahead of print.

    PubMed 42981739

  • Langer S, Holzapfel S, August L, Badura A, Wellmann S, Mack I. Parental knowledge and attitudes to infant immunization in the context of RSV: All about confidence? Vaccine. 2024 Oct 3;42(23):126050. doi: 10.1016/j.vaccine.2024.06.018. Epub 2024 Jun 19.

    PubMed 38902186

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Adenovirus serotype 26 (Ad26)-based respiratory syncytial virus (RSV). preF in people with Respiratory Syncytial Viruses and Lower Respiratory Tract Disease, run by Janssen Vaccines & Prevention B.V. at 272 sites in 14 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 272 sites in United States, South Africa, United Kingdom, New Zealand, Poland and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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) (time frame: From Baseline (Day 1) up to 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04908683, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2025.

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