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
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
3 other identifiers
interventional
25,236
14 countries
272
Brief Summary
The study will enroll up to 27,200 participants in order to demonstrate the efficacy of the active Ad26.RSV.preF-based study vaccine in the prevention of Reverse Transcription Polymerase Chain Reaction (RT-PCR) confirmed Respiratory Syncytial Virus (RSV)-mediated Lower Respiratory Tract Disease (LRTD) when compared to placebo in adults aged 60 years and above.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jul 2021
272 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 27, 2021
CompletedFirst Posted
Study publicly available on registry
June 1, 2021
CompletedStudy Start
First participant enrolled
July 21, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 21, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
July 21, 2023
CompletedResults Posted
Study results publicly available
February 8, 2024
CompletedNovember 13, 2025
November 1, 2025
2 years
May 27, 2021
December 21, 2023
November 6, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (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).
From Baseline (Day 1) up to 12 months
Secondary Outcomes (13)
Number of Participants With First Occurrence of Any RT-PCR-Confirmed RSV-mediated Acute Respiratory Infection (ARI)
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
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
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
Baseline (Day 1) up to 24 months
Number of Participants With Serious Adverse Events (SAEs)
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)
- +8 more secondary outcomes
Study Arms (2)
Group 1: Respiratory Syncytial Virus (RSV) vaccine
EXPERIMENTALAll participants in the active group will receive a single dose intramuscular (IM) injection of study vaccine on Day 1.
Group 2: Placebo
PLACEBO COMPARATORAll participants in the placebo group will receive a single IM injection of matching placebo on Day 1.
Interventions
Participants will receive a single IM injection of an RSV vaccine.
Participants will receive a single IM injection of matching placebo.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (272)
Central Research Associates, Inc.
Birmingham, Alabama, 35205, United States
Synexus Clinical Research US Inc
Birmingham, Alabama, 35211, United States
Achieve Clinical Research, LLC
Birmingham, Alabama, 35216, United States
Optimal Research
Huntsville, Alabama, 35802, United States
Coastal Clinical Research, Inc
Mobile, Alabama, 36608, United States
Synexus Clinical Research US Inc
Chandler, Arizona, 85224, United States
Hope Research Institute
Peoria, Arizona, 85381, United States
Central Phoenix Medical Clinic
Phoenix, Arizona, 85020, United States
Medpharmics, LLC
Phoenix, Arizona, 85379, United States
Clinical Research Consortium Arizona
Tempe, Arizona, 85283, United States
Synexus Clinical Research US Inc
Tucson, Arizona, 85741, United States
Baptist Health Center For Clinical Research
Little Rock, Arkansas, 72205, United States
Rancho Paseo Medical Group
Banning, California, 92220, United States
Hope clinical Research LLC
Canoga Park, California, 91303, United States
Synexus Clinical Research US Inc
Cerritos, California, 90703, United States
eStudySite
Chula Vista, California, 919111, United States
Velocity Clinical Research, San Diego
La Mesa, California, 91942, United States
Paradigm Clinical Research Centers, Inc.
Redding, California, 96001, United States
Optimal Research
San Diego, California, 92108, United States
Encompass Clinical Research
Spring Valley, California, 91978, United States
Synexus Clinical Research US Inc
Vista, California, 92083, United States
Synexus Clinical Research US Inc
Aurora, Colorado, 80014, United States
Tekton Research Inc.
Fort Collins, Colorado, 80528, United States
Tekton Research Inc.
Longmont, Colorado, 80501, United States
Paradigm Clinical Research Centers, Inc.
Wheat Ridge, Colorado, 80033, United States
JEM Research LLC
Atlantis, Florida, 33462, United States
Clinical Research of South Florida, an AMR Company
Coral Gables, Florida, 33134, United States
Prestige Clinical Research Center, Inc.
Coral Gables, Florida, 33134, United States
Avail Clinical Research, LLC
DeLand, Florida, 32720, United States
Velocity Clinical Research, Inc.
Edgewater, Florida, 32132, United States
AMR Fort Myers Clinical Physiology Associates, an AMR company
Fort Myers, Florida, 33912, United States
Velocity Clinical Research, Hallandale Beach
Hallandale, Florida, 33009, United States
Westside Center for Clinical Research
Jacksonville, Florida, 32205, United States
Jacksonville Center For Clinical Research
Jacksonville, Florida, 32216, United States
Altus Research, Inc
Lake Worth, Florida, 33461, United States
Accel Research Sites
Lakeland, Florida, 33803, United States
Compass Research LLC
Leesburg, Florida, 34748, United States
Optimal Research
Melbourne, Florida, 32934, United States
Suncoast Research Group
Miami, Florida, 33135, United States
New Horizon Research Center
Miami, Florida, 33165, United States
Suncoast Research Associates, LLC
Miami, Florida, 33173, United States
Clinical Site Partners, LLC
Miami, Florida, 33186, United States
Healthcare Clinical Data Inc.
North Miami, Florida, 33161, United States
Harmony Clinical Research Inc
North Miami Beach, Florida, 33162, United States
Clinical NeuroScience Solutions Inc
Orlando, Florida, 32801, United States
Headlands Research Orlando
Orlando, Florida, 32806, United States
Synexus Clinical Research US Inc
Orlando, Florida, 32806, United States
Synexus Clinical Research US Inc
Pinellas Park, Florida, 33781, United States
Progressive Medical Research
Port Orange, Florida, 32127, United States
Sandhill Research
St. Petersburg, Florida, 33709, United States
DBC Research
Tamarac, Florida, 33321, United States
Palm Beach Research Center
West Palm Beach, Florida, 33409, United States
Synexus Clinical Research US Inc
Atlanta, Georgia, 30328, United States
Atlanta Center for Medical Research
Atlanta, Georgia, 30331, United States
Accel Research Sites
Eatonton, Georgia, 31024, United States
Meridian Clinical Research, LLC
Savannah, Georgia, 31406, United States
Clinical Research Atlanta
Stockbridge, Georgia, 30281, United States
Advanced Clinical Research
Boise, Idaho, 83642, United States
Christie Clinic
Champaign, Illinois, 61822, United States
Synexus Clinical Research US Inc
Chicago, Illinois, 60602, United States
Optimal Research
Peoria, Illinois, 61614, United States
Medisphere Medical Research Center, Llc
Evansville, Indiana, 47714, United States
The South Bend Clinic Center for Research
South Bend, Indiana, 46617-2808, United States
Buynak Clinical Research
Valparaiso, Indiana, 46383, United States
The Iowa Clinic, P.C.
West Des Moines, Iowa, 50266, United States
Heartland Research Associates, LLC
Augusta, Kansas, 67010, United States
Johnson County Clin-Trials
Lenexa, Kansas, 66219, United States
Heartland Research Associates, LLC
Newton, Kansas, 67114, United States
Heartland Clinical Research
Wichita, Kansas, 67207, United States
Central Kentucky Research Associates, Inc.
Lexington, Kentucky, 40509, United States
University of Louisville
Louisville, Kentucky, 40202, United States
Medpharmics, LLC
Kenner, Louisiana, 70065, United States
Medpharmics, LLC
Lafayette, Louisiana, 70508, United States
Centex Studies, Inc.
Lake Charles, Louisiana, 70601, United States
Clinical Trials of America
Monroe, Louisiana, 71201, United States
Tulane University School of Medicine
New Orleans, Louisiana, 70112, United States
AMR New Orleans, Formerly New Orleans Center for Clinical Research - New Orleans, an AMR company
New Orleans, Louisiana, 70119, United States
Central Maine Medical Center
Lewiston, Maine, 04240, United States
Centennial Medical Group
Elkridge, Maryland, 21075, United States
Optimal Research
Rockville, Maryland, 20850, United States
Synexus Clinical Research US Inc
Richfield, Minnesota, 55423, United States
MedPharmics - Biloxi
Biloxi, Mississippi, 39531, United States
Jefferson City Medical Group Family
Jefferson City, Missouri, 65109, United States
The Center for Pharmaceutical Research (CPR)
Kansas City, Missouri, 64114, United States
Sundance Clinical Research
St Louis, Missouri, 63141, United States
Synexus Clinical Research US Inc
St Louis, Missouri, 63141, United States
Mercury Street Medical Group, PLLC
Butte, Montana, 59701, United States
Meridian Clinical Research, LLC
Norfolk, Nebraska, 68701, United States
Meridian Clinical Research - Omaha
Omaha, Nebraska, 68134, United States
Synexus Clinical Research US Inc
Omaha, Nebraska, 68144, United States
Synexus Clinical Research US Inc
Henderson, Nevada, 89052, United States
Clinical Research Consortium, an AMR company
Las Vegas, Nevada, 89119, United States
Medpharmics, LLC
Albuquerque, New Mexico, 87102, United States
Meridian Clinical Research, LLC
Endwell, New York, 13760, United States
Regional Clinical Research, Inc.
Endwell, New York, 13760, United States
Synexus Clinical Research US Inc
Manhattan, New York, 10017, United States
Harlem Hospital Center
New York, New York, 10027, United States
Finger Lakes Clinical Research
Rochester, New York, 14618, United States
Richmond Behavioral Associates
Staten Island, New York, 10312, United States
CHEAR Center, LLC
The Bronx, New York, 10455, United States
Accellacare Research of Cary
Cary, North Carolina, 27518, United States
American Health Network, LLC
Charlotte, North Carolina, 28277, United States
M3-Emerging Medical Research
Durham, North Carolina, 27704, United States
Medication Management LLC
Greensboro, North Carolina, 27401, United States
Monroe Biomedical Research
Monroe, North Carolina, 28112, United States
Accellacare Research of Cary
Raleigh, North Carolina, 27609, United States
Wake Research Associates
Raleigh, North Carolina, 27612, United States
PMG Research of Wilmington, LLC
Wilmington, North Carolina, 28401, United States
Trial Management Associates, LLC
Wilmington, North Carolina, 28401, United States
Accellacare Research of Cary
Winston-Salem, North Carolina, 27103, United States
Synexus Clinical Research US Inc
Akron, Ohio, 44311, United States
Synexus Clinical Research US Inc
Cincinnati, Ohio, 45236, United States
Velocity Clinical Research
Cincinnati, Ohio, 45242, United States
Rapid Medical Research
Cleveland, Ohio, 44122, United States
Synexus Clinical Research US Inc
Columbus, Ohio, 43212, United States
Lynn Institute of Norman
Norman, Oklahoma, 73072, United States
Lynn Health Science Institute
Oklahoma City, Oklahoma, 73112, United States
Tekton Research Inc.
Yukon, Oklahoma, 73099, United States
Clinical Research Institute of Southern Oregon, P.C.
Grants Pass, Oregon, 97527, United States
Clinical Research Institute of Southern Oregon, P.C.
Medford, Oregon, 97504, United States
Preferred Primary Care Physicians Research
Pittsburgh, Pennsylvania, 15243, United States
Preferred Primary Care Physicians Research
Uniontown, Pennsylvania, 15401, United States
Omega Medical Research
Warwick, Rhode Island, 02886, United States
Synexus Clinical Research US Inc
Anderson, South Carolina, 29621-2062, United States
Velocity Clinical Research, Inc.
Gaffney, South Carolina, 29340, United States
Coastal Carolina Research Center
Mt. Pleasant, South Carolina, 29464, United States
PMG Research of Charleston, LLC
Mt. Pleasant, South Carolina, 29464, United States
Spartanburg Medical Research
Spartanburg, South Carolina, 29303, United States
VitaLink Research Spartanburg
Spartanburg, South Carolina, 29303, United States
Meridian Clinical Research - Dakota Dunes
Dakota Dunes, South Dakota, 57049, United States
PMG Research of Bristol
Bristol, Tennessee, 37620, United States
VGR & NOCCR - Knoxville
Knoxville, Tennessee, 37920, United States
Clinical Research Associates Inc
Nashville, Tennessee, 37203, United States
Central Texas Clinical Research
Austin, Texas, 78705, United States
Optimal Research
Austin, Texas, 78705, United States
Tekton Research Inc.
Austin, Texas, 78745, United States
Tekton Research Inc.
Beaumont, Texas, 78745, United States
Advanced Clinical Research
Cedar Park, Texas, 78613, United States
Synexus Clinical Research US Inc
Dallas, Texas, 75231, United States
North Texas Infectious Diseases Consultants
Dallas, Texas, 75246, United States
Vilo Research Group Inc
Houston, Texas, 77017, United States
Texas Center for Drug Development Inc
Houston, Texas, 77081, United States
Research Your Health
Plano, Texas, 75093, United States
Clinical Trials of Texas Inc
San Antonio, Texas, 78229, United States
Synexus Clinical Research US Inc
San Antonio, Texas, 78229, United States
Tekton Research Inc.
San Antonio, Texas, 78240, United States
DM Clinical Research
Tomball, Texas, 77375, United States
Martine Diagnostic Clinic
Tomball, Texas, 77375, United States
Synexus Clinical Research US Inc
Layton, Utah, 84041, United States
Synexus Clinical Research US Inc
Murray, Utah, 84123, United States
Advanced Clinical Research
West Jordan, Utah, 84088, United States
Charlottesville Medical Research Center, LLC
Charlottesville, Virginia, 22911, United States
Spectrum Medical, Inc
Danville, Virginia, 24541, United States
Health Research of Hampton Roads, Inc
Newport News, Virginia, 23606, United States
Clinical Research Associates of Tidewater
Norfolk, Virginia, 23507, United States
Amherst Family Practice, PC
Winchester, Virginia, 22601, United States
Paratus Clinical Canberra Clinic
Bruce, 2617, Australia
Northside Health
Coffs Harbour, 2450, Australia
Paratus Clinical Kanwal Clinic
Kanwal, 2059, Australia
Mater Hospital Brisbane
South Brisbane, 4101, Australia
UFRR - Universidade Federal de Roraima
Boa Vista, 69304-000, Brazil
CMIP - Centro Mineiro de Pesquisa Ltda
Juiz de Fora, 36010 570, Brazil
Hospital das Clinicas de Porto Alegre
Porto Alegre, 90035-903, Brazil
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto Hospital de Base
São José do Rio Preto, 15090 000, Brazil
CPQuali Pesquisa Clinica LTDA ME
São Paulo, 01228-900, Brazil
Okanagan Clinical Trials
Kelowna, British Columbia, V1Y 1Z9, Canada
LMC Clinical Research dba Manna Research Inc. Burlington
Burlington, Ontario, L7R 1E2, Canada
LMC Clinical Research Inc. (Bayview)
Toronto, Ontario, M4G 3E8, Canada
LMC Clinical Research dba Manna Research Inc. Toronto
Toronto, Ontario, M9W 4L6, Canada
LMC Clinical Research dba Manna Research Inc. Quebec City
Lévis, Quebec, G6W 0M5, Canada
LMC Clinical Research dba Manna Research Inc. Montreal
Pointe-Claire, Quebec, H9R 4S3, Canada
DIEX Recherche Quebec Inc.
Québec, Quebec, G1N 4V3, Canada
DIEX Recherche Joliette Inc.
Saint-Charles-Borromée, Quebec, J6E 2B4, Canada
DIEX Recherche Sherbrooke Inc
Sherbrooke, Quebec, J1L 0H8, Canada
DIEX Recherche Victoriaville Inc.
Victoriaville, Quebec, G6P 6P6, Canada
CENRESIN
Quilota, 2260734, Chile
Centro de Estudios Clínicos e Investigación Médica (CeCim)
Santiago, 8331143, Chile
Centro de Investigacion del Maule
Talca, 3465586, Chile
Donghai County Center for Disease prevention and Control
Lianyungang, 222200, China
Funing County Center for Disease Control and Prevention
Yancheng, 224435, China
Binhai County Center for Disease Control and Prevention
Yancheng, 224554, China
OU Innomedica
Tallinn, 10117, Estonia
Center for Clinical and Basic Research
Tallinn, 10128, Estonia
Clinical Research Centre
Tartu, 50106, Estonia
Espoon rokotetutkimusklinikka
Espoo, 2230, Finland
Etelä-Helsingin rokotetutkimusklinikka
Helsinki, 00100, Finland
Itä-Helsingin rokotetutkimusklinikka
Helsinki, 00930, Finland
Järvenpään rokotetutkimusklinikka
Jarvenpaa, 04400, Finland
Kokkolan rokotetutkimusklinikka
Kokkola, 67100, Finland
Oulun rokotetutkimusklinikka
Oulu, 90220, Finland
Porin rokotetutkimusklinikka
Pori, 28100, Finland
Seinäjoen rokotetutkimusklinikka
Seinäjoki, 60100, Finland
Tampereen rokotetutkimusklinikka
Tampere, 33100, Finland
Turun rokotetutkimusklinikka
Turku, 20520, Finland
Southern Clinical Trials Totara Clinical Research
Auckland, 0600, New Zealand
Southern Clinical Trials, Waitemata
Auckland, 0626, New Zealand
Optimal Clinical Trials
Auckland, 1010, New Zealand
Southern Clinical Trials, Christchurch
Christchurch, 8013, New Zealand
Lakeland Clinical Trials
Hamilton, 3200, New Zealand
P3 Research Ltd
Havelock North, 3410, New Zealand
Southern Clinical Trials Tasman
Main Road Stoke, 7011, New Zealand
P3 Research Ltd
Palmerston North, 4414, New Zealand
P3 Research Limited Kapiti
Paraparaumu, 5032, New Zealand
Lakeland Clinical Trials
Rotorua, 3010, New Zealand
P3 Research Ltd
Tauranga, 3110, New Zealand
Lakeland Clinical Trials
Upper Hutt, 5018, New Zealand
P3 Reaearch Wellington
Wellington, 6021, New Zealand
Synexus Polska Sp. z o.o. Oddzial w Czestochowie
Częstochowa, 42-202, Poland
Synexus Polska Sp. z o.o. Oddzial w Gdansku
Gdansk, 80-382, Poland
Synexus Scm Sp Z o o Oddzial Gdynia
Gdynia, 81 537, Poland
Synexus Polska Sp z o o Oddzial w Katowicach
Katowice, 40 040, Poland
Synexus Polska Sp z o o
Lodz, 90 127, Poland
KO MED Centra Kliniczne LUBLIN
Lublin, 20 362, Poland
Synexus Polska Sp. z.o.o. Oddzial w Poznaniu
Poznan, 60-702, Poland
KO MED Centra Kliniczne Pulawy
Puławy, 24-100, Poland
Centrum Medyczne Pratia Poznan
Skorzewo, 60 185, Poland
KO-MED Centra Kliniczne Staszow
Staszów, 28 200, Poland
Synexus Polska Sp z o o Oddzial w Warszawie
Warsaw, 623832, Poland
Synexus Polska Sp z o o Oddzial we Wroclawiu
Wroclaw, 50 381, Poland
KO MED Centra Kliniczne Zamosc
Zamość, 22 400, Poland
Iatros International
Bloemfontein, 9301, South Africa
Josha Research
Bloemfontein, 9301, South Africa
Madibeng Centre for Research
Brits, 250, South Africa
Synexus Helderberg Clinical Research Centre
Cape Town, 7130, South Africa
TREAD Research Tygerberg Hospital
Cape Town, 7500, South Africa
TASK Central
Cape Town, 7530, South Africa
Tiervlei Trial Centre
Cape Town, 7530, South Africa
Allergy Immunology Unit
Cape Town, 7700, South Africa
Synergy Biomed Research Institute (SBRI)
East London, 5241, South Africa
TASK Central
George, 06530, South Africa
CRISMO Bertha Gxowa Research Centre
Johannesburg, 1401, South Africa
Worthwhile Clinical trials
Johannesburg, 1501, South Africa
Clinresco Centres Pty Ltd
Johannesburg, 1619, South Africa
DJW Research
Krugersdorp, 1739, South Africa
Stanza Clinical Research Centre : Mamelodi
Mamelodi East, 0122, South Africa
Newtown Clinical Research
Newtown, 2113, South Africa
Paarl Research Centre
Paarl, 7646, South Africa
Global Clin Trials Pretoria
Pretoria, 0001, South Africa
Synexus Watermeyer
Pretoria, South Africa
The Aurum Institute Rustenburg Clinical Research Site
Rustenburg, 300, South Africa
REIMED Vosloorus
Vosloorus, 01475, South Africa
Welkom Clinical Trial Centre
Welkom, 9460, South Africa
Be Part Yoluntu Centre
Western Cape, 7626, South Africa
Kaohsiung Medical University Chung Ho Memorial Hospital
Kaohsiung City, 80756, Taiwan
China Medical University Hospital
Taichung, 40447, Taiwan
National Taiwan University Hospital
Taipei, 10002, Taiwan
Taipei Medical University
Taipei, 110, Taiwan
Taipei Veterans General Hospital
Taipei, 11217, Taiwan
Tri-Service General Hospital
Taipei, 11490, Taiwan
Taipei Municipal Wanfang Hospital
Taipei, 116, Taiwan
Chang Gung Memorial Hospital- Linkou
Taoyuan, 33305, Taiwan
Royal Thai Army, Afrims
Bangkok, 10400, Thailand
The Vaccine Trial Center(VTC), Faculty of Tropical Medicine
Bangkok, 10400, Thailand
Siriraj Hospital
Bangkok, 10700, Thailand
Srinagarind Hospital
Khon Kaen, 40002, Thailand
Maharaj Nakorn Chiang Mai hospital Faculty of Medicine
Muang, 50200, Thailand
King Chulalongkorn Memorial Hospital
Pathumwan, 10330, Thailand
Synexus Midlands Clinical Research Centre
Birmingham, B15 2SQ, United Kingdom
FutureMeds Soho Health Centre
Birmingham, B21 9RY, United Kingdom
Bradford Royal Infirmary
Bradford, BD9 6RJ, United Kingdom
FutureMeds Bridle Clinic
Bromborough, CH62 6EE, United Kingdom
Synexus Wales Clinical Research Center
Cardiff, CF15 9SS, United Kingdom
Synexus Lancashire Clinical Research Centre
Chorley, PR7 7NA, United Kingdom
Panthera Biopartners
Glasgow, G51 4TF, United Kingdom
Synexus Scotland Clinical Research Centre
Glasgow, United Kingdom
Synexus Hexham General Hospital
Hexham, NE46 1QJ, United Kingdom
Synexus Merseyside Clinical Research Centre
Liverpool, L22 0LG, United Kingdom
Synexus Manchester Clinical Research Center
Manchester, M15 6SX, United Kingdom
North Manchester General Hospital
Manchester, M8 5RB, United Kingdom
Panthera Biopartners
Preston, PR2 9RB, United Kingdom
Panthera Biopartners
Reading, RG2 9LH, United Kingdom
University Hospital of North Tees
Stockton-on-Tees, TS19 8PE, United Kingdom
Related Publications (1)
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.
PMID: 38902186DERIVED
Results Point of Contact
- Title
- Clinical Franchise Leader
- Organization
- Janssen Vaccines & Prevention B.V.
Study Officials
- STUDY DIRECTOR
Janssen Vaccines & Prevention B.V. Clinical Trial
Janssen Vaccines & Prevention B.V.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 27, 2021
First Posted
June 1, 2021
Study Start
July 21, 2021
Primary Completion
July 21, 2023
Study Completion
July 21, 2023
Last Updated
November 13, 2025
Results First Posted
February 8, 2024
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will share
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