AzTrials
AzTrials

Lower Respiratory Tract IllnessPhase 3RENOIRNCT05035212

Study to Evaluate the Efficacy, Immunogenicity, and Safety of RSVpreF in Adults.

A Phase 3 study testing RSVpreF in people with Lower Respiratory Tract Illness, run by Pfizer at 263 sites in 7 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

Efficacy Study: This randomized, double-blinded, placebo-controlled Phase 3 study is designed to assess the safety, immunogenicity, and efficacy of a single dose of RSVpreF in the prevention of LRTI-RSV in adults: At a dose of 120µg. In adults 60 years of age and older. Read more about this study

Who is it for?
Ages 60 years and olderHealthy volunteers can take part
Conditions the study is for
Lower Respiratory Tract Illness
What is being tested?
RSVpreF
Type of treatment
Vaccines
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
38,861 participants
Where
263 sitesin 7 countries
Study dates
31 Aug 2021to 18 Jan 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

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

  • Participants who are willing and able to comply with all scheduled visits, vaccination plan, laboratory tests, lifestyle considerations, frequent symptom assessment by mobile device application, and other study procedures, including collection of nasal swabs by themselves and by study staff when indicated.
  • Healthy participants who are determined by medical history, physical examination (if required), and clinical judgment of the investigator to be eligible for inclusion in the study.
  • Note: Healthy participants with preexisting stable disease, defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 6 weeks before enrollment, can be included. Specific criteria for participants with known stable infection with HIV, HCV, or HBV can be found in the protocol.
  • Adults who are ambulatory and live in the community, or in assisted living or long-term care residential facilities that provide minimal assistance, such that the participant is primarily responsible for self-care and activities of daily living.
  • Capable of giving signed informed consent as described in the protocol, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol.
  • Male or female participants ≥60 years of age.
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  • Male participants able to father children must agree to use a highly effective method of contraception from the time of informed consent through at least 28 days after study intervention administration.
  • Female participants must not be of childbearing potential.
  • Participants who are willing and able to comply with all scheduled visits, vaccination plan, laboratory tests, lifestyle considerations, frequent symptom assessment by mobile device application, and other study procedures, including collection of nasal swabs by themselves and by study staff when indicated.
  • Healthy participants who are determined by medical history, physical examination (if required), and clinical judgment of the investigator to be eligible for inclusion in the study.
  • Note: Healthy participants with preexisting stable disease, defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 6 weeks before enrollment, can be included. Specific criteria for participants with known stable infection with HIV, HCV, or HBV can be found in the protocol.
  • Adults who are ambulatory and live in the community, or in assisted living or long-term care residential facilities that provide minimal assistance, such that the participant is primarily responsible for self-care and activities of daily living.
  • Capable of giving signed informed consent as described in the protocol, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol.
  • Male or female participants ≥60 years of age.
  • Male participants able to father children must agree to use a highly effective method of contraception from the time of informed consent through at least 28 days after study intervention administration.
  • Female participants must not be of childbearing potential.
  • Participants who received RSVpreF in the efficacy study.
  • Participants who have a Visit 2 serology sample available for testing from the efficacy study, completed the end-of-Season 2 visit (Visit 5), and did not meet exclusion criteria throughout the efficacy study duration.
  • Participants who are willing and able to comply with all scheduled visits, vaccination plan, laboratory tests, lifestyle considerations, frequent symptom assessment by mobile device application, and other study procedures, including collection of nasal swabs by themselves and by study staff when indicated.
  • Healthy participants who are determined by medical history, physical examination (if required), and clinical judgment of the investigator to be eligible for inclusion in the study.
  • Note: Healthy participants with preexisting stable disease, defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 6 weeks before enrollment, can be included. Specific criteria for participants with known stable infection with HIV, HCV, or HBV can be found in the protocol.
  • Adults who are ambulatory and live in the community, or in assisted living or long-term care residential facilities that provide minimal assistance, such that the participant is primarily responsible for self-care and activities of daily living.
  • Capable of giving signed informed consent as described in the protocol, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol.
  • Male or female participants ≥60 years of age.
  • Male participants able to father children must agree to use a highly effective method of contraception from the time of informed consent through at least 28 days after study intervention administration.
  • Female participants must not be of childbearing potential. 6. Participants who received RSVpreF in the efficacy study.
  • Participants who received RSVpreF in the efficacy study.
  • Participants who have a Visit 2 serology sample available for testing from the efficacy study and did not meet exclusion criteria through Visit 4 of the efficacy study.
  • Participants who are willing and able to comply with all scheduled visits, vaccination plan, laboratory tests, lifestyle considerations, frequent symptom assessment by mobile device application, and other study procedures, when indicated.
  • Healthy participants who are determined by medical history, physical examination (if required), and clinical judgment of the investigator to be eligible for inclusion in the study.
  • Note: Healthy participants with preexisting stable disease, defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 6 weeks before enrollment, can be included. Specific criteria for participants with known stable infection with HIV, HCV, or HBV can be found in the protocol.
  • Adults who are ambulatory and live in the community, or in assisted living or long-term care residential facilities that provide minimal assistance, such that the participant is primarily responsible for self-care and activities of daily living.
  • Capable of giving signed informed consent as described in the protocol, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol.
  • Male or female participants ≥60 years of age.
  • Participants who received RSVpreF in the efficacy study.
  • Participants who have a Visit 2 serology sample available for testing from the efficacy study, completed the end-of-Season 2 visit (Visit 5), and did not meet exclusion criteria throughout the efficacy study duration.

Who cannot join

  • Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.
  • History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s) or any related vaccine.
  • Serious chronic disorder including metastatic malignancy, end-stage renal disease with or without dialysis, clinically unstable cardiac disease, or any other disorder that, in the investigator's opinion, excludes the participant from participating in the study.
  • Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination.
  • Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
  • Participation in other studies involving an investigational product within 28 days prior to consent and/or through and including the 6-months follow-up visit (Visit 3).
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  • Note: This criterion does not apply to participants who are participating in a follow-up period for another study involving a study intervention that is an investigational drug or vaccine, if receipt of the last dose was at least 6 months prior to consenting for this study and there is no further dosing anticipated from the previous study during the participant's participation in this study - Individuals who receive chronic systemic treatment with immunosuppressive therapy, including cytotoxic agents, monoclonal antibodies, systemic corticosteroids, or radiotherapy, eg, for cancer or an autoimmune disease, from 60 days before study intervention administration or planned receipt throughout the study. If systemic corticosteroids have been administered short term (<14 days) for treatment of an acute illness, participants should not be enrolled in the study until corticosteroid therapy has been discontinued for at least 28 days before study intervention administration. Inhaled/nebulized, intra articular, intrabursal, or topical (skin or eyes) corticosteroids are permitted.
  • Note: Participants with COPD or asthma can be enrolled if chronic corticosteroids do not exceed a dose equivalent to 10 mg/day of prednisone.
  • Receipt of blood/plasma products or immunoglobulin within 60 days before study intervention administration.
  • Previous vaccination with any licensed or investigational RSV vaccine or planned receipt during study participation.
  • Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.
  • Substudy A
  • Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.
  • History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s) or any related vaccine.
  • Serious chronic disorder including metastatic malignancy, end-stage renal disease with or without dialysis, clinically unstable cardiac disease, or any other disorder that, in the investigator's opinion, excludes the participant from participating in the study.
  • Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination.
  • Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
  • Participation in other studies involving an investigational product within 28 days prior to consent and/or through and including the 6-months follow-up visit (Visit 103).
  • Note: This criterion does not apply to participants who are participating in a follow-up period for another study involving a study intervention that is an investigational drug or vaccine, if receipt of the last dose was at least 6 months prior to consenting for this study and there is no further dosing anticipated from the previous study during the participant's participation in this study
  • Individuals who receive chronic systemic treatment with immunosuppressive therapy, including cytotoxic agents, monoclonal antibodies, systemic corticosteroids, or radiotherapy, eg, for cancer or an autoimmune disease, from 60 days before study intervention administration or planned receipt throughout the study. If systemic corticosteroids have been administered short term (<14 days) for treatment of an acute illness, participants should not be enrolled in the study until corticosteroid therapy has been discontinued for at least 28 days before study intervention administration. Inhaled/nebulized, intra articular, intrabursal, or topical (skin or eyes) corticosteroids are permitted.
  • Note: Participants with COPD or asthma can be enrolled if chronic corticosteroids do not exceed a dose equivalent to 10 mg/day of prednisone.
  • Receipt of blood/plasma products or immunoglobulin within 60 days before study intervention administration.
  • Previous vaccination with any licensed or investigational RSV vaccine or planned receipt during study participation.
  • Note: This criterion does not include the receipt of RSVpreF in the efficacy study. Per inclusion criterion #6, receipt of RSVpreF in the efficacy study is required to participate in Substudy A.
  • Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.
  • Participant was confirmed by the sponsor to have previously received the study intervention more than once.
  • Substudy B
  • Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.
  • History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s) or any related vaccine.
  • Serious chronic disorder including metastatic malignancy, end-stage renal disease with or without dialysis, clinically unstable cardiac disease, or any other disorder that, in the investigator's opinion, excludes the participant from participating in the study.
  • Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination.
  • Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
  • Participation in other studies involving an investigational product within 28 days prior to consent and/or through and including the 6-months follow-up visit (Visit 203).
  • Note: This criterion does not apply to participants who are participating in a follow-up period for another study involving a study intervention that is an investigational drug or vaccine, if receipt of the last dose was at least 6 months prior to consenting for this study and there is no further dosing anticipated from the previous study during the participant's participation in this study - Individuals who receive chronic systemic treatment with immunosuppressive therapy, including cytotoxic agents, monoclonal antibodies, systemic corticosteroids, or radiotherapy, eg, for cancer or an autoimmune disease, from 60 days before study intervention administration or planned receipt throughout the study. If systemic corticosteroids have been administered short term (<14 days) for treatment of an acute illness, participants should not be enrolled in the study until corticosteroid therapy has been discontinued for at least 28 days before study intervention administration. Inhaled/nebulized, intra articular, intrabursal, or topical (skin or eyes) corticosteroids are permitted.
  • Note: Participants with COPD or asthma can be enrolled if chronic corticosteroids do not exceed a dose equivalent to 10 mg/day of prednisone.
  • Receipt of blood/plasma products or immunoglobulin within 60 days before study intervention administration.
  • Previous vaccination with any licensed or investigational RSV vaccine or planned receipt during study participation.
  • Note: This criterion does not include the receipt of RSVpreF in the efficacy study. Per inclusion criterion #6, receipt of RSVpreF in the efficacy study is required to participate in Substudy B.
  • Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.
  • Participant was confirmed by the sponsor to have previously received the study intervention more than once.
  • Participants who completed Vaccination 1 from the efficacy study less than 9 months or greater than 15 months prior to revaccination.
  • Substudy C
  • Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.
  • History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s) or any related vaccine.
  • Serious chronic disorder including metastatic malignancy, end-stage renal disease with or without dialysis, clinically unstable cardiac disease, or any other disorder that, in the investigator's opinion, excludes the participant from participating in the study.
  • Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination.
  • Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
  • Participation in other studies involving an investigational product within 28 days prior to consent and/or through and including the 6-months follow-up visit (Visit 303 or Visit 306).
  • Note: This criterion does not apply to participants who are participating in a follow-up period for another study involving a study intervention that is an investigational drug or vaccine, if receipt of the last dose was at least 6 months prior to consenting for this study and there is no further dosing anticipated from the previous study during the participant's participation in this study
  • Individuals who receive chronic systemic treatment with immunosuppressive therapy, including cytotoxic agents, monoclonal antibodies, systemic corticosteroids, or radiotherapy, eg, for cancer or an autoimmune disease, from 60 days before study intervention administration or planned receipt throughout the study. If systemic corticosteroids have been administered short term (<14 days) for treatment of an acute illness, participants should not be enrolled in the study until corticosteroid therapy has been discontinued for at least 28 days before study intervention administration. Inhaled/nebulized, intra articular, intrabursal, or topical (skin or eyes) corticosteroids are permitted.
  • Note: Participants with COPD or asthma can be enrolled if chronic corticosteroids do not exceed a dose equivalent to 10 mg/day of prednisone.
  • Receipt of blood/plasma products or immunoglobulin within 60 days before study intervention administration.
  • Previous vaccination with any licensed or investigational RSV vaccine or planned receipt during study participation.
  • Note: This criterion does not include the receipt of RSVpreF in the efficacy study. Per inclusion criterion #6, receipt of RSVpreF in the efficacy study is required to participate in Substudy C.
  • Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.
  • Participant was confirmed by the sponsor to have previously received the study intervention more than once.
  • Prior history of any subtype of Guillain-Barré syndrome of any etiology.
  • Current or prior participation in Substudy A or Substudy B.
  • Participants who completed Vaccination 1 from the efficacy study less than 32 months or greater than 40 months prior to revaccination.

Trial locations and contacts

263 sites in 7 countries.

263 sites in 7 countries

United States176 sites

  • Javara - Privia Medical Group Georgia - Albany

    Albany, Georgia, 31707

  • JEM Research Institute

    Atlantis, Florida, 33462

  • Lynn Institute of Denver

    Aurora, Colorado, 80012

  • Benchmark Research

    Austin, Texas, 78705

  • Innovo Research - Austin Regional Clinic

    Austin, Texas, 78726

  • Tekton Research, LLC.

    Austin, Texas, 78745

  • IDEAL Clinical Research

    Aventura, Florida, 33180

  • Tekton Research, LLC.

    Beaumont, Texas, 77706

  • Northwest Clinical Research Center

    Bellevue, Washington, 98007

  • ActivMed Practices & Research, LLC

    Beverly, Massachusetts, 01915

  • Velocity Clinical Research, Binghamton

    Binghamton, New York, 13905

  • St. Vincent's Birmingham (Pharmacy)

    Birmingham, Alabama, 35205

  • St. Vincent's Birmingham

    Birmingham, Alabama, 35205

  • Capital Area Research, LLC

    Camp Hill, Pennsylvania, 17011

  • Hope Clinical Research

    Canoga Park, California, 91303

  • Atrium Health - Strive Vaccine Research Clinic

    Charlotte, North Carolina, 28207

  • Tryon Medical Partners, PLLC

    Charlotte, North Carolina, 28210

  • Accellacare - Charlotte

    Charlotte, North Carolina, 28211

  • Sensenbrenner Primary Care Research Office

    Charlotte, North Carolina, 28277

  • Great Lakes Clinical Trials, LLC dba Flourish Research

    Chicago, Illinois, 60640

  • eStudySite

    Chula Vista, California, 91911

  • Velocity Clinical Research, Cincinnati, Mt. Auburn

    Cincinnati, Ohio, 45219

  • Velocity Clinical Research - Cincinnati

    Cincinnati, Ohio, 45242

  • Velocity Clinical Research, Springdale

    Cincinnati, Ohio, 45246

  • Innovative Research of West Florida

    Clearwater, Florida, 33756

  • Invictus Clinical Research Group, LLC

    Coconut Creek, Florida, 33073

  • Benchmark Research

    Colton, California, 92324

  • Centricity Research Columbus Ohio Multispecialty

    Columbus, Ohio, 43213

  • Javara - Privia Medical Group Gulf Coast - The Woodlands HWH

    Conroe, Texas, 77384

  • The Corvallis Clinic, PC

    Corvallis, Oregon, 97330

  • Nature Coast Clinical Research

    Crystal River, Florida, 34429

  • North Texas Infectious Diseases Consultants, P.A

    Dallas, Texas, 75246

  • Universal Axon Clinical Research, LLC (Administrative)

    Doral, Florida, 33166

  • J. Lewis Research, Inc. / Foothill Family Clinic Draper

    Draper, Utah, 84020

  • West Coast Research

    Dublin, California, 94568

  • Velocity Clinical Research, Providence

    East Greenwich, Rhode Island, 02818

  • Tekton Research, LLC.

    Edmond, Oklahoma, 73013

  • Skyline Medical Center, PC/CCT Research

    Elkhorn, Nebraska, 68022

  • Central Erie Primary Care

    Erie, Pennsylvania, 16508

  • Michigan Center of Medical Research (MICHMER)

    Farmington Hills, Michigan, 48334

  • Benchmark Research

    Fort Worth, Texas, 76135

  • Texas Health Family Care

    Fort Worth, Texas, 76135

  • Allure Health at Mt. Olympus Medical Research

    Friendswood, Texas, 77546

  • Lenzmeier Family Medicine / Avacare

    Glendale, Arizona, 85308

  • Velocity Clinical Research, Grants Pass

    Grants Pass, Oregon, 97527

  • Ascension St. John Hospital Vaccine Research Unit

    Grosse Pointe Woods, Michigan, 48236

  • Drug Trials America

    Hartsdale, New York, 10530

  • Indago Research & Health Center, Inc

    Hialeah, Florida, 33012

  • Doral Medical Research, LLC

    Hialeah, Florida, 33016

  • Coastal Heritage Clinical Research

    Hinesville, Georgia, 31313

  • Corning Center for Clinical Research

    Horseheads, New York, 14845

  • Hany H. Ahmed, MD

    Houston, Texas, 77008

  • Helios Clinical Research - HOU

    Houston, Texas, 77008

  • HG Pediatrics

    Houston, Texas, 77008

  • Trio Clinical Trials, LLC

    Houston, Texas, 77008

  • Van Tran Family Practice

    Houston, Texas, 77008

  • Ventavia Research Group, LLC

    Houston, Texas, 77008

  • Centex Studies

    Houston, Texas, 77058

  • DM Clinical Research - Cy Fair

    Houston, Texas, 77065

  • DM Clinical Research- Cyfair

    Houston, Texas, 77065

  • DM Clinical Research - Bellaire

    Houston, Texas, 77081

  • Centex Studies

    Houston, Texas, 77090

  • DM Clinical Research - Humble

    Humble, Texas, 77338

  • DM Clinical Research, Martin Diagnostic Clinic

    Humble, Texas, 77338

  • Marvel Clinical Research 002, LLC

    Huntington Beach, California, 92647

  • Medical Affiliated Research Center

    Huntsville, Alabama, 35801

  • Snake River Research, PLLC

    Idaho Falls, Idaho, 83404

  • University of Iowa

    Iowa City, Iowa, 52242

  • Ochsner Clinic Foundation

    Kenner, Louisiana, 70065

  • Ochsner Medical Center - Kenner

    Kenner, Louisiana, 70065

  • AMR Clinical

    Knoxville, Tennessee, 37909

  • Accellacare US Inc., d/b/a Accellacare of Knoxville

    Knoxville, Tennessee, 37912

  • M3 Wake Research - Lake City

    Lake City, Florida, 32055

  • Chemidox Clinical Trials

    Lancaster, California, 93534

  • Milton Haber, M.D.

    Laredo, Texas, 78041

  • Milton Haber, MD

    Laredo, Texas, 78041

  • Wr-Crcn, Llc.

    Las Vegas, Nevada, 89106

  • Alliance for Multispecialty Research, LLC

    Las Vegas, Nevada, 89119

  • Tanner Clinic

    Layton, Utah, 84041

  • AMR Clinical

    Lexington, Kentucky, 40509

  • Ark Clinical Research

    Long Beach, California, 90815

  • Tekton Research LLC

    Longmont, Colorado, 80501

  • Downtown L.A. Research Center, Inc.

    Los Angeles, California, 90017

  • Velocity Clinical Research, Medford

    Medford, Oregon, 97504

  • DM Clinical Research

    Melrose Park, Illinois, 60160

  • Solaris Clinical Research

    Meridian, Idaho, 83646

  • SMS Clinical Research

    Mesquite, Texas, 75149

  • Velocity Clinical Research, Metairie

    Metairie, Louisiana, 70006

  • ActivMed Practices & Research, LLC

    Methuen, Massachusetts, 01844

  • Optimus U Corporation

    Miami, Florida, 33125

  • Advance Medical Research Center

    Miami, Florida, 33135

  • Flourish Research - Miami, LLC

    Miami, Florida, 33135

  • Optimus U Corporation

    Miami, Florida, 33135

  • Next Phase Research Alliance

    Miami, Florida, 33144

  • New Horizon Research Center

    Miami, Florida, 33165

  • De La Cruz Research Center, LLC

    Miami, Florida, 33184

  • Global Health Research Center, Inc.

    Miami Lakes, Florida, 33016

  • Clinical Research Consulting

    Milford, Connecticut, 06460

  • MOC Research

    Mishawaka, Indiana, 46544

  • Clinical Research Associates, Inc.

    Nashville, Tennessee, 37203

  • Velocity Clinical Research, North Hollywood

    North Hollywood, California, 91606

  • Las Vegas Clinical Trials

    North Las Vegas, Nevada, 89030

  • Affinity Health Corp

    Oak Brook, Illinois, 60523

  • Accellacare - DuPage

    Oak Lawn, Illinois, 60453

  • Quality Clinical Research

    Omaha, Nebraska, 68114

  • Headlands Research Orlando

    Orlando, Florida, 32819

  • Clinica mi Salud by Focil Med

    Oxnard, California, 93030

  • De Silva Medical Inc

    Palmdale, California, 93551

  • Pines Care Research Center, LLC

    Pembroke Pines, Florida, 33024

  • IDEAL Clinical Research

    Pembroke Pines, Florida, 33026

  • DBC Research USA

    Pembroke Pines, Florida, 33029

  • Penn Prevention Unit

    Philadelphia, Pennsylvania, 19104

  • Phoenix Clinical LLC

    Phoenix, Arizona, 85014

  • HOPE Research Institute

    Phoenix, Arizona, 85018

  • The Pain Center of Arizona

    Phoenix, Arizona, 85018

  • HOPE Research Institute

    Phoenix, Arizona, 85023

  • Cognitive Clinical Trials, LLC

    Phoenix, Arizona, 85044

  • Empire Clinical Research

    Pomona, California, 91767

  • Sound Medical Research

    Port Orchard, Washington, 98366

  • Summit Headlands, LLC

    Portland, Oregon, 97210

  • Kaiser Permanente Northwest Center for Health Research

    Portland, Oregon, 97227

  • ActivMed Practices and Research, LLC.

    Portsmouth, New Hampshire, 03801

  • Paradigm Clinical Research Center

    Redding, California, 96001

  • Artemis Institute for Clinical Research

    Riverside, California, 92503

  • Rochester Clinical Research, LLC

    Rochester, New York, 14609

  • University of Rochester Medical Center

    Rochester, New York, 14642

  • Velocity Clinical Research, Rockville

    Rockville, Maryland, 20854

  • Benchmark Research

    Sacramento, California, 95864

  • Sun Research Institute

    San Antonio, Texas, 78215

  • Clinical Trials of Texas, LLC dba Flourish Research

    San Antonio, Texas, 78229

  • Clinical Trials of Texas, LLC

    San Antonio, Texas, 78229

  • Artemis Institute for Clinical Research

    San Diego, California, 92123

  • California Research Foundation

    San Diego, California, 92123

  • Headlands Research Sarasota

    Sarasota, Florida, 34243

  • Javara - Privia Medical Group Georgia - Savannah

    Savannah, Georgia, 31406

  • Velocity Clinical Research, Savannah

    Savannah, Georgia, 31406

  • Headlands Research - Scottsdale

    Scottsdale, Arizona, 85260

  • Meridian Clinical Research, LLC

    Sioux City, Iowa, 51106

  • South Jersey Infectious Disease

    Somers Point, New Jersey, 08244

  • J. Lewis Research, Inc. / Jordan River Family Medicine

    South Jordan, Utah, 84095

  • Saint Louis University

    St Louis, Missouri, 63104

  • Sundance Clinical Research

    St Louis, Missouri, 63141

  • Stamford Therapeutics Consortium

    Stamford, Connecticut, 06905

  • Clinical Research Atlanta

    Stockbridge, Georgia, 30281

  • Centricity Research Suffolk Primary Care

    Suffolk, Virginia, 23435

  • Virginia Gastroenterology Clinical Research

    Suffolk, Virginia, 23435

  • Dynamed Clinical Research, LP d/b/a DM Clinical Research

    Sugar Land, Texas, 77478

  • Javara Inc.

    Sugar Land, Texas, 77478

  • Mt Olympus Medical Research

    Sugar Land, Texas, 77479

  • Precision Clinical Research

    Sunrise, Florida, 33351

  • MultiCare Institute for Research & Innovation

    Tacoma, Washington, 98405

  • MultiCare Medical Group

    Tacoma, Washington, 98405

  • Alliance for Multispecialty Research, LLC

    Tempe, Arizona, 85281

  • HOPE Research Institute

    Tempe, Arizona, 85284

  • CHEAR Center LLC

    The Bronx, New York, 10455

  • Javara Inc.

    Thomasville, Georgia, 31792

  • Dynamed Clinical Research, LP d/b/a DM Clinical Research

    Tomball, Texas, 77375

  • Oakland Medical Research

    Troy, Michigan, 48085

  • Arcturus Healthcare , PLC, Troy Internal Medicine Research Division

    Troy, Michigan, 48098

  • Noble Clinical Research

    Tucson, Arizona, 85704

  • The Institute for Liver Health dba Arizona Clinical Trials

    Tucson, Arizona, 85712

  • Velocity Clinical Research Valparaiso

    Valparaiso, Indiana, 46383

  • Velocity Clinical Research, Vestal

    Vestal, New York, 13850

  • Diablo Clinical Research, Inc.

    Walnut Creek, California, 94598

  • IMA Clinical Research Warren

    Warren Township, New Jersey, 07059

  • Allegiance Research Specialists, LLC

    Wauwatosa, Wisconsin, 53226

  • Central Washington Health Services Association d/b/a Confluence Health

    Wenatchee, Washington, 98801

  • Research Building

    Wenatchee, Washington, 98801

  • Velocity Clinical Research, Salt Lake City

    West Jordan, Utah, 84088

  • Accellacare - Wilmington - 1917 Tradd Court

    Wilmington, North Carolina, 28401

  • Accellacare - Wilmington

    Wilmington, North Carolina, 28401

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27157

  • Clinical Site Partners, LLC dba Flourish Research

    Winter Park, Florida, 32789

  • Conquest Research

    Winter Park, Florida, 32789

  • University of Massachusetts Chan Medical School

    Worcester, Massachusetts, 01655

  • Tekton Research, Inc

    Yukon, Oklahoma, 73099

Other trials in United States

South Africa21 sites

  • Worthwhile Clinical Trials

    Benoni, Gauteng, 1500

  • Josha Research

    Bloemfontein, Free State, 9301

  • Synexus - Helderberg Clinical Research Centre - Somerset West

    Cape Town, Western Cape, 7130

  • TREAD Research

    Cape Town, Western Cape, 7500

  • MERCLINCO (Pty) Ltd - Kempton

    Kempton Park, Gauteng, 1619

  • MERC Research (Pty) Ltd - Middelburg

    Middelburg, Mpumalanga, 1055

  • Dr A Jacovides & Partners Inc.

    Midrand, Gauteng, 1685

  • Newtown Clinical Research Centre (PTY) LTD

    Newtown, Gauteng, 2001

  • Be Part Yoluntu Centre

    Paarl, Western Cape, 7626

  • Global Clinical Trials

    Pretoria, Gauteng, 0083

  • About Allergy

    Pretoria, Gauteng, 0181

  • Into Research

    Pretoria, Gauteng, 0181

  • Jongaie Research

    Pretoria, Gauteng, 0183

  • Synexus SA- Watermeyer Clinical Research Center

    Pretoria, Gauteng, 0184

  • Emmed Research

    Pretoria, 0002

  • Botho Ke Bontle Health Services

    Pretoria, 0184

  • Helderberg Clinical Trials Centre

    Somerset West, Western Cape, 7129

  • Setshaba Research Centre

    Soshanguve, Gauteng, 0152

  • Wits Vaccines & Infectious Diseases Analytics

    Soweto, Gauteng, 2195

  • FCRN Clinical Trial Centre

    Vereeniging, Gauteng, 1935

  • Welkom Clinical Trial Centre (MERC WELKOM)

    Welkom, Free State, 9460

Other trials in South Africa

Japan19 sites

  • Sasaki Clinic

    Amagasaki, Hyōgo, 660-0827

  • Nihonbashi Sakura Clinic

    Chuo-ku, Tokyo, 103-0025

  • Tokyo Eki Center Building Clinic

    Chuo-ku, Tokyo, 103-0027

  • Fukuwa Clinic

    Chuo-ku, Tokyo, 104-0031

  • Tokyo Asbo Clinic

    Chuo-ku, Tokyo, 104-0031

  • Tenjin General Clinic

    Fukuoka, Fukuoka, 810-0021

  • SOUSEIKAI PS Clinic

    Fukuoka, 812-0025

  • Medical Corp. Seikoukai New Medical Research System Clinic

    Hachioji-shi, Tokyo, 192-0046

  • Seishinkai Inoue Hospital

    Itoshima, Fukuoka, 819-1104

  • Sugiura Clinic

    Kawaguchi, Saitama, 332-0012

  • Medical Corporation Heishinkai OPHAC Hospital

    Osaka, Osaka, 532-0003

  • AMC Nishiumeda Clinic

    Osaka, 530-0001

  • Hillside Clinic Jingumae

    Shibuya-ku, Tokyo, 1500001

  • Clinical Research Hospital Tokyo

    Shinjuku-ku, Tokyo, 160-0004

  • Clinical Research Hospital Tokyo

    Shinjuku-ku, Tokyo, 162-0053

  • Oda Clinic

    Shinjuku-ku, Tokyo, 169-0072

  • Souseikai Sumida Hospital

    Sumida-ku, Tokyo, 130-0004

  • Sekino Hospital

    Toshima-ku, Tokyo, 171-0014

  • Motomachi Takatsuka Naika Clinic

    Yokohama, Kanagawa, 231-0023

Other trials in Japan

Canada15 sites

  • Aggarwal and Associates Limited

    Brampton, Ontario, L6T 0G1

  • Kaye Edmonton Clinic

    Edmonton, Alberta, T6G 1Z1

  • University Of Alberta Hospital

    Edmonton, Alberta, T6G 2B7

  • Dawson Clinical Research Inc

    Guelph, Ontario, N1H 1B1

  • Premier Clinical Trial Network

    Hamilton, Ontario, L8L 5G4

  • Centricity Research Mirabel Multispecialty

    Mirabel, Quebec, J7J 2K8

  • Clinique de Médecine Urbaine du Quartier Latin

    Montreal, Quebec, H2L 4E9

  • Alpha Recherche Clinique

    Québec, Quebec, G2J 0C4

  • Diex Recherche Quebec

    Québec, G1V 4T3

  • Centre de Recherche Saint-Louis inc.

    Québec, G1W 4R4

  • Diex Recherche Sherbrooke

    Sherbrooke, Quebec, J1L 0H8

  • Centricity Research Toronto LMC Multispecialty

    Toronto, Ontario, M4G 3E8

  • Dr. Anil K. Gupta Medicine Professional Corporation

    Toronto, Ontario, M9V 4B4

  • Centricity Research Toronto Manna Multispecialty

    Toronto, Ontario, M9W 4L6

  • Diex Recherche Inc. Division Victoriaville

    Victoriaville, Quebec, G6P 3Z8

Other trials in Canada

Finland13 sites

  • Espoo Vaccine Research Clinic

    Espoo, 02230

  • FVR, Etelä-Helsingin rokotetutkimusklinikka

    Helsinki, 00100

  • Helsinki East Vaccine Research Clinic

    Helsinki, 00930

  • Järvenpää Vaccine Research Clinic

    Jarvenpaa, 04400

  • Terveystalo Jyväskylä

    Jyväskylä, 40100

  • Kokkola Vaccine Research Clinic

    Kokkola, 67100

  • Oulu Vaccine Research Clinic

    Oulu, 90220

  • Pori Vaccine Research Clinic

    Pori, 28100

  • Seinäjoki Vaccine Research Clinic

    Seinäjoki, 60100

  • Tampere Vaccine Research Clinic

    Tampere, 33100

  • Terveystalo Tampere

    Tampere, 33100

  • Terveystalo Turku Pulssi

    Turku, 20100

  • Turku Vaccine Research Clinic

    Turku, 20520

Other trials in Finland

Netherlands11 sites

  • Meander Medisch Centrum

    Amersfoort, 3813 TZ

  • PoliDirect Amsterdam West

    Amsterdam, 1064 BP

  • Huisartsencentrum Parklaan

    Eindhoven, 5613 BE

  • Huisartsenpraktijk Radesingel

    Groningen, 9718 TA

  • Gezondheidscentrum Leonardus

    Helmond, 5701 AH

  • Spaarne Gasthuis

    Hoofddorp, 2134 TM

  • PoliDirect Nieuwegein

    Nieuwegein, 3431 HR

  • Franciscus Gasthuis & Vlietland, location Gasthuis

    Rotterdam, 3045 PM

  • Huisartsen Soest

    Soest, 3762BN

  • UMC Utrecht

    Utrecht, 3584 CX

  • Julius Clinical Breda

    Zeist, 3703 CD

Other trials in Netherlands

Argentina8 sites

  • Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich

    CABA, Buenos Aires, 1426

  • Fundación Respirar

    CABA, Buenos Aires, C1426ABP

  • Clinica Privada del Sol S.A.

    Córdoba, 5000

  • Clinica Privada Instituto Medico Platense S.A.

    La Plata, Buenos Aires, B1900AVG

  • Instituto De Investigaciones Clínicas Mar Del Plata

    Mar del Plata, Buenos Aires, B7600FZO

  • IMAC - Instituto Medico de Alta Complejidad

    Salta, 4400

  • Clinica Mayo de Urgencias Medicas Cruz Blanca S.R.L

    San Miguel de Tucumán, Tucumán Province, 4000

  • Hospital de Clinicas Presidente Nicolas Avellaneda

    San Miguel de Tucumán, Tucumán Province, 4000

Other trials in Argentina

About this study

Official title: A PHASE 3 STUDY TO EVALUATE THE EFFICACY, IMMUNOGENICITY, AND SAFETY OF RESPIRATORY SYNCYTIAL VIRUS (RSV) PREFUSION F SUBUNIT VACCINE IN ADULTS

Efficacy Study: This randomized, double-blinded, placebo-controlled Phase 3 study is designed to assess the safety, immunogenicity, and efficacy of a single dose of RSVpreF in the prevention of LRTI-RSV in adults:

  • At a dose of 120µg.
  • In adults 60 years of age and older.
  • The duration of the study for each participant will be up to approximately 24 months.
  • The study will be conducted in the United States, Canada, Netherlands, Finland, Argentina, Japan and South Africa.
Read more

Substudy A: This study is an extension of the efficacy study and was designed to evaluate the safety and immunogenicity of a second dose of RSVpreF when administered after a dosing interval of approximately 2 years:

  • At a dose of 120µg (as studied in the Phase 3 Efficacy Study)
  • Blood samples will be collected for antibody testing.
  • The duration of the study for each participant will be up to approximately 18 months.
  • The study will be conducted in the United States and Argentina.

Substudy B: This study was designed to evaluate the safety and immunogenicity of a second dose of RSVpreF when administered after a dosing interval of approximately 1 year:

  • At a dose of 120µg (as studied in the Phase 3 Efficacy Study)
  • Blood samples will be collected for antibody testing.
  • The duration of the study for each participant will be up to approximately 18 months.
  • The study will be conducted in Argentina.

Substudy C: This study was designed to evaluate the safety and immunogenicity of a second dose of RSVpreF when administered after a dosing interval of either 3 or 4 years:

  • At a dose of 120µg (as studied in the Phase 3 Efficacy Study)
  • Participants will receive either placebo or a second dose of RSVpreF approximately 3 or 4 years after receiving the initial dose of RSVpreF in the main efficacy study.
  • Blood samples will be collected for antibody testing.
  • The duration of the study for each participant will be up to approximately 24 months.
  • The study will be conducted in the United States and Canada.
Being tested
RSVpreF, Placebo
Keywords
Lower Respiratory Tract Illness, RSV, Vaccine

What participants receive

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

  • RSVpreFBiological

    RSV vaccine (RSVpreF)

  • PlaceboBiological

    Placebo

Study groups in NCT05035212
Study groupRoleWhat they receive
Efficacy Study: RSVpreF vaccineExperimentalRSVpreF
Receives: Biological: RSVpreF
Efficacy Study: Placebo dosePlacebo comparatorPlacebo
Receives: Biological: Placebo
SSA: Vaccination of RSVpreF recipients with RSVpreF (Year 2 revaccination)ExperimentalParticipants who originally received RSVpreF in the Efficacy Study and are eligible for SSA will receive RSVpreF in SSA.
Receives: Biological: RSVpreF
SSA: Vaccination of RSVpreF recipients with PlaceboPlacebo comparatorParticipants who originally received RSVpreF in the Efficacy Study and are eligible for SSA will receive Placebo in SSA.
Receives: Biological: Placebo
SSB: Vaccination of RSVpreF recipients with RSVpreF (Year 1 revaccination)ExperimentalParticipants who originally received RSVpreF in the Efficacy Study and are eligible for SSB will receive RSVpreF in SSB.
Receives: Biological: RSVpreF
SSB: Vaccination of RSVpreF recipients with PlaceboPlacebo comparatorParticipants who originally received RSVpreF in the Efficacy Study and are eligible for SSB will receive Placebo in SSB.
Receives: Biological: Placebo
SSC: Vaccination of RSVpreF recipients with RSVpreF (Year 3 revaccination)ExperimentalParticipants who originally received RSVpreF in the Efficacy Study and are eligible for SSC will receive RSVpreF at the Year 3 vaccination followed by placebo at the Year 4 vaccination in SSC.
Receives: Biological: RSVpreF
SSC: Vaccination of RSVpreF recipients with RSVpreF (Year 4 revaccination)ExperimentalParticipants who originally received RSVpreF in the Efficacy Study and are eligible for SSC will receive placebo at the Year 3 vaccination followed by RSVpreF at the Year 4 vaccination in SSC.
Receives: Biological: RSVpreF
SSC: Vaccination of RSVpreF recipients with PlaceboPlacebo comparatorParticipants who originally received RSVpreF in the Efficacy Study and are eligible for SSC will receive placebo at both the Year 3 and Year 4 vaccination in SSC.
Receives: Biological: Placebo

What is being measured

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

  1. Efficacy Study: Number of first episode of RSV-associated lower respiratory tract illness (LRTI-RSV) in the first RSV season

    Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR)-confirmed RSV A and/or RSV B- associated acute respiratory illness (ARI) is assessed. LRTI-RSV is defined as an ARI with 2 or more of the lower respiratory signs/symptoms lasting more than 1 day during the same illness, plus RT-PCR-confirmed RSV infection within 7 days of ARI symptom onset.

    Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR)-confirmed RSV A and/or RSV B- associated acute respiratory illness (ARI) is assessed. LRTI-RSV is defined as an ARI with 3 or more of the lower respiratory signs/symptoms lasting more than 1 day during the same illness, plus RT-PCR-confirmed RSV infection within 7 days of ARI symptom onset.

    Measured: From Day 15 after vaccination until the end of season 1 visit (an average of 6 months)

  2. Efficacy Study: Proportion of participants reporting prompted local reactions within 7-days after vaccination

    Local reactions included pain at injection site, redness and swelling recorded by participants in an e-diary. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm and graded as mild: 2.5 to 5.0 cm, moderate: > 5.0 to 10.0 cm and severe: >10 cm. Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfere with daily activity and severe: prevented daily activity

    Measured: Within 7 days after vaccination

  3. Efficacy Study: Proportion of participants reporting prompted systemic events within 7-days after vaccination

    Systemic reactions:fever, fatigue/tiredness, headache, nausea, muscle pain, joint pain, vomiting, diarrhea and any systemic event recorded by participants in an e-diary. Fever: greater than equal to (>=)38.0 degrees (deg) Celsius (C), mild (>=38.0 to 38.4 deg C, >38.4 to 38.9 deg C), moderate (>38.9 to 40.0 deg C and >40.0 deg C), severe (>38.9 deg C to 40.0 deg C) and grade 4 (>40.0 deg C). Fatigue, headache, nausea, muscle pain and joint pain were graded as mild: did not interfere with activity, moderate: some interference with activity and severe: prevented daily routine activity. Vomiting was graded as mild: 1 to 2 times in 24 hours(h), moderate: >2 times in 24h and severe: requires intravenous hydration. Diarrhea was graded as mild: 2 to 3 loose stools in 24h, moderate: 4 to 5 loose stools in 24h and severe: 6 or more loose stools in 24h.

    Measured: Within 7 days after vaccination

  4. Efficacy Study: Proportion of participants reporting AE within 1-month after vaccination

    An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. AEs included both serious and non-serious adverse events.

    Measured: Within 1 month after vaccination (up to 35 days)

  5. Efficacy Study: Proportion of participants reporting SAE throughout the study

    SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

    Measured: Throughout the study duration (an average of 30 months)

  6. Efficacy Study: Proportion of participants reporting NDCMC throughout the study

    An NDCMC is defined as a disease or medical condition, not previously identified, that is expected to be persistent or otherwise long-lasting in its effects (eg, asthma).

    Measured: Throughout the study duration (an average of 30 months)

  7. SSA: Respiratory Syncytial Virus Subgroup A (RSV A) and RSV B neutralizing titers from participants who received 2-dose of RSVpreF

    RSV A and RSV B neutralizing titers (NT), expressed as Geometric Mean Titers (GMTs), and geometric mean fold rise (GMFR). The NTs were calculated as the interpolated reciprocal of the serum dilution resulting in 50% reduction in the number of viral focus forming units when compared to the control without test serum.

    Measured: Before revaccination and 1, 6, 12 and 18-months after revaccination with RSVpreF in SSA

  8. SSA: Proportion of participants reporting prompted local reactions within 7-days after revaccination

    Local reactions included pain at injection site, redness and swelling recorded by participants in an e-diary. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm and graded as mild: 2.5 to 5.0 cm, moderate: > 5.0 to 10.0 cm and severe: >10 cm. Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfere with daily activity and severe: prevented daily activity

    Measured: Within 7 days after revaccination

  9. SSA: Proportion of participants reporting prompted systemic events within 7-days after revaccination

    Systemic reactions:fever, fatigue/tiredness, headache, nausea, muscle pain, joint pain, vomiting, diarrhea and any systemic event recorded by participants in an e-diary. Fever: greater than equal to (>=)38.0 degrees (deg) Celsius (C), mild (>=38.0 to 38.4 deg C, >38.4 to 38.9 deg C), moderate (>38.9 to 40.0 deg C and >40.0 deg C), severe (>38.9 deg C to 40.0 deg C) and grade 4 (>40.0 deg C). Fatigue, headache, nausea, muscle pain and joint pain were graded as mild: did not interfere with activity, moderate: some interference with activity and severe: prevented daily routine activity. Vomiting was graded as mild: 1 to 2 times in 24 hours(h), moderate: >2 times in 24h and severe: requires intravenous hydration. Diarrhea was graded as mild: 2 to 3 loose stools in 24h, moderate: 4 to 5 loose stools in 24h and severe: 6 or more loose stools in 24h.

    Measured: Within 7 days after revaccination

  10. SSA: Proportion of participants reporting AE within 1-month after revaccination

    An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. AEs included both serious and non-serious adverse events.

    Measured: Within 1 month after revaccination (up to 35 days)

  11. SSA: Proportion of participants reporting SAE throughout the study

    SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

    Measured: Throughout the study duration (approximately 18 months)

  12. SSA: Proportion of participants reporting NDCMC throughout the study

    An NDCMC is defined as a disease or medical condition, not previously identified, that is expected to be persistent or otherwise long-lasting in its effects (eg, asthma).

    Measured: Throughout the study duration (approximately 18 months)

  13. SSB: Respiratory Syncytial Virus Subgroup A (RSV A) and RSV B neutralizing titers from participants who received 2-dose of RSVpreF

    RSV A and RSV B neutralizing titers (NT), expressed as Geometric Mean Titers (GMTs), and geometric mean fold rise (GMFR). The NTs were calculated as the interpolated reciprocal of the serum dilution resulting in 50% reduction in the number of viral focus forming units when compared to the control without test serum.

    Measured: Before revaccination and 1, 6, 12 and 18-months after revaccination with RSVpreF in SSB

  14. SSB: Proportion of participants reporting prompted local reactions within 7-days after revaccination

    Local reactions included pain at injection site, redness and swelling recorded by participants in an e-diary. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm and graded as mild: 2.5 to 5.0 cm, moderate: > 5.0 to 10.0 cm and severe: >10 cm. Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfere with daily activity and severe: prevented daily activity.

    Measured: Within 7 days after revaccination

  15. SSB: Proportion of participants reporting prompted systemic events within 7-days after revaccination

    Systemic reactions:fever, fatigue/tiredness, headache, nausea, muscle pain, joint pain, vomiting, diarrhea and any systemic event recorded by participants in an e-diary. Fever: greater than equal to (>=)38.0 degrees (deg) Celsius (C), mild (>=38.0 to 38.4 deg C, >38.4 to 38.9 deg C), moderate (>38.9 to 40.0 deg C and >40.0 deg C), severe (>38.9 deg C to 40.0 deg C) and grade 4 (>40.0 deg C). Fatigue, headache, nausea, muscle pain and joint pain were graded as mild: did not interfere with activity, moderate: some interference with activity and severe: prevented daily routine activity. Vomiting was graded as mild: 1 to 2 times in 24 hours(h), moderate: >2 times in 24h and severe: requires intravenous hydration. Diarrhea was graded as mild: 2 to 3 loose stools in 24h, moderate: 4 to 5 loose stools in 24h and severe: 6 or more loose stools in 24h.

    Measured: SSB: Proportion of participants reporting prompted systemic events within 7-days after revaccination

  16. SSB: Proportion of participants reporting AE within 1-month after revaccination

    An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. AEs included both serious and non-serious adverse events.

    Measured: Within 1 month after revaccination (up to 35 days)

  17. SSB: Proportion of participants reporting SAE throughout the study

    SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

    Measured: Throughout the study duration (approximately 18 months)

  18. SSB: Proportion of participants reporting NDCMC throughout the study

    An NDCMC is defined as a disease or medical condition, not previously identified, that is expected to be persistent or otherwise long-lasting in its effects (eg, asthma).

    Measured: Throughout the study duration (approximately 18 months)

  19. SSC: Respiratory Syncytial Virus Subgroup A (RSV A) and RSV B neutralizing titers from participants who received RSVpreF or placebo in SSC (Year 3)

    RSV A and RSV B neutralizing titers (NT), expressed as Geometric Mean NT ratios. The NTs were calculated as the interpolated reciprocal of the serum dilution resulting in 50% reduction in the number of viral focus forming units when compared to the control without test serum.

    Measured: 1 month after revaccination in SSC (Year 3)

  20. SSC: Respiratory Syncytial Virus Subgroup A (RSV A) and RSV B neutralizing titers from participants who received 1 dose in the Main Efficacy Study (preS2) and revaccination in SSC (Year 3)

    RSV A and RSV B neutralizing titers (NT), expressed as Geometric Mean NT ratios. The NTs were calculated as the interpolated reciprocal of the serum dilution resulting in 50% reduction in the number of viral focus forming units when compared to the control without test serum.

    Measured: At preseason 2 (preS2) after receiving the initial vaccination in the efficacy study and 1 month after revaccination in SSC (Year 3)

  21. SSC: Respiratory Syncytial Virus Subgroup A (RSV A) and RSV B neutralizing titers from participants who received 1 dose in the Main Efficacy Study and revaccination in SSC (Year 3)

    RSV A and RSV B neutralizing titers (NT), expressed as Geometric Mean of individual NT ratios (GMIR). The NTs were calculated as the interpolated reciprocal of the serum dilution resulting in 50% reduction in the number of viral focus forming units when compared to the control without test serum.

    Measured: 1 month after receiving the initial vaccination in the efficacy study and 1 month after revaccination in SSC (Year 3)

  22. SSC: Respiratory Syncytial Virus Subgroup A (RSV A) and RSV B neutralizing titers from participants who received RSVpreF or placebo in SSC (Year 4)

    RSV A and RSV B neutralizing titers (NT), expressed as Geometric Mean NT ratios. The NTs were calculated as the interpolated reciprocal of the serum dilution resulting in 50% reduction in the number of viral focus forming units when compared to the control without test serum.

    Measured: 1 month after revaccination in SSC (Year 4)

  23. SSC: Respiratory Syncytial Virus Subgroup A (RSV A) and RSV B neutralizing titers from participants who received 1 dose in the Main Efficacy Study (preS2) and revaccination in SSC (Year 4)

    RSV A and RSV B neutralizing titers (NT), expressed as Geometric Mean NT ratios. The NTs were calculated as the interpolated reciprocal of the serum dilution resulting in 50% reduction in the number of viral focus forming units when compared to the control without test serum.

    Measured: At preseason 2 (preS2) after receiving the initial vaccination in the efficacy study and 1 month after revaccination in SSC (Year 4)

  24. SSC: Respiratory Syncytial Virus Subgroup A (RSV A) and RSV B neutralizing titers from participants who received 1 dose in the Main Efficacy Study and revaccination in SSC (Year 4)

    RSV A and RSV B neutralizing titers (NT), expressed as Geometric Mean of individual NT ratios (GMIR). The NTs were calculated as the interpolated reciprocal of the serum dilution resulting in 50% reduction in the number of viral focus forming units when compared to the control without test serum.

    Measured: 1 month after receiving the initial vaccination in the efficacy study and 1 month after revaccination in SSC (Year 4)

  25. SSC: Proportion of participants reporting prompted local reactions within 7-days after revaccination (Year 3)

    Local reactions included pain at injection site, redness and swelling recorded by participants in an e-diary. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm and graded as mild: 2.5 to 5.0 cm, moderate: > 5.0 to 10.0 cm and severe: >10 cm. Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfere with daily activity and severe: prevented daily activity.

    Measured: Within 7 days after revaccination

  26. SSC: Proportion of participants reporting prompted local reactions within 7-days after revaccination (Year 4)

    Local reactions included pain at injection site, redness and swelling recorded by participants in an e-diary. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm and graded as mild: 2.5 to 5.0 cm, moderate: > 5.0 to 10.0 cm and severe: >10 cm. Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfere with daily activity and severe: prevented daily activity.

    Measured: Within 7 days after revaccination

  27. SSC: Proportion of participants reporting prompted systemic events within 7-days after revaccination (Year 3)

    Systemic reactions:fever, fatigue/tiredness, headache, nausea, muscle pain, joint pain, vomiting, diarrhea and any systemic event recorded by participants in an e-diary. Fever: greater than equal to (>=)38.0 degrees (deg) Celsius (C), mild (>=38.0 to 38.4 deg C, >38.4 to 38.9 deg C), moderate (>38.9 to 40.0 deg C and >40.0 deg C), severe (>38.9 deg C to 40.0 deg C) and grade 4 (>40.0 deg C). Fatigue, headache, nausea, muscle pain and joint pain were graded as mild: did not interfere with activity, moderate: some interference with activity and severe: prevented daily routine activity. Vomiting was graded as mild: 1 to 2 times in 24 hours(h), moderate: >2 times in 24h and severe: requires intravenous hydration. Diarrhea was graded as mild: 2 to 3 loose stools in 24h, moderate: 4 to 5 loose stools in 24h and severe: 6 or more loose stools in 24h.

    Measured: Within 7 days after revaccination

  28. SSC: Proportion of participants reporting prompted systemic events within 7-days after revaccination (Year 4)

    Systemic reactions:fever, fatigue/tiredness, headache, nausea, muscle pain, joint pain, vomiting, diarrhea and any systemic event recorded by participants in an e-diary. Fever: greater than equal to (>=)38.0 degrees (deg) Celsius (C), mild (>=38.0 to 38.4 deg C, >38.4 to 38.9 deg C), moderate (>38.9 to 40.0 deg C and >40.0 deg C), severe (>38.9 deg C to 40.0 deg C) and grade 4 (>40.0 deg C). Fatigue, headache, nausea, muscle pain and joint pain were graded as mild: did not interfere with activity, moderate: some interference with activity and severe: prevented daily routine activity. Vomiting was graded as mild: 1 to 2 times in 24 hours(h), moderate: >2 times in 24h and severe: requires intravenous hydration. Diarrhea was graded as mild: 2 to 3 loose stools in 24h, moderate: 4 to 5 loose stools in 24h and severe: 6 or more loose stools in 24h.

    Measured: Within 7 days after revaccination

  29. SSC: Proportion of participants reporting AE within 1-month after revaccination (Year 3)

    An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. AEs included both serious and non-serious adverse events.

    Measured: Within 1 month after revaccination (up to 35 days)

  30. SSC: Proportion of participants reporting AE within 1-month after revaccination (Year 4)

    An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. AEs included both serious and non-serious adverse events.

    Measured: Within 1 month after revaccination (up to 35 days)

  31. SSC: Proportion of participants reporting SAE after revaccination (Year 3)

    SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

    Measured: Following revaccination and throughout the study duration (approximately 24 months)

  32. SSC: Proportion of participants reporting SAE after revaccination (Year 4)

    SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

    Measured: Following revaccination and throughout the study duration (approximately 12 months)

  33. SSC: Proportion of participants reporting NDCMC after revaccination (Year 3)

    An NDCMC is defined as a disease or medical condition, not previously identified, that is expected to be persistent or otherwise long-lasting in its effects (eg, asthma).

    Measured: Following revaccination and throughout the study duration (approximately 24 months)

  34. SSC: Proportion of participants reporting NDCMC after revaccination (Year 4)

    An NDCMC is defined as a disease or medical condition, not previously identified, that is expected to be persistent or otherwise long-lasting in its effects (eg, asthma).

    Measured: Following revaccination and throughout the study duration (approximately 12 months)

Secondary outcomes (12)

  1. Efficacy Study: Number of first episode of RSV-associated severe LRTI (sLRTI-RSV) in the first RSV season

    Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR)-confirmed RSV A and/or RSV B- associated acute respiratory illness (ARI) is assessed. sLRTI-RSV is defined as LRTI-RSV with at least 1 of the conditions: 1)Hospitalization due to LRTI-RSV; 2)New/increased oxygen supplementation; 3)New/increased mechanical ventilation

    Measured: From Day 15 after vaccination until the end of season 1 visit (an average of 6 months)

  2. Efficacy Study: Number of first episode of LRTI-RSV in the second RSV season

    Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR)-confirmed RSV A and/or RSV B- associated acute respiratory illness (ARI) is assessed. LRTI-RSV is defined as an ARI with 2 or more of the lower respiratory signs/symptoms lasting more than 1 day during the same illness, plus RT-PCR-confirmed RSV infection within 7 days of ARI symptom onset.

    Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR)-confirmed RSV A and/or RSV B- associated acute respiratory illness (ARI) is assessed. LRTI-RSV is defined as an ARI with 3 or more of the lower respiratory signs/symptoms lasting more than 1 day during the same illness, plus RT-PCR-confirmed RSV infection within 7 days of ARI symptom onset.

    Measured: During the second RSV season (an average of 6 months)

  3. Efficacy Study: Number of first episode of LRTI-RSV across 2 RSV seasons

    Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR)-confirmed RSV A and/or RSV B- associated acute respiratory illness (ARI) is assessed. LRTI-RSV is defined as an ARI with 2 or more of the lower respiratory signs/symptoms lasting more than 1 day during the same illness, plus RT-PCR-confirmed RSV infection within 7 days of ARI symptom onset.

    Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR)-confirmed RSV A and/or RSV B- associated acute respiratory illness (ARI) is assessed. LRTI-RSV is defined as an ARI with 3 or more of the lower respiratory signs/symptoms lasting more than 1 day during the same illness, plus RT-PCR-confirmed RSV infection within 7 days of ARI symptom onset.

    Measured: From Day 15 after vaccination until the end of season 2 visit (an average of 12 months of surveillance)

  4. Efficacy Study: Number of first episode of RSV-associated ARI (ARI-RSV) in the first RSV season

    Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR)-confirmed RSV A and/or RSV B- associated acute respiratory illness (ARI) is assessed. ARI-RSV is defined as an ARI with at least 1 signs/symptoms lasting more than 1 day, plus RT-PCR-confirmed RSV infection within 7 days of ARI symptom onset.

    Measured: From Day 15 after vaccination until the end of season 1 visit (an average of 6 months)

  5. Efficacy Study: Number of first episode of ARI-RSV in the second RSV season

    Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR)-confirmed RSV A and/or RSV B- associated acute respiratory illness (ARI) is assessed. ARI-RSV is defined as an ARI with at least 1 signs/symptoms lasting more than 1 day, plus RT-PCR-confirmed RSV infection within 7 days of ARI symptom onset.

    Measured: During the second RSV season (an average of 6 months)

  6. Efficacy Study: Number of first episode of ARI-RSV across 2 RSV seasons

    Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR)-confirmed RSV A and/or RSV B- associated acute respiratory illness (ARI) is assessed. ARI-RSV is defined as an ARI with at least 1 signs/symptoms lasting more than 1 day, plus RT-PCR-confirmed RSV infection within 7 days of ARI symptom onset.

    Measured: From Day 15 after vaccination until the end of season 2 visit (an average of 12 months of surveillance)

  7. Efficacy Study: Number of first episode of sLRTI-RSV in the second RSV season

    Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR)-confirmed RSV A and/or RSV B- associated acute respiratory illness (ARI) is assessed. sLRTI-RSV is defined as LRTI-RSV with at least 1 of the conditions: 1)Hospitalization due to LRTI-RSV; 2)New/increased oxygen supplementation; 3)New/increased mechanical ventilation

    Measured: During the second RSV season (an average of 6 months)

  8. Efficacy Study: Number of first episode of sLRTI-RSV across 2 RSV seasons

    Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR)-confirmed RSV A and/or RSV B- associated acute respiratory illness (ARI) is assessed. sLRTI-RSV is defined as LRTI-RSV with at least 1 of the conditions: 1)Hospitalization due to LRTI-RSV; 2)New/increased oxygen supplementation; 3)New/increased mechanical ventilation

    Measured: From Day 15 after vaccination until the end of season 2 visit (an average of 12 months of surveillance)

  9. Efficacy Study: Respiratory Syncytial Virus Subgroup A (RSV A) and RSV B neutralizing titers

    RSV A and RSV B neutralizing titers (NT), expressed as Geometric Mean Titers (GMTs), and geometric mean fold rise (GMFR). The NTs were calculated as the interpolated reciprocal of the serum dilution resulting in 50% reduction in the number of viral focus forming units when compared to the control without test serum.

    Measured: Before vaccination, 1-month after vaccination, before season 2 (approximately 12 months after vaccination)

  10. SSA: Respiratory Syncytial Virus Subgroup A (RSV A) and RSV B neutralizing titers from participants who received placebo in SSA.

    RSV A and RSV B neutralizing titers (NT), expressed as Geometric Mean Titers (GMTs). The NTs were calculated as the interpolated reciprocal of the serum dilution resulting in 50% reduction in the number of viral focus forming units when compared to the control without test serum.

    Measured: Before revaccination and 1, 6, 12 and 18-months after revaccination with placebo in SSA

  11. SSB: Respiratory Syncytial Virus Subgroup A (RSV A) and RSV B neutralizing titers from participants who received placebo in SSB

    RSV A and RSV B neutralizing titers (NT), expressed as Geometric Mean Titers (GMTs). The NTs were calculated as the interpolated reciprocal of the serum dilution resulting in 50% reduction in the number of viral focus forming units when compared to the control without test serum.

    Measured: Before revaccination and 1, 6, 12 and 18-months after revaccination with placebo in SSB

  12. SSC: Respiratory Syncytial Virus Subgroup A (RSV A) and RSV B neutralizing titers from participants who received placebo in SSC.

    RSV A and RSV B neutralizing titers (NT), expressed as Geometric Mean Titers (GMTs). The NTs were calculated as the interpolated reciprocal of the serum dilution resulting in 50% reduction in the number of viral focus forming units when compared to the control without test serum.

    Measured: Participants receiving placebo at the Year 3 vaccination: 1 month, 3 and 3.5 years after efficacy study vaccination

Timeline

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

  1. First posted5 Sep 2021
  2. Study start31 Aug 2021
  3. Primary completion18 Jan 2027 (estimated)
  4. Study completion18 Jan 2027 (estimated)

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
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
38,861 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05035212
Sponsor's protocol ID
C3671013
Other IDs
2021-003693-31
Acronym
RENOIR
Status last verified
Jan 2026
First submitted
20 Aug 2021
Last updated
28 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Publications

  • Walsh EE, Eiras D, Woodside J, Jiang Q, Patton M, Marc GP, Llapur C, Ramet M, Fukushima Y, Hussen N, Cardona J, Mikati T, Zareba A, Ilangovan K, Lino MM, Kalinina EV, Swanson KA, Gurtman A, Munjal I. Efficacy, Immunogenicity, and Safety of the Bivalent Respiratory Syncytial Virus (RSV) Prefusion F Vaccine in Older Adults Over 2 RSV Seasons. Clin Infect Dis. 2026 Feb 4;81(6):e680-e689. doi: 10.1093/cid/ciaf061.

    PubMed 39928572

  • Walsh EE, Perez Marc G, Zareba AM, Falsey AR, Jiang Q, Patton M, Polack FP, Llapur C, Doreski PA, Ilangovan K, Ramet M, Fukushima Y, Hussen N, Bont LJ, Cardona J, DeHaan E, Castillo Villa G, Ingilizova M, Eiras D, Mikati T, Shah RN, Schneider K, Cooper D, Koury K, Lino MM, Anderson AS, Jansen KU, Swanson KA, Gurtman A, Gruber WC, Schmoele-Thoma B; RENOIR Clinical Trial Group. Efficacy and Safety of a Bivalent RSV Prefusion F Vaccine in Older Adults. N Engl J Med. 2023 Apr 20;388(16):1465-1477. doi: 10.1056/NEJMoa2213836. Epub 2023 Apr 5.

    PubMed 37018468

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing RSVpreF in people with Lower Respiratory Tract Illness, run by Pfizer at 263 sites in 7 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 36 inclusion and 59 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: under way, not looking for participants, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 263 sites in United States, South Africa, Japan, Canada, Finland and 2 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?

This study is still under way. Results are not available in the source record yet.

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?

Efficacy Study: Number of first episode of RSV-associated lower respiratory tract illness (LRTI-RSV) in the first RSV season (time frame: From Day 15 after vaccination until the end of season 1 visit (an average of 6 months)). The study lists 34 primary outcomes in all. 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 NCT05035212, 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 28 Jan 2026.

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