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

NCT ID: NCT05035212

Last Updated: 2026-01-28

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 38861 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-31
• Study Completion Date: 2027-01-18

Brief 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.
• 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.

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.

Conditions

Lower Respiratory Tract Illness

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Efficacy Study: RSVpreF vaccine

RSVpreF

Group Type: EXPERIMENTAL

RSVpreF

Intervention Type: BIOLOGICAL

RSV vaccine (RSVpreF)

Efficacy Study: Placebo dose

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: BIOLOGICAL

Placebo

SSA: Vaccination of RSVpreF recipients with RSVpreF (Year 2 revaccination)

Participants who originally received RSVpreF in the Efficacy Study and are eligible for SSA will receive RSVpreF in SSA.

Group Type: EXPERIMENTAL

RSVpreF

Intervention Type: BIOLOGICAL

RSV vaccine (RSVpreF)

SSA: Vaccination of RSVpreF recipients with Placebo

Participants who originally received RSVpreF in the Efficacy Study and are eligible for SSA will receive Placebo in SSA.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: BIOLOGICAL

Placebo

SSB: Vaccination of RSVpreF recipients with RSVpreF (Year 1 revaccination)

Participants who originally received RSVpreF in the Efficacy Study and are eligible for SSB will receive RSVpreF in SSB.

Group Type: EXPERIMENTAL

RSVpreF

Intervention Type: BIOLOGICAL

RSV vaccine (RSVpreF)

SSB: Vaccination of RSVpreF recipients with Placebo

Participants who originally received RSVpreF in the Efficacy Study and are eligible for SSB will receive Placebo in SSB.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: BIOLOGICAL

Placebo

SSC: Vaccination of RSVpreF recipients with RSVpreF (Year 3 revaccination)

Participants 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.

Group Type: EXPERIMENTAL

RSVpreF

Intervention Type: BIOLOGICAL

RSV vaccine (RSVpreF)

SSC: Vaccination of RSVpreF recipients with RSVpreF (Year 4 revaccination)

Participants 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.

Group Type: EXPERIMENTAL

RSVpreF

Intervention Type: BIOLOGICAL

RSV vaccine (RSVpreF)

SSC: Vaccination of RSVpreF recipients with Placebo

Participants 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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: BIOLOGICAL

Placebo

Interventions

RSVpreF

RSV vaccine (RSVpreF)

Intervention Type: BIOLOGICAL

Placebo

Placebo

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• 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 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 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 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.

Exclusion Criteria

• 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).

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.

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

St. Vincent's Birmingham (Pharmacy)

Birmingham, Alabama, United States

St. Vincent's Birmingham

Birmingham, Alabama, United States

Medical Affiliated Research Center

Huntsville, Alabama, United States

Lenzmeier Family Medicine / Avacare

Glendale, Arizona, United States

Phoenix Clinical LLC

Phoenix, Arizona, United States

HOPE Research Institute

Phoenix, Arizona, United States

The Pain Center of Arizona

Phoenix, Arizona, United States

HOPE Research Institute

Phoenix, Arizona, United States

Cognitive Clinical Trials, LLC

Phoenix, Arizona, United States

Headlands Research - Scottsdale

Scottsdale, Arizona, United States

Alliance for Multispecialty Research, LLC

Tempe, Arizona, United States

HOPE Research Institute

Tempe, Arizona, United States

Noble Clinical Research

Tucson, Arizona, United States

The Institute for Liver Health dba Arizona Clinical Trials

Tucson, Arizona, United States

Hope Clinical Research

Canoga Park, California, United States

eStudySite

Chula Vista, California, United States

Benchmark Research

Colton, California, United States

West Coast Research

Dublin, California, United States

Marvel Clinical Research 002, LLC

Huntington Beach, California, United States

Chemidox Clinical Trials

Lancaster, California, United States

Ark Clinical Research

Long Beach, California, United States

Downtown L.A. Research Center, Inc.

Los Angeles, California, United States

Velocity Clinical Research, North Hollywood

North Hollywood, California, United States

Clinica mi Salud by Focil Med

Oxnard, California, United States

De Silva Medical Inc

Palmdale, California, United States

Empire Clinical Research

Pomona, California, United States

Paradigm Clinical Research Center

Redding, California, United States

Artemis Institute for Clinical Research

Riverside, California, United States

Benchmark Research

Sacramento, California, United States

Artemis Institute for Clinical Research

San Diego, California, United States

California Research Foundation

San Diego, California, United States

Diablo Clinical Research, Inc.

Walnut Creek, California, United States

Lynn Institute of Denver

Aurora, Colorado, United States

Tekton Research LLC

Longmont, Colorado, United States

Clinical Research Consulting

Milford, Connecticut, United States

Stamford Therapeutics Consortium

Stamford, Connecticut, United States

JEM Research Institute

Atlantis, Florida, United States

IDEAL Clinical Research

Aventura, Florida, United States

Innovative Research of West Florida

Clearwater, Florida, United States

Invictus Clinical Research Group, LLC

Coconut Creek, Florida, United States

Nature Coast Clinical Research

Crystal River, Florida, United States

Universal Axon Clinical Research, LLC (Administrative)

Doral, Florida, United States

Indago Research & Health Center, Inc

Hialeah, Florida, United States

Doral Medical Research, LLC

Hialeah, Florida, United States

M3 Wake Research - Lake City

Lake City, Florida, United States

Optimus U Corporation

Miami, Florida, United States

Advance Medical Research Center

Miami, Florida, United States

Flourish Research - Miami, LLC

Miami, Florida, United States

Optimus U Corporation

Miami, Florida, United States

Next Phase Research Alliance

Miami, Florida, United States

New Horizon Research Center

Miami, Florida, United States

De La Cruz Research Center, LLC

Miami, Florida, United States

Global Health Research Center, Inc.

Miami Lakes, Florida, United States

Headlands Research Orlando

Orlando, Florida, United States

Pines Care Research Center, LLC

Pembroke Pines, Florida, United States

IDEAL Clinical Research

Pembroke Pines, Florida, United States

DBC Research USA

Pembroke Pines, Florida, United States

Headlands Research Sarasota

Sarasota, Florida, United States

Precision Clinical Research

Sunrise, Florida, United States

Clinical Site Partners, LLC dba Flourish Research

Winter Park, Florida, United States

Conquest Research

Winter Park, Florida, United States

Javara - Privia Medical Group Georgia - Albany

Albany, Georgia, United States

Coastal Heritage Clinical Research

Hinesville, Georgia, United States

Javara - Privia Medical Group Georgia - Savannah

Savannah, Georgia, United States

Velocity Clinical Research, Savannah

Savannah, Georgia, United States

Clinical Research Atlanta

Stockbridge, Georgia, United States

Javara Inc.

Thomasville, Georgia, United States

Snake River Research, PLLC

Idaho Falls, Idaho, United States

Solaris Clinical Research

Meridian, Idaho, United States

Great Lakes Clinical Trials, LLC dba Flourish Research

Chicago, Illinois, United States

DM Clinical Research

Melrose Park, Illinois, United States

Affinity Health Corp

Oak Brook, Illinois, United States

Accellacare - DuPage

Oak Lawn, Illinois, United States

MOC Research

Mishawaka, Indiana, United States

Velocity Clinical Research Valparaiso

Valparaiso, Indiana, United States

University of Iowa

Iowa City, Iowa, United States

Meridian Clinical Research, LLC

Sioux City, Iowa, United States

AMR Clinical

Lexington, Kentucky, United States

Ochsner Clinic Foundation

Kenner, Louisiana, United States

Ochsner Medical Center - Kenner

Kenner, Louisiana, United States

Velocity Clinical Research, Metairie

Metairie, Louisiana, United States

Velocity Clinical Research, Rockville

Rockville, Maryland, United States

ActivMed Practices & Research, LLC

Beverly, Massachusetts, United States

ActivMed Practices & Research, LLC

Methuen, Massachusetts, United States

University of Massachusetts Chan Medical School

Worcester, Massachusetts, United States

Michigan Center of Medical Research (MICHMER)

Farmington Hills, Michigan, United States

Ascension St. John Hospital Vaccine Research Unit

Grosse Pointe Woods, Michigan, United States

Oakland Medical Research

Troy, Michigan, United States

Arcturus Healthcare , PLC, Troy Internal Medicine Research Division

Troy, Michigan, United States

Saint Louis University

St Louis, Missouri, United States

Sundance Clinical Research

St Louis, Missouri, United States

Skyline Medical Center, PC/CCT Research

Elkhorn, Nebraska, United States

Quality Clinical Research

Omaha, Nebraska, United States

Wr-Crcn, Llc.

Las Vegas, Nevada, United States

Alliance for Multispecialty Research, LLC

Las Vegas, Nevada, United States

Las Vegas Clinical Trials

North Las Vegas, Nevada, United States

ActivMed Practices and Research, LLC.

Portsmouth, New Hampshire, United States

South Jersey Infectious Disease

Somers Point, New Jersey, United States

IMA Clinical Research Warren

Warren Township, New Jersey, United States

Velocity Clinical Research, Binghamton

Binghamton, New York, United States

Drug Trials America

Hartsdale, New York, United States

Corning Center for Clinical Research

Horseheads, New York, United States

Rochester Clinical Research, LLC

Rochester, New York, United States

University of Rochester Medical Center

Rochester, New York, United States

CHEAR Center LLC

The Bronx, New York, United States

Velocity Clinical Research, Vestal

Vestal, New York, United States

Atrium Health - Strive Vaccine Research Clinic

Charlotte, North Carolina, United States

Tryon Medical Partners, PLLC

Charlotte, North Carolina, United States

Accellacare - Charlotte

Charlotte, North Carolina, United States

Sensenbrenner Primary Care Research Office

Charlotte, North Carolina, United States

Accellacare - Wilmington - 1917 Tradd Court

Wilmington, North Carolina, United States

Accellacare - Wilmington

Wilmington, North Carolina, United States

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Velocity Clinical Research, Cincinnati, Mt. Auburn

Cincinnati, Ohio, United States

Velocity Clinical Research - Cincinnati

Cincinnati, Ohio, United States

Velocity Clinical Research, Springdale

Cincinnati, Ohio, United States

Centricity Research Columbus Ohio Multispecialty

Columbus, Ohio, United States

Tekton Research, LLC.

Edmond, Oklahoma, United States

Tekton Research, Inc

Yukon, Oklahoma, United States

The Corvallis Clinic, PC

Corvallis, Oregon, United States

Velocity Clinical Research, Grants Pass

Grants Pass, Oregon, United States

Velocity Clinical Research, Medford

Medford, Oregon, United States

Summit Headlands, LLC

Portland, Oregon, United States

Kaiser Permanente Northwest Center for Health Research

Portland, Oregon, United States

Capital Area Research, LLC

Camp Hill, Pennsylvania, United States

Central Erie Primary Care

Erie, Pennsylvania, United States

Penn Prevention Unit

Philadelphia, Pennsylvania, United States

Velocity Clinical Research, Providence

East Greenwich, Rhode Island, United States

AMR Clinical

Knoxville, Tennessee, United States

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

Knoxville, Tennessee, United States

Clinical Research Associates, Inc.

Nashville, Tennessee, United States

Benchmark Research

Austin, Texas, United States

Innovo Research - Austin Regional Clinic

Austin, Texas, United States

Tekton Research, LLC.

Austin, Texas, United States

Tekton Research, LLC.

Beaumont, Texas, United States

Javara - Privia Medical Group Gulf Coast - The Woodlands HWH

Conroe, Texas, United States

North Texas Infectious Diseases Consultants, P.A

Dallas, Texas, United States

Benchmark Research

Fort Worth, Texas, United States

Texas Health Family Care

Fort Worth, Texas, United States

Allure Health at Mt. Olympus Medical Research

Friendswood, Texas, United States

Hany H. Ahmed, MD

Houston, Texas, United States

Helios Clinical Research - HOU

Houston, Texas, United States

HG Pediatrics

Houston, Texas, United States

Trio Clinical Trials, LLC

Houston, Texas, United States

Van Tran Family Practice

Houston, Texas, United States

Ventavia Research Group, LLC

Houston, Texas, United States

Centex Studies

Houston, Texas, United States

DM Clinical Research - Cy Fair

Houston, Texas, United States

DM Clinical Research- Cyfair

Houston, Texas, United States

DM Clinical Research - Bellaire

Houston, Texas, United States

Centex Studies

Houston, Texas, United States

DM Clinical Research - Humble

Humble, Texas, United States

DM Clinical Research, Martin Diagnostic Clinic

Humble, Texas, United States

Milton Haber, M.D.

Laredo, Texas, United States

Milton Haber, MD

Laredo, Texas, United States

SMS Clinical Research

Mesquite, Texas, United States

Sun Research Institute

San Antonio, Texas, United States

Clinical Trials of Texas, LLC dba Flourish Research

San Antonio, Texas, United States

Clinical Trials of Texas, LLC

San Antonio, Texas, United States

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

Sugar Land, Texas, United States

Javara Inc.

Sugar Land, Texas, United States

Mt Olympus Medical Research

Sugar Land, Texas, United States

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

Tomball, Texas, United States

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

Draper, Utah, United States

Tanner Clinic

Layton, Utah, United States

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

South Jordan, Utah, United States

Velocity Clinical Research, Salt Lake City

West Jordan, Utah, United States

Centricity Research Suffolk Primary Care

Suffolk, Virginia, United States

Virginia Gastroenterology Clinical Research

Suffolk, Virginia, United States

Northwest Clinical Research Center

Bellevue, Washington, United States

Sound Medical Research

Port Orchard, Washington, United States

MultiCare Institute for Research & Innovation

Tacoma, Washington, United States

MultiCare Medical Group

Tacoma, Washington, United States

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

Wenatchee, Washington, United States

Research Building

Wenatchee, Washington, United States

Allegiance Research Specialists, LLC

Wauwatosa, Wisconsin, United States

Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich

CABA, Buenos Aires, Argentina

Fundación Respirar

CABA, Buenos Aires, Argentina

Clinica Privada Instituto Medico Platense S.A.

La Plata, Buenos Aires, Argentina

Instituto De Investigaciones Clínicas Mar Del Plata

Mar del Plata, Buenos Aires, Argentina

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

San Miguel de Tucumán, Tucumán Province, Argentina

Hospital de Clinicas Presidente Nicolas Avellaneda

San Miguel de Tucumán, Tucumán Province, Argentina

Clinica Privada del Sol S.A.

Córdoba, , Argentina

IMAC - Instituto Medico de Alta Complejidad

Salta, , Argentina

Kaye Edmonton Clinic

Edmonton, Alberta, Canada

University Of Alberta Hospital

Edmonton, Alberta, Canada

Aggarwal and Associates Limited

Brampton, Ontario, Canada

Dawson Clinical Research Inc

Guelph, Ontario, Canada

Premier Clinical Trial Network

Hamilton, Ontario, Canada

Centricity Research Toronto LMC Multispecialty

Toronto, Ontario, Canada

Dr. Anil K. Gupta Medicine Professional Corporation

Toronto, Ontario, Canada

Centricity Research Toronto Manna Multispecialty

Toronto, Ontario, Canada

Centricity Research Mirabel Multispecialty

Mirabel, Quebec, Canada

Clinique de Médecine Urbaine du Quartier Latin

Montreal, Quebec, Canada

Alpha Recherche Clinique

Québec, Quebec, Canada

Diex Recherche Sherbrooke

Sherbrooke, Quebec, Canada

Diex Recherche Inc. Division Victoriaville

Victoriaville, Quebec, Canada

Diex Recherche Quebec

Québec, , Canada

Centre de Recherche Saint-Louis inc.

Québec, , Canada

Espoo Vaccine Research Clinic

Espoo, , Finland

FVR, Etelä-Helsingin rokotetutkimusklinikka

Helsinki, , Finland

Helsinki East Vaccine Research Clinic

Helsinki, , Finland

Järvenpää Vaccine Research Clinic

Jarvenpaa, , Finland

Terveystalo Jyväskylä

Jyväskylä, , Finland

Kokkola Vaccine Research Clinic

Kokkola, , Finland

Oulu Vaccine Research Clinic

Oulu, , Finland

Pori Vaccine Research Clinic

Pori, , Finland

Seinäjoki Vaccine Research Clinic

Seinäjoki, , Finland

Tampere Vaccine Research Clinic

Tampere, , Finland

Terveystalo Tampere

Tampere, , Finland

Terveystalo Turku Pulssi

Turku, , Finland

Turku Vaccine Research Clinic

Turku, , Finland

Tenjin General Clinic

Fukuoka, Fukuoka, Japan

Seishinkai Inoue Hospital

Itoshima, Fukuoka, Japan

Sasaki Clinic

Amagasaki, Hyōgo, Japan

Motomachi Takatsuka Naika Clinic

Yokohama, Kanagawa, Japan

Medical Corporation Heishinkai OPHAC Hospital

Osaka, Osaka, Japan

Sugiura Clinic

Kawaguchi, Saitama, Japan

Nihonbashi Sakura Clinic

Chuo-ku, Tokyo, Japan

Tokyo Eki Center Building Clinic

Chuo-ku, Tokyo, Japan

Fukuwa Clinic

Chuo-ku, Tokyo, Japan

Tokyo Asbo Clinic

Chuo-ku, Tokyo, Japan

Medical Corp. Seikoukai New Medical Research System Clinic

Hachioji-shi, Tokyo, Japan

Hillside Clinic Jingumae

Shibuya-ku, Tokyo, Japan

Clinical Research Hospital Tokyo

Shinjuku-ku, Tokyo, Japan

Clinical Research Hospital Tokyo

Shinjuku-ku, Tokyo, Japan

Oda Clinic

Shinjuku-ku, Tokyo, Japan

Souseikai Sumida Hospital

Sumida-ku, Tokyo, Japan

Sekino Hospital

Toshima-ku, Tokyo, Japan

SOUSEIKAI PS Clinic

Fukuoka, , Japan

AMC Nishiumeda Clinic

Osaka, , Japan

Meander Medisch Centrum

Amersfoort, , Netherlands

PoliDirect Amsterdam West

Amsterdam, , Netherlands

Huisartsencentrum Parklaan

Eindhoven, , Netherlands

Huisartsenpraktijk Radesingel

Groningen, , Netherlands

Gezondheidscentrum Leonardus

Helmond, , Netherlands

Spaarne Gasthuis

Hoofddorp, , Netherlands

PoliDirect Nieuwegein

Nieuwegein, , Netherlands

Franciscus Gasthuis & Vlietland, location Gasthuis

Rotterdam, , Netherlands

Huisartsen Soest

Soest, , Netherlands

UMC Utrecht

Utrecht, , Netherlands

Julius Clinical Breda

Zeist, , Netherlands

Josha Research

Bloemfontein, Free State, South Africa

Welkom Clinical Trial Centre (MERC WELKOM)

Welkom, Free State, South Africa

Worthwhile Clinical Trials

Benoni, Gauteng, South Africa

MERCLINCO (Pty) Ltd - Kempton

Kempton Park, Gauteng, South Africa

Dr A Jacovides & Partners Inc.

Midrand, Gauteng, South Africa

Newtown Clinical Research Centre (PTY) LTD

Newtown, Gauteng, South Africa

Global Clinical Trials

Pretoria, Gauteng, South Africa

About Allergy

Pretoria, Gauteng, South Africa

Into Research

Pretoria, Gauteng, South Africa

Jongaie Research

Pretoria, Gauteng, South Africa

Synexus SA- Watermeyer Clinical Research Center

Pretoria, Gauteng, South Africa

Setshaba Research Centre

Soshanguve, Gauteng, South Africa

Wits Vaccines & Infectious Diseases Analytics

Soweto, Gauteng, South Africa

FCRN Clinical Trial Centre

Vereeniging, Gauteng, South Africa

MERC Research (Pty) Ltd - Middelburg

Middelburg, Mpumalanga, South Africa

Synexus - Helderberg Clinical Research Centre - Somerset West

Cape Town, Western Cape, South Africa

TREAD Research

Cape Town, Western Cape, South Africa

Be Part Yoluntu Centre

Paarl, Western Cape, South Africa

Helderberg Clinical Trials Centre

Somerset West, Western Cape, South Africa

Emmed Research

Pretoria, , South Africa

Botho Ke Bontle Health Services

Pretoria, , South Africa

Countries

United States; Argentina; Canada; Finland; Japan; Netherlands; South Africa

References

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 RSV Prefusion F (RSVpreF) Vaccine in Older Adults Over 2 RSV Seasons. Clin Infect Dis. 2025 Feb 10:ciaf061. doi: 10.1093/cid/ciaf061. Online ahead of print.

Reference Type: DERIVED

PMID: 39928572 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 37018468 (View on PubMed)

Related Links

https://pmiform.com/clinical-trial-info-request?StudyID=C3671013

To obtain contact information for a study center near you, click here.

Other Identifiers

2021-003693-31

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

C3671013

Identifier Type: -

Identifier Source: org_study_id