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

January 26, 2026 updated by: Pfizer

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.

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.

Study Overview

Status

Active, not recruiting

Conditions

Lower Respiratory Tract Illness

Intervention / Treatment

Detailed Description

This is a Phase 3, multicenter, randomized, double-blinded, placebo-controlled study to assess the safety, immunogenicity, and efficacy of RSVpreF or placebo (1:1 randomization) in adults. This will be a global study that will span multiple RSV seasons.

Study Type

Interventional

Enrollment (Actual)

38861

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Argentina
- - Córdoba, Argentina, 5000
    - Clinica Privada del Sol S.A.
  - Salta, Argentina, 4400
    - IMAC - Instituto Medico de Alta Complejidad
- Buenos Aires
  - CABA, Buenos Aires, Argentina, 1426
    - Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich
  - CABA, Buenos Aires, Argentina, C1426ABP
    - Fundación Respirar
  - La Plata, Buenos Aires, Argentina, B1900AVG
    - Clinica Privada Instituto Medico Platense S.A.
  - Mar del Plata, Buenos Aires, Argentina, B7600FZO
    - Instituto de Investigaciones Clínicas Mar del Plata
- Tucumán Province
  - San Miguel de Tucumán, Tucumán Province, Argentina, 4000
    - Clínica Mayo de Urgencias Médicas Cruz Blanca S.R.L
  - San Miguel de Tucumán, Tucumán Province, Argentina, 4000
    - Hospital de Clinicas Presidente Nicolas Avellaneda
Canada
- - Québec, Canada, G1W 4R4
    - Centre de Recherche Saint-Louis inc.
  - Québec, Canada, G1V 4T3
    - Diex Recherche Quebec
- Alberta
  - Edmonton, Alberta, Canada, T6G 2B7
    - University of Alberta Hospital
  - Edmonton, Alberta, Canada, T6G 1Z1
    - Kaye Edmonton Clinic
- Ontario
  - Brampton, Ontario, Canada, L6T 0G1
    - Aggarwal and Associates Limited
  - Guelph, Ontario, Canada, N1H 1B1
    - Dawson Clinical Research Inc
  - Hamilton, Ontario, Canada, L8L 5G4
    - Premier Clinical Trial Network
  - Toronto, Ontario, Canada, M9V 4B4
    - Dr. Anil K. Gupta Medicine Professional Corporation
  - Toronto, Ontario, Canada, M9W 4L6
    - Centricity Research Toronto Manna Multispecialty
  - Toronto, Ontario, Canada, M4G 3E8
    - Centricity Research Toronto LMC Multispecialty
- Quebec
  - Mirabel, Quebec, Canada, J7J 2K8
    - Centricity Research Mirabel Multispecialty
  - Montreal, Quebec, Canada, H2L 4E9
    - Clinique de médecine Urbaine du Quartier Latin
  - Québec, Quebec, Canada, G2J 0C4
    - ALPHA Recherche Clinique
  - Sherbrooke, Quebec, Canada, J1L 0H8
    - Diex Recherche Sherbrooke
  - Victoriaville, Quebec, Canada, G6P 3Z8
    - Diex Recherche Inc. Division Victoriaville
Finland
- - Espoo, Finland, 02230
    - Espoo Vaccine Research Clinic
  - Helsinki, Finland, 00930
    - Helsinki East Vaccine Research Clinic
  - Helsinki, Finland, 00100
    - FVR, Etelä-Helsingin rokotetutkimusklinikka
  - Jarvenpaa, Finland, 04400
    - Järvenpää Vaccine Research Clinic
  - Jyväskylä, Finland, 40100
    - Terveystalo Jyvaskyla
  - Kokkola, Finland, 67100
    - Kokkola Vaccine Research Clinic
  - Oulu, Finland, 90220
    - Oulu Vaccine Research Clinic
  - Pori, Finland, 28100
    - Pori Vaccine Research Clinic
  - Seinäjoki, Finland, 60100
    - Seinäjoki Vaccine Research Clinic
  - Tampere, Finland, 33100
    - Tampere Vaccine Research Clinic
  - Tampere, Finland, 33100
    - Terveystalo Tampere
  - Turku, Finland, 20520
    - Turku Vaccine Research Clinic
  - Turku, Finland, 20100
    - Terveystalo Turku Pulssi
Japan
- - Fukuoka, Japan, 812-0025
    - SOUSEIKAI PS Clinic
  - Osaka, Japan, 530-0001
    - AMC Nishiumeda Clinic
- Fukuoka
  - Fukuoka, Fukuoka, Japan, 810-0021
    - Tenjin General Clinic
  - Itoshima, Fukuoka, Japan, 819-1104
    - Seishinkai Inoue Hospital
- Hyōgo
  - Amagasaki, Hyōgo, Japan, 660-0827
    - Sasaki Clinic
- Kanagawa
  - Yokohama, Kanagawa, Japan, 231-0023
    - Motomachi Takatsuka Naika Clinic
- Osaka
  - Osaka, Osaka, Japan, 532-0003
    - Medical Corporation Heishinkai OPHAC Hospital
- Saitama
  - Kawaguchi, Saitama, Japan, 332-0012
    - Sugiura Clinic
- Tokyo
  - Chuo-ku, Tokyo, Japan, 103-0025
    - Nihonbashi Sakura Clinic
  - Chuo-ku, Tokyo, Japan, 104-0031
    - Fukuwa Clinic
  - Chuo-ku, Tokyo, Japan, 103-0027
    - Tokyo Eki Center Building Clinic
  - Chuo-ku, Tokyo, Japan, 104-0031
    - Tokyo Asbo Clinic
  - Hachioji-shi, Tokyo, Japan, 192-0046
    - Medical Corp. Seikoukai New Medical Research System Clinic
  - Shibuya-ku, Tokyo, Japan, 1500001
    - Hillside Clinic Jingumae
  - Shinjuku-ku, Tokyo, Japan, 162-0053
    - Clinical Research Hospital Tokyo
  - Shinjuku-ku, Tokyo, Japan, 169-0072
    - Oda Clinic
  - Shinjuku-ku, Tokyo, Japan, 160-0004
    - Clinical Research Hospital Tokyo
  - Sumida-ku, Tokyo, Japan, 130-0004
    - SOUSEIKAI Sumida Hospital
  - Toshima-ku, Tokyo, Japan, 171-0014
    - Sekino Hospital
Netherlands
- - Amersfoort, Netherlands, 3813 TZ
    - Meander Medisch Centrum
  - Amsterdam, Netherlands, 1064 BP
    - PoliDirect Amsterdam West
  - Eindhoven, Netherlands, 5613 BE
    - Huisartsencentrum Parklaan
  - Groningen, Netherlands, 9718 TA
    - Huisartsenpraktijk Radesingel
  - Helmond, Netherlands, 5701 AH
    - Gezondheidscentrum Leonardus
  - Hoofddorp, Netherlands, 2134 TM
    - Spaarne Gasthuis
  - Nieuwegein, Netherlands, 3431 HR
    - PoliDirect Nieuwegein
  - Rotterdam, Netherlands, 3045 PM
    - Franciscus Gasthuis & Vlietland, location Gasthuis
  - Soest, Netherlands, 3762BN
    - Huisartsen Soest
  - Utrecht, Netherlands, 3584 CX
    - UMC Utrecht
  - Zeist, Netherlands, 3703 CD
    - Julius Clinical Breda
South Africa
- - Pretoria, South Africa, 0002
    - Emmed Research
  - Pretoria, South Africa, 0184
    - Botho ke Bontle Health Services
- Free State
  - Bloemfontein, Free State, South Africa, 9301
    - Josha Research
  - Welkom, Free State, South Africa, 9460
    - Welkom Clinical Trial Centre (MERC WELKOM)
- Gauteng
  - Benoni, Gauteng, South Africa, 1500
    - Worthwhile Clinical Trials
  - Kempton Park, Gauteng, South Africa, 1619
    - MERCLINCO (Pty) Ltd - Kempton
  - Midrand, Gauteng, South Africa, 1685
    - Dr A Jacovides & Partners Inc.
  - Newtown, Gauteng, South Africa, 2001
    - Newtown Clinical Research Centre (PTY) LTD
  - Pretoria, Gauteng, South Africa, 0083
    - Global Clinical Trials
  - Pretoria, Gauteng, South Africa, 0183
    - Jongaie Research
  - Pretoria, Gauteng, South Africa, 0181
    - About Allergy
  - Pretoria, Gauteng, South Africa, 0181
    - Into Research
  - Pretoria, Gauteng, South Africa, 0184
    - Synexus SA- Watermeyer Clinical Research Center
  - Soshanguve, Gauteng, South Africa, 0152
    - Setshaba Research Centre
  - Soweto, Gauteng, South Africa, 2195
    - Wits Vaccines & Infectious Diseases Analytics
  - Vereeniging, Gauteng, South Africa, 1935
    - FCRN Clinical Trial Centre
- Mpumalanga
  - Middelburg, Mpumalanga, South Africa, 1055
    - MERC Research (Pty) Ltd - Middelburg
- Western Cape
  - Cape Town, Western Cape, South Africa, 7500
    - TREAD Research
  - Cape Town, Western Cape, South Africa, 7130
    - Synexus - Helderberg Clinical Research Centre - Somerset West
  - Paarl, Western Cape, South Africa, 7626
    - Be Part Yoluntu Centre
  - Somerset West, Western Cape, South Africa, 7129
    - Helderberg Clinical Trials Centre
United States
- Alabama
  - Birmingham, Alabama, United States, 35205
    - St. Vincent's Birmingham (Pharmacy)
  - Birmingham, Alabama, United States, 35205
    - St. Vincent's Birmingham
  - Huntsville, Alabama, United States, 35801
    - Medical Affiliated Research Center
- Arizona
  - Glendale, Arizona, United States, 85308
    - Lenzmeier Family Medicine / Avacare
  - Phoenix, Arizona, United States, 85014
    - Phoenix Clinical LLC
  - Phoenix, Arizona, United States, 85018
    - HOPE Research Institute
  - Phoenix, Arizona, United States, 85018
    - The Pain Center of Arizona
  - Phoenix, Arizona, United States, 85023
    - HOPE Research Institute
  - Phoenix, Arizona, United States, 85044
    - Cognitive Clinical Trials, LLC
  - Scottsdale, Arizona, United States, 85260
    - Headlands Research - Scottsdale
  - Tempe, Arizona, United States, 85281
    - Alliance for Multispecialty Research, LLC
  - Tempe, Arizona, United States, 85284
    - HOPE Research Institute
  - Tucson, Arizona, United States, 85704
    - Noble Clinical Research
  - Tucson, Arizona, United States, 85712
    - The Institute for Liver Health dba Arizona Clinical Trials
- California
  - Canoga Park, California, United States, 91303
    - HOPE Clinical Research
  - Chula Vista, California, United States, 91911
    - eStudySite
  - Colton, California, United States, 92324
    - Benchmark Research
  - Dublin, California, United States, 94568
    - West Coast Research
  - Huntington Beach, California, United States, 92647
    - Marvel Clinical Research 002, LLC
  - Lancaster, California, United States, 93534
    - Chemidox Clinical Trials
  - Long Beach, California, United States, 90815
    - Ark Clinical Research
  - Los Angeles, California, United States, 90017
    - Downtown L.A. Research Center, Inc.
  - North Hollywood, California, United States, 91606
    - Velocity Clinical Research, North Hollywood
  - Oxnard, California, United States, 93030
    - Clinica mi Salud by Focil Med
  - Palmdale, California, United States, 93551
    - De Silva Medical Inc
  - Pomona, California, United States, 91767
    - Empire Clinical Research
  - Redding, California, United States, 96001
    - Paradigm Clinical Research Center
  - Riverside, California, United States, 92503
    - Artemis Institute for Clinical Research
  - Sacramento, California, United States, 95864
    - Benchmark Research
  - San Diego, California, United States, 92123
    - California Research Foundation
  - San Diego, California, United States, 92123
    - Artemis Institute for Clinical Research
  - Walnut Creek, California, United States, 94598
    - Diablo Clinical Research, Inc.
- Colorado
  - Aurora, Colorado, United States, 80012
    - Lynn Institute of Denver
  - Longmont, Colorado, United States, 80501
    - Tekton Research LLC
- Connecticut
  - Milford, Connecticut, United States, 06460
    - Clinical Research Consulting
  - Stamford, Connecticut, United States, 06905
    - Stamford Therapeutics Consortium
- Florida
  - Atlantis, Florida, United States, 33462
    - JEM Research Institute
  - Aventura, Florida, United States, 33180
    - Ideal Clinical Research
  - Clearwater, Florida, United States, 33756
    - Innovative Research of West Florida
  - Coconut Creek, Florida, United States, 33073
    - Invictus Clinical Research Group, LLC
  - Crystal River, Florida, United States, 34429
    - Nature Coast Clinical Research
  - Doral, Florida, United States, 33166
    - Universal Axon Clinical Research, LLC (Administrative)
  - Hialeah, Florida, United States, 33012
    - Indago Research & Health Center, Inc
  - Hialeah, Florida, United States, 33016
    - Doral Medical Research, LLC
  - Lake City, Florida, United States, 32055
    - M3 Wake Research - Lake City
  - Miami, Florida, United States, 33165
    - New Horizon Research Center
  - Miami, Florida, United States, 33144
    - Next Phase Research Alliance
  - Miami, Florida, United States, 33125
    - Optimus U Corporation
  - Miami, Florida, United States, 33135
    - Advance Medical Research Center
  - Miami, Florida, United States, 33135
    - Optimus U Corporation
  - Miami, Florida, United States, 33184
    - De La Cruz Research Center, LLC
  - Miami, Florida, United States, 33135
    - Flourish Research - Miami, LLC
  - Miami Lakes, Florida, United States, 33016
    - Global Health Research Center, Inc.
  - Orlando, Florida, United States, 32819
    - Headlands Research Orlando
  - Pembroke Pines, Florida, United States, 33029
    - DBC Research USA
  - Pembroke Pines, Florida, United States, 33024
    - Pines Care Research Center, LLC
  - Pembroke Pines, Florida, United States, 33026
    - Ideal Clinical Research
  - Sarasota, Florida, United States, 34243
    - Headlands Research Sarasota
  - Sunrise, Florida, United States, 33351
    - Precision Clinical Research
  - Winter Park, Florida, United States, 32789
    - Conquest Research
  - Winter Park, Florida, United States, 32789
    - Clinical Site Partners, LLC dba Flourish Research
- Georgia
  - Albany, Georgia, United States, 31707
    - Javara - Privia Medical Group Georgia - Albany
  - Hinesville, Georgia, United States, 31313
    - Coastal Heritage Clinical Research
  - Savannah, Georgia, United States, 31406
    - Javara - Privia Medical Group Georgia - Savannah
  - Savannah, Georgia, United States, 31406
    - Velocity Clinical Research, Savannah
  - Stockbridge, Georgia, United States, 30281
    - Clinical Research Atlanta
  - Thomasville, Georgia, United States, 31792
    - Javara inc.
- Idaho
  - Idaho Falls, Idaho, United States, 83404
    - Snake River Research, PLLC
  - Meridian, Idaho, United States, 83646
    - Solaris Clinical Research
- Illinois
  - Chicago, Illinois, United States, 60640
    - Great Lakes Clinical Trials, LLC dba Flourish Research
  - Melrose Park, Illinois, United States, 60160
    - DM Clinical Research
  - Oak Brook, Illinois, United States, 60523
    - Affinity Health Corp
  - Oak Lawn, Illinois, United States, 60453
    - Accellacare - DuPage
- Indiana
  - Mishawaka, Indiana, United States, 46544
    - MOC Research
  - Valparaiso, Indiana, United States, 46383
    - Velocity Clinical Research Valparaiso
- Iowa
  - Iowa City, Iowa, United States, 52242
    - University of Iowa
  - Sioux City, Iowa, United States, 51106
    - Meridian Clinical Research, LLC
- Kentucky
  - Lexington, Kentucky, United States, 40509
    - AMR Clinical
- Louisiana
  - Kenner, Louisiana, United States, 70065
    - Ochsner Clinic Foundation
  - Kenner, Louisiana, United States, 70065
    - Ochsner Medical Center - Kenner
  - Metairie, Louisiana, United States, 70006
    - Velocity Clinical Research, Metairie
- Maryland
  - Rockville, Maryland, United States, 20854
    - Velocity Clinical Research, Rockville
- Massachusetts
  - Beverly, Massachusetts, United States, 01915
    - ActivMed Practices & Research, LLC
  - Methuen, Massachusetts, United States, 01844
    - ActivMed Practices & Research, LLC
  - Worcester, Massachusetts, United States, 01655
    - University of Massachusetts Chan Medical School
- Michigan
  - Farmington Hills, Michigan, United States, 48334
    - Michigan Center of Medical Research (MICHMER)
  - Grosse Pointe Woods, Michigan, United States, 48236
    - Ascension St. John Hospital Vaccine Research Unit
  - Troy, Michigan, United States, 48098
    - Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
  - Troy, Michigan, United States, 48085
    - Oakland Medical Research
- Missouri
  - St Louis, Missouri, United States, 63104
    - Saint Louis University
  - St Louis, Missouri, United States, 63141
    - Sundance Clinical Research
- Nebraska
  - Elkhorn, Nebraska, United States, 68022
    - Skyline Medical Center, PC/CCT Research
  - Omaha, Nebraska, United States, 68114
    - Quality Clinical Research
- Nevada
  - Las Vegas, Nevada, United States, 89119
    - Alliance for Multispecialty Research, LLC
  - Las Vegas, Nevada, United States, 89106
    - Wr-Crcn, Llc.
  - North Las Vegas, Nevada, United States, 89030
    - Las Vegas Clinical Trials
- New Hampshire
  - Portsmouth, New Hampshire, United States, 03801
    - ActivMed Practices and Research, LLC.
- New Jersey
  - Somers Point, New Jersey, United States, 08244
    - South Jersey Infectious Disease
  - Warren Township, New Jersey, United States, 07059
    - IMA Clinical Research Warren
- New York
  - Binghamton, New York, United States, 13905
    - Velocity Clinical Research, Binghamton
  - Hartsdale, New York, United States, 10530
    - Drug Trials America
  - Horseheads, New York, United States, 14845
    - Corning Center for Clinical Research
  - Rochester, New York, United States, 14642
    - University of Rochester Medical Center
  - Rochester, New York, United States, 14609
    - Rochester Clinical Research, LLC
  - The Bronx, New York, United States, 10455
    - CHEAR Center LLC
  - Vestal, New York, United States, 13850
    - Velocity Clinical Research, Vestal
- North Carolina
  - Charlotte, North Carolina, United States, 28207
    - Atrium Health - Strive Vaccine Research Clinic
  - Charlotte, North Carolina, United States, 28210
    - Tryon Medical Partners, PLLC
  - Charlotte, North Carolina, United States, 28277
    - Sensenbrenner Primary Care Research Office
  - Charlotte, North Carolina, United States, 28211
    - Accellacare - Charlotte
  - Wilmington, North Carolina, United States, 28401
    - Accellacare - Wilmington
  - Wilmington, North Carolina, United States, 28401
    - Accellacare - Wilmington - 1917 Tradd Court
  - Winston-Salem, North Carolina, United States, 27157
    - Wake Forest University Health Sciences
- Ohio
  - Cincinnati, Ohio, United States, 45242
    - Velocity Clinical Research - Cincinnati
  - Cincinnati, Ohio, United States, 45246
    - Velocity Clinical Research, Springdale
  - Cincinnati, Ohio, United States, 45219
    - Velocity Clinical Research, Cincinnati, Mt. Auburn
  - Columbus, Ohio, United States, 43213
    - Centricity Research Columbus Ohio Multispecialty
- Oklahoma
  - Edmond, Oklahoma, United States, 73013
    - Tekton Research, LLC.
  - Yukon, Oklahoma, United States, 73099
    - Tekton Research, Inc
- Oregon
  - Corvallis, Oregon, United States, 97330
    - The Corvallis Clinic, PC
  - Grants Pass, Oregon, United States, 97527
    - Velocity Clinical Research, Grants Pass
  - Medford, Oregon, United States, 97504
    - Velocity Clinical Research, Medford
  - Portland, Oregon, United States, 97227
    - Kaiser Permanente Northwest Center for Health Research
  - Portland, Oregon, United States, 97210
    - Summit Headlands, LLC
- Pennsylvania
  - Camp Hill, Pennsylvania, United States, 17011
    - Capital Area Research, LLC
  - Erie, Pennsylvania, United States, 16508
    - Central Erie Primary Care
  - Philadelphia, Pennsylvania, United States, 19104
    - Penn Prevention Unit
- Rhode Island
  - East Greenwich, Rhode Island, United States, 02818
    - Velocity Clinical Research, Providence
- Tennessee
  - Knoxville, Tennessee, United States, 37912
    - Accellacare US Inc., d/b/a Accellacare of Knoxville
  - Knoxville, Tennessee, United States, 37909
    - AMR Clinical
  - Nashville, Tennessee, United States, 37203
    - Clinical Research Associates, Inc.
- Texas
  - Austin, Texas, United States, 78705
    - Benchmark Research
  - Austin, Texas, United States, 78745
    - Tekton Research, LLC.
  - Austin, Texas, United States, 78726
    - Innovo Research - Austin Regional Clinic
  - Beaumont, Texas, United States, 77706
    - Tekton Research, LLC.
  - Conroe, Texas, United States, 77384
    - Javara - Privia Medical Group Gulf Coast - The Woodlands HWH
  - Dallas, Texas, United States, 75246
    - North Texas Infectious Diseases Consultants, P.A
  - Fort Worth, Texas, United States, 76135
    - Benchmark Research
  - Fort Worth, Texas, United States, 76135
    - Texas Health Family Care
  - Friendswood, Texas, United States, 77546
    - Allure Health at Mt. Olympus Medical Research
  - Houston, Texas, United States, 77008
    - Hany H. Ahmed, MD
  - Houston, Texas, United States, 77008
    - HG Pediatrics
  - Houston, Texas, United States, 77008
    - Ventavia Research Group, LLC
  - Houston, Texas, United States, 77008
    - Van Tran Family Practice
  - Houston, Texas, United States, 77008
    - Trio Clinical Trials, LLC
  - Houston, Texas, United States, 77058
    - Centex Studies
  - Houston, Texas, United States, 77090
    - Centex Studies
  - Houston, Texas, United States, 77065
    - DM Clinical Research - Cy Fair
  - Houston, Texas, United States, 77008
    - Helios Clinical Research - HOU
  - Houston, Texas, United States, 77081
    - DM Clinical Research - Bellaire
  - Houston, Texas, United States, 77065
    - DM Clinical Research- Cyfair
  - Humble, Texas, United States, 77338
    - DM Clinical Research - Humble
  - Humble, Texas, United States, 77338
    - DM Clinical Research, Martin Diagnostic Clinic
  - Laredo, Texas, United States, 78041
    - Milton Haber, M.D.
  - Laredo, Texas, United States, 78041
    - Milton Haber, MD
  - Mesquite, Texas, United States, 75149
    - SMS Clinical Research
  - San Antonio, Texas, United States, 78215
    - Sun Research Institute
  - San Antonio, Texas, United States, 78229
    - Clinical Trials of Texas, LLC
  - San Antonio, Texas, United States, 78229
    - Clinical Trials of Texas, LLC dba Flourish Research
  - Sugar Land, Texas, United States, 77478
    - Dynamed Clinical Research, LP d/b/a DM Clinical Research
  - Sugar Land, Texas, United States, 77478
    - Javara inc.
  - Sugar Land, Texas, United States, 77479
    - Mt Olympus Medical Research
  - Tomball, Texas, United States, 77375
    - Dynamed Clinical Research, LP d/b/a DM Clinical Research
- Utah
  - Draper, Utah, United States, 84020
    - J. Lewis Research, Inc. / Foothill Family Clinic Draper
  - Layton, Utah, United States, 84041
    - Tanner Clinic
  - South Jordan, Utah, United States, 84095
    - J. Lewis Research, Inc. / Jordan River Family Medicine
  - West Jordan, Utah, United States, 84088
    - Velocity Clinical Research, Salt Lake City
- Virginia
  - Suffolk, Virginia, United States, 23435
    - Virginia Gastroenterology Clinical Research
  - Suffolk, Virginia, United States, 23435
    - Centricity Research Suffolk Primary Care
- Washington
  - Bellevue, Washington, United States, 98007
    - Northwest Clinical Research Center
  - Port Orchard, Washington, United States, 98366
    - Sound Medical Research
  - Tacoma, Washington, United States, 98405
    - MultiCare Institute for Research & Innovation
  - Tacoma, Washington, United States, 98405
    - MultiCare Medical Group
  - Wenatchee, Washington, United States, 98801
    - Central Washington Health Services Association d/b/a Confluence Health
  - Wenatchee, Washington, United States, 98801
    - Research Building
- Wisconsin
  - Wauwatosa, Wisconsin, United States, 53226
    - Allegiance Research Specialists, LLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Efficacy Study

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.

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

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.

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.

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 103).

- 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

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.

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.

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 203).

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

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, 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.

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.

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 303 or Visit 306).

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Triple

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Efficacy Study: RSVpreF vaccine RSVpreF	Biological: RSVpreF RSV vaccine (RSVpreF)
Placebo Comparator: Efficacy Study: Placebo dose Placebo	Biological: Placebo Placebo
Placebo Comparator: 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.	Biological: Placebo Placebo
Placebo Comparator: 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.	Biological: Placebo Placebo
Experimental: 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.	Biological: RSVpreF RSV vaccine (RSVpreF)
Experimental: 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.	Biological: RSVpreF RSV vaccine (RSVpreF)
Experimental: 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.	Biological: RSVpreF RSV vaccine (RSVpreF)
Experimental: 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.	Biological: RSVpreF RSV vaccine (RSVpreF)
Placebo Comparator: 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.	Biological: Placebo Placebo

What is the study measuring?

Primary Outcome Measures

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy Study: Number of first episode of RSV-associated severe LRTI (sLRTI-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)	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	From Day 15 after vaccination until the end of season 1 visit (an average of 6 months)
Efficacy Study: Number of first episode of LRTI-RSV in the second RSV season Time Frame: During the second RSV season (an average of 6 months)	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.	During the second RSV season (an average of 6 months)
Efficacy Study: Number of first episode of LRTI-RSV across 2 RSV seasons Time Frame: From Day 15 after vaccination until the end of season 2 visit (an average of 12 months of surveillance)	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.	From Day 15 after vaccination until the end of season 2 visit (an average of 12 months of surveillance)
Efficacy Study: Number of first episode of RSV-associated ARI (ARI-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)	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.	From Day 15 after vaccination until the end of season 1 visit (an average of 6 months)
Efficacy Study: Number of first episode of ARI-RSV in the second RSV season Time Frame: During the second RSV season (an average of 6 months)	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.	During the second RSV season (an average of 6 months)
Efficacy Study: Number of first episode of ARI-RSV across 2 RSV seasons Time Frame: From Day 15 after vaccination until the end of season 2 visit (an average of 12 months of surveillance)	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.	From Day 15 after vaccination until the end of season 2 visit (an average of 12 months of surveillance)
Efficacy Study: Number of first episode of sLRTI-RSV in the second RSV season Time Frame: During the second RSV season (an average of 6 months)	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	During the second RSV season (an average of 6 months)
Efficacy Study: Number of first episode of sLRTI-RSV across 2 RSV seasons Time Frame: From Day 15 after vaccination until the end of season 2 visit (an average of 12 months of surveillance)	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	From Day 15 after vaccination until the end of season 2 visit (an average of 12 months of surveillance)
Efficacy Study: Respiratory Syncytial Virus Subgroup A (RSV A) and RSV B neutralizing titers Time Frame: Before vaccination, 1-month after vaccination, before season 2 (approximately 12 months after vaccination)	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.	Before vaccination, 1-month after vaccination, before season 2 (approximately 12 months after vaccination)
SSA: Respiratory Syncytial Virus Subgroup A (RSV A) and RSV B neutralizing titers from participants who received placebo in SSA. Time Frame: Before revaccination and 1, 6, 12 and 18-months after revaccination with 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.	Before revaccination and 1, 6, 12 and 18-months after revaccination with placebo in SSA
SSB: Respiratory Syncytial Virus Subgroup A (RSV A) and RSV B neutralizing titers from participants who received placebo in SSB Time Frame: Before revaccination and 1, 6, 12 and 18-months after revaccination with 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.	Before revaccination and 1, 6, 12 and 18-months after revaccination with placebo in SSB
SSC: Respiratory Syncytial Virus Subgroup A (RSV A) and RSV B neutralizing titers from participants who received placebo in SSC. Time Frame: Participants receiving placebo at the Year 3 vaccination: 1 month, 3 and 3.5 years after efficacy study vaccination	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.	Participants receiving placebo at the Year 3 vaccination: 1 month, 3 and 3.5 years after efficacy study vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Investigators

Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 31, 2021

Primary Completion (Estimated)

January 18, 2027

Study Completion (Estimated)

January 18, 2027

Study Registration Dates

First Submitted

August 20, 2021

First Submitted That Met QC Criteria

August 30, 2021

First Posted (Actual)

September 5, 2021

Study Record Updates

Last Update Posted (Actual)

January 28, 2026

Last Update Submitted That Met QC Criteria

January 26, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

C3671013
2021-003693-31 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Study Overview

Status

Conditions

Intervention / Treatment

Detailed Description

Study Type

Enrollment (Actual)

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Investigators

Publications and helpful links

General Publications

Helpful Links

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Estimated)

Study Completion (Estimated)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

IPD Plan Description

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

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