ACTIVE_NOT_RECRUITING

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

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Conditions

Lower Respiratory Tract IllnessRSVVaccine

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2021-08-31
Study Completion:2027-01-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05035212

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.

Ages Eligible for Study:60 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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.
  2. * 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.
  3. * 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.
  4. * 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.
  5. * Male or female participants ≥60 years of age.
  6. * 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.
  7. * Female participants must not be of childbearing potential.
  1. * Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.
  2. * 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.
  3. * 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.
  4. * Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination.
  5. * 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.
  6. * 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).
  7. * Receipt of blood/plasma products or immunoglobulin within 60 days before study intervention administration.
  8. * Previous vaccination with any licensed or investigational RSV vaccine or planned receipt during study participation.
  9. * 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.

Contacts and Locations

Principal Investigator

Pfizer CT.gov Call Center
STUDY_DIRECTOR
Pfizer

Study Locations (Sites)

St. Vincent's Birmingham (Pharmacy)
Birmingham, Alabama, 35205
United States
St. Vincent's Birmingham
Birmingham, Alabama, 35205
United States
Medical Affiliated Research Center
Huntsville, Alabama, 35801
United States
Lenzmeier Family Medicine / Avacare
Glendale, Arizona, 85308
United States
Phoenix Clinical LLC
Phoenix, Arizona, 85014
United States
HOPE Research Institute
Phoenix, Arizona, 85018
United States
The Pain Center of Arizona
Phoenix, Arizona, 85018
United States
HOPE Research Institute
Phoenix, Arizona, 85023
United States
Cognitive Clinical Trials, LLC
Phoenix, Arizona, 85044
United States
Headlands Research - Scottsdale
Scottsdale, Arizona, 85260
United States
Alliance for Multispecialty Research, LLC
Tempe, Arizona, 85281
United States
HOPE Research Institute
Tempe, Arizona, 85284
United States
Noble Clinical Research
Tucson, Arizona, 85704
United States
The Institute for Liver Health dba Arizona Clinical Trials
Tucson, Arizona, 85712
United States
Hope Clinical Research
Canoga Park, California, 91303
United States
eStudySite
Chula Vista, California, 91911
United States
Benchmark Research
Colton, California, 92324
United States
West Coast Research
Dublin, California, 94568
United States
Marvel Clinical Research 002, LLC
Huntington Beach, California, 92647
United States
Chemidox Clinical Trials
Lancaster, California, 93534
United States
Ark Clinical Research
Long Beach, California, 90815
United States
Downtown L.A. Research Center, Inc.
Los Angeles, California, 90017
United States
Velocity Clinical Research, North Hollywood
North Hollywood, California, 91606
United States
Clinica mi Salud by Focil Med
Oxnard, California, 93030
United States
De Silva Medical Inc
Palmdale, California, 93551
United States
Empire Clinical Research
Pomona, California, 91767
United States
Paradigm Clinical Research Center
Redding, California, 96001
United States
Artemis Institute for Clinical Research
Riverside, California, 92503
United States
Benchmark Research
Sacramento, California, 95864
United States
Artemis Institute for Clinical Research
San Diego, California, 92103
United States
California Research Foundation
San Diego, California, 92123
United States
Diablo Clinical Research, Inc.
Walnut Creek, California, 94598
United States
Lynn Institute of Denver
Aurora, Colorado, 80012
United States
Tekton Research LLC
Longmont, Colorado, 80501
United States
Clinical Research Consulting
Milford, Connecticut, 06460
United States
Stamford Therapeutics Consortium
Stamford, Connecticut, 06905
United States
JEM Research Institute
Atlantis, Florida, 33462
United States
IDEAL Clinical Research
Aventura, Florida, 33180
United States
Innovative Research of West Florida
Clearwater, Florida, 33756
United States
Invictus Clinical Research Group, LLC
Coconut Creek, Florida, 33073
United States
Nature Coast Clinical Research
Crystal River, Florida, 34429
United States
Universal Axon Clinical Research, LLC (Administrative)
Doral, Florida, 33166
United States
Indago Research & Health Center, Inc
Hialeah, Florida, 33012
United States
Doral Medical Research, LLC
Hialeah, Florida, 33016
United States
M3 Wake Research - Lake City
Lake City, Florida, 32055
United States
Optimus U Corporation
Miami, Florida, 33125
United States
Advance Medical Research Center
Miami, Florida, 33135
United States
Optimus U Corporation
Miami, Florida, 33135
United States
Suncoast Research Group
Miami, Florida, 33135
United States
Next Phase Research Alliance
Miami, Florida, 33144
United States
New Horizon Research Center
Miami, Florida, 33165
United States
De La Cruz Research Center, LLC
Miami, Florida, 33184
United States
Global Health Research Center, Inc.
Miami Lakes, Florida, 33016
United States
Headlands Research Orlando
Orlando, Florida, 32819
United States
Pines Care Research Center, LLC
Pembroke Pines, Florida, 33024
United States
IDEAL Clinical Research
Pembroke Pines, Florida, 33026
United States
DBC Research USA
Pembroke Pines, Florida, 33029
United States
Headlands Research Sarasota
Sarasota, Florida, 34243
United States
Precision Clinical Research
Sunrise, Florida, 33351
United States
Clinical Site Partners, Inc
Winter Park, Florida, 32789
United States
Conquest Research
Winter Park, Florida, 32789
United States
Javara - Privia Medical Group Georgia - Albany
Albany, Georgia, 31707
United States
Coastal Heritage Clinical Research
Hinesville, Georgia, 31313
United States
Javara - Privia Medical Group Georgia - Savannah
Savannah, Georgia, 31406
United States
Velocity Clinical Research, Savannah
Savannah, Georgia, 31406
United States
Clinical Research Atlanta
Stockbridge, Georgia, 30281
United States
Javara Inc.
Thomasville, Georgia, 31792
United States
Snake River Research, PLLC
Idaho Falls, Idaho, 83404
United States
Solaris Clinical Research
Meridian, Idaho, 83646
United States
Great Lakes Clinical Trials, LLC dba Flourish Research
Chicago, Illinois, 60640
United States
DM Clinical Research
Melrose Park, Illinois, 60160
United States
Affinity Health Corp
Oak Brook, Illinois, 60523
United States
Accellacare - DuPage
Oak Lawn, Illinois, 60453
United States
MOC Research
Mishawaka, Indiana, 46544
United States
Velocity Clinical Research Valparaiso
Valparaiso, Indiana, 46383
United States
University of Iowa
Iowa City, Iowa, 52242
United States
Meridian Clinical Research, LLC
Sioux City, Iowa, 51106
United States
AMR Clinical
Lexington, Kentucky, 40509
United States
Ochsner Clinic Foundation
Kenner, Louisiana, 70065
United States
Ochsner Medical Center - Kenner
Kenner, Louisiana, 70065
United States
Velocity Clinical Research, Metairie
Metairie, Louisiana, 70006
United States
Velocity Clinical Research, Rockville
Rockville, Maryland, 20854
United States
ActivMed Practices & Research, LLC
Beverly, Massachusetts, 01915
United States
ActivMed Practices & Research, LLC
Methuen, Massachusetts, 01844
United States
University of Massachusetts Chan Medical School
Worcester, Massachusetts, 01655
United States
Michigan Center of Medical Research (MICHMER)
Farmington Hills, Michigan, 48334
United States
Ascension St. John Hospital Vaccine Research Unit
Grosse Pointe Woods, Michigan, 48236
United States
Oakland Medical Research
Troy, Michigan, 48085
United States
Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
Troy, Michigan, 48098
United States
Saint Louis University
St Louis, Missouri, 63104
United States
Sundance Clinical Research
St Louis, Missouri, 63141
United States
Skyline Medical Center, PC/CCT Research
Elkhorn, Nebraska, 68022
United States
Quality Clinical Research
Omaha, Nebraska, 68114
United States
Wr-Crcn, Llc.
Las Vegas, Nevada, 89106
United States
Alliance for Multispecialty Research, LLC
Las Vegas, Nevada, 89119
United States
Las Vegas Clinical Trials
North Las Vegas, Nevada, 89030
United States
ActivMed Practices and Research, LLC.
Portsmouth, New Hampshire, 03801
United States
South Jersey Infectious Disease
Somers Point, New Jersey, 08244
United States
IMA Clinical Research Warren
Warren Township, New Jersey, 07059
United States
Velocity Clinical Research, Binghamton
Binghamton, New York, 13905
United States
Drug Trials America
Hartsdale, New York, 10530
United States
Corning Center for Clinical Research
Horseheads, New York, 14845
United States
Rochester Clinical Research, LLC
Rochester, New York, 14609
United States
University of Rochester Medical Center
Rochester, New York, 14642
United States
CHEAR Center LLC
The Bronx, New York, 10455
United States
Velocity Clinical Research, Vestal
Vestal, New York, 13850
United States
Atrium Health - Strive Vaccine Research Clinic
Charlotte, North Carolina, 28207
United States
Tryon Medical Partners, PLLC
Charlotte, North Carolina, 28210
United States
Accellacare - Charlotte
Charlotte, North Carolina, 28211
United States
Sensenbrenner Primary Care Research Office
Charlotte, North Carolina, 28277
United States
Accellacare - Wilmington - 1917 Tradd Court
Wilmington, North Carolina, 28401
United States
Accellacare - Wilmington
Wilmington, North Carolina, 28401
United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
United States
Velocity Clinical Research, Cincinnati, Mt. Auburn
Cincinnati, Ohio, 45219
United States
Velocity Clinical Research - Cincinnati
Cincinnati, Ohio, 45242
United States
Velocity Clinical Research, Cincinnati, Springdale
Cincinnati, Ohio, 45246
United States
Centricity Research Columbus Ohio Multispecialty
Columbus, Ohio, 43213
United States
Tekton Research, LLC.
Edmond, Oklahoma, 73013
United States
Tekton Research, Inc
Yukon, Oklahoma, 73099
United States
The Corvallis Clinic, PC
Corvallis, Oregon, 97330
United States
Velocity Clinical Research, Grants Pass
Grants Pass, Oregon, 97527
United States
Velocity Clinical Research, Medford
Medford, Oregon, 97504
United States
Summit Headlands, LLC
Portland, Oregon, 97210
United States
Kaiser Permanente Northwest-Center for Health Research
Portland, Oregon, 97227
United States
Capital Area Research, LLC
Camp Hill, Pennsylvania, 17011
United States
Central Erie Primary Care
Erie, Pennsylvania, 16508
United States
Penn Prevention Unit
Philadelphia, Pennsylvania, 19104
United States
Velocity Clinical Research, Providence
East Greenwich, Rhode Island, 02818
United States
AMR Clinical
Knoxville, Tennessee, 37909
United States
Accellacare US Inc., d/b/a Accellacare of Knoxville
Knoxville, Tennessee, 37912
United States
Clinical Research Associates, Inc.
Nashville, Tennessee, 37203
United States
Benchmark Research
Austin, Texas, 78705
United States
Innovo Research - Austin Regional Clinic
Austin, Texas, 78726
United States
Tekton Research, LLC.
Austin, Texas, 78745
United States
Tekton Research, LLC.
Beaumont, Texas, 77706
United States
Privia Medical Group Gulf Coast, PLLC
Conroe, Texas, 77384
United States
North Texas Infectious Diseases Consultants, P.A
Dallas, Texas, 75246
United States
Benchmark Research
Fort Worth, Texas, 76135
United States
Texas Health Family Care
Fort Worth, Texas, 76135
United States
Allure Health at Mt. Olympus Medical Research
Friendswood, Texas, 77546
United States
Hany H. Ahmed, MD
Houston, Texas, 77008
United States
Helios Clinical Research - HOU
Houston, Texas, 77008
United States
HG Pediatrics
Houston, Texas, 77008
United States
Trio Clinical Trials, LLC
Houston, Texas, 77008
United States
Van Tran Family Practice
Houston, Texas, 77008
United States
Ventavia Research Group, LLC
Houston, Texas, 77008
United States
Centex Studies
Houston, Texas, 77058
United States
DM Clinical Research - Cy Fair
Houston, Texas, 77065
United States
DM Clinical Research- Cyfair
Houston, Texas, 77065
United States
DM Clinical Research - Bellaire
Houston, Texas, 77081
United States
Centex Studies
Houston, Texas, 77090
United States
DM Clinical Research - Humble
Humble, Texas, 77338
United States
DM Clinical Research, Martin Diagnostic Clinic
Humble, Texas, 77338
United States
Milton Haber, M.D.
Laredo, Texas, 78041
United States
Milton Haber, MD
Laredo, Texas, 78041
United States
SMS Clinical Research
Mesquite, Texas, 75149
United States
Sun Research Institute
San Antonio, Texas, 78215
United States
Clinical Trials of Texas, LLC dba Flourish Research
San Antonio, Texas, 78229
United States
Clinical Trials of Texas, LLC
San Antonio, Texas, 78229
United States
Dynamed Clinical Research, LP d/b/a DM Clinical Research
Sugar Land, Texas, 77478
United States
Javara Inc.
Sugar Land, Texas, 77478
United States
Mt Olympus Medical Research
Sugar Land, Texas, 77479
United States
Dynamed Clinical Research, LP d/b/a DM Clinical Research
Tomball, Texas, 77375
United States
J. Lewis Research, Inc. / Foothill Family Clinic Draper
Draper, Utah, 84020
United States
Tanner Clinic
Layton, Utah, 84041
United States
J. Lewis Research, Inc. / Jordan River Family Medicine
South Jordan, Utah, 84095
United States
Velocity Clinical Research, Salt Lake City
West Jordan, Utah, 84088
United States
Centricity Research Suffolk Primary Care
Suffolk, Virginia, 23435
United States
Virginia Gastroenterology Clinical Research
Suffolk, Virginia, 23435
United States
Northwest Clinical Research Center
Bellevue, Washington, 98007
United States
Sound Medical Research
Port Orchard, Washington, 98366
United States
MultiCare Institute for Research & Innovation
Tacoma, Washington, 98405
United States
MultiCare Medical Group
Tacoma, Washington, 98405
United States
Central Washington Health Services Association d/b/a Confluence Health
Wenatchee, Washington, 98801
United States
Research Building
Wenatchee, Washington, 98801
United States
Allegiance Research Specialists, LLC
Wauwatosa, Wisconsin, 53226
United States

Collaborators and Investigators

Sponsor: Pfizer

  • Pfizer CT.gov Call Center, STUDY_DIRECTOR, Pfizer

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 Registration Dates

Study Start Date2021-08-31
Study Completion Date2027-01-09

Study Record Updates

Study Start Date2021-08-31
Study Completion Date2027-01-09

Terms related to this study

Keywords Provided by Researchers

  • Lower Respiratory Tract Illness
  • RSV
  • Vaccine

Additional Relevant MeSH Terms

  • Lower Respiratory Tract Illness