Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05035212
Other study ID # C3671013
Secondary ID 2021-003693-31
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date August 31, 2021
Est. completion date September 5, 2025

Study information

Verified date March 2024
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 38249
Est. completion date September 5, 2025
Est. primary completion date September 5, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 60 Years and older
Eligibility 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. Note: Healthy participants with preexisting stable disease, defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 6 weeks before enrollment, can be included. Specific criteria for participants with known stable infection with HIV, HCV, or HBV can be found in the protocol. - Adults who are ambulatory and live in the community, or in assisted living or long-term care residential facilities that provide minimal assistance, such that the participant is primarily responsible for self-care and activities of daily living. - Capable of giving signed informed consent as described in the protocol, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol. - Male or female participants =60 years of age. - Male participants able to father children must agree to use a highly effective method of contraception from the time of informed consent through at least 28 days after study intervention administration. - Female participants must not be of childbearing potential. - Participants who received RSVpreF in the efficacy study. - Participants who have a Visit 2 serology sample available for testing from the efficacy study, completed the end-of-Season 2 visit (Visit 5), and did not meet exclusion criteria throughout the efficacy study duration. 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). 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 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. 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: 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.

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
RSVpreF
RSV vaccine (RSVpreF)
Placebo
Placebo

Locations

Country Name City State
Argentina Fundación Respirar Caba Buenos Aires
Argentina Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich Caba Buenos Aires
Argentina Clinica Privada del Sol S.A. Cordoba
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 IMAC - Instituto Medico de Alta Complejidad Salta
Argentina Clinica Mayo de Urgencias Medicas Cruz Blanca S.R.L San Miguel de Tucuman Tucuman
Argentina Hospital de Clinicas Presidente Nicolas Avellaneda San Miguel de Tucuman Tucuman
Canada Aggarwal and Associates Limited Brampton Ontario
Canada Kaye Edmonton Clinic Edmonton Alberta
Canada Stollery Children's Hospital Edmonton Alberta
Canada University Of Alberta Hospital Edmonton Alberta
Canada Dawson Clinical Research Inc. Guelph Ontario
Canada Hamilton Medical Research Group Hamilton Ontario
Canada Manna Research (Mirabel) Mirabel Quebec
Canada Clinique de Médecine Urbaine du Quartier Latin Montreal Quebec
Canada Centre de Recherche Saint-Louis Quebec
Canada Diex Recherche Quebec Inc. Quebec
Canada Alpha Recherche Clinique Québec Quebec
Canada Diex Recherche Sherbrooke Inc. Sherbrooke Quebec
Canada Diex Recherche Joliette Inc. St-Charles-Borromee Quebec
Canada Dr. Anil K. Gupta Medicine Professional Corporation Toronto Ontario
Canada LMC Clinical Research Inc. (Clinical Pharmacology Unit) Toronto Ontario
Canada Manna Research (Toronto) Toronto Ontario
Canada Diex Recherche Victoriaville Inc. Victoriaville Quebec
Finland Espoo Vaccine Research Clinic Espoo
Finland FVR, Etelä-Helsingin rokotetutkimusklinikka Helsinki
Finland Helsinki East Vaccine Research Clinic Helsinki
Finland Järvenpää Vaccine Research Clinic Järvenpää
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 Seinajoki
Finland Tampere Vaccine Research Clinic Tampere
Finland Terveystalo Tampere Tampere
Finland Terveystalo Turku Pulssi Turku
Finland Turku Vaccine Research Clinic Turku
Japan Sasaki Clinic Amagasaki Hyogo
Japan Fukuwa Clinic Chuo-ku Tokyo
Japan Nihonbashi Sakura Clinic Chuo-ku Tokyo
Japan Tokyo Asbo Clinic Chuo-ku Tokyo
Japan Tokyo Eki Center Building Clinic Chuo-ku Tokyo
Japan SOUSEIKAI PS Clinic Fukuoka
Japan Tenjin General Clinic Fukuoka-shi Fukuoka
Japan Medical Corp. Seikoukai New Medical Research System Clinic Hachioji-shi Tokyo
Japan Seishinkai Inoue Hospital Itoshima Fukuoka
Japan Sugiura Clinic Kawaguchi Saitama
Japan AMC Nishiumeda Clinic Osaka
Japan Medical Corporation Heishinkai OPHAC Hospital Osaka-shi Osaka
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 Motomachi Takatsuka Naika Clinic Yokohama Kanagawa
Netherlands 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
South Africa Worthwhile Clinical Trials Benoni Gauteng
South Africa Josha Research Bloemfontein FREE State
South Africa Synexus - Helderberg Clinical Research Centre - Somerset West Cape Town Western CAPE
South Africa TREAD Research Cape Town Western CAPE
South Africa MERC Research (Pty) Ltd - Kempton Kempton Park Gauteng
South Africa MERCLINCO (Pty) Ltd - Kempton Kempton Park Gauteng
South Africa MERC Research (Pty) Ltd - Middelburg Middelburg Mpumalanga
South Africa Dr A Jacovides & Partners Inc. Midrand Gauteng
South Africa Newtown Clinical Research Centre (PTY) LTD Newtown Gauteng
South Africa Be Part Yoluntu Centre Paarl Western CAPE
South Africa About Allergy Pretoria Gauteng
South Africa Botho Ke Bontle Health Services Pretoria
South Africa Emmed Research Pretoria
South Africa Emmed Research Pretoria Gauteng
South Africa Global Clinical Trials 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 Helderberg Clinical Trials Centre Somerset West Western CAPE
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 Welkom Clinical Trial Centre (MERC WELKOM) Welkom FREE State
United States Javara - Privia Medical Group Georgia - Albany Albany Georgia
United States JEM Research Institute Atlantis Florida
United States Lynn Institute of Denver Aurora Colorado
United States ARC Clinical Research at Four Points Austin Texas
United States Benchmark Research Austin Texas
United States Tekton Research, LLC. Austin Texas
United States IDEAL Clinical Research Aventura Florida
United States Tekton Research, Inc. Beaumont Texas
United States Northwest Clinical Research Center Bellevue Washington
United States ActivMed Practices & Research, LLC Beverly Massachusetts
United States Meridian Clinical Research, LLC Binghamton New York
United States Meridian Clinical Research, LLC Binghamton New York
United States St. Vincent's Birmingham Birmingham Alabama
United States St. Vincent's Birmingham (Pharmacy) Birmingham Alabama
United States CHEAR Center LLC Bronx New York
United States Capital Area Research, LLC Camp Hill Pennsylvania
United States Hope Clinical Research Canoga Park California
United States Accellacare - Charlotte Charlotte North Carolina
United States Accellacare - Charlotte Charlotte North Carolina
United States Atrium Health - Strive Vaccine Research Clinic Charlotte North Carolina
United States Javara Inc. Charlotte North Carolina
United States Sensenbrenner Primary Care Research Office Charlotte North Carolina
United States Tryon Medical Partners, PLLC Charlotte North Carolina
United States Great Lakes Clinical Trials Chicago Illinois
United States eStudySite Chula Vista California
United States Meridian Clinical Research Cincinnati Ohio
United States Meridian Clinical Research Cincinnati Ohio
United States Meridian Clinical Research, LLC Cincinnati Ohio
United States Meridian Clinical Research, LLC Cincinnati Ohio
United States Velocity Clinical Research - Cincinnati Cincinnati Ohio
United States Velocity Clinical Research, Springdale Cincinnati Ohio
United States Innovative Research of West Florida Clearwater Florida
United States Invictus Clinical Research Group, LLC Coconut Creek Florida
United States Benchmark Research Colton California
United States Centricity Research Columbus Ohio Multispecialty Columbus Ohio
United States Javara Inc. Conroe Texas
United States Privia Medical Group Gulf Coast, PLLC Conroe Texas
United States The Corvallis Clinic, PC Corvallis Oregon
United States Nature Coast Clinical Research Crystal River Florida
United States North Texas Infectious Diseases Consultants, P.A Dallas Texas
United States Universal Axon Clinical Research, LLC (Administrative) Doral Florida
United States J. Lewis Research Inc. / Foothill Family Clinic Draper Draper Utah
United States J. Lewis Research, Inc. / Foothill Family Clinic Draper Draper Utah
United States West Coast Research Dublin California
United States Velocity Clinical Research, Providence East Greenwich Rhode Island
United States Tekton Research, Inc Edmond Oklahoma
United States Tekton Research, LLC. Edmond Oklahoma
United States Skyline Medical Center, PC/CCT Research Elkhorn Nebraska
United States Central Erie Primary Care Erie Pennsylvania
United States Michigan Center of Medical Research (MICHMER) Farmington Hills Michigan
United States Benchmark Research Fort Worth Texas
United States Benchmark Research Fort Worth Texas
United States Allure Health at Mt. Olympus Medical Research Friendswood Texas
United States Lenzmeier Family Medicine/CCT Research Glendale Arizona
United States Velocity Clinical Research, Grants Pass Grants Pass Oregon
United States Ascension St. John Hospital Vaccine Research Unit Grosse Pointe Woods Michigan
United States Drug Trials America Hartsdale New York
United States Doral Medical Research, LLC Hialeah Florida
United States Indago Research & Health Center, Inc Hialeah Florida
United States Coastal Heritage Clinical Research Hinesville Georgia
United States Corning Center for Clinical Research Horseheads New York
United States Centex Studies Houston Texas
United States Centex Studies Houston Texas
United States DM Clinical Research - Brookline Houston Texas
United States DM Clinical Research - Cy Fair Houston Texas
United States DM Clinical Research ? CyFair Houston 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 Texas Center for Drug Development, Inc. 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 DM Clinical Research Humble Texas
United States Marvel Clinical Research Huntington Beach California
United States Marvel Clinical Research 002, LLC Huntington Beach California
United States Medical Affiliated Research Center Huntsville Alabama
United States Snake River Research, PLLC Idaho Falls Idaho
United States University of Iowa Iowa City Iowa
United States University of Iowa Hospitals & Clinics Iowa City Iowa
United States Ochsner Clinic Foundation Kenner Louisiana
United States Ochsner Medical Center - Kenner Kenner Louisiana
United States Accellacare US Inc., d/b/a Accellacare of Knoxville Knoxville Tennessee
United States Alliance for Multispecialty Research, LLC Knoxville Tennessee
United States Wr-Msra.Llc Lake City Florida
United States Chemidox Clinical Trials Lancaster California
United States Milton Haber, M.D. Laredo Texas
United States Alliance for Multispecialty Research, LLC Las Vegas Nevada
United States Wr-Crcn, Llc. Las Vegas Nevada
United States Tanner Clinic Layton Utah
United States Alliance for Multispecialty Research, LLC Lexington Kentucky
United States Ark Clinical Research Long Beach California
United States Ark Clinical Research Long Beach California
United States Tekton Research, Inc. Longmont Colorado
United States Downtown L.A. Research Center, Inc. Los Angeles California
United States West Shore Family Practice, P. C. Mechanicsburg Pennsylvania
United States Velocity Clinical Research, Medford Medford Oregon
United States Solaris Clinical Research Meridian Idaho
United States SMS Clinical Research Mesquite Texas
United States Velocity Clinical Research, Metairie Metairie Louisiana
United States ActivMed Practices & Research, LLC Methuen Massachusetts
United States Advance Medical Research Center Miami Florida
United States Clinical Site Partners, Inc dba CSP Miami Miami Florida
United States De La Cruz Research, LLC Miami Florida
United States New Horizon Research Center Miami Florida
United States Next Phase Research Alliance Miami Florida
United States Optimus U Corporation Miami Florida
United States Optimus U Corporation Miami Florida
United States Global Health Research Center, Inc. Miami Lakes Florida
United States Clinical Research Consulting Milford Connecticut
United States MOC Research Mishawaka Indiana
United States Clinical Research Associates, Inc. Nashville Tennessee
United States Ochsner Clinic Foundation New Orleans Louisiana
United States Velocity Clinical Research, North Hollywood North Hollywood California
United States Las Vegas Clinical Trials North Las Vegas Nevada
United States Affinity Health Corp Oak Brook Illinois
United States Quality Clinical Research Omaha Nebraska
United States Headlands Research Orlando Orlando Florida
United States Clinica mi Salud by Focil Med Oxnard California
United States Fomat Medical Research Oxnard California
United States De Silva Medical Inc Palmdale California
United States DBC Research USA Pembroke Pines Florida
United States IDEAL Clinical Research Pembroke Pines Florida
United States Pines Care Research Center, LLC Pembroke Pines Florida
United States Penn Prevention Unit Philadelphia Pennsylvania
United States Cognitive Clinical Trials, LLC Phoenix Arizona
United States HOPE Research Institute Phoenix Arizona
United States HOPE Research Institute Phoenix Arizona
United States Phoenix Clinical LLC Phoenix Arizona
United States The Pain Center of Arizona Phoenix Arizona
United States Empire Clinical Research Pomona California
United States Sound Medical Research Port Orchard Washington
United States Kaiser Permanente Northwest-Center for Health Research Portland Oregon
United States Summit Headlands, LLC Portland Oregon
United States ActivMed Practices and Research, LLC. Portsmouth New Hampshire
United States IMA Clinical Research Raritan New Jersey
United States Paradigm Clinical Research Center Redding California
United States DM Clinical Research River Forest Illinois
United States Artemis Institute for Clinical Research Riverside California
United States Rochester Clinical Research, Inc. Rochester New York
United States Rochester Clinical Research, LLC Rochester New York
United States University of Rochester Medical Center Rochester New York
United States Meridian Clinical Research, LLC Rockville Maryland
United States Velocity Clinical Research, Rockville Rockville Maryland
United States Benchmark Research Sacramento California
United States Saint Louis University Saint Louis Missouri
United States Sundance Clinical Research Saint Louis Missouri
United States Clinical Trials of Texas, LLC San Antonio Texas
United States Sun Research Institute San Antonio Texas
United States Artemis Institute for Clinical Research San Diego California
United States California Research Foundation San Diego California
United States Headlands Research Sarasota Sarasota Florida
United States Javara Inc. Savannah Georgia
United States Privia Medical Group Georgia, LLC Savannah Georgia
United States Velocity Clinical Research, Savannah Savannah Georgia
United States Headlands Research - Scottsdale Scottsdale Arizona
United States Meridian Clinical Research, LLC Sioux City Iowa
United States Velocity Clinical Research, Sioux City Sioux City Iowa
United States South Jersey Infectious Disease Somers Point New Jersey
United States J. Lewis Research, Inc. / Jordan River Family Medicine South Jordan Utah
United States Stamford Therapeutics Consortium Stamford Connecticut
United States Clinical Research Atlanta Stockbridge Georgia
United States Centricity Research Suffolk Primary Care Suffolk Virginia
United States Suffolk Multispecialty Research Suffolk Virginia
United States Virginia Gastroenterology Clinical Research Suffolk Virginia
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 Privia Medical Group Gulf Coast, PLLC Sugar Land Texas
United States Precision Clinical Research Sunrise Florida
United States MultiCare Institute for Research & Innovation Tacoma Washington
United States MultiCare Medical Group Tacoma Washington
United States Alliance for Multispecialty Research, LLC Tempe Arizona
United States HOPE Research Institute Tempe Arizona
United States Javara Inc. Thomasville Georgia
United States Privia Medical Group Georgia, LLC Thomasville Georgia
United States Martin Diagnostic Clinic Tomball Texas
United States Arcturus Healthcare , PLC, Troy Internal Medicine Research Division Troy Michigan
United States Oakland Medical Research Troy Michigan
United States Noble Clinical Research Tucson Arizona
United States The Institute for Liver Health dba Arizona Clinical Trials Tucson Arizona
United States Velocity Clinical Research Valparaiso Valparaiso Indiana
United States Velocity Clinical Research, Vestal Vestal New York
United States Diablo Clinical Research, Inc. Walnut Creek California
United States IMA Clinical Research Warren Warren New Jersey
United States Allegiance Research Specialists, LLC Wauwatosa Wisconsin
United States Central Washington Health Services Association d/b/a Confluence Health Wenatchee Washington
United States Research Building Wenatchee Washington
United States Wenatchee Valley Hospital Wenatchee Washington
United States Velocity Clinical Research, Salt Lake City West Jordan Utah
United States Accellacare - Wilmington Wilmington North Carolina
United States Wake Forest University Health Sciences Winston-Salem North Carolina
United States Clinical Site Partners, Inc Winter Park Florida
United States Conquest Research, LLC Winter Park Florida
United States University of Massachusetts Chan Medical School Worcester Massachusetts
United States Tekton Research, Inc Yukon Oklahoma

Sponsors (1)

Lead Sponsor Collaborator
Pfizer

Countries where clinical trial is conducted

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

Outcome

Type Measure Description Time frame Safety issue
Primary Efficacy Study: Number of first episode of RSV-associated lower respiratory tract illness (LRTI-RSV) in the first RSV season Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR)-confirmed RSV A and/or RSV B- associated acute respiratory illness (ARI) is assessed. LRTI-RSV is defined as an ARI with 2 or more of the lower respiratory signs/symptoms lasting more than 1 day during the same illness, plus RT-PCR-confirmed RSV infection within 7 days of ARI symptom onset.
Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR)-confirmed RSV A and/or RSV B- associated acute respiratory illness (ARI) is assessed. LRTI-RSV is defined as an ARI with 3 or more of the lower respiratory signs/symptoms lasting more than 1 day during the same illness, plus RT-PCR-confirmed RSV infection within 7 days of ARI symptom onset.
From Day 15 after vaccination until the end of season 1 visit (an average of 6 months)
Primary Efficacy Study: Proportion of participants reporting prompted local reactions within 7-days after vaccination Local reactions included pain at injection site, redness and swelling recorded by participants in an e-diary. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm and graded as mild: 2.5 to 5.0 cm, moderate: > 5.0 to 10.0 cm and severe: >10 cm. Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfere with daily activity and severe: prevented daily activity Within 7 days after vaccination
Primary Efficacy Study: Proportion of participants reporting prompted systemic events within 7-days after vaccination Systemic reactions:fever, fatigue/tiredness, headache, nausea, muscle pain, joint pain, vomiting, diarrhea and any systemic event recorded by participants in an e-diary. Fever: greater than equal to (>=)38.0 degrees (deg) Celsius (C), mild (>=38.0 to 38.4 deg C, >38.4 to 38.9 deg C), moderate (>38.9 to 40.0 deg C and >40.0 deg C), severe (>38.9 deg C to 40.0 deg C) and grade 4 (>40.0 deg C). Fatigue, headache, nausea, muscle pain and joint pain were graded as mild: did not interfere with activity, moderate: some interference with activity and severe: prevented daily routine activity. Vomiting was graded as mild: 1 to 2 times in 24 hours(h), moderate: >2 times in 24h and severe: requires intravenous hydration. Diarrhea was graded as mild: 2 to 3 loose stools in 24h, moderate: 4 to 5 loose stools in 24h and severe: 6 or more loose stools in 24h. Within 7 days after vaccination
Primary Efficacy Study: Proportion of participants reporting AE within 1-month after vaccination An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. AEs included both serious and non-serious adverse events. Within 1 month after vaccination (up to 35 days)
Primary Efficacy Study: Proportion of participants reporting SAE throughout the study SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Throughout the study duration (an average of 30 months)
Primary Efficacy Study: Proportion of participants reporting NDCMC throughout the study An NDCMC is defined as a disease or medical condition, not previously identified, that is expected to be persistent or otherwise long-lasting in its effects (eg, asthma). Throughout the study duration (an average of 30 months)
Primary SSA: Respiratory Syncytial Virus Subgroup A (RSV A) and RSV B neutralizing titers from participants who received 2-dose of RSVpreF RSV A and RSV B neutralizing titers (NT), expressed as Geometric Mean Titers (GMTs), and geometric mean fold rise (GMFR). The NTs were calculated as the interpolated reciprocal of the serum dilution resulting in 50% reduction in the number of viral focus forming units when compared to the control without test serum. Before revaccination and 1, 6, 12 and 18-months after revaccination with RSVpreF in SSA
Primary SSA: Proportion of participants reporting prompted local reactions within 7-days after revaccination Local reactions included pain at injection site, redness and swelling recorded by participants in an e-diary. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm and graded as mild: 2.5 to 5.0 cm, moderate: > 5.0 to 10.0 cm and severe: >10 cm. Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfere with daily activity and severe: prevented daily activity Within 7 days after revaccination
Primary SSA: Proportion of participants reporting prompted systemic events within 7-days after revaccination Systemic reactions:fever, fatigue/tiredness, headache, nausea, muscle pain, joint pain, vomiting, diarrhea and any systemic event recorded by participants in an e-diary. Fever: greater than equal to (>=)38.0 degrees (deg) Celsius (C), mild (>=38.0 to 38.4 deg C, >38.4 to 38.9 deg C), moderate (>38.9 to 40.0 deg C and >40.0 deg C), severe (>38.9 deg C to 40.0 deg C) and grade 4 (>40.0 deg C). Fatigue, headache, nausea, muscle pain and joint pain were graded as mild: did not interfere with activity, moderate: some interference with activity and severe: prevented daily routine activity. Vomiting was graded as mild: 1 to 2 times in 24 hours(h), moderate: >2 times in 24h and severe: requires intravenous hydration. Diarrhea was graded as mild: 2 to 3 loose stools in 24h, moderate: 4 to 5 loose stools in 24h and severe: 6 or more loose stools in 24h. Within 7 days after revaccination
Primary SSA: Proportion of participants reporting AE within 1-month after revaccination An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. AEs included both serious and non-serious adverse events. Within 1 month after revaccination (up to 35 days)
Primary SSA: Proportion of participants reporting SAE throughout the study SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Throughout the study duration (approximately 18 months)
Primary SSA: Proportion of participants reporting NDCMC throughout the study An NDCMC is defined as a disease or medical condition, not previously identified, that is expected to be persistent or otherwise long-lasting in its effects (eg, asthma). Throughout the study duration (approximately 18 months)
Primary SSB: Respiratory Syncytial Virus Subgroup A (RSV A) and RSV B neutralizing titers from participants who received 2-dose of RSVpreF RSV A and RSV B neutralizing titers (NT), expressed as Geometric Mean Titers (GMTs), and geometric mean fold rise (GMFR). The NTs were calculated as the interpolated reciprocal of the serum dilution resulting in 50% reduction in the number of viral focus forming units when compared to the control without test serum. Before revaccination and 1, 6, 12 and 18-months after revaccination with RSVpreF in SSB
Primary SSB: Proportion of participants reporting prompted local reactions within 7-days after revaccination Local reactions included pain at injection site, redness and swelling recorded by participants in an e-diary. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm and graded as mild: 2.5 to 5.0 cm, moderate: > 5.0 to 10.0 cm and severe: >10 cm. Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfere with daily activity and severe: prevented daily activity. Within 7 days after revaccination
Primary SSB: Proportion of participants reporting prompted systemic events within 7-days after revaccination Systemic reactions:fever, fatigue/tiredness, headache, nausea, muscle pain, joint pain, vomiting, diarrhea and any systemic event recorded by participants in an e-diary. Fever: greater than equal to (>=)38.0 degrees (deg) Celsius (C), mild (>=38.0 to 38.4 deg C, >38.4 to 38.9 deg C), moderate (>38.9 to 40.0 deg C and >40.0 deg C), severe (>38.9 deg C to 40.0 deg C) and grade 4 (>40.0 deg C). Fatigue, headache, nausea, muscle pain and joint pain were graded as mild: did not interfere with activity, moderate: some interference with activity and severe: prevented daily routine activity. Vomiting was graded as mild: 1 to 2 times in 24 hours(h), moderate: >2 times in 24h and severe: requires intravenous hydration. Diarrhea was graded as mild: 2 to 3 loose stools in 24h, moderate: 4 to 5 loose stools in 24h and severe: 6 or more loose stools in 24h. SSB: Proportion of participants reporting prompted systemic events within 7-days after revaccination
Primary SSB: Proportion of participants reporting AE within 1-month after revaccination An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. AEs included both serious and non-serious adverse events. Within 1 month after revaccination (up to 35 days)
Primary SSB: Proportion of participants reporting SAE throughout the study SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Throughout the study duration (approximately 18 months)
Primary SSB: Proportion of participants reporting NDCMC throughout the study An NDCMC is defined as a disease or medical condition, not previously identified, that is expected to be persistent or otherwise long-lasting in its effects (eg, asthma). Throughout the study duration (approximately 18 months)
Secondary Efficacy Study: Number of first episode of RSV-associated severe LRTI (sLRTI-RSV) in the first RSV season Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR)-confirmed RSV A and/or RSV B- associated acute respiratory illness (ARI) is assessed. sLRTI-RSV is defined as LRTI-RSV with at least 1 of the conditions: 1)Hospitalization due to LRTI-RSV; 2)New/increased oxygen supplementation; 3)New/increased mechanical ventilation From Day 15 after vaccination until the end of season 1 visit (an average of 6 months)
Secondary Efficacy Study: Number of first episode of LRTI-RSV in the second RSV season Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR)-confirmed RSV A and/or RSV B- associated acute respiratory illness (ARI) is assessed. LRTI-RSV is defined as an ARI with 2 or more of the lower respiratory signs/symptoms lasting more than 1 day during the same illness, plus RT-PCR-confirmed RSV infection within 7 days of ARI symptom onset.
Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR)-confirmed RSV A and/or RSV B- associated acute respiratory illness (ARI) is assessed. LRTI-RSV is defined as an ARI with 3 or more of the lower respiratory signs/symptoms lasting more than 1 day during the same illness, plus RT-PCR-confirmed RSV infection within 7 days of ARI symptom onset.
During the second RSV season (an average of 6 months)
Secondary Efficacy Study: Number of first episode of LRTI-RSV across 2 RSV seasons Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR)-confirmed RSV A and/or RSV B- associated acute respiratory illness (ARI) is assessed. LRTI-RSV is defined as an ARI with 2 or more of the lower respiratory signs/symptoms lasting more than 1 day during the same illness, plus RT-PCR-confirmed RSV infection within 7 days of ARI symptom onset.
Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR)-confirmed RSV A and/or RSV B- associated acute respiratory illness (ARI) is assessed. LRTI-RSV is defined as an ARI with 3 or more of the lower respiratory signs/symptoms lasting more than 1 day during the same illness, plus RT-PCR-confirmed RSV infection within 7 days of ARI symptom onset.
From Day 15 after vaccination until the end of season 2 visit (an average of 12 months of surveillance)
Secondary Efficacy Study: Number of first episode of RSV-associated ARI (ARI-RSV) in the first RSV season Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR)-confirmed RSV A and/or RSV B- associated acute respiratory illness (ARI) is assessed. ARI-RSV is defined as an ARI with at least 1 signs/symptoms lasting more than 1 day, plus RT-PCR-confirmed RSV infection within 7 days of ARI symptom onset. From Day 15 after vaccination until the end of season 1 visit (an average of 6 months)
Secondary Efficacy Study: Number of first episode of ARI-RSV in the second RSV season Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR)-confirmed RSV A and/or RSV B- associated acute respiratory illness (ARI) is assessed. ARI-RSV is defined as an ARI with at least 1 signs/symptoms lasting more than 1 day, plus RT-PCR-confirmed RSV infection within 7 days of ARI symptom onset. During the second RSV season (an average of 6 months)
Secondary Efficacy Study: Number of first episode of ARI-RSV across 2 RSV seasons Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR)-confirmed RSV A and/or RSV B- associated acute respiratory illness (ARI) is assessed. ARI-RSV is defined as an ARI with at least 1 signs/symptoms lasting more than 1 day, plus RT-PCR-confirmed RSV infection within 7 days of ARI symptom onset. From Day 15 after vaccination until the end of season 2 visit (an average of 12 months of surveillance)
Secondary Efficacy Study: Number of first episode of sLRTI-RSV in the second RSV season Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR)-confirmed RSV A and/or RSV B- associated acute respiratory illness (ARI) is assessed. sLRTI-RSV is defined as LRTI-RSV with at least 1 of the conditions: 1)Hospitalization due to LRTI-RSV; 2)New/increased oxygen supplementation; 3)New/increased mechanical ventilation During the second RSV season (an average of 6 months)
Secondary Efficacy Study: Number of first episode of sLRTI-RSV across 2 RSV seasons Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR)-confirmed RSV A and/or RSV B- associated acute respiratory illness (ARI) is assessed. sLRTI-RSV is defined as LRTI-RSV with at least 1 of the conditions: 1)Hospitalization due to LRTI-RSV; 2)New/increased oxygen supplementation; 3)New/increased mechanical ventilation From Day 15 after vaccination until the end of season 2 visit (an average of 12 months of surveillance)
Secondary Efficacy Study: Respiratory Syncytial Virus Subgroup A (RSV A) and RSV B neutralizing titers RSV A and RSV B neutralizing titers (NT), expressed as Geometric Mean Titers (GMTs), and geometric mean fold rise (GMFR). The NTs were calculated as the interpolated reciprocal of the serum dilution resulting in 50% reduction in the number of viral focus forming units when compared to the control without test serum. Before vaccination, 1-month after vaccination, before season 2 (approximately 12 months after vaccination)
Secondary SSA: Respiratory Syncytial Virus Subgroup A (RSV A) and RSV B neutralizing titers from participants who received placebo in SSA. RSV A and RSV B neutralizing titers (NT), expressed as Geometric Mean Titers (GMTs), 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 revaccination and 1, 6, 12 and 18-months after revaccination with placebo in SSA
Secondary SSA: Respiratory Syncytial Virus Subgroup A (RSV A) and RSV B neutralizing titers from participants who received RSVpreF in SSA. 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. 1 month after receiving the initial vaccination in the efficacy study and 1 month after revaccination in SSA
Secondary SSB: Respiratory Syncytial Virus Subgroup A (RSV A) and RSV B neutralizing titers from participants who received placebo in SSB RSV A and RSV B neutralizing titers (NT), expressed as Geometric Mean Titers (GMTs), 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 revaccination and 1, 6, 12 and 18-months after revaccination with placebo in SSB
Secondary SSB: Respiratory Syncytial Virus Subgroup A (RSV A) and RSV B neutralizing titers from participants who received RSVpreF in SSB. 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. 1 month after receiving the initial vaccination in the efficacy study and 1 month after revaccination in SSB
See also
  Status Clinical Trial Phase
Completed NCT03756753 - The RAPID Trial: Assessing Point-of-care Influenza and Other Respiratory Virus Diagnostics N/A