Lower Respiratory Tract Illness Clinical Trial
— RENOIROfficial title:
A PHASE 3 STUDY TO EVALUATE THE EFFICACY, IMMUNOGENICITY, AND SAFETY OF RESPIRATORY SYNCYTIAL VIRUS (RSV) PREFUSION F SUBUNIT VACCINE IN ADULTS
Efficacy Study: This randomized, double-blinded, placebo-controlled Phase 3 study is designed to assess the safety, immunogenicity, and efficacy of a single dose of RSVpreF in the prevention of LRTI-RSV in adults: - At a dose of 120µg. - In adults 60 years of age and older. - The duration of the study for each participant will be up to approximately 24 months. - The study will be conducted in the United States, Canada, Netherlands, Finland, Argentina, Japan and South Africa. 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.
| Status | Recruiting |
| Enrollment | 45000 |
| Est. completion date | June 12, 2026 |
| Est. primary completion date | June 12, 2026 |
| 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. |
| 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 - Bellaire | 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 | Milton Haber, MD | 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 |
| Lead Sponsor | Collaborator |
|---|---|
| Pfizer |
United States, Argentina, Canada, Finland, Japan, Netherlands, South Africa,
| 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 |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03756753 -
The RAPID Trial: Assessing Point-of-care Influenza and Other Respiratory Virus Diagnostics
|
N/A |