EICHORCondition: Lower Respiratory Tract Illness · Sponsor: Pfizer
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Efficacy Study: This randomized, double-blinded, placebo-controlled Phase 3 study is designed to assess the safety, immunogenicity, and efficacy of a single dose of RSVpreF in the prevention of LRTI-RSV in adults: * At a dose of 120µg. * In adults 60 years of age and older. * The duration of the study for each participant will be up to approximately 24 months. * The study will be conducted in the United States, Canada, Netherlands, Finland, Argentina, Japan and South Africa. Substudy A: This study is an extension of the efficacy study and was designed to evaluate the safety and immunogenicity of a second dose of RSVpreF when administered after a dosing interval of approximately 2 years: * At a dose of 120µg (as studied in the Phase 3 Efficacy Study) * Blood samples will be collected for antibody testing. * The duration of the study for each participant will be up to approximately 18 months. * The study will be conducted in the United States and Argentina. Substudy B: This study was designed to evaluate the safety and immunogenicity of a second dose of RSVpreF when administered after a dosing interval of approximately 1 year: * At a dose of 120µg (as studied in the Phase 3 Efficacy Study) * Blood samples will be collected for antibody testing. * The duration of the study for each participant will be up to approximately 18 months. * The study will be conducted in Argentina. Substudy C: This study was designed to evaluate the safety and immunogenicity of a second dose of R…
This description comes directly from the study's public registry record.
No contact information is available for this study as per the public registry record.
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| St. Vincent's Birmingham (Pharmacy) | Birmingham, Alabama, United States | — |
| St. Vincent's Birmingham | Birmingham, Alabama, United States | — |
| Medical Affiliated Research Center | Huntsville, Alabama, United States | — |
| Lenzmeier Family Medicine / Avacare | Glendale, Arizona, United States | — |
| Phoenix Clinical LLC | Phoenix, Arizona, United States | — |
| HOPE Research Institute | Phoenix, Arizona, United States | — |
| The Pain Center of Arizona | Phoenix, Arizona, United States | — |
| HOPE Research Institute | Phoenix, Arizona, United States | — |
| Cognitive Clinical Trials, LLC | Phoenix, Arizona, United States | — |
| Headlands Research - Scottsdale | Scottsdale, Arizona, United States | — |
| Alliance for Multispecialty Research, LLC | Tempe, Arizona, United States | — |
| HOPE Research Institute | Tempe, Arizona, United States | — |
+ 251 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT05035212