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NCT05035212 · ClinicalTrials.gov registry record · Phase 3
Study to Evaluate the Efficacy, Immunogenicity, and Safety of RSVpreF in Adults.
A Phase 3 study of Lower Respiratory Tract Illness, sponsored by Pfizer.
- Active
- Registry status
- Phase 3
- Development phase
- 38,861
- Enrollment target
- 20
- Study locations
NCT05035212 is a Phase 3 study of Lower Respiratory Tract Illness that is active but no longer recruiting, run by Pfizer. The registered enrollment target is 38,861 participants. The trial reports 20 study locations across 3 states.
The verdict
NCT05035212, a Phase 3 study of Lower Respiratory Tract Illness, is active but no longer recruiting, sponsored by Pfizer.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 38,861 participants
- Enrollment target
- 20
- Study locations
Study 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. Substudy C: This study was designed to evaluate the safety and immunogenicity of a second dose of RSVpreF when administered after a dosing interval of either 3 or 4 years: * At a dose of 120µg (as studied in the Phase 3 Efficacy Study) * Participants will receive either placebo or a second dose of RSVpreF approximately 3 or 4 years after receiving the initial dose of RSVpreF in the main efficacy study. * Blood samples will be collected for antibody testing. * The duration of the study for each participant will be up to approximately 24 months. * The study will be conducted in the United Stat
Conditions Studied
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL RSVpreF
Study Locations (20)
Arizona
- Lenzmeier Family Medicine / Avacare - Glendale
- Phoenix Clinical LLC - Phoenix
- HOPE Research Institute - Phoenix
- The Pain Center of Arizona - Phoenix
- HOPE Research Institute - Phoenix
- Cognitive Clinical Trials, LLC - Phoenix
- Headlands Research - Scottsdale - Scottsdale
- Alliance for Multispecialty Research, LLC - Tempe
- HOPE Research Institute - Tempe
- Noble Clinical Research - Tucson
- The Institute for Liver Health dba Arizona Clinical Trials - Tucson
California
- Hope Clinical Research - Canoga Park
- eStudySite - Chula Vista
- Benchmark Research - Colton
- West Coast Research - Dublin
- Marvel Clinical Research 002, LLC - Huntington Beach
- Chemidox Clinical Trials - Lancaster
Alabama
- St. Vincent's Birmingham (Pharmacy) - Birmingham
- St. Vincent's Birmingham - Birmingham
- Medical Affiliated Research Center - Huntsville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38,861 participants |
| Start Date | 2021-08-31 |
| Est. Completion | 2027-01-18 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05035212
The ClinicalTrials.gov registry entry for NCT05035212 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 38,861 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pfizer, which has 1,845 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Lower Respiratory Tract Illness appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05035212 reports 20 study locations spanning 3 distinct geographic areas - top geographies include Arizona, California, Alabama.
Frequently Asked Questions
What is clinical trial NCT05035212 about?
NCT05035212 is a clinical study titled "Study to Evaluate the Efficacy, Immunogenicity, and Safety of RSVpreF 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 st...
What is the current status of trial NCT05035212?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 38,861 participants. The study started on 2021-08-31. Estimated completion is 2027-01-18.
What conditions does trial NCT05035212 study?
This clinical trial studies the following conditions: Lower Respiratory Tract Illness.
What interventions are being tested in trial NCT05035212?
The interventions under investigation include: Placebo (BIOLOGICAL), RSVpreF (BIOLOGICAL).
Who is sponsoring clinical trial NCT05035212?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05035212 being conducted?
This trial has 20 study locations across Alabama, Arizona, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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