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RSVpreF

BIOLOGICAL11 trials

Sponsors

Pfizer, Hvivo, University of British Columbia, Pfizer Inc.

Conditions

HIVHealthyHealthy ParticipantsLower Respiratory Tract IllnessRESPIRATORY SYNCYTIAL VIRUS (RSV)RSV ImmunizationRSV InfectionRespiratory

Phase 1

A Study to Examine Respiratory Combination Vaccines Against Respiratory Syncytial Virus (RSV) and Flu in Older Adults
CompletedNCT05788237
PfizerHealthy
Start: 2023-03-09End: 2023-09-27Updated: 2024-11-22

Phase 2

Study of RSVpreF Vaccination and RSV Challenge in Healthy Adults
CompletedNCT04785612
HvivoRespiratory Syncytial Virus Infections
Start: 2020-11-10End: 2021-08-16Updated: 2024-08-07
A Study to Learn About Two or More Vaccines That Are Put Together as One Shot Against Infectious Lung Illnesses, Including COVID-19 and Respiratory Syncytial Virus (RSV).
CompletedNCT05886777
PfizerHealthy Participants
Start: 2023-06-05End: 2024-01-01Updated: 2024-12-18

Phase 3

A Trial to Evaluate the Efficacy and Safety of RSVpreF in Infants Born to Women Vaccinated During Pregnancy.
CompletedNCT04424316
PfizerRespiratory Tract Infection
Start: 2020-06-17End: 2023-10-27Updated: 2025-02-11
Study to Evaluate the Efficacy, Immunogenicity, and Safety of RSVpreF in Adults.
Active, not recruitingNCT05035212
PfizerLower Respiratory Tract Illness
Start: 2021-08-31End: 2027-01-18Updated: 2026-01-28
A Study to Assess the Safety, Tolerability, and Immunogenicity of RSVpreF in Adults at High Risk of Severe RSV Disease
CompletedNCT05842967
PfizerRESPIRATORY SYNCYTIAL VIRUS (RSV)
Start: 2023-05-11End: 2024-03-18Updated: 2025-08-08
A Phase 3 Study of Revaccination in Subsequent Pregnancies With Bivalent RSV Vaccine and Duration of Protection of a Single Dose
RecruitingNCT06866405
PfizerRSV Infection
Start: 2025-04-16End: 2028-02-24Target: 550Updated: 2026-07-09
A Phase 3 Study of Revaccination in Subsequent Pregnancies With RSV Vaccine and Duration of Protection of a Single Dose
Active, not recruitingPACTR202601676008648
Pfizer Inc.Respiratory
Start: 2025-12-05Target: 70Updated: 2026-06-22
A Study to Learn Safety and Immune Response to Study Vaccine -RSVpreF in Adults at High Risk of Severe RSV Disease.
RecruitingNCT07543380
PfizerRespiratory Syncytial Virus (RSV)
Start: 2026-05-11End: 2026-08-31Target: 130Updated: 2026-06-02
A Phase 3 Study in India to Describe the Safety and Immunogenicity of RSVpreF
Not yet recruitingNCT07653100
PfizerRespiratory Syncytial Virus (RSV)
Start: 2026-06-22End: 2027-01-25Target: 540Updated: 2026-07-09

Phase 4

Study of HIV-Exposed Pregnancies and Transplacental Antibody Delivery Following RSVpreF
Not yet recruitingNCT07693166
University of British ColumbiaHIV, RSV Immunization
Start: 2026-09-01End: 2028-03-01Target: 20Updated: 2026-07-09

Related Papers

Integrated Analysis of the Safety Experience in Adults with the Bivalent Respiratory Syncytial Virus Prefusion F Vaccine
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Immunogenicity and Safety of the Bivalent Respiratory Syncytial Virus Prefusion F Subunit Vaccine in Immunocompromised or Renally Impaired Adults
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Efficacy, Immunogenicity, and Safety of the Bivalent Respiratory Syncytial Virus (RSV) Prefusion F Vaccine in Older Adults Over 2 RSV Seasons
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Safety and Immunogenicity of Concomitant Administration and Combined Administration of Bivalent BNT162b2 COVID-19 Vaccine and Bivalent RSVpreF Respiratory Syncytial Virus Vaccine with or Without Quadrivalent Influenza Vaccine in Adults ≥ 65 Years of Age
Vaccines2025-02-053 citations
P-596. Immunobridging Demonstrating Effectiveness of the Bivalent Respiratory Syncytial Virus (RSV) Prefusion F Subunit Vaccine in Adults 18-59 Years of Age at High Risk of Severe RSV Disease in a Phase 3 Trial: The C3671023 MONeT Study Results
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P-605. Bivalent RSV Prefusion F-Based Subunit Vaccine Generates High and Durable Neutralizing Titers Across an Entire RSV Season among Older Adults
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P-600. Efficacy of a Bivalent RSVpreF Vaccine in Older Adults Across a Second RSV Season
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571. Safety and Immunogenicity of Coadministered Bivalent BNT162b2 COVID-19 Vaccine and Bivalent RSVpreF Respiratory Syncytial Virus Vaccine With and Without Quadrivalent Influenza Vaccine in Adults ≥ 65 Years of Age
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P-595. Public Health Impact of RSVpreF Vaccination on Older Adult Disease Outcomes
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Evaluation of Clinical Case Definitions for Respiratory Syncytial Virus Lower Respiratory Tract Infection in Young Children
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Bivalent Prefusion F Vaccine in Pregnancy to Prevent RSV Illness in Infants
New England Journal of Medicine2023-04-05828 citations
Efficacy and Safety of a Bivalent RSV Prefusion F Vaccine in Older Adults
New England Journal of Medicine2023-04-05566 citations
LB748. Efficacy And Safety Of Bivalent Respiratory Syncytial Virus (RSVpreF) Vaccine In Older Adults
Open Forum Infectious Diseases2022-12-013 citations

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