RSVpreF

BIOLOGICAL8 trials

Sponsors

Pfizer, Hvivo

Conditions

HealthyHealthy ParticipantsLower Respiratory Tract IllnessRESPIRATORY SYNCYTIAL VIRUS (RSV)RSV InfectionRespiratory Syncytial Virus (RSV)Respiratory Syncytial Virus InfectionsRespiratory Tract Infection

Phase 1

A Study to Examine Respiratory Combination Vaccines Against Respiratory Syncytial Virus (RSV) and Flu in Older Adults

CompletedNCT05788237

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: 2026-05-15

A Study to Learn Safety and Immune Response to Study Vaccine -RSVpreF in Adults at High Risk of Severe RSV Disease.

Not yet recruitingNCT07543380

PfizerRespiratory Syncytial Virus (RSV)

Start: 2026-05-11End: 2026-08-31Target: 130Updated: 2026-05-14

Related Papers

Integrated Analysis of the Safety Experience in Adults with the Bivalent Respiratory Syncytial Virus Prefusion F Vaccine

Vaccines2025-08-011 citations

Immunogenicity and Safety of the Bivalent Respiratory Syncytial Virus Prefusion F Subunit Vaccine in Immunocompromised or Renally Impaired Adults

Vaccines2025-03-196 citations

Efficacy, Immunogenicity, and Safety of the Bivalent Respiratory Syncytial Virus (RSV) Prefusion F Vaccine in Older Adults Over 2 RSV Seasons

Clinical Infectious Diseases2025-02-1027 citations

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

Open Forum Infectious Diseases2025-01-292 citations

P-605. Bivalent RSV Prefusion F-Based Subunit Vaccine Generates High and Durable Neutralizing Titers Across an Entire RSV Season among Older Adults

Open Forum Infectious Diseases2025-01-291 citations

P-600. Efficacy of a Bivalent RSVpreF Vaccine in Older Adults Across a Second RSV Season

Open Forum Infectious Diseases2025-01-29

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

Open Forum Infectious Diseases2025-01-29

P-595. Public Health Impact of RSVpreF Vaccination on Older Adult Disease Outcomes

Open Forum Infectious Diseases2025-01-29

Efficacy, Safety, and Immunogenicity of the MATISSE (Maternal Immunization Study for Safety and Efficacy) Maternal Respiratory Syncytial Virus Prefusion F Protein Vaccine Trial

Obstetrics and Gynecology2025-01-0255 citations

Preterm Birth Frequency and Associated Outcomes From the MATISSE (Maternal Immunization Study for Safety and Efficacy) Maternal Trial of the Bivalent Respiratory Syncytial Virus Prefusion F Protein Vaccine

Obstetrics and Gynecology2025-01-0222 citations

Bivalent RSVpreF Vaccine in Adults 18 to &lt;60 Years Old With High-Risk Conditions

Clinical Infectious Diseases2024-11-0713 citations

Efficacy and safety of bivalent RSVpreF maternal vaccination to prevent RSV illness in Japanese infants: Subset analysis from the pivotal randomized phase 3 MATISSE trial

Vaccine2024-06-1116 citations

1632. Bivalent RSV Prefusion F-Based Subunit Vaccine Generates High Neutralizing Titers in Older Adults

Open Forum Infectious Diseases2023-11-271 citations

1630. Clinical Profile of Acute Respiratory Illness (ARI) Events in the Phase 3 Trial The RSV Vaccine Efficacy Study iN Older Adults Immunized against RSV Disease (RENOIR)

Open Forum Infectious Diseases2023-11-271 citations

1634. Respiratory Syncytial Virus-Associated Health Care Utilization in the Pivotal Phase 3 Trial RSV Vaccine Efficacy Study In Older Adults Immunized Against RSV Disease (RENOIR)

Open Forum Infectious Diseases2023-11-27

Evaluation of Clinical Case Definitions for Respiratory Syncytial Virus Lower Respiratory Tract Infection in Young Children

Journal of the Pediatric Infectious Diseases Society2023-05-0114 citations

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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