RSVPreF3 vaccine

Pipeline

Status by Indication[3][1]

Competition

Competitive Landscape

4 competitors in Respiratory Syncytial Virus Infections

#DrugCompanyPhaseTrials

1

Rsvpref3 OA Investigational Vaccine

GSK

Phase 3

22

Rsvpref3 OA Vaccine

GSK

Phase 3

23

RSVPreF3 vaccine

GSK

Phase 3

44

Adjuvanted Rsvpref3 Vaccine

GSK

Phase 2

15

Ziresovir

SShanghai Ark Biopharmaceutical Co., Ltd.

Preclinical

1

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Clinical

Trials by Indication[1]

Respiratory Syncytial Virus (RSV)5 trials

A Study on the Immune Response, Safety and the Occurrence of Respiratory Syncytial Virus (RSV)-Associated Respiratory Tract Illness After Administration of RSV OA Vaccine in Adults 60 Years and Older

Completed·GSK·Phase 3·NCT06551181·2,621 enrolled

A Study on the Immune Response and Safety of Vaccine Against Respiratory Syncytial Virus (RSV) Given to Adults 18 to 49 Years of Age at Increased Risk for Respiratory Syncytial Virus Disease, Compared to Older Adults 60 Years of Age and Above

Completed·GSK·Phase 3·NCT06389487·1,459 enrolled

Efficacy Study of GSK's Investigational Respiratory Syncytial Virus (RSV) Vaccine in Adults Aged 60 Years and Above

Completed·GSK·Phase 3·NCT04886596·26,675 enrolled

Show 2 more trials

A Study of 3 Lots of an Investigational Vaccine Against Respiratory Syncytial Virus (RSV) in Adults Aged 60 Years and Above

Completed·GSK·Phase 3·NCT05059301·770 enrolled

Study to Assess the Immune Response, the Safety and the Reactogenicity of Respiratory Syncytial Virus (RSV) Prefusion Protein 3 Older Adult (OA) (RSVPreF3 OA) Investigational Vaccine When co Administered With PCV20 in Older Adults

Completed·GSK·Phase 3·NCT05879107·1,113 enrolled

Respiratory Syncytial Virus Infections4 trials

A Phase 3b, Randomized, Open Label, Multicountry, Multi-center, Extension and Crossover Vaccination Study to Evaluate the Immunogenicity and Safety of Different Revaccination Schedules and Persistence of a Single Dose of the RSVPreF3 OA Vaccine in Adults Aged 60 Years and Above Who Participated in the RSV OA=ADJ-006 Study

Active, not recruiting·GSK·Phase 3·NCT06534892·10,212 enrolled

A Phase 3, Randomized, Open-label, Multi-country Study to Evaluate the Immunogenicity, Safety, Reactogenicity and Persistence of a Single Dose of the RSVPreF3 OA Investigational Vaccine and Different Revaccination Schedules in Adults Aged 60 Years and Above

Active, not recruiting·GSK·Phase 3·NCT04732871·1,720 enrolled

A Phase 3, Randomized, Controlled, Observer Blind, Immuno-bridging Study to Evaluate Immunogenicity, Reactogenicity, Safety of a Single Dose of GSK's RSVPreF3 OA Investigational Vaccine in Chinese Adults 18-59 Years of Age at Increased Risk of Respiratory Syncytial Virus Disease

Active, not recruiting·GSK·Phase 3·NCT07220109·750 enrolled

Show 1 more trial

A Phase 3, Randomized, Placebo-controlled, Observer-blind Study in India to Evaluate Immune Response, Reactogenicity and Safety of a Single Intramuscular Dose of RSVPreF3 OA Investigational Vaccine When Administered to Older Adults >=60 Years of Age and Adults 50-59 Years of Age at Increased Risk of Respiratory Syncytial Virus Lower Respiratory Tract Disease

Completed·GSK·Phase 3·NCT06614725·751 enrolled

Influenza3 trials

A Study on the Immune Response and Safety Elicited by a Vaccine Against Respiratory Syncytial Virus (RSV) When Given Alone and Together With a Vaccine Against Influenza in Adults Aged 65 Years and Above

Completed·GSK·Phase 3·NCT05559476·1,029 enrolled

A Study on the Immune Response and Safety of a Vaccine Against Respiratory Syncytial Virus (RSV) When Given Alone or Co-administered With an Adjuvanted Vaccine Against Influenza in Adults Aged 65 Years and Above

Completed·GSK·Phase 3·NCT05568797·1,045 enrolled

A Study on the Immune Response and Safety Elicited by a Vaccine Against Respiratory Syncytial Virus (RSV) When Given Alone and Together With a Vaccine Against Influenza in Adults Aged 60 Years and Above

Completed·GSK·Phase 3·NCT04841577·976 enrolled

Kidney Transplant1 trial

A Study on the Immune Response and Safety of an RSV Vaccine When Given to Adults 18 Years of Age and Above Who Received Lung or Kidney Transplant and Are at an Increased Risk of Respiratory Syncytial Virus Lower Respiratory Tract Disease and Compared to Healthy Adults 50 Years of Age and Above

Completed·GSK·Phase 2·NCT05921903·386 enrolled

Diphtheria1 trial

A Study of a Vaccine Against Respiratory Syncytial Virus (RSV) When Given Alone and Together With a Vaccine Against Diphtheria, Pertussis and Tetanus (Tdap) Viruses Followed by a 2nd Dose of the RSV Vaccine to Healthy Non-Pregnant Women

Completed·GSK·Phase 2·NCT04138056·509 enrolled

5 more indications

COVID-191 trial

A Study on the Immune Response and Safety of a Vaccine Against Respiratory Syncytial Virus (RSV) When Given Alone and Together With a COVID-19 mRNA Vaccine in Adults Aged 50 Years and Above

Completed·GSK·Phase 3·NCT06374394·841 enrolled

Pregnancy1 trial

A Follow-up Study to Describe the Safety of Study Participants Who Received RSVPreF3 Maternal Vaccination (Any Dose) or Controls From Previous RSV MAT Studies During Any Pregnancy Conceived Post Vaccination/Control

Completed·GSK·Phase 3·NCT05705440·3,855 enrolled

Lower Respiratory Tract Disease1 trial

A Study on the Immune Response and Safety of a Vaccine Against Respiratory Syncytial Virus Given to Adults 50-59 Years of Age, Including Adults at Increased Risk of Respiratory Syncytial Virus Lower Respiratory Tract Disease, Compared to Older Adults 60 Years of Age and Above

Completed·GSK·Phase 3·NCT05590403·1,544 enrolled

Herpes Zoster1 trial

A Study on Safety and Immune Response of Investigational RSV OA Vaccine in Combination With Herpes Zoster Vaccine in Healthy Adults

Completed·GSK·Phase 3·NCT05966090·530 enrolled

Immunogenicity1 trial

Extension Study to Evaluate the Safety and Immunogenicity of a Revaccination Dose of the RSVPreF3 OA Investigational Vaccine in Adults 60 Years and Older Who Participated in the RSV OA=ADJ-002 Study

Completed·GSK·Phase 2·NCT04657198·126 enrolled

Details

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