GSK-3844766A
- Generic Name
- GSK-3844766A
- Drug Type
- Biotech
- Background
GSK-3844766A is an adjuvanted vaccine developed by GlaxoSmithKline Biologicals. It comprises lyophilized recombinant respiratory syncytial virus glycoprotein F (RSVPreF3) stabilized in pre-fusion conformation as the antigen component, which is reconstituted at the time of use with the accompanying vial of AS01E adjuvant as the adjuvant suspension component.
On May 3, 2023, it was approved by the FDA for immunization against lower respiratory tract disease (LRTD) as the first respiratory syncytial virus (RSV) vaccine approved in the United States. It was also later approved by Health Canada on August 4, 2023.
- Indication
GSK-3844766A is indicated for active immunization for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in individuals 60 years of age and older by the FDA and Health Canada.
In the US, it is also indicated for the active immunization of pregnant individuals at 32 through 36 weeks gestational age for the prevention of LRTD and severe LRTD caused by respiratory syncytial virus (RSV) in infants from birth through 6 months of age.
- Associated Conditions
- Lower Respiratory Tract Disease caused by Respiratory Syncytial Virus (RSV), Lower Respiratory Tract Infection (LRTI), Severe Lower Respiratory Tract Disease caused by Respiratory Syncytial Virus (RSV)
- Associated Therapies
- Active Immunization
Safety and Immunogenicity Study of Revaccination With SCB-1019T in Healthy Adults
- Conditions
- RSV Infection
- Interventions
- First Posted Date
- 2025-02-24
- Last Posted Date
- 2025-05-14
- Lead Sponsor
- Clover Biopharmaceuticals USA, LLC
- Target Recruit Count
- 160
- Registration Number
- NCT06843317
- Locations
- 🇺🇸
AMR Phoenix, Phoenix, Arizona, United States
🇺🇸AMR Fort Myers, Fort Myers, Florida, United States
🇺🇸AMR Lexington, Lexington, Kentucky, United States
A Study in India on the Immune Response and Safety of a Respiratory Syncytial Virus (RSV) Older Adults (OA) Vaccine When Given to Older Adults 60 Years of Age and Above and Adults 50-59 Years of Age at Increased Risk (AIR) of Respiratory Syncytial Virus Lower Respiratory Tract Disease (RSV-LRTD)
- Conditions
- Respiratory Syncytial Virus Infections
- Interventions
- Combination Product: Placebo
- First Posted Date
- 2024-09-26
- Last Posted Date
- 2024-10-04
- Lead Sponsor
- GlaxoSmithKline
- Target Recruit Count
- 750
- Registration Number
- NCT06614725
- Locations
- 🇮🇳
GSK Investigational Site, Vadu Budruk Pune, India
An Extension and Crossover Vaccination Study on the Immune Response and Safety of a Vaccine Against Respiratory Syncytial Virus Given to Adults 60 Years of Age and Above Who Participated in RSV OA=ADJ-006 Study
- Conditions
- Respiratory Syncytial Virus Infections
- Interventions
- First Posted Date
- 2024-08-02
- Last Posted Date
- 2025-04-08
- Lead Sponsor
- GlaxoSmithKline
- Target Recruit Count
- 15500
- Registration Number
- NCT06534892
- Locations
- 🇬🇧
GSK Investigational Site, Witney, United Kingdom
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
- Conditions
- Respiratory Syncytial Virus Infections
- Interventions
- First Posted Date
- 2024-04-29
- Last Posted Date
- 2025-04-04
- Lead Sponsor
- GlaxoSmithKline
- Target Recruit Count
- 1459
- Registration Number
- NCT06389487
- Locations
- 🇿🇦
GSK Investigational Site, Reiger Park, South Africa
A Study on Safety and Immune Response of Investigational RSV OA Vaccine in Combination With Herpes Zoster Vaccine in Healthy Adults
- Conditions
- Respiratory Syncytial VirusesRespiratory Syncytial Virus Infections
- Interventions
- Biological: HZ/su vaccine
- First Posted Date
- 2023-07-28
- Last Posted Date
- 2025-04-01
- Lead Sponsor
- GlaxoSmithKline
- Target Recruit Count
- 530
- Registration Number
- NCT05966090
- Locations
- 🇨🇦
GSK Investigational Site, Toronto, Canada
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
- Conditions
- Respiratory Syncytial Virus Infections
- Interventions
- First Posted Date
- 2023-06-27
- Last Posted Date
- 2025-05-11
- Lead Sponsor
- GlaxoSmithKline
- Target Recruit Count
- 387
- Registration Number
- NCT05921903
- Locations
- 🇪🇸
GSK Investigational Site, Santander, Spain
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
- Conditions
- Respiratory Syncytial Virus Infections
- Interventions
- First Posted Date
- 2023-05-30
- Last Posted Date
- 2025-05-18
- Lead Sponsor
- GlaxoSmithKline
- Target Recruit Count
- 1113
- Registration Number
- NCT05879107
- Locations
- 🇪🇸
GSK Investigational Site, Valencia, Spain
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
- Conditions
- Respiratory Syncytial Virus Infections
- Interventions
- Drug: Placebo
- First Posted Date
- 2022-10-21
- Last Posted Date
- 2025-03-06
- Lead Sponsor
- GlaxoSmithKline
- Target Recruit Count
- 1544
- Registration Number
- NCT05590403
- Locations
- 🇪🇸
GSK Investigational Site, Vigo, Spain
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
- Conditions
- Respiratory Syncytial Virus Infections
- Interventions
- Biological: FLU vaccine
- First Posted Date
- 2022-10-06
- Last Posted Date
- 2024-03-15
- Lead Sponsor
- GlaxoSmithKline
- Target Recruit Count
- 1045
- Registration Number
- NCT05568797
- Locations
- 🇬🇧
GSK Investigational Site, Peterborough, United Kingdom
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
- Conditions
- Respiratory Syncytial Virus Infections
- Interventions
- Biological: FLU HD vaccine
- First Posted Date
- 2022-09-29
- Last Posted Date
- 2024-04-04
- Lead Sponsor
- GlaxoSmithKline
- Target Recruit Count
- 1029
- Registration Number
- NCT05559476
- Locations
- 🇺🇸
GSK Investigational Site, San Antonio, Texas, United States
Drug Development Updates
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