Overview
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)
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/02/24 | Phase 1 | Recruiting | Clover Biopharmaceuticals USA, LLC | ||
2024/09/26 | Phase 3 | Recruiting | |||
2024/08/02 | Phase 3 | Recruiting | |||
2024/04/29 | Phase 3 | Completed | |||
2024/04/18 | Phase 3 | Completed | |||
2024/01/08 | Phase 1 | Completed | |||
2023/07/28 | Phase 3 | Completed | |||
2023/06/27 | Phase 2 | Completed | |||
2023/05/30 | Phase 3 | Completed | |||
2022/10/21 | Phase 3 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| No FDA approvals found for this drug. | |||||
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
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