{"id":"rsvpref3-oa-vaccine","safety":{"commonSideEffects":[{"rate":null,"effect":"Injection site pain"},{"rate":null,"effect":"Injection site erythema"},{"rate":null,"effect":"Myalgia"},{"rate":null,"effect":"Fatigue"},{"rate":null,"effect":"Headache"}]},"_chembl":{"chemblId":"CHEMBL2108573","moleculeType":"Vaccine component"},"_dailymed":null,"mechanism":{"_ai_source":"anthropic-haiku","explanation":"The vaccine uses a rationally designed prefusion-stabilized RSV F protein (PreF3) formulated with an oil-in-water adjuvant (OA) to enhance immunogenicity. This design aims to induce robust antibody and T-cell responses that neutralize RSV and prevent infection or severe disease. The prefusion conformation is believed to be more immunogenic and closer to the native viral structure than postfusion forms.","oneSentence":"RSVPreF3 OA is a recombinant protein vaccine that presents a stabilized prefusion form of the respiratory syncytial virus (RSV) F glycoprotein to elicit protective immune responses against RSV infection.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:32:56.800Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Prevention of respiratory syncytial virus (RSV) disease in older adults (≥60 years)"},{"name":"Prevention of RSV disease in infants via maternal immunization (under investigation)"}]},"trialDetails":[{"nctId":"NCT04732871","phase":"PHASE3","title":"Immunogenicity, Safety, Reactogenicity and Persistence of an Investigational Respiratory Syncytial Virus (RSV) Vaccine in Adults Aged 60 Years and Above","status":"ACTIVE_NOT_RECRUITING","sponsor":"GlaxoSmithKline","startDate":"2021-02-15","conditions":"Respiratory Syncytial Virus Infections","enrollment":1720},{"nctId":"NCT07220109","phase":"PHASE3","title":"A Study on the Immune Response and Safety of Vaccine Against Respiratory Syncytial Virus Given to Chinese Adults 18 to 59 Years of Age at Increased Risk of Respiratory Syncytial Virus Disease","status":"RECRUITING","sponsor":"GlaxoSmithKline","startDate":"2025-10-29","conditions":"Respiratory Syncytial Virus Infections","enrollment":750},{"nctId":"NCT06534892","phase":"PHASE3","title":"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","status":"ACTIVE_NOT_RECRUITING","sponsor":"GlaxoSmithKline","startDate":"2024-08-01","conditions":"Respiratory Syncytial Virus Infections","enrollment":10212},{"nctId":"NCT07092865","phase":"PHASE2","title":"A Study Evaluating Persistence of the Immune Response of the Adjuvanted Respiratory Syncytial Virus (RSV) Vaccine and the Safety and Immune Response Following Revaccination in Adults 18 Years of Age and Above Who Received Lung or Kidney Transplant","status":"RECRUITING","sponsor":"GlaxoSmithKline","startDate":"2025-08-06","conditions":"Respiratory Syncytial Virus Infections","enrollment":184},{"nctId":"NCT06551181","phase":"PHASE3","title":"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","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2024-08-05","conditions":"Respiratory Syncytial Virus Infections","enrollment":2621},{"nctId":"NCT06374394","phase":"PHASE3","title":"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","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2024-04-29","conditions":"Respiratory Syncytial Virus Infections","enrollment":841},{"nctId":"NCT06614725","phase":"PHASE3","title":"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)","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2024-10-01","conditions":"Respiratory Syncytial Virus Infections","enrollment":751},{"nctId":"NCT06389487","phase":"PHASE3","title":"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","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2024-04-29","conditions":"Respiratory Syncytial Virus Infections","enrollment":1459},{"nctId":"NCT05921903","phase":"PHASE2","title":"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","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2023-07-28","conditions":"Respiratory Syncytial Virus Infections","enrollment":386},{"nctId":"NCT04886596","phase":"PHASE3","title":"Efficacy Study of GSK's Investigational Respiratory Syncytial Virus (RSV) Vaccine in Adults Aged 60 Years and Above","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2021-05-25","conditions":"Respiratory Syncytial Virus Infections","enrollment":26675},{"nctId":"NCT05879107","phase":"PHASE3","title":"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","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2023-05-26","conditions":"Respiratory Syncytial Virus Infections","enrollment":1113},{"nctId":"NCT05966090","phase":"PHASE3","title":"A Study on Safety and Immune Response of Investigational RSV OA Vaccine in Combination With Herpes Zoster Vaccine in Healthy Adults","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2023-07-28","conditions":"Respiratory Syncytial Viruses, Respiratory Syncytial Virus Infections","enrollment":530},{"nctId":"NCT05590403","phase":"PHASE3","title":"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","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2022-10-28","conditions":"Respiratory Syncytial Virus Infections","enrollment":1544},{"nctId":"NCT05568797","phase":"PHASE3","title":"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","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2022-10-14","conditions":"Respiratory Syncytial Virus Infections","enrollment":1045},{"nctId":"NCT05559476","phase":"PHASE3","title":"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","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2022-10-20","conditions":"Respiratory Syncytial Virus Infections","enrollment":1029},{"nctId":"NCT04841577","phase":"PHASE3","title":"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","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2021-04-27","conditions":"Respiratory Syncytial Virus Infections","enrollment":976},{"nctId":"NCT05059301","phase":"PHASE3","title":"A Study of 3 Lots of an Investigational Vaccine Against Respiratory Syncytial Virus (RSV) in Adults Aged 60 Years and Above","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2021-10-01","conditions":"Respiratory Syncytial Virus Infections","enrollment":770},{"nctId":"NCT04657198","phase":"PHASE2","title":"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","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2020-12-09","conditions":"Respiratory Syncytial Virus Infections","enrollment":126}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":8,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"phase_3","status":"active","brandName":"RSVPreF3 OA vaccine","genericName":"RSVPreF3 OA vaccine","companyName":"GlaxoSmithKline","companyId":"gsk","modality":"Biologic","firstApprovalDate":"","aiSummary":"RSVPreF3 OA is a recombinant protein vaccine that presents a stabilized prefusion form of the respiratory syncytial virus (RSV) F glycoprotein to elicit protective immune responses against RSV infection. Used for Prevention of respiratory syncytial virus (RSV) disease in older adults (≥60 years), Prevention of RSV disease in infants via maternal immunization (under investigation).","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":1,"withResults":1},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}