{"id":"rsv-f-vaccine-with-adjuvant","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 contains the RSV fusion (F) protein, a key surface antigen that the virus uses to enter host cells. When administered with an adjuvant to enhance immune response, it trains the immune system to recognize and neutralize RSV before infection occurs. This approach aims to prevent RSV disease across age groups, particularly in older adults and infants.","oneSentence":"This vaccine stimulates the immune system to produce antibodies and cellular immunity against the respiratory syncytial virus (RSV) F protein, preventing RSV infection.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T01:32:56.686Z","_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)"}]},"trialDetails":[{"nctId":"NCT02624947","phase":"PHASE3","title":"A Study to Determine the Safety and Efficacy of the RSV F Vaccine to Protect Infants Via Maternal Immunization","status":"COMPLETED","sponsor":"Novavax","startDate":"2015-12","conditions":"Respiratory Syncytial Virus Infections","enrollment":4636},{"nctId":"NCT02247726","phase":"PHASE2","title":"RSV F Vaccine Maternal Immunization Study in Healthy Third-trimester Pregnant Women.","status":"COMPLETED","sponsor":"Novavax","startDate":"2014-09","conditions":"Respiratory Syncytial Virus Infections","enrollment":50},{"nctId":"NCT03026348","phase":"PHASE2","title":"Safety and Immunogenicity Study to Evaluate Single- or Two-Dose Regimens Of RSV F Vaccine With and Without Aluminum Phosphate or Matrix-M1™ Adjuvants In Clinically-Stable Older Adults","status":"COMPLETED","sponsor":"Novavax","startDate":"2017-01","conditions":"Respiratory Syncytial Viruses","enrollment":300},{"nctId":"NCT03049488","phase":"PHASE1","title":"Dose, Safety, Tolerability and Immunogenicity of a Stabilized Prefusion RSV F Subunit Protein Vaccine, VRC-RSVRGP084-00-VP (DS-Cav1), Alone or With Alum Adjuvant, in Healthy Adults","status":"COMPLETED","sponsor":"National Institute of Allergy and Infectious Diseases (NIAID)","startDate":"2017-02-22","conditions":"Respiratory Syncytial Virus","enrollment":95},{"nctId":"NCT02472548","phase":"PHASE1","title":"A Study to Evaluate the Safety and Reactogenicity of DPX-RSV(A), a Respiratory Syncytial Virus Vaccine","status":"COMPLETED","sponsor":"Dalhousie University","startDate":"2015-05","conditions":"Respiratory Syncytial Virus","enrollment":40},{"nctId":"NCT02298179","phase":"PHASE1","title":"A Study to Evaluate the Safety and Ability of the Vaccine to Induce Antibodies Against the Respiratory Syncytial Virus in Healthy Adults","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2014-12-19","conditions":"Respiratory Syncytial Virus (RSV)","enrollment":288},{"nctId":"NCT01960686","phase":"PHASE2","title":"RSV F Dose-Ranging Study in Women","status":"COMPLETED","sponsor":"Novavax","startDate":"2013-10","conditions":"Respiratory Syncytial Virus Infections","enrollment":720},{"nctId":"NCT02296463","phase":"PHASE1","title":"A Phase I Randomized, Observer-Blinded, Dose-Ranging Study in Healthy Subjects 24 to <72 Months of Age","status":"COMPLETED","sponsor":"Novavax","startDate":"2014-11","conditions":"Respiratory Synctial Virus","enrollment":32},{"nctId":"NCT01704365","phase":"PHASE2","title":"RSV-F Vaccine Dose Ranging Study in Young Women","status":"COMPLETED","sponsor":"Novavax","startDate":"2012-10","conditions":"Respiratory Syncytial Virus (RSV)","enrollment":330},{"nctId":"NCT01709019","phase":"PHASE1","title":"RSV-F Vaccine and Influenza Vaccine Co-Administration Study in the Elderly","status":"COMPLETED","sponsor":"Novavax","startDate":"2012-10","conditions":"Respiratory Syncytial Virus (RSV)","enrollment":220}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":0,"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":"RSV F vaccine with adjuvant","genericName":"RSV F vaccine with adjuvant","companyName":"Novavax","companyId":"novavax","modality":"Biologic","firstApprovalDate":"","aiSummary":"This vaccine stimulates the immune system to produce antibodies and cellular immunity against the respiratory syncytial virus (RSV) F protein, preventing 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).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}