{"id":"expec9v","safety":{"commonSideEffects":[{"rate":null,"effect":"Injection site reactions (pain, erythema, swelling)"},{"rate":null,"effect":"Fever"},{"rate":null,"effect":"Myalgia"},{"rate":null,"effect":"Fatigue"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"ExPEC9V targets nine serotypes of extraintestinal pathogenic E. coli, which are responsible for urinary tract infections, bacteremia, and other invasive infections. The vaccine works by inducing both humoral and cellular immune responses to prevent infection and reduce disease severity caused by these pathogenic strains.","oneSentence":"ExPEC9V is a vaccine designed to stimulate immune responses against extraintestinal pathogenic E. coli (ExPEC) strains.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:11:54.178Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Prevention of urinary tract infections caused by ExPEC"},{"name":"Prevention of bacteremia and invasive infections caused by ExPEC"}]},"trialDetails":[{"nctId":"NCT04899336","phase":"PHASE3","title":"A Study of Vaccination With 9-valent Extraintestinal Pathogenic Escherichia Coli Vaccine (ExPEC9V) in the Prevention of Invasive Extraintestinal Pathogenic Escherichia Coli Disease in Adults Aged 60 Years And Older With a History of Urinary Tract Infection in the Past 2 Years","status":"COMPLETED","sponsor":"Janssen Research & Development, LLC","startDate":"2021-06-30","conditions":"Invasive Extraintestinal Pathogenic Escherichia Coli Disease (IED) Prevention","enrollment":17935},{"nctId":"NCT06134804","phase":"PHASE3","title":"A Study of 9-valent Extraintestinal Pathogenic Escherichia Coli Vaccine (ExPEC9V) and High-dose Quadrivalent Influenza Vaccine, With and Without Co-administration, in Adults Aged 65 Years or Older","status":"COMPLETED","sponsor":"Janssen Research & Development, LLC","startDate":"2023-10-24","conditions":"Invasive Extraintestinal Pathogenic Escherichia Coli Disease (IED) Prevention","enrollment":959}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":6,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["VAC52416,","JNJ-78901563","VAC52416; JNJ-78901563"],"phase":"phase_3","status":"active","brandName":"ExPEC9V","genericName":"ExPEC9V","companyName":"Janssen Research & Development, LLC","companyId":"johnson-johnson","modality":"Biologic","firstApprovalDate":"","aiSummary":"ExPEC9V is a vaccine designed to stimulate immune responses against extraintestinal pathogenic E. coli (ExPEC) strains. Used for Prevention of urinary tract infections caused by ExPEC, Prevention of bacteremia and invasive infections caused by ExPEC.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}