{"id":"bcg-vaccine-ip-serum-institute-of-india","safety":{"commonSideEffects":[{"rate":"10-30","effect":"Local reaction at injection site (erythema, induration)"},{"rate":"1-5","effect":"Regional lymphadenitis"},{"rate":"1-3","effect":"Fever"},{"rate":"<0.1","effect":"BCG-itis (disseminated infection, rare)"}]},"_chembl":{"chemblId":"CHEMBL2108905","moleculeType":"Vaccine component"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"BCG (Bacillus Calmette-Guérin) is a live attenuated mycobacterium that primes cellular immunity against Mycobacterium tuberculosis. It works by inducing both CD4+ and CD8+ T-cell responses and activating macrophages to provide protection against tuberculosis infection and disease progression.","oneSentence":"BCG vaccine stimulates the immune system to recognize and attack tuberculosis-causing bacteria through activation of T-cells and macrophages.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T01:03:49.193Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Tuberculosis prevention in infants and high-risk populations"},{"name":"Potential immunotherapeutic use in bladder cancer (investigational)"}]},"trialDetails":[{"nctId":"NCT01250249","phase":"PHASE3","title":"A Study of Comparing Safety and Reactogenicity, of Lyophilized BCG Vaccine IP of Green Signal Bio Pharma Private Limited, India With BCG Vaccine of Serum Institute of India Limited in 120 Healthy Children.","status":"COMPLETED","sponsor":"Green Signal Biopharma Private Limited","startDate":"2008-11","conditions":"Healthy","enrollment":120}],"_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":["BCG Vaccine IP (SIIL)"],"phase":"phase_3","status":"active","brandName":"BCG Vaccine IP - Serum Institute of India","genericName":"BCG Vaccine IP - Serum Institute of India","companyName":"Green Signal Biopharma Private Limited","companyId":"green-signal-biopharma-private-limited","modality":"Biologic","firstApprovalDate":"","aiSummary":"BCG vaccine stimulates the immune system to recognize and attack tuberculosis-causing bacteria through activation of T-cells and macrophages. Used for Tuberculosis prevention in infants and high-risk populations, Potential immunotherapeutic use in bladder cancer (investigational).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}