{"id":"pcv21","safety":{"commonSideEffects":[{"rate":null,"effect":"Injection site pain"},{"rate":null,"effect":"Injection site erythema"},{"rate":null,"effect":"Injection site swelling"},{"rate":null,"effect":"Myalgia"},{"rate":null,"effect":"Fatigue"},{"rate":null,"effect":"Headache"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"PCV21 contains polysaccharide capsules from 21 different serotypes of Streptococcus pneumoniae conjugated to a protein carrier, which enhances immunogenicity. The vaccine triggers both humoral and cellular immune responses, generating antibodies and T-cell memory against these serotypes. This provides protection against invasive pneumococcal disease, pneumonia, and other infections caused by these bacterial serotypes.","oneSentence":"PCV21 is a pneumococcal conjugate vaccine that stimulates immune responses against 21 serotypes of Streptococcus pneumoniae to prevent pneumococcal disease.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:25:57.275Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Prevention of pneumococcal disease in adults"},{"name":"Prevention of invasive pneumococcal disease, pneumonia, and otitis media"}]},"trialDetails":[{"nctId":"NCT07284654","phase":"PHASE3","title":"Safety, Tolerability, and Immunogenicity of VAX-31 in Adults ≥50 Years With Immunobridging to Adults 18-49","status":"RECRUITING","sponsor":"Vaxcyte, Inc.","startDate":"2025-12-01","conditions":"Pneumococcal Vaccines","enrollment":4000},{"nctId":"NCT07135453","phase":"PHASE4","title":"Induction of Cross-protective Antibodies for Serogroup 33 by Pneumococcal Conjugate Vaccines","status":"NOT_YET_RECRUITING","sponsor":"University of Alabama at Birmingham","startDate":"2026-03","conditions":"Vaccine, Pneumococcal Disease","enrollment":70},{"nctId":"NCT06824194","phase":"PHASE3","title":"Study of the Safety of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants From Approximately 2 Months of Age","status":"RECRUITING","sponsor":"Sanofi","startDate":"2025-02-18","conditions":"Pneumococcal Immunization","enrollment":2320},{"nctId":"NCT06975878","phase":"PHASE3","title":"Study of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants From Approximately 2 Months of Age","status":"ACTIVE_NOT_RECRUITING","sponsor":"Sanofi","startDate":"2025-05-22","conditions":"Pneumococcal Immunization, Healthy Volunteers","enrollment":1092},{"nctId":"NCT07348692","phase":"PHASE3","title":"Lot-to-lot Consistency Study of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants From 2 Months of Age","status":"RECRUITING","sponsor":"Sanofi","startDate":"2026-01-20","conditions":"Pneumococcal Immunization, Healthy Volunteers","enrollment":896},{"nctId":"NCT06736041","phase":"PHASE3","title":"Study of a 4-Dose Regimen of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants From Approximately 2 Months of Age","status":"ACTIVE_NOT_RECRUITING","sponsor":"Sanofi Pasteur, a Sanofi Company","startDate":"2024-12-18","conditions":"Pneumococcal Immunization","enrollment":1714},{"nctId":"NCT06824181","phase":"PHASE3","title":"Study of Mixed Vaccination Schedules With a 21-valent Pneumococcal Conjugate Vaccine and a 20-valent Pneumococcal Conjugate Vaccine in Healthy Infants From Approximately 2 Months of Age","status":"ACTIVE_NOT_RECRUITING","sponsor":"Sanofi","startDate":"2025-02-27","conditions":"Pneumococcal Immunization","enrollment":580},{"nctId":"NCT07247188","phase":"PHASE3","title":"Study of a Single Dose of a 21-valent Pneumococcal Conjugate Vaccine in Children and Adolescents With Sickle Cell Disease","status":"RECRUITING","sponsor":"Sanofi","startDate":"2026-01-20","conditions":"Sickle Cell Disease","enrollment":100},{"nctId":"NCT07071909","phase":"PHASE1, PHASE2","title":"Immune Reconstitution Monitoring and Pneumococcal Vaccination in Patients Treated With CAR-T Cells","status":"WITHDRAWN","sponsor":"UNC Lineberger Comprehensive Cancer Center","startDate":"2025-01-20","conditions":"Malignancy, Cancer, Hematological Malignancies","enrollment":""},{"nctId":"NCT06822907","phase":"PHASE4","title":"Immunogenicity and Safety PCV-20 of the Vaccine Administered During an Acute Febrile Illness in Adults","status":"NOT_YET_RECRUITING","sponsor":"Centre Hospitalier Universitaire de Saint Etienne","startDate":"2026-01","conditions":"Acute Febrile Illness, Pneumococcal Infections","enrollment":1052},{"nctId":"NCT06838000","phase":"PHASE3","title":"Study of the Safety and Immunogenicity of Catch-up Vaccination With a 21-valent Pneumococcal Conjugate 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Use","enrollment":100}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":61,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Capvaxive"],"phase":"phase_3","status":"active","brandName":"PCV21","genericName":"PCV21","companyName":"Sanofi Pasteur, a Sanofi Company","companyId":"sanofi-pasteur-a-sanofi-company","modality":"Biologic","firstApprovalDate":"","aiSummary":"PCV21 is a pneumococcal conjugate vaccine that stimulates immune responses against 21 serotypes of Streptococcus pneumoniae to prevent pneumococcal disease. Used for Prevention of pneumococcal disease in adults, Prevention of invasive pneumococcal disease, pneumonia, and otitis media.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}