{"id":"vaxelis-vaccine","safety":{"commonSideEffects":[{"rate":null,"effect":"Injection site reactions (pain, redness, swelling)"},{"rate":null,"effect":"Fever"},{"rate":null,"effect":"Irritability"},{"rate":null,"effect":"Drowsiness"},{"rate":null,"effect":"Loss of appetite"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"anthropic-haiku","explanation":"Vaxelis combines antigens from 11 different pathogens (diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, Haemophilus influenzae type b, meningococcal serogroup C, measles, mumps, rubella, and varicella) in a single injection. It works by presenting these antigens to the immune system, triggering both humoral (antibody) and cell-mediated immune responses to provide protection against these diseases.","oneSentence":"Vaxelis is a combination vaccine that stimulates the immune system to produce antibodies and cellular immunity against multiple infectious diseases simultaneously.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T00:53:15.026Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Active immunization against diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, Haemophilus influenzae type b, meningococcal disease (serogroup C), measles, mumps, rubella, and varicella in infants and children"}]},"trialDetails":[{"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":"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":"NCT06397768","phase":"PHASE3","title":"Co-administration Study of an Investigational Live-Attenuated Respiratory Syncytial Virus Vaccine in Infants and Toddlers","status":"TERMINATED","sponsor":"Sanofi Pasteur, a Sanofi Company","startDate":"2024-05-13","conditions":"RSV Immunization","enrollment":2226},{"nctId":"NCT06647407","phase":"PHASE1, PHASE2","title":"Safety and Immunogenicity of an Investigational Pentavalent Meningococcal ABCYW Vaccine Against Meningococcal Disease in Children, Toddlers, and Infants","status":"ACTIVE_NOT_RECRUITING","sponsor":"Sanofi Pasteur, a Sanofi Company","startDate":"2024-11-05","conditions":"Meningococcal Immunization, Healthy Volunteers","enrollment":750},{"nctId":"NCT05856396","phase":"PHASE4","title":"Maternal Determinants of Infant Immunity to Pertussis","status":"COMPLETED","sponsor":"Centre Hospitalier Universitaire Saint Pierre","startDate":"2023-09-12","conditions":"Vaccination; Infection, Maternal-Fetal Relations, Pertussis","enrollment":200},{"nctId":"NCT04535037","phase":"PHASE4","title":"A Study to Evaluate Immunogenicity and Safety of GlaxoSmithKline (GSK)'s Infanrix Hexa Vaccine (DTPa-HBV-IPV/Hib) Versus MCM Vaccine BV's Vaxelis Vaccine (DTaP5-HBV-IPV-Hib) in Healthy Infants and Toddlers","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2021-05-26","conditions":"Diphtheria","enrollment":500},{"nctId":"NCT04978818","phase":"PHASE4","title":"Immunogenicity of H. Influenzae Type b PRP-OMP Vaccines in American Indian and Alaska Native Children (the HibVax Study)","status":"COMPLETED","sponsor":"Johns Hopkins Bloomberg School of Public Health","startDate":"2022-01-27","conditions":"Haemophilus Influenzae Type B Infection","enrollment":333},{"nctId":"NCT04016714","phase":"PHASE3","title":"Safety, Tolerability, and Immunogenicity of a 3-dose Regimen of V114 in Healthy Infants (PNEU-PED-EU-2/V114-026)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2019-08-28","conditions":"Pneumococcal Infections","enrollment":1191},{"nctId":"NCT04490499","phase":"PHASE3","title":"A Hepatitis B Vaccine Challenge Study After Previous Vaxelis® Vaccination (V419-013)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2020-09-02","conditions":"Hepatitis B","enrollment":207},{"nctId":"NCT01480258","phase":"PHASE3","title":"Safety, Tolerability, and Immunogenicity of V419 in Healthy Infants When Given at 2, 4, and 11 to 12 Months (V419-008)","status":"COMPLETED","sponsor":"MCM Vaccines B.V.","startDate":"2011-11-23","conditions":"Bacterial Infections, Virus Diseases","enrollment":1315},{"nctId":"NCT01553279","phase":"PHASE3","title":"Immunogenicity and Safety of V419 (PR51) in Combination With MCC in Infants and Toddlers (V419-011)","status":"COMPLETED","sponsor":"MCM Vaccines B.V.","startDate":"2012-03-30","conditions":"Neisseria Meningitidis, Bacterial Infections, Virus Diseases","enrollment":284},{"nctId":"NCT01839188","phase":"PHASE3","title":"Spanish Mixed HEXA/PENTA/HEXA Schedule (V419-010)","status":"COMPLETED","sponsor":"MCM Vaccines B.V.","startDate":"2013-05-01","conditions":"Neisseria Meningitidis, Bacterial Infections, Virus Diseases","enrollment":385}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":41,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Vaxelis™","Vaxelis®"],"phase":"phase_3","status":"active","brandName":"Vaxelis vaccine","genericName":"Vaxelis vaccine","companyName":"Sanofi","companyId":"sanofi","modality":"Biologic","firstApprovalDate":"","aiSummary":"Vaxelis is a combination vaccine that stimulates the immune system to produce antibodies and cellular immunity against multiple infectious diseases simultaneously. Used for Active immunization against diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, Haemophilus influenzae type b, meningococcal disease (serogroup C), measles, mumps, rubella, and varicella in infants and children.","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}