{"id":"infanrix-hexa-prevenar-rotarix-vaccine","safety":{"commonSideEffects":[{"rate":"10-50","effect":"Injection site reactions (pain, redness, swelling)"},{"rate":"10-30","effect":"Fever"},{"rate":"10-40","effect":"Irritability"},{"rate":"10-30","effect":"Drowsiness"},{"rate":"5-15","effect":"Loss of appetite"},{"rate":"5-10","effect":"Diarrhea"}]},"_chembl":{"chemblId":"CHEMBL2108573","moleculeType":"Vaccine component"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Infanrix hexa is a hexavalent vaccine containing inactivated toxoids and antigens that trigger adaptive immune responses. Prevenar (pneumococcal conjugate vaccine) uses polysaccharide-protein conjugates to enhance immunogenicity against Streptococcus pneumoniae serotypes. Rotarix is a live attenuated rotavirus vaccine that induces mucosal and systemic immunity. Together, these vaccines provide protection against multiple pediatric infectious diseases through humoral and cell-mediated immune responses.","oneSentence":"This combination vaccine stimulates the immune system to produce antibodies and cellular immunity against diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, Haemophilus influenzae type b, pneumococcal disease, and rotavirus.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T01:15:55.509Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Active immunization of infants and children against diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, and Haemophilus influenzae type b"},{"name":"Active immunization against pneumococcal disease (Streptococcus pneumoniae)"},{"name":"Active immunization against rotavirus gastroenteritis"}]},"trialDetails":[{"nctId":"NCT06647407","phase":"PHASE1, PHASE2","title":"Safety and Immunogenicity of an Investigational Pentavalent Meningococcal ABCYW 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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":"NCT01119625","phase":"PHASE3","title":"Immunological Persistence After Priming With GSK1024850A Vaccine and Safety& Immunogenicity After Booster Dose","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2010-07-12","conditions":"Infections, Streptococcal","enrollment":238},{"nctId":"NCT01090453","phase":"PHASE2","title":"Study of GlaxoSmithKline Biologicals' GSK2202083A Vaccine in Healthy Infants","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2010-05-17","conditions":"Tetanus, Hepatitis B, Haemophilus Influenzae Type b","enrollment":480},{"nctId":"NCT00808444","phase":"PHASE3","title":"Primary Vaccination Study With a Pneumococcal Conjugate Vaccine in Healthy Children 6-12wks of Age","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2009-01-05","conditions":"Infections, Streptococcal","enrollment":466},{"nctId":"NCT00533507","phase":"PHASE3","title":"Primary Vaccination Study With a Pneumococcal Conjugate Vaccine in Healthy Children 6 to 8 Weeks of Age","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2007-09-18","conditions":"Infections, Rotavirus","enrollment":230},{"nctId":"NCT00370318","phase":"PHASE3","title":"Prophylactic Antipyretic Treatment in Children Receiving Pneumococcal Conjugate and Standard Infant Vaccines","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2006-09","conditions":"Infections, Rotavirus","enrollment":400},{"nctId":"NCT01983540","phase":"PHASE3","title":"Antibody Persistence at Age 3.5 and 4.5 Years After Primary and Booster DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccination","status":"COMPLETED","sponsor":"Sanofi Pasteur, a Sanofi Company","startDate":"2013-10","conditions":"Diphtheria, Tetanus, Whooping Cough","enrollment":558},{"nctId":"NCT01177722","phase":"PHASE3","title":"A Study of DTaP-IPV-Hep B-PRP-T Vaccine Given With Prevenar™ and Rotarix™ in Healthy Latin American Infants","status":"COMPLETED","sponsor":"Sanofi Pasteur, a Sanofi Company","startDate":"2010-08","conditions":"Diphtheria, Tetanus, Whooping Cough","enrollment":1375}],"_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":"Infanrix hexa + Prevenar + Rotarix vaccine","genericName":"Infanrix hexa + Prevenar + Rotarix vaccine","companyName":"Sanofi Pasteur, a Sanofi Company","companyId":"sanofi","modality":"Biologic","firstApprovalDate":"","aiSummary":"This combination vaccine stimulates the immune system to produce antibodies and cellular immunity against diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, Haemophilus influenzae type b, pneumococcal disease, and rotavirus. Used for Active immunization of infants and children against diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, and Haemophilus influenzae type b, Active immunization against pneumococcal disease (Streptococcus pneumoniae), Active immunization against rotavirus gastroenteritis.","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}