{"id":"malaria-vaccine-257049","safety":{"commonSideEffects":[{"rate":null,"effect":"Injection site pain or swelling"},{"rate":null,"effect":"Fever"},{"rate":null,"effect":"Fatigue"},{"rate":null,"effect":"Myalgia"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Malaria Vaccine 257049 (likely RTS,S/Mosquirix or a related candidate) uses recombinant protein technology to present malaria parasite antigens to the immune system, triggering both cellular and humoral immune responses. The vaccine is designed to prevent parasites from infecting hepatocytes and/or reduce parasitemia levels, thereby preventing clinical malaria disease.","oneSentence":"This vaccine stimulates the immune system to recognize and attack Plasmodium parasites that cause malaria by targeting the parasite's pre-erythrocytic and blood-stage antigens.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:20:06.145Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Malaria prevention in endemic populations, particularly children and infants"}]},"trialDetails":[{"nctId":"NCT00289185","phase":"PHASE2","title":"Study of Safety, Immunogenicity and Efficacy of a Candidate Malaria Vaccine in Tanzanian Infants","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2006-09-27","conditions":"Malaria, Malaria Vaccines","enrollment":340},{"nctId":"NCT00197067","phase":"PHASE1","title":"A Study to Evaluate the Safety and Immunogenicity of GSK Biologicals' Candidate Vaccines RTS,S/AS02D (0.5 mL Dose) and RTS,S/AS02A (0.25 mL Dose) Administered IM According to a 0, 1, 2 Month Vaccination Schedule in Children Aged 3 to 5 Years Living in a Malaria-endemic Region of Mozambique.","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2004-03-15","conditions":"Malaria","enrollment":200},{"nctId":"NCT02207816","phase":"PHASE3","title":"An Extension to Study MALARIA-055 PRI (NCT00866619) to Evaluate the Long-term Efficacy, Safety and Immunogenicity of GSK Biologicals' Candidate Malaria Vaccine in Infants and Children in Africa","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2014-09-18","conditions":"Malaria","enrollment":3084},{"nctId":"NCT00866619","phase":"PHASE3","title":"Efficacy of GSK Biologicals' Candidate Malaria Vaccine 257049 Against Malaria Disease in Infants and Children in Africa","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2009-03-27","conditions":"Malaria","enrollment":15459},{"nctId":"NCT01345240","phase":"PHASE3","title":"Study to Evaluate Immunogenicity of the Hepatitis B Antigen of the GSK Biologicals' Candidate Malaria Vaccine (257049)","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2011-11-17","conditions":"Malaria, Malaria Vaccines","enrollment":705},{"nctId":"NCT01857869","phase":"PHASE2","title":"Efficacy, Safety and Immunogenicity Study of GlaxoSmithKline(GSK) Biologicals' Candidate Malaria Vaccine 257049 in the Sporozoite Challenge Model in Healthy Malaria-naïve Adults","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2013-05-20","conditions":"Malaria","enrollment":64},{"nctId":"NCT01366534","phase":"PHASE2","title":"Safety, Immunogenicity and Efficacy Against of a Combined Malaria Vaccine in Healthy Malaria-naïve Adults","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2011-08-10","conditions":"Malaria","enrollment":67},{"nctId":"NCT01148459","phase":"PHASE3","title":"Safety and Immunogenicity of GSK Biologicals' Investigational Malaria Vaccine in HIV Infected Infants and Children","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2010-07-30","conditions":"Malaria","enrollment":200},{"nctId":"NCT00197028","phase":"PHASE2","title":"Examine Safety and Immune Responses of GSK 257049 Vaccine When Administered to Infants Living in a Malaria-endemic Region","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2005-08-23","conditions":"Malaria","enrollment":214},{"nctId":"NCT01323972","phase":"PHASE3","title":"Consistency of Immunogenicity and Non Inferiority of GSK Biologicals' Candidate Malaria Vaccine Lots in Children","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2011-05-16","conditions":"Malaria","enrollment":327},{"nctId":"NCT00436007","phase":"PHASE2","title":"Safety and Immunogenicity Study of GSK Biologicals' Malaria Vaccine 257049, When Incorporated Into an EPI Regimen","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2007-04-30","conditions":"Malaria","enrollment":511},{"nctId":"NCT01231503","phase":"PHASE2","title":"Safety and Immunogenicity of GSK Biologicals' Malaria Vaccine 257049 When Administered on 7 Schedules to African Infants","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2011-01-13","conditions":"Malaria","enrollment":480},{"nctId":"NCT00380393","phase":"PHASE2","title":"Efficacy of RTS,S/AS01 Vaccine Against Episodes of Malaria Due to P. Falciparum Infection in Children.","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2007-01-03","conditions":"Malaria","enrollment":894},{"nctId":"NCT00360230","phase":"PHASE2","title":"Partially-blind (Observer-blind) Study of Safety and Immunogenicity of Two Malaria Vaccines in Ghanaian Children","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2006-08-30","conditions":"Malaria","enrollment":540},{"nctId":"NCT00307021","phase":"PHASE2","title":"Double-blind Study of Safety and Immunogenicity of Two Candidate Malaria Vaccines in Gabonese Children","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2006-04-07","conditions":"Malaria","enrollment":180},{"nctId":"NCT00443131","phase":"PHASE2","title":"Characterisation of the Immune Responses of 2 Experimental Malaria Vaccines","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2007-03-26","conditions":"Malaria","enrollment":36},{"nctId":"NCT00323622","phase":"PHASE2","title":"Long-Term Follow-up of Children for a 2-Year Period to Confirm the Safety and Immunogenicity of GSK 257049 Vaccine","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2005-04","conditions":"Malaria","enrollment":1737}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":1,"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":"Malaria Vaccine 257049","genericName":"Malaria Vaccine 257049","companyName":"GlaxoSmithKline","companyId":"gsk","modality":"Biologic","firstApprovalDate":"","aiSummary":"This vaccine stimulates the immune system to recognize and attack Plasmodium parasites that cause malaria by targeting the parasite's pre-erythrocytic and blood-stage antigens. Used for Malaria prevention in endemic populations, particularly children and infants.","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":1,"withResults":1},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}