{"id":"standard-iiv4","safety":{"commonSideEffects":[{"rate":"10-30","effect":"Injection site soreness"},{"rate":"5-15","effect":"Injection site erythema"},{"rate":"5-15","effect":"Injection site swelling"},{"rate":"5-15","effect":"Myalgia"},{"rate":"5-15","effect":"Headache"},{"rate":"5-15","effect":"Fatigue"},{"rate":"<5","effect":"Low-grade fever"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"The vaccine contains inactivated (killed) influenza virus particles representing two influenza A subtypes (H1N1 and H3N2) and two influenza B lineages. When administered, it triggers both humoral and cellular immune responses, leading to the production of neutralizing antibodies and T-cell mediated immunity against the included viral strains, thereby providing protection against seasonal influenza infection.","oneSentence":"Standard IIV4 is an inactivated influenza vaccine that stimulates the immune system to produce antibodies against four strains of influenza virus.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T00:09:17.375Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Seasonal influenza prevention in adults and children ≥6 months of age"}]},"trialDetails":[{"nctId":"NCT03598439","phase":"PHASE4","title":"Randomized Influenza Vaccine Evaluation of Immune Response","status":"COMPLETED","sponsor":"Marshfield Clinic Research Foundation","startDate":"2018-07-30","conditions":"Influenza","enrollment":366},{"nctId":"NCT05513391","phase":"PHASE3","title":"Study With Quadrivalent Recombinant Influenza Vaccine (RIV4) Compared With Egg-Based Quadrivalent Influenza Vaccine (IIV4) in Participants Aged 3 to 8 Years","status":"TERMINATED","sponsor":"Sanofi Pasteur, a Sanofi Company","startDate":"2022-11-10","conditions":"Influenza Immunization","enrollment":366},{"nctId":"NCT02623075","phase":"","title":"Influenza Vaccine Responses as a Means of Assessing Immune Competence in Chimeric Kidney/Stem Cell Transplant Recipients","status":"COMPLETED","sponsor":"Northwestern University","startDate":"2015-10","conditions":"Influenza","enrollment":19},{"nctId":"NCT05028361","phase":"PHASE4","title":"Simultaneous mRNA COVID-19 and IIV4 Vaccination Study","status":"COMPLETED","sponsor":"Duke University","startDate":"2021-10-04","conditions":"Quality of Life, Injection Site Reaction, Adverse Drug Event","enrollment":348},{"nctId":"NCT03969641","phase":"PHASE4","title":"Safety of RIV4 Versus IIV4 in Pregnant Women","status":"COMPLETED","sponsor":"Duke University","startDate":"2019-09-05","conditions":"Safety, Adverse Event Following Immunisation, Birth Outcomes","enrollment":384},{"nctId":"NCT04460781","phase":"","title":"Surveillance Study to Assess the Safety of Flublok Quadrivalent (Influenza Vaccine) in Pregnant Women and Their Offspring","status":"COMPLETED","sponsor":"Sanofi Pasteur, a Sanofi Company","startDate":"2018-09-17","conditions":"Influenza","enrollment":96175}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":40,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Flulaval Quadrivalent"],"phase":"marketed","status":"active","brandName":"Standard IIV4","genericName":"Standard IIV4","companyName":"Marshfield Clinic Research Foundation","companyId":"marshfield-clinic-research-foundation","modality":"Biologic","firstApprovalDate":"","aiSummary":"Standard IIV4 is a quadrivalent inactivated influenza vaccine used to study the quality of life, injection site reactions, adverse drug events, systemic reactions, and influenza immunization. It is administered as an intervention in clinical trials, alongside mRNA COVID-19 vaccines and a placebo, and is classified as a small molecule modality.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}