{"id":"licensed-influenza-vaccine","rwe":[],"tags":[],"safety":{"drugInteractions":[{"drug":"Aspirin","action":"Avoid","effect":"Increased risk of bleeding"},{"drug":"Warfarin","action":"Monitor","effect":"Increased risk of bleeding"},{"drug":"Corticosteroids","action":"Monitor","effect":"Decreased antibody response"},{"drug":"Immunosuppressants","action":"Monitor","effect":"Decreased antibody response"},{"drug":"Interferons","action":"Monitor","effect":"Decreased antibody response"},{"drug":"Thalidomide","action":"Monitor","effect":"Decreased antibody response"},{"drug":"Zanamivir","action":"Monitor","effect":"Decreased antibody response"},{"drug":"Oseltamivir","action":"Monitor","effect":"Decreased antibody response"},{"drug":"Peramivir","action":"Monitor","effect":"Decreased antibody response"},{"drug":"Amantadine","action":"Monitor","effect":"Decreased antibody response"},{"drug":"Rimantadine","action":"Monitor","effect":"Decreased antibody response"}],"commonSideEffects":[{"type":"common","effect":"Injection site pain (PAIN)","drugRate":"73.5%","organSystem":"General disorders","placeboRate":"","totalAtRisk":309,"totalAffected":227,"trialsReporting":1},{"type":"common","effect":"Fatigue (FATIGUE)","drugRate":"58.3%","organSystem":"General disorders","placeboRate":"","totalAtRisk":309,"totalAffected":180,"trialsReporting":1},{"type":"common","effect":"Headache (HEADACHE)","drugRate":"47.6%","organSystem":"Nervous system disorders","placeboRate":"","totalAtRisk":309,"totalAffected":147,"trialsReporting":1},{"type":"common","effect":"Chills (CHILLS)","drugRate":"37.9%","organSystem":"General disorders","placeboRate":"","totalAtRisk":309,"totalAffected":117,"trialsReporting":1},{"type":"common","effect":"Myalgia (MUSCLE PAIN)","drugRate":"36.9%","organSystem":"Musculoskeletal and connective tissue disorders","placeboRate":"","totalAtRisk":309,"totalAffected":114,"trialsReporting":1},{"type":"common","effect":"Arthralgia (JOINT PAIN)","drugRate":"24.9%","organSystem":"Musculoskeletal and connective tissue disorders","placeboRate":"","totalAtRisk":309,"totalAffected":77,"trialsReporting":1},{"type":"common","effect":"Diarrhoea (DIARRHEA)","drugRate":"14.6%","organSystem":"Gastrointestinal disorders","placeboRate":"","totalAtRisk":309,"totalAffected":45,"trialsReporting":1},{"type":"common","effect":"Injection site erythema (REDNESS)","drugRate":"14.2%","organSystem":"General disorders","placeboRate":"","totalAtRisk":309,"totalAffected":44,"trialsReporting":1},{"type":"common","effect":"Pyrexia (FEVER)","drugRate":"13.9%","organSystem":"General disorders","placeboRate":"","totalAtRisk":309,"totalAffected":43,"trialsReporting":1},{"type":"common","effect":"Injection site swelling (SWELLING)","drugRate":"12.9%","organSystem":"General disorders","placeboRate":"","totalAtRisk":309,"totalAffected":40,"trialsReporting":1},{"type":"common","effect":"Vomiting (VOMITING)","drugRate":"3.9%","organSystem":"Gastrointestinal disorders","placeboRate":"","totalAtRisk":309,"totalAffected":12,"trialsReporting":1},{"type":"common","effect":"Upper respiratory tract infection","drugRate":"1.3%","organSystem":"Infections and infestations","placeboRate":"","totalAtRisk":309,"totalAffected":4,"trialsReporting":1},{"type":"common","effect":"COVID-19","drugRate":"0.3%","organSystem":"Infections and infestations","placeboRate":"","totalAtRisk":309,"totalAffected":1,"trialsReporting":1}],"contraindications":["History of severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine (other than egg), or to a previous dose of any influenza vaccine (any egg-based IIV, ccIIV, RIV, or LAIV of any valency)","History of Guillain-Barré syndrome within 6 weeks of receipt of influenza vaccine","Moderate or severe acute illness with or without fever","History of severe allergic reaction (e.g., anaphylaxis) to RIV of any valency, or to any component of RIV3","Receipt of influenza antiviral medication within the previous 48 hours for oseltamivir and zanamivir, 5 days for peramivir (due to potential interference with vaccine effectiveness)","Persons with cochlear implants (due to potential for CSF leak, which might exist for some period after implantation)","Persons with active communication between the cerebrospinal fluid (CSF) and the oropharynx, nasopharynx, nose, or ear","Pregnancy","Close contacts and caregivers of severely immunosuppressed persons who require a protected environment","Children and adults who are immunocompromised due to any cause, including but not limited to medications, congenital conditions, or HIV/AIDS","Children aged 2 through 4 years who have received a diagnosis of asthma or whose parents or caregivers report that a child has had wheezing in the past year","History of severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine (other than egg), or to a previous dose of any influenza vaccine (any egg-based IIV, ccIIV, RIV, or LAIV of any valency)"],"specialPopulations":{"Pregnancy":"LAIV3 should not be used during pregnancy but can be used postpartum. Any age-appropriate IIV3 or RIV3 should be used and may be given in any trimester. Women who are or who might be pregnant during the influenza season should receive influenza vaccine.","Geriatric use":"","Paediatric use":"Children aged 2 through 4 years who have received a diagnosis of asthma or whose parents or caregivers report that a healthcare provider has said the child has wheezing or asthma should not receive LAIV3.","Renal impairment":"","Hepatic impairment":""},"seriousAdverseEvents":[{"event":"Meningitis bacterial","detail":"MedDRA: Infections and infestations. Reported in 1 trial(s).","severity":"serious","incidence":"0.3%"},{"event":"Seizure","detail":"MedDRA: Nervous system disorders. Reported in 1 trial(s).","severity":"serious","incidence":"0.3%"},{"event":"Thrombocytopenia","detail":"MedDRA: Blood and lymphatic system disorders. Reported in 1 trial(s).","severity":"serious","incidence":"0.0%"},{"event":"Acute cardiac event","detail":"MedDRA: Cardiac disorders. Reported in 1 trial(s).","severity":"serious","incidence":"0.0%"},{"event":"Acute myocardial infarction","detail":"MedDRA: Cardiac disorders. Reported in 1 trial(s).","severity":"serious","incidence":"0.0%"},{"event":"Atrial fibrillation","detail":"MedDRA: Cardiac disorders. Reported in 1 trial(s).","severity":"serious","incidence":"0.0%"},{"event":"Bradycardia","detail":"MedDRA: Cardiac disorders. Reported in 1 trial(s).","severity":"serious","incidence":"0.0%"},{"event":"Cardiac arrest","detail":"MedDRA: Cardiac disorders. Reported in 1 trial(s).","severity":"serious","incidence":"0.0%"},{"event":"Cardiac failure acute","detail":"MedDRA: Cardiac disorders. Reported in 1 trial(s).","severity":"serious","incidence":"0.0%"},{"event":"Cardiac failure congestive","detail":"MedDRA: Cardiac disorders. Reported in 1 trial(s).","severity":"serious","incidence":"0.0%"},{"event":"Cardiogenic shock","detail":"MedDRA: Cardiac disorders. Reported in 1 trial(s).","severity":"serious","incidence":"0.0%"},{"event":"Coronary artery stenosis","detail":"MedDRA: Cardiac disorders. Reported in 1 trial(s).","severity":"serious","incidence":"0.0%"},{"event":"Myocardial infarction","detail":"MedDRA: Cardiac disorders. Reported in 1 trial(s).","severity":"serious","incidence":"0.0%"},{"event":"Sinus bradycardia","detail":"MedDRA: Cardiac disorders. Reported in 1 trial(s).","severity":"serious","incidence":"0.0%"},{"event":"Ventricular tachycardia","detail":"MedDRA: Cardiac disorders. Reported in 1 trial(s).","severity":"serious","incidence":"0.0%"},{"event":"Vertigo positional","detail":"MedDRA: Ear and labyrinth disorders. Reported in 1 trial(s).","severity":"serious","incidence":"0.0%"},{"event":"Chest pain","detail":"MedDRA: General disorders. Reported in 1 trial(s).","severity":"serious","incidence":"0.0%"},{"event":"Non-cardiac chest pain","detail":"MedDRA: General disorders. Reported in 1 trial(s).","severity":"serious","incidence":"0.0%"},{"event":"Abdominal pain","detail":"MedDRA: Gastrointestinal disorders. Reported in 1 trial(s).","severity":"serious","incidence":"0.0%"},{"event":"Constipation","detail":"MedDRA: Gastrointestinal disorders. Reported in 1 trial(s).","severity":"serious","incidence":"0.0%"},{"event":"Duodenal ulcer perforation","detail":"MedDRA: Gastrointestinal disorders. Reported in 1 trial(s).","severity":"serious","incidence":"0.0%"},{"event":"Impaired gastric emptying","detail":"MedDRA: Gastrointestinal disorders. Reported in 1 trial(s).","severity":"serious","incidence":"0.0%"},{"event":"Intestinal obstruction","detail":"MedDRA: Gastrointestinal disorders. Reported in 1 trial(s).","severity":"serious","incidence":"0.0%"},{"event":"Pancreatitis","detail":"MedDRA: Gastrointestinal disorders. Reported in 1 trial(s).","severity":"serious","incidence":"0.0%"},{"event":"Umbilical hernia, obstructive","detail":"MedDRA: Gastrointestinal disorders. Reported in 1 trial(s).","severity":"serious","incidence":"0.0%"},{"event":"Biliary colic","detail":"MedDRA: Hepatobiliary disorders. Reported in 1 trial(s).","severity":"serious","incidence":"0.0%"},{"event":"Cholecystitis acute","detail":"MedDRA: Hepatobiliary disorders. Reported in 1 trial(s).","severity":"serious","incidence":"0.0%"},{"event":"Hepatic steatosis","detail":"MedDRA: Hepatobiliary disorders. Reported in 1 trial(s).","severity":"serious","incidence":"0.0%"},{"event":"Hepatitis alcoholic","detail":"MedDRA: Hepatobiliary disorders. Reported in 1 trial(s).","severity":"serious","incidence":"0.0%"},{"event":"Hypertransaminasaemia","detail":"MedDRA: Hepatobiliary disorders. Reported in 1 trial(s).","severity":"serious","incidence":"0.0%"}]},"trials":[],"aliases":["Influenza HA, Biken, and","Fluarix tetra"],"company":"Pfizer","patents":[],"pricing":[],"_sources":{"patents":{"url":"","method":"deterministic","source":"FDA Orange Book + Purple Book","rawText":"","confidence":1,"sourceType":"fda_orange_book","retrievedAt":"2026-04-19T23:12:11.256541+00:00"},"aiSummary":{"url":"","method":"ai_extraction","source":"AI Strategic Summary","aiModel":"featherless","rawText":"","confidence":0.9,"sourceType":"ai_extraction","retrievedAt":"2026-04-19T23:12:19.848710+00:00"},"chemblData":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL2109042/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-19T23:12:04.679381+00:00"},"trialDetails":{"url":"","method":"deterministic","source":"ClinicalTrials.gov (1 trials with endpoints)","rawText":"","confidence":1,"sourceType":"ctgov_results","retrievedAt":"2026-04-19T23:12:21.495258+00:00"},"targetProtein":{"url":"https://www.uniprot.org/uniprot/Q9Y6S7","method":"api_direct","source":"UniProt (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"uniprot","retrievedAt":"2026-04-19T23:11:58.632531+00:00"},"publicationCount":{"url":"","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-19T23:12:03.239550+00:00"},"recentPublications":{"url":"","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-19T23:12:04.141575+00:00"},"participantFlowData":{"url":"","method":"deterministic","source":"ClinicalTrials.gov participantFlowModule","rawText":"","confidence":1,"sourceType":"ctgov_results","retrievedAt":"2026-04-19T23:12:21.495205+00:00"},"structuredTrialResults":{"url":"","method":"deterministic","source":"ClinicalTrials.gov resultsSection (1 trials)","rawText":"","confidence":1,"sourceType":"ctgov_results","retrievedAt":"2026-04-19T23:12:21.495202+00:00"},"safety.commonSideEffects":{"url":"","method":"deterministic","source":"ClinicalTrials.gov (1 trials with results)","rawText":"Aggregated from 1 trials. Top AE: Injection site pain (PAIN) (73.5%)","confidence":1,"sourceType":"ctgov_results","retrievedAt":"2026-04-19T23:12:21.495005+00:00"},"safety.seriousAdverseEvents":{"url":"","method":"deterministic","source":"ClinicalTrials.gov (1 trials)","rawText":"","confidence":1,"sourceType":"ctgov_results","retrievedAt":"2026-04-19T23:12:21.495021+00:00"}},"allNames":"assorted licensed hand sanitizer grape 01","offLabel":[],"timeline":[],"aiSummary":"Pfizer's Assorted Licensed Hand Sanitizer Grape 01, despite its misleading name, is an influenza vaccine that holds a significant market position as one of the world's best-selling drugs. Its competitive advantage is not clearly defined due to the lack of specified mechanism and clinical trial data, but it faces strong competition from alternatives like Oseltamivir (Tamiflu) and Zanamivir (Relenza), which offer options for individuals with egg allergies. A key risk is the requirement for a PD-L1 companion diagnostic for several indications, which may limit its broader applicability and market reach. The pipeline outlook remains uncertain given the absence of ongoing clinical trials and the presence of established competitors in the influenza vaccine market.","brandName":"Assorted Licensed Hand Sanitizer Grape 01","ecosystem":[],"isGeneric":true,"mechanism":{"target":"unknown","novelty":"unknown","modality":"vaccine","drugClass":"vaccine","explanation":"Unfortunately, the provided information does not specify the mechanism of action of Pfizer's licensed influenza vaccine. This makes it difficult to understand how the vaccine works at a molecular level. Further research is needed to determine the exact mechanism of action.","oneSentence":"The mechanism of action is not specified.","technicalDetail":"The mechanism of action of Pfizer's licensed influenza vaccine is not specified, making it challenging for healthcare professionals to understand its pharmacological properties. Without this information, it is difficult to determine the vaccine's potential interactions with other medications or its effects on specific patient populations."},"_companyIR":{"url":"https://www.pfizer.com/investors","revenueRefs":[],"pipelineRefs":[]},"chemblData":{"prodrug":0,"chemblId":"CHEMBL2109042","maxPhase":"3.0","chirality":1,"parenteral":false,"availability":null,"moleculeType":"Vaccine component","withdrawnFlag":false,"naturalProduct":0,"blackBoxWarning":0,"oralBioavailable":false},"commercial":{"yoyGrowth":"7%","annualCostUS":"$80,000/yr","genericStatus":"Generic — off-patent","currentRevenue":"","patientPopulation":"millions of patients","peakSalesEstimate":""},"fdaRecalls":[],"references":[{"id":1,"url":"https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=Licensed influenza vaccine","fields":["mechanism","safety","indications","administration"],"source":"FDA Drug Label (DailyMed)"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=Licensed%20influenza%20vaccine","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=Licensed influenza vaccine","fields":["publications"],"source":"PubMed/NCBI"},{"id":4,"url":"https://www.ebi.ac.uk/chembl/","fields":["molecular"],"source":"ChEMBL (EMBL-EBI)"},{"id":5,"url":"https://www.ema.europa.eu/","fields":["regulatoryStatus"],"source":"European Medicines Agency (EMA)"},{"id":6,"url":"https://list.essentialmeds.org/","fields":["regulatoryStatus"],"source":"WHO Essential Medicines List"}],"_tgaChecked":true,"_validation":{"fieldsValidated":3,"lastValidatedAt":"2026-04-19T23:12:19.848785+00:00","fieldsConflicting":0,"overallConfidence":0.95},"_whoChecked":true,"biosimilars":[],"competitors":[{"name":"Oseltamivir (Tamiflu)","company":"Drug","advantage":"Alternative to flu vaccine for individuals with egg allergy"},{"name":"Zanamivir (Relenza)","company":"Drug","advantage":"Alternative to flu vaccine for individuals with egg allergy"},{"name":"Recombinant influenza vaccine (RIV4, Flublok)","company":"Drug","advantage":"Recommended alternative for individuals with egg allergy"}],"dataSources":[{"url":"https://tavily.com","name":"Tavily AI Search","fields":["latestUpdates"],"retrievedDate":"2026-04-07"},{"url":"https://jina.ai/reader","name":"Jina Reader","fields":["commercialAnalysis"],"retrievedDate":"2026-04-07"},{"url":"https://groq.com","name":"Groq (Llama 3.1 8B)","fields":["commercialAnalysis"],"retrievedDate":"2026-04-07"}],"genericName":"licensed influenza vaccine","indications":{"approved":[{"name":"Influenza prevention","regulator":"FDA"},{"name":"Influenza vaccination","regulator":"FDA"},{"name":"Influenza protection","regulator":"FDA"}],"offLabel":[],"pipeline":[]},"_mhraChecked":true,"labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT06178991","phase":"PHASE3","title":"A Study to Evaluate the Safety, Tolerability, and Immunogenicity of a Combined Modified RNA Vaccine Candidate Against COVID-19 and Influenza.","status":"","acronym":null,"sponsor":"BioNTech SE","isPivotal":false,"primaryCI":"","primaryHR":"","enrollment":8795,"indication":"Influenza, COVID-19","endpointCount":18,"primaryPValue":"","completionDate":"","primaryEndpoint":"Cohort 1: Percentage of Participants With Any Local Reactions for up to 7 Days Following Vaccination in Investigational Vaccine Extremity"}],"_emaApprovals":[{"date":"","name":"Licensed influenza vaccine","status":"Authorised","regulator":"EMA"}],"genericFilers":[],"latestUpdates":[{"url":"https://www.precedenceresearch.com/hand-sanitizer-market","date":"2026-04-07","type":"news","title":"Hand Sanitizer Market Size to Hit USD 9.47 Billion By 2035","source":"www.precedenceresearch.com"},{"url":"https://www.coherentmarketinsights.com/market-insight/hand-sanitizer-market-5235","date":"2026-04-07","type":"news","title":"Hand Sanitizer Market Size, Share and Analysis, 2026-2033","source":"www.coherentmarketinsights.com"},{"url":"https://www.globalstocks.in/stock-offers/usa/health-beauty/for-sale-kids-licensed-hand-sanitizer-084-oz-usa/37940","date":"2026-04-07","type":"news","title":"For Sale Kids Licensed Hand Sanitizer 0.84 oz USA","source":"www.globalstocks.in"},{"url":"https://www.fda.gov/drugs/drug-alerts-and-statements/fda-updates-hand-sanitizers-consumers-should-not-use","date":"2026-04-07","type":"news","title":"FDA updates on hand sanitizers consumers should not use","source":"www.fda.gov"},{"url":"https://cdn.pfizer.com/pfizercom/product-pipeline/050217-Pipeline-Update.pdf","date":"2026-04-07","type":"news","title":"[PDF] Pfizer Pipeline","source":"cdn.pfizer.com"}],"manufacturing":[{"role":"Manufacturer","site":"Shenzhen Lantern Scicence Co.,Ltd.","location":"","operator":"Shenzhen Lantern Scicence Co.,Ltd."}],"molecularData":{"oral":false,"chemblId":"CHEMBL2109042","moleculeType":"Vaccine component","molecularWeight":""},"targetProtein":{"url":"https://www.uniprot.org/uniprot/Q9Y6S7","function":"","geneName":"unknown","organism":"Homo sapiens","uniprotId":"Q9Y6S7","proteinName":"MutL C-terminal dimerisation domain-containing protein","sequenceLength":391,"molecularWeight":43818,"subcellularLocation":""},"_patentsChecked":true,"_warningLetters":[{"date":"03/28/2023","subject":"11/07/2022\tTodos Medical Ltd aka Todos Medical USA Inc\tCenter for Food Safety and Applied Nutrition"},{"date":"03/27/2026","subject":"Feedback form"}],"crossReferences":{"chemblId":"CHEMBL2109042"},"formularyStatus":[],"_offLabelChecked":true,"chemblMechanisms":[{"actionType":null,"targetChemblId":null,"mechanismComment":null,"mechanismOfAction":"Biological vaccine - induces immune response"}],"developmentCodes":[],"ownershipHistory":[{"period":"?-present","_source":"FDA label","companyName":"Shenzhen Lantern Scicence Co.,Ltd.","relationship":"Originator"}],"publicationCount":22,"therapeuticAreas":["Infectious Disease"],"biosimilarFilings":[],"commercialAnalysis":{"text":"Assorted Licensed Hand Sanitizer Grape 01, licensed by Pfizer, is a product in the hand sanitizer market. According to Precedence Research, the hand sanitizer market size is expected to hit USD 9.47 billion by 2035 [1]. As of 2026, the market size is estimated to be USD 7.57 billion, with a CAGR of 2.6% from 2026 to 2033 [2]. This growth is driven by the increasing demand for hygiene products due to the COVID-19 pandemic.\n\nThe competitive landscape of the hand sanitizer market is dominated by various players, including Pfizer. However, the market is expected to face threats from patent cliffs and label expansions. For instance, the expiration of patents for existing hand sanitizer products may lead to increased competition and decreased revenue for Pfizer [3]. Additionally, the market may see the entry of new pipeline competitors, which could further intensify competition.\n\nKey upcoming catalysts for the hand sanitizer market include the expansion of distribution channels and the increasing demand for eco-friendly products. According to Coherent Market Insights, the hand sanitizer market is expected to grow significantly due to the increasing adoption of hand sanitizers in various distribution channels, including e-commerce and hypermarkets/supermarkets [2]. Furthermore, the market is expected to see a shift towards eco-friendly products, which could provide opportunities for Pfizer to expand its product portfolio.\n\nIn conclusion, the hand sanitizer market is expected to continue growing, driven by the increasing demand for hygiene products. However, Pfizer's Assorted Licensed Hand Sanitizer Grape 01 may face threats from patent cliffs and label expansions. The company should focus on expanding its distribution channels and developing eco-friendly products to stay competitive in the market.\n\nReferences:\n[1] Precedence Research, [No Date]\n[2] Coherent Market Insights, 16 Mar, 2026\n[3] Limited data available on patent cliffs and label expansions for Pfizer's Assorted Licensed Hand Sanitizer Grape 01.","model":"llama-3.1-8b (Groq)","sources":[{"url":"https://www.precedenceresearch.com/hand-sanitizer-market","date":"","title":"Hand Sanitizer Market Size to Hit USD 9.47 Billion By 2035","source":"www.precedenceresearch.com"},{"url":"https://www.coherentmarketinsights.com/market-insight/hand-sanitizer-market-5235","date":"","title":"Hand Sanitizer Market Size, Share and Analysis, 2026-2033","source":"www.coherentmarketinsights.com"},{"url":"https://www.globalstocks.in/stock-offers/usa/health-beauty/for-sale-kids-licensed-hand-sanitizer-084-oz-usa/37940","date":"","title":"For Sale Kids Licensed Hand Sanitizer 0.84 oz USA","source":"www.globalstocks.in"}],"disclaimer":"AI-generated analysis based on public sources. Verify with primary sources for investment decisions.","generatedDate":"2026-04-07"},"recentPublications":[{"pmid":"41675207","title":"Uptake of Newly Licensed Influenza Vaccine Formulations Among Patients Receiving Chronic Hemodialysis During the 2010/2011 to 2021/2022 Influenza Seasons.","authors":"Sahrmann JM, Layton JB, Nickel KB, Davis JW, Dharnidharka VR","journal":"Kidney Med","pubDate":"2026 Mar"}],"_drugWebsiteChecked":true,"participantFlowData":[{"nctId":"NCT06178991","groups":[{"id":"FG000","title":"Cohort 1, Arm A: Influenza Vaccine and COVID-19 Vaccine (Combination A) and Placebo","description":"Participants 18 to 64 years of age were administered with Influenza vaccine and coronavirus disease 2019 (COVID-19) vaccine (combination A) and placebo, intramuscularly on Day 1."},{"id":"FG001","title":"Cohort 1, Arm B: COVID-19 Vaccine and Licensed Influenza Vaccine Concomitant Administration","description":"Participants 18 to 64 years of age were administered concomitantly with 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Study","milestones":[{"type":"STARTED","counts":{"FG000":"313","FG001":"160","FG002":"3142","FG003":"1572","FG004":"1197","FG005":"1195","FG006":"607","FG007":"609"}},{"type":"Vaccinated","counts":{"FG000":"309","FG001":"159","FG002":"3127","FG003":"1563","FG004":"1189","FG005":"1191","FG006":"605","FG007":"607"}},{"type":"COMPLETED","counts":{"FG000":"304","FG001":"148","FG002":"2938","FG003":"1468","FG004":"1110","FG005":"1125","FG006":"571","FG007":"583"}},{"type":"NOT COMPLETED","counts":{"FG000":"9","FG001":"12","FG002":"204","FG003":"104","FG004":"87","FG005":"70","FG006":"36","FG007":"26"}}],"dropWithdraws":[{"type":"Withdrawal by Subject","counts":{"FG000":"2","FG001":"6","FG002":"44","FG003":"23","FG004":"7","FG005":"7","FG006":"7","FG007":"5"}},{"type":"Lost to Follow-up","counts":{"FG000":"2","FG001":"4","FG002":"133","FG003":"65","FG004":"68","FG005":"57","FG006":"25","FG007":"18"}},{"type":"Death","counts":{"FG000":"1","FG001":"0","FG002":"2","FG003":"1","FG004":"1","FG005":"0","FG006":"1","FG007":"1"}},{"type":"Randomized but not Vaccinated","counts":{"FG000":"4","FG001":"1","FG002":"15","FG003":"9","FG004":"8","FG005":"4","FG006":"2","FG007":"2"}},{"type":"Other: Unspecified","counts":{"FG000":"0","FG001":"1","FG002":"7","FG003":"6","FG004":"1","FG005":"1","FG006":"1","FG007":"0"}},{"type":"Physician Decision","counts":{"FG000":"0","FG001":"0","FG002":"2","FG003":"0","FG004":"2","FG005":"1","FG006":"0","FG007":"0"}},{"type":"Protocol 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Placebo","lowerLimit":"69.4","upperLimit":"79.4"},{"value":"59.1","spread":"","groupId":"OG001","groupTitle":"Cohort 1, Arm B: COVID-19 Vaccine and Licensed Influenza Vaccine Concomitant Administration","lowerLimit":"51.1","upperLimit":"66.8"}],"analyses":[],"paramType":"NUMBER","timeFrame":"From Day 1 through Day 7 after Vaccination [Vaccination on Day 1]","description":"Local reactions included redness, swelling, and pain at the injection site, were recorded in the electronic dairy (e-diary) or case report form (CRF) after vaccination. Local reactions were graded per the 'Local Reaction Grading Scale' per protocol. Percentage of participants with at least 1 local reaction of grade 1 and above were reported in this outcome measure.","unitOfMeasure":"Percentage of participants","reportingStatus":"POSTED"},{"type":"PRIMARY","title":"Cohort 2: Percentage of Participants With Any Local Reactions for up to 7 Days Following Vaccination in Investigational Vaccine Extremity","results":[{"value":"73.4","spread":"","groupId":"OG000","groupTitle":"Cohort 2, Arm C: Influenza Vaccine and COVID-19 Vaccine (Combination B) and Placebo","lowerLimit":"71.8","upperLimit":"75.0"},{"value":"63.5","spread":"","groupId":"OG001","groupTitle":"Cohort 2, Arm D: COVID-19 Vaccine and Licensed Influenza Vaccine Concomitant Administration","lowerLimit":"61.0","upperLimit":"65.9"}],"analyses":[],"paramType":"NUMBER","timeFrame":"From Day 1 through Day 7 after Vaccination [Vaccination on Day1]","description":"Local reactions included redness, swelling, and pain at the injection site, were recorded in the e-diary or CRF after vaccination. Local reactions were graded per the 'Local Reaction Grading Scale' per protocol. Percentage of participants with at least 1 local reaction of grade 1 and above were reported in this outcome measure.","unitOfMeasure":"Percentage of participants","reportingStatus":"POSTED"},{"type":"PRIMARY","title":"Cohort 3: Percentage of Participants With Any Local Reactions for up to 7 Days Following Vaccination in Investigational Vaccine Extremity","results":[{"value":"73.4","spread":"","groupId":"OG000","groupTitle":"Cohort 3, Arm E: Influenza Vaccine and COVID-19 Vaccine (Combination B)","lowerLimit":"70.8","upperLimit":"75.9"},{"value":"62.5","spread":"","groupId":"OG001","groupTitle":"Cohort 3, Arm F: COVID-19 Vaccine","lowerLimit":"59.6","upperLimit":"65.2"},{"value":"34.8","spread":"","groupId":"OG002","groupTitle":"Cohort 3, Arm G: Licensed Influenza Vaccine","lowerLimit":"31.0","upperLimit":"38.7"},{"value":"66.3","spread":"","groupId":"OG003","groupTitle":"Cohort 3, Arm H: Investigational Influenza Vaccine","lowerLimit":"62.4","upperLimit":"70.1"}],"analyses":[],"paramType":"NUMBER","timeFrame":"From Day 1 through Day 7 after Vaccination [Vaccination on Day 1]","description":"Local reactions included redness, swelling, and pain at the injection site, were recorded in the e-diary or CRF after vaccination. Local reactions were graded per the 'Local Reaction Grading Scale' per protocol. Percentage of participants with at least 1 local reaction of grade 1 and above were reported in this outcome measure.","unitOfMeasure":"Percentage of participants","reportingStatus":"POSTED"},{"type":"PRIMARY","title":"Cohort 1: Percentage of Participants With Any Systemic Events for up to 7 Days Following Vaccination","results":[{"value":"71.8","spread":"","groupId":"OG000","groupTitle":"Cohort 1, Arm A: Influenza Vaccine and COVID-19 Vaccine (Combination A) and Placebo","lowerLimit":"66.4","upperLimit":"76.7"},{"value":"54.1","spread":"","groupId":"OG001","groupTitle":"Cohort 1, Arm B: COVID-19 Vaccine and Licensed Influenza Vaccine Concomitant Administration","lowerLimit":"46.0","upperLimit":"62.0"}],"analyses":[],"paramType":"NUMBER","timeFrame":"From Day 1 through Day 7 after Vaccination [Vaccination on Day 1]","description":"Systemic events including fever, vomiting, diarrhea, headache, fatigue, chills, new or worsened muscle pain and new or worsened joint pain were recorded in an e-diary or CRF after vaccination. Systemic events were graded per the 'Systemic Events Grading Scale' per protocol. Percentage of participants with at least 1 systemic event of grade 1 and above were reported in this outcome measure.","unitOfMeasure":"Percentage of participants","reportingStatus":"POSTED"},{"type":"PRIMARY","title":"Cohort 2: Percentage of Participants With Any Systemic Events for up to 7 Days Following Vaccination","results":[{"value":"70.8","spread":"","groupId":"OG000","groupTitle":"Cohort 2, Arm C: Influenza Vaccine and COVID-19 Vaccine (Combination B) and Placebo","lowerLimit":"69.2","upperLimit":"72.4"},{"value":"59.9","spread":"","groupId":"OG001","groupTitle":"Cohort 2, Arm D: COVID-19 Vaccine and Licensed Influenza Vaccine Concomitant Administration","lowerLimit":"57.4","upperLimit":"62.3"}],"analyses":[],"paramType":"NUMBER","timeFrame":"From Day 1 through Day 7 after Vaccination [Vaccination on Day 1]","description":"Systemic events including fever, vomiting, diarrhea, headache, fatigue, chills, new or worsened muscle pain and new or worsened joint pain were recorded in an e-diary or CRF after vaccination. Systemic events were graded per the 'Systemic Events Grading Scale' per protocol. Percentage of participants with at least 1 systemic event of grade 1 and above were reported in this outcome measure.","unitOfMeasure":"Percentage of participants","reportingStatus":"POSTED"},{"type":"PRIMARY","title":"Cohort 3: Percentage of Participants With Any Systemic Events for up to 7 Days Following Vaccination","results":[{"value":"66.7","spread":"","groupId":"OG000","groupTitle":"Cohort 3, Arm E: Influenza Vaccine and COVID-19 Vaccine (Combination B)","lowerLimit":"63.9","upperLimit":"69.4"},{"value":"52.1","spread":"","groupId":"OG001","groupTitle":"Cohort 3, Arm F: COVID-19 Vaccine","lowerLimit":"49.2","upperLimit":"55.0"},{"value":"43.9","spread":"","groupId":"OG002","groupTitle":"Cohort 3, Arm G: Licensed Influenza Vaccine","lowerLimit":"39.9","upperLimit":"47.9"},{"value":"61.1","spread":"","groupId":"OG003","groupTitle":"Cohort 3, Arm H: Investigational Influenza Vaccine","lowerLimit":"57.0","upperLimit":"65.0"}],"analyses":[],"paramType":"NUMBER","timeFrame":"From Day 1 through Day 7 after Vaccination [Vaccination on Day 1]","description":"Systemic events including fever, vomiting, diarrhea, headache, fatigue, chills, new or worsened muscle pain and new or worsened joint pain were recorded in an e-diary or CRF after vaccination. Systemic events were graded per the 'Systemic Events Grading Scale' per protocol. Percentage of participants with at least 1 systemic event of grade 1 and above were reported in this outcome measure.","unitOfMeasure":"Percentage of participants","reportingStatus":"POSTED"},{"type":"PRIMARY","title":"Cohort 1: Percentage of Participants Reporting Adverse Events (AEs) From Vaccination Through 4 Weeks After Vaccination","results":[{"value":"5.8","spread":"","groupId":"OG000","groupTitle":"Cohort 1, Arm A: Influenza Vaccine and COVID-19 Vaccine (Combination A) and Placebo","lowerLimit":"3.5","upperLimit":"9.1"},{"value":"10.1","spread":"","groupId":"OG001","groupTitle":"Cohort 1, Arm B: COVID-19 Vaccine and Licensed Influenza Vaccine Concomitant Administration","lowerLimit":"5.9","upperLimit":"15.8"}],"analyses":[],"paramType":"NUMBER","timeFrame":"From Vaccination on Day 1 through 4 Weeks after Vaccination","description":"An AE was defined as any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. AEs included both serious and all non-serious AEs. Serious AE (SAE) was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria - resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, any other pre-specified criteria in protocol of the study or other important medical event. Only AEs collected by non-systematic assessment (excluding local reactions and systematic events) were included in this outcome measure.","unitOfMeasure":"Percentage of participants","reportingStatus":"POSTED"},{"type":"PRIMARY","title":"Cohort 2: Percentage of Participants Reporting AEs From Vaccination Through 4 Weeks After Vaccination","results":[{"value":"6.4","spread":"","groupId":"OG000","groupTitle":"Cohort 2, Arm C: Influenza Vaccine and COVID-19 Vaccine (Combination B) and Placebo","lowerLimit":"5.6","upperLimit":"7.3"},{"value":"6.1","spread":"","groupId":"OG001","groupTitle":"Cohort 2, Arm D: COVID-19 Vaccine and Licensed Influenza Vaccine Concomitant Administration","lowerLimit":"4.9","upperLimit":"7.4"}],"analyses":[],"paramType":"NUMBER","timeFrame":"From Vaccination on Day 1 through 4 Weeks after Vaccination","description":"An AE was defined as any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. AEs included both serious and all non-serious AEs. SAE was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria - resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, any other pre-specified criteria in protocol of the study or other important medical event. Only AEs collected by non-systematic assessment (excluding local reactions and systematic events) were included in this outcome measure.","unitOfMeasure":"Percentage of participants","reportingStatus":"POSTED"},{"type":"PRIMARY","title":"Cohort 3: Percentage of Participants Reporting AEs From Vaccination Through 4 Weeks After Vaccination","results":[{"value":"3.8","spread":"","groupId":"OG000","groupTitle":"Cohort 3, Arm E: Influenza Vaccine and COVID-19 Vaccine (Combination B)","lowerLimit":"2.8","upperLimit":"5.0"},{"value":"4.8","spread":"","groupId":"OG001","groupTitle":"Cohort 3, Arm F: COVID-19 Vaccine","lowerLimit":"3.6","upperLimit":"6.2"},{"value":"4.1","spread":"","groupId":"OG002","groupTitle":"Cohort 3, Arm G: Licensed Influenza Vaccine","lowerLimit":"2.7","upperLimit":"6.0"},{"value":"4.1","spread":"","groupId":"OG003","groupTitle":"Cohort 3, Arm H: Investigational Influenza Vaccine","lowerLimit":"2.7","upperLimit":"6.0"}],"analyses":[],"paramType":"NUMBER","timeFrame":"From Vaccination on Day 1 through 4 Weeks after Vaccination","description":"An AE was defined as any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. AEs included both serious and all non-serious AEs. SAE was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria - resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, any other pre-specified criteria in protocol of the study or other important medical event. Only AEs collected by non-systematic assessment (excluding local reactions and systematic events) were included in this outcome measure.","unitOfMeasure":"Percentage of participants","reportingStatus":"POSTED"},{"type":"PRIMARY","title":"Cohort 1: Percentage of Participants Reporting SAEs From Vaccination Through 6 Months After Vaccination","results":[{"value":"0.6","spread":"","groupId":"OG000","groupTitle":"Cohort 1, Arm A: Influenza Vaccine and COVID-19 Vaccine (Combination A) and Placebo","lowerLimit":"0.1","upperLimit":"2.3"},{"value":"2.5","spread":"","groupId":"OG001","groupTitle":"Cohort 1, Arm B: COVID-19 Vaccine and Licensed Influenza Vaccine Concomitant Administration","lowerLimit":"0.7","upperLimit":"6.3"}],"analyses":[],"paramType":"NUMBER","timeFrame":"From Vaccination on Day 1 through 6 Months after Vaccination","description":"SAE was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria - resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, and any other pre-specified criteria in protocol of the study or other important medical event.","unitOfMeasure":"Percentage of participants","reportingStatus":"POSTED"},{"type":"PRIMARY","title":"Cohort 2: Percentage of Participants Reporting SAEs From Vaccination Through 6 Months After Vaccination","results":[{"value":"0.7","spread":"","groupId":"OG000","groupTitle":"Cohort 2, Arm C: Influenza Vaccine and COVID-19 Vaccine (Combination B) and Placebo","lowerLimit":"0.5","upperLimit":"1.1"},{"value":"1.4","spread":"","groupId":"OG001","groupTitle":"Cohort 2, Arm D: COVID-19 Vaccine and Licensed Influenza Vaccine Concomitant Administration","lowerLimit":"0.9","upperLimit":"2.1"}],"analyses":[],"paramType":"NUMBER","timeFrame":"From Vaccination on Day 1 through 6 Months after Vaccination","description":"SAE was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria - resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, and any other pre-specified criteria in protocol of the study or other important medical event.","unitOfMeasure":"Percentage of participants","reportingStatus":"POSTED"},{"type":"PRIMARY","title":"Cohort 3: Percentage of Participants Reporting SAEs From Vaccination Through 6 Months After Vaccination","results":[{"value":"0.8","spread":"","groupId":"OG000","groupTitle":"Cohort 3, Arm E: Influenza Vaccine and COVID-19 Vaccine (Combination B)","lowerLimit":"0.4","upperLimit":"1.5"},{"value":"1.3","spread":"","groupId":"OG001","groupTitle":"Cohort 3, Arm F: COVID-19 Vaccine","lowerLimit":"0.7","upperLimit":"2.1"},{"value":"0.8","spread":"","groupId":"OG002","groupTitle":"Cohort 3, Arm G: Licensed Influenza Vaccine","lowerLimit":"0.3","upperLimit":"1.9"},{"value":"1.2","spread":"","groupId":"OG003","groupTitle":"Cohort 3, Arm H: Investigational Influenza Vaccine","lowerLimit":"0.5","upperLimit":"2.4"}],"analyses":[],"paramType":"NUMBER","timeFrame":"From Vaccination on Day 1 through 6 Months after Vaccination","description":"SAE was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria - resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, and any other pre-specified criteria in protocol of the study or other important medical event.","unitOfMeasure":"Percentage of participants","reportingStatus":"POSTED"},{"type":"PRIMARY","title":"Cohort 2: Geometric Mean Titer (GMT) and Geometric Mean Ratio (GMR) of Strain-Specific Hemagglutination Inhibition Assay (HAI) Titers at 4 Weeks After Vaccination: Non-inferiority","results":[{"value":"37.4","spread":"","groupId":"OG000","groupTitle":"Cohort 2, Arm C: Influenza Vaccine and COVID-19 Vaccine (Combination B) and Placebo","lowerLimit":"35.5","upperLimit":"39.5"},{"value":"56.4","spread":"","groupId":"OG001","groupTitle":"Cohort 2, Arm D: COVID-19 Vaccine and Licensed Influenza Vaccine Concomitant Administration","lowerLimit":"52.4","upperLimit":"60.6"}],"analyses":[{"ciPct":"95","pValue":"","ciLower":"1.25","ciUpper":"1.52","groupIds":["OG000","OG001"],"estimateType":"GMR","estimateValue":"1.38","pValueComment":"","dispersionType":"","dispersionValue":"","groupDescription":"H1N1","statisticalMethod":"","statisticalComment":"","testedNonInferiority":"NON_INFERIORITY"},{"ciPct":"95","pValue":"","ciLower":"1.58","ciUpper":"1.86","groupIds":["OG000","OG001"],"estimateType":"GMR","estimateValue":"1.71","pValueComment":"","dispersionType":"","dispersionValue":"","groupDescription":"H3N2","statisticalMethod":"","statisticalComment":"","testedNonInferiority":"NON_INFERIORITY"},{"ciPct":"95","pValue":"","ciLower":"0.61","ciUpper":"0.73","groupIds":["OG000","OG001"],"estimateType":"GMR","estimateValue":"0.66","pValueComment":"","dispersionType":"","dispersionValue":"","groupDescription":"Victoria","statisticalMethod":"","statisticalComment":"","testedNonInferiority":"NON_INFERIORITY"}],"paramType":"GEOMETRIC_MEAN","timeFrame":"At 4 Weeks after Vaccination","description":"GMTs and the corresponding 2-sided confidence interval (CIs) were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). Assay results below the lower limit of quantitation (LLOQ) were set to 0.5 \\*LLOQ. GMTs were reported in the descriptive data section of this outcome measure. GMRs were reported in the statistical analysis section. Data was reported for the following strains: H1N1, H3N2 and Victoria.","unitOfMeasure":"Titer","reportingStatus":"POSTED"},{"type":"PRIMARY","title":"Cohort 2: Percentage of Participants and Difference in Percentage of Participants With Strain-Specific HAI Seroconversion at 4 Weeks After Vaccination: Non-inferiority","results":[{"value":"31.7","spread":"","groupId":"OG000","groupTitle":"Cohort 2, Arm C: Influenza Vaccine and COVID-19 Vaccine (Combination B) and Placebo","lowerLimit":"29.6","upperLimit":"33.8"},{"value":"45.4","spread":"","groupId":"OG001","groupTitle":"Cohort 2, Arm D: COVID-19 Vaccine and Licensed Influenza Vaccine Concomitant Administration","lowerLimit":"42.2","upperLimit":"48.6"}],"analyses":[{"ciPct":"95","pValue":"","ciLower":"14.1","ciUpper":"21.6","groupIds":["OG000","OG001"],"estimateType":"Difference in percentage of participants","estimateValue":"17.9","pValueComment":"","dispersionType":"","dispersionValue":"","groupDescription":"H1N1","statisticalMethod":"","statisticalComment":"","testedNonInferiority":"NON_INFERIORITY"},{"ciPct":"95","pValue":"","ciLower":"21.7","ciUpper":"29.3","groupIds":["OG000","OG001"],"estimateType":"Difference in percentage of participants","estimateValue":"25.6","pValueComment":"","dispersionType":"","dispersionValue":"","groupDescription":"H3N2","statisticalMethod":"","statisticalComment":"","testedNonInferiority":"NON_INFERIORITY"},{"ciPct":"95","pValue":"","ciLower":"-17.5","ciUpper":"-10.0","groupIds":["OG000","OG001"],"estimateType":"Difference in percentage of participants","estimateValue":"-13.7","pValueComment":"","dispersionType":"","dispersionValue":"","groupDescription":"Victoria","statisticalMethod":"","statisticalComment":"","testedNonInferiority":"NON_INFERIORITY"}],"paramType":"NUMBER","timeFrame":"At 4 Weeks after Vaccination","description":"Seroconversion was defined as having an HAI titer \\<1:10 prior to vaccination and greater than or equal to (\\>=) 1:40 at the postvaccination time point of interest, or an HAI titer of \\>=1:10 prior to vaccination with a minimum 4-fold rise at the postvaccination time point of interest. Percentage of participants with seroconversion were reported in the descriptive data section of this outcome measure. Difference in percentage of participants with seroconversion were reported in the statistical analysis section. Data was reported for the following strains: H1N1, H3N2 and Victoria.","unitOfMeasure":"Percentage of participants","reportingStatus":"POSTED"},{"type":"PRIMARY","title":"Cohort 2: GMT and GMR of Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) Neutralizing Titers at 4 Weeks After Vaccination: Non-inferiority","results":[{"value":"3535.1","spread":"","groupId":"OG000","groupTitle":"Cohort 2, Arm C: Influenza Vaccine and COVID-19 Vaccine (Combination B) and Placebo","lowerLimit":"3370.0","upperLimit":"3708.4"},{"value":"3476.6","spread":"","groupId":"OG001","groupTitle":"Cohort 2, Arm D: COVID-19 Vaccine and Licensed Influenza Vaccine Concomitant Administration","lowerLimit":"3256.7","upperLimit":"3711.4"}],"analyses":[{"ciPct":"95","pValue":"","ciLower":"0.94","ciUpper":"1.10","groupIds":["OG000","OG001"],"estimateType":"GMR","estimateValue":"1.02","pValueComment":"","dispersionType":"","dispersionValue":"","groupDescription":"","statisticalMethod":"","statisticalComment":"","testedNonInferiority":"NON_INFERIORITY"}],"paramType":"GEOMETRIC_MEAN","timeFrame":"At 4 Weeks after Vaccination","description":"GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5 \\*LLOQ. GMTs were reported in the descriptive data section of this outcome measure. GMRs were reported in the statistical analysis section.","unitOfMeasure":"Titer","reportingStatus":"POSTED"},{"type":"PRIMARY","title":"Cohort 2: Percentage of Participants and Difference in Percentage of Participants With SARS-CoV-2 Seroresponse at 4 Weeks After Vaccination: Non-inferiority","results":[{"value":"75.5","spread":"","groupId":"OG000","groupTitle":"Cohort 2, Arm C: Influenza Vaccine and COVID-19 Vaccine (Combination B) and Placebo","lowerLimit":"73.9","upperLimit":"77.1"},{"value":"73.7","spread":"","groupId":"OG001","groupTitle":"Cohort 2, Arm D: COVID-19 Vaccine and Licensed Influenza Vaccine Concomitant Administration","lowerLimit":"71.4","upperLimit":"76.0"}],"analyses":[{"ciPct":"95","pValue":"","ciLower":"-0.9","ciUpper":"4.6","groupIds":["OG000","OG001"],"estimateType":"Difference in percentage of participants","estimateValue":"1.8","pValueComment":"","dispersionType":"","dispersionValue":"","groupDescription":"","statisticalMethod":"","statisticalComment":"","testedNonInferiority":"NON_INFERIORITY"}],"paramType":"NUMBER","timeFrame":"At 4 Weeks after Vaccination","description":"Seroresponse was defined as achieving a postvaccination \\>=4-fold rise from baseline (before the study vaccination). If the baseline measurement was below the LLOQ, the postvaccination measure of \\>=4\\*LLOQ was considered seroresponse. Percentage of participants with seroresponse were reported in the descriptive data section of this outcome measure. Difference in percentage of participants with seroresponse were reported in the statistical analysis section.","unitOfMeasure":"Percentage of participants","reportingStatus":"POSTED"}],"secondaryEndpoints":[{"type":"SECONDARY","title":"Cohort 3: GMT and GMR of Strain-Specific HAI Titers at 4 Weeks After Vaccination: Non-inferiority","results":[{"value":"39.2","spread":"","groupId":"OG000","groupTitle":"Cohort 3, Arm E: Influenza Vaccine and COVID-19 Vaccine (Combination B)","lowerLimit":"36.6","upperLimit":"42.1"},{"value":"67.4","spread":"","groupId":"OG001","groupTitle":"Cohort 3, Arm G: Licensed Influenza Vaccine","lowerLimit":"61.1","upperLimit":"74.3"},{"value":"31.5","spread":"","groupId":"OG002","groupTitle":"Cohort 3, Arm H: Investigational Influenza Vaccine","lowerLimit":"28.6","upperLimit":"34.6"}],"analyses":[{"ciPct":"95","pValue":"","ciLower":"1.01","ciUpper":"1.34","groupIds":["OG000","OG001"],"estimateType":"GMR","estimateValue":"1.16","pValueComment":"","dispersionType":"","dispersionValue":"","groupDescription":"H1N1","statisticalMethod":"","statisticalComment":"","testedNonInferiority":"NON_INFERIORITY"},{"ciPct":"95","pValue":"","ciLower":"0.85","ciUpper":"1.11","groupIds":["OG000","OG002"],"estimateType":"GMR","estimateValue":"0.97","pValueComment":"","dispersionType":"","dispersionValue":"","groupDescription":"H1N1","statisticalMethod":"","statisticalComment":"","testedNonInferiority":"NON_INFERIORITY"},{"ciPct":"95","pValue":"","ciLower":"1.56","ciUpper":"1.97","groupIds":["OG000","OG001"],"estimateType":"GMR","estimateValue":"1.75","pValueComment":"","dispersionType":"","dispersionValue":"","groupDescription":"H3N2","statisticalMethod":"","statisticalComment":"","testedNonInferiority":"NON_INFERIORITY"},{"ciPct":"95","pValue":"","ciLower":"0.82","ciUpper":"1.03","groupIds":["OG000","OG002"],"estimateType":"GMR","estimateValue":"0.92","pValueComment":"","dispersionType":"","dispersionValue":"","groupDescription":"H3N2","statisticalMethod":"","statisticalComment":"","testedNonInferiority":"NON_INFERIORITY"},{"ciPct":"95","pValue":"","ciLower":"0.52","ciUpper":"0.66","groupIds":["OG000","OG001"],"estimateType":"GMR","estimateValue":"0.58","pValueComment":"","dispersionType":"","dispersionValue":"","groupDescription":"Victoria","statisticalMethod":"","statisticalComment":"","testedNonInferiority":"NON_INFERIORITY"},{"ciPct":"95","pValue":"","ciLower":"1.11","ciUpper":"1.40","groupIds":["OG000","OG002"],"estimateType":"GMR","estimateValue":"1.25","pValueComment":"","dispersionType":"","dispersionValue":"","groupDescription":"Victoria","statisticalMethod":"","statisticalComment":"","testedNonInferiority":"NON_INFERIORITY"}],"paramType":"GEOMETRIC_MEAN","timeFrame":"At 4 Weeks after Vaccination","description":"GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5 \\*LLOQ. GMTs were reported in the descriptive data section of this outcome measure. GMRs were reported in the statistical analysis section. 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GMRs were reported in the statistical analysis section.","unitOfMeasure":"Titer","reportingStatus":"POSTED"}]}],"genericManufacturerList":[],"phase":"marketed","status":"active","companyName":"Pfizer","companyId":"pfizer","modality":"Biologic","firstApprovalDate":"","enrichmentLevel":5,"visitCount":8,"regulatoryByCountry":[{"country_code":"US","regulator":"FDA","status":"approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null}],"pricingByCountry":[{"country_code":"US","currency":"USD","price_amount":"80000.00","price_per":"year","price_type":"annual_list","annual_cost_usd":null,"reimbursement_status":null}],"trialStats":{"total":6,"withResults":2},"validation":{"fieldsValidated":3,"lastValidatedAt":"2026-04-19T23:12:19.848785+00:00","fieldsConflicting":0,"overallConfidence":0.95},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}