[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100543389":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":36,"centralContacts":41,"locations":47,"responsibleParty":65,"collaborators":67,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":35,"eligibilityCriteria":77,"healthyVolunteers":78,"sex":79,"minAge":80,"maxAge":35,"enrollmentInfo":81,"targetDuration":35,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":91,"overallStatus":49,"whyStopped":35,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},{"fullName":5,"class":6},"Vaxine Pty Ltd","INDUSTRY",[8,15,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Covid-19 vaccine group","EXPERIMENTAL","Subjects in this group will receive two sublingual doses of COVID-19 vaccine two weeks apart. Three months after the second dose they will receive two sublingual doses of influenza vaccine two weeks apart.",[13,14],"Biological: Covid-19 vaccine","Biological: Influenza vaccine",{"label":16,"type":10,"description":17,"interventionNames":18},"Influenza vaccine group","Subjects in this group will receive two sublingual doses of influenza vaccine two weeks apart. Three months after the second dose they will receive two sublingual doses of COVID-19 vaccine two weeks apart.",[13,14],{"label":20,"type":10,"description":21,"interventionNames":22},"Combined vaccine group","Subjects in this group will receive two sublingual doses of combined COVID-19 and influenza vaccine two weeks apart. Three months after the second dose they will receive two sublingual doses of placebo vaccine two weeks apart.",[13,14],[24,31],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"BIOLOGICAL","Covid-19 vaccine","Recombinant SARS-CoV-2 spike protein with Advax-CpG55.2 adjuvant",[20,9,16],[30],"SARS-CoV-2 vaccine",{"type":25,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"Influenza vaccine","Inactivated seasonal influenza vaccine with Advax-CpG55.2 adjuvant",[20,9,16],null,[37],{"name":38,"affiliation":39,"role":40},"Dimitar Sajkov, MBBS\u002FPhD","ARASMI","PRINCIPAL_INVESTIGATOR",[42],{"name":43,"role":44,"phone":45,"phoneExt":35,"email":46},"Sharen Pringle, GradCert","CONTACT","0437033400","office@arasmi.org",[48],{"facility":39,"status":49,"city":50,"state":51,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"RECRUITING","Adelaide","South Australia","5042","Australia","AU",{"type":56,"coordinates":57},"Point",[58,59],138.59863,-34.92866,{"lat":59,"lon":58},[62,63],{"name":43,"role":44,"phone":45,"phoneExt":35,"email":46},{"name":64,"role":40,"phone":35,"phoneExt":35,"email":35},"Dimitar Sajkov, MBBS",{"type":66,"investigatorFullName":35,"investigatorTitle":35,"investigatorAffiliation":35,"oldNameTitle":35,"oldOrganization":35},"SPONSOR",[68],{"name":69,"class":70},"Australian Respiratory and Sleep Medicine Institute","OTHER","100543389","phase-1-covid-19-and-influenza-oral-vaccine-study-100543389",false,"NCT06355232","Covid-19 and Influenza Oral Vaccine Study","A Binded, Randomised, Controlled Cross-over Trial to Assess the Safety and Efficacy of Mucosal Covid-19 and Influenza Vaccines","Inclusion Criteria:\n\n* Able to provide written informed consent\n* Males or females 18 years of age or older\n* Understand and are likely to comply with planned study procedures and be available for all study visits.\n* Do not plan to have a non-study COVID-19 or influenza vaccine within the next 6 months.\n\nExclusion Criteria:\n\n* Allergy to COVID-19 or seasonal influenza vaccine or one of its components e.g. polysorbate 80.\n* Have received a COVID-19 or influenza vaccine or an experimental agent within 30 days prior to the study vaccination or expect to receive another experimental agent or a COVID-19 or influenza vaccine during the trial reporting period.\n* Any serious medical, social or mental condition which, in the opinion of the investigator, would be detrimental to the subjects or the study.",true,"ALL","18 Years",{"count":82,"type":83},100,"ESTIMATED","INTERVENTIONAL",[86],"PHASE1","The purpose of the current study is to assess the effectiveness of protein-based COVID-19 or influenza vaccines when given individually or together via oral\u002F sublingual mucosal route instead of intramuscular delivery. The comparator will be a seasonal influenza vaccine which will also be administered with Advax-CpG adjuvant via the oral route. This study will use a cross-over design and everyone in the study will over a space of about 4 months receive both the COVID-19 and influenza vaccines.",[89,90],"covid19 Infection","Influenza, Human",[92,93,94,95,96,97,98,99],"covid-19","influenza","pandemic","mucosal","spikogen","advax","adjuvant","vaccine","2025-09-16",{"date":102,"type":103},"2025-09-17","ACTUAL",{"date":105,"type":103},"2024-05-01",{"date":107,"type":83},"2026-12-31",{"name":5,"class":6},1]