[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100617106":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":18,"locations":29,"responsibleParty":41,"collaborators":44,"id":46,"slug":47,"hasResults":48,"nctId":49,"briefTitle":50,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":53,"sex":54,"minAge":55,"maxAge":56,"enrollmentInfo":57,"targetDuration":18,"studyType":60,"phases":61,"briefSummary":63,"conditions":64,"keywords":66,"overallStatus":71,"whyStopped":18,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":81},{"fullName":5,"class":6},"Karolinska Institutet","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Concomitant HPV vaccination and screening intervention arm","EXPERIMENTAL","Eligible women were invited by letter, push notification (via their personal mobile telephones) to attend a vaccination site for concomitant HPV vaccination (with the nonavalent vaccine Gardasil 9) and HPV-based cervical screening (using a self-sample). After 3 years women who had received their first vaccine dose were invited to receive a second dose of the nonavalent HPV vaccine and to give a second screening sample.",[13],"Biological: Gardasil 9 2 dose regimen",{"label":15,"type":16,"description":17,"interventionNames":18},"Unvaccinated comparison group","NO_INTERVENTION","The unvaccinated comparison group will be comprised of unvaccinated women attending routine screening in Sweden (whole trial or Stockholm region in the piloting phase).",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"BIOLOGICAL","Gardasil 9 2 dose regimen","Women ages 22-26 will be offered concomitant vaccination (1 dose of Gardasil9) and HPV screening. A second dose of Gardasil9 will be administered 3 years later.",[9],[26],{"name":27,"affiliation":5,"role":28},"Joakim Dillner, MD PhD","PRINCIPAL_INVESTIGATOR",[30],{"facility":31,"status":18,"city":32,"state":18,"zip":18,"country":33,"countryCode":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":18},"Karolinska University Hospital","Stockholm","Sweden","SE",{"type":36,"coordinates":37},"Point",[38,39],18.06871,59.32938,{"lat":39,"lon":38},{"type":28,"investigatorFullName":42,"investigatorTitle":43,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Joakim Dillner","Professor",[45],{"name":31,"class":6},"100617106","phase-4-vaccine-effectiveness-of-one-dose-of-the-nonavalent-human-papillomavirus-hpv-vaccine-among-young-adult-women-in-sweden-among-women-participating-in-a-clinical-trial-of-concomitant-hpv-vaccination-and-screening-100617106",false,"NCT07314307","Vaccine Effectiveness of One Dose of the Nonavalent Human Papillomavirus (HPV) Vaccine Among Young-adult Women in Sweden Among Women Participating in a Clinical Trial of Concomitant HPV Vaccination and Screening","FASTER1DOSE","Inclusion Criteria:\n\n* Eligible women will include resident women born between 1994-1999 (1993-1999 in the non intervention arm), who have not opted out of the screening program and who consent to participate in the study.\n\nExclusion Criteria:\n\n* Known history of severe allergic reaction or hypersensitivity to any of the components of the HPV vaccine.For GARDASIL 9: Amorphous aluminium hydroxyphosphate sulphate adjuvant, Sodium chloride, L-histidine, Polysorbate 80 or Sodium borate\n* Known history of immune-related disorders\n* Current acute severe febrile illness, except for minor infections such as a cold, mild upper respiratory infection or low-grade fever.\n* Administration of immunoglobulin or blood-derived products within 6 months prior to scheduled HPV vaccine first dose\n* Current pregnancy (reported)\n* Women with a total hysterectomy",true,"FEMALE","22 Years","31 Years",{"count":58,"type":59},150000,"ESTIMATED","INTERVENTIONAL",[62],"PHASE4","This study aims to evaluate the vaccine effectiveness of 1 dose the nonavalent human papillomavirus (HPV) vaccine against HPV16, 18, 31, 33, 45, 52, and 58 infection among young adult women in Sweden participating in a nationwide HPV elimination trial.",[65],"Incident HPV16, 18, 31, 33, 45, 52 or 58 Infection",[67,68,69,70],"HPV","Vaccine effectiveness","one dose","Even Faster","ACTIVE_NOT_RECRUITING","2025-12-17",{"date":74,"type":75},"2026-01-02","ACTUAL",{"date":77,"type":75},"2021-05-03",{"date":79,"type":59},"2028-12-31",{"name":5,"class":6},1]