[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100452315":3},{"organization":4,"armGroups":7,"interventions":27,"overallOfficials":40,"centralContacts":33,"locations":44,"responsibleParty":67,"collaborators":33,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":33,"eligibilityCriteria":75,"healthyVolunteers":71,"sex":76,"minAge":77,"maxAge":78,"enrollmentInfo":79,"targetDuration":33,"studyType":82,"phases":83,"briefSummary":85,"conditions":86,"keywords":88,"overallStatus":96,"whyStopped":33,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},{"fullName":5,"class":6},"GlaxoSmithKline","INDUSTRY",[8,15,19,23],{"label":9,"type":10,"description":11,"interventionNames":12},"RSV_dTpa-P Group","EXPERIMENTAL","Healthy non-pregnant girls 9-17 years of age received a single dose of RSV MAT vaccine at Day 1 and were scheduled to receive a single dose of dTpa vaccine at Day 31 and to be followed-up until end of study (180 days post-vaccine administration). Participants who were enrolled and were due to receive the dTpa vaccine at Day 31, did no longer receive the dTpa as part of this study, but they were provided with an option to decide to receive dTpa vaccination as part of standard of care\u002Flocal recommendation on immunization.",[13,14],"Combination Product: RSV MAT vaccine","Combination Product: dTpa vaccine",{"label":16,"type":10,"description":17,"interventionNames":18},"dTpa_RSV-P Group","Healthy non-pregnant girls 9-17 years of age were scheduled to receive a single dose of dTpa vaccine at Day 1 and a single dose of RSV MAT vaccine at Day 31 and to be followed-up until end of study (180 days post-vaccine administration), but there were no participants assigned to this study group, and hence, there was no vaccine administered in this study group.",[13,14],{"label":20,"type":10,"description":21,"interventionNames":22},"RSV_dTpa-A Group","Healthy non-pregnant adult women 18-49 years of age received a single dose of RSV MAT vaccine at Day 1 and were scheduled to receive a single dose of dTpa vaccine at Day 31 and to be followed-up until end of study (180 days post-vaccine administration). Participants who were enrolled and were due to receive the dTpa vaccine at Day 31, did no longer receive the dTpa as part of this study, but they were provided with an option to decide to receive dTpa vaccination as part of standard of care\u002Flocal recommendation on immunization.",[13,14],{"label":24,"type":10,"description":25,"interventionNames":26},"dTpa_RSV-A Group","Healthy non-pregnant adult women 18-49 years of age received a single dose of dTpa vaccine at Day 1 and were scheduled to receive a single dose of RSV MAT vaccine at Day 31 and to be followed-up until end of study (180 days post-vaccine administration). RSV MAT vaccine was no longer administered to participants at Day 31.",[13,14],[28,34],{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"COMBINATION_PRODUCT","RSV MAT vaccine","Single dose of the RSV MAT vaccine reconstituted with NaCl solution was planned to be administered intramuscularly, in the non-dominant arm, at Day 1 or at Day 31, depending on the vaccination schedule.\n\nRSV MAT vaccine was no longer administered to participants at Day 31. No vaccine was administered in the dTpa\\_RSV-P Group, since there were no participants assigned to it.",[20,9,24,16],null,{"type":29,"name":35,"description":36,"armGroupLabels":37,"otherNames":38},"dTpa vaccine","Single dose of the dTpa vaccine was planned to be administered intramuscularly, in the non-dominant arm, at Day 1 or at Day 31, depending on the vaccination schedule.\n\nTwo formulations of dTpa vaccine are licensed in the US and outside of the US (ex-US), respectively. dTpa-US formulation was administered to participants in centers located in the US, while dTpa-ex-US formulation was planned to be administered to participants in centers ex-US. The dTpa-ex-US formulation was not applicable in this study anymore as no non-US sites were initiated before the decision to stop the study.\n\nThe participants in RSV\\_dTpa-P and RSV\\_dTpa-A study groups were provided with an option to decide to receive dTpa vaccination as part of standard of care\u002Flocal recommendation on immunization.\n\nNo vaccine was administered in the dTpa\\_RSV-P Group, since there were no participants assigned to it.",[20,9,24,16],[39],"Boostrix",[41],{"name":42,"affiliation":5,"role":43},"GSK Clinical Trials","STUDY_DIRECTOR",[45,58],{"facility":46,"status":33,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":33},"GSK Investigational Site","Miami","Florida","33142","United States","US",{"type":53,"coordinates":54},"Point",[55,56],-80.19366,25.77427,{"lat":56,"lon":55},{"facility":46,"status":33,"city":59,"state":60,"zip":61,"country":50,"countryCode":51,"cosmosGeoPoint":62,"geoPoint":66,"contacts":33},"Beaumont","Texas","77706",{"type":53,"coordinates":63},[64,65],-94.10185,30.08605,{"lat":65,"lon":64},{"type":68,"investigatorFullName":33,"investigatorTitle":33,"investigatorAffiliation":33,"oldNameTitle":33,"oldOrganization":33},"SPONSOR","100452315","phase-3-a-study-to-evaluate-the-safety-and-immune-response-to-an-unadjuvanted-rsv-maternal-vaccine-in-healthy-non-pregnant-females-from-9-to-49-years-of-age-100452315",true,"NCT05169905","A Study to Evaluate the Safety and Immune Response to an Unadjuvanted RSV Maternal Vaccine in Healthy Non-pregnant Females From 9 to 49 Years of Age","A Phase III, Randomized, Open-label, Active Vaccine-controlled Crossover Study to Evaluate the Reactogenicity, Safety and Immune Response of Unadjuvanted RSV Maternal Vaccine in Healthy Non-pregnant Girls From 9 to 17 Years of Age, and in Non-pregnant Adult Women From 18 to 49 Years of Age","Inclusion Criteria:\n\nHealthy Non-pregnant Adult Women from 18-49 YOA\n\n* Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol.\n* Written or witnessed\u002Fthumb printed informed consent obtained from the participant prior to performance of any study-specific procedure.\n* A healthy female participant, as established by medical history and clinical examination, between and including 18 to 49 YOA at the time of the first study intervention administration.\n* Body mass index (based on participant's report) 17.0 to 39.9 kg\u002Fm\\^2, inclusive for adult participants.\n* Female participants of childbearing potential may be enrolled in the study, if the participant:\n\n  * has practiced adequate contraception for 1 month prior to study intervention administration, and\n  * has a negative pregnancy test on the day of study intervention administration, and\n  * has agreed to continue adequate contraception during the entire treatment period and for 1 month after completion of the study intervention administrations.\n* Female participants of non-childbearing potential may be enrolled in the study. Non-childbearing potential is defined as, current bilateral tubal ligation or occlusion, hysterectomy, bilateral ovariectomy or post-menopause.\n\nHealthy non-pregnant Girls from 9-17 YOA\n\n* Participants and participants' parent(s)\u002FLegally Acceptable Representative(s) (LAR), who, in the opinion of the investigator, can and will comply with the requirements of the protocol.\n* Written or witnessed\u002Fthumb printed informed consent obtained from the participant\\*\u002Fparent(s)\u002FLAR(s) of the participant prior to performance of any study-specific procedure.\n\n  * \\*Written informed consent obtained from parents\u002FLARs and written informed assent obtained from the participant if she is less than legal age. The legal age is determined according to local regulations in each participating country.\n  * In case the legal age is achieved during the conduct of the study, an additional written informed consent from the participant should be obtained at the time of the legal age.\n* A healthy female participant between and including 9 and 17 YOA at the time of the first study intervention administration.\n\n  * Female participants of non-childbearing potential may be enrolled in the study. Non-childbearing potential is defined as pre-menarche, current bilateral tubal ligation or occlusion, hysterectomy, or bilateral ovariectomy.\n* Body mass index by age between 5 percentile and 95 percentile (inclusive) for pediatric participants.\n* Female participants of childbearing potential may be enrolled in the study, if the participant:\n\n  * has a negative pregnancy test on the day of study intervention administration, and is abstinent during the entire treatment period and for 1 month before and after completion of the study intervention administration series (and if so, this is to be documented in the source documents at each vaccination visit)\n  * or has practiced adequate contraception for 1 month prior to study intervention administration and has agreed to continue adequate contraception during the entire treatment period and for 1 month after completion of the study intervention administration series.\n\nExclusion Criteria:\n\nMedical conditions\n\n* Any clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study.\n* History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention(s).\n* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).\n* Current autoimmune disorder (based on medical history and physical examination), for which the participant has received immune-modifying therapy within 6 months, before study vaccination.\n* Hypersensitivity to latex.\n* Acute or chronic clinically significant abnormality or poorly controlled pre-existent co-morbidities or any other clinical conditions, as determined by physical examination or medical history that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study.\n* Significant or uncontrolled psychiatric illness.\n* Documented human immunodeficiency virus (HIV)-positive participant.\n* Any clinically significant\\* hematological parameter and\u002For biochemical laboratory abnormality from the test requested by the investigator based on medical judgment prior to enrolment\n\n  * \\*The investigator should use his\u002Fher clinical judgment to decide whether the test is needed, and which abnormalities are clinically significant. If he\u002Fshe decides to run this test, the investigator will need to review the test results before proceeding with the administration of the study vaccine.\n* Lymphoproliferative disorder or malignancy within 5 years before study vaccination (excluding effectively treated non-melanoma skin cancer).\n\nPrior\u002FConcomitant therapy\n\n* Use of any investigational or non-registered product (drug, vaccine or medical device) other than the study intervention(s) during the period beginning 30 days before the first doses (Day -29 to Day 1), or their planned use during the study period.\n* Planned administration\u002Fadministration of a vaccine not foreseen by the study protocol within the period starting 30 days before the first dose and ending 30 days after the last dose of study intervention(s)\\* administration with the exception of any licensed influenza vaccine which may be administered ≥ 15 days before or after study vaccinations (dTpa and RSV maternal vaccines).\n\n  * \\*In case emergency mass vaccination for an unforeseen public health threat (e.g. a pandemic) is organized by public health authorities outside the routine immunization program, the time period described above can be reduced if necessary for that vaccine (if it is used according to the local governmental recommendations and that the Sponsor is notified accordingly). Therefore, COVID-19 vaccines will be allowed, when administered ≥ 15 days before or after study vaccinations (dTpa and RSV maternal vaccines).\n* Administration of long-acting immune-modifying drugs at any time during the study period (e.g. infliximab).\n* Administration of immunoglobulins and\u002For any blood products or plasma derivatives during the period starting 3 months before the administration of the first dose of study intervention(s) or planned administration during the study period.\n* Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs during the period starting 3 months prior to the first study intervention dose(s) to 2 months after first vaccination. For corticosteroids, this will mean prednisone equivalent ≥5 mg\u002Fday for adult participants\u002F ≥0.5 mg\u002Fkg\u002Fday. Inhaled and topical steroids are allowed.\n* Previous experimental vaccination against RSV.\n* Boostrix (dTpa) administration for which the vaccination is not aligned with the local recommendations for dTap vaccination or not aligned with the locally approved Boostrix (dTpa) prescribing information.\n\nPrior\u002FConcurrent clinical study experience\n\n• Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational intervention (drug\u002Finvasive medical device).\n\nOther exclusions\n\n* Pregnant or lactating female.\n* Female planning to become pregnant or planning to discontinue contraceptive precautions.\n* Alcoholism or substance use disorder within the past 24 months based on the presence of two or more of the following abuse criteria: hazardous use, social\u002Finterpersonal problems related to use, neglected major roles to use, withdrawal tolerance, use of larger amounts or longer, repeated attempts to quit or control use, much time spent using, physical or psychological problems related to use, activities given up to use, craving.\n* Any study personnel or their immediate dependents, family, or household members.\n* Child in care.","FEMALE","9 Years","49 Years",{"count":80,"type":81},9,"ACTUAL","INTERVENTIONAL",[84],"PHASE3","The purpose of this study was to evaluate the reactogenicity, safety and immune response of a single intramuscular dose of the respiratory syncytial virus maternal (RSV MAT) vaccine in healthy non-pregnant girls 9-17 years of age (YOA) compared to non-pregnant adult women 18-49 YOA. The combined reduced-antigen-content diphtheria, tetanus and acellular pertussis (dTpa) vaccine was planned to be used as an active control for safety and reactogenicity evaluation.\n\nFollowing a recommendation from the Independent Data Monitoring Committee of NCT04605159 (RSV MAT 009), GSK made the decision to stop enrolment and vaccination in this study. Enrolled study participants were monitored as part of the study until study completion.",[87],"Respiratory Syncytial Virus Infections",[89,90,91,92,93,94,95],"Respiratory Syncytial Virus Maternal vaccine","Combined reduced-antigen-content diphtheria, tetanus and acellular pertussis vaccine","Reactogenicity","Safety","Immunogenicity","Healthy non-pregnant girl","Healthy non-pregnant adult women","COMPLETED","2023-04-06",{"date":99,"type":81},"2023-04-07",{"date":101,"type":81},"2022-02-02",{"date":103,"type":81},"2022-08-03",{"name":5,"class":6},2]