[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100639043":3},{"organization":4,"armGroups":7,"interventions":132,"overallOfficials":138,"centralContacts":204,"locations":213,"responsibleParty":280,"collaborators":138,"id":282,"slug":283,"hasResults":284,"nctId":285,"briefTitle":286,"officialTitle":287,"acronym":138,"eligibilityCriteria":288,"healthyVolunteers":289,"sex":290,"minAge":291,"maxAge":292,"enrollmentInfo":293,"targetDuration":138,"studyType":296,"phases":297,"briefSummary":300,"conditions":301,"keywords":303,"overallStatus":216,"whyStopped":138,"lastUpdateSubmitDate":309,"lastUpdatePostDateStruct":310,"startDateStruct":313,"completionDateStruct":315,"leadSponsor":317,"locationsCount":318},{"fullName":5,"class":6},"GlaxoSmithKline","INDUSTRY",[8,14,19,24,29,34,39,44,50,56,61,66,71,76,81,86,90,94,98,103,108,112,116,120,124,128],{"label":9,"type":10,"description":11,"interventionNames":12},"RSV\u002FhMPV_X_low dose_Ph1_Younger Adults (YA) Group","EXPERIMENTAL","YA participants receive a single dose of RSV\u002FhMPV\\_X low dose vaccine in Phase 1, at Day 1.",[13],"Biological: RSV\u002FhMPV_X low dose vaccine",{"label":15,"type":10,"description":16,"interventionNames":17},"RSV\u002FhMPV_X_medium dose_Ph1_YA Group","YA participants receive a single dose of RSV\u002FhMPV\\_X medium dose vaccine in Phase 1, at Day 1.",[18],"Biological: RSV\u002FhMPV_X medium dose vaccine",{"label":20,"type":10,"description":21,"interventionNames":22},"RSV\u002FhMPV_X_high dose_Ph1_YA Group","YA participants receive a single dose of RSV\u002FhMPV\\_X high dose vaccine in Phase 1, at Day 1.",[23],"Biological: RSV\u002FhMPV_X high dose vaccine",{"label":25,"type":10,"description":26,"interventionNames":27},"hMPV_Y_high dose_Ph1_YA Group","YA participants receive a single dose of hMPV\\_Y high dose vaccine in Phase 1, at Day 1.",[28],"Biological: hMPV_Y high dose vaccine",{"label":30,"type":10,"description":31,"interventionNames":32},"hMPV_Z_low dose_Ph1_YA Group","YA participants receive a single dose of hMPV\\_Z low dose vaccine in Phase 1, at Day 1.",[33],"Biological: hMPV_Z low dose vaccine",{"label":35,"type":10,"description":36,"interventionNames":37},"hMPV_Z_medium dose_Ph1_YA Group","YA participants receive a single dose of hMPV\\_Z medium dose vaccine in Phase 1, at Day 1.",[38],"Biological: hMPV_Z medium dose vaccine",{"label":40,"type":10,"description":41,"interventionNames":42},"hMPV_Z_high dose_Ph1_YA Group","YA participants receive a single dose of hMPV\\_Z high dose vaccine in Phase 1, at Day 1.",[43],"Biological: hMPV_Z high dose vaccine",{"label":45,"type":46,"description":47,"interventionNames":48},"Control Vaccine_Ph1_YA Group","ACTIVE_COMPARATOR","YA participants receive a single dose of control vaccine in Phase 1, at Day 1.",[49],"Biological: Control vaccine",{"label":51,"type":52,"description":53,"interventionNames":54},"Placebo_Ph1_YA Group","PLACEBO_COMPARATOR","YA participants receive a single dose of placebo in Phase 1, at Day 1.",[55],"Combination Product: Placebo",{"label":57,"type":10,"description":58,"interventionNames":59},"RSV\u002FhMPV_V_low dose_Ph1 and Ph2_Older Adults (OA) Group","OA participants receive a single dose of RSV\u002FhMPV\\_V low dose vaccine in both Phase 1 and Phase 2, at Day 1.",[60],"Biological: RSV\u002FhMPV_V low dose vaccine",{"label":62,"type":10,"description":63,"interventionNames":64},"RSV\u002FhMPV_V_medium dose_Ph1 and Ph2_OA Group","OA participants receive a single dose of RSV\u002FhMPV\\_V medium dose vaccine in both Phase 1 and Phase 2, at Day 1.",[65],"Biological: RSV\u002FhMPV_V medium dose vaccine",{"label":67,"type":10,"description":68,"interventionNames":69},"RSV\u002FhMPV_V_high dose_Ph1 and Ph2_OA Group","OA participants receive a single dose of RSV\u002FhMPV\\_V high dose vaccine in both Phase 1 and Phase 2, at Day 1.",[70],"Biological: RSV\u002FhMPV_V high dose vaccine",{"label":72,"type":10,"description":73,"interventionNames":74},"RSV\u002FhMPV_W_low dose_Ph1 and Ph2_OA Group","OA participants receive a single dose of RSV\u002FhMPV\\_W low dose vaccine in both Phase 1 and Phase 2, at Day 1.",[75],"Biological: RSV\u002FhMPV_W low dose vaccine",{"label":77,"type":10,"description":78,"interventionNames":79},"RSV\u002FhMPV_W_medium dose_Ph1 and Ph2_OA Group","OA participants receive a single dose of RSV\u002FhMPV\\_W medium dose vaccine in both Phase 1 and Phase 2, at Day 1.",[80],"Biological: RSV\u002FhMPV_W medium dose vaccine",{"label":82,"type":10,"description":83,"interventionNames":84},"RSV\u002FhMPV_W_high dose_Ph1 and Ph2_OA Group","OA participants receive a single dose of RSV\u002FhMPV\\_W high dose vaccine in both Phase 1 and Phase 2, at Day 1.",[85],"Biological: RSV\u002FhMPV_W high dose vaccine",{"label":87,"type":10,"description":88,"interventionNames":89},"RSV\u002FhMPV_X_low dose_Ph1 and Ph2_OA Group","OA participants receive a single dose of RSV\u002FhMPV\\_X low dose vaccine in both Phase 1 and Phase 2, at Day 1.",[13],{"label":91,"type":10,"description":92,"interventionNames":93},"RSV\u002FhMPV_X_medium dose_Ph1 and Ph2_OA Group","OA participants received a single dose of RSV\u002FhMPV\\_X medium dose vaccine in both Phase 1 and Phase 2, at Day 1.",[18],{"label":95,"type":10,"description":96,"interventionNames":97},"RSV\u002FhMPV_X_high dose_Ph1 and Ph2_OA Group","OA participants receive a single dose of RSV\u002FhMPV\\_X high dose vaccine in both Phase 1 and Phase 2, at Day 1.",[23],{"label":99,"type":10,"description":100,"interventionNames":101},"hMPV_Y_low dose_Ph1_OA Group","OA participants receive a single dose of hMPV\\_Y low dose vaccine in Phase 1, at Day 1.",[102],"Biological: hMPV_Y low dose vaccine",{"label":104,"type":10,"description":105,"interventionNames":106},"hMPV_Y_medium dose_Ph1 and Ph2_OA Group","OA participants receive a single dose of hMPV\\_Y medium dose vaccine in both Phase 1 and Phase 2, at Day 1.",[107],"Biological: hMPV_Y medium dose vaccine",{"label":109,"type":10,"description":110,"interventionNames":111},"hMPV_Y_high dose_Ph1 and Ph2_OA Group","OA participants receive a single dose of hMPV\\_Y high dose vaccine in both Phase 1 and Phase 2, at Day 1.",[28],{"label":113,"type":10,"description":114,"interventionNames":115},"hMPV_Z_low dose_Ph1_OA Group","OA participants receive a single dose of hMPV\\_Z low dose vaccine in Phase 1, at Day 1.",[33],{"label":117,"type":10,"description":118,"interventionNames":119},"hMPV_Z_medium dose_Ph1_OA Group","OA participants receive a single dose of hMPV\\_Z medium dose vaccine in Phase 1, at Day 1.",[38],{"label":121,"type":10,"description":122,"interventionNames":123},"hMPV_Z_high dose_Ph1_OA Group","OA participants receive a single dose of hMPV\\_Z high dose vaccine in Phase 1, at Day 1.",[43],{"label":125,"type":46,"description":126,"interventionNames":127},"Control Vaccine_Ph1 and Ph2_OA Group","OA participants receive a single dose of control vaccine in both Phase 1 and Phase 2, at Day 1.",[49],{"label":129,"type":52,"description":130,"interventionNames":131},"Placebo_Ph1 and Ph2_OA Group","OA participants receive a single dose of placebo in both Phase 1 and Phase 2, at Day 1.",[55],[133,139,143,147,151,155,159,163,167,171,175,179,183,187,191,195,199],{"type":134,"name":135,"description":136,"armGroupLabels":137,"otherNames":138},"BIOLOGICAL","RSV\u002FhMPV_V low dose vaccine","RSV\u002FhMPV\\_V low dose vaccine administered intramuscularly.",[57],null,{"type":134,"name":140,"description":141,"armGroupLabels":142,"otherNames":138},"RSV\u002FhMPV_V medium dose vaccine","RSV\u002FhMPV\\_V medium dose vaccine administered intramuscularly.",[62],{"type":134,"name":144,"description":145,"armGroupLabels":146,"otherNames":138},"RSV\u002FhMPV_V high dose vaccine","RSV\u002FhMPV\\_V high dose vaccine administered intramuscularly.",[67],{"type":134,"name":148,"description":149,"armGroupLabels":150,"otherNames":138},"RSV\u002FhMPV_W low dose vaccine","RSV\u002FhMPV\\_W low dose vaccine administered intramuscularly.",[72],{"type":134,"name":152,"description":153,"armGroupLabels":154,"otherNames":138},"RSV\u002FhMPV_W medium dose vaccine","RSV\u002FhMPV\\_W medium dose vaccine administered intramuscularly.",[77],{"type":134,"name":156,"description":157,"armGroupLabels":158,"otherNames":138},"RSV\u002FhMPV_W high dose vaccine","RSV\u002FhMPV\\_W high dose vaccine administered intramuscularly.",[82],{"type":134,"name":160,"description":161,"armGroupLabels":162,"otherNames":138},"RSV\u002FhMPV_X low dose vaccine","RSV\u002FhMPV\\_X low dose vaccine administered intramuscularly.",[87,9],{"type":134,"name":164,"description":165,"armGroupLabels":166,"otherNames":138},"RSV\u002FhMPV_X medium dose vaccine","RSV\u002FhMPV\\_X medium dose vaccine administered intramuscularly.",[91,15],{"type":134,"name":168,"description":169,"armGroupLabels":170,"otherNames":138},"RSV\u002FhMPV_X high dose vaccine","RSV\u002FhMPV\\_X high dose vaccine administered intramuscularly.",[95,20],{"type":134,"name":172,"description":173,"armGroupLabels":174,"otherNames":138},"hMPV_Y low dose vaccine","hMPV\\_Y low dose vaccine administered intramuscularly.",[99],{"type":134,"name":176,"description":177,"armGroupLabels":178,"otherNames":138},"hMPV_Y medium dose vaccine","hMPV\\_Y medium dose vaccine administered intramuscularly.",[104],{"type":134,"name":180,"description":181,"armGroupLabels":182,"otherNames":138},"hMPV_Y high dose vaccine","hMPV\\_Y high dose vaccine administered intramuscularly.",[109,25],{"type":134,"name":184,"description":185,"armGroupLabels":186,"otherNames":138},"hMPV_Z low dose vaccine","hMPV\\_Z low dose vaccine administered intramuscularly.",[113,30],{"type":134,"name":188,"description":189,"armGroupLabels":190,"otherNames":138},"hMPV_Z medium dose vaccine","hMPV\\_Z medium dose vaccine administered intramuscularly.",[117,35],{"type":134,"name":192,"description":193,"armGroupLabels":194,"otherNames":138},"hMPV_Z high dose vaccine","hMPV\\_Z high dose vaccine administered intramuscularly.",[121,40],{"type":134,"name":196,"description":197,"armGroupLabels":198,"otherNames":138},"Control vaccine","Control vaccine administered intramuscularly.",[125,45],{"type":200,"name":201,"description":202,"armGroupLabels":203,"otherNames":138},"COMBINATION_PRODUCT","Placebo","Placebo administered intramuscularly.",[129,51],[205,210],{"name":206,"role":207,"phone":208,"phoneExt":138,"email":209},"US GSK Clinical Trials Call Center","CONTACT","877-379-3718","GSKClinicalSupportHD@gsk.com",{"name":211,"role":207,"phone":212,"phoneExt":138,"email":209},"EU GSK Clinical Trials Call Center","+44 (0) 20 89904466",[214,236,250,266],{"facility":215,"status":216,"city":217,"state":218,"zip":219,"country":220,"countryCode":221,"cosmosGeoPoint":222,"geoPoint":227,"contacts":228},"GSK Investigational Site","RECRUITING","Lenexa","Kansas","66219","United States","US",{"type":223,"coordinates":224},"Point",[225,226],-94.73357,38.95362,{"lat":226,"lon":225},[229,230,233],{"name":206,"role":207,"phone":208,"phoneExt":138,"email":209},{"name":231,"role":207,"phone":232,"phoneExt":138,"email":209},"EU GSK Clinical Trials Call Centre","+44 (0) 20 8990 4466",{"name":234,"role":235,"phone":138,"phoneExt":138,"email":138},"Thomas Kreamer","PRINCIPAL_INVESTIGATOR",{"facility":215,"status":216,"city":237,"state":238,"zip":239,"country":220,"countryCode":221,"cosmosGeoPoint":240,"geoPoint":244,"contacts":245},"Seattle","Washington","98104",{"type":223,"coordinates":241},[242,243],-122.33207,47.60621,{"lat":243,"lon":242},[246,247,248],{"name":206,"role":207,"phone":208,"phoneExt":138,"email":209},{"name":231,"role":207,"phone":232,"phoneExt":138,"email":209},{"name":249,"role":235,"phone":138,"phoneExt":138,"email":138},"Nicole Ehrhardt",{"facility":215,"status":216,"city":251,"state":252,"zip":253,"country":254,"countryCode":255,"cosmosGeoPoint":256,"geoPoint":260,"contacts":261},"Botany","New South Wales","2019","Australia","AU",{"type":223,"coordinates":257},[258,259],151.19591,-33.94599,{"lat":259,"lon":258},[262,263,264],{"name":206,"role":207,"phone":208,"phoneExt":138,"email":209},{"name":231,"role":207,"phone":232,"phoneExt":138,"email":209},{"name":265,"role":235,"phone":138,"phoneExt":138,"email":138},"Ronald Mak",{"facility":215,"status":216,"city":267,"state":268,"zip":269,"country":254,"countryCode":255,"cosmosGeoPoint":270,"geoPoint":274,"contacts":275},"Camberwell","Victoria","3124",{"type":223,"coordinates":271},[272,273],145.0694,-37.84205,{"lat":273,"lon":272},[276,277,278],{"name":206,"role":207,"phone":208,"phoneExt":138,"email":209},{"name":231,"role":207,"phone":232,"phoneExt":138,"email":209},{"name":279,"role":235,"phone":138,"phoneExt":138,"email":138},"Rishi Shah",{"type":281,"investigatorFullName":138,"investigatorTitle":138,"investigatorAffiliation":138,"oldNameTitle":138,"oldOrganization":138},"SPONSOR","100639043","phase-1-a-study-of-investigational-rsvhmpv-combination-and-investigational-hmpv-vaccines-in-younger-and-older-adults-100639043",false,"NCT07628049","A Study of Investigational RSV\u002FhMPV Combination and Investigational hMPV Vaccines in Younger and Older Adults","A Phase 1\u002F2, Randomized, Controlled, Observer-blind, Multicentre Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of GSK Biologicals' Investigational Respiratory Syncytial Virus (RSV)\u002FHuman Metapneumovirus (hMPV) Combination and Investigational hMPV Vaccines When Administered Intramuscularly According to a Single Dose Schedule in Younger Adults ≥18 to ≤49 Years and Older Adults Aged ≥60 to ≤80 Years","Inclusion criteria:\n\nParticipants are eligible to be included in the study only if all of the following criteria apply:\n\n* Written informed consent obtained from the participant prior to performance of any study-specific procedure.\n* Participants who can and will comply with the requirements of the protocol (e.g., completion of the eDiary, return for follow-up visits, ability to access and utilize a phone or other electronic communications).\n* Body Mass Index (BMI) between 18 kg\u002Fm\\^2 and 33 kg\u002Fm\\^2, inclusive.\n\nSpecific inclusion criteria for OA\n\n* A male or female between and including, 60 to 80 YOA at the time of the study intervention administration.\n* Healthy participants or medically stable patients as established by medical history and physical examination.\n\nSpecific inclusion criteria for YA\n\n* A male or female participant between and including 18 to 49 YOA at the time of the study intervention administration.\n* Healthy participants as established by medical history, clinical examination and laboratory assessment at screening.\n* Participants of non-childbearing potential may be enrolled in the clinical study.\n* Participant of childbearing potential may be enrolled in the study if the participant:\n\n  * has used two methods of contraception, at-least one of which must be a highly effective method, and the other being male condom for male sexual partners of POCBP to be used during sexual intercourse (with the exception of sexual abstinence, vasectomized partner and male partner who has been sterilized, in which case contraception is not required), at-least 30 days prior to study intervention administration, and has agreed to continue using above contraception requirements for 8 weeks after study intervention administration.\n  * has a negative serum pregnancy test at screening and negative urine pregnancy test prior to study intervention administration on Day 1.\n\nExclusion criteria:\n\nParticipants are excluded from participating in the study if any of the following criteria apply:\n\n* History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention(s).\n* Any medical condition that in the judgment of the investigator would make IM injection unsafe.\n* Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease (e.g., current malignancy, HIV) or immunosuppressive\u002Fcytotoxic therapy (e.g., medication used during cancer chemotherapy, organ transplantation, or to treat autoimmune disorders), based on medical history and physical examination (no laboratory testing required).\n* Acute or unstable chronic pulmonary, cardiovascular, hepatic, or renal functional abnormality, as determined by physical examination and medical history.\n* Documented history of HIV, HBV, HCV infection.\n* History of RSV and \u002For hMPV-associated illness, diagnosed serologically or microbiologically in the last 12 months.\n* Recurrent history or uncontrolled neurological disorders or seizures, or history of demyelinating conditions (including GBS).\n* Any history of dementia or any medical condition that moderately or severely impairs cognition.\n* Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the clinical study.\n* Significant underlying illness that in the opinion of the investigator would be expected to prevent completion of the study (e.g., life-threatening disease).\n* Use of any investigational or non-registered product (drug, vaccine, or invasive medical device) other than the study intervention during the period beginning 30 days before study intervention administration (Day -29 to Day 1), or within 5 half-lives, whichever is longer, or their planned use during the study period.\n* Has previously received an investigational or approved vaccine or antibody for prevention of hMPV and\u002For RSV-associated diseases.\n* Chronic administration of immune-modifying drugs (defined as more than 14 consecutive days in total) and\u002For planned use of long-acting immune-modifying treatments at any time up to the end of the study.\n\n  * Up to 3 months prior to the study intervention administration:\n\n    * For corticosteroids, this will mean prednisone equivalent \\>=20 mg\u002Fday for adult participants. Inhaled, topical and intra-articular steroids are allowed.\n    * Administration of immunoglobulins and\u002For any blood products or plasma derivatives.\n  * Up to 6 months prior to study intervention administration: long-acting immune-modifying drugs including among others immunotherapy (e.g., TNF-inhibitors), monoclonal antibodies, antitumoral medication.\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.\n* History of chronic alcohol consumption and\u002For drug abuse as deemed by the investigator to render the potential participant unable\u002Funlikely to provide accurate safety reports or comply with study procedures.\n* Participation of any study personnel or their immediate dependents, family, or household members.\n* Planned move during the study period that will prohibit participating in the study until study end.\n* Bedridden participants.\n\nSpecific exclusion criteria for OA population\n\n* Planned or actual administration of a vaccine not foreseen by the study protocol in the period beginning 30 days before study intervention administration (Day - 29 to Day 1), or their planned use 30 days after study intervention administration, with the exception of inactivated, subunit and split influenza vaccines or COVID-19 vaccines which can be administered up to 14 days before or from 14 days after the study intervention administration.\n* At screening (Phase 1 only), participants with:\n\n  * \\>=Grade 2 abnormalities for the following parameters, regardless of clinical significance, should be excluded:\n\n    * Hematologic: hemoglobin (Hb), white blood cells (WBC), platelets, absolute cell counts of lymphocytes, neutrophils, eosinophils,\n    * Biochemical: alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), bilirubin, creatinine, blood urea nitrogen (BUN).\n  * Grade 1\u002Fmild hematologic and\u002F or biochemical laboratory abnormalities that are not clinically significant in the clinical judgment of the investigator, may be included.\n\nSpecific exclusion criteria for YA population\n\n* Pregnant or lactating participant.\n* Female planning to become pregnant or planning to discontinue contraceptive precautions for 8 weeks after study intervention administration.\n* Planned or actual administration of a vaccine not foreseen by the study protocol in the period beginning 30 days before study intervention administration (Day - 29 to Day 1), or their planned use 30 days after study intervention administration.\n* At screening, participants with:\n\n  * \\>=Grade 2 abnormalities for the following parameters, regardless of clinical significance, should be excluded:\n\n    * Hematologic: Hb, WBC, platelets, absolute cell counts of lymphocytes, neutrophils, eosinophils,\n    * Biochemical: ALT, AST, ALP, bilirubin, creatinine, BUN.\n  * Grade 1\u002Fmild hematologic and\u002F or biochemical laboratory abnormalities that are not clinically significant in the clinical judgment of the investigator, may be included.\n* Use of any medication, including prescription and non-prescription drugs or herbal remedies (such as St. John's wort) beginning 14 days (or 5 half-lives) prior to study intervention administration and\u002For planned administration during the study period. Certain medications may be permitted (Eg: contraceptives for POCBP).",true,"ALL","18 Years","80 Years",{"count":294,"type":295},1456,"ESTIMATED","INTERVENTIONAL",[298,299],"PHASE1","PHASE2","The aim of this study is to evaluate the safety, reactogenicity, and immune response of the different formulations of the investigational RSV\u002FhMPV combination vaccine and investigational hMPV vaccine in younger and older adults.",[302],"Respiratory Syncytial Virus Infections+Metapneumovirus",[304,305,306,307,308],"Safety","Reactogenicity","Immunogenicity","Respiratory syncytial virus (RSV)","Human metapneumovirus (hMPV)","2026-08-19",{"date":311,"type":312},"2026-08-20","ACTUAL",{"date":314,"type":312},"2026-06-05",{"date":316,"type":295},"2029-04-05",{"name":5,"class":6},4]