[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658813":3},{"organization":4,"outcomesModule":7,"designInfo":39,"detailedDescription":38,"studyPopulation":38,"armGroups":49,"interventions":73,"overallOfficials":85,"centralContacts":38,"locations":38,"responsibleParty":89,"collaborators":38,"id":91,"slug":92,"hasResults":93,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":38,"eligibilityCriteria":97,"healthyVolunteers":98,"sex":99,"minAge":100,"maxAge":101,"enrollmentInfo":102,"targetDuration":38,"studyType":105,"phases":106,"briefSummary":108,"conditions":109,"keywords":38,"overallStatus":111,"whyStopped":38,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":38},{"fullName":5,"class":6},"Merck Sharp & Dohme LLC","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":34,"otherOutcomes":38},[9,13,17,20,24,28,31],{"measure":10,"description":11,"timeFrame":12},"Percentage of Participants With Immediate Reactions After Vaccination","The percentage of participants with immediate reactions after vaccination will be reported.","Up to approximately 30 minutes after vaccination",{"measure":14,"description":15,"timeFrame":16},"Percentage of Participants With a Solicited Injection-Site Adverse Event","An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants with a solicited injection-site AE (ie, pre-listed in the participant's diary) will be reported.","Up to approximately 7 days after vaccination",{"measure":18,"description":19,"timeFrame":16},"Percentage of Participants With a Solicited Systemic Adverse Event","An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The percentage of participants with a solicited systemic AE (ie, pre-listed in the participant's diary) will be reported.",{"measure":21,"description":22,"timeFrame":23},"Percentage of Participants With an Unsolicited Adverse Event","An unsolicited AE is an AE that was not solicited using a vaccination report card and that is communicated by a participant (or their legally acceptable representative, if applicable). Unsolicited AEs include serious and nonserious AEs. The percentage of participants with an unsolicited adverse event will be reported.","Up to approximately 28 days after vaccination",{"measure":25,"description":26,"timeFrame":27},"Percentage of Participants With a Serious Adverse Event (SAE)","An SAE is defined as any untoward medical occurrence that at any dose, results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability\u002Fincapacity, or is a congenital anomaly\u002Fbirth defect. The percentage of participants with a SAE will be reported.","Up to approximately 12 months after vaccination",{"measure":29,"description":30,"timeFrame":27},"Percentage of Participants With a Medically Attended Adverse Event (MAAE)","MAAEs are defined as adverse events in which medical attention is received during an unscheduled, non-routine outpatient visit, such as an emergency department visit, office visit, or an urgent care visit with any medical personnel for any reason. The percentage of participants with a MAAE will be reported.",{"measure":32,"description":33,"timeFrame":27},"Percentage of Participants With an Adverse Event of Special Interest (AESI) Including Potential Immune-Mediated Diseases (pIMDs)","AESIs are selected serious and nonserious AEs which include but are not limited to pIMDs defined as a subset of AEs that includes both: established autoimmune disease(s) and inflammatory and\u002For neurologic disorder(s), which might or might not have an autoimmune etiology. The percentage of participants with an AESI will be reported.",[35],{"measure":36,"description":37,"timeFrame":23},"Geometric Mean Ratio (GMR) of Anti-Respiratory Syncytial Virus-A (RSV-A) Neutralizing Antibodies Elicited by V175\u002FV175A Relative to Control Vaccine","Titers of Anti-RSV-A Neutralizing Antibody will be measured via the virus reduction neutralization test. GMR of Anti-Respiratory Syncytial Virus-A (RSV-A) Neutralizing Antibodies Elicited by V175\u002FV175A relative to control vaccine will be reported.",null,{"allocation":40,"interventionModel":41,"interventionModelDescription":38,"primaryPurpose":42,"observationalModel":38,"timePerspective":38,"maskingInfo":43},"RANDOMIZED","SEQUENTIAL","PREVENTION",{"masking":44,"maskingDescription":38,"whoMasked":45},"TRIPLE",[46,47,48],"PARTICIPANT","INVESTIGATOR","OUTCOMES_ASSESSOR",[50,56,61,67],{"label":51,"type":52,"description":53,"interventionNames":54},"V175","EXPERIMENTAL","Participants will receive a single intramuscular (IM) vaccination of V175 on Day 1.",[55],"Biological: V175",{"label":57,"type":52,"description":58,"interventionNames":59},"V175A","Participants will receive a single IM vaccination of V175A on Day 1.",[60],"Biological: V175A",{"label":62,"type":63,"description":64,"interventionNames":65},"Control Vaccine","ACTIVE_COMPARATOR","Participants will receive a single IM vaccination of control vaccine on Day 1.",[66],"Biological: Control Vaccine",{"label":68,"type":69,"description":70,"interventionNames":71},"Placebo","PLACEBO_COMPARATOR","Participants will receive a single IM vaccination of placebo on Day 1.",[72],"Other: Placebo",[74,78,80,82],{"type":75,"name":51,"description":76,"armGroupLabels":77,"otherNames":38},"BIOLOGICAL","Intramuscular administration",[51],{"type":75,"name":57,"description":76,"armGroupLabels":79,"otherNames":38},[57],{"type":75,"name":62,"description":76,"armGroupLabels":81,"otherNames":38},[62],{"type":83,"name":68,"description":76,"armGroupLabels":84,"otherNames":38},"OTHER",[68],[86],{"name":87,"affiliation":5,"role":88},"Medical Director","STUDY_DIRECTOR",{"type":90,"investigatorFullName":38,"investigatorTitle":38,"investigatorAffiliation":38,"oldNameTitle":38,"oldOrganization":38},"SPONSOR","100658813","phase-1-a-clinical-trial-of-v175-and-v175a-in-healthy-adults-100658813",false,"NCT07855510","A Clinical Trial of V175 and V175A in Healthy Adults","A Phase 1, Randomized, Double-Blind, Comparator-Controlled, Dose Escalation Trial to Evaluate the Safety, Tolerability, and Immunogenicity of V175 and V175A in Healthy Adults","Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\n\n* Is in good health\n* Is an individual of any sex\u002Fgender, from 18 years to 49 years of age inclusive, or 60 years to 84 years of age inclusive\n* Has a body mass index between 18 and 35 kg\u002Fm\\^2, inclusive\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Has a history of cancer (malignancy)\n* Has any known or suspected autoimmune disease or immunosuppressive condition, acquired or congenital\n* Has a history of Guillain-Barré Syndrome",true,"ALL","18 Years","84 Years",{"count":103,"type":104},564,"ESTIMATED","INTERVENTIONAL",[107],"PHASE1","Researchers are looking for new vaccines to prevent lower respiratory tract infections. A lower respiratory tract infection is an infection in the lower part of the airways and\u002For the lungs. Respiratory syncytial virus (RSV), amongst other respiratory viruses, can cause these infections.\n\nThis trial will look at the RSV multivalent vaccines V175 and V175A in healthy participants. The goal of the trial is to learn about the safety of V175 and V175A and if participants tolerate them.",[110],"Lower Respiratory Tract Infection","NOT_YET_RECRUITING","2026-09-28",{"date":114,"type":115},"2026-10-02","ACTUAL",{"date":117,"type":104},"2026-10-27",{"date":119,"type":104},"2028-08-08",{"name":5,"class":6}]