[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659155":3},{"organization":4,"outcomesModule":7,"designInfo":54,"detailedDescription":53,"studyPopulation":53,"armGroups":60,"interventions":67,"overallOfficials":75,"centralContacts":79,"locations":53,"responsibleParty":86,"collaborators":53,"id":88,"slug":89,"hasResults":90,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":53,"eligibilityCriteria":94,"healthyVolunteers":95,"sex":96,"minAge":97,"maxAge":53,"enrollmentInfo":98,"targetDuration":53,"studyType":101,"phases":102,"briefSummary":104,"conditions":105,"keywords":107,"overallStatus":110,"whyStopped":53,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":53},{"fullName":5,"class":6},"Sanofi","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":53},[9],{"measure":10,"description":11,"timeFrame":12},"Geometric Mean Fold Rise (GMFR) in pseudovirus neutralizing antibody titers (ID50) against the Omicron subvariant included in the vaccine formulation from pre-vaccination to 28 days post-vaccination.","Superior neutralizing antibody response is defined as a GMFR with a lower bound of the two-sided 95% confidence interval greater than 4.0 within each age cohort.","Day 1 (pre-vaccination) and Day 29 (28 days after vaccination)",[14,17,21,25,29,32,36,39,43,47,50],{"measure":15,"description":16,"timeFrame":12},"Geometric Mean Titers (GMTs) of Pseudovirus Neutralizing Antibodies Against the Omicron Subvariant Included in the Vaccine Formulation","Pseudovirus neutralizing antibody responses against the Omicron subvariant included in the vaccine formulation will be measured as geometric mean titers (GMTs).",{"measure":18,"description":19,"timeFrame":20},"Seroresponse Rate (SRR) in Pseudovirus Neutralizing Antibody Titers Against the Omicron Subvariant Used in the Vaccine Formulation","Seroresponse is defined as a pre-vaccination antibody titer below the lower limit of quantitation (LLOQ) and a post-vaccination antibody titer ≥ 4 × LLOQ; at least a 4-fold rise when the pre-vaccination titer is ≥ LLOQ and \\\u003C 4 × LLOQ; or at least a 2-fold rise when the pre-vaccination titer is ≥ 4 × LLOQ.","Day 29 (28 days after vaccination)",{"measure":22,"description":23,"timeFrame":24},"Presence of Immediate Adverse Events (AEs)","Number of participants reporting immediate adverse events within 30 minutes following study vaccination.","Within 30 minutes after vaccination on Day 1",{"measure":26,"description":27,"timeFrame":28},"Presence of Solicited Injection Site Reactions","Number of participants reporting solicited injection site reactions during the 8-day period including the day of vaccination.","Day 1 through Day 8",{"measure":30,"description":31,"timeFrame":28},"Presence of Solicited Systemic Reactions","Number of participants reporting solicited systemic reactions during the 8-day period including the day of vaccination.",{"measure":33,"description":34,"timeFrame":35},"Presence of Unsolicited Adverse Events (AEs)","Number of participants reporting unsolicited adverse events during the 28-day period including the day of vaccination.","Day 1 through Day 28",{"measure":37,"description":38,"timeFrame":35},"Presence of Medically Attended Adverse Events (MAAEs)","Number of participants reporting medically attended adverse events (MAAEs) during the 28-day period including the day of vaccination.",{"measure":40,"description":41,"timeFrame":42},"Presence of Related Medically Attended Adverse Events (MAAEs)","Number of participants reporting medically attended adverse events considered related to the study intervention from Day 29 through the end of the study.","Day 29 through approximately Day 91",{"measure":44,"description":45,"timeFrame":46},"Presence of Adverse Events of Special Interest (AESIs)","Number of participants reporting adverse events of special interest (AESIs) throughout the study. Protocol-defined AESIs include anaphylaxis; myocarditis, pericarditis, or myopericarditis; and new onset or worsening of potential immune-mediated disease.","Day 1 through approximately Day 91",{"measure":48,"description":49,"timeFrame":46},"Presence of Serious Adverse Events (SAEs)","Number of participants reporting serious adverse events (SAEs) throughout the study.",{"measure":51,"description":52,"timeFrame":46},"Presence of Adverse Events (AEs) Leading to Study Discontinuation","Number of participants reporting adverse events leading to study discontinuation throughout the study.",null,{"allocation":55,"interventionModel":56,"interventionModelDescription":53,"primaryPurpose":57,"observationalModel":53,"timePerspective":53,"maskingInfo":58},"NA","SINGLE_GROUP","PREVENTION",{"masking":59,"maskingDescription":53,"whoMasked":53},"NONE",[61],{"label":62,"type":63,"description":64,"interventionNames":65},"Nuvaxovid","EXPERIMENTAL","Participants will receive a single intramuscular injection of Nuvaxovid on Day 1",[66],"Biological: Omicron Subvariant-Based SARS-CoV-2 Recombinant Spike Vaccine Adjuvanted With Matrix-M",[68],{"type":69,"name":70,"description":71,"armGroupLabels":72,"otherNames":73},"BIOLOGICAL","Omicron Subvariant-Based SARS-CoV-2 Recombinant Spike Vaccine Adjuvanted With Matrix-M","Pharmaceutical form: Sterile suspension for injection Route of administration: Intramuscular injection",[62],[62,74],"NUVAXOVID™",[76],{"name":77,"affiliation":5,"role":78},"Clinical Sciences & Operations Study Director","STUDY_DIRECTOR",[80],{"name":81,"role":82,"phone":83,"phoneExt":84,"email":85},"Trial Transparency email recommended (Toll free number for US & Canada)","CONTACT","800-633-1610","6","contact-us@sanofi.com",{"type":87,"investigatorFullName":53,"investigatorTitle":53,"investigatorAffiliation":53,"oldNameTitle":53,"oldOrganization":53},"SPONSOR","100659155","phase-4-study-of-a-recombinant-spike-covid-19-vaccine-with-matrix-m-in-older-adults-and-people-at-increased-risk-of-severe-covid-19-100659155",false,"NCT07861542","Study of a Recombinant Spike COVID-19 Vaccine With Matrix-M in Older Adults and People at Increased Risk of Severe COVID-19","A Phase 4 Open-label, Single-arm Study to Evaluate the Safety and Immunogenicity of an Omicron Subvariant-based SARS-CoV-2 Recombinant Spike (rS) Vaccine Adjuvanted With Matrix-M in Participants ≥ 65 Years of Age and Participants 12 Through 64 Years of Age Who Are at Increased Risk for Severe COVID-19 Illness","Inclusion Criteria:\n\nTo be included in this study, each individual must satisfy all the following criteria:\n\n* Participants ≥ 65 years of age, or participants 12 through 64 years of age who have at least 1 underlying condition that puts them at increased risk for severe outcomes from COVID-19 at the time of study vaccination.\n* Previously vaccinated with a COVID-19 vaccine, with the last dose administered ≥ 90 days prior to study vaccination.\n* Participants must not be pregnant or breastfeeding. Participants of childbearing potential must have a negative highly sensitive pregnancy test at enrollment and must agree to use an effective method of contraception or remain abstinent from ≥ 4 weeks before study vaccination through ≥ 4 weeks after vaccination.\n\nExclusion Criteria:\n\nParticipants are not eligible if any of the following criteria are met:\n\n* Known or suspected congenital or acquired immunodeficiency; receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the past 6 months; or long-term use of systemic corticosteroids.\n* History of virologically confirmed SARS-CoV-2 infection within 90 days before study vaccination.\n* Known systemic hypersensitivity to any component of the study intervention or a history of a life-threatening reaction to the study intervention or to a product containing the same substances.\n* Prior history of myocarditis, pericarditis, or myopericarditis.\n* Receipt of any vaccine within 28 days before study vaccination, except for influenza vaccine, which may be administered at least 14 days before study vaccination.\n* Receipt of an investigational or marketed COVID-19 vaccine within 90 days before study vaccination.\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.",true,"ALL","12 Years",{"count":99,"type":100},660,"ESTIMATED","INTERVENTIONAL",[103],"PHASE4","The purpose of this study is to evaluate the safety and immunogenicity of a single dose of Sanofi's Omicron subvariant-based Nuvaxovid in participants ≥ 65 years of age and participants 12 through 64 years of age who have at least one underlying condition that puts them at increased risk for severe outcomes of COVID-19 and who have been previously vaccinated with a COVID-19 vaccine ≥ 90 days prior to study vaccination.\n\nStudy details include:\n\n* The study duration will be approximately 3 months per participant.\n* Study intervention will be administered via a single intramuscular (IM) injection into the deltoid muscle on Day 1.\n* The visit frequency will be Day 1, Day 9 telephone call, Day 29, and Day 91 telephone call (3-month safety follow-up).",[106],"COVID-19",[108,106,109],"NUVAXOVID","SARS-CoV-2 Infection","NOT_YET_RECRUITING","2026-09-30",{"date":113,"type":114},"2026-10-06","ACTUAL",{"date":116,"type":100},"2026-10-02",{"date":118,"type":100},"2027-01-27",{"name":5,"class":6}]