[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100609580":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":33,"centralContacts":34,"locations":40,"responsibleParty":115,"collaborators":117,"id":128,"slug":129,"hasResults":130,"nctId":131,"briefTitle":132,"officialTitle":133,"acronym":134,"eligibilityCriteria":135,"healthyVolunteers":136,"sex":137,"minAge":138,"maxAge":139,"enrollmentInfo":140,"targetDuration":33,"studyType":143,"phases":144,"briefSummary":146,"conditions":147,"keywords":33,"overallStatus":43,"whyStopped":33,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":150,"startDateStruct":153,"completionDateStruct":155,"leadSponsor":157,"locationsCount":158},{"fullName":5,"class":6},"Serum Life Science Europe GmbH","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"2x 1 mg wSp vaccine","EXPERIMENTAL","Intramuscular (IM) injections of 0.5 mL containing 1 mg of total protein",[13],"Biological: wSp vaccine",{"label":15,"type":16,"description":17,"interventionNames":18},"2x 0.5 mL saline","PLACEBO_COMPARATOR","Intramuscular (IM) injections of 0.5 mL saline",[19],"Biological: Saline (0.9% NaCl)",[21,29],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"BIOLOGICAL","wSp vaccine","wSp vaccine will be administered as intramuscular (IM) injections of 0.5 mL (thus 1 mg total protein). wSp vaccine is supplied as single-dose glass vials in saline (0.9% sodium chloride) at 2 mg protein\u002FmL, with aluminum hydroxide at 1.2 mg elemental Al\u002FmL. Dose 1 will be given preferably in the left thigh at approximately 7 months of age, and dose 2 will be given preferably in the right thigh at approximately 9 months of age.",[9],[27,28],"SPWCV","PATH-wSP",{"type":22,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"Saline (0.9% NaCl)","Saline will be administered as intramuscular (IM) injections of 0.5 mL. Dose 1 will be given preferably in the left thigh at approximately 7 months of age and dose 2 will be given preferably in the right thigh at approximately 9 months of age.",[15],null,[35],{"name":36,"role":37,"phone":38,"phoneExt":33,"email":39},"Marcus May, MD","CONTACT","+49 511 16 99 08 0","may@sls-eu.com",[41,60,70,76,87,93,104],{"facility":42,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Pittsford Pediatrics","RECRUITING","Pittsford","New York","14534","United States","US",{"type":50,"coordinates":51},"Point",[52,53],-77.515,43.09062,{"lat":53,"lon":52},[56],{"name":57,"role":37,"phone":58,"phoneExt":33,"email":59},"Rahul Sengupta","585-385-1710","rsendr.d@gmail.com",{"facility":61,"status":62,"city":63,"state":45,"zip":64,"country":47,"countryCode":48,"cosmosGeoPoint":65,"geoPoint":69,"contacts":33},"Western New York Geneva Pediatrics","ACTIVE_NOT_RECRUITING","Rochester","14456",{"type":50,"coordinates":66},[67,68],-77.61556,43.15478,{"lat":68,"lon":67},{"facility":71,"status":62,"city":63,"state":45,"zip":72,"country":47,"countryCode":48,"cosmosGeoPoint":73,"geoPoint":75,"contacts":33},"Bay Creek Pediatrics","14580",{"type":50,"coordinates":74},[67,68],{"lat":68,"lon":67},{"facility":77,"status":43,"city":63,"state":45,"zip":78,"country":47,"countryCode":48,"cosmosGeoPoint":79,"geoPoint":81,"contacts":82},"Long Pond Pediatrics","14606",{"type":50,"coordinates":80},[67,68],{"lat":68,"lon":67},[83],{"name":84,"role":37,"phone":85,"phoneExt":33,"email":86},"Tracy Wright","585-225-0950","tracyarora79@gmail.com",{"facility":88,"status":62,"city":63,"state":45,"zip":89,"country":47,"countryCode":48,"cosmosGeoPoint":90,"geoPoint":92,"contacts":33},"Rochester Medical Group General Pediatric Associates","14621",{"type":50,"coordinates":91},[67,68],{"lat":68,"lon":67},{"facility":94,"status":43,"city":63,"state":45,"zip":95,"country":47,"countryCode":48,"cosmosGeoPoint":96,"geoPoint":98,"contacts":99},"Westside Pediatric Group","14624",{"type":50,"coordinates":97},[67,68],{"lat":68,"lon":67},[100],{"name":101,"role":37,"phone":102,"phoneExt":33,"email":103},"David Sayre","585-247-5400","dsayre59@gmail.com",{"facility":105,"status":43,"city":63,"state":45,"zip":106,"country":47,"countryCode":48,"cosmosGeoPoint":107,"geoPoint":109,"contacts":110},"Panorama Pediatrics","14625",{"type":50,"coordinates":108},[67,68],{"lat":68,"lon":67},[111],{"name":112,"role":37,"phone":113,"phoneExt":33,"email":114},"Kim Vogelsang","585-381-4848","KVogelsang@panoramapeds.com",{"type":116,"investigatorFullName":33,"investigatorTitle":33,"investigatorAffiliation":33,"oldNameTitle":33,"oldOrganization":33},"SPONSOR",[118,121,124,126],{"name":119,"class":120},"National Institute of Allergy and Infectious Diseases (NIAID)","NIH",{"name":122,"class":123},"Rochester General Hospital","OTHER",{"name":125,"class":6},"Serum Institute of India Pvt. Ltd.",{"name":127,"class":123},"Alira Health","100609580","phase-2-safety-and-efficacy-of-wsp-vaccine-in-young-children-100609580",false,"NCT07216430","Safety and Efficacy of wSp Vaccine in Young Children","A Phase 2 Study Evaluating the Safety and Efficacy of Whole-Cell Pneumococcal Vaccine (wSp) in Reducing Nasopharyngeal Colonization by Streptococcus Pneumoniae in Young Children.","wSp005","Inclusion Criteria:\n\n1. Male or female who is 6 months (- 30 to +75 days) of age at time of enrollment\n2. Healthy subject as established by medical history and clinical examination before entering into the study.\n3. Received 3 doses of PCV15 or PCV20.\n4. Written informed consent obtained from the subject's parent\u002Flegal guardian.\n5. Parent\u002Flegal guardian able and willing to bring subject to all study visits.\n\nExclusion Criteria:\n\n1. Has a history of invasive pneumococcal disease (positive blood culture and\u002For positive cerebrospinal fluid culture).\n2. Known or suspected impairment of immunological function, based on medical history and physical examination.\n3. Has a history of congenital or acquired immunodeficiency.\n4. Chronic administration (defined \\> 14 consecutive days) of immunosuppressants or other immune-modifying drugs.\n5. Prior receipt since birth of immunoglobulins and\u002For any blood products or planned administration during the study period.\n6. Expected to receive systemic corticosteroids within 14 days prior to any dose of study vaccine.\n7. External auditory canal atresia\u002Fstenosis.\n8. Has known or history of functional or anatomic asplenia.\n9. Has a bleeding disorder in which intramuscular vaccination would be contraindicated.\n10. Participation in another investigational or interventional trial within the 28-day period before enrollment and during the conduct of the study. Participation in observational studies is permitted.\n11. Direct descendant (child or grandchild) of study site personnel.\n\n    Temporary exclusion criteria\n\n    For day of vaccination:\n12. Fever (transcutaneous temperature ≥38.0°C) or acute illness, at investigator's discretion\n13. Has received systemic corticosteroids (equivalent of prednisone \\> 0.5 mg\u002Fkg\u002Fday or equivalent) and not completed this course of treatment at least 30 days prior to the study vaccination. Inhaled, topical, and ophthalmic steroids are allowed.",true,"ALL","5 Months","7 Months",{"count":141,"type":142},320,"ESTIMATED","INTERVENTIONAL",[145],"PHASE2","The goal of this clinical trial is to evaluate whether the wSp vaccine can prevent nasopharyngeal colonization by pneumococcal bacteria in healthy young children who have received routine PCV15 or PCV20 vaccination.\n\nThe main questions it aims to answer are:\n\nDoes wSp vaccine reduce pneumococcal colonization in the nose? Does wSp vaccine safely stimulate the immune system to produce antibodies and protective immune responses?\n\nResearchers will compare children receiving two injections of wSp vaccine to those receiving saline placebo to see if wSp vaccine reduces colonization and boosts immunity.\n\nParticipants will:\n\nReceive two injections of either wSp or saline at approximately 7 and 9 months of age.\n\nHave blood samples taken at 6 and\u002For 12 months to measure immune responses. Have nasal swabs collected at several time points and during infections from 6-24 months.\n\nBe monitored for ear infections, respiratory illnesses, and other pneumococcal-related infections.",[148],"Acute Otitis Media (AOM)","2026-05-29",{"date":151,"type":152},"2026-06-02","ACTUAL",{"date":154,"type":152},"2025-09-29",{"date":156,"type":142},"2029-06",{"name":5,"class":6},7]