En undersøgelse af tre forskellige doser af VAC52416 (ExPEC10V) hos voksne i alderen 60 til 85 år i stabil sundhed
4. juni 2026 opdateret af: Janssen Research & Development, LLC
En randomiseret, observatørblind, første-i-menneskelig fase 1/2a-undersøgelse til evaluering af sikkerheden, reaktogeniciteten og immunogeniciteten af tre forskellige doser af VAC52416 (ExPEC10V) hos voksne i alderen 60 til 85 år i stabil sundhed
Formålet med denne undersøgelse er at vurdere sikkerheden, reaktogeniciteten og immunogeniciteten af 3 forskellige doser af ExPEC10V og at vælge den optimale dosis til yderligere klinisk udvikling (kohorte 1).
Kohorte 2 har til formål at udvide datasættet, der understøtter kort- og langsigtet sikkerhed og immunogenicitet af den optimale dosis af ExPEC10V, udvalgt fra de primære analyseresultater fra kohorte 1. Kohorte 2 vil omfatte deltagere i stabilt helbred med en historie med urinveje infektion (UTI) inden for de seneste 5 år og vil blive inkluderet i undersøgelsen for at understøtte planen for sen udvikling af ExPEC-vaccine.
Studieoversigt
Status
Afsluttet
Intervention / Behandling
Detaljeret beskrivelse
ExPEC10V (JNJ-69968054) er en 10-valent vaccinekandidat under udvikling til forebyggelse af invasiv ekstraintestinal patogen Escherichia coli (ExPEC) sygdom (IED) hos voksne 60 år og ældre.
ExPEC10V består af O-antigen polysaccharider (PS'er) af ExPEC serotyperne O1A, O2, O4, O6A, O8, O15, O16, O18A, O25B og O75 separat biokonjugeret til bærerproteinet, en genetisk afgiftet form af exotoxin A (EPA) stammer fra Pseudomonas aeruginosa.
Da virkningsmekanismen for konjugerede vacciner til forebyggelse af invasiv sygdom ikke forventes at blive påvirket af antibiotikaresistensmekanismer, kan ExPEC10V-vaccine give beskyttelse mod IED forårsaget af lægemiddelresistente og modtagelige ExPEC-serotyper.
Undersøgelsen består af to kohorter.
Kohorte 1 består af tre perioder: en screeningsperiode (28 dage), en observatørblind opfølgningsperiode (181 dage) med vaccination på dag 1 og en åben langtidsopfølgningsperiode (LTFU) (fra dag 182 indtil 5 år [Dag 1826] efter vaccination).
Kohorte 2 består også af tre perioder: en screeningsperiode (28 dage), en dobbeltblind opfølgningsperiode (181 dage) med vaccination på dag 1 og en dobbeltblind LTFU-periode (fra dag 182 til 1 år). Dag 366] efter vaccination).
Slutningen af kohorte 1 betragtes som år 5-besøget (dag 1826) for den sidste deltager.
Slutningen af kohorte 2 betragtes som år 1-besøget (dag 366) for den sidste deltager.
Nøgleimmunogenicitetsvurderinger vil omfatte vurdering af ExPEC10V- og ExPEC4V-serotypespecifikke totale immunoglobulin G-antistofniveauer fremkaldt af vaccinen og ExPEC10V- og ExPEC4V-serotypespecifikke funktionelle antistoffer.
Nøgle sikkerhedsvurderinger omfatter opfordrede lokale og systemiske bivirkninger, uopfordrede bivirkninger, SAE'er, fysiske undersøgelser, målinger af vitale tegn og, kun for kohorte 1, kliniske laboratorietests.
Studiets samlede varighed er op til 5 år.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
836
Fase
- Fase 2
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Alken, Belgien, 3570
- Anima
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Liège, Belgien, 4000
- ATC Pharma
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Merksem, Belgien, 2170
- Clinical Pharmacology Unit
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Alabama
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Huntsville, Alabama, Forenede Stater, 35802
- Optimal Research 2
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Florida
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Melbourne, Florida, Forenede Stater, 32934
- Optimal Research
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Miami, Florida, Forenede Stater, 33143
- Qps-Mra, Llc
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Illinois
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Peoria, Illinois, Forenede Stater, 61614
- Optimal Research 1
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Indiana
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Evansville, Indiana, Forenede Stater, 47714
- Synexus Clinical Research US Inc 4
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Kansas
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Lenexa, Kansas, Forenede Stater, 66219
- Johnson County Clin-Trials
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Minnesota
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Richfield, Minnesota, Forenede Stater, 55432
- Synexus Clinical Research US Inc 2
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New York
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Manhattan, New York, Forenede Stater, 10017
- Synexus Clinical Research US Inc 3
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Rochester, New York, Forenede Stater, 14609
- Rochester Clinical Research, Inc
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Ohio
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Akron, Ohio, Forenede Stater, 44311
- Synexus Clinical Research US Inc 1
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Columbus, Ohio, Forenede Stater, 43212
- Synexus Clinical Research US Inc
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South Carolina
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North Charleston, South Carolina, Forenede Stater, 29405
- Coastal Carolina Research Center
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Nantes, Frankrig, 44093
- CHU Nantes
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Paris, Frankrig, 75014
- Hôpital Cochin
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Paris, Frankrig, 75018
- APHP - Hopital Bichat - Claude Bernard
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Pierre-Bénite, Frankrig, 69495
- CHU Lyon Sud
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Rennes, Frankrig, 35000
- Chu Rennes Hopital Pontchaillou
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Tours, Frankrig, 37000
- CHRU Tours Hôpital Bretonneau
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Almere Stad, Holland, 1311 RL
- EB Flevo Research
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Groningen, Holland, NZ 9728
- PRA Health Sciences
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Barcelona, Spanien, 08003
- Hosp. Del Mar
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Córdoba, Spanien, 14004
- Hosp Reina Sofia
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Madrid, Spanien, 28046
- Hosp. Univ. La Paz
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Madrid, Spanien, 28006
- Hosp. Univ. de La Princesa
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Santander, Spanien, 39008
- Hosp. Univ. Marques de Valdecilla
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Seville, Spanien, 41009
- Hosp. Virgen Macarena
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
60 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Beskrivelse
Inklusionskriterier:
- Skal have et kropsmasseindeks (BMI) på mere end (>) 18,5 eller mindre end 40 kilogram pr. kvadratmeter (kg/m^2)
- Før randomisering skal en kvinde være: postmenopausal - En postmenopausal tilstand er defineret som ingen menstruation i 12 måneder uden en alternativ medicinsk årsag; eller ikke har til hensigt at blive gravid på nogen måde
- Skal være sund eller medicinsk stabil
- Skal underskrive en informeret samtykkeformular (ICF), der angiver, at han eller hun forstår formålet med og procedurerne for undersøgelsen og er villig til at deltage i undersøgelsen
- Villig og i stand til at overholde de livsstilsbegrænsninger, der er specificeret i denne protokol
- Indvilliger i ikke at donere blod før 12 uger efter modtagelse af undersøgelsesvaccinen
Ekskluderingskriterier:
- Akut sygdom (dette omfatter ikke mindre sygdomme såsom diarré eller mild øvre luftvejsinfektion) eller temperatur højere end lig med >=38,0 grader Celsius (100,4 grader Fahrenheit) inden for 24 timer før administration af undersøgelsesvaccine, eller, relevant for Kun kohorte 2, en igangværende eller mistænkt symptomatisk urinvejsinfektion (UTI); tilmelding på et senere tidspunkt er tilladt (forudsat at screeningsvinduet på 28 dage overholdes)
- Anamnese med malignitet inden for 5 år før screening (undtagelser er plade- og basalcellekarcinomer i huden og carcinom in situ i livmoderhalsen, eller malignitet, som anses for helbredt med minimal risiko for tilbagefald)
- Kendte allergier, overfølsomhed eller intolerance over for ExPEC10V eller dets hjælpestoffer
- Gælder kun for kohorte 1: kendt allergi eller historie med anafylaksi eller andre alvorlige bivirkninger på vacciner eller vaccineprodukter (inklusive nogen af bestanddelene i de aktive kontrolvacciner)
- Kontraindikation til intramuskulære (IM) injektioner og blodprøver, f.eks. blødningsforstyrrelser
- Unormal funktion af immunsystemet
- Har haft større psykiatrisk sygdom og/eller stofmisbrug eller alkoholmisbrug inden for de seneste 12 måneder
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Kohorte 1: ExPEC10V (lav dosis)
Deltagerne vil blive randomiseret til at modtage en enkelt intramuskulær (IM) injektion af lavdosis ExPEC10V på dag 1.
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Deltagerne vil modtage en enkelt IM-injektion af ExPEC10V (1 ud af 3 doser [lav eller medium eller høj]) i kohorte 1 og ExPEC10V valgt dosis (baseret på de primære analyseresultater af kohorte 1) i kohorte 2 på dag 1.
Andre navne:
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Eksperimentel: Kohorte 1: ExPEC10V (medium dosis)
Deltagerne vil blive randomiseret til at modtage en enkelt IM-injektion af medium dosis ExPEC10V på dag 1.
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Deltagerne vil modtage en enkelt IM-injektion af ExPEC10V (1 ud af 3 doser [lav eller medium eller høj]) i kohorte 1 og ExPEC10V valgt dosis (baseret på de primære analyseresultater af kohorte 1) i kohorte 2 på dag 1.
Andre navne:
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Eksperimentel: Kohorte 1: ExPEC10V (høj dosis)
Deltagerne vil blive randomiseret til at modtage en enkelt IM-injektion af højdosis ExPEC10V på dag 1.
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Deltagerne vil modtage en enkelt IM-injektion af ExPEC10V (1 ud af 3 doser [lav eller medium eller høj]) i kohorte 1 og ExPEC10V valgt dosis (baseret på de primære analyseresultater af kohorte 1) i kohorte 2 på dag 1.
Andre navne:
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Eksperimentel: Kohorte 1: ExPEC4V
Deltagerne vil blive randomiseret til at modtage en enkelt IM-injektion af ExPEC4V på dag 1.
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Deltagerne vil modtage en enkelt IM-injektion af ExPEC4V på dag 1.
Andre navne:
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Eksperimentel: Kohorte 1: Prevnar 13
Deltagerne vil blive randomiseret til at modtage en enkelt IM-injektion af Prevnar 13 på dag 1.
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Deltagerne vil modtage en enkelt IM-injektion af Prevnar 13 på dag 1.
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Eksperimentel: Kohorte 2: ExPEC10V
Deltagerne vil blive randomiseret til at modtage en enkelt IM-injektion af udvalgt dosis af ExPEC10V på dag 1.
Den ExPEC10V-dosis, der bruges i kohorte 2, vil være baseret på de primære analyseresultater (dag 30) af kohorte 1.
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Deltagerne vil modtage en enkelt IM-injektion af ExPEC10V (1 ud af 3 doser [lav eller medium eller høj]) i kohorte 1 og ExPEC10V valgt dosis (baseret på de primære analyseresultater af kohorte 1) i kohorte 2 på dag 1.
Andre navne:
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Placebo komparator: Kohorte 2: Placebo
Deltagerne vil blive randomiseret til at modtage en enkelt IM-injektion af matchende placebo på dag 1.
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Deltagerne vil modtage en enkelt IM-injektion af matchende placebo på dag 1.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Kohorte 1: Antal deltagere med opfordrede lokale (injektionssted) bivirkninger (AE'er) i 14 dage efter vaccination på dag 1
Tidsramme: Op til 14 dage efter vaccination på dag 1 (fra dag 1 op til dag 15)
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Antallet af deltagere med anmodede lokale AE'er i 14 dage efter vaccination på dag 1 blev rapporteret.
En AE er enhver uønsket medicinsk hændelse i en klinisk undersøgelsesdeltager, der har administreret et lægemiddel (undersøgelsesmæssigt eller ikke-undersøgelsesmæssigt) produkt.
En AE har ikke nødvendigvis en årsagssammenhæng med undersøgelsesvaccinen.
Opfordrede lokale AE'er var præcist definerede begivenheder, som deltagerne specifikt blev spurgt om, og som blev noteret af deltagerne i dagbogen.
Opfordrede lokale (injektionssted) AE'er omfattede smerter/ømhed på injektionsstedet, erytem og hævelse på undersøgelsesvaccinens injektionssted, blev brugt til at vurdere reaktogeniciteten af undersøgelsesvaccinen og var foruddefineret lokale (injektionssted).
Alle opfordrede AE'er på injektionsstedet (lokalt) blev anset for at være relateret til undersøgelsens vaccineadministration.
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Op til 14 dage efter vaccination på dag 1 (fra dag 1 op til dag 15)
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Kohorte 1: Antal deltagere med anmodede systemiske bivirkninger (AE'er) indsamlet i 14 dage efter vaccination på dag 1
Tidsramme: Op til 14 dage efter vaccination på dag 1 (fra dag 1 op til dag 15)
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Antallet af deltagere med anmodede systemiske bivirkninger 14 dage efter vaccination på dag 1 blev rapporteret.
En AE var enhver uønsket medicinsk hændelse i en klinisk undersøgelse, hvor der blev administreret et medicinsk (undersøgelsesmæssigt eller ikke-undersøgelsesmæssigt) produkt.
En AE har ikke nødvendigvis en årsagssammenhæng med undersøgelsesvaccinen.
Anmodede systemiske bivirkninger omfattede træthed, hovedpine, kvalme, feber og myalgi, som deltagerne specifikt blev spurgt til, og som blev noteret af deltagerne i deres deltagerdagbog i 14 dage efter vaccination (vaccinationsdagen og de efterfølgende 14 dage).
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Op til 14 dage efter vaccination på dag 1 (fra dag 1 op til dag 15)
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Kohorte 1: Antal deltagere med uopfordrede bivirkninger (AE'er) op til 29 dage efter vaccination på dag 1
Tidsramme: Op til 29 dage efter vaccination på dag 1 (fra dag 1 op til dag 30)
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Antallet af deltagere med uopfordrede AE'er op til 29 dage efter vaccination på dag 1 blev rapporteret.
En AE var enhver uønsket medicinsk hændelse i en klinisk undersøgelse, hvor der blev administreret et medicinsk (undersøgelsesmæssigt eller ikke-undersøgelsesmæssigt) produkt.
En AE har ikke nødvendigvis en årsagssammenhæng med undersøgelsesvaccinen.
Uopfordrede AE'er var alle AE'er, for hvilke deltageren ikke er specifikt udspurgt i deltagerdagbogen.
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Op til 29 dage efter vaccination på dag 1 (fra dag 1 op til dag 30)
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Kohorte 1: Antal deltagere med alvorlige bivirkninger (SAE) op til dag 181
Tidsramme: Dag 1 (efter vaccination) op til dag 181
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Antal deltagere med SAE'er op til dag 181 blev rapporteret.
En AE var enhver uønsket medicinsk hændelse i en klinisk undersøgelse, hvor der blev administreret et medicinsk (undersøgelsesmæssigt eller ikke-undersøgelsesmæssigt) produkt.
En AE har ikke nødvendigvis en årsagssammenhæng med undersøgelsesvaccinen.
En SAE er en AE, der resulterer i et af følgende udfald eller anses for væsentlig af en hvilken som helst anden årsag: død; indledende eller længerevarende indlæggelse; livstruende oplevelse (umiddelbar risiko for at dø); vedvarende eller betydelig handicap/inhabilitet; medfødt anomali/fødselsdefekt; mistanke om overførsel af ethvert smitstof via et lægemiddel eller medicinsk vigtigt.
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Dag 1 (efter vaccination) op til dag 181
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Kohorte 2: Antal deltagere med opfordrede lokale (injektionssted) bivirkninger (AE'er) indsamlet i 14 dage efter vaccination på dag 1
Tidsramme: Op til 14 dage efter vaccination på dag 1 (fra dag 1 op til dag 15)
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Antallet af deltagere med anmodede lokale AE'er i 14 dage efter vaccination på dag 1 blev rapporteret.
En AE er enhver uønsket medicinsk hændelse i en klinisk undersøgelsesdeltager, der har administreret et lægemiddel (undersøgelsesmæssigt eller ikke-undersøgelsesmæssigt) produkt.
En AE har ikke nødvendigvis en årsagssammenhæng med undersøgelsesvaccinen.
Opfordrede lokale AE'er var præcist definerede begivenheder, som deltagerne specifikt blev spurgt om, og som blev noteret af deltagerne i dagbogen.
Opfordrede lokale (injektionssted) AE'er omfattede smerter/ømhed på injektionsstedet, erytem og hævelse på undersøgelsesvaccinens injektionssted, blev brugt til at vurdere reaktogeniciteten af undersøgelsesvaccinen og var foruddefineret lokale (injektionssted).
Alle opfordrede AE'er på injektionsstedet (lokalt) blev anset for at være relateret til undersøgelsens vaccineadministration.
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Op til 14 dage efter vaccination på dag 1 (fra dag 1 op til dag 15)
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Kohorte 2: Antal deltagere med anmodede systemiske bivirkninger (AE'er) indsamlet i 14 dage efter vaccination på dag 1
Tidsramme: Op til 14 dage efter vaccination på dag 1 (fra dag 1 op til dag 15)
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Antallet af deltagere med anmodede systemiske bivirkninger 14 dage efter vaccination på dag 1 blev rapporteret.
En AE var enhver uønsket medicinsk hændelse i en klinisk undersøgelse, hvor der blev administreret et medicinsk (undersøgelsesmæssigt eller ikke-undersøgelsesmæssigt) produkt.
En AE har ikke nødvendigvis en årsagssammenhæng med undersøgelsesvaccinen.
Anmodede systemiske bivirkninger omfattede træthed, hovedpine, kvalme, feber og myalgi, som deltagerne specifikt blev spurgt til, og som blev noteret af deltagerne i deres deltagerdagbog i 14 dage efter vaccination (vaccinationsdagen og de efterfølgende 14 dage).
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Op til 14 dage efter vaccination på dag 1 (fra dag 1 op til dag 15)
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Kohorte 2: Antal deltagere med uopfordrede bivirkninger (AE'er) 29 dage efter vaccination på dag 1
Tidsramme: Op til 29 dage efter vaccination på dag 1 (fra dag 1 op til dag 30)
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Antallet af deltagere med uopfordrede AE'er op til 29 dage efter vaccination på dag 1 blev rapporteret.
En AE var enhver uønsket medicinsk hændelse i en klinisk undersøgelse, hvor der blev administreret et medicinsk (undersøgelsesmæssigt eller ikke-undersøgelsesmæssigt) produkt.
En AE har ikke nødvendigvis en årsagssammenhæng med undersøgelsesvaccinen.
Uopfordrede AE'er var alle AE'er, for hvilke deltageren ikke er specifikt udspurgt i deltagerdagbogen.
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Op til 29 dage efter vaccination på dag 1 (fra dag 1 op til dag 30)
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Kohorte 2: Antal deltagere med alvorlige bivirkninger (SAE) op til dag 181
Tidsramme: Dag 1 (efter vaccination) op til dag 181
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Antal deltagere med SAE'er op til dag 181 blev rapporteret.
En AE var enhver uønsket medicinsk hændelse i en klinisk undersøgelse, hvor der blev administreret et medicinsk (undersøgelsesmæssigt eller ikke-undersøgelsesmæssigt) produkt.
En AE har ikke nødvendigvis en årsagssammenhæng med undersøgelsesvaccinen.
En SAE er en AE, der resulterer i et af følgende udfald eller anses for væsentlig af en hvilken som helst anden årsag: død; indledende eller længerevarende indlæggelse; livstruende oplevelse (umiddelbar risiko for at dø); vedvarende eller betydelig handicap/inhabilitet; medfødt anomali/fødselsdefekt; mistanke om overførsel af ethvert smitstof via et lægemiddel eller medicinsk vigtigt.
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Dag 1 (efter vaccination) op til dag 181
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Cohort 1: Geometric Mean Titers (GMTs) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by Multiplex Electrochemiluminescent (ECL) Based Immunoassay on Day 15
Tidsramme: Day 15
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GMTs of serotype-specific total IgG serum antibodies as measured by multiplex ECL based immunoassay were reported.
GMTs for each antigen serotypes O1A, O2, O4, O6A, O8, O15, O16, O18A, O25B, O75 and exotoxin protein A (EPA) were determined in serum from collected blood samples.
Lower limit of quantification (LLOQ) values for O1A: 69149, O2: 65287, O4: 67356, O6A: 150748, O8: 72196, O15: 66910, O16: 71586, O18A: 70519, O25B: 61990, O75: 133019, and EPA: 66165.
Any titer less than LLOQ is replaced by half of LLOQ (0.5*LLOQ).
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Day 15
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Cohort 1: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype Specific Antibodies as Measured by Multiplex ECL Based Immunoassay on Day 15
Tidsramme: Baseline (Day 1, pre-vaccination) and Day 15
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GMR of fold changes from baseline for serotype specific antibodies as measured by multiplex ECL based immunoassay on Day 15 were reported.
GMR for each antigen serotypes O1A, O2, O4, O6A, O8, O15, O16, O18A, O25B, O75 and EPA were determined in serum from collected blood samples by multiplex ECL based immunoassay.
GMR of fold change from baseline was calculated as the ratio of GMTs on Day 15 and pre-vaccination (on Day 1).
Any titer less than LLOQ is replaced by value of LLOQ.
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Baseline (Day 1, pre-vaccination) and Day 15
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Cohort 1: Percentage of Participants With a Greater Than or Equal to (>=) 2-Fold and >=4-Fold Increase From Baseline in Serotype Specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Day 15
Tidsramme: Baseline (Day 1, pre-vaccination) and Day 15
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Percentage of participants with a >=2-fold and >=4-fold increase (FI) from baseline in serotype specific serum antibody titers as measured by multiplex ECL based immunoassay on Day 15 was reported.
The fold (>=2-fold and >=4-fold) increase from baseline to Day 15 for the serotypes O1A, O2, O4, O6A, O8, O15, O16, O18A, O25B, O75 and EPA was calculated as the ratio of titer values of serum antibody on Day 15 and pre-vaccination (on day 1) that is Day 15/Day 1.
Any titer less than LLOQ is replaced by value of LLOQ.
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Baseline (Day 1, pre-vaccination) and Day 15
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Cohort 1: Geometric Mean Titers (GMT) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by Multiplex Opsonophagocytic Assay (MOPA) on Day 15
Tidsramme: Day 15
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GMTs of serotype-specific total IgG serum antibodies as measured by MOPA were reported.
GMTs for each antigen serotypes O1A, O2, O4, O6A, O8, O15, O16, O18A, O25B and O75 were determined in serum from collected blood samples.
LLOQ values were: O1A: 53, O2: 51, O4: 29, O6A: 47, O8: 196, O15: 37, O16: 54, O18A: 12, O25B: 65, and O75: 37. Any titer less than LLOQ is replaced by half of LLOQ (0.5*LLOQ).
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Day 15
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Cohort 1: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype Specific Antibodies as Measured by MOPA on Day 15
Tidsramme: Baseline (Day 1, pre-vaccination), Day 15
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GMR of fold changes from baseline for serotype specific antibodies as measured by MOPA on Day 15 were reported.
GMR for each antigen serotypes O1A, O2, O4, O6A, O8, O15, O16, O18A, O25B and O75 were determined in serum from collected blood samples by MOPA.
GMR of fold change from baseline was calculated as the ratio of GMTs on Day 15 and pre-vaccination (on Day 1).
Any titer less than LLOQ is replaced by value of LLOQ.
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Baseline (Day 1, pre-vaccination), Day 15
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Cohort 1: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by MOPA on Day 15
Tidsramme: Baseline (Day 1, pre-vaccination) and Day 15
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Percentage of participants with a >=2-fold and >=4-fold increase from baseline in serotype specific serum antibody titers as measured by MOPA on Day 15 was reported.
The fold (>=2-fold and >=4-fold) increase from baseline to Day 15 for the serotypes O1A, O2, O4, O6A, O8, O15, O16, O18A, O25B, and O75 was calculated as the ratio of titer values of serum antibody on Day 15 and pre-vaccination (on day 1) that is, Day 15/Day 1.
Any titer less than LLOQ is replaced by value of LLOQ.
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Baseline (Day 1, pre-vaccination) and Day 15
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Cohort 2: Geometric Mean Titers (GMTs) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by Multiplex ECL Based Immunoassay on Day 30
Tidsramme: At Day 30
|
GMTs of serotype-specific total IgG serum antibodies as measured by multiplex ECL based immunoassay were reported.
GMTs for each antigen serotypes O1A, O2, O4, O6A, O8, O15, O16, O18A, O25B, O75 and EPA were determined in serum from collected blood samples.
LLOQ values for O1A: 69149, O2: 65287, O4: 67356, O6A: 150748, O8: 72196, O15: 66910, O16: 71586, O18A: 70519, O25B: 61990, O75: 133019, and EPA: 66165.
Any titer less than LLOQ is replaced by half of LLOQ (0.5*LLOQ).
|
At Day 30
|
|
Cohort 2: Geometric Mean Ratio (GMR) of Fold Changes From Baseline For Serotype-specific Antibodies Measured by Multiplex ECL Based Immunoassay on Day 30
Tidsramme: Baseline (Day 1, pre-vaccination) and Day 30
|
GMR of fold changes from baseline for serotype-specific antibodies as measured by multiplex ECL based immunoassay on Day 30 were reported.
GMR for each antigen serotypes O1A, O2, O4, O6A, O8, O15, O16, O18A, O25B, O75 and EPA were determined in serum from collected blood samples by multiplex ECL based immunoassay.
GMR of fold change from baseline was calculated as the ratio of GMTs on Day 30 and pre-vaccination (on Day 1).
Any titer less than LLOQ is replaced by value of LLOQ.
|
Baseline (Day 1, pre-vaccination) and Day 30
|
|
Cohort 2: Percentage of Participants With a >=2-Fold and >=4-Fold Increase From Baseline in Serotype Specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Day 30
Tidsramme: Baseline (Day 1, pre-vaccination) and Day 30
|
Percentage of participants with a >=2-fold and >=4-fold increase from baseline in serotype specific serum antibody titers as measured by multiplex ECL based immunoassay on Day 30 was reported.
The fold (>=2-fold and >=4-fold) increase from baseline to Day 30 for the serotypes O1A, O2, O4, O6A, O8, O15, O16, O18A, O25B, O75 and EPA was calculated as the ratio of titer values of serum antibody on Day 30 and pre-vaccination (on day 1) that is, Day 30/Day 1.
Any titer less than LLOQ is replaced by value of LLOQ.
|
Baseline (Day 1, pre-vaccination) and Day 30
|
|
Cohort 2: Geometric Mean Titer (GMT) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by Multiplex Opsonophagocytic Assay (MOPA) on Day 30
Tidsramme: At Day 30
|
GMTs of serotype-specific total IgG serum antibodies as measured by MOPA were reported.
GMTs for each antigen serotypes O1A, O2, O4, O6A, O15, O16, O18A, O25B, and O75 were determined in serum from collected blood samples.
For serotype O8 functional IgG serum antibodies were not evaluated as the assay was not able to detect vaccine-induced functional antibodies against the O8 serotype.
LLOQ values were O1A: 33, O2: 42, O4: 12, O6A: 62, O15: 75, O16: 17, O18A: 44, O25B: 58, O75: 14.
Any titer less than LLOQ is replaced by half of LLOQ (0.5*LLOQ).
|
At Day 30
|
|
Cohort 2: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype Specific Antibodies as Measured by MOPA on Day 30
Tidsramme: Baseline (Day 1, pre-vaccination) and Day 30
|
GMR of fold changes from baseline for serotype specific antibodies as measured by MOPA on Day 30 were reported.
GMR for each antigen serotypes O1A, O2, O4, O6A, O15, O16, O18A, O25B and O75 were determined in serum from collected blood samples by MOPA.
GMR of fold change from baseline was calculated as the ratio of GMTs on Day 30 and pre-vaccination (on Day 1).
For serotype O8 functional IgG serum antibodies were not evaluated as the assay was not able to detect vaccine-induced functional antibodies against the O8 serotype.
Any titer less than LLOQ is replaced by value of LLOQ.
|
Baseline (Day 1, pre-vaccination) and Day 30
|
|
Cohort 2: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibodies Titers Measured by MOPA on Day 30
Tidsramme: Baseline (Day 1, pre-vaccination) and Day 30
|
Percentage of participants with a >=2-fold and >=4-fold increase from baseline in serotype specific serum antibodies titers as measured by MOPA on Day 30 was reported.
The fold (>=2-fold and >=4-fold increase from baseline to Day 30 for the serotypes O1A, O2, O4, O6A, O15, O16, O18A, O25B and O75 was calculated as the ratio of titer values of serum antibodies on Day 30 and pre-vaccination (on day 1 that is, Day 30/Day 1.
For serotype O8 functional IgG serum antibodies were not evaluated as the assay was not able to detect vaccine-induced functional antibodies against the O8 serotype.
Any titer less than LLOQ is replaced by value of LLOQ.
|
Baseline (Day 1, pre-vaccination) and Day 30
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Kohorte 2: Antal deltagere med alvorlige bivirkninger (SAE'er) relateret til undersøgelsesvaccine eller undersøgelsesprocedure fra dag 182 til slutningen af undersøgelsen (dag 1826)
Tidsramme: Fra dag 182 til studiets afslutning (dag 1826)
|
En AE er enhver uønsket medicinsk hændelse hos en deltager, der deltager i en klinisk undersøgelse, som ikke nødvendigvis har en årsagssammenhæng med det farmaceutiske/biologiske middel, der undersøges.
En SAE er en AE, der resulterer i et af følgende udfald eller anses for væsentlig af en hvilken som helst anden årsag: død; indledende eller længerevarende indlæggelse; livstruende oplevelse (umiddelbar risiko for at dø); vedvarende eller betydelig handicap/inhabilitet; medfødt anomali/fødselsdefekt; mistanke om overførsel af ethvert smitstof via et lægemiddel eller medicinsk vigtigt.
|
Fra dag 182 til studiets afslutning (dag 1826)
|
|
Cohort 1: Correlation Between the Multiplex ECL-Based Immunoassay and the MOPA Functional Titers by Serotypes on Day 15
Tidsramme: Day 15
|
Correlation between the multiplex ECL-based immunoassay and the MOPA functional titers by serotypes (O1A, O2, O4, O6A, O8, O15, O16, O18A, O25B and O75) on Day 15 were analyzed.
Any titer less than LLOQ is replaced by half of LLOQ (0.5*LLOQ).
|
Day 15
|
|
Cohort 1: Geometric Mean Titers (GMTs) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by Multiplex ECL Based Immunoassay on Days 30 and 181
Tidsramme: Days 30 and 181
|
GMTs of serotype-specific total IgG serum antibodies as measured by multiplex ECL based immunoassay on Days 30 and 181 were reported.
GMTs for each antigen serotypes O1A, O2, O4, O6A, O8, O15, O16, O18A, O25B, O75 and EPA were determined in serum from collected blood samples.
LLOQ values for O1A: 69149, O2: 65287, O4: 67356, O6A: 150748, O8: 72196, O15: 66910, O16: 71586, O18A: 70519, O25B: 61990, O75: 133019, and EPA: 66165.
Any titer less than LLOQ is replaced by half of LLOQ (0.5*LLOQ).
|
Days 30 and 181
|
|
Cohort 1: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype-specific Antibodies Measured by Multiplex ECL Based Immunoassay on Days 30 and 181
Tidsramme: Baseline (Day 1, pre-vaccination) and Days 30 and 181
|
GMR of fold changes from baseline for serotype specific antibodies measured by multiplex ECL based immunoassay on Days 30 and 181 were reported.
GMR for each antigen serotypes O1A, O2, O4, O6A, O8, O15, O16, O18A, O25B, O75 and EPA were determined in serum from collected blood samples by ECL based immunoassay.
GMR of fold change from baseline was calculated as the ratio of GMTs on Days 30 and 181 and pre-vaccination (on Day 1).
Any titer less than LLOQ is replaced by value of LLOQ.
|
Baseline (Day 1, pre-vaccination) and Days 30 and 181
|
|
Cohort 1: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase From Baseline in Serotype-specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Days 30 and 181
Tidsramme: Day 1 (pre-vaccination) and Days 30 and 181
|
Percentage of participants with a >=2-fold and >=4-fold increase from baseline in serotype (ST)-specific serum antibody titers as measured by multiplex ECL based immunoassay on Days 30 and 181 was reported.
The fold (>=2-fold and >=4-fold) increase from baseline to Days 30 and 181 for the serotypes O1A, O2, O4, O6A, O8, O15, O16, O18A, O25B, O75 and EPA was calculated as the ratio of titer values of serum antibody on Day 30 and Day 181 and pre-vaccination (on Day 1 that is, Day 30/Day 1 and Day 181/Day 1).
Any titer less than LLOQ is replaced by value of LLOQ.
|
Day 1 (pre-vaccination) and Days 30 and 181
|
|
Cohort 1: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype Specific Antibodies as Measured by MOPA on Days 30 and 181
Tidsramme: Baseline (Day 1, pre-vaccination) and Days 30 and 181
|
GMRs for each O-antigen (serotypes O1A, O2, O4, O6A, O15, O16, O18A, O25B and O75) were determined using a validated MOPA.
For sample pairs with available validated MOPA results from both Day 1 and Day 30, or Day 1 and 181, GMR from baseline for serotype specific antibodies was calculated as the ratio of GMTs on Days 30 or 181 and pre-vaccination (on Day 1).
For serotype O8 functional IgG serum antibodies were not evaluated as the assay was not able to detect vaccine-induced functional antibodies against the O8 serotype.
Any titer less than LLOQ is replaced by value of LLOQ.
|
Baseline (Day 1, pre-vaccination) and Days 30 and 181
|
|
Cohort 1: Geometric Mean Titers (GMTs) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by MOPA on Days 30 and 181
Tidsramme: Days 30 and 181
|
GMTs of serotype-specific total IgG serum antibodies as measured by MOPA on Days 30 and 181 were reported.
GMTs for each antigen serotypes O1A, O2, O4, O6A,O15, O16, O18A, O25B and O75 were determined in serum from collected blood samples.
For serotype O8 functional IgG serum antibodies were not evaluated as the assay was not able to detect vaccine-induced functional antibodies against the O8 serotype.
LLOQ values were O1A: 33, O2: 42, O4: 12, O6A: 62, O15: 75, O16: 17, O18A: 44, O25B: 58, O75: 14.
Any titer less than LLOQ is replaced by half of LLOQ (0.5*LLOQ).
|
Days 30 and 181
|
|
Cohort 1: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by MOPA on Days 30 and 181
Tidsramme: Day 1 (pre-vaccination) and Days 30 and 181
|
For sample pairs with available validated MOPA results, for each O-antigen (serotypes O1A, O2, O4, O6A, O15, O16, O18A, O25B and O75), the fold increase was calculated as the ratio of validated MOPA results on Days 30 or 181 and pre-vaccination (Day 30/Day 1 and 181/Day 1).
The percentage of participants with >=2-fold and >=4-fold increase in serotype-specific serum antibody titers was calculated.
For serotype O8 functional IgG serum antibodies were not evaluated as the assay was not able to detect vaccine-induced functional antibodies against the O8 serotype.
Any titer less than LLOQ is replaced by value of LLOQ.
|
Day 1 (pre-vaccination) and Days 30 and 181
|
|
Cohort 1: Number of Participants With Serious Adverse Events (SAEs) Related to Study Vaccine or Study Procedure From Day 182 up to End of Study (Day 1826)
Tidsramme: From Day 182 up to end of study (Day 1826)
|
Number of participants with SAEs related to study vaccine or study procedure was reported.
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent understudy.
An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission of any infectious agent via a medicinal product or medically important.
|
From Day 182 up to end of study (Day 1826)
|
|
Cohort 1: Geometric Mean Titers (GMTs) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Tidsramme: Days 366, 731, 1096, 1461 and 1826
|
GMTs of serotype-specific total IgG serum antibodies as measured by ECL based immunoassay were reported.
GMTs for each antigen serotypes O1A, O2, O4, O6A, O8, O15, O16, O18A, O25B, O75 and EPA were determined in serum from collected blood samples.
LLOQ values for O1A: 69149, O2: 65287, O4: 67356, O6A: 150748, O8: 72196, O15: 66910, O16: 71586, O18A: 70519, O25B: 61990, O75: 133019, and EPA: 66165.
Any titer less than LLOQ is replaced by half of LLOQ (0.5*LLOQ).
|
Days 366, 731, 1096, 1461 and 1826
|
|
Cohort 1: Percentage of Participants With a >=2-Fold and >=4-Fold Increase From Baseline in Serotype Specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Tidsramme: Baseline (Day 1, pre-vaccination) and Days 366, 731, 1096, 1461, 1826
|
Percentage of participants with a >=2-fold and >=4-fold increase from baseline in serotype specific serum antibody titers as measured by multiplex ECL based immunoassay on Days 366, 731, 1096, 1461, and 1826 was reported.
The fold (>=2-fold and >=4-fold) increase from baseline to Days 366, 731, 1096, 1461, and 1826 for the serotypes O1A, O2, O4, O6A, O8, O15, O16, O18A, O25B, O75 and EPA was calculated as the ratio of titer values of serum antibody on Days 366, 731, 1096, 1461 and 1826 and pre-vaccination (on day 1) that is, Day 366/Day 1, 731/Day 1, 1096/Day 1, 1461/Day 1 and 1826/Day 1.
Any titer less than LLOQ is replaced by value of LLOQ.
|
Baseline (Day 1, pre-vaccination) and Days 366, 731, 1096, 1461, 1826
|
|
Cohort 1: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype-specific Antibodies Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826
Tidsramme: Baseline (Day 1, pre-vaccination) and Days 366, 731, 1096, 1461, 1826
|
GMR of fold changes from baseline for serotype specific antibodies as measured by multiplex ECL based immunoassay on Days 366, 731, 1096, 1461 and 1826 were reported.
GMR for each antigen serotypes O1A, O2, O4, O6A, O8, O15, O16, O18A, O25B, O75 and EPA were determined in serum from collected blood samples by ECL based immunoassay.
GMR of fold change from baseline was calculated as the ratio of GMTs on Days 366, 731, 1096, 1461 and 1826 and pre-vaccination (on Day 1).
Any titer less than LLOQ is replaced by value of LLOQ.
|
Baseline (Day 1, pre-vaccination) and Days 366, 731, 1096, 1461, 1826
|
|
Cohort 1: Geometric Mean Titer (GMT) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by MOPA on Days 366, 731, 1096, and 1461
Tidsramme: Days 366, 731, 1096, 1461
|
GMTs of serotype-specific total IgG serum antibodies as measured by MOPA were reported.
GMTs for each antigen serotypes O1A, O2, O4, O6A, O15, O16, O18A, O25B and O75 were determined in serum from collected blood samples.
For serotype O8 functional IgG serum antibodies were not evaluated as the assay was not able to detect vaccine-induced functional antibodies against the O8 serotype.
Data was planned to be analyzed for specified arms only.
LLOQ values for O1A: 33, O2: 42, O4: 12, O6A: 62, O15: 75, O16: 17, O18A: 44, O25B: 58, O75: 14.
Any titer less than LLOQ is replaced by half of LLOQ (0.5*LLOQ).
|
Days 366, 731, 1096, 1461
|
|
Cohort 1: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype Specific Antibodies as Measured by MOPA on Days 366, 731, 1096, and 1461
Tidsramme: Baseline (Day 1, pre-vaccination) and Days 366, 731, 1096, 1461
|
GMR of fold changes from baseline for serotype specific antibodies as measured by MOPA on Days 366, 731, 1096, 1461 were reported.
GMR for each antigen serotypes O1A, O2, O4, O6A, O15, O16, O18A, O25B and O75 were determined in serum from collected blood samples by MOPA.
GMR of fold change from baseline was calculated as the ratio of GMTs on Days 366, 731, 1096, 1461 and pre-vaccination (on Day 1).
For serotype O8 functional IgG serum antibodies were not evaluated as the assay was not able to detect vaccine-induced functional antibodies against the O8 serotype.
Any titer less than LLOQ is replaced by value of LLOQ.
|
Baseline (Day 1, pre-vaccination) and Days 366, 731, 1096, 1461
|
|
Cohort 1: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by MOPA on Days 366, 731, 1096, and 1461
Tidsramme: Baseline (Day 1, pre-vaccination) and Days 366, 731, 1096, and 1461
|
The fold (>=2-fold and >=4-fold) increase from baseline to Days 366, 731, 1096, and 1461 for the serotypes O1A, O2, O4, O6A, O15, O16, O18A, O25B, and O75 was calculated as the ratio of titer values of serum antibody on Days 366, 731, 1096, 1461 and pre-vaccination (on day 1) that is, Day 366/Day 1, 731/Day 1, 1096/Day 1, 1461/Day 1.
For serotype O8 functional IgG serum antibodies were not evaluated as the assay was not able to detect vaccine-induced functional antibodies against the O8 serotype.
Any titer less than LLOQ is replaced by value of LLOQ.
|
Baseline (Day 1, pre-vaccination) and Days 366, 731, 1096, and 1461
|
|
Cohort 2: Correlation Between the Multiplex ECL-Based Immunoassay and the MOPA Functional Titers by Serotype on Day 30
Tidsramme: Day 30
|
Correlation between the multiplex ECL-based immunoassay and the MOPA functional titers by serotypes O1A, O2, O4, O6A, O15, O16, O18A, O25B, and O75 on Day 30 was analyzed.
Data was planned to be analyzed for specified arms only.
For serotype O8 functional IgG serum antibodies were not evaluated as the assay was not able to detect vaccine-induced functional antibodies against the O8 serotype.
|
Day 30
|
|
Cohort 2: Geometric Mean Titers (GMTs) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by Multiplex ECL Based Immunoassay on Days 15 and 181
Tidsramme: At Days 15 and 181
|
GMTs of serotype-specific total IgG serum antibodies as measured by ECL based immunoassay were reported.
GMTs for each antigen serotypes O1A, O2, O4, O6A, O8, O15, O16, O18A, O25B, O75 and EPA were determined in serum from collected blood samples.
Data was planned to be analyzed for specified arms only.
LLOQ values for O1A: 69149, O2: 65287, O4: 67356, O6A: 150748, O8: 72196, O15: 66910, O16: 71586, O18A: 70519, O25B: 61990, O75: 133019, and EPA: 66165.
Any titer less than LLOQ is replaced by half of LLOQ (0.5*LLOQ).
|
At Days 15 and 181
|
|
Cohort 2: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype-specific Antibodies Measured by Multiplex ECL Based Immunoassay on Days 15 and 181
Tidsramme: Baseline (Day 1, pre-vaccination), Days 15 and 181
|
GMR of fold changes from baseline for serotype specific antibodies as measured by multiplex ECL based immunoassay on Days 15 and 181 were reported.
GMR for each antigen serotypes O1A, O2, O4, O6A, O8, O15, O16, O18A, O25B, and O75 were determined in serum from collected blood samples by ECL based immunoassay.
GMR of fold change from baseline was calculated as the ratio of GMTs on Days 15 and 181 and pre-vaccination (on Day 1).
Any titer less than LLOQ is replaced by value of LLOQ.
|
Baseline (Day 1, pre-vaccination), Days 15 and 181
|
|
Cohort 2: Percentage of Participants With a >= 2-Fold Increase in Serotype-specific Serum Antibody Titers Measured by Multiplex ECL Based Immunoassay on Days 15 and 181
Tidsramme: Baseline (Day 1, pre-vaccination), Days 15 and 181
|
Percentage of participants with a >=2-fold increase from baseline in serotype specific serum antibody titers as measured by multiplex ECL based immunoassay on Days 15 and 181 were reported.
The fold (>=2-fold increase from baseline to Days 15 and 181) for the serotypes O1A, O2, O4, O6A, O8, O15, O16, O18A, O25B, and O75 was calculated as the ratio of titer values of serum antibody on Days 15 and 181 and pre-vaccination (on Day 1 that is Day 15/Day 1 and Day 181/Day 1).
|
Baseline (Day 1, pre-vaccination), Days 15 and 181
|
|
Cohort 2: Percentage of Participants With a >= 4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by Multiplex ECL Based Immunoassay on Days 15 and 181
Tidsramme: Baseline (Day 1, pre-vaccination), Days 15 and 181
|
Percentage of participants with a >=4-fold increase from baseline in serotype specific serum antibody titers as measured by multiplex ECL based immunoassay on Days 15 and 181 were reported.
The fold (>=4-fold increase from baseline to Days 15 and 181) for the serotypes O1A, O2, O4, O6A, O8, O15, O16, O18A, O25B, and O75 was calculated as the ratio of titer values of serum antibody on Days 15 and 181 and pre-vaccination (on Day 1 that is Day 15/Day 1 and Day 181/Day 1).
|
Baseline (Day 1, pre-vaccination), Days 15 and 181
|
|
Cohort 2: Geometric Mean Titers (GMTs) of Serotype-specific Total IgG Serum Antibodies Against Specified Antigens Measured by MOPA on Day 181
Tidsramme: At Day 181
|
GMTs of serotype-specific total IgG serum antibodies as measured by MOPA were reported.
Serotypes: O1A, O2, O4, O6A, O15, O16, O18A, O25B, and O75 were determined in serum from collected blood samples.
For serotype O8 functional IgG serum antibodies were not evaluated as the assay was not able to detect vaccine-induced functional antibodies against the O8 serotype.
LLOQ values for O1A: 33, O2: 42, O4: 12, O6A: 62, O15: 75, O16: 17, O18A: 44, O25B: 58, O75: 14.
Any titer less than LLOQ is replaced by half of LLOQ (0.5*LLOQ).
|
At Day 181
|
|
Cohort 2: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by MOPA on Day 181
Tidsramme: Baseline (Day 1, pre-vaccination) and Day 181
|
Percentage of participants with a >=2-fold and >=4-fold increase from baseline in serotype specific serum antibody titers as measured by MOPA on Day 181 was reported.
The fold (>=2-fold and >=4-fold) increase from baseline to Day 181 for the serotypes O1A, O2, O4, O6A, O15, O16, O18A, O25B and O75 was calculated as the ratio of titer values of serum antibody on Day 181 and pre-vaccination (on Day 1) that is, Day 181/Day 1.
For serotype O8 functional IgG serum antibodies were not evaluated as the assay was not able to detect vaccine-induced functional antibodies against the O8 serotype.
Any titer less than LLOQ is replaced by value of LLOQ.
|
Baseline (Day 1, pre-vaccination) and Day 181
|
|
Cohort 2: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype-specific Antibodies Measured by MOPA on Day 181
Tidsramme: Baseline (Day 1, pre-vaccination), Day 181
|
GMR of fold changes from baseline for serotype specific antibodies as measured by MOPA on Day 181 were reported.
GMR for each antigen serotypes O1A, O2, O4, O6A, O15, O16, O18A, O25B and O75 were determined in serum from collected blood samples by MOPA.
GMR of fold change from baseline was calculated as the ratio of GMTs on Day 181 and pre-vaccination (on Day 1).
For serotype O8 functional IgG serum antibodies were not evaluated as the assay was not able to detect vaccine-induced functional antibodies against the O8 serotype.
Any titer less than LLOQ is replaced by value of LLOQ.
|
Baseline (Day 1, pre-vaccination), Day 181
|
|
Cohort 2: Geometric Mean Titers (GMTs) of Serotype-specific Antibodies Against Specified Antigens Measured by Multiplex ECL Based Immunoassay on Day 366
Tidsramme: At Day 366
|
GMTs of serotype-specific antibodies as measured by ECL based immunoassay were reported.
GMTs for the serotypes O1A, O2, O4, O6A, O8, O15, O16, O18A, O25B, O75 were determined.
Any titer less than LLOQ is replaced by half of LLOQ (0.5*LLOQ).
|
At Day 366
|
|
Cohort 2: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by Multiplex ECL Based Immunoassay on Day 366
Tidsramme: Baseline (Day 1, pre-vaccination), Day 366
|
Percentage of participants with a >=2-fold and >=4-fold increase from baseline in serotype specific serum antibody titers as measured by multiplex ECL based immunoassay on Day 366 was reported.
The fold (>=2-fold and >=4- fold) increase from baseline to Day 366 for the serotypes O1A, O2, O4, O6A, O8, O15, O16, O18A, O25B, O75 was calculated as the ratio of titer values of serum antibodies on Day 366 and pre-vaccination (on day 1) that is, Day 366/ Day 1.
Any titer less than LLOQ is replaced by value of LLOQ.
|
Baseline (Day 1, pre-vaccination), Day 366
|
|
Cohort 2: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype-specific Antibodies Measured by Multiplex ECL Based Immunoassay on Day 366
Tidsramme: Baseline (Day 1, pre-vaccination), Day 366
|
GMR of fold changes from baseline for serotype specific antibodies as measured by multiplex ECL based immunoassay on Day 366 were reported.
GMR for each antigen serotypes O1A, O2, O4, O6A, O8, O15, O16, O18A, O25B, O75 were determined in serum from collected blood samples by ECL based immunoassay.
GMR of fold change from baseline was calculated as the ratio of GMTs on Day 366 and pre-vaccination (on Day 1).
Any titer less than LLOQ is replaced by value of LLOQ.
|
Baseline (Day 1, pre-vaccination), Day 366
|
|
Cohort 2: Geometric Mean Titers (GMTs) of Serotype-specific Total IgG Serum Antibodies Against Specified Antigens Measured by MOPA on Day 366
Tidsramme: At Day 366
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GMTs of serotype-specific total IgG serum antibodies as measured by MOPA were reported.
GMTs for each antigen serotypes O1A, O2, O4, O6A, O15, O16, O18A, O25B, and O75 were determined in serum from collected blood samples.
For serotype O8 functional IgG serum antibodies were not evaluated as the assay was not able to detect vaccine-induced functional antibodies against the O8 serotype.
LLOQ values for O1A: 33, O2: 42, O4: 12, O6A: 62, O15: 75, O16: 17, O18A: 44, O25B: 58, O75: 14.
Any titer less than LLOQ is replaced by half of LLOQ (0.5*LLOQ).
|
At Day 366
|
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Cohort 2: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype-specific Antibodies Measured by MOPA on Day 366
Tidsramme: Baseline (Day 1, pre-vaccination), Day 366
|
GMR of fold changes from baseline for serotype specific antibodies as measured by MOPA on Day 366 were reported.
GMR for each antigen serotypes O1A, O2, O4, O6A, O15, O16, O18A, O25B and O75 were determined in serum from collected blood samples by MOPA.
GMR of fold change from baseline was calculated as the ratio of GMTs on Day 366 and pre-vaccination (on Day 1).
For serotype O8 functional IgG serum antibodies were not evaluated as the assay was not able to detect vaccine-induced functional antibodies against the O8 serotype.
Any titer less than LLOQ is replaced by value of LLOQ.
|
Baseline (Day 1, pre-vaccination), Day 366
|
|
Cohort 2: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by MOPA on Day 366
Tidsramme: Baseline (Day 1, pre-vaccination), Day 366
|
Percentage of participants with a >=2-fold and >=4-fold increase from baseline in serotype specific serum antibody titers as measured by MOPA on Day 366 was reported.
The >=2-fold and >=4-fold increase from baseline to Day 366 for the serotypes O1A, O2, O4, O6A, O15, O16, O18A, O25B and O75 was calculated as the ratio of titer values of serum antibody on Day 366 and pre-vaccination (on day 1) that is, Day 366/Day 1.
For serotype O8 functional IgG serum antibodies were not evaluated as the assay was not able to detect vaccine-induced functional antibodies against the O8 serotype.
Any titer less than LLOQ is replaced by value of LLOQ.
|
Baseline (Day 1, pre-vaccination), Day 366
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Studieleder: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
6. juni 2019
Primær færdiggørelse (Faktiske)
8. juni 2021
Studieafslutning (Faktiske)
18. december 2024
Datoer for studieregistrering
Først indsendt
25. januar 2019
Først indsendt, der opfyldte QC-kriterier
25. januar 2019
Først opslået (Faktiske)
28. januar 2019
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
5. juni 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
4. juni 2026
Sidst verificeret
1. juni 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CR108580
- VAC52416BAC1001 (Anden identifikator: Janssen Research & Development, LLC)
- 2020-000657-27 (EudraCT nummer)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
Datadelingspolitikken for Janssen Pharmaceutical Companies of Johnson & Johnson er tilgængelig på www.janssen.com/clinical-trials\transparency.
Som nævnt på dette websted kan anmodninger om adgang til undersøgelsesdata indsendes via Yale open Data Access (YODA) Project-websted på yoda.yale.edu
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ja
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .