Tutkimus turvallisuudesta, reaktogeenisyydestä ja immuunivasteesta GVGH iNTS-GMMA -rokotteelle invasiivista ei-typhoidista salmonellaa vastaan aikuisilla, lapsilla ja imeväisillä
maanantai 31. elokuuta 2026 päivittänyt: GlaxoSmithKline
Vaiheen IIa tarkkailijasokea, satunnaistettu, kontrolloitu, ikääntymisen eskaloituva, yhden keskuksen interventiotutkimus GVGH iNTS -rokotteen turvallisuuden, reaktogeenisyyden ja immuunivasteen arvioimiseksi S. Typhimurium- ja S. Enteritidis -bakteeria vastaan aikuisilla, lapsilla ja Imeväiset, mukaan lukien annoksen löytäminen imeväisille, Afrikassa
Tämän tutkimuksen tarkoituksena on arvioida GlaxoSmithKline (GSK) Vaccines Institute for Global Healthin (GVGH) invasiivisten ei-typhoidaalisten Salmonella-yleistettyjen moduulien kalvoantigeenien (iNTS-GMMA) S. Typhimurium -rokotteen turvallisuutta, reaktogeenisyyttä ja immuunivastetta. ja S. Enteritidis iän vähentämiseen ja annosten nostamiseen Afrikan väestössä alkaen aikuisista (18–50-vuotiaat), sitten lapsista (24–59 kuukauden ikäiset) ja lopuksi pikkulapsille (9 kuukautta ja 6 kuukautta). viikon iässä).
Imeväiset ovat perusrokotuksen kohteena 6 viikon iästä alkaen.
Tutkimuksen yleiskatsaus
Tila
Valmis
Ehdot
Yksityiskohtainen kuvaus
Tutkimus toteutetaan kahdessa vaiheessa:
Vaihe 1: Ikäerottelu aikuisista lapsiin ja imeväisiin
- Aikuiset osallistujat saavat joko iNTS-GMMA-annoksen C (korkea) tai kontrollirokotteen lihakseen päivänä 1 ja päivänä 57.
- Lapsiosallistujat saavat joko annoksen B (keskikokoinen) tai annoksen C (korkea) ehdokasrokotteesta tai kontrollista päivänä 1 ja päivänä 57.
- Osallistujat pikkulapsille (9 kuukauden ikäiset) saavat joko annoksen A (pieni), annoksen B (keskikokoinen) tai annoksen C (korkea) ehdokasrokotteesta tai kontrollista päivänä 1, päivänä 85 ja päivänä 169.
- Osallistujat (6 viikon ikäiset) saavat joko annoksen A (pieni), annoksen B (keskikokoinen) tai annoksen C (korkea) ehdokasrokotteesta tai kontrollista päivänä 1, päivänä 85 (aloitusvaihe) ja päivänä 232 (Tehostusvaihe).
Vaihe 2: Annoksen löytäminen 6 viikon ikäisillä imeväisillä
-Imeväiset (6 viikon ikäiset) saavat yhden ehdokasrokotteen tai kontrollin kolmesta annostasosta (annos A [pieni], annos B [keskikokoinen] tai annos C [korkea]) päivänä 1, päivänä 85 ( Esikäsittelyvaihe) ja päivä 232 (tehostevaihe).
Opintotyyppi
Interventio
Ilmoittautuminen (Todellinen)
183
Vaihe
- Vaihe 2
Yhteystiedot ja paikat
Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.
Opiskelupaikat
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Kumasi, Ghana
- GSK Investigational Site
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Osallistumiskriteerit
Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Lapsi
- Aikuinen
Hyväksyy terveitä vapaaehtoisia
Joo
Kuvaus
Sisällyttämiskriteerit:
Kaikki osallistujat (aikuiset, lapset, 9 kuukauden ikäiset imeväiset ja 6 viikon ikäiset lapset) rekisteröidään Ghanan kliiniseen paikkaan, ja heidän on täytettävä KAIKKI seuraavat kriteerit tutkimukseen osallistuessaan:
- Osallistujat ja/tai osallistujien vanhemmat/laillisesti hyväksyttävä edustaja(t) (LAR), jotka tutkijan mielestä voivat ja tulevat noudattamaan protokollan vaatimuksia (esim. päiväkirjakorttien täyttäminen, palautus) seurantakäyntejä varten).
- Kirjallinen tai todistaja/peukalopainettu tietoinen suostumus, joka on saatu osallistujalta/vanhemmilta/LAR:ilta ennen minkään tutkimuskohtaisen toimenpiteen suorittamista.
- Terveet osallistujat sairaushistorian, kliinisen tutkimuksen ja laboratoriotutkimusten perusteella.
- Osallistujat, jotka täyttävät seulontavaatimukset.
- Osallistujat negatiiviset ihmisen immuunikatovirukselle (HIV), hepatiitti B:lle ja hepatiitti C:lle.
Aikuisten osallistujien on täytettävä KAIKKI seuraavat kriteerit tutkimukseen osallistuessaan:
- Mies tai nainen, joka on 18–50 vuoden ikäinen ensimmäisen tutkimuksen aikana.
- Naisosapuolet, jotka eivät ole raskaana, voidaan ottaa mukaan tutkimukseen. Ei-hedelmöityspotentiaali määritellään ennen kuukautisia, meneillään olevaa kahdenvälistä munanjohtimen ligaatiota tai okkluusiota, kohdunpoistoa, molemminpuolista munasarjan poistoa tai postmenopaussia.
- Hedelmällisessä iässä olevat naispuoliset osallistujat voidaan ilmoittautua tutkimukseen, jos osallistuja:
on käyttänyt riittävää ehkäisyä kuukauden ajan ennen tutkimusinterventiota ja:
- hänellä on negatiivinen raskaustesti tutkimustoimenpiteen antamispäivänä ja
- on suostunut jatkamaan riittävää ehkäisyä koko hoitojakson ajan ja kuukauden ajan tutkimuksen interventiohoitosarjan päättymisen jälkeen.
Ghana-korttia käytetään lähdeasiakirjana aikuisten iän varmentamiseen.
Lapsiosallistujien on täytettävä KAIKKI seuraavat kriteerit tutkimukseen osallistuessaan:
- Mies tai nainen, joka on 24–59 kuukauden ikäinen ensimmäisen tutkimuksen aikana.
- Aiemmin suoritetut rutiinilapsuuden rokotukset osallistujan vanhempien/LAR:ien parhaan tietämyksen mukaan.
- Syntynyt ≥37 viikon raskausajan jälkeen.
Vauvan osallistujien on täytettävä KAIKKI seuraavat kriteerit tutkimukseen osallistuessaan:
- Mies tai nainen, joka on 6 viikon tai 9 kuukauden ikäinen ensimmäisen tutkimuksen interventioantamisen aikaan.
- Syntynyt ≥37 viikon raskausajan jälkeen.
- Syntynyt äidille, joka on seronegatiivinen HIV:lle, B-hepatiittivirukselle ja C-hepatiittivirukselle.
Tie terveyteen -kaaviota käytetään lähdeasiakirjana vahvistamaan lasten ja vauvojen iät.
Poissulkemiskriteerit:
Lääketieteelliset olosuhteet
- Potilasasiakirjojen mukaan tunnettu altistuminen S. Typhimuriumille tai S. Enteritidisille vauvojen ja lasten syntymästä alkaen ja aikuisilla 3 vuoden iässä
- Aiemmin havaittu reaktio tai yliherkkyys, jota mikä tahansa tutkimuksen interventioiden komponentti todennäköisesti pahentaa.
- Yliherkkyys, mukaan lukien allergia, lääkkeille tai lääkinnällisille laitteille, joita käytetään tässä tutkimuksessa.
- Progressiiviset, epävakaat tai hallitsemattomat kliiniset tilat.
- Mikä tahansa vahvistettu tai epäilty immuunivastetta heikentävä tai immuunipuutostila sairaushistorian ja fyysisen tutkimuksen perusteella
- Suuret synnynnäiset epämuodostumat tutkijan arvioiden mukaan.
- Akuutti tai krooninen kliinisesti merkittävä keuhkojen, sydän- ja verisuonisairauksien, maksan tai munuaisten toimintahäiriö, joka on määritetty fyysisellä tutkimuksella tai laboratoriotesteillä.
- Akuutti sairaus ja/tai kuume ilmoittautumishetkellä (kuume määritellään lämpötilaksi ≥ 38,0 °C).
- Toistuva historia tai hallitsemattomat neurologiset häiriöt tai kohtaukset.
- Mikä tahansa kliinisesti merkittävä hematologinen ja/tai biokemiallinen laboratoriopoikkeavuus.
- Aliravitsemus määritellään WHO:n Z-pisteeksi alle -2 SD.
- Malariainfektio määritellään aseksuaalisten loisten esiintymiseksi veressä.
- Kliiniset sairaudet, jotka ovat vasta-aiheisia lihaksensisäiselle rokotukselle ja verikokeelle.
- Mikä tahansa käyttäytymis- tai kognitiivinen vajaatoiminta tai psykiatrinen sairaus, joka voi tutkijan mielestä häiritä osallistujan kykyä osallistua tutkimukseen.
- Mikä tahansa muu kliininen tila, joka voi tutkijan mielestä aiheuttaa lisäriskiä osallistujalle tutkimukseen osallistumisen vuoksi.
Aikaisempi/samaaikainen hoito
- Aiemmat tutkittavat inNTS- tai GMMA-rokotteet osallistujan elämässä.
- Muiden tutkimus- tai rekisteröimättömien tuotteiden kuin tutkimusinterventioiden käyttö 30 päivää ennen ensimmäistä tutkimusinterventioiden annosta alkavalla ajanjaksolla tai niiden suunniteltu käyttö tutkimusjakson aikana.
- Suunniteltu rokotteen antaminen/anto, jota ei ole ennakoitu tutkimusprotokollassa ajanjaksolla, joka alkaa 14 päivää ennen jokaista annosta ja päättyy 28 päivää viimeisen tutkimusinterventioiden antamisen jälkeen, lukuun ottamatta influenssarokotteita ja rokotteita, jotka annetaan osana kansanterveyttä rokotuskampanja.
Rokote, jota tutkimussuunnitelmassa ei ole ennakoitu ja joka on annettu ajanjaksolla, joka alkaa 14 päivää ennen ensimmäistä annosta ja päättyy 14 päivää viimeisen tutkimusinterventioannoksen jälkeen elävien rokotteiden tapauksessa tai 7 päivää inaktivoitujen rokotteiden tapauksessa*, flunssaa lukuun ottamatta rokotteet tai COVID-19-rokote, joita voidaan harkita tapauskohtaisesti.
- Jos kansanterveysviranomaiset järjestävät kiireellisen joukkorokotuksen odottamattoman kansanterveysuhan (esim. pandemia) varalta rutiininomaisen rokotusohjelman ulkopuolella, voidaan yllä kuvattua ajanjaksoa lyhentää, jos sitä käytetään paikallishallinnon suositusten ja sponsorin mukaisesti. on ilmoitettu.
Tällaisissa olosuhteissa osallistujan voidaan katsoa olevan kelvollinen tutkimukseen ilmoittautumiseen ja/tai tutkimusinterventiohoitoon sen jälkeen, kun asianmukainen viivästysjakso on kulunut ja osallistumis-/poissulkemiskriteerit on tarkistettu uudelleen ja jos osallistujan on vahvistettu kelpoiseksi.
- Pitkävaikutteisten immuunijärjestelmää muokkaavien lääkkeiden antaminen milloin tahansa tutkimusjakson aikana.
- Immunoglobuliinien ja/tai minkä tahansa verituotteiden tai plasmajohdannaisten antaminen syntymästä lähtien (6 viikon ikäiselle lapselle) tai ajanjaksona, joka alkaa 3 kuukautta ennen ensimmäisen annoksen antamista tutkimusinterventioihin tai suunniteltua antoa tutkimusjakson aikana.
- Immunosuppressanttien tai muiden immuunijärjestelmää modifioivien lääkkeiden krooninen antaminen (määritelty yli 14 päivää yhteensä) ajanjakson aikana, joka alkaa 3 kuukautta ennen ensimmäistä tutkimuksen interventioannosta (-annoksia) tutkimuksen loppuun asti. Kortikosteroidien osalta tämä tarkoittaa prednisonia, joka on suurempi tai yhtä suuri kuin (>=) 20 mg/vrk aikuisille osallistujille/>= 0,5 mg/kg/vrk ja enintään 20 mg/vrk lapsipotilaille (vauvoille ja lapsille). Inhaloitavat ja paikalliset steroidit ovat sallittuja.
Aikaisempi/samanaikainen kokemus kliinisistä tutkimuksista
• Osallistuminen samanaikaisesti toiseen kliiniseen tutkimukseen milloin tahansa tutkimusjakson aikana, jossa osallistuja on altistunut tai tulee altistumaan tutkittavalle tai ei-tutkimukselliselle interventiolle (rokote, lääke ja laite).
Muut poikkeukset
- Raskaana oleva tai imettävä nainen.
- Nainen, joka suunnittelee raskautta tai aikoo lopettaa ehkäisyn käytön.
- Aiempi/nykyinen krooninen alkoholinkäyttö ja/tai huumeiden väärinkäyttö. Tästä päätetään tutkijan harkinnan mukaan.
- Kaikki tutkimushenkilöstö tai heidän välittömät huollettavat, perheenjäsenet tai kotitalouden jäsenet.
- Lapsi hoidossa.
Opintosuunnitelma
Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Ennaltaehkäisy
- Jako: Satunnaistettu
- Inventiomalli: Peräkkäinen tehtävä
- Naamiointi: Nelinkertaistaa
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
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Kokeellinen: Adults_Dose C Group
Adults, 18-50 years of age, will receive 2 doses of the iNTS-GMMA Dose C (high dose) vaccine at Day 1 and Day 57.
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-2 doses of iNTS-GMMA Dose C vaccine administered intramuscularly, at Day 1 and Day 57 to adults and children in the Adults_Dose C and Children_Dose C groups; -3 doses of iNTS-GMMA Dose C vaccine administered intramuscularly, at Day 1, Day 85 and Day 169 to infants in the Infants_9M_Dose C group, and at Day 1, Day 57 and at Day 232 to infants in the Infants_6W_Dose C group.
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Active Comparator: Adults_Control Group
Adults, 18-50 years of age, will receive 1 dose of the MenACWY vaccine at Day 1 and 1 dose of Placebo at Day 57.
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1 annos lumelääkettä annettuna lihakseen päivänä 57 aikuisille Adults_Control-ryhmässä.
-1 dose of MenACWY vaccine administered intramuscularly at Day 1 to adults in the Adults_Control group; -2 doses of MenACWY vaccine administered intramuscularly at Day 1 and Day 57 to children in the Children_Control B and Children_Control C groups, and at Day 1 and Day 85 to infants in the Infants_9M_Control A, Infants_9M_Control B and Infants_9M_Control C groups; -3 doses of MenACWY vaccine administered intramuscularly at Day 1, Day 57 and at Day 232 to infants in the Infants_6W_Control A, Infants_6W_Control B and Infants_6W_Control C groups.
A 4th dose of MenACWY vaccine is administered after the trial ends, to infants in the aforementioned study groups, as per the licensed indication and in private vaccination settings.
Muut nimet:
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Kokeellinen: Children_Dose B Group
Children, 24-59 months of age, will receive 2 doses of the iNTS-GMMA Dose B (medium dose) vaccine at Day 1 and Day 57.
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-2 doses of iNTS-GMMA Dose B vaccine administered intramuscularly, at Day 1 and Day 57 to children in the Children_Dose B group; -3 doses of iNTS-GMMA Dose B vaccine administered intramuscularly, at Day 1, Day 85 and Day 169 to infants in the Infants_9M_Dose B group, and at Day 1, Day 57 and Day at 232 to infants in the Infants_6W_Dose B group.
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Active Comparator: Children_Control B Group
Children, 24-59 months of age, will receive 2 doses of the MenACWY vaccine at Day 1 and Day 57.
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-1 dose of MenACWY vaccine administered intramuscularly at Day 1 to adults in the Adults_Control group; -2 doses of MenACWY vaccine administered intramuscularly at Day 1 and Day 57 to children in the Children_Control B and Children_Control C groups, and at Day 1 and Day 85 to infants in the Infants_9M_Control A, Infants_9M_Control B and Infants_9M_Control C groups; -3 doses of MenACWY vaccine administered intramuscularly at Day 1, Day 57 and at Day 232 to infants in the Infants_6W_Control A, Infants_6W_Control B and Infants_6W_Control C groups.
A 4th dose of MenACWY vaccine is administered after the trial ends, to infants in the aforementioned study groups, as per the licensed indication and in private vaccination settings.
Muut nimet:
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Kokeellinen: Children_Dose C Group
Children, 24-59 months of age, will receive 2 doses of the iNTS-GMMA Dose C (high dose) vaccine at Day 1 and Day 57.
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-2 doses of iNTS-GMMA Dose C vaccine administered intramuscularly, at Day 1 and Day 57 to adults and children in the Adults_Dose C and Children_Dose C groups; -3 doses of iNTS-GMMA Dose C vaccine administered intramuscularly, at Day 1, Day 85 and Day 169 to infants in the Infants_9M_Dose C group, and at Day 1, Day 57 and at Day 232 to infants in the Infants_6W_Dose C group.
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Active Comparator: Children_Control C Group
Children, 24-59 months of age, will receive 2 doses of the MenACWY vaccine at Day 1 and Day 57.
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-1 dose of MenACWY vaccine administered intramuscularly at Day 1 to adults in the Adults_Control group; -2 doses of MenACWY vaccine administered intramuscularly at Day 1 and Day 57 to children in the Children_Control B and Children_Control C groups, and at Day 1 and Day 85 to infants in the Infants_9M_Control A, Infants_9M_Control B and Infants_9M_Control C groups; -3 doses of MenACWY vaccine administered intramuscularly at Day 1, Day 57 and at Day 232 to infants in the Infants_6W_Control A, Infants_6W_Control B and Infants_6W_Control C groups.
A 4th dose of MenACWY vaccine is administered after the trial ends, to infants in the aforementioned study groups, as per the licensed indication and in private vaccination settings.
Muut nimet:
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Kokeellinen: Infants_9M_Dose A Group
Infants, 9 months of age, will receive 3 doses of the iNTS-GMMA Dose A (low dose) vaccine at Day 1, Day 85 and Day 169.
These infants will also receive an Expanded Program on Immunization (EPI) vaccination with Measles and Rubella Vaccine (MR-VAC) and Yellow Fever (YF) vaccine at 28 days after the first study intervention administration occurring at Day 1, at the local EPI vaccination centers, and not part of the current clinical trial.
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3 doses of iNTS-GMMA Dose A vaccine administered intramuscularly, at Day 1, Day 85 and Day 169 to infants in the Infants_9M_Dose A group, and at Day 1, Day 57 and Day at 232 to infants in the Infants_6W_Dose A group.
Measles and Rubella vaccine is administered to study participants, as part of an Expanded Program on Immunization (EPI) vaccination at the local EPI vaccination centers, and not part of the current clinical trial, as follows: - at 28 days after the first study intervention administration (occurring at Day 1) to infants in the Infants_9M_Dose A, Infants_9M_Control A, Infants_9M_Dose B, Infants_9M_Control B, Infants_9M_Dose C and Infants_9M_Control C groups.
- at 28 days after the third study intervention administration (occurring at Day 232) to infants in Infants_6W_Dose A, Infants_6W_Control A, Infants_6W_Dose B, Infants_6W_Control B, Infants_6W_Dose C and Infants_6W_Control C groups.
Muut nimet:
Yellow Fever vaccine is administered to study participants, as part of an Expanded Program on Immunization (EPI) vaccination at the local EPI vaccination centers, and not part of the current clinical trial, as follows: - at 28 days after the first study intervention administration (occurring at Day 1) to infants in the Infants_9M_Dose A, Infants_9M_Control A, Infants_9M_Dose B, Infants_9M_Control B, Infants_9M_Dose C and Infants_9M_Control C groups.
- at 28 days after the third study intervention administration (occurring at Day 232) to infants in Infants_6W_Dose A, Infants_6W_Control A, Infants_6W_Dose B, Infants_6W_Control B, Infants_6W_Dose C and Infants_6W_Control C groups.
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Active Comparator: Infants_9M_Control A Group
Infants, 9 months of age, will receive 2 doses of the MenACWY vaccine at Day 1 and Day 85 and 1 dose of the DTPa-HBV-IPV+Hib vaccine at Day 169.
These infants will also receive an EPI vaccination with MR-VAC and YF vaccine at 28 days after the first study intervention administration occurring at Day 1, at the local EPI vaccination centers, and not part of the current clinical trial.
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1 annos DTPa-HBV-IPV+Hib-rokotetta annettuna lihaksensisäisesti päivänä 169 imeväisille ryhmissä Infants_9M_Control A, Infants_9M_Control B ja Infants_9M_Control C.
Muut nimet:
-1 dose of MenACWY vaccine administered intramuscularly at Day 1 to adults in the Adults_Control group; -2 doses of MenACWY vaccine administered intramuscularly at Day 1 and Day 57 to children in the Children_Control B and Children_Control C groups, and at Day 1 and Day 85 to infants in the Infants_9M_Control A, Infants_9M_Control B and Infants_9M_Control C groups; -3 doses of MenACWY vaccine administered intramuscularly at Day 1, Day 57 and at Day 232 to infants in the Infants_6W_Control A, Infants_6W_Control B and Infants_6W_Control C groups.
A 4th dose of MenACWY vaccine is administered after the trial ends, to infants in the aforementioned study groups, as per the licensed indication and in private vaccination settings.
Muut nimet:
Measles and Rubella vaccine is administered to study participants, as part of an Expanded Program on Immunization (EPI) vaccination at the local EPI vaccination centers, and not part of the current clinical trial, as follows: - at 28 days after the first study intervention administration (occurring at Day 1) to infants in the Infants_9M_Dose A, Infants_9M_Control A, Infants_9M_Dose B, Infants_9M_Control B, Infants_9M_Dose C and Infants_9M_Control C groups.
- at 28 days after the third study intervention administration (occurring at Day 232) to infants in Infants_6W_Dose A, Infants_6W_Control A, Infants_6W_Dose B, Infants_6W_Control B, Infants_6W_Dose C and Infants_6W_Control C groups.
Muut nimet:
Yellow Fever vaccine is administered to study participants, as part of an Expanded Program on Immunization (EPI) vaccination at the local EPI vaccination centers, and not part of the current clinical trial, as follows: - at 28 days after the first study intervention administration (occurring at Day 1) to infants in the Infants_9M_Dose A, Infants_9M_Control A, Infants_9M_Dose B, Infants_9M_Control B, Infants_9M_Dose C and Infants_9M_Control C groups.
- at 28 days after the third study intervention administration (occurring at Day 232) to infants in Infants_6W_Dose A, Infants_6W_Control A, Infants_6W_Dose B, Infants_6W_Control B, Infants_6W_Dose C and Infants_6W_Control C groups.
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Kokeellinen: Infants_9M_Dose B Group
Infants, 9 months of age, will receive 3 doses of the iNTS-GMMA Dose B (medium dose) vaccine at Day 1, Day 85 and Day 169.
These infants will also receive an EPI vaccination withMR-VAC and YF vaccine at 28 days after the first study intervention administration occurring at Day 1, at the local EPI vaccination centers, and not part of the current clinical trial.
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-2 doses of iNTS-GMMA Dose B vaccine administered intramuscularly, at Day 1 and Day 57 to children in the Children_Dose B group; -3 doses of iNTS-GMMA Dose B vaccine administered intramuscularly, at Day 1, Day 85 and Day 169 to infants in the Infants_9M_Dose B group, and at Day 1, Day 57 and Day at 232 to infants in the Infants_6W_Dose B group.
Measles and Rubella vaccine is administered to study participants, as part of an Expanded Program on Immunization (EPI) vaccination at the local EPI vaccination centers, and not part of the current clinical trial, as follows: - at 28 days after the first study intervention administration (occurring at Day 1) to infants in the Infants_9M_Dose A, Infants_9M_Control A, Infants_9M_Dose B, Infants_9M_Control B, Infants_9M_Dose C and Infants_9M_Control C groups.
- at 28 days after the third study intervention administration (occurring at Day 232) to infants in Infants_6W_Dose A, Infants_6W_Control A, Infants_6W_Dose B, Infants_6W_Control B, Infants_6W_Dose C and Infants_6W_Control C groups.
Muut nimet:
Yellow Fever vaccine is administered to study participants, as part of an Expanded Program on Immunization (EPI) vaccination at the local EPI vaccination centers, and not part of the current clinical trial, as follows: - at 28 days after the first study intervention administration (occurring at Day 1) to infants in the Infants_9M_Dose A, Infants_9M_Control A, Infants_9M_Dose B, Infants_9M_Control B, Infants_9M_Dose C and Infants_9M_Control C groups.
- at 28 days after the third study intervention administration (occurring at Day 232) to infants in Infants_6W_Dose A, Infants_6W_Control A, Infants_6W_Dose B, Infants_6W_Control B, Infants_6W_Dose C and Infants_6W_Control C groups.
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Active Comparator: Infants_9M_Control B Group
Infants, 9 months of age, will receive 2 doses of the MenACWY vaccine at Day 1 and Day 85 and 1 dose of the DTPa-HBV-IPV+Hib vaccine at Day 169.
These infants will also receive an EPI vaccination with MR-VAC and YF vaccine at 28 days after the first study intervention administration occurring at Day 1, at the local EPI vaccination centers, and not part of the current clinical trial.
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1 annos DTPa-HBV-IPV+Hib-rokotetta annettuna lihaksensisäisesti päivänä 169 imeväisille ryhmissä Infants_9M_Control A, Infants_9M_Control B ja Infants_9M_Control C.
Muut nimet:
-1 dose of MenACWY vaccine administered intramuscularly at Day 1 to adults in the Adults_Control group; -2 doses of MenACWY vaccine administered intramuscularly at Day 1 and Day 57 to children in the Children_Control B and Children_Control C groups, and at Day 1 and Day 85 to infants in the Infants_9M_Control A, Infants_9M_Control B and Infants_9M_Control C groups; -3 doses of MenACWY vaccine administered intramuscularly at Day 1, Day 57 and at Day 232 to infants in the Infants_6W_Control A, Infants_6W_Control B and Infants_6W_Control C groups.
A 4th dose of MenACWY vaccine is administered after the trial ends, to infants in the aforementioned study groups, as per the licensed indication and in private vaccination settings.
Muut nimet:
Measles and Rubella vaccine is administered to study participants, as part of an Expanded Program on Immunization (EPI) vaccination at the local EPI vaccination centers, and not part of the current clinical trial, as follows: - at 28 days after the first study intervention administration (occurring at Day 1) to infants in the Infants_9M_Dose A, Infants_9M_Control A, Infants_9M_Dose B, Infants_9M_Control B, Infants_9M_Dose C and Infants_9M_Control C groups.
- at 28 days after the third study intervention administration (occurring at Day 232) to infants in Infants_6W_Dose A, Infants_6W_Control A, Infants_6W_Dose B, Infants_6W_Control B, Infants_6W_Dose C and Infants_6W_Control C groups.
Muut nimet:
Yellow Fever vaccine is administered to study participants, as part of an Expanded Program on Immunization (EPI) vaccination at the local EPI vaccination centers, and not part of the current clinical trial, as follows: - at 28 days after the first study intervention administration (occurring at Day 1) to infants in the Infants_9M_Dose A, Infants_9M_Control A, Infants_9M_Dose B, Infants_9M_Control B, Infants_9M_Dose C and Infants_9M_Control C groups.
- at 28 days after the third study intervention administration (occurring at Day 232) to infants in Infants_6W_Dose A, Infants_6W_Control A, Infants_6W_Dose B, Infants_6W_Control B, Infants_6W_Dose C and Infants_6W_Control C groups.
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Kokeellinen: Infants_9M_Dose C Group
Infants, 9 months of age, will receive 3 doses of the iNTS-GMMA Dose C (high dose) vaccine at Day 1, Day 85 and Day 169.
These infants will also receive an EPI vaccination with MR-VAC and YF vaccine at 28 days after the first study intervention administration occurring at Day 1, at the local EPI vaccination centers, and not part of the current clinical trial.
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-2 doses of iNTS-GMMA Dose C vaccine administered intramuscularly, at Day 1 and Day 57 to adults and children in the Adults_Dose C and Children_Dose C groups; -3 doses of iNTS-GMMA Dose C vaccine administered intramuscularly, at Day 1, Day 85 and Day 169 to infants in the Infants_9M_Dose C group, and at Day 1, Day 57 and at Day 232 to infants in the Infants_6W_Dose C group.
Measles and Rubella vaccine is administered to study participants, as part of an Expanded Program on Immunization (EPI) vaccination at the local EPI vaccination centers, and not part of the current clinical trial, as follows: - at 28 days after the first study intervention administration (occurring at Day 1) to infants in the Infants_9M_Dose A, Infants_9M_Control A, Infants_9M_Dose B, Infants_9M_Control B, Infants_9M_Dose C and Infants_9M_Control C groups.
- at 28 days after the third study intervention administration (occurring at Day 232) to infants in Infants_6W_Dose A, Infants_6W_Control A, Infants_6W_Dose B, Infants_6W_Control B, Infants_6W_Dose C and Infants_6W_Control C groups.
Muut nimet:
Yellow Fever vaccine is administered to study participants, as part of an Expanded Program on Immunization (EPI) vaccination at the local EPI vaccination centers, and not part of the current clinical trial, as follows: - at 28 days after the first study intervention administration (occurring at Day 1) to infants in the Infants_9M_Dose A, Infants_9M_Control A, Infants_9M_Dose B, Infants_9M_Control B, Infants_9M_Dose C and Infants_9M_Control C groups.
- at 28 days after the third study intervention administration (occurring at Day 232) to infants in Infants_6W_Dose A, Infants_6W_Control A, Infants_6W_Dose B, Infants_6W_Control B, Infants_6W_Dose C and Infants_6W_Control C groups.
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Active Comparator: Infants_9M_Control C Group
Infants, 9 months of age, will receive 2 doses of the MenACWY vaccine at Day 1 and Day 85 and 1 dose of the DTPa-HBV-IPV+Hib vaccine at Day 169.
These infants will also receive an EPI vaccination with MR-VAC and YF vaccine at 28 days after the first study intervention administration occurring at Day 1, at the local EPI vaccination centers, and not part of the current clinical trial.
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1 annos DTPa-HBV-IPV+Hib-rokotetta annettuna lihaksensisäisesti päivänä 169 imeväisille ryhmissä Infants_9M_Control A, Infants_9M_Control B ja Infants_9M_Control C.
Muut nimet:
-1 dose of MenACWY vaccine administered intramuscularly at Day 1 to adults in the Adults_Control group; -2 doses of MenACWY vaccine administered intramuscularly at Day 1 and Day 57 to children in the Children_Control B and Children_Control C groups, and at Day 1 and Day 85 to infants in the Infants_9M_Control A, Infants_9M_Control B and Infants_9M_Control C groups; -3 doses of MenACWY vaccine administered intramuscularly at Day 1, Day 57 and at Day 232 to infants in the Infants_6W_Control A, Infants_6W_Control B and Infants_6W_Control C groups.
A 4th dose of MenACWY vaccine is administered after the trial ends, to infants in the aforementioned study groups, as per the licensed indication and in private vaccination settings.
Muut nimet:
Measles and Rubella vaccine is administered to study participants, as part of an Expanded Program on Immunization (EPI) vaccination at the local EPI vaccination centers, and not part of the current clinical trial, as follows: - at 28 days after the first study intervention administration (occurring at Day 1) to infants in the Infants_9M_Dose A, Infants_9M_Control A, Infants_9M_Dose B, Infants_9M_Control B, Infants_9M_Dose C and Infants_9M_Control C groups.
- at 28 days after the third study intervention administration (occurring at Day 232) to infants in Infants_6W_Dose A, Infants_6W_Control A, Infants_6W_Dose B, Infants_6W_Control B, Infants_6W_Dose C and Infants_6W_Control C groups.
Muut nimet:
Yellow Fever vaccine is administered to study participants, as part of an Expanded Program on Immunization (EPI) vaccination at the local EPI vaccination centers, and not part of the current clinical trial, as follows: - at 28 days after the first study intervention administration (occurring at Day 1) to infants in the Infants_9M_Dose A, Infants_9M_Control A, Infants_9M_Dose B, Infants_9M_Control B, Infants_9M_Dose C and Infants_9M_Control C groups.
- at 28 days after the third study intervention administration (occurring at Day 232) to infants in Infants_6W_Dose A, Infants_6W_Control A, Infants_6W_Dose B, Infants_6W_Control B, Infants_6W_Dose C and Infants_6W_Control C groups.
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Kokeellinen: Infants_6W_Dose A Group
Infants, 6 weeks of age, will receive 3 doses of the iNTS-GMMA Dose A (low dose) vaccine at Day 1, Day 57 and at Day 232.
These infants will also receive an EPI vaccination with MR-VAC and YF vaccine at 28 days after the third study intervention administration occurring at Day 232, at the local EPI vaccination centers, and not part of the current clinical trial.
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3 doses of iNTS-GMMA Dose A vaccine administered intramuscularly, at Day 1, Day 85 and Day 169 to infants in the Infants_9M_Dose A group, and at Day 1, Day 57 and Day at 232 to infants in the Infants_6W_Dose A group.
Measles and Rubella vaccine is administered to study participants, as part of an Expanded Program on Immunization (EPI) vaccination at the local EPI vaccination centers, and not part of the current clinical trial, as follows: - at 28 days after the first study intervention administration (occurring at Day 1) to infants in the Infants_9M_Dose A, Infants_9M_Control A, Infants_9M_Dose B, Infants_9M_Control B, Infants_9M_Dose C and Infants_9M_Control C groups.
- at 28 days after the third study intervention administration (occurring at Day 232) to infants in Infants_6W_Dose A, Infants_6W_Control A, Infants_6W_Dose B, Infants_6W_Control B, Infants_6W_Dose C and Infants_6W_Control C groups.
Muut nimet:
Yellow Fever vaccine is administered to study participants, as part of an Expanded Program on Immunization (EPI) vaccination at the local EPI vaccination centers, and not part of the current clinical trial, as follows: - at 28 days after the first study intervention administration (occurring at Day 1) to infants in the Infants_9M_Dose A, Infants_9M_Control A, Infants_9M_Dose B, Infants_9M_Control B, Infants_9M_Dose C and Infants_9M_Control C groups.
- at 28 days after the third study intervention administration (occurring at Day 232) to infants in Infants_6W_Dose A, Infants_6W_Control A, Infants_6W_Dose B, Infants_6W_Control B, Infants_6W_Dose C and Infants_6W_Control C groups.
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Active Comparator: Infants_6W_Control A Group
Infants, 6 weeks of age, will receive 3 doses of the MenACWY vaccine at Day 1, Day 57 and at Day 232 To allow completion of the vaccination schedule, a fourth dose of the MenACWY vaccine is administered after the trial ends, as per the licensed indication and in private vaccination settings.
These infants also will receive an EPI vaccination with MR-VAC and YF vaccine at 28 days after the third study intervention administration occurring at Day 232, at the local EPI vaccination centers, and not part of the current clinical trial.
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-1 dose of MenACWY vaccine administered intramuscularly at Day 1 to adults in the Adults_Control group; -2 doses of MenACWY vaccine administered intramuscularly at Day 1 and Day 57 to children in the Children_Control B and Children_Control C groups, and at Day 1 and Day 85 to infants in the Infants_9M_Control A, Infants_9M_Control B and Infants_9M_Control C groups; -3 doses of MenACWY vaccine administered intramuscularly at Day 1, Day 57 and at Day 232 to infants in the Infants_6W_Control A, Infants_6W_Control B and Infants_6W_Control C groups.
A 4th dose of MenACWY vaccine is administered after the trial ends, to infants in the aforementioned study groups, as per the licensed indication and in private vaccination settings.
Muut nimet:
Measles and Rubella vaccine is administered to study participants, as part of an Expanded Program on Immunization (EPI) vaccination at the local EPI vaccination centers, and not part of the current clinical trial, as follows: - at 28 days after the first study intervention administration (occurring at Day 1) to infants in the Infants_9M_Dose A, Infants_9M_Control A, Infants_9M_Dose B, Infants_9M_Control B, Infants_9M_Dose C and Infants_9M_Control C groups.
- at 28 days after the third study intervention administration (occurring at Day 232) to infants in Infants_6W_Dose A, Infants_6W_Control A, Infants_6W_Dose B, Infants_6W_Control B, Infants_6W_Dose C and Infants_6W_Control C groups.
Muut nimet:
Yellow Fever vaccine is administered to study participants, as part of an Expanded Program on Immunization (EPI) vaccination at the local EPI vaccination centers, and not part of the current clinical trial, as follows: - at 28 days after the first study intervention administration (occurring at Day 1) to infants in the Infants_9M_Dose A, Infants_9M_Control A, Infants_9M_Dose B, Infants_9M_Control B, Infants_9M_Dose C and Infants_9M_Control C groups.
- at 28 days after the third study intervention administration (occurring at Day 232) to infants in Infants_6W_Dose A, Infants_6W_Control A, Infants_6W_Dose B, Infants_6W_Control B, Infants_6W_Dose C and Infants_6W_Control C groups.
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Kokeellinen: Infants_6W_Dose B Group
Infants, 6 weeks of age, will receive 3 doses of the iNTS-GMMA Dose B (medium dose) vaccine at Day 1, Day 57 and at Day 232.
These infants will also receive an EPI vaccination with MR-VAC and YF vaccine at 28 days after the third study intervention administration occurring at Day 232, at the local EPI vaccination centers, and not part of the current clinical trial.
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-2 doses of iNTS-GMMA Dose B vaccine administered intramuscularly, at Day 1 and Day 57 to children in the Children_Dose B group; -3 doses of iNTS-GMMA Dose B vaccine administered intramuscularly, at Day 1, Day 85 and Day 169 to infants in the Infants_9M_Dose B group, and at Day 1, Day 57 and Day at 232 to infants in the Infants_6W_Dose B group.
Measles and Rubella vaccine is administered to study participants, as part of an Expanded Program on Immunization (EPI) vaccination at the local EPI vaccination centers, and not part of the current clinical trial, as follows: - at 28 days after the first study intervention administration (occurring at Day 1) to infants in the Infants_9M_Dose A, Infants_9M_Control A, Infants_9M_Dose B, Infants_9M_Control B, Infants_9M_Dose C and Infants_9M_Control C groups.
- at 28 days after the third study intervention administration (occurring at Day 232) to infants in Infants_6W_Dose A, Infants_6W_Control A, Infants_6W_Dose B, Infants_6W_Control B, Infants_6W_Dose C and Infants_6W_Control C groups.
Muut nimet:
Yellow Fever vaccine is administered to study participants, as part of an Expanded Program on Immunization (EPI) vaccination at the local EPI vaccination centers, and not part of the current clinical trial, as follows: - at 28 days after the first study intervention administration (occurring at Day 1) to infants in the Infants_9M_Dose A, Infants_9M_Control A, Infants_9M_Dose B, Infants_9M_Control B, Infants_9M_Dose C and Infants_9M_Control C groups.
- at 28 days after the third study intervention administration (occurring at Day 232) to infants in Infants_6W_Dose A, Infants_6W_Control A, Infants_6W_Dose B, Infants_6W_Control B, Infants_6W_Dose C and Infants_6W_Control C groups.
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Active Comparator: Infants_6W_Control B Group
Infants ,6 weeks of age, will receive 3 doses of the MenACWY vaccine at Day 1, Day 57 and at Day 232.
To allow completion of the vaccination schedule, a fourth dose of the MenACWY vaccine is administered after the trial ends, as per the licensed indication and in private vaccination settings.
These infants will also receive an EPI vaccination with MR-VAC and YF vaccine at 28 days after the third study intervention administration occurring at Day 232, at the local EPI vaccination centers, and not part of the current clinical trial.
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-1 dose of MenACWY vaccine administered intramuscularly at Day 1 to adults in the Adults_Control group; -2 doses of MenACWY vaccine administered intramuscularly at Day 1 and Day 57 to children in the Children_Control B and Children_Control C groups, and at Day 1 and Day 85 to infants in the Infants_9M_Control A, Infants_9M_Control B and Infants_9M_Control C groups; -3 doses of MenACWY vaccine administered intramuscularly at Day 1, Day 57 and at Day 232 to infants in the Infants_6W_Control A, Infants_6W_Control B and Infants_6W_Control C groups.
A 4th dose of MenACWY vaccine is administered after the trial ends, to infants in the aforementioned study groups, as per the licensed indication and in private vaccination settings.
Muut nimet:
Measles and Rubella vaccine is administered to study participants, as part of an Expanded Program on Immunization (EPI) vaccination at the local EPI vaccination centers, and not part of the current clinical trial, as follows: - at 28 days after the first study intervention administration (occurring at Day 1) to infants in the Infants_9M_Dose A, Infants_9M_Control A, Infants_9M_Dose B, Infants_9M_Control B, Infants_9M_Dose C and Infants_9M_Control C groups.
- at 28 days after the third study intervention administration (occurring at Day 232) to infants in Infants_6W_Dose A, Infants_6W_Control A, Infants_6W_Dose B, Infants_6W_Control B, Infants_6W_Dose C and Infants_6W_Control C groups.
Muut nimet:
Yellow Fever vaccine is administered to study participants, as part of an Expanded Program on Immunization (EPI) vaccination at the local EPI vaccination centers, and not part of the current clinical trial, as follows: - at 28 days after the first study intervention administration (occurring at Day 1) to infants in the Infants_9M_Dose A, Infants_9M_Control A, Infants_9M_Dose B, Infants_9M_Control B, Infants_9M_Dose C and Infants_9M_Control C groups.
- at 28 days after the third study intervention administration (occurring at Day 232) to infants in Infants_6W_Dose A, Infants_6W_Control A, Infants_6W_Dose B, Infants_6W_Control B, Infants_6W_Dose C and Infants_6W_Control C groups.
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Kokeellinen: Infants_6W_Dose C Group
Infants ,6 weeks of age, will receive 3 doses of the iNTS-GMMA Dose C (high dose) vaccine at Day 1, Day 57 and at Day 232.
These infants will also receive an EPI vaccination with MR-VAC and YF vaccine at 28 days after the third study intervention administration occurring at Day 232, at the local EPI vaccination centers, and not part of the current clinical trial.
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-2 doses of iNTS-GMMA Dose C vaccine administered intramuscularly, at Day 1 and Day 57 to adults and children in the Adults_Dose C and Children_Dose C groups; -3 doses of iNTS-GMMA Dose C vaccine administered intramuscularly, at Day 1, Day 85 and Day 169 to infants in the Infants_9M_Dose C group, and at Day 1, Day 57 and at Day 232 to infants in the Infants_6W_Dose C group.
Measles and Rubella vaccine is administered to study participants, as part of an Expanded Program on Immunization (EPI) vaccination at the local EPI vaccination centers, and not part of the current clinical trial, as follows: - at 28 days after the first study intervention administration (occurring at Day 1) to infants in the Infants_9M_Dose A, Infants_9M_Control A, Infants_9M_Dose B, Infants_9M_Control B, Infants_9M_Dose C and Infants_9M_Control C groups.
- at 28 days after the third study intervention administration (occurring at Day 232) to infants in Infants_6W_Dose A, Infants_6W_Control A, Infants_6W_Dose B, Infants_6W_Control B, Infants_6W_Dose C and Infants_6W_Control C groups.
Muut nimet:
Yellow Fever vaccine is administered to study participants, as part of an Expanded Program on Immunization (EPI) vaccination at the local EPI vaccination centers, and not part of the current clinical trial, as follows: - at 28 days after the first study intervention administration (occurring at Day 1) to infants in the Infants_9M_Dose A, Infants_9M_Control A, Infants_9M_Dose B, Infants_9M_Control B, Infants_9M_Dose C and Infants_9M_Control C groups.
- at 28 days after the third study intervention administration (occurring at Day 232) to infants in Infants_6W_Dose A, Infants_6W_Control A, Infants_6W_Dose B, Infants_6W_Control B, Infants_6W_Dose C and Infants_6W_Control C groups.
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Active Comparator: Infants_6W_Control C Group
Infants ,6 weeks of age, will receive 3 doses of the MenACWY vaccine at Day 1, Day 57 and at Day 232.
To allow completion of the vaccination schedule, a fourth dose of the MenACWY vaccine is administered after the trial ends, as per the licensed indication and in private vaccination settings.
These infants will also receive an EPI vaccination with MR-VAC and YF vaccine at 28 days after the third study intervention administration occurring at Day 232, at the local EPI vaccination centers, and not part of the current clinical trial.
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-1 dose of MenACWY vaccine administered intramuscularly at Day 1 to adults in the Adults_Control group; -2 doses of MenACWY vaccine administered intramuscularly at Day 1 and Day 57 to children in the Children_Control B and Children_Control C groups, and at Day 1 and Day 85 to infants in the Infants_9M_Control A, Infants_9M_Control B and Infants_9M_Control C groups; -3 doses of MenACWY vaccine administered intramuscularly at Day 1, Day 57 and at Day 232 to infants in the Infants_6W_Control A, Infants_6W_Control B and Infants_6W_Control C groups.
A 4th dose of MenACWY vaccine is administered after the trial ends, to infants in the aforementioned study groups, as per the licensed indication and in private vaccination settings.
Muut nimet:
Measles and Rubella vaccine is administered to study participants, as part of an Expanded Program on Immunization (EPI) vaccination at the local EPI vaccination centers, and not part of the current clinical trial, as follows: - at 28 days after the first study intervention administration (occurring at Day 1) to infants in the Infants_9M_Dose A, Infants_9M_Control A, Infants_9M_Dose B, Infants_9M_Control B, Infants_9M_Dose C and Infants_9M_Control C groups.
- at 28 days after the third study intervention administration (occurring at Day 232) to infants in Infants_6W_Dose A, Infants_6W_Control A, Infants_6W_Dose B, Infants_6W_Control B, Infants_6W_Dose C and Infants_6W_Control C groups.
Muut nimet:
Yellow Fever vaccine is administered to study participants, as part of an Expanded Program on Immunization (EPI) vaccination at the local EPI vaccination centers, and not part of the current clinical trial, as follows: - at 28 days after the first study intervention administration (occurring at Day 1) to infants in the Infants_9M_Dose A, Infants_9M_Control A, Infants_9M_Dose B, Infants_9M_Control B, Infants_9M_Dose C and Infants_9M_Control C groups.
- at 28 days after the third study intervention administration (occurring at Day 232) to infants in Infants_6W_Dose A, Infants_6W_Control A, Infants_6W_Dose B, Infants_6W_Control B, Infants_6W_Dose C and Infants_6W_Control C groups.
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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Number of adult participants 18-50 years of age with solicited administration site events
Aikaikkuna: During 7 days after the first study intervention administration occurring at Day 1
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The solicited administration site events are pain, redness and swelling.
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During 7 days after the first study intervention administration occurring at Day 1
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Number of adult participants 18-50 years of age with solicited administration site events
Aikaikkuna: During 7 days after the second study intervention administration occurring at Day 57
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The solicited administration site events are pain, redness and swelling.
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During 7 days after the second study intervention administration occurring at Day 57
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Number of adult participants 18-50 years of age with solicited systemic events
Aikaikkuna: During 7 days after the first study intervention administration occurring at Day 1
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The solicited systemic events are fever, headache, myalgia, arthralgia and fatigue.
Fever is defined as axillary temperature higher than or equal to (>=) 38.0 degrees Celsius (°C)/100.4
degrees Fahrenheit (°F).
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During 7 days after the first study intervention administration occurring at Day 1
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Number of adult participants 18-50 years of age with solicited systemic events
Aikaikkuna: During 7 days after the second study intervention administration occurring at Day 57
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The solicited systemic events are fever, headache, myalgia, arthralgia and fatigue.
Fever is defined as axillary temperature >= 38.0 °C/100.4
degrees °F.
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During 7 days after the second study intervention administration occurring at Day 57
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Number of adult participants 18-50 years of age with unsolicited adverse events (AEs)
Aikaikkuna: During 28 days after the first study intervention administration occurring at Day 1
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An unsolicited AE is any AE reported in addition to those solicited during the clinical study.
Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms will be reported as an unsolicited adverse event.
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During 28 days after the first study intervention administration occurring at Day 1
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Number of adult participants 18-50 years of age with unsolicited adverse events (AEs)
Aikaikkuna: During 28 days after the second study intervention administration occurring at Day 57
|
An unsolicited AE is any AE reported in addition to those solicited during the clinical study.
Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms will be reported as an unsolicited adverse event.
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During 28 days after the second study intervention administration occurring at Day 57
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Number of adult participants 18-50 years of age with serious adverse events (SAEs)
Aikaikkuna: From first study intervention administration (Day 1) up to the end of study participation (Day 85)
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An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, or results in abnormal pregnancy outcomes.
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From first study intervention administration (Day 1) up to the end of study participation (Day 85)
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Number of adult participants 18-50 years of age with adverse events (AEs) leading to withdrawal from the study or discontinuation of study intervention
Aikaikkuna: From first study intervention administration (Day 1) up to the end of study participation (Day 85)
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An AE is any untoward medical occurrence (an unfavorable/unintended sign - including an abnormal laboratory finding), symptom, or disease (new or exacerbated) in a clinical study participant that is temporally associated with the study intervention.
The AE may or may not be considered related to the study intervention.
Any AEs that lead to discontinuation of study intervention and/or the study are considered under this outcome measure.
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From first study intervention administration (Day 1) up to the end of study participation (Day 85)
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Number of adult participants 18-50 years of age with deviations from reference ranges or baseline values for hematological, renal and hepatic panel test results
Aikaikkuna: At Day 8 (7 days after the first study intervention administration)
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Clinically significant abnormal laboratory findings are those which are not associated with an underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition.
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At Day 8 (7 days after the first study intervention administration)
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Number of adult participants 18-50 years of age with deviations from reference ranges or baseline values for hematological, renal and hepatic panel test results
Aikaikkuna: At Day 64 (7 days after the second study intervention administration)
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Clinically significant abnormal laboratory findings are those which are not associated with an underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition.
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At Day 64 (7 days after the second study intervention administration)
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Number of child participants 24-59 months of age with solicited administration site events
Aikaikkuna: During 7 days after the first study intervention administration occurring at Day 1
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The solicited administration site events are pain, redness and swelling.
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During 7 days after the first study intervention administration occurring at Day 1
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Number of child participants 24-59 months of age with solicited administration site events
Aikaikkuna: During 7 days after the second study intervention administration occurring at Day 57
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The solicited administration site events are pain, redness and swelling.
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During 7 days after the second study intervention administration occurring at Day 57
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Number of child participants 24-59 months of age with solicited systemic events
Aikaikkuna: During 7 days after the first study intervention administration occurring at Day 1
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The solicited systemic events are fever, irritability/fussiness, loss of appetite, drowsiness and vomiting.
Fever is defined as axillary temperature >= 38.0 °C/100.4
degrees °F.
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During 7 days after the first study intervention administration occurring at Day 1
|
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Number of child participants 24-59 months of age with solicited systemic events
Aikaikkuna: During 7 days after the second study intervention administration occurring at Day 57
|
The solicited systemic events are fever, irritability/fussiness, loss of appetite, drowsiness and vomiting.
Fever is defined as axillary temperature >= 38.0 °C/100.4
degrees °F.
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During 7 days after the second study intervention administration occurring at Day 57
|
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Number of child participants 24-59 months of age with unsolicited AEs
Aikaikkuna: During 28 days after the first study intervention administration occurring at Day 1
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During 28 days after the first study intervention administration occurring at Day 1
|
|
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Number of child participants 24-59 months of age with unsolicited AEs
Aikaikkuna: During 28 days after the second study intervention administration occurring at Day 57
|
During 28 days after the second study intervention administration occurring at Day 57
|
|
|
Number of child participants 24-59 months of age with serious adverse events (SAEs)
Aikaikkuna: From first study intervention administration (Day 1) up to the end of study participation (Day 85)
|
From first study intervention administration (Day 1) up to the end of study participation (Day 85)
|
|
|
Number of child participants 24-59 months of age with AEs leading to withdrawal from the study or discontinuation of study intervention
Aikaikkuna: From first study intervention administration (Day 1) up to the end of study participation (Day 85)
|
From first study intervention administration (Day 1) up to the end of study participation (Day 85)
|
|
|
Number of child participants 24-59 months of age with deviations from reference ranges or baseline values for hematological, renal and hepatic panel test results
Aikaikkuna: At Day 8 (7 days after the first study intervention administration)
|
At Day 8 (7 days after the first study intervention administration)
|
|
|
Number of child participants 24-59 months of age with deviations from reference ranges or baseline values for hematological, renal and hepatic panel test results
Aikaikkuna: At Day 64 (7 days after the second study intervention administration)
|
At Day 64 (7 days after the second study intervention administration)
|
|
|
Number of infant participants 9 months of age with solicited administration site events
Aikaikkuna: During 7 days after the first study intervention administration occurring at Day 1
|
The solicited administration site events are pain, redness and swelling.
|
During 7 days after the first study intervention administration occurring at Day 1
|
|
Number of infant participants 9 months of age with solicited administration site events
Aikaikkuna: During 7 days after the second study intervention administration occurring at Day 85
|
The solicited administration site events are pain, redness and swelling.
|
During 7 days after the second study intervention administration occurring at Day 85
|
|
Number of infant participants 9 months of age with solicited administration site events
Aikaikkuna: During 7 days after the third study intervention administration occurring at Day 169
|
The solicited administration site events are pain, redness and swelling.
|
During 7 days after the third study intervention administration occurring at Day 169
|
|
Number of infant participants 9 months of age with solicited systemic events
Aikaikkuna: During 7 days after the first study intervention administration occurring at Day 1
|
The solicited systemic events are fever, irritability/fussiness, loss of appetite, drowsiness, and vomiting.
Fever is defined as axillary temperature >= 38.0 °C/100.4
degrees °F.
|
During 7 days after the first study intervention administration occurring at Day 1
|
|
Number of infant participants 9 months of age with solicited systemic events
Aikaikkuna: During 7 days after the second study intervention administration occurring at Day 85
|
The solicited systemic events are fever, irritability/fussiness, loss of appetite, drowsiness, and vomiting.
Fever is defined as axillary temperature >= 38.0 °C/100.4
degrees °F.
|
During 7 days after the second study intervention administration occurring at Day 85
|
|
Number of infant participants 9 months of age with solicited systemic events
Aikaikkuna: During 7 days after the third study intervention administration occurring at Day 169
|
The solicited systemic events are fever, irritability/fussiness, loss of appetite, drowsiness, and vomiting.
Fever is defined as axillary temperature >= 38.0 °C/100.4
degrees °F.
|
During 7 days after the third study intervention administration occurring at Day 169
|
|
Number of infant participants 9 months of age with unsolicited adverse events (AEs)
Aikaikkuna: During 28 days after the first study intervention administration occurring at Day 1
|
During 28 days after the first study intervention administration occurring at Day 1
|
|
|
Number of infant participants 9 months of age with unsolicited adverse events (AEs)
Aikaikkuna: During 28 days after the second study intervention administration occurring at Day 85
|
During 28 days after the second study intervention administration occurring at Day 85
|
|
|
Number of infant participants 9 months of age with unsolicited adverse events (AEs)
Aikaikkuna: During 28 days after the third study intervention administration occurring at Day 169
|
During 28 days after the third study intervention administration occurring at Day 169
|
|
|
Number of infant participants 9 months of age with serious adverse events (SAEs)
Aikaikkuna: From first study intervention administration (Day 1) up to the end of study participation (Day 337)
|
From first study intervention administration (Day 1) up to the end of study participation (Day 337)
|
|
|
Number of infant participants 9 months of age with adverse events (AEs) leading to withdrawal from the study or discontinuation of study intervention
Aikaikkuna: From first study intervention administration (Day 1) up to the end of study participation (Day 337)
|
From first study intervention administration (Day 1) up to the end of study participation (Day 337)
|
|
|
Number of infant participants 9 months of age with deviations from reference range or baseline values for hematological, renal and hepatic panel test results
Aikaikkuna: At Day 8 (7 days after the first study intervention administration)
|
At Day 8 (7 days after the first study intervention administration)
|
|
|
Number of infant participants 9 months of age with deviations from reference range or baseline values for hematological, renal and hepatic panel test results
Aikaikkuna: At Day 92 (7 days after the second study intervention administration)
|
At Day 92 (7 days after the second study intervention administration)
|
|
|
Number of infant participants 9 months of age with deviations from reference range or baseline values for hematological, renal and hepatic panel test results
Aikaikkuna: At Day 176 (7 days after the third study intervention administration)
|
At Day 176 (7 days after the third study intervention administration)
|
|
|
Number of infant participants 6 weeks of age with solicited administration site events
Aikaikkuna: During 7 days after the first study intervention administration occurring at Day 1
|
The solicited administration site events are pain, redness and swelling.
|
During 7 days after the first study intervention administration occurring at Day 1
|
|
Number of infant participants 6 weeks of age with solicited administration site events
Aikaikkuna: During 7 days after the second study intervention administration occurring at Day 57
|
The solicited administration site events are pain, redness and swelling.
|
During 7 days after the second study intervention administration occurring at Day 57
|
|
Number of infant participants 6 weeks of age with solicited systemic events
Aikaikkuna: During 7 days after the first study intervention administration occurring at Day 1
|
The solicited systemic events are fever, irritability/fussiness, loss of appetite, drowsiness, and vomiting.
Fever is defined as axillary temperature >= 38.0 °C/100.4
degrees °F.
|
During 7 days after the first study intervention administration occurring at Day 1
|
|
Number of infant participants 6 weeks of age with solicited systemic events
Aikaikkuna: During 7 days after the second study intervention administration occurring at Day 57
|
The solicited systemic events are fever, irritability/fussiness, loss of appetite, drowsiness, and vomiting.
Fever is defined as axillary temperature >= 38.0 °C/100.4
degrees °F.
|
During 7 days after the second study intervention administration occurring at Day 57
|
|
Number of infant participants 6 weeks of age with unsolicited adverse events (AEs)
Aikaikkuna: During 28 days after the first study intervention administration occurring at Day 1
|
During 28 days after the first study intervention administration occurring at Day 1
|
|
|
Number of infant participants 6 weeks of age with unsolicited adverse events (AEs)
Aikaikkuna: During 28 days after the second study intervention administration occurring at Day 57
|
During 28 days after the second study intervention administration occurring at Day 57
|
|
|
Number of infant participants 6 weeks of age with SAEs
Aikaikkuna: From first study intervention administration (Day 1) up to 28 days after second study intervention (Day 85)
|
From first study intervention administration (Day 1) up to 28 days after second study intervention (Day 85)
|
|
|
Number of infant participants 6 weeks of age with adverse events (AEs) leading to MR-VAC administration withdrawal from the study or discontinuation of study intervention
Aikaikkuna: From first study intervention administration (Day 1) up to 28 days after second study intervention (Day 85)
|
From first study intervention administration (Day 1) up to 28 days after second study intervention (Day 85)
|
|
|
Number of infant participants 6 weeks of age with deviations from reference ranges or baseline values for hematological, renal, and hepatic panel test results
Aikaikkuna: At Day 8 (7 days after the first study intervention administration)
|
At Day 8 (7 days after the first study intervention administration)
|
|
|
Number of infant participants 6 weeks of age with deviations from reference ranges or baseline values for hematological, renal, and hepatic panel test results at Day 64
Aikaikkuna: At Day 64 (7 days after the second study intervention administration)
|
At Day 64 (7 days after the second study intervention administration)
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Anti-invasiiviset nontyphoidal Salmonellan (iNTS) serotyyppispesifiset immunoglobuliini G (IgG) geometriset keskiarvopitoisuudet (GMC:t) aikuisilla 18–50-vuotiailla osallistujilla
Aikaikkuna: Päivinä 1 ja 57 (ennen jokaista tutkimusinterventiota) ja päivinä 29 ja 85 (28 päivää kunkin tutkimuksen interventioantamisen jälkeen)
|
Anti-S.
Typhimurium OAg kokonais-IgG ja anti-S.
Enteritidis OAg:n kokonais-IgG GMC:t arvioidaan.
|
Päivinä 1 ja 57 (ennen jokaista tutkimusinterventiota) ja päivinä 29 ja 85 (28 päivää kunkin tutkimuksen interventioantamisen jälkeen)
|
|
Anti-invasiiviset nontyphoidal Salmonellan (iNTS) serotyyppispesifiset immunoglobuliini G (IgG) geometriset keskiarvopitoisuudet (GMC:t) 24–59 kuukauden ikäisillä lapsilla
Aikaikkuna: Päivinä 1 ja 57 (ennen jokaista tutkimusinterventiota) ja päivinä 29 ja 85 (28 päivää kunkin tutkimuksen interventioantamisen jälkeen)
|
Anti-S.
Typhimurium OAg kokonais-IgG ja anti-S.
Enteritidis OAg:n kokonais-IgG GMC:t arvioidaan.
|
Päivinä 1 ja 57 (ennen jokaista tutkimusinterventiota) ja päivinä 29 ja 85 (28 päivää kunkin tutkimuksen interventioantamisen jälkeen)
|
|
Anti-invasiiviset nontyphoidal Salmonellan (iNTS) serotyyppispesifiset immunoglobuliini G (IgG) geometriset keskiarvopitoisuudet (GMC:t) 9 kuukauden ikäisillä lapsilla
Aikaikkuna: Päivinä 1, 85 ja 169 (ennen jokaista tutkimusinterventiota) ja päivinä 29, 113 ja 197 (28 päivää kunkin tutkimuksen interventioantamisen jälkeen)
|
Anti-S.
Typhimurium OAg kokonais-IgG ja anti-S.
Enteritidis OAg:n kokonais-IgG GMC:t arvioidaan.
|
Päivinä 1, 85 ja 169 (ennen jokaista tutkimusinterventiota) ja päivinä 29, 113 ja 197 (28 päivää kunkin tutkimuksen interventioantamisen jälkeen)
|
|
Anti-invasiiviset nontyphoidal Salmonellan (iNTS) serotyyppispesifiset immunoglobuliini G (IgG) geometriset keskiarvopitoisuudet (GMC:t) 6 viikon ikäisillä osallistujilla
Aikaikkuna: Päivinä 1, 57 ja 232 (ennen kutakin tutkimusinterventiota) päivinä 29, 85 ja 260 (28 päivää kunkin tutkimuksen interventioantamisen jälkeen) ja päivänä 239 (7 päivää kolmannen tutkimuksen interventioantamisen jälkeen)
|
Anti-S.
Typhimurium OAg kokonais-IgG ja anti-S.
Enteritidis OAg:n kokonais-IgG GMC:t arvioidaan.
|
Päivinä 1, 57 ja 232 (ennen kutakin tutkimusinterventiota) päivinä 29, 85 ja 260 (28 päivää kunkin tutkimuksen interventioantamisen jälkeen) ja päivänä 239 (7 päivää kolmannen tutkimuksen interventioantamisen jälkeen)
|
|
Number of infant participants 6 weeks of age with solicited administration site events
Aikaikkuna: During 7 days after the third study intervention administration occurring at Day 232
|
The solicited administration site events are pain, redness and swelling.
|
During 7 days after the third study intervention administration occurring at Day 232
|
|
Number of infant participants 6 weeks of age with solicited systemic events
Aikaikkuna: During 7 days after the third study intervention administration occurring at Day 232
|
The solicited systemic events are fever, irritability/fussiness, loss of appetite, drowsiness, and vomiting.
Fever is defined as axillary temperature >= 38.0 °C/100.4
degrees °F.
|
During 7 days after the third study intervention administration occurring at Day 232
|
|
Number of infant participants 6 weeks of age with unsolicited AEs
Aikaikkuna: During 28 days after the third study intervention administration occurring at Day 232
|
During 28 days after the third study intervention administration occurring at Day 232
|
|
|
Number of infant participants 6 weeks of age with SAEs
Aikaikkuna: From 28 days after the second study intervention administration (Day 85) up to end of study participation (Day 400)
|
From 28 days after the second study intervention administration (Day 85) up to end of study participation (Day 400)
|
|
|
Number of infant participants 6 weeks of age with adverse events (AEs) leading to withdrawal from the study or withholding further study intervention administration
Aikaikkuna: From 28 days after the second study intervention administration (Day 85) up to end of study participation (Day 400)
|
From 28 days after the second study intervention administration (Day 85) up to end of study participation (Day 400)
|
|
|
Number of infant participants 6 weeks of age with deviations from reference ranges or baseline values for hematological, renal, and hepatic panel test results
Aikaikkuna: At Day 239 (7 days after the study intervention administration)
|
At Day 239 (7 days after the study intervention administration)
|
|
|
Number of adult participants 18-50 years of age achieving, for each antigen (Ag), at least a 2-fold and 4-fold rise in anti-invasive nontyphoidal Salmonella (iNTS) serotype specific immunoglobulin G (IgG) antibody concentration
Aikaikkuna: At Days 29 and 85 (28 days after each study intervention administration) compared to Day 1 (baseline, prior to first study intervention administration)
|
Anti-S.
Typhimurium OAg total IgG and anti-S.
Enteritidis OAg total IgG antibody concentrations are assessed.
|
At Days 29 and 85 (28 days after each study intervention administration) compared to Day 1 (baseline, prior to first study intervention administration)
|
|
Number of child participants 24-59 months of age achieving, for each antigen (Ag), at least a 2-fold and 4-fold rise in anti-invasive nontyphoidal Salmonella (iNTS) serotype specific immunoglobulin G (IgG) antibody concentration
Aikaikkuna: At Days 29 and 85 (28 days after each study intervention administration) compared to Day 1 (baseline, prior to first study intervention administration)
|
Anti-S.
Typhimurium OAg total IgG and anti-S.
Enteritidis OAg total IgG antibody concentrations are assessed.
|
At Days 29 and 85 (28 days after each study intervention administration) compared to Day 1 (baseline, prior to first study intervention administration)
|
|
Number of infant participants 9 months of age achieving, for each antigen (Ag), at least a 2-fold and 4-fold rise in anti-invasive nontyphoidal Salmonella (iNTS) serotype specific immunoglobulin G (IgG) antibody concentration
Aikaikkuna: At Days 29, 113 and 197 (28 days after each study intervention administration) compared to Day 1 (baseline, prior to first study intervention administration)
|
Anti-S.
Typhimurium OAg total IgG and anti-S.
Enteritidis OAg total IgG antibody concentrations are assessed.
|
At Days 29, 113 and 197 (28 days after each study intervention administration) compared to Day 1 (baseline, prior to first study intervention administration)
|
|
Number of infant participants 6 weeks of age achieving, for each antigen (Ag), at least a 2-fold and 4-fold rise in anti-invasive nontyphoidal Salmonella (iNTS) serotype specific immunoglobulin G (IgG) antibody concentration
Aikaikkuna: At Days 29, 85 and 260 (28 days after each study intervention administration) and at Day 239 (7 days after the third study intervention administration) compared to Day 1 (baseline, prior to first study intervention administration)
|
Anti-S.
Typhimurium OAg total IgG and anti-S.
Enteritidis OAg total IgG antibody concentrations are assessed.
|
At Days 29, 85 and 260 (28 days after each study intervention administration) and at Day 239 (7 days after the third study intervention administration) compared to Day 1 (baseline, prior to first study intervention administration)
|
Yhteistyökumppanit ja tutkijat
Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.
Sponsori
Yhteistyökumppanit
Tutkijat
- Opintojohtaja: GSK Clinical Trials, GlaxoSmithKline
Opintojen ennätyspäivät
Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan julkisella verkkosivustolla.
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Maanantai 15. tammikuuta 2024
Ensisijainen valmistuminen (Todellinen)
Torstai 6. elokuuta 2026
Opintojen valmistuminen (Todellinen)
Torstai 6. elokuuta 2026
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Tiistai 19. joulukuuta 2023
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Torstai 18. tammikuuta 2024
Ensimmäinen Lähetetty (Todellinen)
Perjantai 19. tammikuuta 2024
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Keskiviikko 2. syyskuuta 2026
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Maanantai 31. elokuuta 2026
Viimeksi vahvistettu
Lauantai 1. elokuuta 2026
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
- Infektiot
- Bakteeri-infektiot
- Bakteeri-infektiot ja mykoosit
- Gram-negatiiviset bakteeri-infektiot
- Enterobacteriaceae-infektiot
- Salmonella-infektiot
- Biologiset tuotteet
- Monimutkaiset seokset
- Bakteerirokotteet
- Rokotteet
- Virusrokotteet
- Meningokokkirokotteet
- Uhka
- Kumpiteri-tetanus-solunlisäinen pertussis-inaktivoitu poliovirus-Haemophilus influenzae B -konjugaatti-hepatiitti B -rokote
- Keltakuumeen rokote
- Ruteella-rokote
Muut tutkimustunnusnumerot
- 217218
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
JOO
IPD-suunnitelman kuvaus
Tämän tutkimuksen IPD on saatavilla Clinical Study Data Request -sivuston kautta.
IPD-jaon aikakehys
IPD on saatavilla 6 kuukauden kuluessa tutkimuksen primaaristen päätepisteiden tulosten, tärkeimpien toissijaisten päätepisteiden ja turvallisuustietojen julkaisemisesta.
IPD-jaon käyttöoikeuskriteerit
Käyttöoikeus myönnetään sen jälkeen, kun tutkimusehdotus on lähetetty ja saatu riippumattomalta arviointipaneelilta hyväksynnän ja tiedonjakosopimuksen solmimisen jälkeen.
Käyttöoikeus tarjotaan aluksi 12 kuukauden ajaksi, mutta sitä voidaan perustellusti pidentää enintään 12 kuukaudeksi.
IPD-jakamista tukeva tietotyyppi
- STUDY_PROTOCOL
- MAHLA
- ICF
- CSR
Lääke- ja laitetiedot, tutkimusasiakirjat
Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta
Ei
Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta
Ei
Yhdysvalloissa valmistettu ja sieltä viety tuote
Ei
Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .