Tutkimus GVGH altSonflex1-2-3 -rokotteen turvallisuudesta ja immuunivasteesta shigelloosia vastaan aikuisilla, lapsilla ja imeväisillä
torstai 18. kesäkuuta 2026 päivittänyt: GlaxoSmithKline
Vaiheellinen vaihe I/II tarkkailijasokea, satunnaistettu, kontrolloitu, usean maan kattava tutkimus GVGH altSonflex1-2-3 -rokotteen turvallisuuden, reaktogeenisyyden ja immuunivasteiden arvioimiseksi S. Sonnei ja S. Flexneri, serotyypit 1b, 2a , ja 3a, aikuisilla Euroopassa (vaihe 1), jota seuraa iän vähentäminen aikuisista lapsiin ja imeväisiin sekä annoksen löytäminen imeväisille Afrikassa (vaihe 2)
Tämän kliinisen tutkimuksen tavoitteena on arvioida ensimmäistä kertaa ihmisillä (FTIH) altSonflex1-2-3-ehdokasrokotteen turvallisuutta ja immunogeenisyyttä S. sonnei- ja S. flexneri -serotyyppejä 1b, 2a ja 3a vastaan.
Rokote annetaan ensimmäisen kerran Euroopassa 18–50-vuotiaille aikuisille.
Myöhemmin rokote annetaan Afrikan shigelloosia sairastavalle väestölle, ensin 18–50-vuotiaille aikuisille, sitten 24–59 kuukauden ikäisille lapsille ja lopuksi 9 kuukauden ikäisille vauvoille.
Vauvat saavat myös kolmannen rokotuksen.
Kolme erilaista rokoteannosta [pienet (annos A), keskisuuret (annos B) ja suuret (annos C) antigeenimäärät] arvioidaan käyttämällä ikääntymistä vähentävää lähestymistapaa (vähiten haavoittuvasta aikuisväestöstä haavoittuvimpaan lapsiryhmään). ).
Tämän tutkimuksen tulokset mahdollistavat sopivimman annoksen valinnan rokotteen jatkokehitystä varten 9 kuukauden ikäisille vauvoille, jotka ovat tämän rokotteen pääkohdeikäryhmä.
Tutkimuksen yleiskatsaus
Tila
Valmis
Ehdot
Opintotyyppi
Interventio
Ilmoittautuminen (Todellinen)
551
Vaihe
- Vaihe 2
- Vaihe 1
Yhteystiedot ja paikat
Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.
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
9 kuukautta - 50 vuotta (Lapsi, Aikuinen)
Hyväksyy terveitä vapaaehtoisia
Joo
Kuvaus
Sisällyttämiskriteerit:
Kaikki osallistujat:
• Osallistujat ja/tai osallistujien vanhemmat/laillisesti hyväksyttävät edustajat LAR:t, jotka tutkijan mielestä voivat ja tulevat noudattamaan protokollan vaatimuksia (esim. päiväkirjakorttien täyttäminen, paluu seurantakäynneille).
- Kirjallinen tai todistaja/peukalopainettu tietoinen suostumus, joka on saatu osallistujalta/vanhemmilta/LAR:ilta ennen minkään tutkimuskohtaisen toimenpiteen suorittamista.
- Terveet osallistujat sairaushistorian, kliinisen tutkimuksen ja laboratorioarvioinnin perusteella.
- Osallistujat, jotka täyttävät kaikki seulontavaatimukset.
- Osallistujat, jotka ovat seronegatiivisia hepatiitti B:lle ja hepatiitti C:lle.
- Osallistujat negatiiviset ihmisen leukosyyttiantigeenille B27 (HLA-B27).
Aikuiset 18-50 vuotta:
- Mies tai nainen, joka on 18-50 vuoden ikäinen ensimmäisen tutkimuksen aikana.
- Nainen, joka ei ole raskaana, voidaan ottaa mukaan tutkimukseen. Ei-hedelmöityspotentiaali määritellään kuukautisia edeltäväksi, meneillään olevaksi kahdenväliseksi munanjohtimien ligaatioksi tai tukkeutumiseksi, kohdun poisto, molemminpuolinen munasarjan poisto tai vaihdevuodet jälkeinen.
- Hedelmällisessä iässä olevat naispuoliset osallistujat voidaan ottaa mukaan tutkimukseen, jos osallistuja:
- on käyttänyt riittävää ehkäisyä kuukauden ajan ennen tutkimusinterventioantoa, ja
- hänellä on negatiivinen raskaustesti tutkimustoimenpiteen antamispäivänä ja
- on suostunut jatkamaan riittävää ehkäisyä koko hoitojakson ajan ja kuukauden ajan tutkimuksen interventiohoitosarjan päättymisen jälkeen.
- Ihmisen immuunikatoviruksen (HIV) seronegatiiviset osallistujat.
24-59 kuukauden ikäiset lapset:
- Mies tai nainen, joka on 24–59 kuukauden ikäinen ensimmäisen rokotuksen aikaan.
- Normaali ravitsemuksellinen Z-pistemäärä (-2 standardipoikkeama tai suurempi).
- Aiemmin suoritetut rutiinilapsuuden rokotukset osallistujan vanhemman/LAR:n parhaan tietämyksen mukaan.
- Syntynyt ≥37 viikon raskausajan jälkeen.
- Osallistujat seronegatiiviset HIV:lle.
9 kuukauden ikäiset vauvat:
- Mies tai nainen 9 kuukauden ikäinen ensimmäisen rokotuksen aikaan.
- Normaali ravintoarvo Z-pisteet (-2 standardipoikkeamaa tai enemmän).
- Aiemmin suoritetut rutiinilapsuuden rokotukset osallistujan vanhemman/LAR:n parhaan tietämyksen mukaan.
- Syntynyt ≥37 viikon raskausajan jälkeen.
- Osallistujat olivat HIV-negatiivisia deoksiribonukleiinihapon (DNA) polymeraasiketjureaktion (PCR) testin perusteella.
Poissulkemiskriteerit:
Kaikki osallistujat:
• Tiedossa oleva altistuminen Shigellalle osallistujan elinaikana, mikä on vahvistettu osallistujan haastattelussa tai dokumentoitu potilasasiakirjoilla (esim. mikrobiologisesti varmistetun Shigella-infektion historia), äskettäin matkustamalla* (kahden vuoden sisällä) maahan, jossa Shigella tai muu enteerinen sairastuu infektiot ovat endeemisiä tai äskettäin ammatinharjoittajia* (kolmen vuoden sisällä), joihin liittyy Shigella-lajeja.
Matkustuksesta tai ammatista johtuva poissulkeminen koskee vain 18–50-vuotiaita aikuisia Euroopassa (vaihe 1).
• Progressiiviset, epävakaat tai hallitsemattomat kliiniset tilat.
• Aiemmat (tunnetut tai epäillyt) reaktiot tai yliherkkyydet, joita mikä tahansa tutkimusrokotteen komponentti todennäköisesti pahentaa.
• Mikä tahansa vahvistettu tai epäilty immuunivastetta heikentävä tai immuunipuutostila, joka perustuu sairaushistoriaan ja fyysiseen tutkimukseen (laboratoriotestejä ei vaadita).
• Yliherkkyys, mukaan lukien allergia, lääkkeille tai lääkinnällisille laitteille, joita käytetään tässä tutkimuksessa.
- Kliiniset sairaudet, jotka ovat vasta-aiheisia IM-rokotteelle ja verikokeille.
- Mikä tahansa käyttäytymis- tai kognitiivinen heikentyminen tai psykiatrinen sairaus, joka voi tutkijan mielestä häiritä osallistujan kykyä osallistua tutkimukseen.
- Akuutti sairaus ja/tai kuume (määritelty lämpötilaksi ≥ 38,0 °C) ilmoittautumishetkellä*.
Osallistuja voidaan vielä ilmoittautua tutkimukseen silloin, kun akuutti sairaus ja/tai kuume on parantunut.
• Kliinisesti merkittävät hematologiset ja/tai biokemialliset laboratoriopoikkeamat.
- Vahvistettu positiivinen COVID-19-testi ajanjaksolla, joka alkoi 30 päivää ennen ensimmäistä tutkimusrokotteiden antoa (päivä -30 - päivä 1).
- Mikä tahansa muu kliininen tila, joka voi tutkijan mielestä aiheuttaa lisäriskiä osallistujalle tutkimukseen osallistumisen vuoksi.
- Pitkävaikutteisten immuunijärjestelmää muokkaavien lääkkeiden antaminen milloin tahansa tutkimusjakson aikana (esim. infliksimabi).
- Ennen kokeellisen Shigella-rokotteen tai elävän Shigella-haasteen vastaanottamista.
- Minkä tahansa tutkimustuotteen tai rekisteröimättömän tuotteen (lääkkeen, rokotteen tai lääkinnällisen laitteen)* käyttö 30 päivää ennen ensimmäistä tutkimusinterventioannosta alkavana ajanjaksona (päivä -30 - päivä 1) tai suunniteltu käyttö tutkimuksen aikana. opiskelujakso.
Yrttien ja perinteisten hoitojen käyttöä ei pidetä poissulkemiskriteerinä
• Rokote, jota ei ole ennakoitu tutkimuspöytäkirjassa*, annettu ajanjaksolla, joka alkaa -21 päivää ennen ensimmäistä annosta (-28 päivää elävien rokotteiden tapauksessa) ja päättyy tutkimuksen viimeisen annoksen jälkeen**.
Pöytäkirjan sallimia rokotteita ovat influenssa- ja COVID-19-rokotteet kaikille osallistujille sekä EPI-rokotteet lapsille ja imeväisille.
Hätämassarokotuksen tapauksessa yllä olevaa ajanjaksoa voidaan lyhentää.
- Osallistuminen samanaikaisesti toiseen kliiniseen tutkimukseen milloin tahansa tutkimusjakson aikana, jossa osallistuja on altistunut tai tulee altistumaan tutkittavalle tai ei-tutkimukselliselle interventiolle (lääke tai invasiivinen lääkintälaite).
- Kaikki tutkimushenkilöstö tai välittömät huollettavat, perheenjäsenet tai perheenjäsenet.
Aikuiset 18-50 vuotta:
- Akuutti tai krooninen sairaus, kliinisesti merkittävä keuhkojen, sydän- ja verisuonisairauksien, maksan tai munuaisten toimintahäiriö, joka on määritetty fyysisellä tarkastuksella tai laboratoriotesteillä.
- Immunosuppressanttien tai muiden immuunijärjestelmää modifioivien lääkkeiden krooninen antaminen (määritelty yli 14 päivää yhteensä) ajanjakson aikana, joka alkaa 3 kuukautta ennen ensimmäistä rokotetutkimuksen interventiota. Kortikosteroidien osalta tämä tarkoittaa prednisonia ekvivalenttia ≥ 20 mg/vrk aikuisille osallistujille. Inhaloitavat ja paikalliset steroidit ovat sallittuja.
- Raskaana oleva tai imettävä nainen.
- Nainen, joka suunnittelee raskautta tai aikoo lopettaa ehkäisyn käytön.
- Aiempi tai nykyinen krooninen alkoholinkäyttö ja/tai huumeiden väärinkäyttö.
18-50-vuotiaat aikuiset ja 24-59 kuukauden ikäiset lapset:
• Immunoglobuliinien ja/tai minkä tahansa verituotteiden tai plasmajohdannaisten antaminen tai luuytimensiirto ajanjaksona, joka alkaa 3 kuukautta ennen ensimmäistä tutkimusrokoteannosta tai suunniteltu annostelu tutkimusjakson aikana.
24–59 kuukauden ikäiset lapset ja 9 kuukauden ikäiset lapset:
- Akuutti tai krooninen kliinisesti merkittävä keuhkojen, sydän- ja verisuonisairauksien, maksan tai munuaisten toimintahäiriö, joka on määritetty fyysisellä tutkimuksella tai laboratoriotesteillä.
- Immunosuppressanttien tai muiden immuunijärjestelmää muokkaavien lääkkeiden krooninen anto (määritelty yli 14 päivää yhteensä) ajanjakson aikana, joka alkaa 3 kuukautta ennen ensimmäistä rokoteannosta. Kortikosteroidien osalta tämä tarkoittaa prednisonia ≥ 0,5 mg/kg/vrk tai 20 mg/vrk sen mukaan, kumpi on suurin annos lapsipotilaille. Inhaloitavat ja paikalliset steroidit ovat sallittuja.
- Lapsi hoidossa.
9 kuukauden ikäiset vauvat:
• Immunoglobuliinien ja/tai minkä tahansa verituotteiden tai plasmajohdannaisten antaminen tai luuytimensiirto syntymästä lähtien tai suunniteltu annostelu tutkimusjakson aikana.
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: Stage 1 Adults: altSonflex1-2-3 High Dose Group 1
European participants 18-50 years of age were randomized to receive a high dose of altSonflex1-2-3 on Day 1 and Day 85. High dose of altSonflex1-2-3 contained 15 micrograms (µg) of O-antigen (OAg) each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
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2 doses in adults 18-50 years of age and children 24-59 months of age, 3 doses in infants 9 months of age
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Kokeellinen: Stage 1 Adults: altSonflex1-2-3 High Dose Group 2
European participants 18-50 years of age were randomized to receive a high dose of altSonflex1-2-3 on Day 1 and Day 169.
High dose of altSonflex1-2-3 contained 15 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
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2 doses in adults 18-50 years of age and children 24-59 months of age, 3 doses in infants 9 months of age
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Placebo Comparator: Stage 1 Adults: Placebo Group
European participants 18-50 years of age were randomized to receive 1 dose of Placebo on Day 1 and on Day 85 or 169.
All participants in Step 1 that received placebo were pooled, as pre-specified in Statistical Analysis Plan.
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2 doses in adults 18-50 years of age (stage 1)
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Kokeellinen: Stage 2 Adults: altSonflex1-2-3 High Dose
African participants 18-50 years of age were randomized to receive a high dose of altSonflex1-2-3 on Day 1 and Day 85. High dose of altSonflex1-2-3 contained of 15 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
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2 doses in adults 18-50 years of age and children 24-59 months of age, 3 doses in infants 9 months of age
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Active Comparator: Stage 2 Adults: Control
African participants 18-50 years of age were randomized to receive 1 dose of MENVEO as comparator on Day 1 and 1 dose of BOOSTRIX as comparator Day 85.
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1 dose in adults 18-50 years of age (stage 2) and children 24-59 months of age and 2 doses in infants 9 months of age
1 dose in adults 18-50 years of age (stage 2)
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Kokeellinen: Stage 2 Children: altSonflex1-2-3 Medium Dose
African participants 24-59 months of age were randomized to receive a medium dose of altSonflex1-2-3 on Day 1 and Day 85. Medium dose of altSonflex1-2-3 contained 7.5 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
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2 doses in children 24-59 months of age, 3 doses in infants 9 months of age
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Kokeellinen: Stage 2 Children: altSonflex1-2-3 High Dose
African participants 24-59 months of age were randomized to receive a high dose of altSonflex1-2-3 on Day 1 and Day 85. High dose of altSonflex1-2-3 contained 15 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
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2 doses in adults 18-50 years of age and children 24-59 months of age, 3 doses in infants 9 months of age
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Active Comparator: Stage 2 Children: Control
African participants 24-59 months of age were randomized to receive 1 dose of MENVEO as comparator on Day 1 and 1 dose of TYPHIM VI as comparator on Day 85.
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1 dose in adults 18-50 years of age (stage 2) and children 24-59 months of age and 2 doses in infants 9 months of age
1 dose in children 24-59 months of age
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Kokeellinen: Stage 2 Infants safety cohort: altSonflex1-2-3 Low Dose
African participants 9 months of age were randomized to receive a low dose of altSonflex1-2-3 on Day 1, Day 85 and Day 253.
The measles-rubella vaccine (MR-VAC) was administered on Day 29 and Day 281.
Low dose of altSonflex1-2-3 contained 3.75 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
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3 doses in infants 9 months of age
2 doses in children 24-59 months of age
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Kokeellinen: Stage 2 Infants safety cohort: altSonflex1-2-3 Medium Dose
African participants 9 months of age were randomized to receive a medium dose of altSonflex1-2-3 on Day 1, Day 85 and Day 253.
MR-VAC was administered on Day 29 and Day 281.
Medium dose of altSonflex1-2-3 contained 7.5 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
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2 doses in children 24-59 months of age, 3 doses in infants 9 months of age
2 doses in children 24-59 months of age
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Kokeellinen: Stage 2 Infants safety cohort: altSonflex1-2-3 High Dose
African participants 9 months of age were randomized to receive a high dose of altSonflex1-2-3 on Day 1, Day 85 and Day 253.
MR-VAC was administered on Day 29 and Day 281.
High dose of altSonflex1-2-3 contained 15 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
|
2 doses in adults 18-50 years of age and children 24-59 months of age, 3 doses in infants 9 months of age
2 doses in children 24-59 months of age
|
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Active Comparator: Stage 2 Infants safety cohort: Control
African participants 9 months of age were randomized to receive a dose of MENVEO as comparator on Day 1 and Day 85 and INFRANRIX HEXA as comparator on Day 253.
MR-VAC was administered on Day 29 and Day 281.
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1 dose in adults 18-50 years of age (stage 2) and children 24-59 months of age and 2 doses in infants 9 months of age
2 doses in children 24-59 months of age
1 dose in infants 9 months of age
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Kokeellinen: Stage 2 Infants dose-finding cohort: altSonflex1-2-3 Low Dose
African participants 9 months of age were randomized to receive a low dose of altSonflex1-2-3 on Day 1, Day 85 and Day 253.
MR-VAC was co-administered on Day 1 and Day 253.
This cohort was created to identify the preferred dose among low, medium and high doses.
Low dose of altSonflex1-2-3 contained 3.75 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
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3 doses in infants 9 months of age
2 doses in children 24-59 months of age
|
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Kokeellinen: Stage 2 Infants dose-finding cohort: altSonflex1-2-3 Medium Dose
African participants 9 months of age were randomized to receive a medium dose of altSonflex1-2-3 on Day 1, Day 85 and Day 253.
MR-VAC was co-administered on Day 1 and Day 253.
This cohort was created to identify the preferred dose among low, medium and high doses.
Medium dose of altSonflex1-2-3 contained 7.5 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
|
2 doses in children 24-59 months of age, 3 doses in infants 9 months of age
2 doses in children 24-59 months of age
|
|
Kokeellinen: Stage 2 Infants dose-finding cohort: altSonflex1-2-3 High Dose
African participants 9 months of age were randomized to receive a high dose of altSonflex1-2-3 on Day 1, Day 85 and Day 253.
MR-VAC was co-administered on Day 1 and Day 253.
This cohort was created to identify the preferred dose among low, medium and high doses.
High dose of altSonflex1-2-3 contained 15 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
|
2 doses in adults 18-50 years of age and children 24-59 months of age, 3 doses in infants 9 months of age
2 doses in children 24-59 months of age
|
|
Active Comparator: Stage 2 Infants dose-finding cohort: Control
African participants 9 months of age were randomized to receive a dose of MENVEO as comparator on Day 1 and Day 85 and INFRANRIX HEXA as comparator on Day 253.
MR-VAC was co-administered on Day 1 and Day 253.
This cohort was created to identify the preferred dose among low, medium and high doses.
|
1 dose in adults 18-50 years of age (stage 2) and children 24-59 months of age and 2 doses in infants 9 months of age
2 doses in children 24-59 months of age
1 dose in infants 9 months of age
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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Stage 2: Geometric Mean Concentrations (GMCs) of Anti-serotype Specific Shigella Lipopolysaccharide (LPS)/O-Antigen (OAg) Serum Immunoglobulin G (IgG) in Participants 9 Months of Age in Africa
Aikaikkuna: At Day 281 (28 days after the third study intervention)
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Anti-serotype specific Shigella LPS/OAg serum IgG GMCs were measured by enzyme-linked immunosorbent assay (ELISA) and expressed in ELISA units per milliliter (EU/mL) of serum.
Four serotypes were tested.
Due to the fact, that the Per protocol set (PPS) for Stage 2 Infants - dose finding cohort had less than the 72 participants per group defined in the protocol as a minimum number of participants to ensure power of the analysis, the Stage 2 Infants Safety cohort and Dose-finding cohort were pooled for the statistical analysis as per the Statistical Analysis Plan.
As per protocol, statistical analysis was performed only for the S. sonnei serotype, comparing Stage 2 Infants: Pooled groups (medium vs low dose); and Stage 2 Infants Dose-finding groups (high vs low dose).
The objective of this outcome measure is to identify the preferred dose of each component of the altSonflex1-2-3 vaccine for infants 9 months of age in Africa, therefore control groups were not analyzed.
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At Day 281 (28 days after the third study intervention)
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Stage 1: Number of Participants 18 to 50 Years of Age in Europe With Solicited Administration Site Events
Aikaikkuna: Within 7 days after each study intervention (administered at Day 1, Day 85 and Day 169 [depending on the vaccination schedule])
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The solicited administration site events assessed were erythema, pain, and swelling.
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Within 7 days after each study intervention (administered at Day 1, Day 85 and Day 169 [depending on the vaccination schedule])
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Stage 1: Number of Adults 18 to 50 Years of Age in Europe With Solicited Systemic Events
Aikaikkuna: Within 7 days after each study intervention (administered at Day 1, Day 85 and Day 169 [depending on the vaccination schedule])
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The solicited systemic event assessed was fever.
Fever is defined as temperature equal to or above (=>) 38.0°C.
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Within 7 days after each study intervention (administered at Day 1, Day 85 and Day 169 [depending on the vaccination schedule])
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Stage 1: Number of Participants 18 to 50 Years of Age in Europe With Unsolicited Adverse Events (AEs)
Aikaikkuna: Within 28 days after each study intervention (administered at at Day 1, Day 85 and Day 169 [depending on the vaccination schedule])
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An unsolicited AE is defined as an 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 is reported as an unsolicited adverse event.
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Within 28 days after each study intervention (administered at at Day 1, Day 85 and Day 169 [depending on the vaccination schedule])
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Stage 1: Number of Participants 18 to 50 Years of Age in Europe With Serious Adverse Events (SAEs)
Aikaikkuna: From Day 1 to Day 113 and/or Day 197
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An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, results in abnormal pregnancy outcomes or any other situation based on appropriate medical or scientific judgement.
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From Day 1 to Day 113 and/or Day 197
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Stage 1: Number of Participants 18 to 50 Years of Age in Europe With Deviations From Normal Values of Haematological, Renal, and Hepatic Panel Test Results After First Study Intervention
Aikaikkuna: At Day 8
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Panel tests include measures of alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine, basophils, eosinophils, erythrocytes, haematocrit, haemoglobin, lymphocytes, monocytes, neutrophils, platelets and white blood cells (WBC).
Categories reported when comparing Day 1 (baseline) and normal range hematological, renal and hepatic laboratory results are defined as follows: <parameter>,<range at baseline>,<range at timing>, where range is being classified as Below = value below; Within = value within; and Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.
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At Day 8
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Stage 1: Number of Participants 18 to 50 Years of Age in Europe With Deviations From Normal Values of Haematological, Renal, and Hepatic Panel Test Results After Second Study Intervention
Aikaikkuna: At Day 92 (Stage 1 Adults: altSonflex1-2-3 High Dose Group 1), at Day 176 (Stage 1 Adults: altSonflex1-2-3 High Dose Group 2) and at Day 92/Day 176 (Stage 1 Adults: Placebo Group)
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Panel tests include measures of ALT, AST, creatinine, basophils, eosinophils, erythrocytes, haematocrit, haemoglobin, lymphocytes, monocytes, neutrophils, platelets and WBC.
Categories reported when comparing Day 85/Day 169 (baseline) and normal range hematological, renal and hepatic laboratory results are defined as follows: <parameter>,<range at baseline>,<range at timing>, where range is being classified as Below = value below; Within = value within; and Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.
|
At Day 92 (Stage 1 Adults: altSonflex1-2-3 High Dose Group 1), at Day 176 (Stage 1 Adults: altSonflex1-2-3 High Dose Group 2) and at Day 92/Day 176 (Stage 1 Adults: Placebo Group)
|
|
Stage 2: Number of Participants 18 to 50 Years of Age in Africa With Solicited Administration Site Events
Aikaikkuna: Within 7 days after each study intervention (administered at Day 1 and Day 85)
|
The solicited administration site events assessed were pain, erythema, and swelling.
|
Within 7 days after each study intervention (administered at Day 1 and Day 85)
|
|
Stage 2: Number of Participants 18 to 50 Years of Age in Africa With Solicited Systemic Events
Aikaikkuna: Within 7 days after each study intervention (administered at Day 1 and Day 85)
|
The solicited systemic event assessed was fever.
Fever is defined as temperature equal to or above (=>) 38.0°C.
|
Within 7 days after each study intervention (administered at Day 1 and Day 85)
|
|
Stage 2: Number of Participants 18 to 50 Years of Age in Africa With Unsolicited Adverse Events (AEs)
Aikaikkuna: Within 28 days after each study intervention (administered at Day 1 and Day 85)
|
An unsolicited AE is defined as an 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 is reported as an unsolicited adverse event.
|
Within 28 days after each study intervention (administered at Day 1 and Day 85)
|
|
Stage 2: Number of Participants 18 to 50 Years of Age in Africa With Serious Adverse Events (SAEs)
Aikaikkuna: From Day 1 to Day 113
|
An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, results in abnormal pregnancy outcomes or any other situation based on appropriate medical or scientific judgement.
|
From Day 1 to Day 113
|
|
Stage 2: Number of Participants 18 to 50 Years of Age in Africa With Deviations From Normal Values of Haematological, Renal, and Hepatic Panel Test Results After First Study Intervention
Aikaikkuna: At Day 8
|
Panel tests include measures of ALT, AST, creatinine, basophils, eosinophils, erythrocytes, haematocrit, haemoglobin, lymphocytes, monocytes, neutrophils, platelets and WBC.
Categories reported when comparing Day 1 (baseline) and normal range hematological, renal and hepatic laboratory results are defined as follows: <parameter>,<range at baseline>,<range at timing>, where range is being classified as Below = value below; Within = value within; and Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.
|
At Day 8
|
|
Stage 2: Number of Participants 18 to 50 Years of Age in Africa With Deviations From Normal Values of Haematological, Renal, and Hepatic Panel Test Results After Second Study Intervention
Aikaikkuna: At Day 92
|
Panel tests include measures of ALT, AST, creatinine, basophils, eosinophils, erythrocytes, haematocrit, haemoglobin, lymphocytes, monocytes, neutrophils, platelets and WBC.
Categories reported when comparing Day 85 (baseline) and normal range hematological, renal and hepatic laboratory results are defined as follows: <parameter>,<range at baseline>,<range at timing>, where range is being classified as Below = value below; Within = value within; and Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.
|
At Day 92
|
|
Stage 2: Number of Participants 24 to 59 Months of Age in Africa With Solicited Administration Site Events
Aikaikkuna: Within 7 days after each study intervention (administered at Day 1 and Day 85)
|
The solicited administration site events assessed were erythema, pain, and swelling.
|
Within 7 days after each study intervention (administered at Day 1 and Day 85)
|
|
Stage 2: Number of Participants 24 to 59 Months of Age in Africa With Solicited Systemic Events
Aikaikkuna: Within 7 days after each study intervention (administered at Day 1 and Day 85)
|
The solicited systemic event assessed was fever.
Fever is defined as temperature equal to or above (=>) 38.0°C.
|
Within 7 days after each study intervention (administered at Day 1 and Day 85)
|
|
Stage 2: Number of Participants 24 to 59 Months of Age in Africa With Unsolicited Adverse Events (AEs)
Aikaikkuna: Within 28 days after each study intervention (administered at Day 1 and Day 85)
|
An unsolicited AE is defined as an 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 is reported as an unsolicited adverse event.
|
Within 28 days after each study intervention (administered at Day 1 and Day 85)
|
|
Stage 2: Number of Participants 24 to 59 Months of Age in Africa With Serious Adverse Events (SAEs)
Aikaikkuna: From Day 1 to Day 113
|
An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, results in abnormal pregnancy outcomes or any other situation based on appropriate medical or scientific judgement.
|
From Day 1 to Day 113
|
|
Stage 2: Number of Participants 24 to 59 Months of Age in Africa With Deviations From Normal Values of Haematological, Renal, and Hepatic Panel Test Results After First Study Intervention
Aikaikkuna: At Day 8
|
Panel tests include measures of ALT, AST, creatinine, basophils, eosinophils, erythrocytes, haematocrit, haemoglobin, lymphocytes, monocytes, neutrophils, platelets and WBC.
Categories reported when comparing Day 1 (baseline) and normal range hematological, renal and hepatic laboratory results are defined as follows: <parameter>,<range at baseline>,<range at timing>, where range is being classified as Below = value below; Within = value within; and Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.
|
At Day 8
|
|
Stage 2: Number of Participants 24 to 59 Months of Age in Africa With Deviations From Normal Values of Haematological, Renal, and Hepatic Panel Test Results After Second Study Intervention
Aikaikkuna: At Day 92
|
Panel tests include measures of ALT, AST, creatinine, basophils, eosinophils, erythrocytes, haematocrit, haemoglobin, lymphocytes, monocytes, neutrophils, platelets and WBC.
Categories reported when comparing Day 85 (baseline) and normal range hematological, renal and hepatic laboratory results are defined as follows: <parameter>,<range at baseline>,<range at timing>, where range is being classified as Below = value below; Within = value within; and Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.
|
At Day 92
|
|
Stage 2: Number of Participants 9 Months of Age in Africa With Solicited Administration Site Events - Infants Safety Cohort
Aikaikkuna: Within 7 days after each study intervention (administered at Day 1, Day 85 and Day 253)
|
The solicited administration site events assessed were erythema, pain, and swelling.
|
Within 7 days after each study intervention (administered at Day 1, Day 85 and Day 253)
|
|
Stage 2: Number of Participants 9 Months of Age in Africa With Solicited Administration Site Events - Infants Dose-finding Cohort
Aikaikkuna: Within 7 days after each study intervention (administered at Day 1, Day 85 and Day 253)
|
The solicited administration site events assessed were erythema, pain, and swelling.
|
Within 7 days after each study intervention (administered at Day 1, Day 85 and Day 253)
|
|
Stage 2: Number of Participants 9 Months of Age in Africa With Solicited Systemic Events - Infants Safety Cohort
Aikaikkuna: Within 7 days after each study intervention (administered at Day 1, Day 85 and Day 253)
|
The solicited systemic event is fever.
Fever is defined as temperature equal to or above (=>) 38.0°C.
|
Within 7 days after each study intervention (administered at Day 1, Day 85 and Day 253)
|
|
Stage 2: Number of Participants 9 Months of Age in Africa With Solicited Systemic Events - Infants Dose-finding Cohort
Aikaikkuna: Within 7 days after each study intervention (administered at Day 1, Day 85 and Day 253)
|
The solicited systemic event is fever.
Fever is defined as temperature equal to or above (=>) 38.0°C.
|
Within 7 days after each study intervention (administered at Day 1, Day 85 and Day 253)
|
|
Stage 2: Number of Participants 9 Months of Age in Africa With Unsolicited Adverse Events (AEs) - Infants Safety Cohort
Aikaikkuna: Within 28 days after each study intervention (administered at Day 1, Day 85 and Day 253)
|
An unsolicited AE is defined as an 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 is reported as an unsolicited adverse event.
|
Within 28 days after each study intervention (administered at Day 1, Day 85 and Day 253)
|
|
Stage 2: Number of Participants 9 Months of Age in Africa With Unsolicited Adverse Events (AEs) - Infants Dose-finding Cohort
Aikaikkuna: Within 28 days after each study intervention (administered at Day 1, Day 85 and Day 253)
|
An unsolicited AE is defined as an 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 is reported as an unsolicited adverse event.
|
Within 28 days after each study intervention (administered at Day 1, Day 85 and Day 253)
|
|
Stage 2: Number of Participants 9 Months of Age in Africa With Serious Adverse Events (SAEs) - Infants Safety Cohort
Aikaikkuna: From Day 1 to Day 281
|
An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, results in abnormal pregnancy outcomes or any other situation based on appropriate medical or scientific judgement.
|
From Day 1 to Day 281
|
|
Stage 2: Number of Participants 9 Months of Age in Africa With Serious Adverse Events (SAEs) - Infants Dose-finding Cohort
Aikaikkuna: From Day 1 to Day 281
|
An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, results in abnormal pregnancy outcomes or any other situation based on appropriate medical or scientific judgement.
|
From Day 1 to Day 281
|
|
Stage 2: Number of Participants 9 Months of Age in Africa With Deviations From Normal Values of Haematological, Renal, and Hepatic Panel Test Results After First Study Intervention - Infants Safety Cohort
Aikaikkuna: At Day 8
|
Panel tests include measures of alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine, potassium, sodium, urea, basophils, eosinophils, erythrocytes, haematocrit, haemoglobin, lymphocytes, monocytes, neutrophils, platelets and white blood cells (WBC).
Categories reported when comparing Day 1 (baseline) and normal range hematological, renal and hepatic laboratory results are defined as follows: <parameter>,<range at baseline>,<range at timing>, where range is being classified as Below = value below; Within = value within; and Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.
|
At Day 8
|
|
Stage 2: Number of Participants 9 Months of Age in Africa With Deviations From Normal Values of Haematological, Renal, and Hepatic Panel Test Results After First Study Intervention - Infants Dose-finding Cohort
Aikaikkuna: At Day 8
|
Panel tests include measures of ALT, AST, creatinine, basophils, eosinophils, erythrocytes, haematocrit, haemoglobin, lymphocytes, monocytes, neutrophils, platelets and WBC.
Categories reported when comparing Day 1 (baseline) and normal range hematological, renal and hepatic laboratory results are defined as follows: <parameter>,<range at baseline>,<range at timing>, where range is being classified as Below = value below; Within = value within; and Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.
|
At Day 8
|
|
Stage 2: Number of Participants 9 Months of Age in Africa With Deviations From Normal Values of Haematological, Renal, and Hepatic Panel Test Results After Second Study Intervention - Infants Safety Cohort
Aikaikkuna: At Day 92
|
Panel tests include measures of ALT, AST, creatinine, potassium, sodium, urea, basophils, eosinophils, erythrocytes, haematocrit, haemoglobin, lymphocytes, monocytes, neutrophils, platelets and WBC.
Categories reported when comparing Day 1 (baseline) and normal range hematological, renal and hepatic laboratory results are defined as follows: <parameter>,<range at baseline>,<range at timing>, where range is being classified as Below = value below; Within = value within; and Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.
|
At Day 92
|
|
Stage 2: Number of Participants 9 Months of Age in Africa With Deviations From Normal Values of Haematological, Renal, and Hepatic Panel Test Results After Second Study Intervention - Infants Dose-finding Cohort
Aikaikkuna: At Day 92
|
Panel tests include measures of alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine, potassium, sodium, urea, basophils, eosinophils, erythrocytes, haematocrit, haemoglobin, lymphocytes, monocytes, neutrophils, platelets and white blood cells (WBC).
Categories reported when comparing Day 1 (baseline) and normal range hematological, renal and hepatic laboratory results are defined as follows: <parameter>,<range at baseline>,<range at timing>, where range is being classified as Below = value below; Within = value within; and Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.
|
At Day 92
|
|
Stage 2: Number of Participants 9 Months of Age in Africa With Deviations From Normal Values of Haematological, Renal, and Hepatic Panel Test Results After Third Study Intervention - Infants Safety Cohort
Aikaikkuna: At Day 260
|
Panel tests include measures of ALT, AST, creatinine, basophils, eosinophils, erythrocytes, haematocrit, haemoglobin, lymphocytes, monocytes, neutrophils, platelets and WBC.
Categories reported when comparing Day 1 (baseline) and normal range hematological, renal and hepatic laboratory results are defined as follows: <parameter>,<range at baseline>,<range at timing>, where range is being classified as Below = value below; Within = value within; and Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.
|
At Day 260
|
|
Stage 2: Number of Participants 9 Months of Age in Africa With Deviations From Normal Values of Haematological, Renal, and Hepatic Panel Test Results After Third Study Intervention - Infants Dose-finding Cohort
Aikaikkuna: At Day 260
|
Panel tests include measures of alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine, potassium, sodium, urea, basophils, eosinophils, erythrocytes, haematocrit, haemoglobin, lymphocytes, monocytes, neutrophils, platelets and white blood cells (WBC).
Categories reported when comparing Day 1 (baseline) and normal range hematological, renal and hepatic laboratory results are defined as follows: <parameter>,<range at baseline>,<range at timing>, where range is being classified as Below = value below; Within = value within; and Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.
|
At Day 260
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Stage 1: Anti-serotype Specific Shigella LPS/OAg Serum IgG GMCs in Participants 18 to 50 Years of Age in Europe
Aikaikkuna: At Day 1 and Day 85/Day 169(before each study intervention); at Day 15 (14 days after the first study intervention); at Day 29 and Day 113/Day 197 (28 days after each study intervention)
|
Anti-serotype specific Shigella LPS/OAg serum IgG GMCs were measured by ELISA and expressed in EU/mL of serum.
S. sonnei, S. flexneri 1b, S. flexneri 2a, and S. flexneri 3a serotypes were tested.
|
At Day 1 and Day 85/Day 169(before each study intervention); at Day 15 (14 days after the first study intervention); at Day 29 and Day 113/Day 197 (28 days after each study intervention)
|
|
Stage 2: Anti-serotype Specific Shigella LPS/OAg Serum IgG GMCs in Participants 18 to 50 Years of Age in Africa
Aikaikkuna: At Day 1 and Day 85 (before each study intervention administration) and Day 29 and Day 113 (28 days after each study intervention administration)
|
At Day 1 and Day 85 (before each study intervention administration) and Day 29 and Day 113 (28 days after each study intervention administration)
|
|
|
Stage 2: Anti-serotype Specific Shigella LPS/OAg Serum IgG GMCs in Participants 24 to 59 Months of Age in Africa
Aikaikkuna: At Day 1 and Day 85 (before each study intervention) and Day 29 and Day 113 (28 days after each study intervention)
|
At Day 1 and Day 85 (before each study intervention) and Day 29 and Day 113 (28 days after each study intervention)
|
|
|
Stage 2: Anti-serotype Specific Shigella LPS/OAg Serum IgG GMCs in Participants 9 Months of Age in Africa - Infants Safety Cohort
Aikaikkuna: At Day 1, Day 85 and Day 253 (before each study intervention administration) and Day 29, Day 113 and Day 281 (28 days after each study intervention administration)
|
At Day 1, Day 85 and Day 253 (before each study intervention administration) and Day 29, Day 113 and Day 281 (28 days after each study intervention administration)
|
|
|
Stage 2: Anti-serotype Specific Shigella LPS/OAg Serum IgG GMCs in Participants 9 Months of Age in Africa - Dose-finding Cohort
Aikaikkuna: At Day 1, Day 85 and Day 253 (before each study intervention administration) and Day 29, Day 113 and Day 281 (28 days after each study intervention administration)
|
At Day 1, Day 85 and Day 253 (before each study intervention administration) and Day 29, Day 113 and Day 281 (28 days after each study intervention administration)
|
|
|
Stage 1: Number of Participants 18 to 50 Years of Age Achieving a GVGH ELISA Level Equivalent to ≥1:800 Titer Against S. Sonnei LPS/OAg
Aikaikkuna: At Day 1 and Day 85/Day 169 (before each study intervention); at Day 15 (14 days after the first study intervention); at Day 29 and Day 113/Day 197 (28 days after each study intervention)
|
At Day 1 and Day 85/Day 169 (before each study intervention); at Day 15 (14 days after the first study intervention); at Day 29 and Day 113/Day 197 (28 days after each study intervention)
|
|
|
Stage 2: Number of Participants 18 to 50 Years of Age Achieving a GVGH ELISA Level Equivalent to ≥1:800 Titer Against S. Sonnei LPS/OAg
Aikaikkuna: At Day 1 and Day 85 (before each study intervention) and Day 29 and Day 113 (28 days after each study intervention)
|
At Day 1 and Day 85 (before each study intervention) and Day 29 and Day 113 (28 days after each study intervention)
|
|
|
Stage 2: Number of Participants 24 to 59 Months of Age Achieving a GVGH ELISA Level Equivalent to ≥1:800 Titer Against S. Sonnei LPS/OAg
Aikaikkuna: At Day 1 and Day 85 (before each study intervention) and Day 29 and Day 113 (28 days after each study intervention)
|
At Day 1 and Day 85 (before each study intervention) and Day 29 and Day 113 (28 days after each study intervention)
|
|
|
Stage 2: Number of Participants 9 Months of Age Achieving a GVGH ELISA Level Equivalent to ≥1:800 Titer Against S. Sonnei LPS/Oag - Safety Cohort
Aikaikkuna: At Day 1, Day 85 and Day 253 (before each study intervention) and Day 29, Day 113 and Day 281 (28 days after each study intervention)
|
At Day 1, Day 85 and Day 253 (before each study intervention) and Day 29, Day 113 and Day 281 (28 days after each study intervention)
|
|
|
Stage 2: Number of Participants 9 Months of Age Achieving a GVGH ELISA Level Equivalent to ≥1:800 Titer Against S. Sonnei LPS/Oag - Dose-finding Cohort
Aikaikkuna: At Day 1, Day 85 and Day 253 (before each study intervention) and Day 29, Day 113 and Day 281 (28 days after each study intervention)
|
At Day 1, Day 85 and Day 253 (before each study intervention) and Day 29, Day 113 and Day 281 (28 days after each study intervention)
|
|
|
Stage 1: Number of Participants 18 to 50 Years of Age Achieving a GVGH ELISA Level Equivalent to ≥1:1600 Titer Against S. Sonnei LPS/OAg
Aikaikkuna: At Day 1 and Day 85/Day 169 (before each study intervention); at Day 15 (14 days after the first study intervention); at Day 29 and Day 113/Day 197 (28 days after each study intervention)
|
At Day 1 and Day 85/Day 169 (before each study intervention); at Day 15 (14 days after the first study intervention); at Day 29 and Day 113/Day 197 (28 days after each study intervention)
|
|
|
Stage 2: Number of Participants 18 to 50 Years of Age Achieving a GVGH ELISA Level Equivalent to ≥1:1600 Titer Against S. Sonnei LPS/OAg
Aikaikkuna: At Day 1 and Day 85 (before each study intervention) and Day 29 and Day 113 (28 days after each study intervention)
|
At Day 1 and Day 85 (before each study intervention) and Day 29 and Day 113 (28 days after each study intervention)
|
|
|
Stage 2: Number of Participants 24 to 59 Months of Age Achieving a GVGH ELISA Level Equivalent to ≥1:1600 Titer Against S. Sonnei LPS/OAg
Aikaikkuna: At Day 1 and Day 85 (before each study intervention) and Day 29 and Day 113 (28 days after each study intervention)
|
At Day 1 and Day 85 (before each study intervention) and Day 29 and Day 113 (28 days after each study intervention)
|
|
|
Stage 2: Number of Participants 9 Months of Age Achieving a GVGH ELISA Level Equivalent to ≥1:1600 Titer Against S. Sonnei LPS/OAg - Safety Cohort
Aikaikkuna: At Day 1, Day 85 and Day 253 (before each study intervention) and Day 29, Day 113 and Day 281 (28 days after each study intervention)
|
At Day 1, Day 85 and Day 253 (before each study intervention) and Day 29, Day 113 and Day 281 (28 days after each study intervention)
|
|
|
Stage 2: Number of Participants 9 Months of Age Achieving a GVGH ELISA Level Equivalent to ≥1:1600 Titer Against S. Sonnei LPS/OAg - Dose-finding Cohort
Aikaikkuna: At Day 1, Day 85 and Day 253 (before each study intervention) and Day 29, Day 113 and Day 281 (28 days after each study intervention)
|
At Day 1, Day 85 and Day 253 (before each study intervention) and Day 29, Day 113 and Day 281 (28 days after each study intervention)
|
|
|
Stage 1: Number of Participants 18 to 50 Years of Age Showing at Least a 4-fold Increase in Anti-serotype Specific Shigella LPS/OAg Serum IgG Concentrations, as Measured by GVGH ELISA
Aikaikkuna: At Day 15 (14 days after the first study intervention) and at Day 29 and Day 113/Day 197 (28 days after each study intervention) compared to baseline (Day 1 and Day 85/Day 169)
|
At Day 15 (14 days after the first study intervention) and at Day 29 and Day 113/Day 197 (28 days after each study intervention) compared to baseline (Day 1 and Day 85/Day 169)
|
|
|
Stage 2: Number of Participants 18 to 50 Years of Age Showing at Least a 4-fold Increase in Anti-serotype Specific Shigella LPS/OAg Serum IgG Concentrations, as Measured by GVGH ELISA
Aikaikkuna: At Day 29 and Day 113 (28 days after each study intervention) compared to baseline (Day 1 and Day 85)
|
At Day 29 and Day 113 (28 days after each study intervention) compared to baseline (Day 1 and Day 85)
|
|
|
Stage 2: Number of Participants 24 to 59 Months of Age Showing at Least a 4-fold Increase in Anti-serotype Specific Shigella LPS/OAg Serum IgG Concentrations, as Measured by GVGH ELISA
Aikaikkuna: At Day 29 and Day 113 (28 days after each study intervention) compared to baseline (Day 1 and Day 85)
|
At Day 29 and Day 113 (28 days after each study intervention) compared to baseline (Day 1 and Day 85)
|
|
|
Stage 2: Number of Participants 9 Months of Age Showing at Least a 4-fold Increase in Anti-serotype Specific Shigella LPS/OAg Serum IgG Concentrations, as Measured by GVGH ELISA - Safety Cohort
Aikaikkuna: At Day 29, Day 113 and Day 281 (28 days after each study intervention) compared to baseline (Day 1, Day 85 and Day 253)
|
At Day 29, Day 113 and Day 281 (28 days after each study intervention) compared to baseline (Day 1, Day 85 and Day 253)
|
|
|
Stage 2: Number of Participants 9 Months of Age Showing at Least a 4-fold Increase in Anti-serotype Specific Shigella LPS/OAg Serum IgG Concentrations, as Measured by GVGH ELISA - Dose-finding Cohort
Aikaikkuna: At Day 29, Day 113 and Day 281 (28 days after each study intervention) compared to baseline (Day 1, Day 85 and Day 253)
|
At Day 29, Day 113 and Day 281 (28 days after each study intervention) compared to baseline (Day 1, Day 85 and Day 253)
|
|
|
Stage 2: Anti-measles IgG Concentrations in Participants 9 Months of Age in the Dose-finding Cohort
Aikaikkuna: At Day 1 (before first measles and rubella vaccine (MR-VAC)) and at Day 281 (28 days after the second MR-VAC administration)
|
At Day 1 (before first measles and rubella vaccine (MR-VAC)) and at Day 281 (28 days after the second MR-VAC administration)
|
|
|
Stage 2: Anti-rubella IgG Concentrations in Participants 9 Months of Age in the Dose-finding Groups
Aikaikkuna: At Day 1 (before first measles and rubella vaccine (MR-VAC)) and at Day 281 (28 days after the second MR-VAC administration)
|
At Day 1 (before first measles and rubella vaccine (MR-VAC)) and at Day 281 (28 days after the second MR-VAC administration)
|
|
|
Stage 2: Number of Participants 9 Months of Age in the Dose-finding Groups Achieving Anti-measles IgG Concentrations of ≥150 Milli International Units Per Milliliter (mIU/mL) and ≥200 mIU/mL
Aikaikkuna: Day 281 (28 days after the second MR-VAC administration)
|
Day 281 (28 days after the second MR-VAC administration)
|
|
|
Stage 2: Number of Participants 9 Months of Age in the Dose-finding Groups Achieving Anti-rubella IgG Concentrations of ≥4 mIU/mL and ≥10 mIU/mL
Aikaikkuna: Day 281 (28 days after the second MR-VAC administration)
|
Day 281 (28 days after the second MR-VAC administration)
|
Yhteistyökumppanit ja tutkijat
Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.
Sponsori
Tutkijat
- Opintojohtaja: GSK Clinical Trials, GlaxoSmithKline
Julkaisuja ja hyödyllisiä linkkejä
Tutkimusta koskevien tietojen syöttämisestä vastaava henkilö toimittaa nämä julkaisut vapaaehtoisesti. Nämä voivat koskea mitä tahansa tutkimukseen liittyvää.
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)
Keskiviikko 6. lokakuuta 2021
Ensisijainen valmistuminen (Todellinen)
Tiistai 24. kesäkuuta 2025
Opintojen valmistuminen (Todellinen)
Tiistai 24. kesäkuuta 2025
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Keskiviikko 29. syyskuuta 2021
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Keskiviikko 29. syyskuuta 2021
Ensimmäinen Lähetetty (Todellinen)
Maanantai 11. lokakuuta 2021
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Maanantai 22. kesäkuuta 2026
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Torstai 18. kesäkuuta 2026
Viimeksi vahvistettu
Maanantai 1. kesäkuuta 2026
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
- Merkit ja oireet, ruoansulatus
- Suoliston sairaudet
- Infektiot
- Ruoansulatuskanavan sairaudet
- Ruoansulatuskanavan sairaudet
- Gastroenteriitti
- Bakteeri-infektiot
- Bakteeri-infektiot ja mykoosit
- Gram-negatiiviset bakteeri-infektiot
- Enterobacteriaceae-infektiot
- Punatauti
- Patologiset tilat, merkit ja oireet
- Merkit ja oireet
- Ripuli
- Punatauti, basillaari
- Biologiset tuotteet
- Monimutkaiset seokset
- Bakteerirokotteet
- Rokotteet
- Meningokokkirokotteet
- Boostrix
- Kumpiteri-tetanus-solunlisäinen pertussis-inaktivoitu poliovirus-Haemophilus influenzae B -konjugaatti-hepatiitti B -rokote
- Vi polysakkaridirokote, lavantauti
Muut tutkimustunnusnumerot
- 212149
- 2021-000891-12 (EudraCT-numero)
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, keskeisten toissijaisten päätepisteiden ja turvallisuustietojen tulosten 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 .