Uno studio sulla sicurezza, reattogenicità e risposta immunitaria al vaccino GVGH iNTS-GMMA contro la salmonella invasiva non tifoidea negli adulti, nei bambini e nei neonati
31 agosto 2026 aggiornato da: GlaxoSmithKline
Uno studio interventistico di Fase IIa in cieco per l'osservatore, randomizzato, controllato, con riduzione dell'età, in un unico centro per valutare la sicurezza, la reattogenicità e la risposta immunitaria del vaccino GVGH iNTS contro S. Typhimurium e S. Enteritidis, negli adulti, nei bambini e Neonati, inclusa la determinazione della dose nei neonati, in Africa
Lo scopo di questo studio è valutare la sicurezza, la reattogenicità e la risposta immunitaria del vaccino candidato GlaxoSmithKline (GSK) Vaccines Institute for Global Health (GVGH) invasivo non tifoideo per Salmonella generalizzato per antigeni di membrana (iNTS-GMMA) contro S. Typhimurium e S. Enteritidis con un approccio di riduzione dell'età e aumento della dose nella popolazione africana, iniziando con gli adulti (18-50 anni di età), poi sui bambini (24-59 mesi di età) e infine sui neonati (9 mesi e 6 settimane di età).
I neonati sono il bersaglio della vaccinazione primaria a partire dalle 6 settimane di età.
Panoramica dello studio
Stato
Completato
Condizioni
Descrizione dettagliata
Lo studio sarà condotto in due fasi:
Fase 1: riduzione dell'età da adulti a bambini e neonati
- I partecipanti adulti riceveranno iNTS-GMMA Dose C (alta) o un vaccino di controllo per via intramuscolare il giorno 1 e il giorno 57.
- I bambini partecipanti riceveranno la Dose B (media) o la Dose C (alta) del vaccino candidato o il controllo il Giorno 1 e il Giorno 57.
- I partecipanti neonati (9 mesi di età) riceveranno la Dose A (bassa), la Dose B (media) o la Dose C (alta) del vaccino candidato o del controllo il Giorno 1, il Giorno 85 e il Giorno 169.
- I partecipanti neonati (6 settimane di età) riceveranno la Dose A (bassa), la Dose B (media) o la Dose C (alta) del vaccino candidato o del controllo il Giorno 1, il Giorno 85 (fase di priming) e il Giorno 232 (Fase di richiamo).
Fase 2: determinazione della dose nei neonati di 6 settimane di età
-I neonati (6 settimane di età) riceveranno uno dei tre livelli di dose (Dose A [basso], Dose B [media] o Dose C [alta]) del vaccino candidato o del controllo il Giorno 1, Giorno 85 ( Fase di priming) e il giorno 232 (fase di booster).
Tipo di studio
Interventistico
Iscrizione (Effettivo)
183
Fase
- Fase 2
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Kumasi, Ghana
- GSK Investigational Site
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Bambino
- Adulto
Accetta volontari sani
Sì
Descrizione
Criterio di inclusione:
Tutti i partecipanti (adulti, bambini, neonati di 9 mesi di età e neonati di 6 settimane di età) saranno arruolati nel sito clinico in Ghana e dovranno soddisfare TUTTI i seguenti criteri all'ingresso nello studio:
- I partecipanti e/o i loro genitori/rappresentanti legalmente accettabili (LAR), che, secondo l'opinione dello sperimentatore, possono e rispetteranno i requisiti del protocollo (ad esempio, completamento delle schede del diario, restituzione per le visite di controllo).
- Consenso informato scritto o testimoniato/stampato con il pollice ottenuto dal partecipante/genitore(i)/LAR(i) del partecipante prima dell'esecuzione di qualsiasi procedura specifica dello studio.
- Partecipanti sani come stabilito dall'anamnesi, dall'esame clinico e dalle indagini di laboratorio.
- Partecipanti che soddisfano i requisiti di screening.
- Partecipanti negativi al virus dell'immunodeficienza umana (HIV), all'epatite B e all'epatite C.
I partecipanti adulti devono soddisfare TUTTI i seguenti criteri all'ingresso nello studio:
- Un maschio o una femmina di età compresa tra 18 e 50 anni al momento della prima somministrazione dell'intervento dello studio.
- Partecipanti di sesso femminile in età non fertile potranno essere arruolate nello studio. Il potenziale non fertile è definito come pre-menarca, attuale legatura o occlusione delle tube bilaterale, isterectomia, ovariectomia bilaterale o post-menopausa.
- Le partecipanti di sesso femminile in età fertile possono essere arruolate nello studio se il partecipante:
ha praticato una contraccezione adeguata per 1 mese prima della somministrazione dell'intervento in studio e:
- ha un test di gravidanza negativo il giorno della somministrazione dell'intervento dello studio e
- ha accettato di continuare una contraccezione adeguata durante l'intero periodo di trattamento e per 1 mese dopo il completamento della serie di interventi di somministrazione dello studio.
La carta del Ghana verrà utilizzata come documento originale per verificare l'età degli adulti.
I partecipanti minorenni devono soddisfare TUTTI i seguenti criteri all'ingresso nello studio:
- Un maschio o una femmina di età compresa tra 24 e 59 mesi compresi al momento della prima somministrazione dell'intervento dello studio.
- Vaccinazioni infantili di routine completate in precedenza secondo la migliore conoscenza dei genitori/LAR del partecipante.
- Nato dopo un periodo di gestazione ≥ 37 settimane.
I partecipanti neonati devono soddisfare TUTTI i seguenti criteri all'ingresso nello studio:
- Un maschio o una femmina di 6 settimane o 9 mesi di età al momento della prima somministrazione dell'intervento in studio.
- Nato dopo un periodo di gestazione ≥ 37 settimane.
- Nato da madre sieronegativa per HIV, virus dell'epatite B e virus dell'epatite C.
La Road to Health Chart sarà utilizzata come documento di partenza per confermare le età dei bambini e dei neonati.
Criteri di esclusione:
Condizioni mediche
- Esposizione nota a S. Typhimurium o S. Enteritidis durante il periodo che inizia alla nascita per neonati e bambini e a 3 anni per gli adulti, come documentato dalle cartelle cliniche dei pazienti
- Anamnesi di qualsiasi reazione o ipersensibilità che potrebbe essere esacerbata da qualsiasi componente degli interventi dello studio.
- Ipersensibilità, inclusa l'allergia, ai medicinali o alle apparecchiature mediche il cui utilizzo è previsto in questo studio.
- Condizioni cliniche progressive, instabili o incontrollate.
- Qualsiasi condizione immunosoppressiva o immunodeficiente confermata o sospetta, sulla base dell'anamnesi e dell'esame obiettivo
- Difetti congeniti maggiori, secondo la valutazione dello sperimentatore.
- Anomalie funzionali polmonari, cardiovascolari, epatiche o renali acute o croniche clinicamente significative, determinate mediante esame fisico o test di screening di laboratorio.
- Malattia acuta e/o febbre al momento dell'arruolamento (la febbre è definita come temperatura ≥ 38,0°C).
- Anamnesi ricorrente o disturbi neurologici o convulsioni non controllati.
- Qualsiasi anomalia di laboratorio ematologica e/o biochimica clinicamente significativa.
- Denutrizione definita come punteggio Z OMS inferiore a -2 SD.
- Infezione malarica definita come la presenza di parassiti asessuali nel sangue.
- Condizioni cliniche che rappresentano una controindicazione alla vaccinazione intramuscolare e ai prelievi di sangue.
- Qualsiasi deterioramento comportamentale o cognitivo o malattia psichiatrica che, a giudizio dello sperimentatore, potrebbe interferire con la capacità del partecipante di partecipare allo studio.
- Qualsiasi altra condizione clinica che, a giudizio dello sperimentatore, potrebbe comportare un rischio aggiuntivo per il partecipante a causa della partecipazione allo studio.
Terapia precedente/concomitante
- Storia di aver ricevuto vaccini iNTS o GMMA sperimentali nella vita del partecipante.
- Utilizzo di qualsiasi prodotto sperimentale o non registrato diverso dagli interventi in studio durante il periodo che inizia 30 giorni prima della prima dose degli interventi in studio, o loro utilizzo pianificato durante il periodo di studio.
- Somministrazione programmata/somministrazione di un vaccino non prevista dal protocollo di studio nel periodo che inizia 14 giorni prima di ciascuna dose e termina 28 giorni dopo l'ultima dose di somministrazione degli interventi di studio, ad eccezione dei vaccini antinfluenzali e dei vaccini somministrati nell'ambito di un programma di sanità pubblica campagna di vaccinazione.
Un vaccino non previsto dal protocollo di studio somministrato durante il periodo che inizia 14 giorni prima della prima dose e termina 14 giorni dopo l'ultima dose di somministrazione degli interventi di studio per i vaccini vivi o 7 giorni in caso di vaccini inattivati*, ad eccezione dell'influenza vaccini o vaccino COVID-19 che possono essere presi in considerazione caso per caso.
- Se la vaccinazione di massa di emergenza per una minaccia imprevista per la salute pubblica (ad esempio, una pandemia) è organizzata dalle autorità sanitarie pubbliche al di fuori del programma di immunizzazione di routine, il periodo di tempo sopra descritto può essere ridotto se, a condizione che venga utilizzato secondo le raccomandazioni del governo locale e dello Sponsor. viene notificato.
In tali circostanze, un partecipante può essere considerato idoneo all'iscrizione allo studio e/o alla somministrazione dell'intervento allo studio dopo che è trascorso il periodo di ritardo appropriato e i criteri di inclusione/esclusione sono stati ricontrollati e se il partecipante è confermato idoneo.
- Somministrazione di farmaci immunomodificanti a lunga azione in qualsiasi momento durante il periodo di studio.
- Somministrazione di immunoglobuline e/o eventuali prodotti sanguigni o derivati del plasma dalla nascita (per neonati di 6 settimane di età) o durante il periodo che inizia 3 mesi prima della somministrazione della prima dose dell'intervento/i dello studio o della somministrazione pianificata durante il periodo di studio.
- Somministrazione cronica (definita come più di 14 giorni in totale) di immunosoppressori o altri farmaci immunomodificanti durante il periodo che inizia 3 mesi prima della prima dose di intervento dello studio fino alla fine dello studio. Per i corticosteroidi, ciò significherà un equivalente di prednisone maggiore o uguale a (>=) 20 mg/giorno per i partecipanti adulti/>= 0,5 mg/kg/giorno con un massimo di 20 mg/giorno per i partecipanti pediatrici (neonati e bambini). Sono consentiti gli steroidi per via inalatoria e topica.
Esperienza in studi clinici precedenti/contemporanei
• Partecipazione contemporanea a un altro studio clinico, in qualsiasi momento durante il periodo di studio, in cui il partecipante è stato o sarà esposto a un intervento sperimentale o non sperimentale (vaccino, farmaco e dispositivo).
Altre esclusioni
- Femmina in gravidanza o in allattamento.
- Donne che pianificano una gravidanza o che pianificano di interrompere le precauzioni contraccettive.
- Storia di/attuale consumo cronico di alcol e/o abuso di droghe. Questo sarà deciso a discrezione dell'investigatore.
- Qualsiasi personale dello studio o persone a suo carico immediate, familiari o membri del nucleo familiare.
- Bambino in cura.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione sequenziale
- Mascheramento: Quadruplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: 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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Comparatore attivo: 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 dose di Placebo somministrata per via intramuscolare al Giorno 57 agli adulti nel gruppo Adulti_Controllo.
-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.
Altri nomi:
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Sperimentale: 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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Comparatore attivo: 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.
Altri nomi:
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Sperimentale: 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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Comparatore attivo: 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.
Altri nomi:
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Sperimentale: 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.
Altri nomi:
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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Comparatore attivo: 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 dose di vaccino DTPa-HBV-IPV+Hib somministrata per via intramuscolare al giorno 169 ai neonati nei gruppi Infants_9M_Control A, Infants_9M_Control B e Infants_9M_Control C.
Altri nomi:
-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.
Altri nomi:
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.
Altri nomi:
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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Sperimentale: 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.
Altri nomi:
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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Comparatore attivo: 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 dose di vaccino DTPa-HBV-IPV+Hib somministrata per via intramuscolare al giorno 169 ai neonati nei gruppi Infants_9M_Control A, Infants_9M_Control B e Infants_9M_Control C.
Altri nomi:
-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.
Altri nomi:
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.
Altri nomi:
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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Sperimentale: 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.
Altri nomi:
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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Comparatore attivo: 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 dose di vaccino DTPa-HBV-IPV+Hib somministrata per via intramuscolare al giorno 169 ai neonati nei gruppi Infants_9M_Control A, Infants_9M_Control B e Infants_9M_Control C.
Altri nomi:
-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.
Altri nomi:
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.
Altri nomi:
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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Sperimentale: 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.
Altri nomi:
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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Comparatore attivo: 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.
Altri nomi:
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.
Altri nomi:
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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Sperimentale: 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.
Altri nomi:
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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Comparatore attivo: 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.
Altri nomi:
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.
Altri nomi:
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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Sperimentale: 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.
Altri nomi:
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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Comparatore attivo: 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.
|
-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.
Altri nomi:
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.
Altri nomi:
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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Number of adult participants 18-50 years of age with solicited administration site events
Lasso di tempo: 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 adult participants 18-50 years of age with solicited administration site events
Lasso di tempo: 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 adult participants 18-50 years of age with solicited systemic events
Lasso di tempo: During 7 days after the first study intervention administration occurring at Day 1
|
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).
|
During 7 days after the first study intervention administration occurring at Day 1
|
|
Number of adult participants 18-50 years of age with solicited systemic events
Lasso di tempo: During 7 days after the second study intervention administration occurring at Day 57
|
The solicited systemic events are fever, headache, myalgia, arthralgia and fatigue.
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 adult participants 18-50 years of age with unsolicited adverse events (AEs)
Lasso di tempo: During 28 days after the first study intervention administration occurring at Day 1
|
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.
|
During 28 days after the first study intervention administration occurring at Day 1
|
|
Number of adult participants 18-50 years of age with unsolicited adverse events (AEs)
Lasso di tempo: 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.
|
During 28 days after the second study intervention administration occurring at Day 57
|
|
Number of adult participants 18-50 years of age with serious adverse events (SAEs)
Lasso di tempo: From first study intervention administration (Day 1) up to the end of study participation (Day 85)
|
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.
|
From first study intervention administration (Day 1) up to the end of study participation (Day 85)
|
|
Number of adult participants 18-50 years of age with adverse events (AEs) leading to withdrawal from the study or discontinuation of study intervention
Lasso di tempo: From first study intervention administration (Day 1) up to the end of study participation (Day 85)
|
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)
|
|
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
Lasso di tempo: At Day 8 (7 days after the first study intervention administration)
|
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.
|
At Day 8 (7 days after the first study intervention administration)
|
|
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
Lasso di tempo: At Day 64 (7 days after the second study intervention administration)
|
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.
|
At Day 64 (7 days after the second study intervention administration)
|
|
Number of child participants 24-59 months of age with solicited administration site events
Lasso di tempo: 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 child participants 24-59 months of age with solicited administration site events
Lasso di tempo: 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 child participants 24-59 months of age with solicited systemic events
Lasso di tempo: 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 child participants 24-59 months of age with solicited systemic events
Lasso di tempo: 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 child participants 24-59 months of age with unsolicited AEs
Lasso di tempo: 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 child participants 24-59 months of age with unsolicited AEs
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: At Day 64 (7 days after the second study intervention administration)
|
At Day 64 (7 days after the second study intervention administration)
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Concentrazioni medie geometriche (GMC) di immunoglobulina G (IgG) sierotipo specifico anti-invasivo per Salmonella non tifoidea (iNTS) in partecipanti adulti di età compresa tra 18 e 50 anni
Lasso di tempo: Ai Giorni 1 e 57 (prima di ciascuna somministrazione dell'intervento in studio) e ai Giorni 29 e 85 (28 giorni dopo ciascuna somministrazione dell'intervento in studio)
|
Anti-S.
Typhimurium OAg IgG totali e anti-S.
Vengono valutate le GMC IgG totali di Enteritidis OAg.
|
Ai Giorni 1 e 57 (prima di ciascuna somministrazione dell'intervento in studio) e ai Giorni 29 e 85 (28 giorni dopo ciascuna somministrazione dell'intervento in studio)
|
|
Concentrazioni medie geometriche (GMC) di immunoglobulina G (IgG) sierotipo specifico anti-invasivo per Salmonella non tifoidea (iNTS) nei bambini partecipanti di età compresa tra 24 e 59 mesi
Lasso di tempo: Ai Giorni 1 e 57 (prima di ciascuna somministrazione dell'intervento in studio) e ai Giorni 29 e 85 (28 giorni dopo ciascuna somministrazione dell'intervento in studio)
|
Anti-S.
Typhimurium OAg IgG totali e anti-S.
Vengono valutate le GMC IgG totali di Enteritidis OAg.
|
Ai Giorni 1 e 57 (prima di ciascuna somministrazione dell'intervento in studio) e ai Giorni 29 e 85 (28 giorni dopo ciascuna somministrazione dell'intervento in studio)
|
|
Concentrazioni medie geometriche (GMC) di immunoglobulina G (IgG) sierotipo specifico anti-invasivo per Salmonella non tifoidea (iNTS) nei partecipanti neonati di 9 mesi di età
Lasso di tempo: Ai giorni 1, 85 e 169 (prima di ogni somministrazione di intervento in studio) e ai giorni 29, 113 e 197 (28 giorni dopo ogni somministrazione di intervento in studio)
|
Anti-S.
Typhimurium OAg IgG totali e anti-S.
Vengono valutate le GMC IgG totali di Enteritidis OAg.
|
Ai giorni 1, 85 e 169 (prima di ogni somministrazione di intervento in studio) e ai giorni 29, 113 e 197 (28 giorni dopo ogni somministrazione di intervento in studio)
|
|
Concentrazioni medie geometriche (GMC) di immunoglobulina G (IgG) sierotipo specifico anti-invasivo per Salmonella non tifoidea (iNTS) nei neonati partecipanti di 6 settimane di età
Lasso di tempo: Ai giorni 1, 57 e 232 (prima di ogni somministrazione dell'intervento di studio) ai giorni 29, 85 e 260 (28 giorni dopo ogni somministrazione dell'intervento di studio) e al giorno 239 (7 giorni dopo la terza somministrazione dell'intervento di studio)
|
Anti-S.
Typhimurium OAg IgG totali e anti-S.
Vengono valutate le GMC IgG totali di Enteritidis OAg.
|
Ai giorni 1, 57 e 232 (prima di ogni somministrazione dell'intervento di studio) ai giorni 29, 85 e 260 (28 giorni dopo ogni somministrazione dell'intervento di studio) e al giorno 239 (7 giorni dopo la terza somministrazione dell'intervento di studio)
|
|
Number of infant participants 6 weeks of age with solicited administration site events
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Collaboratori
Investigatori
- Direttore dello studio: GSK Clinical Trials, GlaxoSmithKline
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
15 gennaio 2024
Completamento primario (Effettivo)
6 agosto 2026
Completamento dello studio (Effettivo)
6 agosto 2026
Date di iscrizione allo studio
Primo inviato
19 dicembre 2023
Primo inviato che soddisfa i criteri di controllo qualità
18 gennaio 2024
Primo Inserito (Effettivo)
19 gennaio 2024
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
2 settembre 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
31 agosto 2026
Ultimo verificato
1 agosto 2026
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Infezioni
- Infezioni batteriche
- Infezioni batteriche e micosi
- Infezioni batteriche Gram-negative
- Infezioni da Enterobatteriacee
- Infezioni da salmonella
- Prodotti biologici
- Miscele complesse
- Vaccini batterici
- Vaccini
- Vaccini virali
- Vaccini meningococcici
- Minaccia
- Difterite-tetanus-Acellulare pertosse-inattivato Poliovirus-Haemophilus influenzae B Coniugato-epatite B Vccano
- Vaccino contro la febbre gialla
- Vaccino contro la rosolia
Altri numeri di identificazione dello studio
- 217218
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
SÌ
Descrizione del piano IPD
L'IPD per questo studio sarà reso disponibile tramite il sito di richiesta dei dati dello studio clinico.
Periodo di condivisione IPD
L'IPD sarà reso disponibile entro 6 mesi dalla pubblicazione dei risultati degli endpoint primari, degli endpoint secondari chiave e dei dati di sicurezza dello studio.
Criteri di accesso alla condivisione IPD
L'accesso viene fornito dopo che una proposta di ricerca è stata presentata e ha ricevuto l'approvazione da parte del comitato di revisione indipendente e dopo che è stato stipulato un accordo di condivisione dei dati.
L'accesso è previsto per un periodo iniziale di 12 mesi ma può essere concessa una proroga, ove motivata, fino ad altri 12 mesi.
Tipo di informazioni di supporto alla condivisione IPD
- STUDIO_PROTOCOLLO
- LINFA
- ICF
- RSI
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
prodotto fabbricato ed esportato dagli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .