성인, 소아 및 유아의 이질에 대한 GVGH altSonflex1-2-3 백신의 안전성 및 면역반응에 관한 연구
2026년 6월 18일 업데이트: GlaxoSmithKline
S. Sonnei 및 S. Flexneri, 혈청형 1b, 2a에 대한 GVGH altSonflex1-2-3 백신에 대한 안전성, 반응성 및 면역 반응을 평가하기 위한 단계적 I/II 관찰자 맹검, 무작위, 통제, 다국가 연구 , 및 3a, 유럽의 성인(1단계)에 이어 성인에서 어린이 및 유아로의 연령 축소, 아프리카의 유아에서 선량 찾기(2단계)
현재 임상 연구의 목적은 S. sonnei 및 S. flexneri 혈청형 1b, 2a 및 3a에 대한 altSonflex1-2-3 후보 백신의 안전성과 면역원성을 인간(FTIH)에서 처음으로 평가하는 것입니다.
이 백신은 유럽에서 18세에서 50세 사이의 성인에게 처음으로 투여될 것입니다.
그 후, 이 백신은 아프리카의 세균성 이질 발병 집단에 처음에는 18세에서 50세 사이의 성인, 그 다음에는 24개월에서 59개월 사이의 어린이, 마지막으로 9개월 된 유아에게 투여될 것입니다.
영유아도 3차 예방접종을 받습니다.
세 가지 다른 용량의 백신[항원의 저(용량 A), 중간(용량 B) 및 높은(용량 C) 양]은 연령 축소 접근법(가장 취약한 성인 인구에서 가장 취약한 소아 인구까지)을 사용하여 평가됩니다. ).
이 연구의 결과는 이 백신의 주요 대상 연령 그룹인 생후 9개월 유아의 추가 백신 개발을 위한 가장 적절한 용량을 선택할 수 있게 할 것입니다.
연구 개요
상태
완전한
정황
연구 유형
중재적
등록 (실제)
551
단계
- 2 단계
- 1단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
9개월 (어린이, 성인)
건강한 자원 봉사자를 받아들입니다
예
설명
포함 기준:
모든 참가자:
• 참가자 및/또는 참가자의 부모/법적으로 허용되는 대리인 LAR(들)은 조사자의 의견에 따라 프로토콜의 요구 사항을 준수할 수 있고 준수할 것입니다(예: 다이어리 카드 작성, 후속 방문을 위해 반환).
- 연구 특정 절차를 수행하기 전에 참가자/부모(들)/참가자의 LAR(들)로부터 얻은 서면 또는 목격자/엄지손가락으로 인쇄된 정보에 입각한 동의서.
- 병력, 임상 검사 및 실험실 평가에 의해 확립된 건강한 참가자.
- 모든 심사 요건을 충족하는 참가자.
- B형 간염 및 C형 간염에 대해 혈청 음성인 참가자.
- 인간 백혈구 항원 B27(HLA-B27)에 대해 음성인 참가자.
18세에서 50세 사이의 성인:
- 첫 번째 연구 개입 투여 시점에 18세에서 50세 사이의 남성 또는 여성.
- 가임 가능성이 있는 여성 참여자는 연구에 등록할 수 있습니다. 비가임 가능성은 초경 전, 현재 양측 난관 결찰 또는 폐색, 자궁절제술, 양측 난소절제술 또는 폐경 후로 정의됩니다.
- 가임 여성 참가자는 참가자가 다음과 같은 경우 연구에 등록할 수 있습니다.
- 연구 중재 투여 전 1개월 동안 적절한 피임법을 실천했으며,
- 연구 개입 투여 당일에 임신 테스트 결과가 음성이고,
- 전체 치료 기간 동안 및 연구 중재 투여 시리즈 완료 후 1개월 동안 적절한 피임법을 지속하기로 동의했습니다.
- 인간 면역결핍 바이러스(HIV)에 대한 혈청음성 참가자.
24~59개월 어린이:
- 첫 번째 백신 접종 시점에 24개월에서 59개월 사이의 남성 또는 여성.
- 정상적인 영양 Z 점수(-2 표준 편차 이상).
- 참여자의 부모(들)/LAR(들)에 대한 최선의 지식으로 이전에 완료한 일상적인 아동기 예방 접종.
- 임신 기간 ≥37주 후에 태어났습니다.
- 참가자는 HIV에 대해 혈청 음성입니다.
생후 9개월 유아:
- 1차 접종 당시 생후 9개월령의 수컷 또는 암컷.
- 정상적인 영양 Z 점수(-2 표준 편차 이상).
- 참여자의 부모(들)/LAR(들)에 대한 최선의 지식으로 이전에 완료한 일상적인 아동기 예방 접종.
- 임신 기간 ≥37주 후에 태어났습니다.
- 참가자는 디옥시리보핵산(DNA) 폴리머라제 연쇄 반응(PCR) 테스트에서 확인된 HIV 음성입니다.
제외 기준:
모든 참가자:
• 참가자와의 면담 중에 확인되거나 환자 기록(예: 미생물학적으로 확인된 이질균 감염 이력)에 의해 확인된 참가자의 일생 동안 알려진 이질균 노출, 이질균 또는 기타 장염이 발생한 국가로의 최근 여행*(2년 이내) 감염은 시겔라 종과 관련된 풍토병이거나 최근 직업*(3년 이내)입니다.
여행 또는 직업으로 인한 제외는 유럽에서 18세에서 50세 사이의 성인에게만 적용됩니다(1단계).
• 진행성, 불안정성 또는 통제되지 않는 임상 상태.
• 연구 백신의 구성 요소에 의해 악화될 가능성이 있는 반응 또는 과민증의 병력(알려지거나 의심됨).
• 병력 및 신체 검사를 기반으로 확인되거나 의심되는 면역억제 또는 면역결핍 상태(검사실 검사가 필요하지 않음).
• 이 연구에서 사용이 예상되는 의약품 또는 의료 장비에 대한 알레르기를 포함한 과민성.
- IM 백신 접종 및 혈액 채취에 대한 금기 사항을 나타내는 임상 조건.
- 조사자의 의견에 따라 연구에 참여하는 참가자의 능력을 방해할 수 있는 모든 행동 또는 인지 장애 또는 정신 질환.
- 등록 당시의 급성 질환 및/또는 발열(체온 ≥ 38.0°C로 정의됨)*.
참가자는 급성 질환 및/또는 열이 해결된 시점에 여전히 연구에 등록할 수 있습니다.
• 임상적으로 의미 있는 모든 혈액학적 및/또는 생화학적 실험실 이상.
- 연구 백신을 처음 투여하기 30일 전부터 시작하는 기간(-30일에서 1일) 동안 COVID-19 검사에서 양성으로 확인되었습니다.
- 연구자의 의견에 따라 연구 참여로 인해 참여자에게 추가적인 위험을 초래할 수 있는 기타 모든 임상 상태.
- 연구 기간 동안 언제든지 지속형 면역 조절 약물의 투여(예: 인플릭시맙).
- 실험용 이질균 백신 또는 살아있는 이질균 챌린지의 사전 수령.
- 연구 개입의 첫 번째 투여 전 30일 동안 시작하는 기간(-30일에서 1일) 동안 연구 백신 이외의 모든 연구 또는 미등록 제품(약물, 백신 또는 의료 기기)*의 사용 또는 공부 기간.
허브 및 전통 치료법의 사용은 제외 기준으로 간주되지 않습니다.
• 첫 번째 투여 전 -21일(생백신의 경우 -28일)부터 연구 중재 투여의 마지막 투여 후 끝나는 기간 동안 투여된 연구 프로토콜에 의해 예상되지 않은* 백신.**.
프로토콜에서 허용하는 백신에는 모든 참가자의 독감 및 COVID-19 백신과 어린이 및 유아의 EPI 백신이 포함됩니다.
긴급 대량 접종의 경우 상기 기간을 단축할 수 있다.
- 참가자가 연구 또는 비연구 개입(약물 또는 침습적 의료 기기)에 노출되었거나 노출될 예정인 연구 기간 중 언제든지 다른 임상 연구에 동시에 참여.
- 모든 연구 인력 또는 직계 부양가족, 가족 또는 가족 구성원.
18세에서 50세 사이의 성인:
- 급성 또는 만성 질환, 임상적으로 유의한 폐, 심혈관, 간 또는 신장 기능 이상(신체 검사 또는 검사실 선별 검사에 의해 결정됨).
- 첫 번째 백신 연구 개입 전 3개월이 시작되는 기간 동안 면역억제제 또는 기타 면역 조절 약물의 만성 투여(총 14일 이상으로 정의). 코르티코스테로이드의 경우 이는 성인 참가자의 경우 프레드니손 등가물이 ≥20mg/일임을 의미합니다. 흡입 및 국소 스테로이드가 허용됩니다.
- 임신 또는 수유중인 여성.
- 임신을 계획 중이거나 피임 예방 조치를 중단할 계획인 여성.
- 만성 알코올 소비 및/또는 약물 남용의 병력 또는 현재.
18~50세 성인 및 24~59개월 어린이:
• 면역글로불린 및/또는 모든 혈액 제제 또는 혈장 유도체의 투여, 또는 골수 이식, 첫 번째 연구 백신 투여 전 3개월 동안 시작하거나 연구 기간 동안 계획된 투여.
24~59개월 어린이 및 9개월 유아:
- 신체 검사 또는 실험실 선별 검사에 의해 결정된 급성 또는 만성 임상적으로 유의한 폐, 심혈관, 간 또는 신장 기능 이상.
- 1차 접종 3개월 전부터 면역억제제 또는 기타 면역조절약물을 만성적으로 투여(총 14일 이상)한 경우. 코르티코스테로이드의 경우 이는 프레드니손 ≥0.5mg/kg/일 또는 20mg/일 중 소아 참여자의 최대 용량을 의미합니다. 흡입 및 국소 스테로이드가 허용됩니다.
- 돌보고 있는 아이.
생후 9개월 유아:
• 태어날 때부터 면역글로불린 및/또는 모든 혈액 제제 또는 혈장 유도체 또는 골수 이식의 투여 또는 연구 기간 동안 계획된 투여.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 순차적 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 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).
|
2 doses in adults 18-50 years of age and children 24-59 months of age, 3 doses in infants 9 months of age
|
|
실험적: 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).
|
2 doses in adults 18-50 years of age and children 24-59 months of age, 3 doses in infants 9 months of age
|
|
위약 비교기: 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.
|
2 doses in adults 18-50 years of age (stage 1)
|
|
실험적: 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).
|
2 doses in adults 18-50 years of age and children 24-59 months of age, 3 doses in infants 9 months of age
|
|
활성 비교기: 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.
|
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)
|
|
실험적: 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).
|
2 doses in children 24-59 months of age, 3 doses in infants 9 months of age
|
|
실험적: 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).
|
2 doses in adults 18-50 years of age and children 24-59 months of age, 3 doses in infants 9 months of age
|
|
활성 비교기: 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.
|
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
|
|
실험적: 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).
|
3 doses in infants 9 months of age
2 doses in children 24-59 months of age
|
|
실험적: 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).
|
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
|
|
실험적: 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
|
|
활성 비교기: 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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실험적: 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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실험적: 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).
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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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실험적: 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).
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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
2 doses in children 24-59 months of age
|
|
활성 비교기: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
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
기간: At Day 281 (28 days after the third study intervention)
|
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
기간: Within 7 days after each study intervention (administered at Day 1, Day 85 and Day 169 [depending on the vaccination schedule])
|
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
기간: Within 7 days after each study intervention (administered at Day 1, Day 85 and Day 169 [depending on the vaccination schedule])
|
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])
|
|
Stage 1: Number of Participants 18 to 50 Years of Age in Europe With Unsolicited Adverse Events (AEs)
기간: Within 28 days after each study intervention (administered at at Day 1, Day 85 and Day 169 [depending on the vaccination schedule])
|
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)
기간: From Day 1 to Day 113 and/or Day 197
|
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
기간: At Day 8
|
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
기간: 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)
|
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)
|
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Stage 2: Number of Participants 18 to 50 Years of Age in Africa With Solicited Administration Site Events
기간: 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.
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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
기간: 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.
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Within 7 days after each study intervention (administered at Day 1 and Day 85)
|
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Stage 2: Number of Participants 18 to 50 Years of Age in Africa With Unsolicited Adverse Events (AEs)
기간: 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)
|
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Stage 2: Number of Participants 18 to 50 Years of Age in Africa With Serious Adverse Events (SAEs)
기간: 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.
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From Day 1 to Day 113
|
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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
기간: 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.
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At Day 8
|
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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
기간: 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.
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At Day 92
|
|
Stage 2: Number of Participants 24 to 59 Months of Age in Africa With Solicited Administration Site Events
기간: 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
기간: 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)
기간: 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)
기간: 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.
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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
기간: 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
기간: 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.
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At Day 92
|
|
Stage 2: Number of Participants 9 Months of Age in Africa With Solicited Administration Site Events - Infants Safety Cohort
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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.
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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
기간: 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
기간: 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
기간: 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
기간: 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.
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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
기간: 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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Stage 1: Anti-serotype Specific Shigella LPS/OAg Serum IgG GMCs in Participants 18 to 50 Years of Age in Europe
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)
|
|
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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
기간: 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)
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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)
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|
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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
기간: 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)
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|
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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
기간: 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
기간: 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)
|
|
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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
기간: 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
기간: 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)
|
|
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Stage 2: Anti-measles IgG Concentrations in Participants 9 Months of Age in the Dose-finding Cohort
기간: 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)
|
|
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Stage 2: Anti-rubella IgG Concentrations in Participants 9 Months of Age in the Dose-finding Groups
기간: 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)
|
|
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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
기간: 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
기간: Day 281 (28 days after the second MR-VAC administration)
|
Day 281 (28 days after the second MR-VAC administration)
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
수사관
- 연구 책임자: GSK Clinical Trials, GlaxoSmithKline
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2021년 10월 6일
기본 완료 (실제)
2025년 6월 24일
연구 완료 (실제)
2025년 6월 24일
연구 등록 날짜
최초 제출
2021년 9월 29일
QC 기준을 충족하는 최초 제출
2021년 9월 29일
처음 게시됨 (실제)
2021년 10월 11일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 6월 22일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 6월 18일
마지막으로 확인됨
2026년 6월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 212149
- 2021-000891-12 (EudraCT 번호)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
이 연구에 대한 IPD는 임상 연구 데이터 요청 사이트를 통해 제공됩니다.
IPD 공유 기간
IPD는 연구의 1차 종점, 주요 2차 종점 및 안전성 데이터의 결과를 발표한 후 6개월 이내에 제공될 예정입니다.
IPD 공유 액세스 기준
액세스는 연구 제안서가 제출되고 독립 검토 패널의 승인을 받은 후 데이터 공유 계약이 체결된 후에 제공됩니다.
액세스는 초기 12개월 동안 제공되지만 정당한 경우 최대 12개월까지 연장할 수 있습니다.
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- ICF
- CSR
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
미국에서 제조되어 미국에서 수출되는 제품
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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