성인, 소아 및 영유아를 대상으로 침습성 비장티푸스성 살모넬라균에 대한 GVGH iNTS-GMMA 백신의 안전성, 반응성 및 면역반응에 관한 연구
2026년 8월 31일 업데이트: GlaxoSmithKline
성인, 아동 및 성인에서 S. Typhimurium 및 S. Enteritidis에 대한 GVGH iNTS 백신의 안전성, 반응성 및 면역 반응을 평가하기 위한 제2a상 관찰자 맹검, 무작위, 대조, 연령 단계적 확대, 단일 센터 중재 연구 아프리카의 유아 용량 측정을 포함한 유아
이 연구의 목적은 S. Typhimurium에 대한 GlaxoSmithKline(GSK) 세계 보건 백신 연구소(GVGH) 막 항원에 대한 침습성 비장티푸스성 살모넬라 일반화 모듈(iNTS-GMMA) 후보 백신의 안전성, 반응성 및 면역 반응을 평가하는 것입니다. S. Enteritidis는 성인(18~50세)부터 시작하여 어린이(24~59개월), 마지막으로 유아(9개월 및 6개월)까지 아프리카 인구의 연령 감소 및 용량 증가 접근법을 사용합니다. 주).
영유아는 생후 6주부터 1차 접종 대상입니다.
연구 개요
상태
완전한
정황
상세 설명
연구는 두 단계로 진행됩니다:
1단계: 성인에서 아동 및 유아로의 연령 하향화
- 성인 참가자는 1일차와 57일차에 iNTS-GMMA 용량 C(고) 또는 대조 백신을 근육 내로 투여받게 됩니다.
- 어린이 참가자는 1일차와 57일차에 후보 백신의 투여량 B(중간) 또는 투여량 C(고) 또는 대조군을 투여받게 됩니다.
- 유아 참가자(9개월)는 1일차, 85일차, 169일차에 후보 백신의 용량 A(낮음), 용량 B(중간), 용량 C(높음) 또는 대조군을 투여받게 됩니다.
- 유아 참가자(6주령)는 1일차, 85일차(프라이밍 단계) 및 232일차에 후보 백신 또는 대조군의 용량 A(낮음), 용량 B(중간) 또는 용량 C(높음)를 투여받게 됩니다. (부스터 단계).
2단계: 생후 6주 영아의 용량 측정
-유아(6주령)는 1일차, 85일차에 후보 백신 또는 대조군의 세 가지 용량 수준(용량 A(낮음), 용량 B(중간) 또는 용량 C(높음)) 중 하나를 투여받게 됩니다( 프라이밍 단계) 및 232일차(부스터 단계).
연구 유형
중재적
등록 (실제)
183
단계
- 2 단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Kumasi, 가나
- GSK Investigational Site
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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
- 어린이
- 성인
건강한 자원 봉사자를 받아들입니다
예
설명
포함 기준:
모든 참가자(성인, 어린이, 9개월된 유아 및 6주된 유아)는 가나의 임상 현장에 등록되며 연구 시작 시 다음 기준을 모두 충족해야 합니다.
- 조사관의 의견에 따라 프로토콜의 요구 사항(예: 일기 카드 작성, 반환)을 준수할 수 있고 준수할 참가자 및/또는 참가자의 부모/법적으로 허용되는 대리인(LAR) 후속 방문을 위해).
- 연구별 절차를 수행하기 전에 참가자/부모/LAR로부터 얻은 서면 또는 증인/엄지 인쇄 사전 동의.
- 병력, 임상 검사 및 실험실 조사를 통해 확립된 건강한 참가자.
- 심사 요건을 충족하는 참가자.
- 참가자는 인간 면역결핍 바이러스(HIV), B형 간염, C형 간염에 음성입니다.
성인 참가자는 연구 시작 시 다음 기준을 모두 충족해야 합니다.
- 첫 번째 연구 개입 투여 당시 18세에서 50세 사이의 남성 또는 여성.
- 가임 가능성이 없는 여성 참가자도 연구에 등록할 수 있습니다. 비임신 가능성은 초경 전, 현재 양측 난관 결찰 또는 폐색, 자궁 적출술, 양측 난소 절제술 또는 폐경 후로 정의됩니다.
- 가임기 여성 참가자는 다음과 같은 경우 연구에 등록할 수 있습니다.
연구 개입 투여 전 1개월 동안 적절한 피임법을 실천했으며,
- 연구 중재 투여 당일에 임신 테스트 결과 음성이었으며,
- 전체 치료 기간 동안 그리고 일련의 연구 개입 투여 완료 후 1개월 동안 적절한 피임법을 계속하기로 동의했습니다.
가나 카드는 성인의 연령을 확인하기 위한 원본 문서로 사용됩니다.
아동 참가자는 연구 시작 시 다음 기준을 모두 충족해야 합니다.
- 첫 번째 연구 개입 투여 당시 24개월에서 59개월 사이의 남성 또는 여성.
- 참가자의 부모/LAR이 아는 바에 따라 이전에 정기 아동 예방접종을 완료했습니다.
- 37주 이상의 임신 기간을 거친 후 출생합니다.
유아 참가자는 연구 시작 시 다음 기준을 모두 충족해야 합니다.
- 첫 번째 연구 개입 투여 당시 생후 6주 또는 9개월된 남성 또는 여성.
- 37주 이상의 임신 기간을 거친 후 출생합니다.
- HIV, B형 간염 바이러스, C형 간염 바이러스에 대한 혈청 음성인 어머니에게서 태어났습니다.
Road to Health Chart는 어린이와 유아의 연령을 확인하기 위한 원본 문서로 사용됩니다.
제외 기준:
질병
- 환자 기록에 기록된 바와 같이 영유아의 경우 출생 후부터, 성인의 경우 3세에 S. Typhimurium 또는 S. Enteritidis에 노출된 것으로 알려졌습니다.
- 연구 개입의 모든 구성요소에 의해 악화될 가능성이 있는 반응 또는 과민증의 병력.
- 본 연구에서 사용이 예상되는 의약품 또는 의료 장비에 대한 알레르기를 포함한 과민증.
- 진행성, 불안정성 또는 통제되지 않는 임상 상태.
- 병력 및 신체 검사를 토대로 확인되거나 의심되는 면역억제 또는 면역결핍 상태
- 연구자가 평가한 주요 선천적 결함.
- 신체 검사 또는 실험실 선별 검사를 통해 결정된 급성 또는 만성 임상적으로 유의미한 폐, 심혈관, 간 또는 신장 기능 이상.
- 등록 당시 급성 질환 및/또는 발열(발열은 체온 ≥ 38.0°C로 정의됨).
- 재발성 병력 또는 조절되지 않는 신경학적 장애 또는 발작.
- 임상적으로 유의미한 혈액학적 및/또는 생화학적 실험실 이상.
- 영양결핍은 WHO Z-점수가 -2 SD 미만으로 정의됩니다.
- 말라리아 감염은 혈액에 무성 기생충이 존재하는 것으로 정의됩니다.
- 근육 주사 및 채혈에 대한 금기를 나타내는 임상 조건.
- 연구자의 의견으로 참가자의 연구 참여 능력을 방해할 수 있는 모든 행동 또는 인지 장애 또는 정신 질환.
- 연구자의 의견으로 연구 참여로 인해 참가자에게 추가적인 위험을 초래할 수 있는 기타 임상 상태.
이전/병용 치료
- 참가자의 생애 동안 시험용 iNTS 또는 GMMA 백신을 접종한 이력.
- 연구 중재의 첫 번째 투여 전 30일부터 시작하는 기간 동안 연구 중재 이외의 연구용 또는 미등록 제품의 사용 또는 연구 기간 동안 계획된 사용.
- 독감 백신 및 공중 보건의 일환으로 투여되는 백신을 제외하고, 매 투여 전 14일부터 시작하여 연구 중재 투여의 마지막 투여 후 28일까지 종료되는 기간에 연구 계획서에서 예견되지 않은 백신의 계획된 투여/투여 예방접종 캠페인.
생백신의 경우 첫 번째 투여 전 14일부터 마지막 투여 후 14일까지, 불활성화 백신*의 경우 7일 동안 투여되는 연구 프로토콜에서 예측되지 않은 백신(독감 제외) 백신 또는 사례별로 고려될 수 있는 코로나19 백신.
- 예상치 못한 공중 보건 위협(예: 전염병)에 대한 긴급 대량 예방 접종이 공중 보건 당국에 의해 정기 예방 접종 프로그램 외부에서 조직되는 경우, 위에 설명된 기간은 지방 정부 권장 사항 및 후원자에 따라 사용되는 경우 단축될 수 있습니다. 통보됩니다.
이러한 상황에서 참가자는 적절한 지연 기간이 지나고 포함/제외 기준을 다시 확인한 후 참가자가 적격하다고 확인되면 연구 등록 및/또는 연구 중재 시행에 적격한 것으로 간주될 수 있습니다.
- 연구 기간 중 언제든지 지속성 면역조절 약물을 투여합니다.
- 면역글로불린 및/또는 혈액 제제 또는 혈장 파생물을 출생 시(생후 6주령 유아의 경우) 또는 첫 번째 연구 중재 투여 전 3개월부터 시작하는 기간 동안 또는 연구 기간 중 계획된 투여를 통해 투여합니다.
- 첫 번째 연구 중재 용량 이전 3개월부터 연구가 종료될 때까지의 기간 동안 면역억제제 또는 기타 면역조절 약물을 만성적으로 투여(총 14일 이상으로 정의)합니다. 코르티코스테로이드의 경우 이는 성인 참가자의 경우 20mg/일 이상(>=) 프레드니손/소아 참가자(유아 및 어린이)의 경우 최대 20mg/일, >= 0.5mg/kg/일을 의미합니다. 흡입 및 국소 스테로이드가 허용됩니다.
이전/현재 임상 연구 경험
• 연구 기간 중 언제라도 다른 임상 연구에 동시에 참여하며 참가자는 연구 또는 비연구 개입(백신, 약물 및 장치)에 노출되었거나 노출될 예정입니다.
기타 제외
- 임신 또는 수유중인 여성.
- 임신을 계획하고 있거나 피임 예방조치를 중단할 계획을 갖고 있는 여성.
- 만성 알코올 소비 및/또는 약물 남용의 병력/현재. 이는 조사관의 판단에 따라 결정됩니다.
- 모든 연구 인력 또는 직계 부양가족, 가족 또는 가족 구성원.
- 보살핌을 받는 아이.
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 |
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실험적: 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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활성 비교기: 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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성인_대조군의 성인에게 57일차에 위약 1회 용량을 근육내 투여했습니다.
-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.
다른 이름들:
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실험적: 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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활성 비교기: 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.
다른 이름들:
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실험적: 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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활성 비교기: 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.
다른 이름들:
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실험적: 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.
다른 이름들:
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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활성 비교기: 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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DTPa-HBV-IPV+Hib 백신 1회 용량을 Infants_9M_Control A, Infants_9M_Control B 및 Infants_9M_Control C 그룹의 유아에게 169일차에 근육 내 투여합니다.
다른 이름들:
-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.
다른 이름들:
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.
다른 이름들:
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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실험적: 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.
다른 이름들:
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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활성 비교기: 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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DTPa-HBV-IPV+Hib 백신 1회 용량을 Infants_9M_Control A, Infants_9M_Control B 및 Infants_9M_Control C 그룹의 유아에게 169일차에 근육 내 투여합니다.
다른 이름들:
-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.
다른 이름들:
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.
다른 이름들:
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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실험적: 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.
다른 이름들:
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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활성 비교기: 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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DTPa-HBV-IPV+Hib 백신 1회 용량을 Infants_9M_Control A, Infants_9M_Control B 및 Infants_9M_Control C 그룹의 유아에게 169일차에 근육 내 투여합니다.
다른 이름들:
-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.
다른 이름들:
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.
다른 이름들:
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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실험적: 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.
다른 이름들:
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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활성 비교기: 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.
다른 이름들:
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.
다른 이름들:
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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실험적: 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.
다른 이름들:
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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활성 비교기: 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.
다른 이름들:
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.
다른 이름들:
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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실험적: 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.
다른 이름들:
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.
|
|
활성 비교기: 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.
다른 이름들:
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.
다른 이름들:
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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Number of adult participants 18-50 years of age with solicited administration site events
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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)
기간: 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
|
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Number of adult participants 18-50 years of age with serious adverse events (SAEs)
기간: 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.
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From first study intervention administration (Day 1) up to the end of study participation (Day 85)
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Number of adult participants 18-50 years of age with adverse events (AEs) leading to withdrawal from the study or discontinuation of study intervention
기간: From first study intervention administration (Day 1) up to the end of study participation (Day 85)
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An AE is any untoward medical occurrence (an unfavorable/unintended sign - including an abnormal laboratory finding), symptom, or disease (new or exacerbated) in a clinical study participant that is temporally associated with the study intervention.
The AE may or may not be considered related to the study intervention.
Any AEs that lead to discontinuation of study intervention and/or the study are considered under this outcome measure.
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From first study intervention administration (Day 1) up to the end of study participation (Day 85)
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Number of adult participants 18-50 years of age with deviations from reference ranges or baseline values for hematological, renal and hepatic panel test results
기간: At Day 8 (7 days after the first study intervention administration)
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Clinically significant abnormal laboratory findings are those which are not associated with an underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition.
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At Day 8 (7 days after the first study intervention administration)
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Number of adult participants 18-50 years of age with deviations from reference ranges or baseline values for hematological, renal and hepatic panel test results
기간: 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)
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Number of child participants 24-59 months of age with solicited administration site events
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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
기간: At Day 64 (7 days after the second study intervention administration)
|
At Day 64 (7 days after the second study intervention administration)
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
18~50세 성인 참가자의 항침습적 비장티푸스성 살모넬라(iNTS) 혈청형 특이적 면역글로불린 G(IgG) 기하평균농도(GMC)
기간: 1일과 57일(각 연구 중재 투여 전) 및 29일과 85일(각 연구 중재 투여 후 28일)
|
안티S.
Typhimurium OAg 총 IgG 및 항-S.
Enteritidis OAg 총 IgG GMC가 평가됩니다.
|
1일과 57일(각 연구 중재 투여 전) 및 29일과 85일(각 연구 중재 투여 후 28일)
|
|
24~59개월 어린이 참가자의 항침습적 비장티푸스성 살모넬라(iNTS) 혈청형 특이적 면역글로불린 G(IgG) 기하 평균 농도(GMC)
기간: 1일과 57일(각 연구 중재 투여 전) 및 29일과 85일(각 연구 중재 투여 후 28일)
|
안티S.
Typhimurium OAg 총 IgG 및 항-S.
Enteritidis OAg 총 IgG GMC가 평가됩니다.
|
1일과 57일(각 연구 중재 투여 전) 및 29일과 85일(각 연구 중재 투여 후 28일)
|
|
9개월 된 유아 참가자의 항침습적 비장티푸스성 살모넬라(iNTS) 혈청형 특이 면역글로불린 G(IgG) 기하 평균 농도(GMC)
기간: 1일차, 85일 및 169일차(각 연구 중재 투여 전) 및 29일차, 113일 및 197일차(각 연구 중재 투여 후 28일)
|
안티S.
Typhimurium OAg 총 IgG 및 항-S.
Enteritidis OAg 총 IgG GMC가 평가됩니다.
|
1일차, 85일 및 169일차(각 연구 중재 투여 전) 및 29일차, 113일 및 197일차(각 연구 중재 투여 후 28일)
|
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6주령 유아 참가자의 항침습적 비장티푸스성 살모넬라(iNTS) 혈청형 특이적 면역글로불린 G(IgG) 기하 평균 농도(GMC)
기간: 1일, 57일 및 232일(각 연구 중재 투여 전) 29일, 85일 및 260일(각 연구 중재 투여 후 28일) 및 239일(3차 연구 중재 투여 후 7일)
|
안티S.
Typhimurium OAg 총 IgG 및 항-S.
Enteritidis OAg 총 IgG GMC가 평가됩니다.
|
1일, 57일 및 232일(각 연구 중재 투여 전) 29일, 85일 및 260일(각 연구 중재 투여 후 28일) 및 239일(3차 연구 중재 투여 후 7일)
|
|
Number of infant participants 6 weeks of age with solicited administration site events
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
협력자
수사관
- 연구 책임자: GSK Clinical Trials, GlaxoSmithKline
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)
2024년 1월 15일
기본 완료 (실제)
2026년 8월 6일
연구 완료 (실제)
2026년 8월 6일
연구 등록 날짜
최초 제출
2023년 12월 19일
QC 기준을 충족하는 최초 제출
2024년 1월 18일
처음 게시됨 (실제)
2024년 1월 19일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 9월 2일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 8월 31일
마지막으로 확인됨
2026년 8월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 217218
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
본 연구의 IPD는 임상 연구 데이터 요청 사이트를 통해 제공됩니다.
IPD 공유 기간
IPD는 연구의 1차 평가변수, 주요 2차 평가변수 및 안전성 데이터의 결과를 발표한 후 6개월 이내에 제공될 예정입니다.
IPD 공유 액세스 기준
연구 제안서를 제출하고 독립 검토 패널로부터 승인을 받은 후, 데이터 공유 계약이 체결된 후에 액세스가 제공됩니다.
액세스는 처음 12개월 동안 제공되지만 정당한 경우 최대 12개월까지 연장이 허용될 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. .