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임상시험 NCT07074665은(는) Malaria (Plasmodium Falciparum)에 대해 대상자모집전 상태입니다. 모든 세부 정보를 보려면 임상시험 레이더 카드 뷰와 AI 발견 도구를 확인하거나 여기에서 무엇이든 물어보세요. | ||
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옥스퍼드 대학교Dose Finding Trial of R21/Matrix-M in School Children
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임상시험 NCT07074665은(는) 예방을(를) 알아보기 위한 연구입니다. 이 연구는 Malaria (Plasmodium Falciparum)에 대해 진행되며, 2상 중재연구으로 현재 상태는 대상자모집전입니다. 참여 신청은 2025년 10월 1일부터 가능하며, 40명의 참여자를 모집할 예정입니다. 옥스퍼드 대학교이(가) 진행하는 이 연구는 2026년 12월 1일까지 진행될 예정입니다. ClinicalTrials.gov의 가장 최근 정보는 2025년 7월 20일에 갱신되었습니다.
간단한 개요
This trial is a double-blind, randomised, trial recruiting participants from the R21 phase IIb trial (VAC 076) which took place between May 2019 and July 2023 in Nanoro, Burkina Faso.
Participants (n=30-40) who have previously received four doses of the 5µg R21/50µg Matrix-M malaria vaccine in VAC 076 will be randomised to receive either 5µg R21/50µg Matrix-M or 10µg R21/50µg Matrix-M. Safety and immunogenicity of a booster at school age at these two different doses will be assessed. Participants will be followed up for one year after the booster.
공식 제목
A Phase II Randomised Trial to Evaluate the Safety and Immunogenicity of a R21/Matrix-M Booster Vaccine at Two Different Doses in Burkinabe School Children
질환/상태
Malaria (Plasmodium Falciparum)기타 연구 식별자
- VAC101
NCT 번호
실제 연구 시작일
2025-10
최신 업데이트 게시
2025-07-20
예상 연구 완료일
2026-12
계획된 등록 인원
40
연구종류
중재연구
단계/상
2상
상태
대상자모집전
키워드
Malaria Vaccine
R21/Matrix-M
R21/Matrix-M
주요 목적
예방
설계 할당
무작위배정
중재 모델
평행설계
맹검 (마스킹)
사중맹검
시험군 / 개입
| 참가자 그룹/시험군 | 개입/치료 |
|---|---|
실험적Group A Participants in this arm will be given one dose of 5µg R21/50µg Matrix-M | 5Μg R21/50ΜG Matrix-m R21/Matrix-M is a vaccine against P. falciparum malaria, which has WHO prequalification and policy recommendation in children over 5 months old in malaria endemic areas. The standard paediatric dose is 5µg R21/50µg Matrix-M. |
실험적Group B Participants in this arm will be given one dose of 10µg R21/50µg Matrix-M | 10Μg R21/50ΜG Matrix-m R21/Matrix-M is a vaccine against P. falciparum malaria, which has WHO prequalification and policy recommendation in children over 5 months old in malaria endemic areas. 10µg R21/50µg Matrix-M is the standard adult dose. |
주요결과변수
이차결과변수
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
Reactogenicity | Reactogenicity of an additional late booster of R21/Matrix-M at different doses, in school age children living in Burkina Faso. This will be measured through: 1) the occurrence of solicited local reactogenicity signs and symptoms for 7 days following the vaccination and 2) the occurrence of solicited systemic reactogenicity signs and symptoms for 7 days following the vaccination. | 7 days after vaccination |
Safety - unsolicited AEs | Safety of an additional late booster of R21/Matrix-M at different doses, in school age children living in Burkina Faso will be assessed through the occurrence of unsolicited adverse events for 28 days following the vaccination. | 28 days following vaccination |
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
Immunogenicity | Humoral immunogenicity by anti-CSP antibody concentrations after school age booster of R21/Matrix-M at different doses. | At baseline and one, six and twelve months after vaccination |
Safety - SAEs | Serious adverse events (SAEs) following school age booster vaccination. | 1 year after vaccination |
Safety - deaths | Any deaths following school age booster vaccination | 1 year after vaccination |
적격성 기준
연령대
어린이
최소 연령
6 Years
참여 가능한 성별
전체
건강한 참가자 허용
네
- The child received four doses of R21/Matrix-M in the phase IIb study evaluating R21/MatrixM in Nanoro, Burkina Faso (VAC 076).
- Signed informed consent/thumb-printed and witnessed informed consent obtained from the parent(s)/guardian(s) of the child to join the trial.
- The investigator believes that the parents/guardians can and will comply with the requirements of the protocol if the child is enrolled in the study.
- The child is a permanent resident of the study area and is expected to remain a resident for the duration of the trial.
- The child is enrolled in another malaria vaccine trial.
- The child has a history of allergic disease or reactions likely to be exacerbated by any component of the malaria vaccine.
- The child has a history of allergic reactions, significant IgE-mediated events or anaphylaxis to previous immunisations.
- The child has major congenital defects.
- The child has anaemia associated with clinical signs of symptoms of decompensation, or a haemoglobin of ≤ 5.0 g/dL.
- The child has been administered immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate.
- The child has malnutrition requiring hospital admission.
- The child has an acute or chronic, clinically significant pulmonary, cardiovascular, gastrointestinal, endocrine, neurological, skin, hepatic or renal functional abnormality, as determined by medical history, physical examination or laboratory tests.
- Children currently meeting the WHO criteria for HIV disease of stage 3 or 4 severity. A previous history of stage 3 or 4 disease is not an exclusion. Note: There will be no routine testing for HIV. Positive diagnoses will be recorded at screening if known.
- The child has received an investigational drug or investigational vaccine other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- The child is currently participating in another clinical trial if likely to affect data interpretation of this trial.
- The child has any significant disease, disorder or situation which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial.
옥스퍼드 대학교244개의 진행 중인 임상시험 탐색 가능Institut de Recherche en Sciences de la Sante, Burkina Faso연구 대표 연락처
연락처: Mehreen Datoo, +44 7859035715, [email protected]
1 1개국에 임상시험 장소
Unité de Recherche Clinique de Nanoro (URCN), Nanoro, PO Box 11 BP 218 Ouaga CMS 11, Burkina Faso
Halidou Tinto, 연락처, +226 70346354, [email protected]