Randomized, placebo-controlled, double-blind, three-arm, clinical trial to assess safety, tolerability and protective efficacy of PfSPZ-CVac and PfSPZ Vaccine in 1-12 years old African children naturally exposed to malaria parasites

Centre de Recherches Médicale de Lambaréné0 个研究点目标入组 0 人开始时间: 2017年12月15日最近更新: 2023年5月29日

适应症

试验速览

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•Recruited children will be healthy population with the following inclusion criteria:
•-Healthy children aged 1 to 12 years
•-Provision of written informed consent of a legal representative of age 18 or above and provision of informed assent by underage participants in concordance with Gabonese national guidelines.
•-Able and willing to comply with all study requirements
•-Residence in the area throughout the study period
•-Household member reachable by mobile phone during the immunization phase
•-Correct answers on the informed consent quiz for legal representatives

•Children will not enter the study if any of the following apply:
•-Receipt of an investigational product in the 30 days preceding enrollment
•-Immunization with more than 3 other vaccines or at least one live vaccine within the past four weeks
•-Use of immunoglobulins or blood products within 3 months prior to enrolment
•-Known intolerance to, or contraindications to the use of chloroquine or clindamycin
•-Known or suspected HIV infection or any other immunosuppressive state
•-Positive for hepatitis B surface antigen (HBsantigen)
•-Seropositive for hepatitis C virus (antibodies to HCV)
•-A hemoglobin concentration <9 g/dl
•-History of non-febrile or atypical febrile seizures
•-Pregnancy or lactation
•-Any other significant disease, disorder or finding which, in the opinion of the investigator, may significantly increase the risk to the child because of participation in the study or impair interpretation of the study data
•In case of inconclusive results in laboratory tests or other diagnostic procedures, the test will be repeated. If doubts about the results persist, volunteers will be considered ineligible.

发起方

Centre de Recherches Médicale de Lambaréné