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 sites0 target enrollmentDecember 15, 2017

ConditionsMalaria

Overview

No summary available.

Registry

who.int

Start Date

December 15, 2017

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

Centre de Recherches Médicale de Lambaréné

•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