IMPACT 2002+ methodology is selected to perform the impact assessment within the SC since it proposes a feasible implementation of a combined midpoint-endpoint evaluation.
It is possible that growth inhibitory antibodies have a more important function in children than adults, an important consideration in blood stage vaccine endpoint evaluation.
Understanding the development of parasite growth inhibition within the context of natural malaria infection and transmission is essential to blood stage vaccine endpoint evaluation.
During the primary phase of the study, i.e. up to month 10, the study was partially blinded, whereby investigators involved in endpoint evaluation and parents/guardians were blinded to the vaccine administered, but not to the schedule.
‡PROBE (Prospective, Randomized, Open with Blinded Endpoint evaluation) design trials.
Power calculation was conducted for gastric emptying Thalf the primary endpoint evaluation.
A total of 229 patients were available for primary endpoint evaluation (modified intention to treat population).
In order to make comparisons the CLEEN project has planned a baseline as well as an endpoint evaluation.
CRTs of health system interventions focus on assessing the intended impact the intervention using a singular primary endpoint evaluation.
SCOT is an active comparator, streamlined clinical trial with a Prospective, Randomised, Open label, Blinded Endpoint evaluation (PROBE) design.
