Study design
This phase IV, non-blinded, randomized non-inferiority trial took place at four urban health centers and three satellite clinics in the cities of Posadas, Eldorado, and Oberá in Misiones Province, Argentina. Centers were selected based on location in a YF endemic area, accessibility, capacity to carry out the protocol, and average number of children vaccinated each month. The study protocol was approved by the medical ethics committees of the MOH of Argentina and PAHO. In accordance with human subjects’ review procedures at the CDC, it was determined that the CDC was not formally engaged in this human-subjects research. The study was retrospectively registered in ClinicalTrials.gov (NCT03368495) on 11/12/2017 and the national regulatory agency for medical technology (ANMAT) was informed.