We report the first long-term safety follow-up, and booster
studies of the investigational WRAIR/GSK Vaccines tetravalent
DENV vaccine candidate (either original master seed
[F17/Pre] or re-derived [F17]) administered to children and
infants in a dengue endemic setting. We observed that a
booster dose of the vaccine administered at either 1 year or
more than 3 years after primary vaccination appeared safe
and generally well tolerated when given to young subjects
who were primed by previous F17/Pre and JEV vaccinations
during childhood or infancy. Long-term safety evaluation
in both studies revealed no clinically important findings and
no SAEs or AE-related withdrawals following the primary
and booster vaccination. Overall, AE reporting following
booster vaccinations was similar to that following the primary
vaccination studies.