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Objective.

The safety and immunogenicity of tetravalent live-attenuated dengue vaccines after a three dose vaccination series were evaluated in Thai children.

Method.

One hundred three healthy flavivirus-seronegative schoolchildren ages 5 to 12 years were randomized to receive either dengue vaccine containing 3, 2, 1 and 2 log 10 of the 50% cell culture infective dose, respectively, of the live-attenuated dengue vaccine serotypes 1, 2, 3 and 4 per dose (F3212; n= 40) or 3, 3, 1 and 3 log 10 of the 50% cell culture infective dose (F3313; n= 42) or purified Vero cell rabies vaccine (control group; n= 21) given in a two dose schedule (3 to 5 months apart). A third dose was administered 8 to 12 months after the second dose to 90 subjects. Safety and immunogenicity were evaluated within 28 days after each injection.

Results.

No serious adverse event related to the vaccines occurred. Most children experienced mild to …