Definitions for "Phase ii clinical trial"
a clinical study that examines the new drug's safety and efficacy at various doses and involves approximately 100 to 500 volunteer patients suffering from the disease.
a clinical trial on more persons than in phase I; intended to evaluate the efficacy of a treatment for the condition it is intended to treat; possible side effects are monitored
Controlled clinical study of a vaccine to identify common short-term side effects and risks associated with the vaccine, to collect additional information on its immunogenicity, and to collect initial information on efficacy. Phase II trials enroll some subjects who have the same characteristics as persons who would be enrolled in an efficacy (Phase III) trial of a vaccine. Phase II trials enroll up to several hundred participants.