FIG 1.

Trial profile. Asterisks (*) indicate a protocol deviation (PD), in which the subject was randomized to receive the 60-μg dose but was mistakenly administered the 30-μg dose (the subject was included in the immunogenicity data set for the 60-μg dose). Discontinuation by choice denotes discontinuation at the request of the patient, unrelated to adverse events. Of the 10 participants who discontinued due to an AE, three were judged to be related or possibly related to the vaccination: one reported fatigue, one arthralgia, headache, fatigue, and myalgia, and one alopecia areata (also reported in the medical history) and moderate arthritis (acute arthritis of the proximal interphalangeal finger joints of two fingers of the right hand; an X-ray examination gave no indication of arthritis or arthrosis). Of the two participants who discontinued due to progressive disease, one discontinued due to symptoms of hypothyroidism and the other one due to symptoms associated with type 2 diabetes. Of six participants who discontinued between the primary and booster immunizations due to being assessed as seropositive by C6-ELISA, 1 was subsequently confirmed by line blot, and five were seronegative by line blot. adj, adjuvanted.