’ Severe « measuring >3 0 cm and persisting

Severe « measuring >3 0 cm and persisting longer than 24 hours t Severe = preventing everyday normal activity a Rvalue <0 05 b p-value <0 01 c p-value <0 001 Subjects with Previous Lyme Disease Subjects with previous Lyme disease were assessed using two definitions subiects whose baseline sera were evaluated for Western blot (WB) positivity and subjects who at study entry self-reported a previous history of Lyme disease Study participants did not routinely have baseline sera tested bv WB for Lyme disease WB at baseline was performed for subjects who were noted to nave a positive or equivocal WB during a visit for suspected Lyme disease or when tested at months 12 or 20 Baseline serology was thus found to be positive in 250 subjects out of 628 tested The nature and incidence of adverse events (either early or late) did not differ between vaccinees determined to have been WB-positive at baseline (n=l24) compared to vaccinees determined to have been WB-negetive at baseline (n=151) There were 1.206 subjects enrolled in the study who self-reported a previous history of Lyme disease (610 vaccinees. 596 placebo recipients) For adverse events occurring within the first 30 days, there was an increased incidence of musculoskeletal symptoms in vac cinees with a history of Lyme disease compared to vaccinees with no history of Lyme disease (20% vs 13% pcO.oOD. No such difference was observed in the placebo group (13% vs 11%. p=0 24) Subjects with a previous history of Lyme disease had an increased incidence of late (>30 bays post-vaccination) musculoskeletal symptoms compared to subjects without a history of Lyme disease m both the vaccine and placebo groups There was no significant difference in late musculoskeletal adverse events between vaccine and placebo recipients with a history of Lyme disease (33% vs. 35%. p=0 51). Subjects with a self-reported prior history of Lyme disease had a greater incidence of psychiatric disorders (early and late), central, peripheral and autonomic nervous system disorders (late), and gastrointestinal disorders (late) than subjects with no prior history of Lyme disease However, there was no significant difference in the incidence of any of these disorders between vaccine and placebo recipients with a prior history of Lyme disease Among the 10.936 subjects enrolled in the efficacy trial and followed for -20 months, a total ot 15 deaths occurred (10 vaccine. 5 placebo) None of these deaths were judged to be treatment-related by investigators In the vaccine group, causes of death included: cancer (5). myocardial infarction (3). sudden death (1). cardiac arrest (1). In the placebo group, causes of death included cancer (1), sudden cardiac death (1), cardiac arrest (1), sejltic shock (1), homicide (1). As with all pharmaceuticals, it is possible that expanded commercial use of the vaccine could reveal rare adverse events not observed in clinical studies Manufactured by SmithKIine Beec Rixensart. Belgium Distributed by SmithKIine Beec hem Pharmaceuticals Philadelphia, PA 19101 ® SmithKIine Beec ham, 1998 LYMEnx and Tip-Lok are trademarks of SmithKIine Beecham

BRS-LYL1

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