25.62b >633 10 05 4080* 32 91 30 23

25.62b >633 10 05 4080* 32 91 30 23 36 56 37 19 3.0 k 28 1169° 528 02 00 348 226 _00 00 ' Severe = measuring >30 cm and persisting longer than 24 hours f Severe = preventing ewrgoav normal actrwtv a (lvalue <005 b p-value <0.01 c r>value <0 001 Subjects with Previous Lyme Diseese Subjects with previous Lyme disease were assessed using two definitions subiects whose baseline sera were evaluated lor Western blot IWBI positivity and subiects who at study entry self-reported a previous history ol Lyme disease

Study participants did not routinely have baseline sera tested by WB for Lyme disease WB at baseline was performed for subiects who were noted to have a positive or equivocal WB during a visit tor suspected Lyme disease or when tested at months 12 or 20 ' Baseline serology was thus found to be positive in 260 subiects out of 628 tested The nature and incidence of adverse events (either early or late) did not differ between vac- > cinees determined to have been WB-positive at baseline In-1241 compared to vaccmees determined to have been WB-negative at baseline (n= 1S1).

There were 1,206 subiects enrolled in the study who self-reported a previous history of Lyme disease 1610 vaccinees, 596 placebo recipients! For adverse events occurring within

the first 30 days, there was an increased incidence of musculoskeletal symptoms in vaccmees with a history of Lyme disease compared lo vaccinees with no history of Lyme disease 120% vs 13% p<0 001) No such difference was observed in the placebo V0141113% f

vs 11 %. p-0 24) Subjects with a previc-s history of Lyme disease had an increased incidence of late (>30 days post-veccmationl musculoskeletal symptoms compared to subjects without a history of Lyme disease in 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 133% vs 35%, p-0 51) , Subjects with a self-reported prior history of Lyme disease had a greater incidence of pay- i

chiatnc disorders (early and late), central, peripheral and autonomic nervous system disorders

Hate), and gastromt-stina! disorders (late) than subjects with no prior history of Lyme

disease However, there was no significant difference in the moidence 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 mcyiths. a *

total of 15 deaths occurred 110 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 11) In the placebo group, causes ol death included, cancer (1). sudden cardiac death (11. cardac arrest (1). . septic 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 SmithKIifM Biichim Bloto Rixensart. Belgium Distributed by \ SmHhlCHne Beechem Ptienvisoeiilteele Philadelphia: PA 19101 O Smith Kline Beecham. 1998 SpVtaMi Arthralgia any Arthralgia severe' fatigue, any fatigue severe' Headache any Headache severe’ Rash, any Rash severe* fever £99 5°f fever >102 2°f 1194c 4 52 0 7 00 20 90 16 83 05 005 20 65 19 10 05 005 4 23* 151 00 00 149 075 00 00 10 70 8.29 02 03 201^ 1181 15 13 1443 1231 12 05 4 98d 2 01 00 00 100 0 50 00 00 * I3 43b 7 54 00 03 2189s 16 33 10 10 19 90 18 34 12 18 5.47* 1 76 02 00 100 101 00 00 LYMErix and Tip-Lok are trademarks of SmithKhne Beecham BRS-LYL1