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Safety and Efficacy of Two Courses of OM-85 BV in the Prevention of Respiratory Tract Infections in Children During 12 Months: Results2

Safety and Efficacy of Two Courses of OM-85 BV in the Prevention of Respiratory Tract Infections in Children During 12 Months: Results2The numbers of patients included per month from July 1997 to February 1998 were 5, 1, 8, 12, 11, 5, 7, and 5, respectively. Table 4 contains the mean and SDs and difference for the trial end points; the number of ARTIs; illness duration; number of antibiotic courses; number of drug courses (treatment courses including antibiotics); duration of concomitant treatment (number of days receiving any drug treatment); and days out of school. Lung Cancer
Except for the absenteeism, the cumulative figures of the end points showed a significant difference between the groups from the second month of the trial to the end of the trial (p < 0.05 by Student’s t test, and Mann-Whitney U test). The ANOVA for repeated measures for the monthly evolution of such variables (except absenteeism) showed a significant difference between the groups and within the groups as well as significant interaction of the effect of the groups and the different measures throughout the trial (p < 0.01).
Regarding the monthly severity score in visual analog scale for consecutive months, there were significant differences (p < 0.05 by Student’s t test) in month 2 (OM-85 BV 21.81 ± 6.81 vs placebo 30.64 ± 13.02) and month 12 (20.61 ± 5.61 vs 30.47 ± 12.05, respectively).
If we only considered the children with ages < 6 years, the OM-85 BV group (n = 23) had 4.87 ± 1.94 ARTIs and the placebo group (n = 21) had 8.28 ± 2.85 (p < 0.01 by Student’s t test and Mann-Whitney U test), ie, a difference of — 3.42 (95% CI, — 4.92 to — 1.91), 41.18% fewer infections.
Four patients in the OM-85 BV group had five adverse events. One patient experienced one episode of papular rash and 9 months later bronchospasm, another patient underwent kidney surgery to correct hydronephrosis, another suffered tongue and lip herpes, and another had conjunctivitis. Only the rash was considered to be related to the medication intake. Six patients in the control group had six adverse events. One patient had bronchospasm, another had otitis externa, another had salmonellosis, two patients suffered seizures due to fever provoked by ARTI, and another patient underwent a tonsillectomy.
Table 4—End Point Data

Variables OM-85 BV (n = 26) Placebo (n = 28) Difference, 95% CI
ARTIs, No. 5.04 ± 1.99 8.0 ± 2.55 — 2.96 (— 4.22, — 1.7)t
5.0 (4.0, 6.25) 8.0 (6.0, 10.0)
Total duration of illness, d 35.23 ± 17.64 60.75 ± 25.44 — 25.52 (— 37.56, — 13.47)t
30.5 (21.5, 45.5) 55.0 (43.0, 78.5)
Antibiotic courses, No. 2.46 ± 2.08 4.46 ± 2.08 — 2.0 (— 3.14, — 0.86)t
1.5 (1.0, 4.25) 4.0 (3.0, 6.0)
Drug courses (including 5.04 ± 1.99 7.96 ± 2.56 — 2.92 (— 4.18, — 1.67)t
antibiotics), No. 5.0 (4.0, 6.25) 7.5 (6.0, 10.0)
Duration of treatment (days taking 35.65 ± 18.61 60.79 ± 24.01 — 25.13 (— 36.93, — 13.33)t
any drug), No. 31.0 (20.0, 46.25) 55.5 (46.25, 76.5)
Absenteeism (days out of the 3.64 ± 3.18 5.81 ± 9.76 — 2.17 (— 7.68, 3.35)
school or day-care center), No.{ 3.5 (0.75, 6.0) 2.0 (0.5, 6.5)