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Table 6 Confirmed P. aeruginosa infections up to day 90 (overall and stratified by time period for first time of onset) (ITT population)

From: A randomized placebo-controlled phase II study of a Pseudomonas vaccine in ventilated ICU patients

Culture typea Time period IC43 100 μg with adj IC43 100 μg w/o adj IC43 200 μg with adj Placebo Overall
   N = 104 N = 98 N = 101 N = 98 P valueb
   n (%) N n (%) N n (%) N n (%) N 
Invasive Overall 14 (13.5) 104 11 (11.2) 98 14 (14.0) 100 6 (6.1) 98 0.2533
infectionc Day 0 (baseline) 3 (2.9) 104 0 (0.0) 98 4 (4.0) 100 0 (0.0) 98  
  Days 0 to ≤7d 7 (6.7) 104 5 (5.1) 98 9 (9.0) 100 4 (4.1) 98  
  >Days 7 to ≤14 2 (2.1) 97 2 (2.2) 89 4 (4.4) 90 1 (1.3) 79  
  >Days 14 ≤ 90 5 (6.0) 84 4 (4.9) 81 1 (1.3) 79 1 (1.4) 74  
Bacteremia Overall 10 (9.6) 104 7 (7.1) 98 9 (8.9) 101 6 (6.1) 98 0.7943
  Day 0 (baseline) 1 (1.0) 104 0 (0.0) 98 1 (1.0) 101 0 (0.0) 98  
  Days 0 to ≤7d 4 (3.8) 104 5 (5.1) 98 5 (5.0) 101 4 (4.1) 98  
  >Days 7 to ≤14 1 (1.0) 97 1 (1.1) 89 3 (3.3) 91 1 (1.3) 79  
  >Days 14 ≤ 90 5 (6.0) 84 1 (1.2) 81 1 (1.3) 80 1 (1.4) 74  
Pneumonia Overall 5 (4.8) 104 4 (4.1) 98 6 (6.0) 100 0 (0.0) 98 0.0693
  Day 0 (baseline) 2 (2.0) 104 0 (0.0) 98 4 (4.0) 100 0 (0.0) 98  
  Days 0 to ≤7d 4 (3.8) 104 0 (0.0) 98 5 (5.0) 100 0 (0.0) 98  
  >Days 7 to ≤14 1 (1.0) 97 1 (1.1) 89 1 (1.1) 90 0 (0.0) 79  
  >Days 14 ≤ 90 0 (0.0) 84 3 (3.7) 81 0 (0.0) 79 0 (0.0) 74  
Tracheo-bronchitis Overall 5 (4.8) 104 12 (12.2) 98 9 (9.0) 100 8 (8.2) 98 0.3022
Day 0 (baseline) 0 (0.0) 104 1 (1.0) 98 1 (1.0) 100 0 (0.0) 98  
Days 0 to ≤7d 3 (2.9) 104 4 (4.1) 98 4 (4.0) 100 5 (5.1) 98  
>Days 7 to ≤14 1 (1.0) 97 6 (6.7) 89 0 (0.0) 90 0 (0.0) 79  
>Days 14 ≤ 90 1 (1.2) 84 2 (2.5) 81 5 (6.3) 79 2 (2.7) 74  
Central venous catheter infection Overall 1 (1.2) 84 0 (0.0) 74 3 (4.1) 73 2 (2.6) 76 0.2863
Day 0 (baseline) 0 (0.0) 84 0 (0.0) 74 0 (0.0) 73 0 (0.0) 76  
Days 0 to ≤7d 0 (0.0) 84 0 (0.0) 74 1 (1.4) 73 0 (0.0) 76  
>Days 7 to ≤14 0 (0.0) 77 0 (0.0) 67 0 (0.0) 66 0 (0.0) 60  
>Days 14 ≤ 90 1 (1.6) 64 0 (0.0) 61 2 (3.5) 57 2 (3.6) 55  
Wound infection Overall 9 (11.0) 82 6 (8.5) 71 8 (10.7) 75 6 (7.8) 77 0.8960
Day 0 (baseline) 1 (1.2) 82 0 (0.0) 71 2 (2.7) 75 1 (1.3) 77  
Days 0 to ≤7d 4 (4.9) 82 2 (2.8) 71 3 (4.0) 75 2 (2.6) 77  
>Days 7 to ≤14 0 (0.0) 75 2 (3.1) 64 1 (1.5) 67 2 (3.3) 61  
>Days 14 ≤ 90 5 (8.1) 62 2 (3.4) 58 4 (6.9) 58 2 (3.5) 57  
Urinary tract infection Overall 4 (3.8) 104 5 (5.1) 98 7 (6.9) 101 9 (9.3) 97 0.4380
Day 0 (baseline) 0 (0.0) 104 0 (0.0) 98 1 (1.0) 101 0 (0.0) 97  
Days 0 to ≤7d 0 (0.0) 104 1 (1.0) 98 2 (2.0) 101 1 (1.0) 97  
>Days 7 to ≤14 2 (2.1) 97 0 (0.0) 89 2 (2.2) 91 3 (3.8) 78  
>Days 14 ≤ 90 2 (2.4) 84 4 (4.9) 81 3 (3.8) 80 5 (6.8) 73  
  1. Note, percentages are based on the numbers of non-missing observations (n). ITT intention-to-treat, n (%) number (%) of patients, N number of patients in treatment group, N’ number of patients with assessable data at start of the observation period, w/o adj without aluminum hydroxide adjuvant, with adj with aluminum hydroxide adjuvant. aConfirmed by Clinical Endpoint Committee. bFisher-Freeman-Halton test, cbacteremia or pneumonia. dData from day 0 (baseline) are included in the row for days 0 to ≤7. Therefore, the data for Overall include the rows for days 0 to ≤7, >days 7 to ≤14, and > days 14 to ≤90 rows, but not row for day 0 (baseline)