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Table 5 Seroconversion rates from days 0 to 14 (ITT population)

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

Treatment group

Patients seroconverted by day 14a n (N)

Percentage

95% Confidence intervalb

IC43 100 μg with adj

52 (80)

65.0%

(54.1%, 74.5%)

IC43 100 μg w/o adj

58 (72)

80.6%

(70.0%, 88.0%)

IC43 200 μg with adj

54 (72)

75.0%

(63.9%, 83.6%)

Placebo

5 (71)

7.0%

(3.0%, 15.4%)

  1. aSeroconversion defined as ≥4-fold increase in Outer membrane protein F/I hybrid vaccine (OprF/I)-specific IgG antibody titer from days 0 to 14. b95% Confidence interval calculated according to Wilson’s method, as recommended by Altman [17]. ITT intention-to-treat, n number of patients seroconverted, N number of patients with data, w/o adj without aluminum hydroxide adjuvant, with adj with aluminum hydroxide adjuvant
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Critical Care

ISSN: 1364-8535