Specifically, approximately 10 h after Selleckchem PF 01367338 receipt of a 60-μg dose of rLP2086 vaccine, Prevenar®, Infanrix hexa®, Meningitec®, and Rotarix®, the subject developed

a fever (39.0 °C). A lumbar puncture was performed, and initial results showed 500 cells (95% PMNs), protein 0.5 mg/dl (normal), glucose 60 mg/dl (normal), and red blood cell count of 10 mm3. The subject was treated with cefotaxime and vancomycin after the lumbar puncture; the fever cleared by the next evening and the child remained afebrile and well. The workup did not identify a causative organism; blood and cerebrospinal fluid (CSF) bacterial and viral cultures were negative; polymerase chain reaction tests of the BYL719 research buy CSF were also negative. Although the aseptic meningitis was ultimately considered not vaccine related by the treating physician, review of safety data by a project-independent safety committee revealed 80% of vaccine recipients at the 60-μg dose experienced

mild to moderate fever (90% including the case of aseptic meningitis). The sponsor decided to terminate the trial after the vaccine was deemed not acceptable in this population. Forty-six subjects were randomized: 22 received 20 μg rLP2086, 10 received 60 μg rLP2086, and 14 received routine childhood vaccines only. Mean age was 65.5 days; 48% were girls; all were white. All subjects received 1 vaccine dose; no postvaccination blood samples were drawn. At least

1 local reaction was reported for 11 (50%) subjects in the 20-μg group, 7 (70%) subjects in the 60-μg group, and 5 (36%) subjects in the control group. The rates of all reactions, except erythema, were lowest in the control group and highest in the 60-μg group (Table 1). The most common local reaction was tenderness, with a mean duration of 1.3 days, 2.7 days, and 1.0 day in the 20-μg, 60-μg, and control groups, respectively. Five subjects receiving rLP2086 experienced tenderness that interfered with limb movement. Most subjects experienced ≥1 systemic event. The most common event was irritability, reported for 17 (77%), 9 (90%), and 9 (64%) subjects in the 20-μg, 60-μg, and control groups. Rates of the other systemic reactions old and anti-pyretic medication use were lowest in the control group and highest in the 60-μg group, with the exception of decreased sleep (Table 1). Duration of events was 1.0–3.3 days. Fever ≥38 °C was reported in the majority of rLP2086 vaccine recipients: 14 (64%) in the 20-μg group and 8 (80%) in the 60-μg group compared with 4 (29%) in the control group (Fig. 2). In most cases, the temperature was 38.0–39.0 °C; 2 subjects in the 20-μg group and 1 subject in the 60-μg group had fever of >39.0–40.0 °C. No fevers were >40.0 °C. The mean duration of fever was 1.0–2.1 days. The subject with aseptic meningitis also reported a fever between >39.0 and 40.