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      Correction to: Aspinall S, et al. Human Vaccines and Immunotherapeutics Volume 8, Issue 8; pp.1109–18

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          Abstract

          Subsequent to publication of this paper errors in Table 5 (solicited local and systemic adverse events…) have come to light. Below is the revised table. Table 5 Solicited local and systemic adverse events reported within five days of each vaccination in the Core Study and Booster Phase based on the safety population   Core study n (%) [95% CI]a Booster phase n (%) [95% CI]a Adverse events Lot AN = 119 Lot BN = 120 Lot CN = 121 PooledN = 360 Booster plus Rouvax (concomitantly) N = 105 Booster plus Rouvax (1 month later) N = 110 PooledN = 215 Local               Induration 21 (17.6)[11.3,25.7] 29 (24.2)[16.8,32.8] 31 (25.6)[18.1,34.4] 81 (22.5)[18.3,27.2] 25 (23.8)[16.0,33.1] 24 (21.8)[14.5,30.7] 49 (22.8)[17.4,29.0] Systemic               ≥ 1 event reported 96 (80.7)[72.4,87.3] 96 (80.0)[71.7,86.7] 83 (68.6)[59.5,76.7] 275 (76.4)[71.7,80.7] 69 (65.7)[55.8,74.7] 60 (54.5)[44.8,64.1] 129 (60.0)[53.1,66.6] Feverb 44 (37.0)[28.3,46.3] 41(34.2)[28.8,43.4] 38 (31.4)[23.3,40.5] 123(34.2)[29.3,39.3] 20 (19.0)[12.0,27.9] 16 (14.5)[8.5,22.5] 36 (16.7)[12.0,22.4] Rash 28 (23.5)[16.2,32.2] 31 (25.8)[18.3,34.6] 29 (24.0)[16.7,32.6] 88(24.4)[20.1,29.2] 5 (4.8)[1.6,10.8] 10 (9.1)[4.4,16.1] 15 (7.0)[4.0,11.2] Change in eating habits 28 (23.5)[16.2,32.2] 32 (26.7)[19.0,35.5] 34 (28.1)[20.3,37.0] 94(26.1)[21.6,31.0] 30 (28.6)[20.2,38.2] 27 (24.5)[16.8,33.7] 57 (26.5)[20.7,32.9] Sleepiness 47 (39.5)[30.7,48.9] 45 (37.5)[28.8,46.8] 44 (36.4)[27.8,45.6] 136(37.8)[32.7,43.0] 29 (27.6)[19.3,37.2] 26 (23.6)[16.1,32.7] 55 (25.6)[19.9,32.0] Unusual crying 55 (46.2)[37.0,55.6] 59 (49.2)[39.9,58.4] 51 (42.1)[33.2,51.5] 165(45.8)[40.6,51.1] 35 (33.3)[24.4,43.2] 31 (28.2)[20.0,37.6] 66 (30.7)[24.6,37.3] Persistent crying 13 (10.9)[5.9,18.0] 11 (9.2)[4.7,15.8] 10 (8.3)[4.0,14.7] 34(9.4)[6.6,12.9] 2 (1.9)[0.2,6.7] 2 (1.8)[0.2,6.4] 4 (1.9)[0.5,4.7] Irritability 42 (35.3)[26.8,44.6] 39 (32.5)[24.2,41.7] 34 (28.1)[20.3,37.0] 115(31.9)[27.2,37.0] 28 (26.7)[18.5,36.2] 21 (19.1)[12.2,27.7] 49 (22.8)[17.4,29.0] Vomiting 28 (23.5)[16.2,32.2] 30 (25.0)[17.5,33.7] 26 (21.5)[14.5,29.9] 84(23.3)[19.1,28.1] 10 (9.5)[4.7,16.8] 5 (4.5)[1.5,10.3] 15 (7.0)[4.0,11.2] Diarrhea 20 (16.8)[10.6,24.8] 27 (22.5)[15.4,31.0] 23 (19.0)[12.4,27.1] 70(19.4)[15.5,23.9] 8 (7.6)[3.3,14.5] 11 (10.0)[5.1,17.2] 19 (8.8)[5.4,13.5] a Values (%) based on number of infants experiencing an event/total number of infants receiving at least one injection (N). bFever defined as body temperature ≥ 38.0 °C. N = total number of infants receiving at least one injection (i.e. safety population). All local adverse events were considered vaccination-related; values for systemic adverse events represent all solicited adverse events reported, regardless of whether or not they were considered vaccination-related

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          Author and article information

          Journal
          Hum Vaccin Immunother
          Hum Vaccin Immunother
          HV
          Human Vaccines & Immunotherapeutics
          Landes Bioscience
          2164-5515
          2164-554X
          01 April 2013
          01 April 2013
          01 April 2013
          : 9
          : 4
          : 937
          Affiliations
          [1 ]Synexus Clinical Research SA (Pty) Ltd, Pretoria, South Africa
          [2 ]Crucell Switzerland AG; Bern, Switzerland
          Author notes
          [* ]Correspondence to: Katharina Hartmann, Email: katharina.hartmann@ 123456crucell.ch
          Article
          2013HV0904C1 24580
          10.4161/hv.24580
          3903918
          6fca3484-1386-4e4b-9997-c75e62caa5f4
          Copyright © 2013 Landes Bioscience

          This is an open-access article licensed under a Creative Commons Attribution-NonCommercial 3.0 Unported License. The article may be redistributed, reproduced, and reused for non-commercial purposes, provided the original source is properly cited.

          History
          : 30 January 2013
          : 30 January 2013
          Categories
          Correction

          Molecular medicine
          Molecular medicine

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