PMID- 29549036
OWN - NLM
STAT- MEDLINE
DCOM- 20181211
LR  - 20191210
IS  - 1873-0442 (Electronic)
IS  - 1477-8939 (Linking)
VI  - 22
DP  - 2018 Mar-Apr
TI  - Safety and immunogenicity of an inactivated Vero cell_derived Japanese 
      encephalitis vaccine (IXIARO((R)), JESPECT((R))) in a pediatric population in JE 
      non-endemic countries: An uncontrolled, open-label phase 3 study.
PG  - 18-24
LID - S1477-8939(18)30046-2 [pii]
LID - 10.1016/j.tmaid.2018.03.003 [doi]
AB  - BACKGROUND: Young travelers to South-East Asia may be at risk for Japanese 
      encephalitis (JE). METHODS: IXIARO((R)) (0.25 ml or 0.5 ml, depending on age) were 
      administrated to 100 travelers aged >/= 2 months to < 18 years. Solicited AEs were 
      collected for 7 days after each injection, unsolicited adverse events (AEs) for a 
      total of 7 months. JE neutralizing antibodies were assessed in 64 subjects. 
      RESULTS: The most common solicited local AEs were redness (3/12 subjects), 
      induration and tenderness (both 1/12) with 0.25 ml IXIARO((R)), and tenderness 
      (44/88) and pain (22/88) with 0.5 ml IXIARO((R)). Common solicited systemic AEs 
      were diarrhea (2/12) and loss of appetite (1/12) with 0.25 ml IXIARO((R)) and 
      muscle pain (27/88) and excessive fatigue (10/88) with 0.5 ml IXIARO((R)). In 
      total, up to day 56, AEs were reported by 10/12 (83.3%) of subjects who received 
      the 0.25 ml dose and 67/88 (76.1%) of those vaccinated with the 0.5 ml dose. All 
      subjects (62/62; 100%) developed protective levels of JE neutralizing antibodies 
      by Day 56 and 31/34 (91.2%) retained protective titers at Month 7. CONCLUSIONS: 
      IXIARO((R)) was generally well tolerated in children, with an overall AE profile 
      similar to adults. IXIARO((R)) was highly immunogenic in both dose groups.
CI  - Copyright (c) 2018 The Authors. Published by Elsevier Ltd.. All rights reserved.
FAU - Jelinek, Tomas
AU  - Jelinek T
AD  - Berlin Center for Travel & Tropical Diseases, Berlin and Institute of Medical 
      Microbiology, Immunology and Hygiene, University of Cologne, Germany.
FAU - Cromer, Michael A
AU  - Cromer MA
AD  - Tampa Clinical Research, Inc., Tampa, FL, USA.
FAU - Cramer, Jakob P
AU  - Cramer JP
AD  - Takeda Pharmaceuticals International AG, Switzerland.
FAU - Mills, Deborah J
AU  - Mills DJ
AD  - Dr. Deb - The Travel Doctor, Brisbane, Queensland, Australia.
FAU - Lessans, Kenneth
AU  - Lessans K
AD  - Passport Health, Inc., Baltimore, MD, USA.
FAU - Gherardin, Anthony W
AU  - Gherardin AW
AD  - The Travel Doctor - TMVC Pty Ltd, Melbourne Docklands, Victoria, Australia.
FAU - Barnett, Elizabeth D
AU  - Barnett ED
AD  - Boston Medical Center, Section of Pediatric Infectious Diseases, Boston, MA, USA.
FAU - Hagmann, Stefan H F
AU  - Hagmann SHF
AD  - Bronx - Lebanon Hospital Center, Division of Pediatric Infectious Diseases, New 
      York, NY, USA.
FAU - Askling, Helena H
AU  - Askling HH
AD  - Karolinska Institutet, Dept. of Medicine, Unit for Infectious Diseases, Solna, 
      Sweden.
FAU - Kiermayr, Sigrid
AU  - Kiermayr S
AD  - Valneva Austria GmbH, Campus Vienna Biocenter, Vienna, Austria.
FAU - Kadlecek, Vera
AU  - Kadlecek V
AD  - Valneva Austria GmbH, Campus Vienna Biocenter, Vienna, Austria.
FAU - Eder-Lingelbach, Susanne
AU  - Eder-Lingelbach S
AD  - Valneva Austria GmbH, Campus Vienna Biocenter, Vienna, Austria.
FAU - Taucher, Christian
AU  - Taucher C
AD  - Valneva Austria GmbH, Campus Vienna Biocenter, Vienna, Austria. Electronic 
      address: christian.taucher@valneva.com.
FAU - Dubischar, Katrin L
AU  - Dubischar KL
AD  - Valneva Austria GmbH, Campus Vienna Biocenter, Vienna, Austria.
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
DEP - 20180313
PL  - Netherlands
TA  - Travel Med Infect Dis
JT  - Travel medicine and infectious disease
JID - 101230758
RN  - 0 (Antibodies, Neutralizing)
RN  - 0 (Antibodies, Viral)
RN  - 0 (Japanese Encephalitis Vaccines)
SB  - IM
MH  - Adolescent
MH  - Animals
MH  - Antibodies, Neutralizing/blood
MH  - Antibodies, Viral/blood
MH  - Child
MH  - Child, Preschool
MH  - Chlorocebus aethiops
MH  - Encephalitis, Japanese/immunology/*prevention & control
MH  - Female
MH  - Follow-Up Studies
MH  - Humans
MH  - Immunogenicity, Vaccine/*immunology
MH  - Japanese Encephalitis Vaccines/adverse effects/*immunology/*standards
MH  - Male
MH  - Safety
MH  - Travel
MH  - Vero Cells
OTO - NOTNLM
OT  - Children
OT  - IXIARO
OT  - Immunogenicity
OT  - Japanese encephalitis vaccine
OT  - Safety
EDAT- 2018/03/20 06:00
MHDA- 2018/12/12 06:00
CRDT- 2018/03/18 06:00
PHST- 2017/11/02 00:00 [received]
PHST- 2018/03/06 00:00 [revised]
PHST- 2018/03/12 00:00 [accepted]
PHST- 2018/03/20 06:00 [pubmed]
PHST- 2018/12/12 06:00 [medline]
PHST- 2018/03/18 06:00 [entrez]
AID - S1477-8939(18)30046-2 [pii]
AID - 10.1016/j.tmaid.2018.03.003 [doi]
PST - ppublish
SO  - Travel Med Infect Dis. 2018 Mar-Apr;22:18-24. doi: 10.1016/j.tmaid.2018.03.003. 
      Epub 2018 Mar 13.