PMID- 20673824
OWN - NLM
STAT- MEDLINE
DCOM- 20101129
LR  - 20191210
IS  - 1873-2518 (Electronic)
IS  - 0264-410X (Linking)
VI  - 28
IP  - 39
DP  - 2010 Sep 7
TI  - Safety analysis of a Vero-cell culture derived Japanese encephalitis vaccine, 
      IXIARO (IC51), in 6 months of follow-up.
PG  - 6463-9
LID - 10.1016/j.vaccine.2010.07.040 [doi]
AB  - Japanese encephalitis (JE) is the most common viral encephalitis in Asia. IXIARO 
      is a Vero cell-derived, inactivated JE virus vaccine which has recently been 
      approved in the US, Europe, Canada and Australia (trade name JESPECT). This 
      overview of the safety and tolerability of IXIARO, for 6 months after the first 
      vaccination in 7 Phase III trials, includes: 3558 subjects with at least one 
      IXIARO vaccination, 435 subjects with a JE-VAX (manufactured by BIKEN, 
      distributed by Sanofi Pasteur) vaccination, and 657 with phosphate-buffered 
      saline solution with 0.1% Al(OH)(3) (PBS+Alum) control vaccination. The 
      percentage of subjects reporting solicited local adverse events (AEs) with IXIARO 
      (54%) was similar to PBS+Alum vaccination (56%) as were solicited systemic 
      adverse events (40% IXIARO; 40% PBS+Alum vaccination). JE-VAX showed a higher 
      frequency of subjects with solicited local adverse events (61%) but a slightly 
      lower frequency of subjects with solicited systemic adverse events (36%). The 
      frequency of subjects with any solicited and unsolicited AE with IXIARO (64%) was 
      also similar to PBS+Alum vaccination (61%) and JE-VAX (64%); as for subjects with 
      serious AEs (1% IXIARO; 2% PBS+Alum vaccination, 1% JE-VAX). No serious allergic 
      reactions were observed in any group. This safety analysis indicates that IXIARO 
      has a favorable safety profile, comparable to PBS+Alum control vaccination and 
      appears to have a better local tolerability profile than JE-VAX.
CI  - Copyright (c) 2010 Elsevier Ltd. All rights reserved.
FAU - Dubischar-Kastner, Katrin
AU  - Dubischar-Kastner K
AD  - Intercell AG, Campus Vienna Biocenter 3, 1030 Wien, Austria.
FAU - Kaltenboeck, Astrid
AU  - Kaltenboeck A
FAU - Klingler, Anton
AU  - Klingler A
FAU - Jilma, Bernd
AU  - Jilma B
FAU - Schuller, Elisabeth
AU  - Schuller E
LA  - eng
PT  - Journal Article
DEP - 20100729
PL  - Netherlands
TA  - Vaccine
JT  - Vaccine
JID - 8406899
RN  - 0 (Japanese Encephalitis Vaccines)
SB  - IM
MH  - Adult
MH  - Animals
MH  - Chlorocebus aethiops
MH  - Clinical Trials, Phase III as Topic
MH  - Encephalitis, Japanese/prevention & control
MH  - Female
MH  - Follow-Up Studies
MH  - Humans
MH  - Japanese Encephalitis Vaccines/administration & dosage/*adverse effects
MH  - Male
MH  - Middle Aged
MH  - Vero Cells
MH  - Young Adult
EDAT- 2010/08/03 06:00
MHDA- 2010/12/14 06:00
CRDT- 2010/08/03 06:00
PHST- 2010/04/20 00:00 [received]
PHST- 2010/07/13 00:00 [revised]
PHST- 2010/07/14 00:00 [accepted]
PHST- 2010/08/03 06:00 [entrez]
PHST- 2010/08/03 06:00 [pubmed]
PHST- 2010/12/14 06:00 [medline]
AID - S0264-410X(10)01035-2 [pii]
AID - 10.1016/j.vaccine.2010.07.040 [doi]
PST - ppublish
SO  - Vaccine. 2010 Sep 7;28(39):6463-9. doi: 10.1016/j.vaccine.2010.07.040. Epub 2010 
      Jul 29.