Universität zu Köln

Jelinek, Tomas, Cromer, Michael A., Cramer, Jakob P., Mills, Deborah J., Lessans, Kenneth, Gherardin, Anthony W., Barnett, Elizabeth D., Hagmann, Stefan H. F., Askling, Helena H., Kiermayr, Sigrid, Kadlecek, Vera, Eder-Lingelbach, Susanne, Taucher, Christian and Dubischar, Katrin L. (2018). 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. Travel Med. Infect. Dis., 22. S. 18 - 25. OXFORD: ELSEVIER SCI LTD. ISSN 1873-0442

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Abstract

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.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Jelinek, Tomas UNSPECIFIED UNSPECIFIED UNSPECIFIED Cromer, Michael A. UNSPECIFIED UNSPECIFIED UNSPECIFIED Cramer, Jakob P. UNSPECIFIED UNSPECIFIED UNSPECIFIED Mills, Deborah J. UNSPECIFIED UNSPECIFIED UNSPECIFIED Lessans, Kenneth UNSPECIFIED UNSPECIFIED UNSPECIFIED Gherardin, Anthony W. UNSPECIFIED UNSPECIFIED UNSPECIFIED Barnett, Elizabeth D. UNSPECIFIED UNSPECIFIED UNSPECIFIED Hagmann, Stefan H. F. UNSPECIFIED UNSPECIFIED UNSPECIFIED Askling, Helena H. UNSPECIFIED UNSPECIFIED UNSPECIFIED Kiermayr, Sigrid UNSPECIFIED UNSPECIFIED UNSPECIFIED Kadlecek, Vera UNSPECIFIED UNSPECIFIED UNSPECIFIED Eder-Lingelbach, Susanne UNSPECIFIED UNSPECIFIED UNSPECIFIED Taucher, Christian UNSPECIFIED UNSPECIFIED UNSPECIFIED Dubischar, Katrin L. UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-193923
DOI:	10.1016/j.tmaid.2018.03.003
Journal or Publication Title:	Travel Med. Infect. Dis.
Volume:	22
Page Range:	S. 18 - 25
Date:	2018
Publisher:	ELSEVIER SCI LTD
Place of Publication:	OXFORD
ISSN:	1873-0442
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language VIRUS; IC51; RECOMMENDATIONS; CHILDREN; TRIAL; BLIND Multiple languages Public, Environmental & Occupational Health; Infectious Diseases Multiple languages
Refereed:	Yes
URI:	http://kups.ub.uni-koeln.de/id/eprint/19392