Tomas Jelinek1, Michael A Cromer2, Jakob P Cramer3, Deborah J Mills4, Kenneth Lessans5, Anthony W Gherardin6, Elizabeth D Barnett7, Stefan H F Hagmann8, Helena H Askling9, Sigrid Kiermayr10, Vera Kadlecek10, Susanne Eder-Lingelbach10, Christian Taucher11, Katrin L Dubischar10. 1. Berlin Center for Travel & Tropical Diseases, Berlin and Institute of Medical Microbiology, Immunology and Hygiene, University of Cologne, Germany. 2. Tampa Clinical Research, Inc., Tampa, FL, USA. 3. Takeda Pharmaceuticals International AG, Switzerland. 4. Dr. Deb - The Travel Doctor, Brisbane, Queensland, Australia. 5. Passport Health, Inc., Baltimore, MD, USA. 6. The Travel Doctor - TMVC Pty Ltd, Melbourne Docklands, Victoria, Australia. 7. Boston Medical Center, Section of Pediatric Infectious Diseases, Boston, MA, USA. 8. Bronx - Lebanon Hospital Center, Division of Pediatric Infectious Diseases, New York, NY, USA. 9. Karolinska Institutet, Dept. of Medicine, Unit for Infectious Diseases, Solna, Sweden. 10. Valneva Austria GmbH, Campus Vienna Biocenter, Vienna, Austria. 11. Valneva Austria GmbH, Campus Vienna Biocenter, Vienna, Austria. Electronic address: christian.taucher@valneva.com.
Abstract
BACKGROUND: Young travelers to South-East Asia may be at risk for Japanese encephalitis (JE). METHODS: IXIARO® (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®, and tenderness (44/88) and pain (22/88) with 0.5 ml IXIARO®. Common solicited systemic AEs were diarrhea (2/12) and loss of appetite (1/12) with 0.25 ml IXIARO® and muscle pain (27/88) and excessive fatigue (10/88) with 0.5 ml IXIARO®. 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® was generally well tolerated in children, with an overall AE profile similar to adults. IXIARO® was highly immunogenic in both dose groups.
BACKGROUND: Young travelers to South-East Asia may be at risk for Japanese encephalitis (JE). METHODS: IXIARO® (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®, and tenderness (44/88) and pain (22/88) with 0.5 ml IXIARO®. Common solicited systemic AEs were diarrhea (2/12) and loss of appetite (1/12) with 0.25 ml IXIARO® and muscle pain (27/88) and excessive fatigue (10/88) with 0.5 ml IXIARO®. 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® was generally well tolerated in children, with an overall AE profile similar to adults. IXIARO® was highly immunogenic in both dose groups.