Safety of the Inactivated Japanese Encephalitis Virus Vaccine IXIARO in Children: An Open-label, Randomized,

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Katrin L Dubischar1, Vera Kadlecek, Benjamin Sablan

  • 1From the *Valneva Austria GmbH, Vienna, Austria; †Department of Pediatrics, University of the Philippines, ‡Department of Health, Research Institute for Tropical Medicine, and §Section of Infectious and Tropical Diseases, Department of Pediatrics, Universtity of the Philippines, College of Medicine, Philippine General Hospital, Manila, Philippines; and ¶Department of Health, Research Institute for Tropical Medicine, Muntinlupa, Philippines.

The Pediatric Infectious Disease Journal
|April 26, 2017
PubMed

Insights

The Japanese encephalitis virus vaccine IXIARO demonstrated a comparable safety profile to control vaccines in children. Adverse event rates were similar across age groups, with fewer events seen in older children.

Area of Science:

  • Pediatric Vaccinology
  • Infectious Disease Control
  • Public Health

Background:

  • Japanese encephalitis (JE) is a significant health threat in Asia, impacting children and travelers.
  • The safety of the JE vaccine IXIARO in pediatric populations requires thorough investigation.

Purpose of the Study:

  • To assess the safety profile of the Japanese encephalitis virus vaccine IXIARO in children.
  • To compare adverse event rates of IXIARO against control vaccines (Prevnar and HAVRIX 720) in pediatric subjects.

Main Methods:

  • A randomized study involving 1869 children aged 2 months to 17 years.
  • Participants received either IXIARO or control vaccines, with adverse events monitored up to 7 months post-vaccination.

Main Results:

  • No significant differences in adverse events (AEs), serious AEs, or medically attended AEs were observed between vaccine groups.
  • AE incidence was highest in infants (<1 year) and decreased with age; fever was the most common systemic reaction.

Conclusions:

  • IXIARO exhibits a comparable safety profile to control vaccines in pediatric populations.
  • The vaccine is deemed safe for children, with AE rates consistent with other routine pediatric immunizations.
Abstract

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