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Immunogenicity and safety of IXIARO (IC51) in a Phase II study in healthy Indian children between 1 and 3 years of age.

Abstract
For adults the standard administration of the Japanese encephalitis vaccine IXIARO is two injections of 6 microg in a 28-day interval. Immunogenicity and safety of 3 and 6 microg of IXIARO compared to JenceVac were investigated in 60 healthy Indian children aged between 1 and 3 years. JE specific neutralizing antibodies were measured at baseline and 28 days after the first and second vaccination. On Day 56 SCR of the 3 and 6 microg IXIARO and the JenceVac group were 95.7%, 95.2% and 90.9%, respectively, and GMT were 201, 218 and 230, respectively, both without statistically significant difference between the three groups. Local and systemic tolerability were captured in a diary 7 days post-vaccination. No apparent difference was seen in the safety profile between the vaccines. These first immunogenicity and safety data in children are promising and support the use of a 3 microg dose in children below the age of three for further development of IXIARO in the paediatric population.
AuthorsA Kaltenböck, K Dubischar-Kastner, E Schuller, Mahima Datla, C S Klade, T S A Kishore
JournalVaccine (Vaccine) Vol. 28 Issue 3 Pg. 834-9 (Jan 08 2010) ISSN: 1873-2518 [Electronic] Netherlands
PMID19857447 (Publication Type: Clinical Trial, Phase II, Comparative Study, Journal Article)
Chemical References
  • Antibodies, Neutralizing
  • Antibodies, Viral
  • Japanese Encephalitis Vaccines
Topics
  • Antibodies, Neutralizing (blood)
  • Antibodies, Viral (blood)
  • Child, Preschool
  • Drug-Related Side Effects and Adverse Reactions
  • Encephalitis, Japanese (prevention & control)
  • Female
  • Humans
  • Immunization, Secondary
  • India
  • Infant
  • Japanese Encephalitis Vaccines (administration & dosage, adverse effects, immunology)
  • Male

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