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.
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Authors | A Kaltenböck, K Dubischar-Kastner, E Schuller, Mahima Datla, C S Klade, T S A Kishore |
Journal | Vaccine
(Vaccine)
Vol. 28
Issue 3
Pg. 834-9
(Jan 08 2010)
ISSN: 1873-2518 [Electronic] Netherlands |
PMID | 19857447
(Publication Type: Clinical Trial, Phase II, Comparative Study, Journal Article)
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Chemical References |
- Antibodies, Neutralizing
- Antibodies, Viral
- Japanese Encephalitis Vaccines
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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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