The dose for children aged between 2 months and 3 years is 0.25ml and for children aged 3 to 18 years is 0.5ml. The lower dose is administered using the existing 0.5ml prefilled syringe but healthcare professionals must discard the excess volume before injection, as directed in the product literature. For both age groups, the vaccine should be given as two doses 28 days apart. There are no data available on booster doses in the paediatric population.
Give by intramuscular injection
The vaccine should be injected intramuscularly into the deltoid muscle; however, the anterolateral aspect of the thigh may be used in infants. The subcutaneous route may be used in patients with bleeding disorders, although there are no clinical efficacy data to support administration by this route.
Efficacy supported by two key studies
Evidence supporting this licence extension comes from two key randomised, open-label studies investigating the immunogenicity and safety in children aged between 2 months and 18 years. The first study was conducted in the Philippines, a country where JEV is endemic, and the second is an ongoing, uncontrolled trial in non-endemic countries (the US, Europe and Australia) in subjects with planned travel to an endemic area.
In both studies, seroconversion rates, defined as JEV neutralising antibody titre ≥1:10, were at least 85% at month 7 following vaccination. The safety profile was comparable to that of Havrix or Prevenar.
Further information: Novartis Vaccines