Page 450 - TBE_Book_V2_2019

Chapter 14: Prevention

Another pediatric study investigated immune formulation to the former vaccine containing
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response in 149 and 152 children 1–11 years polygeline was demonstrated. In addition,
of age, who were vaccinated with FSME- the rapid immunization schedule using the
IMMUN Junior and Encepur Children, new formulation was investigated. 17,19,20 The
respectively, in the context of a primary new formulation was also shown to be safe
immunization schedule. According to the NT and immunogenic in a review of data from
based on the Neudörfl strain, seropositivity clinical trials and post-marketing experience in
rates after the second vaccination in the approximately 7,500 subjects ages 1 to 77
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combined age groups was 100.0% in children years. The immunogenicity of the vaccine
who received FSME-IMMUN Junior and 97.8% and the advantages of the rapid immunization
in those who received 2 vaccinations with schedule were further confirmed in a number
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Encepur Children. A third vaccination with of pediatric trials that enrolled more than
FSME-IMMUN Junior induced 100% sero- 3,500 children 1–11 years of age. 21,22 The
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positivity in both study groups. immunogenicity of the rapid schedule in
children, as well as the interchangeability with
An earlier pediatric study, which investigated FSME-IMMUN when given as a third dose, was
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the immune response in 334 children to both shown by Wittermann et al. Seropositivity
FSME-IMMUN Junior and Encepur Children for rates of 99% and 100% were determined at 3
the first 2 vaccinations, using the conventional and 5 years, respectively, after booster doses
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as well as the rapid immunization schedule, in children 1–11 years of age.
found higher seropositivity rates (NT ≥10) in
the Encepur-immunized group versus the Russian vaccines
group that received FSME-IMMUN Junior,
using either vaccination schedule. Upon The Russian vaccines, TBE-Moscow (Klesch-E-
completion of the primary vaccination course, Vac) and EnceVir, have been evaluated in 2
and after the third dose (given with Encepur clinical studies, each involving 200 adults.
Children), >95% of all children achieved an NT Antibody titers ≥1:80 (hemagglutination
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≥10. Both studies confirmed the inter- inhibition [HI] test) were detected following 2
changeability of the 2 TBE vaccines when doses, 2 or 5 months apart, in 84% and 93% of
given as a third dose in the context of a subjects receiving TBE-Moscow vaccine and in
conventional or rapid primary immunization 82% and 89% of the vaccinees who received
schedule. EnceVir, respectively. 24,25
Encepur Another study with an age-stratified analysis
of 325 subjects found at least a 4-fold increase
Data on the immunogenicity of Encepur from of HI-antibody titers in 96%, 93%, and 89%,
8 clinical and post-marketing studies, which respectively, for each of 3 age groups: 3–6
included 7,500 subjects, showed 100% years, 7–14 years, and 15–18 years, after
seroconversion or a 4-fold rise in anti-TBEV vaccination with TBE-Moscow vaccine, versus
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antibodies after primary immunization. 84%, 97%, and 92%, respectively, for the same
Similar immunogenicity was achieved with age groups after receiving the EnceVir
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either conventional or rapid immunization vaccine.
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schedules (see Table 2).
No significant differences regarding
In 3 studies, comprising a total of 3,118 immunogenicity against different TBEV strains
subjects between ages 12 and 76 years, the could be found between TBE-Moscow vaccine
non-inferiority of the new polygeline-free and FSME Immun Inject (FSMEV propagated in

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