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Clinical Trial
. 2012 Jun;8(6):736-42.
doi: 10.4161/hv.20058. Epub 2012 Jun 1.

Antibody persistence after two vaccinations with either FSME-IMMUN® Junior or ENCEPUR® Children followed by third vaccination with FSME-IMMUN® Junior

Roman Prymula  1 , Eva Maria Pöllabauer, Borislava G Pavlova, Alexandra Löw-Baselli, Sandor Fritsch, Rudolf Angermayr, Alexander Geisberger, P Noel Barrett, Hartmut J Ehrlich
Affiliations
Clinical Trial

Antibody persistence after two vaccinations with either FSME-IMMUN® Junior or ENCEPUR® Children followed by third vaccination with FSME-IMMUN® Junior

Roman Prymula et al. Hum Vaccin Immunother. 2012 Jun.

Abstract

Tick-borne encephalitis (TBE) vaccination strategies to induce optimal seroprotection in children are under constant evaluation. This multi-center, randomized, controlled, phase III clinical study examined antibody persistence in children aged 1-11 y following two prospectively administered doses of either the FSME-IMMUN® Junior or Encepur Children® vaccines, as well as investigating the immunogenicity, safety and vaccine interchangeability of a third vaccination with FSME-IMMUN(®) Junior. A high level of antibody persistence was observed in all subjects 6 mo after the first of two vaccinations with either pediatric TBE vaccine. Based on both immunological tests and viral antigens used, slightly higher seropositivity rates and higher GMCs /GMTs were found in children vaccinated with FSME-IMMUN® Junior compared with those who received Encepur® Children. Seropositivity rates across all age strata combined six months after the first vaccination with FSME-IMMUN® 0.25 mL Junior were 95.1% as determined by Immunozym ELISA, 93.2% as determined by Enzygnost ELISA and 95.3% as determined by NT; compared with 62.6%, 80.5% and 91.0% respectively after vaccination with Encepur® Children. A third vaccination with FSME-IMMUN(®) Junior induced 100% seropositivity in both study groups and was well tolerated as demonstrated by the low rates of systemic and injection site reactions. Subjects who received either FSME-IMMUN Junior® or Encepur(®) Children vaccine for the first two vaccinations and FSME-IMMUN Junior® for the third showed a comparably strong immune response regardless of the previous TBE vaccine administered, demonstrating that two vaccinations with Encepur® Children can successfully be followed by a third vaccination with FSME-IMMUN Junior®.

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