Vaccine 28 (2010) 4680–4685 Contents lists available at ScienceDirect Vaccine journal homepage: www.elsevier.com/locate/vaccine Comparison of immunogenicity and safety between two paediatric TBE vaccines Eva Maria Pöllabauer a , Borislava G. Pavlova a,∗ , Alexandra Löw-Baselli a , Sandor Fritsch a , Roman Prymula b , Rudolf Angermayr c , Wolfgang Draxler a , Clair Firth a , Jael Bosman a , Barbara Valenta a , Peter Harmacek a , Friedrich Maritsch a , P. Noel Barrett a , Hartmut J. Ehrlich a a Global R&D, Baxter BioScience, Industriestrasse 67, A-1220 Vienna, Austria b University of Defence, Department of Epidemiology, Hradec Kralove, Czech Republic c General Practice, Wels, Austria article info Article history: Received 16 February 2010 Received in revised form 1 April 2010 Accepted 14 April 2010 Available online 28 April 2010 Keywords: Tick-borne encephalitis Paediatric vaccines FSME-IMMUN ® Junior Encepur ® Children abstract TBE vaccination strategies capable of inducing strong paediatric immunogenicity and acceptable reac- togenicity are still under evaluation. This single-blind, multi-center, randomized, controlled, phase III clinical study compared the immunogenicity and safety of the two paediatric TBE vaccines available in Europe (FSME-IMMUN ® Junior and Encepur ® Children) following administration of two doses of either vaccine in 303 children aged 1–11 years. Regardless of immunological test or viral antigen used, immuno- logical responses were consistently higher in children vaccinated with FSME-IMMUN ® Junior than those vaccinated with Encepur ® Children. FSME-IMMUN ® Junior is also non-inferior to Encepur ® Children, with respect to NT seropositivity rates (p < 0.0001). Systemic reaction rates were low and similar between the vaccines. However, among children aged 7–11 years, local reactions were significantly higher after the first (p < 0.01) and second (p < 0.001) vaccination with Encepur ® Children than with FSME-IMMUN ® Junior, affecting half the children in the former group: 22.4% and 10.2% with FSME-IMMUN ® Junior vs. 49.0% and 51.0% for Encepur ® Children. © 2010 Elsevier Ltd. All rights reserved. 1. Introduction Tick-borne encephalitis (TBE) is a central nervous system infec- tion which has been shown to result in long-term neurological sequelae in up to 46% of patients or take a lethal course in 1–2% of cases [1,2]. The etiologic agent, tick-borne encephalitis virus (TBEV), is a member of the family of the Flaviviridae, an arbovirus that is transmitted to humans by infected tick vectors (e.g. Ixodes ricinus). The prevalence of TBE in human populations in endemic areas varies widely (throughout Europe and parts of Asia), with recent reports of the disease spreading beyond its previous boundaries due to a variety of factors including climate, social, economic and demographic changes influencing tick populations [3,4]. Although TBE in children is generally considered to be a milder illness than in adults, there have been a number of reports of severe cases among the paediatric population [5–8]. While direct compari- son of clinical and epidemiological characteristics of TBE in children and adults has revealed differences in several clinical and labora- tory features, it has corroborated the conclusion that the course of the disease is the same in both groups [8]. ∗ Corresponding author. Tel.: +43 1 201003298; fax: +43 1 201005055. E-mail address: borislava pavlova@baxter.com (B.G. Pavlova). Once the disease has developed, the only remedy for TBE is symptomatic treatment, thus necessitating effective prevention through vaccination [9]. The risk of developing a postencephalitic syndrome (for months to years after the acute illness) or resid- ual neurologic sequelae and even fatal outcome in children is considered sufficient to warrant the inclusion of children in endemic areas in the routine paediatric vaccination schedule of many European countries. During the first years of life, the immune maturation is responsible for a progressive increase in antibody responses that can be elicited against vaccine antigens. Paediatric TBE vaccine formulations and immunisation strate- gies capable of meeting the challenge of both strong neonatal immunogenicity and acceptable reactogenicity are still under eval- uation. In Europe, two paediatric TBE vaccines are available on the market: FSME-IMMUN ® 0.25 mL Junior (Baxter Innovations GmbH, Vienna, Austria) which is indicated for use in children and adoles- cents aged 1–15 years, and Encepur ® 0.25 mL Children (Novartis Vaccines and Diagnostics GmbH & Co., Marburg, Germany) indi- cated for children aged 1–11 years. The antigenic components of both inactivated vaccines are homologous and induce a similar immune response [10]. According to the manufacturer’s recom- mendations, the conventional paediatric primary vaccination schedule consists of three doses of the vaccine administered at 0, 1–3, and 9–12 months for Encepur ® Children, or at 0, 1–3, and 5–12 months for FSME-IMMUN ® Junior. 0264-410X/$ – see front matter © 2010 Elsevier Ltd. All rights reserved. doi:10.1016/j.vaccine.2010.04.047