Clinical evaluation to determine the appropriate paediatric formulation of a tick-borne encephalitis vaccine

Vaccine

Volumn 28, Issue 29, 2010, Pages 4558-4565

  Pöllabauer, Eva Maria ^a   Fritsch, Sandor ^a   Pavlova, Borislava G ^a   Löw Baselli, Alexandra ^a   Firth, Clair ^a   Koska, Manuela ^a   Maritsch, Friedrich ^a   Barrett, P Noel ^a   Ehrlich, Hartmut J ^a  

^a BAXTER BIOSCIENCE   (Austria)

Author keywords

FSME IMMUN ; Paediatric vaccine; TBE

Indexed keywords

FSME IMMUN; TICK BORNE ENCEPHALITIS VACCINE; TICOVAC; UNCLASSIFIED DRUG;

ANOREXIA; ARTHRALGIA; CLINICAL TRIAL; DEVELOPMENTAL DISORDER; DRUG EFFICACY; DRUG FEVER; DRUG FORMULATION; DRUG INDUCED HEADACHE; DRUG SAFETY; ECCHYMOSIS; ENDEMIC DISEASE; FATIGUE; HEALTH PROGRAM; HEMATOMA; HUMAN; IMMUNE RESPONSE; IMMUNOGENICITY; INCIDENCE; INJECTION SITE ERYTHEMA; INJECTION SITE INDURATION; INJECTION SITE PAIN; INJECTION SITE PRURITUS; INJECTION SITE REACTION; INJECTION SITE SWELLING; INSOMNIA; LYMPHADENOPATHY; MALAISE; MYALGIA; NAUSEA; NEUROLOGIC DISEASE; OPEN STUDY; OPTIMAL DRUG DOSE; PREVALENCE; PRIORITY JOURNAL; RESTLESSNESS; REVIEW; SEROCONVERSION; SLEEP DISORDER; TICK BORNE ENCEPHALITIS; TICK BORNE ENCEPHALITIS FLAVIVIRUS; VACCINATION; VIRUS TRANSMISSION; VOMITING;

ADOLESCENT; ADULT; ANTIBODIES, VIRAL; CHILD; CHILD, PRESCHOOL; DOSAGE FORMS; DOSE-RESPONSE RELATIONSHIP, IMMUNOLOGIC; DOUBLE-BLIND METHOD; ENCEPHALITIS VIRUSES, TICK-BORNE; ENCEPHALITIS, TICK-BORNE; HUMANS; IMMUNOGLOBULIN G; INFANT; PEDIATRICS; VIRAL VACCINES; YOUNG ADULT;

EID: 77953230906     PISSN: 0264410X     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.vaccine.2010.04.075     Document Type: Review

References (28)

1. Barrett P.N., Schober-Bendixen S., and Ehrlich H.E. History of TBE vaccines. Vaccine 21 April (Suppl. 1) (2003) S41-S49
2. Lindgren E., and Gustafson R. Tick-borne encephalitis in Sweden and climate change. Lancet 358 9275 (2001) 16-18
3. Brauchli Y.B., Gittermann M., Michot M., Kraehenbuehl S., and Gnehm H.E. A fatal tick bite occurring during the course of tick-borne encephalitis vaccination. Pediatr Infect Dis J 27 April (4) (2008) 363-365
4. Jones N., Sperl W., Koch J., Holzmann H., and Radauer W. Tick-borne encephalitis in a 17 day old newborn resulting in severe neurologic impairment. Pediatr Infect Dis J 26 2 (2007) 185-186
5. Schmolck H., Maritz E., Kletzin I., and Korinthenberg R. Neurological, neuropsychological and electroencephalographic findings after European tick-borne encephalitis in children. J Child Neurol 20 (2005) 506-508
6. Grubbauer H.M., Dornbusch H.J., Spork D., Zobel G., Trop M., and Zenz W. Tick-borne encephalitis in a 3-month-old child. Eur J Pediatr 151 (1992) 743-744
7. Logar M., Arnez M., Kolbl J., Avsic-Zupanc T., and Strle F. Comparison of the epidemiological and clinical features of tick-borne encephalitis in children and adults. Infection 28 March-April (2) (2000) 74-77
8. Lesnicar G., Poljak M., Seme K., and Lesnicar J. Pediatric tick-borne encephalitis in 371 cases from an endemic region in Slovenia, 1959 to 2000. Pediatr Infect Dis J 22 July (7) (2003) 612-617
9. Cizman M., Rakar R., Zakotnik B., Pokorn M., and Arnez M. Severe forms of tick-borne encephalitis in children. Wien Klin Wochenschrift III 12 (1999) 484-487
10. Fritsch P., Gruber-Sedlmayr U., Pansi H., Zoehrer B., Mutz I., Spork D., et al. Tick-borne encephalitis in Styrian children from 1981 to 2005: a retrospective study and a review of the literature. Acta Paediatr 97 (2008) 535-538
11. Zenz W., Pansi H., Zoehrer B., Mutz I., Holzmann H., and Kraigher A. Tick borne encephalitis in children in Styria and Slovenia between 1980 and 2003. Pediatr Infect Dis J 24 October (10) (2005) 892-896
12. Kunze U., Asokliene L., Bektimirov T., Busse A., Chmelik V., Heinz F.X., et al. Tick-borne encephalitis in childhood-consensus 2004. Wien Med Wochenschr 154 May (9-10) (2004) 242-245
13. Barrett P.N., Dorner F., Ehrlich H., and Plotkin S.A. Tick-borne encephalitis virus vaccine. In: Plotkin S.A., Orenstein W.A., and Offit P.A. (Eds). Vaccines. 4th ed. (2004), Elsevier Inc., Pennsylvania, USA 1039-1055 [chapter 38]
14. Donoso Mantke O., Schädler R., and Niedrig M. A survey on cases of tick-borne encephalitis in European countries. Euro Surveill 13 April (17) (2008)
15. The International Scientific-Working Group on Tick-Borne Encephalitis (TBE/FSME). Epidemiology 2007. Reported Cases, http://www.isw-tbe.info [accessed December 2009].
16. Daniel M., Kríz B., Danielová V., Valter J., and Kott I. Correlation between meteorological factors and tick-borne encephalitis incidence in the Czech Republic. Parasitol Res 103 December (Suppl. 1) (2008) S97-S107
17. Marth E., and Kleinhappl B. Albumin is a necessary stabilizer of TBE-vaccine to avoid fever in children after vaccination. Vaccine 20 November (3-4) (2001) 532-537
18. Pavlova B.G., Loew-Baselli A., Fritsch S., Poellabauer E.M., Vartian N., Rinke I., et al. Tolerability of modified tick-borne encephalitis vaccine FSME-IMMUN NEW in children: results of post-marketing surveillance. Vaccine 21 January (7-8) (2003) 742-745
19. Adner N., Leibl H., Enzersberger O., Kirgios M., and Wahlberg T. Pharmacokinetics of human tick-borne encephalitis virus antibody levels after injection with human tick-borne encephalitis immunoglobulin, solvent/detergent treated, FSME-BULIN S/D in healthy volunteers. Scand J Infect Dis 33 (2001) 843-847
20. Cancer Therapy Evaluation Program, Common Toxicity Criteria, Version 2.0; 1999, April 30.
21. Agresti A. Chap. 3. 4. 2: estimating proportions and relative risk. Categorical data analysis (1990), Wiley & Sons 55 Eq. 3.17
22. Ehrlich H.J., Pavlova B.G., Fritsch S., Poellabauer E.M., Loew-Baselli A., Obermann-Slupetzky O., et al. Randomized, phase II dose-finding studies of a modified tick-borne encephalitis vaccine: evaluation of safety and immunogenicity. Vaccine 22 December (2) (2003) 217-223
23. Heinz F.X., Holzmann H., Essl A., and Kundi M. Field effectiveness of vaccination against tick-borne encephalitis. Vaccine 25 (2007) 7557-7567
24. Bartlett J.A., Schleifer S.J., Demetrikopoulos M., Delaney B., Shiflett S., and Keller S.E. Immune function in healthy adolescents. Clin Diagn Lab Immunol 5 (1998) 105-113
25. Bartlett J.A., Goldklang A.R., Schleifer S.J., and Keller S.E. Immune function in healthy inner-city children. Clin Diagn Lab Immunol 8 July (4) (2001) 740-746
26. Luebke R.W., Chen D.H., Dietert R., Yang Y., King M., and Luster M.I. The comparative immunotoxicity of five selected compounds following developmental or adult exposure. J Toxicol Environ Health B: Crit Rev 9 (2006) 1-26
27. Krishnaraj R., Zaks A., and Unterman T. Relationship between plasma IGF-I levels, in vitro correlates of immunity, and human senescence. Clin Immunol Immunopathol 88 September (3) (1998) 264-270
28. Linquist L. Tick-borne encephalitis (TBE) in childhood. Acta Paediatr 97 (2008) 532-534