4.5 Article

Safe vaccination of children with a virosomal adjuvanted influenza vaccine

Journal

VACCINE
Volume 27, Issue 8, Pages 1261-1265

Publisher

ELSEVIER SCI LTD
DOI: 10.1016/j.vaccine.2008.12.008

Keywords

Vaccines; Child; Virosome; Influenza; Human; Safety

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A post-marketing study was conducted in 26 paediatric practices in Germany to collect safety information oil the virosomal adjuvanted influenza vaccine Inflexal (R) V (in Germany marketed as Infectovac Flu (R)). Children aged 6 months to 6 years received one or two doses. Adverse events were documented by parents/legal guardians in a questionnaire for four days after vaccination. The rates of adverse events were low: 14% of vaccine exposures were associated with systemic and 25% with local adverse events. Most symptoms were mild to moderate and resolved within a few days. Nearly 100% of parents/legal guardians would agree to have their child vaccinated again with Inflexal (R) V. Vaccination with Inflexal (R) V was safe, well tolerated and highly accepted by parents/legal guardians. (C) 2008 Elsevier Ltd. All rights reserved.

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