Safe vaccination of children with a virosomal adjuvanted influenza vaccine.
A post-marketing study was conducted in 26 paediatric practices in Germany to collect safety information on the virosomal adjuvanted influenza vaccine Inflexal V (in Germany marketed as Infectovac Flu). 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 V. Vaccination with Inflexal V was safe, well tolerated and highly accepted by parents/legal guardians.
Künzi
Valérie
V
Crucell, Berna Biotech Ltd, Rehhagstrasse 79, 3018 Berne, Switzerland. valerie.kuenzi@crucell.ch
Dornseiff
Martin
M
Horwath
Jörg
J
Hartmann
Katharina
K
D002648:Child; D002675:Child, Preschool; D005858:Germany; D006801:Humans; D007223:Infant; D007252:Influenza Vaccines / Q000009:adverse effects* / Q000276:immunology*; D011358:Product Surveillance, Postmarketing; D011795:Surveys and Questionnaires; D022721:Vaccines, Virosome / Q000009:adverse effects* / Q000276:immunology*
C475022:Inflexal V; D007252:Influenza Vaccines; D022721:Vaccines, Virosome