bioCSL Limited's 2009 clinical trial to assess the immunogenicity and safety of trivalent influenza vaccine in US children raises concern

According to the Swedish MPA Response Assessment Report the results of the 2005-2006 study are "suggestive of a possible increase in reactogenicity in paediatric participants with subsequent vaccination using Afluria vaccine" ('Afluria' is a trade name for bioCSL TIV) [4]. bioCSL...

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Veröffentlicht in:	Vaccine 2015-10, Vol.33 (42), p.5492-5492
Hauptverfasser:	Effler, Paul V., MD, MPH, Kelly, Heath A., MBBS, MPH
Format:	Artikel
Sprache:	eng
Schlagworte:	Allergy and Immunology Female Humans Immunization Immunogenicity Influenza Influenza Vaccines - adverse effects Influenza Vaccines - immunology Influenza, Human - prevention & control Male Pediatrics Vaccination - adverse effects Vaccination - methods Vaccines
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Beschreibung
Zusammenfassung:	According to the Swedish MPA Response Assessment Report the results of the 2005-2006 study are "suggestive of a possible increase in reactogenicity in paediatric participants with subsequent vaccination using Afluria vaccine" ('Afluria' is a trade name for bioCSL TIV) [4]. bioCSL responded by suggesting the increased reactogenicity observed following 2006 CSL TIV in young children was "not clinically meaningful".
ISSN:	0264-410X 1873-2518
DOI:	10.1016/j.vaccine.2015.05.020