Enhancing the reproducibility of serological methods used to evaluate immunogenicity of pandemic H1N1 influenza vaccines—An effective EU regulatory approach

Highlights ► Lab-to-Lab reproducibility of haemagglutination inhibition and neutralisation assay. ► Assays for evaluation of influenza vaccine immunogenicity for regulatory approval. ► EMA central retesting: control authorities retest sera from pandemic vaccine trials. ► Almost 2000 sera from all EU...

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Veröffentlicht in:	Vaccine 2012-06, Vol.30 (27), p.4113-4122
Hauptverfasser:	Wagner, Ralf, Göpfert, Constanze, Hammann, Joanna, Neumann, Britta, Wood, John, Newman, Robert, Wallis, Chantal, Alex, Nina, Pfleiderer, Michael
Format:	Artikel
Sprache:	eng
Schlagworte:	Adolescent Adult Aged Aged, 80 and over Allergy and Immunology Antibodies, Neutralizing - blood Antibodies, Viral - blood blood serum Child Child, Preschool Clinical Laboratory Techniques - standards clinical trials European Union Female Haemagglutination-inhibition Humans immune response Immunoassay - standards Immunogenicity Infant Infant, Newborn influenza Influenza A Virus, H1N1 Subtype - immunology Influenza Vaccines - immunology Influenza Vaccines - standards Influenza, Human - prevention & control Laboratories Male Middle Aged Neutralisation neutralization neutralization tests pandemic Pandemic influenza Pandemics Reference Standards Regulatory assessment Reproducibility of Results Serological assays Swine flu Vaccination - standards Vaccine immunogenicity Vaccines Young Adult
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Zusammenfassung:	Highlights ► Lab-to-Lab reproducibility of haemagglutination inhibition and neutralisation assay. ► Assays for evaluation of influenza vaccine immunogenicity for regulatory approval. ► EMA central retesting: control authorities retest sera from pandemic vaccine trials. ► Almost 2000 sera from all EU manufacturers retested: high variability of results. ► Reproducibility markedly improved by inclusion of calibrated antiserum standard.
ISSN:	0264-410X 1873-2518
DOI:	10.1016/j.vaccine.2012.02.077