A dose ranging safety and immunogenicity study of GlaxoSmithKline (GSK) Biologicals’ GSK1557484A vaccine in children 6 to less than 36 months of age

Mise à jour : Il y a 4 ans
Référence : EUCTR2015-003458-42

Femme et Homme

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Extrait

Primary Doses • To assess the performance of alternative dosing regimens for primary immunization with Q-Pan H5N1 vaccine using an immunogenicity-fever index that considers: - immunogenicity by Hemagglutination Inhibition (HI) assay 21 days after the second priming dose. - fever scores after the first and second priming doses. - immunogenicity by Microneutralization (MN) assay 21 days after the second priming dose. - fever scores after the first and second priming doses. Booster Dose • To assess the performance of dosing regimens for booster immunization with Q-Pan H5N1 vaccine considering: - immune response (IR) by HI assay 7 days after a 12-month booster dose of Hemagglutinin (HA) Q-Pan H5N1 plain antigen. - immune response by MN assay 7 days after a 12-month booster dose of HA Q-Pan H5N1 plain antigen.


Critère d'inclusion

  • Healthy volunteers (Active immunization against influenza A virus H5N1 subtype)

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