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A Phase II, Randomized, Controlled, Double-blind, Multi-center, Study to Evaluate Safety and Immunogenicity of Two Doses, Administered Three Weeks Apart, of Two Monovalent H5N1 (Surface Antigen Adjuva...

Mise à jour : Il y a 5 ans
Référence : EUCTR2009-012385-31

A Phase II, Randomized, Controlled, Double-blind, Multi-center, Study to Evaluate Safety and Immunogenicity of Two Doses, Administered Three Weeks Apart, of Two Monovalent H5N1 (Surface Antigen Adjuvanted with MF59C.1) Influenza Vaccines Containing 3.75 mcg or 7.5 mcg of H5N1 Influenza Antigen, in Non-elderly Adult and Elderly Subjects

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Extrait

Primary To demonstrate the non-inferiority of antibody responses of two 0.5 mL intramuscular (IM) injections administered 3 weeks apart of a monovalent MF59-adjuvanted H5N1 pandemic vaccine containing 3.75µg H5N1 antigen dose to a pandemic vaccine containing a 7.5µg H5N1antigen dose in terms of post-immunization geometric mean titers (GMT) Co-Primary Once non-inferiority has been shown as determined by SRH, subsequently non-inferiority will be assessed as determined by HI test in a stepwise procedure, thus non-inferiority can be concluded if either non-inferiority can be shown for SRH only or if it can be shown for both SRH and HI

Critère d'inclusion

  • Avian influenza

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