Phase III, Multicenter Study to Evaluate the Safety, immune response, and effectiveness of Two Doses of aH5N1 vaccine when Administered to Adult and Elderly Subjects With and Without Underlying Diseas...

Mise à jour : Il y a 4 ans
Référence : EUCTR2011-003603-37

Phase III, Multicenter Study to Evaluate the Safety, immune response, and effectiveness of Two Doses of aH5N1 vaccine when Administered to Adult and Elderly Subjects With and Without Underlying Diseases

Femme et Homme

  • | Pays :
  • -
  • | Organes :
  • -
  • | Spécialités :
  • -

Extrait

Primary Immunogenicity Objective: To evaluate homologous antibody responses to aH5N1 vaccine 3 weeks after second vaccination (day 43) according to CHMP immunogenicity criteria1 in adult (18 through 60 years of age) and elderly (≥61 years of age) subjects who are healthy or with underlying medical condition, as measured by hemagglutination inhibition (HI) assay. Primary Safety Objective: To evaluate in pooled age groups 18 years of age and older solicited and unsolicited adverse events in adults and elderly subjects who are healthy or with underlying medical condition who have received aTIV or aH5N1 vaccine.


Critère d'inclusion

  • Pandemic influenza

Liens