Extrait

Co-primary Immunogenicity Objective • To assess the superiority of the haemagglutination inhibition (HI) antibody response against A/turkey/Turkey/01/2005 (H5N1) 10 days following H5N1 vaccination at Day 182 [1.9 µg A/turkey/Turkey/01/2005 (H5N1) HA antigen adjuvanted with AS03B] in subjects previously primed with 2 doses of heterologous A/Indonesia/5/2005 (H5N1) vaccine (Group H5N1_H5N1) versus non primed subjects (Group Havrix_H5N1). Co-primary Safety Objective • To evaluate the safety of the paediatric H5N1 vaccine when administered as a 2-dose primary vaccination to subjects 3 to 17 years of age in terms of occurrence of medically attended adverse events (MAEs) from Day 0 to Day 182 and to the Day 364 visit.

Critère d'inclusion

• Prime-boost immunisation of healthy subjects aged 3 to 17 years against pandemic H5N1 influenza