Additional Relevant Details The Japanese Ministry of Health, Labour and Welfare has approved the New Drug Application (“NDA”) for a conjugate vaccine to prevent infections caused by Haemophilus influenzae type b (Hib) in children aged from 2 months to under 5 years of age. The vaccine was licensed from Novartis (Switzerland)* in May 2009 (Novartis' product name: VAXEM Hib). The vaccine is supplied as a suspension for injection that does not require reconstitution.


The application approval is based on positive Phase 3 clinical results of a multicenter, randomized, double-blind, parallel-group, comparative study in 416 Japanese children, which evaluated the safety and immunogenicity of this vaccine compared to a Hib vaccine licensed in Japan.