Safety and Immunogenicity of a Vero Cell Culture–Derived Whole-Virus Influenza A(H5N1) Vaccine in a Pediatric Population

BACKGROUND: Children are highly vulnerable to infection with novel influenza viruses. It is essential to develop candidate pandemic influenza vaccines that are safe and effective in the pediatric population. METHODS: Infants and children aged 6-35 months and 3-8 years, respectively, were randomized to receive 2 immunizations with a 7.5-µg or 3.75-µg hemagglutinin (HA) dose of a nonadjuvanted whole-virus A/Vietnam(H5N1) vaccine; adolescents aged 9-17 years received a 7.5-µg dose only. A subset of participants received a booster immunization with an A/Indonesia(H5N1) vaccine approximately 1 year later. HA and neuraminidase antibody responses were assessed. RESULTS: Vaccination was safe and well tolerated; adverse reactions were transient and predominantly mild. Two immunizations with the 7.5-µg dose of A/Vietnam vaccine induced virus microneutralization (MN) titers of ≥1:20 against the A/Vietnam strain in 68.8%-85.4% of participants in the different age groups. After the booster, 93.1%-100% of participants achieved MN titers of ≥1:20 against the A/Vietnam and A/Indonesia strains. Neuraminidase-inhibiting antibodies were induced in ≥90% of participants after 2 immunizations with the 7.5 µg A/Vietnam vaccine and in 100% of participants after the booster. CONCLUSIONS: A whole-virus influenza A(H5N1) vaccine is suitable for prepandemic or pandemic immunization in a pediatric population. CLINICAL TRIALS REGISTRATION: NCT01052402.