Diary cards were used to record solicited local and general AEs occurring within 7 days following vaccination and all unsolicited AEs occurring within 21 days following each vaccination. pIMDs (a subset of AEs that

include both autoimmune diseases and other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology), MAEs and SAEs were recorded through the entire study period, up to Month 12. The intensity of all solicited AEs, except for fever, was graded on a standard scale of (0–3), Grade 1 being those that did not interfere with normal activities and Grade 3 being those that prevented normal activities (Grade 3 redness and swelling: diameter >100 mm). Fever was graded on a scale of 0–4; Grade 3 fever: temperatures ≥39.0 to ≤40.0 °C; Grade 4 fever: Vorinostat cell line temperatures >40.0 °C. Parents contacted the study NVP-BEZ235 research buy center within 24 h, if their children showed symptoms of ILI, i.e. fever ≥38.0 °C accompanied by cough or sore throat. Reverse transcriptase polymerase chain reaction testing (RT-qPCR) was used to identify ILIs due to H1N1/2009 infection. A sample size of at least 252 children (54 receiving one of the three regimens of adjuvanted vaccines and 90 receiving the non-adjuvanted vaccine) was estimated to provide a power of >99.9% to meet the primary

objective, assuming the reference points for SPR, SCR and GMFR to be 90.0, 90.0 and 30.0%, respectively. The SCR, SPR, GMFR,

and incidence of AEs were calculated with 95% confidence interval (CI). No statistical comparisons between vaccine groups for immunogenicity analysis were performed. The analyses of immunogenicity were performed on the per protocol cohort which included evaluable children who met the eligibility criteria and adhered to protocol-defined procedures. The analyses for safety were performed on the total vaccinated cohort (TVC), which included all enrolled children receiving at least one vaccine nearly dose. All statistical analyses were performed using Statistical Analysis Software (SAS) Libraries version 9.1. Between February and May 2010, 310 children received primary vaccine doses and completed the Day 42 visit (TVC). Of these, 308 completed the study through Day 364. Fig. 1 presents the reasons for elimination of subjects from the analyses at different time points. The mean age of subjects in the TVC at the time of vaccination was 14.2 years (range: 10–17 years) and the mean body mass index was 20.3 kg/m2; 53.5% of children were females. All subjects were of Caucasian heritage. The baseline demographic characteristics were similar across all treatment groups (Table 1). Table 2 presents the HI antibody responses against the H1N1/2009 strain. Before vaccination, 42.4–53.8% of subjects across the four treatment groups had seroprotective levels of HI antibody titers (∼70.0% were seropositive).