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Non-inferiority criteria were met separately for children in the sub-groups 6 months through 35 months of age and 3 years through 8 years of age as measured by geometric mean titers (GMTs) and seroconversion rates.
Both studies evaluated the activity of Gardasil in two ways--by measuring geometric mean titer antibody * activity produced by the vaccine against the four HPV types, and by measuring seroconversion rates for HPV-6, 11, 16, and 18.
With regard to WNV antibodies, the ELISA detected 44 positive samples and 1 doubtful sample, of which 29 were confirmed as positive by virus-neutralization test (virus-neutralization test titers ranging from 10 to 640; geometric mean titer = 20).
After a single immunization at the 3,000 microgram dose level, seven of eight subjects achieved antibody titers that are considered protective, with a geometric mean titer over 200 mIU/ml.
They then recorded each samplehs geometric mean titer (GMT), a measure of its ability to neutralize a virus.
Immunogenicity was measured by (1) the percentage of individuals who were seropositive for antibodies against the relevant vaccine HPV type, and (2) the Geometric Mean Titer (GMT).
Inovio recently reported that its SynCon H5N1 plasmid construct generated high levels of antigen-specific binding antibodies and exhibited a four-fold or greater rise in geometric mean titers and HAI titers ranging from 1:20 to 1:80 against six different H5N1 virus strains.
Notably, although few of the prepandemic serum samples tested had evidence of antibody titers [greater than or equal to] 40 to any of the swine H1 viruses, the convalescent-phase serum sample of most persons had detectable antibody titers to other influenza viruses: CS (H1N1) Sw4167 (93% seropositive at a titer of [greater than or equal to] 40; geometric mean titer [GMT] 121.