During the 2013-2014 influenza season, CKD patients undergoing HD participated in the study. The patients were randomized into two groups (MF59-adjuvanted vaccine group or non-adjuvanted vaccine group) and were immunized with the respective vaccine. Sera were collected prior to vaccination and at 1and 6 months post vaccination. Levels of hemagglutination inhibition (HI) antibodies were measured.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
174
Seroprotection rate (A/H1N1, A/H3N2, B)
the proportion of participants with a HI titer level of ≥1:40
Time frame: 1 month after vaccination
Seroconversion rate (A/H1N1, A/H3N2, B)
the percentage of subjects with either a pre-vaccination HI titer ≥1:10 and a ≥4-fold increase in 1 month after vaccination HI antibody titer from pre-vaccination or pre-vaccination HI titer \<1:10 and a 1 month after vaccination HI titer of ≥1:40
Time frame: Change of titer from pre-vaccination to 1 month after vaccination
GMT fold change (A/H1N1, A/H3N2, B)
GMT ratio of the 1 month after vaccination titer to pre-vaccination titer
Time frame: Change of GMT from pre-vaccination to 1 month after vaccination
Seroprotection rate (A/H1N1, A/H3N2, B)
the proportion of participants with a HI titer level of ≥1:40
Time frame: 6 months after vaccination
Seroconversion rate (A/H1N1, A/H3N2, B)
the percentage of subjects with either a pre-vaccination HI titer ≥1:10 and a ≥4-fold increase in 6 months after vaccination HI antibody titer from pre-vaccination or pre-vaccination HI titer \<1:10 and a 6 months after vaccination HI titer of ≥1:40
Time frame: Change of titer from pre-vaccination to 6 months after vaccination
GMT fold change (A/H1N1, A/H3N2, B)
GMT ratio of the 6 months after vaccination titer to pre-vaccination titer
Time frame: Change of GMT from pre-vaccination to 6 months after vaccination
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