Supplementary Table 2. CHMP criteria for Hemagglutination inhibition (HI) response to vaccination.
Vaccine Group TIV (n=30) ATIV (n=25) TIV (n=30) ATIV (n=25) TIV (n=30) ATIV (n=25)
73% 100% 9.99 41 93% 100%
(54%-88%) (86%-100%) (5.87-17) (23-74) (78%-99%) (86%-100%)
93% 100% 35 199 97% 100%
(78%-99%) (86%-100%) (24-51) (130-303) (83%-100%) (86%-100%)
53% 100% 5.63 34 57% 100%
(34%-72%) (86%-100%) (3.83-8.29) (22-52) (37%-75%) (86%-100%)
7% 32% 1.38 3.35 10% 32%
(1%-22%) (15%-54%) (0.91-2.09) (2.11-5.3) (2%-27%) (15%-54%)
27% 68% 2.28 6.49 27% 68%
(12%-46%) (46%-85%) (1.42-3.66) (3.83-11) (12%-46%) (46%-85%) Seroconversion or
Significant Increase
Geometric Mean Ratio (Day 50/Day 1)
A/H1N1/California/07/2009
A/H3N2/Victoria/210/2009
% of Subjects with HI Titers ≥ 1: 40
B/Malaysia/04 Homologous strains
H et er ol og ou s
strains
B/Brisbane/60/2008
A/H3N2/Uruguay/07
HI results were evaluated as I) percentage of subjects achieving Seroconversion (defined as a change in HI titer of < 1:10 on day 1 to a HI titer ≥ 1:40 at day 50) or significant increase in HI titers (defined as a 4 fold or greater increase in titer in a subject with a day 1 titer ≥ 1:10);
II) Geometric Mean Ratio (GMR) of HI on day 50 /day 1 ; III) percentage of subjects achieving seroprotection (defined as the proportion of subjects with an HI titer ≥ 1:40 post vaccination). All analyses were done using the per protocol set (PPS).
