Vaccine Information: FLUZONE QUADRIVALENT SOUTHERN HEMISPHERE (Page 5 of 6)

14.4 Immunogenicity of the 0.5 mL Dose of Fluzone Quadrivalent in Children 6 Months through 35 Months of Age

In Study 2 (NCT02915302) [see Adverse Reactions (6.1)] , 1027 children, 6 months through 35 months of age, were included in the per-protocol immunogenicity analysis. The distribution of demographic characteristics was similar to that of the safety analysis set [see Adverse Reactions (6.1)].

In this study, children 6 months through 35 months of age received one or two doses of either 0.25 mL or 0.5 mL of Fluzone Quadrivalent. Non-inferiority of the 0.5 mL dose(s) relative to the 0.25 mL dose(s) of Fluzone Quadrivalent was demonstrated for all four strains based on pre- specified criteria (lower limit of the 2-sided 95% CI of the ratio of GMTs between groups >0.667; lower limit of the 2-sided 95% CI of the difference in seroconversion rates >-10%). GMT ratios (GMT0.5-mL dose divided by GMT0.25-mL dose ) for the A/H1N1, A/H3N2, B Victoria lineage, and B Yamagata lineage strains were 1.42 (95% CI: 1.16; 1.74), 1.48 (95% CI: 1.21; 1.82), 1.33 (95% CI: 1.09; 1.62), and 1.41 (95% CI: 1.17; 1.70), respectively. Seroconversion rate (SCR) differences (SCR0.5-mL dose minus SCR0.25-mL dose ) for the A/H1N1, A/H3N2, B Victoria lineage, and B Yamagata lineage strains were 4.6% (95% CI: -0.4%; 9.6%), 5.1% (95% CI: 0.4%; 9.8%), 1.3% (95% CI: -2.9%; 5.6%), and 2.6% (95% CI: -1.4%; 6.5%).

14.5 Immunogenicity of Fluzone Quadrivalent in Adults ≥18 Years of Age

In Study 3 (NCT00988143) [see Adverse Reactions (6.1)] , 565 adults 18 years of age and older who had received one dose of Fluzone Quadrivalent, TIV-1, or TIV-2 were included in the per- protocol immunogenicity analysis. The distribution of demographic characteristics was similar to that of the safety analysis set [see Adverse Reactions (6.1)].

HI antibody GMTs 21 days following vaccination with Fluzone Quadrivalent were non-inferior to those following each TIV for all four strains, based on pre-specified criteria (see Table 12).

Table 12: Study 3*: Non-inferiority of Fluzone Quadrivalent Relative to TIV for Each Strain by HI Antibody GMTs at 21 Days Post-Vaccination, Adults 18 Years of Age and Older (Per- protocol Analysis Set)†
*
NCT00988143
†
Per-protocol analysis set included all persons who had no study protocol deviations
‡
Fluzone Quadrivalent containing A/Brisbane/59/2007 (H1N1), A/Uruguay/716/2007 (H3N2), B/Brisbane/60/2008 (Victoria lineage), and B/Florida/04/2006 (Yamagata lineage)
§
N is the number of participants in the per-protocol analysis set
Pooled TIV group includes participants vaccinated with either TIV-1 or TIV-2
#
Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the ratio of GMTs (Fluzone Quadrivalent divided by pooled TIV for the A strains, or the TIV containing the corresponding B strain) was >2/3
Þ
2009-2010 Fluzone TIV containing A/Brisbane/59/2007 (H1N1), A/Uruguay/716/2007 (H3N2), and B/Brisbane/60/2008 (Victoria lineage), licensed
ß
2008-2009 Fluzone TIV containing A/Brisbane/59/2007 (H1N1), A/Uruguay/716/2007 (H3N2), and B/Florida/04/2006 (Yamagata lineage), licensed
à
TIV-2 did not contain B/Brisbane/60/2008
è
TIV-1 did not contain B/Florida/04/2006
Antigen Strain Fluzone Quadrivalent ‡N § =190 Pooled TIV N § =375 GMT Ratio(95% CI)#
GMT GMT
A (H1N1) 161 151 1.06 (0.87; 1.31)
A (H3N2) 304 339 0.90 (0.70; 1.15)
Fluzone Quadrivalent ‡N § =190 TIV-1Þ(B Victoria)N § =187 TIV-2ß(B Yamagata)N § =188 GMT Ratio(95% CI)#
GMT GMT GMT
B/Brisbane/60/2008(B Victoria) 101 114 (44.0)à 0.89 (0.70; 1.12)
B/Florida/04/2006(B Yamagata) 155 (78.1)è 135 1.15 (0.93; 1.42)

14.6 Immunogenicity of Fluzone Quadrivalent in Geriatric Adults ≥65 Years of Age

In Study 4 (NCT01218646) [see Adverse Reactions (6.1)] , 660 adults 65 years of age and older were included in the per-protocol immunogenicity analysis. The distribution of demographic characteristics was similar to that of the safety analysis set [see Adverse Reactions (6.1)].

HI antibody GMTs 21 days following vaccination with Fluzone Quadrivalent were non-inferior to those following TIV for all four strains, based on pre-specified criteria (see Table 13).

Seroconversion rates 21 days following Fluzone Quadrivalent were non-inferior to those following TIV for H3N2, B/Brisbane, and B/Florida, but not for H1N1 (see Table 14). The HI antibody GMT following Fluzone Quadrivalent was higher than that following TIV-1 for B/Florida but not higher than that following TIV-2 for B/Brisbane, based on pre-specified criteria (the lower limit of the 2-sided 95% CI of the ratio of the GMTs [Fluzone Quadrivalent divided by TIV] >1.5 for each B strain in Fluzone Quadrivalent compared with the corresponding B strain not contained in each TIV). Seroconversion rates following Fluzone Quadrivalent were higher than those following TIV for the B strain not contained in each respective TIV, based on pre- specified criteria (the lower limit of the two 2-sided 95% CI of the difference of the seroconversion rates [Fluzone Quadrivalent minus TIV] >10% for each B strain in Fluzone Quadrivalent compared with the corresponding B strain not contained in each TIV).

Table 13: Study 4*: Non-inferiority of Fluzone Quadrivalent Relative to TIV for Each Strain by HI Antibody GMTs at 21 Days Post-Vaccination, Adults 65 Years of Age and Older (Per-protocol Analysis Set)†
*
NCT01218646
†
Per-protocol analysis set included all persons who had no study protocol deviations
‡
Fluzone Quadrivalent containing A/California/07/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria lineage), and B/Florida/04/2006 (Yamagata lineage)
§
N is the number of participants in the per-protocol analysis set
Pooled TIV group includes participants vaccinated with either TIV-1 or TIV-2
#
Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the ratio of GMTs (Fluzone Quadrivalent divided by pooled TIV for the A strains, or the TIV containing the corresponding B strain) was >0.66
Þ
2010-2011 Fluzone TIV containing A/California/07/2009 (H1N1), A/Victoria/210/2009 (H3N2), and B/Brisbane/60/2008 (Victoria lineage), licensed
ß
Investigational TIV containing A/California/07/2009 (H1N1), A/Victoria/210/2009 (H3N2), and B/Florida/04/2006 (Yamagata lineage), non-licensed
à
TIV-2 did not contain B/Brisbane/60/2008
è
TIV-1 did not contain B/Florida/04/2006
Antigen Strain Fluzone Quadrivalent ‡N § =220 Pooled TIV N § =440 GMT Ratio (95% CI)#
GMT GMT
A (H1N1) 231 270 0.85 (0.67; 1.09)
A (H3N2) 501 324 1.55 (1.25; 1.92)
Fluzone Quadrivalent ‡N § =220 TIV-1Þ(B Victoria)N § =219 TIV-2ß(B Yamagata)N § =221 GMT Ratio (95% CI)#
GMT GMT GMT
B/Brisbane/60/2008(B Victoria) 73.8 57.9 (42.2)à 1.27 (1.05; 1.55)
B/Florida/04/2006(B Yamagata) 61.1 (28.5)è 54.8 1.11 (0.90; 1.37)
Table 14: Study 4*: Non-inferiority of Fluzone Quadrivalent Relative to TIV for Each Strain by Seroconversion Rates at 21 Days Post-Vaccination, Adults 65 Years of Age and Older (Per-protocol Analysis Set)†
*
NCT01218646
†
Per-protocol analysis set included all persons who had no study protocol deviations
‡
Fluzone Quadrivalent containing A/California/07/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria lineage), and B/Florida/04/2006 (Yamagata lineage)
§
N is the number of participants in the per-protocol analysis set
Pooled TIV group includes participants vaccinated with either TIV-1 or TIV-2
#
Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference in seroconversion rates (Fluzone Quadrivalent minus pooled TIV for the A strains, or the TIV containing the corresponding B strain) was >-10%
Þ
Seroconversion: Paired samples with pre-vaccination HI titer <1:10 and post-vaccination titer ≥1:40 or a minimum 4-fold increase for participants with pre-vaccination titer ≥1:10
ß
2010-2011 Fluzone TIV containing A/California/07/2009 (H1N1), A/Victoria/210/2009 (H3N2), and B/Brisbane/60/2008 (Victoria lineage), licensed
à
Investigational TIV containing A/California/07/2009 (H1N1), A/Victoria/210/2009 (H3N2), and B/Florida/04/2006 (Yamagata lineage), non-licensed
è
TIV-2 did not contain B/Brisbane/60/2008
ð
TIV-1 did not contain B/Florida/04/2006
Antigen Strain Fluzone Quadrivalent ‡N § =220 Pooled TIV N § =440 Difference of Seroconversion Rate(95% CI)#
Seroconversion Þ (%)
A (H1N1) 65.91 69.77 -3.86 (-11.50; 3.56)
A (H3N2) 69.09 59.32 9.77 (1.96; 17.20)
Fluzone Quadrivalent ‡N § =220 TIV-1ß(B Victoria)N § =219 TIV-2à(B Yamagata)N § =221 Difference of Seroconversion Rate(95% CI)#
Seroconversion Þ (%)
B/Brisbane/60/2008(B Victoria) 28.64 18.72 (8.60)è 9.91 (1.96; 17.70)
B/Florida/04/2006(B Yamagata) 33.18 (9.13)ð 31.22 1.96 (-6.73; 10.60)

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