Vaccine Information: FLUZONE QUADRIVALENT SOUTHERN HEMISPHERE (Page 4 of 6)

14.3 Immunogenicity of Fluzone Quadrivalent in Children 6 Months through 8 Years of Age

In Study 1 (NCT01240746) [see Adverse Reactions (6.1)], 1419 children 6 months through 35 months of age and 2101 children 3 years through 8 years of age were included in the per-protocol immunogenicity analysis. Participants 6 months through 35 months of age received one or two 0.25 mL doses and participants 3 years though 8 years of age received one or two 0.5 mL doses of Fluzone Quadrivalent, TIV-1, or TIV-2. For participants who received two doses, the doses were administered approximately 4 weeks apart. The distribution of demographic characteristics was similar to that of the safety analysis set [see Adverse Reactions (6.1)].

HI antibody geometric mean titers (GMTs) and seroconversion rates 28 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 10 and Table 11).

Table 10: Study 1*: Non-inferiority of Fluzone Quadrivalent Relative to TIV for Each Strain by HI Antibody GMTs at 28 Days Post-Vaccination, Persons 6 Months Through 8 Years of Age (Per-protocol Analysis Set)
*
NCT01240746
Participants 6-35 months old received 1 or 2 doses (0.25 mL) and participants 3-8 years old received 1 or 2 doses (0.5 mL) as per ACIP recommendation
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
Þ
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
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/60/2006
Antigen Strain Fluzone Quadrivalent §N =2339 Pooled TIV # N =1181 GMT Ratio (95% CI)Þ
GMT GMT
A (H1N1) 1124 1096 1.03 (0.93; 1.14)
A (H3N2) 822 828 0.99 (0.91; 1.08)
Fluzone Quadrivalent §N =2339 TIV-1ß(B Victoria)N =582 TIV-2à(B Yamagata)N =599 GMT Ratio (95% CI)Þ
GMT GMT GMT
B/Brisbane/60/2008(B Victoria) 86.1 64.3 (19.5)è 1.34 (1.20; 1.50)
B/Florida/04/2006(B Yamagata) 61.5 (16.3)ð 58.3 1.06 (0.94; 1.18)
Table 11: Study 1*: Non-inferiority of Fluzone Quadrivalent Relative to TIV for Each Strain by Seroconversion Rates at 28 Days Post-Vaccination, Persons 6 Months Through 8 Years of Age (Per-protocol Analysis Set)
*
NCT01240746
Participants 6-35 months old received 1 or 2 doses (0.25 mL) and participants 3-8 years old received 1 or 2 doses (0.5 mL) as per ACIP recommendations
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
Þ
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%
ß
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
à
2010-2011 Fluzone TIV containing A/California/07/2009 (H1N1), A/Victoria/210/2009 (H3N2), and B/Brisbane/60/2008 (Victoria lineage), licensed
è
Investigational TIV containing A/California/07/2009 (H1N1), A/Victoria/210/2009 (H3N2), and B/Florida/04/2006 (Yamagata lineage), non-licensed
ð
TIV-2 did not contain B/Brisbane/60/2008
ø
TIV-1 did not contain B/Florida/04/2006
Antigen Strain Fluzone Quadrivalent §N =2339 Pooled TIV #N =1181 Difference of Seroconversion Rates(95% CI)Þ
Seroconversion ß (%)
A (H1N1) 92.4 91.4 0.9 (-0.9; 3.0)
A (H3N2) 88.0 84.2 3.8 (1.4; 6.3)
Fluzone Quadrivalent §N =2339 TIV-1à(B Victoria)N =582 TIV-2è(B Yamagata)N =599 Difference of Seroconversion Rates(95% CI)Þ
Seroconversion ß (%)
B/Brisbane/60/2008(B Victoria) 71.8 61.1 (20.0)ð 10.7 (6.4; 15.1)
B/Florida/04/2006(B Yamagata) 66.1 (17.9)ø 64.0 2.0 (-2.2; 6.4)

Non-inferiority immunogenicity criteria based on HI antibody GMTs and seroconversion rates were also met when age subgroups (6 months to <36 months and 3 years to <9 years) were examined. In addition, HI antibody GMTs and 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 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 and 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).

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