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Trial record 74 of 112 for:    mf59

Safety, Tolerability, and Immunogenicity of the Adjuvanted Trivalent Subunit Influenza Vaccine and the Non-Adjuvanted Trivalent Subunit Influenza Vaccine Compared to the Non-Adjuvanted Trivalent Split Influenza Vaccine in Children 6 to < 72 Months of Age

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ClinicalTrials.gov Identifier: NCT01346592
Recruitment Status : Completed
First Posted : May 3, 2011
Results First Posted : May 6, 2014
Last Update Posted : March 26, 2015
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Investigator);   Primary Purpose: Prevention
Condition Influenza Disease
Interventions Biological: Trivalent split influenza vaccine (TIV)
Biological: MF59-adjuvanted trivalent influenza vaccine (aTIV)
Biological: Licensed comparator trivalent split influenza vaccine (comparator TIV)
Enrollment 6104
Recruitment Details Participants were enrolled from 8 sites in Argentina, 5 sites in Australia, 2 sites in Chile, 12 sites in Philippines, and 5 sites in South Africa.
Pre-assignment Details 4 of the enrolled subjects were not randomized hence were not included in the trial.
Arm/Group Title aTIV (6 to <72 Months) Comparator TIV (6 to <72 Months) TIV (6 to <72 Months)
Hide Arm/Group Description Subjects received an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29 Subjects received a licensed comparator trivalent split influenza vaccine (comparator TIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29 Subjects received an investigational trivalent split influenza vaccine (TIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
Period Title: Overall Study
Started 3136 1478 1486
Completed 2983 1389 1408
Not Completed 153 89 78
Reason Not Completed
Lost to Follow-up             62             29             29
Protocol Violation             2             1             0
Death             1             3             4
Adverse Event             0             1             0
Withdrawal by Subject             77             51             38
Inappropriate enrollment             3             1             1
Administrative reason             1             0             0
Unable to Classify             7             3             6
Arm/Group Title aTIV (6 to <72 Months) Comparator TIV (6 to <72 Months) TIV (6 to <72 Months) Total
Hide Arm/Group Description Subjects received an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29 Subjects received a licensed comparator trivalent split influenza vaccine (comparator TIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29 Subjects received an investigational trivalent split influenza vaccine (TIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29 Total of all reporting groups
Overall Number of Baseline Participants 3136 1478 1486 6100
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 3136 participants 1478 participants 1486 participants 6100 participants
37.1  (18.6) 30.0  (16.9) 30.2  (16.9) 33.7  (18.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3136 participants 1478 participants 1486 participants 6100 participants
Female
1545
  49.3%
745
  50.4%
731
  49.2%
3021
  49.5%
Male
1591
  50.7%
733
  49.6%
755
  50.8%
3079
  50.5%
1.Primary Outcome
Title Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of Geometric Mean Titers (GMTs) Against Homologous Strains
Hide Description The non-inferiority of Hemagglutination Inhibition (HI) antibody responses of aTIV compared to TIV and comparator TIV assessed in terms of post vaccination GMTs at three weeks after last vaccination against the three homologous vaccine strains.
Time Frame Day 1, Day 50
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the Per Protocol Set (PPS) i.e all subjects in the enrolled population who correctly received the study vaccine, provided evaluable serum samples at relevant time-points and had no major protocol violations as defined prior to unblinding.
Arm/Group Title aTIV (6 to <72 Months) Comparator TIV (6 to <72 Months) TIV (6 to <72 Months)
Hide Arm/Group Description:
Subjects received an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV), subjects aged between 6 to <36 months received two doses (Day 1 & 29) while subjects aged ≥36 months received one dose (at Day 1) of the vaccine
Subjects received a licensed comparator trivalent split influenza vaccine (comparator TIV), subjects aged between 6 to <36 months received two doses (Day 1 & 29) while subjects aged ≥36 months received one dose (at Day 1) of the vaccine
Subjects received an investigational trivalent split influenza vaccine (TIV), subjects aged between 6 to <36 months received two doses (Day 1 & 29) while subjects aged ≥36 months received one dose (Day 1) of the vaccine
Overall Number of Participants Analyzed 682 757 765
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
H1N1 - Day 1 (N=681,757,765)
28
(24 to 33)
24
(21 to 28)
27
(23 to 31)
H1N1 - Day 50 (N=681,757,765)
1537
(1382 to 1709)
629
(567 to 698)
480
(433 to 532)
H3N2 - Day 1
40
(35 to 47)
42
(36 to 49)
44
(38 to 51)
H3N2 - Day 50
1908
(1785 to 2040)
1012
(948 to 1080)
803
(752 to 857)
B strain Day 1
9.87
(9.08 to 11)
10
(9.41 to 11)
10
(9.33 to 11)
B strain Day 50
492
(450 to 537)
160
(147 to 175)
157
(144 to 171)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection aTIV (6 to <72 Months), Comparator TIV (6 to <72 Months)
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Noninferiority was established if the lower limit of the confidence interval of the day 50 ratio of GMTs was >0.667
Method of Estimation Estimation Parameter GMT ratio (H1N1 strain)
Estimated Value 2.44
Confidence Interval (2-Sided) 97.6%
2.06 to 2.9
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection aTIV (6 to <72 Months), Comparator TIV (6 to <72 Months)
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Noninferiority was established if the lower limit of the confidence interval of the day 50 ratio of GMTs was >0.667
Method of Estimation Estimation Parameter GMT ratio (H3N2 strain)
Estimated Value 1.89
Confidence Interval (2-Sided) 97.6%
1.69 to 2.1
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection aTIV (6 to <72 Months), Comparator TIV (6 to <72 Months)
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Noninferiority was established if the lower limit of the confidence interval of the day 50 ratio of GMTs was >0.667
Method of Estimation Estimation Parameter GMT ratio (B strain)
Estimated Value 3.07
Confidence Interval (2-Sided) 97.6%
2.66 to 3.54
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection aTIV (6 to <72 Months), TIV (6 to <72 Months)
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Noninferiority was established if the lower limit of the confidence interval of the day 50 ratio of GMTs was >0.667
Method of Estimation Estimation Parameter GMT ratio (H1N1 strain)
Estimated Value 3.2
Confidence Interval (2-Sided) 97.6%
2.7 to 3.8
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection aTIV (6 to <72 Months), TIV (6 to <72 Months)
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Noninferiority was established if the lower limit of the confidence interval of the day 50 ratio of GMTs was >0.667
Method of Estimation Estimation Parameter GMT ratio (H3N2 strain)
Estimated Value 2.38
Confidence Interval (2-Sided) 97.6%
2.14 to 2.65
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection aTIV (6 to <72 Months), TIV (6 to <72 Months)
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Noninferiority was established if the lower limit of the confidence interval of the day 50 ratio of GMTs was >0.667
Method of Estimation Estimation Parameter GMT ratio (B strain)
Estimated Value 3.14
Confidence Interval (2-Sided) 97.6%
2.72 to 3.62
Estimation Comments [Not Specified]
2.Primary Outcome
Title Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of Percentage of Subjects Achieving Seroconversion or ≥4-fold Increase in HI Titers Against Homologous Strains
Hide Description

The non-inferiority of HI antibody responses of aTIV compared to TIV and comparator TIV assessed in terms of percentage of subjects achieving seroconversion or ≥4-fold increase in HI titers at three weeks after last vaccination against the three homologous vaccine strains.

Seroconversion defined as prevaccination HI titer <10 and postvaccination HI titer ≥40 or at least a 4-fold increase in HI titers from prevaccination HI titer ≥10.

Time Frame Day 50
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the PPS.
Arm/Group Title aTIV (6 to <72 Months) Comparator TIV (6 to <72 Months) TIV (6 to <72 Months)
Hide Arm/Group Description:
Subjects received an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
Subjects received a licensed comparator trivalent split influenza vaccine (comparator TIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
Subjects received an investigational trivalent split influenza vaccine (TIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
Overall Number of Participants Analyzed 682 757 765
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of subjects
H1N1 - (N=680,757,765)
92.9
(90.8 to 94.8)
84.5
(81.8 to 87.1)
79.4
(76.3 to 82.2)
H3N2
96.5
(94.8 to 97.7)
92.3
(90.2 to 94.1)
89.4
(87 to 91.5)
B strain
98
(96.6 to 98.9)
86
(83.3 to 88.4)
84.6
(81.8 to 87.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection aTIV (6 to <72 Months), Comparator TIV (6 to <72 Months)
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority was established if the lower bound of the confidence interval for day 50 vaccine group difference was >-10%.
Method of Estimation Estimation Parameter Group difference (H1N1 strain)
Estimated Value 9.09
Confidence Interval (2-Sided) 97.6%
5.48 to 12.69
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection aTIV (6 to <72 Months), Comparator TIV (6 to <72 Months)
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority was established if the lower bound of the confidence interval for day 50 vaccine group difference was >-10%
Method of Estimation Estimation Parameter Group difference (H3N2 strain)
Estimated Value 4.07
Confidence Interval (2-Sided) 97.6%
1.58 to 6.55
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection aTIV (6 to <72 Months), Comparator TIV (6 to <72 Months)
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority was established if the lower bound of the confidence interval for day 50 vaccine group difference was > -10%
Method of Estimation Estimation Parameter Group difference (B strain)
Estimated Value 11.82
Confidence Interval (2-Sided) 97.6%
8.72 to 14.92
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection aTIV (6 to <72 Months), TIV (6 to <72 Months)
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority was established if the lower bound of the confidence interval for day 50 vaccine group difference was > -10%
Method of Estimation Estimation Parameter Group difference (H1N1 strain)
Estimated Value 14.21
Confidence Interval (2-Sided) 97.6%
10.3 to 18.13
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection aTIV (6 to <72 Months), TIV (6 to <72 Months)
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority was established if the lower bound of the confidence interval for day 50 vaccine group difference was > -10%
Method of Estimation Estimation Parameter Group difference (H3N2 strain)
Estimated Value 7.31
Confidence Interval (2-Sided) 97.6%
4.47 to 10.14
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection aTIV (6 to <72 Months), TIV (6 to <72 Months)
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority was established if the lower bound of the confidence interval for day 50 vaccine group difference was > -10%
Method of Estimation Estimation Parameter Group difference (B strain)
Estimated Value 11.1
Confidence Interval (2-Sided) 97.6%
8.11 to 14.1
Estimation Comments [Not Specified]
3.Primary Outcome
Title Comparison of Antibody Responses of TIV Versus Comparator TIV in Terms of Geometric Mean Titers (GMTs) Against Homologous Strains (6 to <36 Months)
Hide Description The non-inferiority of HI antibody responses of TIV to that of comparator TIV, in subjects aged 6 to <36 Months, assessed in terms of post vaccination GMTs at three weeks after last vaccination against the three homologous vaccine strains.
Time Frame Day 1, Day 50
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the PPS.
Arm/Group Title TIV (6 to <36months) Comparator TIV (6 to <36months)
Hide Arm/Group Description:
Subjects received two doses of 0.25 mL each, of investigational trivalent split influenza vaccine (TIV), at Days 1 & 29
Subjects received two doses of 0.25 mL each, of the licensed trivalent split influenza vaccine (comparator TIV), at Days 1 & 29
Overall Number of Participants Analyzed 642 635
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
H1N1 - Day 1
23
(20 to 27)
20
(17 to 23)
H1N1 - Day 50
370
(328 to 419)
487
(431 to 551)
H3N2 - Day 1
29
(24 to 33)
28
(24 to 33)
H3N2 - Day 50
698
(650 to 749)
912
(849 to 980)
B strain Day 1
9.42
(8.63 to 10)
9.42
(8.62 to 10)
B -strain Day 50
144
(130 to 159)
152
(138 to 168)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection TIV (6 to <36months), Comparator TIV (6 to <36months)
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority was established if the lower bound of the confidence interval for day 50 GMT group ratios was >0.667
Method of Estimation Estimation Parameter Group ratio (H1N1 strain)
Estimated Value 0.76
Confidence Interval (2-Sided) 97.4%
0.62 to 0.93
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection TIV (6 to <36months), Comparator TIV (6 to <36months)
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority was established if the lower bound of the confidence interval for day 50 GMT group ratios was >0.667
Method of Estimation Estimation Parameter GMT ratio (H3N2 strain)
Estimated Value 0.77
Confidence Interval (2-Sided) 97.4%
0.68 to 0.86
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection TIV (6 to <36months), Comparator TIV (6 to <36months)
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority was established if the lower bound of the confidence interval for day 50 GMT group ratios was >0.667
Method of Estimation Estimation Parameter GMT ratio (B strain)
Estimated Value 0.94
Confidence Interval (2-Sided) 97.4%
0.8 to 1.11
Estimation Comments [Not Specified]
4.Primary Outcome
Title Comparison of Antibody Responses of TIV Versus Comparator TIV in Terms of Percentage of Subjects Achieving Seroconversion or ≥4-fold Increase in HI Titer Against Homologous Strains in Subjects 6 to <36 Months of Age
Hide Description The non-inferiority of HI antibody responses of TIV to that of the licensed comparator TIV assessed in terms of percentage of subjects achieving seroconversion or ≥4-fold increase in HI titers at three weeks after last vaccination against the three homologous vaccine strains.
Time Frame Day 50
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects aged 6 through <36 months of age - Per Protocol Set (PPS).
Arm/Group Title TIV (6 to <36months) Comparator TIV (6 to <36months)
Hide Arm/Group Description:
Subjects received two doses of 0.25 mL each, of investigational trivalent split influenza vaccine (TIV), at Days 1 & 29
Subjects received two doses of 0.25 mL each, of the licensed trivalent split influenza vaccine (comparator TIV), at Days 1 & 29
Overall Number of Participants Analyzed 642 635
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of subjects
H1N1
78.8
(75.5 to 81.9)
84.1
(81 to 86.9)
H3N2
89.9
(87.3 to 92.1)
92.6
(90.3 to 94.5)
B strain
82.7
(79.6 to 85.6)
85.5
(82.5 to 88.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection TIV (6 to <36months), Comparator TIV (6 to <36months)
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority was established if the lower bound of the confidence interval for day 50 vaccine group differences was > -10%
Method of Estimation Estimation Parameter Group difference (H1N1 strain)
Estimated Value -5.3
Confidence Interval (2-Sided) 97.4%
-10.13 to -0.47
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection TIV (6 to <36months), Comparator TIV (6 to <36months)
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority was established if the lower bound of the confidence interval for day 50 vaccine group differences was > -10%
Method of Estimation Estimation Parameter Group difference (H3N2 strain)
Estimated Value -2.84
Confidence Interval (2-Sided) 97.4%
-6.16 to 0.5
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection TIV (6 to <36months), Comparator TIV (6 to <36months)
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority was established if the lower bound of the confidence interval for day 50 vaccine group differences was > -10%
Method of Estimation Estimation Parameter Group difference (B strain)
Estimated Value -2.49
Confidence Interval (2-Sided) 97.4%
-7.01 to 2
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of GMTs Against Homologous Strains (6 to <24 Months)
Hide Description The superiority of HI antibody responses, in subjects 6 to <24 months of age, of aTIV compared to TIV and comparator TIV assessed in terms of post vaccination GMTs at three weeks after last vaccination against the three homologous vaccine strains.
Time Frame Day 1, Day 50
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the Full Analysis Set (FAS) i.e all enrolled subjects who received study vaccination and provided serum samples.
Arm/Group Title aTIV (6 to <24 Months) Comparator TIV (6 to <24 Months) TIV (6 to <24 Months)
Hide Arm/Group Description:
Subjects received two doses of 0.25 mL each, of the investigational MF59-adjuvanted trivalent split influenza vaccine (aTIV), at Days 1 & 29
Subjects received two doses of 0.25 mL each, of the licensed comparator trivalent split influenza vaccine (comparator TIV), at Days 1 & 29
Subjects received two doses of 0.25 mL each, of the investigational trivalent split influenza vaccine (TIV), at Days 1 & 29
Overall Number of Participants Analyzed 266 389 387
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
H1N1 - Day 1
12
(9.52 to 14)
9.87
(8.36 to 12)
12
(9.95 to 14)
H1N1 - Day 50
1080
(899 to 1297)
298
(256 to 347)
205
(176 to 238)
H3N2 - Day 1
15
(12 to 19)
15
(12 to 18)
17
(14 to 21)
H3N2 - Day 50
1709
(1536 to 1903)
758
(694 to 828)
552
(505 to 603)
B strain Day 1
7.75
(6.83 to 8.78)
8.18
(7.37 to 9.07)
7.92
(7.14 to 8.79)
B strain Day 50
616
(534 to 711)
133
(118 to 149)
112
(100 to 127)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection aTIV (6 to <24 Months), Comparator TIV (6 to <24 Months)
Comments Superiority was concluded if the lower limit of the confidence interval for the day 50 vaccine group GMT ratios for at least 2 homologous strains was >1.5.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter GMT ratio (H1N1 strain)
Estimated Value 3.63
Confidence Interval (2-Sided) 95%
2.86 to 4.6
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection aTIV (6 to <24 Months), Comparator TIV (6 to <24 Months)
Comments superiority was concluded if the lower limit of the confidence interval of the day 50 vaccine group GMT ratios for at least 2 homologous strains was >1.5
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter GMT ratio (H3N2 strain)
Estimated Value 2.25
Confidence Interval (2-Sided) 95%
1.96 to 2.59
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection aTIV (6 to <24 Months), Comparator TIV (6 to <24 Months)
Comments superiority was concluded if the lower limit of the confidence interval of the day 50 vaccine group GMT ratios for at least 2 homologous strains was >1.5
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter GMT ratio (B strain)
Estimated Value 4.64
Confidence Interval (2-Sided) 95%
3.86 to 5.59
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection aTIV (6 to <24 Months), TIV (6 to <24 Months)
Comments superiority was concluded if the lower limit of the confidence interval of the day 50 vaccine group GMT ratios for at least 2 homologous strains was >1.5
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter GMT ratio (H1N1 strain)
Estimated Value 5.28
Confidence Interval (2-Sided) 95%
4.16 to 6.7
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection aTIV (6 to <24 Months), TIV (6 to <24 Months)
Comments superiority was concluded if the lower limit of the confidence interval of the day 50 vaccine group GMT ratios for at least 2 homologous strains was >1.5
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter GMT ratio (H3N2 strain)
Estimated Value 3.1
Confidence Interval (2-Sided) 95%
2.69 to 3.56
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection aTIV (6 to <24 Months), TIV (6 to <24 Months)
Comments superiority was concluded if the lower limit of the confidence interval of the day 50 vaccine group GMT ratios for at least 2 homologous strains was >1.5
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter GMT ratio (B strain)
Estimated Value 4.64
Confidence Interval (2-Sided) 95%
3.86 to 5.59
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms Percentage of Subjects Achieving Seroconversion or ≥4-fold Increase in HI Titer Against Homologous Strains (6 to <24 Months)
Hide Description The superiority of HI antibody responses, in subjects 6 to <24 months of age, of aTIV compared to TIV and comparator TIV assessed in terms of number of subjects achieving seroconversion at three weeks after last vaccination against the three homologous vaccine strains.
Time Frame Day 50
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the FAS
Arm/Group Title aTIV (6 to <24 Months) Comparator TIV (6 to <24 Months) TIV (6 to <24 Months)
Hide Arm/Group Description:
Subjects received two doses of 0.25 mL each, of the investigational MF59-adjuvanted trivalent split influenza vaccine (aTIV), at Days 1 & 29
Subjects received two doses of 0.25 mL each, of the licensed comparator trivalent split influenza vaccine (comparator TIV), at Days 1 & 29
Subjects received two doses of 0.25 mL each, of the investigational trivalent split influenza vaccine (TIV), at Days 1 & 29
Overall Number of Participants Analyzed 266 389 387
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of subjects
H1N1
95.5
(92.3 to 97.7)
85.1
(81.2 to 88.5)
77.8
(73.3 to 81.8)
H3N2
98.1
(95.7 to 99.4)
95.6
(93.1 to 97.4)
92.5
(89.4 to 94.9)
B strain
98.1
(95.7 to 99.4)
85.4
(81.4 to 88.7)
79.3
(75 to 83.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection aTIV (6 to <24 Months), Comparator TIV (6 to <24 Months)
Comments superiority was concluded if the lower limit of the confidence interval of day 50 vaccine group difference,for at least 2 homologous strains, was >10%
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Group difference (H1N1 strain)
Estimated Value 10.4
Confidence Interval (2-Sided) 95%
6.1 to 14.7
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection aTIV (6 to <24 Months), Comparator TIV (6 to <24 Months)
Comments superiority was concluded if the lower limit of the confidence interval of day 50 vaccine group difference,for at least 2 homologous strains, was >10%
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Group difference (H3N2 strain)
Estimated Value 2.5
Confidence Interval (2-Sided) 95%
-0.12 to 5.1
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection aTIV (6 to <24 Months), Comparator TIV (6 to <24 Months)
Comments superiority was concluded if the lower limit of the confidence interval of day 50 vaccine group difference,for at least 2 homologous strains, was >10%
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Group difference (B strain)
Estimated Value 12.8
Confidence Interval (2-Sided) 95%
8.9 to 16.7
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection aTIV (6 to <24 Months), TIV (6 to <24 Months)
Comments superiority was concluded if the lower limit of the confidence interval of day 50 vaccine group difference,for at least 2 homologous strains, was >10%
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Group difference (H1N1 strain)
Estimated Value 17.7
Confidence Interval (2-Sided) 95%
12.9 to 22.6
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection aTIV (6 to <24 Months), TIV (6 to <24 Months)
Comments superiority was concluded if the lower limit of the confidence interval of day 50 vaccine group difference,for at least 2 homologous strains, was >10%
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Group difference (H3N2 strain)
Estimated Value 5.6
Confidence Interval (2-Sided) 95%
2.5 to 8.7
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection aTIV (6 to <24 Months), TIV (6 to <24 Months)
Comments superiority was concluded if the lower limit of the confidence interval of day 50 vaccine group difference,for at least 2 homologous strains, was >10%
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Group difference (B strain)
Estimated Value 18.8
Confidence Interval (2-Sided) 95%
14.4 to 23.1
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of GMTs Against Homologous Strains (6 to <72 Months)-FAS
Hide Description The superiority of HI antibody responses, in subjects 6 to <72 months of age, of aTIV compared to TIV and comparator TIV assessed in terms of post vaccination GMTs at three weeks after last vaccination against the three homologous vaccine strains.
Time Frame Day 1, Day 50
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the FAS
Arm/Group Title aTIV (6 to <72 Months) Comparator TIV (6 to <72 Months) TIV (6 to <72 Months)
Hide Arm/Group Description:
Subjects received an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
Subjects received a licensed comparator trivalent split influenza vaccine (comparator TIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
Subjects received an investigational trivalent split influenza vaccine (TIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
Overall Number of Participants Analyzed 747 839 849
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
H1N1 - Day 1 (N=746,839,849)
29
(25 to 33)
24
(21 to 28)
27
(23 to 31)
H1N1 - Day 50 (N=746,839,849)
1519
(1372 to 1683)
637
(577 to 704)
473
(428 to 522)
H3N2 - Day 1
41
(36 to 48)
42
(37 to 49)
44
(38 to 50)
H3N2 - Day 50
1909
(1791 to 2035)
1016
(954 to 1081)
796
(748 to 847)
B strain - Day 1
9.97
(9.2 to 11)
10
(9.49 to 11)
10
(9.33 to 11)
B strain-Day 50
480
(441 to 523)
164
(151 to 178)
156
(144 to 169)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection aTIV (6 to <72 Months), Comparator TIV (6 to <72 Months)
Comments superiority was concluded if the lower limit of the confidence interval of the day 50 vaccine group GMT ratios for at least 2 homologous strains was >1.5
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter GMT Ratio (H1N1 strain)
Estimated Value 2.38
Confidence Interval (2-Sided) 95%
2.07 to 2.75
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection aTIV (6 to <72 Months), Comparator TIV (6 to <72 Months)
Comments superiority was concluded if the lower limit of the confidence interval of the day 50 vaccine group GMT ratios for at least 2 homologous strains was >1.5
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter GMT Ratio (H3N2 strain)
Estimated Value 1.88
Confidence Interval (2-Sided) 95%
1.72 to 2.06
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection aTIV (6 to <72 Months), Comparator TIV (6 to <72 Months)
Comments superiority was concluded if the lower limit of the confidence interval of the day 50 vaccine group GMT ratios for at least 2 homologous strains was >1.5
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter GMT Ratio (B strain)
Estimated Value 2.93
Confidence Interval (2-Sided) 95%
2.6 to 3.3
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection aTIV (6 to <72 Months), TIV (6 to <72 Months)
Comments superiority was concluded if the lower limit of the confidence interval of the day 50 vaccine group GMT ratios for at least 2 homologous strains was >1.5
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter GMT Ratio (H1N1 strain)
Estimated Value 3.21
Confidence Interval (2-Sided) 95%
2.79 to 3.71
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection aTIV (6 to <72 Months), TIV (6 to <72 Months)
Comments superiority was concluded if the lower limit of the confidence interval of the day 50 vaccine group GMT ratios for at least 2 homologous strains was >1.5
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter GMT Ratio (H3N2 strain)
Estimated Value 2.4
Confidence Interval (2-Sided) 95%
2.19 to 2.62
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection aTIV (6 to <72 Months), TIV (6 to <72 Months)
Comments superiority was concluded if the lower limit of the confidence interval of the day 50 vaccine group GMT ratios for at least 2 homologous strains was >1.5
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter GMT Ratio (B strain)
Estimated Value 3.08
Confidence Interval (2-Sided) 95%
2.73 to 3.47
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of Percentage of Subjects Achieving Seroconversion or ≥4 Fold Increase in HI Titers Against Homologous Strains (6 to <72 Months)-FAS
Hide Description The superiority of HI antibody responses, in subjects 6 to <24 months of age, of aTIV compared to TIV and comparator TIV assessed in terms of number of subjects achieving seroconversion ≥4 fold increase in HI titers at three weeks after last vaccination against the three homologous vaccine strains.
Time Frame Day 50
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the FAS
Arm/Group Title aTIV (6 to <72 Months) Comparator TIV (6 to <72 Months) TIV (6 to <72 Months)
Hide Arm/Group Description:
Subjects received an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
Subjects received a licensed comparator trivalent split influenza vaccine (comparator TIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
Subjects received an investigational trivalent split influenza vaccine (TIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
Overall Number of Participants Analyzed 747 839 849
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of subjects
H1N1
92.8
(90.7 to 94.5)
83.7
(81 to 86.1)
78.8
(75.9 to 81.5)
H3N2
96.4
(94.8 to 97.6)
92.3
(90.2 to 94)
89.8
(87.5 to 91.7)
B strain
97.5
(96.1 to 98.5)
86.4
(83.9 to 88.7)
84.5
(81.8 to 86.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection aTIV (6 to <72 Months), Comparator TIV (6 to <72 Months)
Comments superiority was concluded if the lower limit of the confidence interval of day 50 vaccine group difference,for at least 2 homologous strains, was >10%
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Group difference (H1N1 strain)
Estimated Value 9.3
Confidence Interval (2-Sided) 95%
6.3 to 12.4
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection aTIV (6 to <72 Months), Comparator TIV (6 to <72 Months)
Comments superiority was concluded if the lower limit of the confidence interval of day 50 vaccine group difference,for at least 2 homologous strains, was >10%
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Group difference (H3N2 strain)
Estimated Value 3.9
Confidence Interval (2-Sided) 95%
1.8 to 5.9
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection aTIV (6 to <72 Months), Comparator TIV (6 to <72 Months)
Comments superiority was concluded if the lower limit of the confidence interval of day 50 vaccine group difference,for at least 2 homologous strains, was >10%
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Group difference (B strain)
Estimated Value 10.7
Confidence Interval (2-Sided) 95%
8.1 to 13.3
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection aTIV (6 to <72 Months), TIV (6 to <72 Months)
Comments superiority was concluded if the lower limit of the confidence interval of day 50 vaccine group difference,for at least 2 homologous strains, was >10%
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Group difference (H1N1 strain)
Estimated Value 14.4
Confidence Interval (2-Sided) 95%
11.1 to 17.7
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection aTIV (6 to <72 Months), TIV (6 to <72 Months)
Comments superiority was concluded if the lower bound of 95% CI of day 50 vaccine group difference,for at least 2 homologous strains, was >10%
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Group difference (H3N2 strain)
Estimated Value 6.8
Confidence Interval (2-Sided) 95%
4.5 to 9.1
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection aTIV (6 to <72 Months), TIV (6 to <72 Months)
Comments superiority was concluded if the lower limit of the confidence interval of day 50 vaccine group difference,for at least 2 homologous strains, was >10%
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Group difference (B strain)
Estimated Value 10.9
Confidence Interval (2-Sided) 95%
8.3 to 13.4
Estimation Comments [Not Specified]
9.Secondary Outcome
Title The HI GMTs Against Homologous Strains, by Vaccine Group
Hide Description The HI antibody titers against the three homologous strains following vaccination with either aTIV, licensed comparator or TIV, at three weeks and at six months after vaccination are reported as GMTs.
Time Frame Day 1, Day 29, Day 50, Day 209
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on FAS (Persistence) i.e. all subjects in the enrolled population who actually received a study vaccination, and provided evaluable serum samples at all relevant timepoints and also at day 209.
Arm/Group Title aTIV (6 to <72 Months) Comparator TIV (6 to <72 Months) TIV (6 to <72 Months)
Hide Arm/Group Description:
Subjects received an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
Subjects received a licensed comparator trivalent split influenza vaccine (comparator TIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
Subjects received an investigational trivalent split influenza vaccine (TIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
Overall Number of Participants Analyzed 715 822 820
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
H1N1 - Day 1 (N=714,822,820)
28
(24 to 32)
24
(20 to 27)
27
(23 to 31)
H1N1 - Day 29
647
(562 to 745)
159
(139 to 182)
170
(148 to 194)
H1N1 - Day 50 (N=714,822,820)
1507
(1358 to 1673)
635
(575 to 702)
475
(429 to 525)
H1N1 - Day 209 (N=715,822,819)
276
(246 to 311)
97
(87 to 109)
107
(96 to 120)
H3N2 - Day 1
42
(36 to 48)
43
(37 to 49)
43
(38 to 50)
H3N2 - Day 29
1087
(1004 to 1176)
558
(517 to 602)
453
(420 to 490)
H3N2 - Day 50
1920
(1799 to 2050)
1013
(952 to 1079)
810
(760 to 862)
H3N2 - Day 209
462
(423 to 505)
277
(254 to 301)
242
(222 to 263)
B - Day 1
10
(9.29 to 11)
10
(9.57 to 11)
10
(9.34 to 11)
B - Day 29
119
(106 to 134)
58
(52 to 65)
61
(54 to 68)
B - Day 50
488
(447 to 532)
166
(153 to 180)
159
(146 to 173)
B- Day 209
125
(114 to 136)
57
(53 to 62)
61
(56 to 66)
10.Secondary Outcome
Title Geometric Mean Ratio (GMR) of Post- Versus Pre-vaccination HI Titers Against Homologous Strains
Hide Description The GMR of post-vaccination versus pre-vaccination HI titers against homologous strains, three weeks (day 29/day 1; day 50/day 1)and six months (day 209/day 1) after vaccination with either aTIV, licensed comparator or TIV.
Time Frame Day 29, Day 50, Day 209
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on FAS (Persistence)
Arm/Group Title aTIV (6 to <72 Months) Comparator TIV (6 to <72 Months) TIV (6 to <72 Months)
Hide Arm/Group Description:
Subjects received an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
Subjects received a licensed comparator trivalent split influenza vaccine (comparator TIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
Subjects received an investigational trivalent split influenza vaccine (TIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
Overall Number of Participants Analyzed 715 822 820
Geometric Mean (95% Confidence Interval)
Unit of Measure: Ratios
H1N1, Day 29:Day 1 (N=714,822,820)
27
(23 to 31)
6.81
(5.94 to 7.81)
7.13
(6.22 to 8.18)
H1N1, Day 50:Day 1 (N=713,822,820)
58
(51 to 67)
27
(24 to 31)
19
(17 to 21)
H1N1, Day 209:Day 1 (N=714,822,819)
11
(9.79 to 13)
4.15
(3.68 to 4.69)
4.37
(3.87 to 4.94)
H3N2, Day 29:Day 1
29
(26 to 32)
15
(14 to 16)
12
(11 to 13)
H3N2, Day 50:Day 1 (N=715,822,820)
48
(43 to 54)
25
(23 to 28)
20
(18 to 22)
H3N2, Day 209:Day 1
12
(10 to 13)
6.93
(6.14 to 7.83)
6.02
(5.33 to 6.81)
B strain, Day 29:Day 1
12
(11 to 14)
6.18
(5.49 to 6.95)
6.38
(5.66 to 7.18)
B strain, Day 50:Day 1
49
(45 to 54)
17
(15 to 18)
16
(15 to 18)
B strain, Day 209:Day 1
13
(12 to 14)
5.76
(5.26 to 6.3)
6.15
(5.62 to 6.73)
11.Secondary Outcome
Title Percentage of Subjects With HI Titers ≥40 Against Homologous Strains, by Vaccine Group
Hide Description The percentage of subjects demonstrating HI titers ≥40,against homologous strains, at three weeks and six months after vaccination with aTIV or licensed comparator or TIV.
Time Frame Day 1, Day 29, Day 50, Day 209
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on FAS (Persistence)
Arm/Group Title aTIV (6 to <72 Months) Comparator TIV (6 to <72 Months) TIV (6 to <72 Months)
Hide Arm/Group Description:
Subjects received an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
Subjects received a licensed comparator trivalent split influenza vaccine (comparator TIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
Subjects received an investigational trivalent split influenza vaccine (TIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
Overall Number of Participants Analyzed 715 822 820
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of subjects
H1N1, Day 1 (N=714,822,820)
40.6
(37 to 44.3)
33.1
(29.9 to 36.4)
36.3
(33 to 39.7)
H1N1, Day 29
89.8
(87.3 to 91.9)
55
(51.5 to 58.4)
57.9
(54.5 to 61.3)
H1N1, Day 50 (N=714,822,820)
99.3
(98.4 to 99.8)
91.1
(89 to 93)
88.2
(85.8 to 90.3)
H1N1, Day 209 (N=715, 822,819)
88.8
(86.3 to 91)
59.5
(56 to 62.9)
63.2
(59.8 to 66.6)
H3N2, Day 1
52.6
(48.9 to 56.3)
45.5
(42.1 to 49)
44.6
(41.2 to 48.1)
H3N2, Day 29
98.9
(97.8 to 99.5)
95.9
(94.3 to 97.1)
93.5
(91.6 to 95.1)
H3N2, Day 50
99.7
(99 to 100)
99.5
(98.8 to 99.9)
99.4
(98.6 to 99.8)
H3N2, Day 209
99.3
(98.4 to 99.8)
94.3
(92.5 to 95.8)
88.4
(86 to 90.5)
B strain, Day 1
22.1
(19.1 to 25.3)
21.1
(18.3 to 24)
20.5
(17.8 to 23.4)
B strain, Day 29
69
(65.4 to 72.3)
48.2
(44.7 to 51.7)
45.6
(42.2 to 49.1)
B strain, Day 50
98.9
(97.8 to 99.5)
89.1
(86.7 to 91.1)
87
(84.5 to 89.2)
B strain, Day 209
93.4
(91.4 to 95.1)
67.9
(64.6 to 71.1)
67
(63.6 to 70.2)
12.Secondary Outcome
Title Percentage of Subjects Achieving Seroconversion or ≥4 Fold Increase in HI Titers, Against Homologous Strains
Hide Description The percentage of subjects achieving seroconversion ≥4 fold increase in HI titers from baseline, against homologous strains, at three weeks and six months after vaccination with ATIV or licensed comparator or TIV.
Time Frame Day 29, Day 50, Day 209
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on FAS (Persistence)
Arm/Group Title aTIV (6 to <72 Months) Comparator TIV (6 to <72 Months) TIV (6 to <72 Months)
Hide Arm/Group Description:
Subjects received an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
Subjects received a licensed comparator trivalent split influenza vaccine (comparator TIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
Subjects received an investigational trivalent split influenza vaccine (TIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
Overall Number of Participants Analyzed 715 822 820
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of subjects
H1N1, Day 29 (N=714,822,820)
83.6
(80.7 to 86.3)
48.5
(45.1 to 52.1)
51.5
(48 to 54.9)
H1N1, Day 50 (N=713,822,820)
92.6
(90.4 to 94.4)
83.9
(81.3 to 86.4)
79
(76.1 to 81.8)
H1N1, Day 209 (N=714,822,819)
71.7
(68.3 to 75)
39.5
(36.2 to 43)
41.9
(38.5 to 45.3)
H3N2, Day 29
95.8
(94.1 to 97.2)
90.3
(88 to 92.2)
86.7
(84.2 to 89)
H3N2, Day 50
96.5
(94.9 to 97.7)
92.1
(90 to 93.8)
90
(87.7 to 92)
H3N2, Day 209
77.6
(74.4 to 80.6)
62.5
(59.1 to 65.9)
55.6
(52.1 to 59.1)
B strain, Day 29
68.4
(64.8 to 71.8)
47
(43.5 to 50.4)
44
(40.6 to 47.5)
B strain, Day 50
97.6
(96.2 to 98.6)
86.6
(84.1 to 88.9)
85
(82.4 to 87.4)
B strain, Day 209
87.3
(84.6 to 89.6)
59.7
(56.3 to 63.1)
61.5
(58 to 64.8)
13.Secondary Outcome
Title Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of GMTs Against Homologous Strains, Subjects at Risk/Not at Risk, by Age Subgroup
Hide Description The non-inferiority of Hemagglutination Inhibition (HI) antibody responses of aTIV compared to TIV and comparator TIV assessed in terms of post vaccination GMTs at three weeks after last vaccination against the three homologous vaccine strains, in subjects with a defined set of underlying medical conditions (at risk) and healthy subjects (not at risk), by age sub group.
Time Frame Day 50
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the PPS.
Arm/Group Title aTIV (6 to <72 Months) Compartor TIV (6 to <72 Months) TIV (6 to <72 Months) aTIV (6 to <36 Months) Compartor TIV (6 to <36 Months) TIV (6 to <36 Months) aTIV (36 to <72 Months) Comparator TIV (36 to <72 Months) TIV (36 to <72 Months)
Hide Arm/Group Description:
Subjects received an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV), subjects aged between 6 to <36 months received two doses (Day 1 & 29) while subjects aged ≥36 months received one dose (at Day 1) of the vaccine
Subjects received a licensed comparator trivalent split influenza vaccine (comparator TIV), subjects aged between 6 to <36 months received two doses (Day 1 & 29) while subjects aged ≥36 months received one dose (at Day 1) of the vaccine
Subjects received an investigational trivalent split influenza vaccine (TIV), subjects aged between 6 to <36 months received two doses (Day 1 & 29) while subjects aged ≥36 months received one dose (Day 1) of the vaccine
Subjects received two doses (Day 1 & 29) of an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV)
Subjects received two doses (Day 1 & 29) of a licensed comparator trivalent split influenza vaccine (comparator TIV)
Subjects received two doses (Day 1 & 29) of an investigational trivalent split influenza vaccine (TIV)
Subjects received one dose (Day 1) of investigational MF59-adjuvanted trivalent influenza vaccine (aTIV)
Subjects received one dose (Day 1) of a licensed comparator trivalent split influenza vaccine (comparator TIV)
Subjects received one dose (Day 1) of an investigational trivalent split influenza vaccine (TIV)
Overall Number of Participants Analyzed 660 722 739 425 612 623 235 110 116
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
H1N1nonrisk(N=659,722,739,425,612,623,234,110,116)
1516
(1358 to 1692)
566
(509 to 628)
431
(388 to 478)
1341
(1165 to 1544)
478
(425 to 537)
366
(326 to 411)
2111
(1840 to 2423)
1365
(1117 to 1668)
879
(723 to 1068)
H3N2nonrisk(N=660,722,739,425,612,623,235,110,116)
1897
(1772 to 2030)
1014
(950 to 1082)
804
(754 to 857)
1863
(1711 to 2028)
912
(849 to 979)
695
(648 to 746)
2311
(2080 to 2568)
1526
(1309 to 1780)
1497
(1289 to 1739)
B nonrisk(N=660,722,739,425,612,623,235,110,116)
492
(450 to 539)
162
(148 to 176)
157
(144 to 170)
559
(498 to 627)
149
(136 to 164)
141
(128 to 155)
431
(380 to 488)
226
(188 to 272)
254
(212 to 304)
H1N1 at risk(N=22,35,26,12,23,19,10,12,7)
1706
(990 to 2939)
772
(502 to 1185)
631
(383 to 1041)
1414
(658 to 3040)
603
(350 to 1040)
519
(283 to 950)
2187
(956 to 5002)
1241
(583 to 2641)
1030
(383 to 2767)
H3N2 at risk(N=22,35,26,12,23,19,10,12,7)
2306
(1665 to 3194)
941
(727 to 1220)
709
(526 to 955)
2323
(1407 to 3835)
794
(552 to 1140)
665
(447 to 988)
2319
(1622 to 3315)
1306
(940 to 1815)
826
(538 to 1267)
B at risk(N=22,35,26,12,23,19,10,12,7)
495
(307 to 797)
143
(98 to 209)
179
(116 to 278)
694
(367 to 1316)
125
(79 to 199)
132
(79 to 220)
365
(184 to 724)
200
(108 to 372)
312
(131 to 743)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection aTIV (6 to <72 Months), Compartor TIV (6 to <72 Months)
Comments No risk subjects.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.
Method of Estimation Estimation Parameter GMT Ratio (H1N1 strain)
Estimated Value 2.68
Confidence Interval (2-Sided) 95%
2.3 to 3.12
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection aTIV (6 to <72 Months), Compartor TIV (6 to <72 Months)
Comments No risk subjects.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.
Method of Estimation Estimation Parameter GMT Ratio (H3N2 strain)
Estimated Value 1.87
Confidence Interval (2-Sided) 95%
1.7 to 2.05
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection aTIV (6 to <72 Months), Compartor TIV (6 to <72 Months)
Comments No risk subjects.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.
Method of Estimation Estimation Parameter GMT ratio (B strain)
Estimated Value 3.04
Confidence Interval (2-Sided) 95%
2.68 to 3.44
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection aTIV (6 to <72 Months), Compartor TIV (6 to <72 Months)
Comments At risk subjects.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.
Method of Estimation Estimation Parameter GMT ratio (H1N1 strain)
Estimated Value 2.21
Confidence Interval (2-Sided) 95%
1.11 to 4.42
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection aTIV (6 to <72 Months), Compartor TIV (6 to <72 Months)
Comments At risk subjects.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.
Method of Estimation Estimation Parameter GMT ratio (H3N2 strain)
Estimated Value 2.45
Confidence Interval (2-Sided) 95%
1.61 to 3.72
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection aTIV (6 to <72 Months), Compartor TIV (6 to <72 Months)
Comments At risk subjects
Type of Statistical Test Non-Inferiority or Equivalence
Comments Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.
Method of Estimation Estimation Parameter GMT ratio (B strain)
Estimated Value 3.46
Confidence Interval (2-Sided) 95%
1.88 to 6.34
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection aTIV (6 to <72 Months), TIV (6 to <72 Months)
Comments No risk subjects.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.
Method of Estimation Estimation Parameter GMT ratios (H1N1 strain)
Estimated Value 3.52
Confidence Interval (2-Sided) 95%
3.03 to 4.1
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection aTIV (6 to <72 Months), TIV (6 to <72 Months)
Comments No risk subjects.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.
Method of Estimation Estimation Parameter GMT ratio (H3N2 strain)
Estimated Value 2.36
Confidence Interval (2-Sided) 95%
2.15 to 2.59
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection aTIV (6 to <72 Months), TIV (6 to <72 Months)
Comments No risk subjects.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.
Method of Estimation Estimation Parameter GMT ratio (B strain)
Estimated Value 3.14
Confidence Interval (2-Sided) 95%
2.78 to 3.56
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection aTIV (6 to <72 Months), TIV (6 to <72 Months)
Comments At risk subjects.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.
Method of Estimation Estimation Parameter GMT ratio (H1N1 strain)
Estimated Value 2.7
Confidence Interval (2-Sided) 95%
1.28 to 5.68
Estimation Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection aTIV (6 to <72 Months), TIV (6 to <72 Months)
Comments At risk subjects.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.
Method of Estimation Estimation Parameter GMT ratio (H3N2 strain)
Estimated Value 3.25
Confidence Interval (2-Sided) 95%
2.09 to 5.06
Estimation Comments [Not Specified]
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection aTIV (6 to <72 Months), TIV (6 to <72 Months)
Comments At risk subjects.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.
Method of Estimation Estimation Parameter GMT ratio (B strain)
Estimated Value 2.76
Confidence Interval (2-Sided) 95%
1.44 to 5.3
Estimation Comments [Not Specified]
Show Statistical Analysis 13 Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection aTIV (6 to <36 Months), Compartor TIV (6 to <36 Months)
Comments No risk subjects.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.
Method of Estimation Estimation Parameter GMT ratio (H1N1 strain)
Estimated Value 2.81
Confidence Interval (2-Sided) 95%
2.34 to 3.37
Estimation Comments [Not Specified]
Show Statistical Analysis 14 Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection aTIV (6 to <36 Months), Compartor TIV (6 to <36 Months)
Comments No risk subjects.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.
Method of Estimation Estimation Parameter GMT ratio (H3N2 strain)
Estimated Value 2.04
Confidence Interval (2-Sided) 95%
1.83 to 2.28
Estimation Comments [Not Specified]
Show Statistical Analysis 15 Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection aTIV (6 to <36 Months), Compartor TIV (6 to <36 Months)
Comments No risk subjects
Type of Statistical Test Non-Inferiority or Equivalence
Comments Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.
Method of Estimation Estimation Parameter GMT ratio (B strain)
Estimated Value 3.74
Confidence Interval (2-Sided) 95%
3.22 to 4.34
Estimation Comments [Not Specified]
Show Statistical Analysis 16 Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection aTIV (6 to <36 Months), Compartor TIV (6 to <36 Months)
Comments At risk subjects.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.
Method of Estimation Estimation Parameter GMT ratio (H1N1 strain)
Estimated Value 2.34
Confidence Interval (2-Sided) 95%
0.92 to 6
Estimation Comments [Not Specified]
Show Statistical Analysis 17 Hide Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection aTIV (6 to <36 Months), Compartor TIV (6 to <36 Months)
Comments At risk subjects.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.
Method of Estimation Estimation Parameter GMT ratio (H3N2 strain)
Estimated Value 2.93
Confidence Interval (2-Sided) 95%
1.57 to 5.45
Estimation Comments [Not Specified]
Show Statistical Analysis 18 Hide Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection aTIV (6 to <36 Months), Compartor TIV (6 to <36 Months)
Comments At risk subjects
Type of Statistical Test Non-Inferiority or Equivalence
Comments Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.
Method of Estimation Estimation Parameter GMT ratio (B strain)
Estimated Value 5.55
Confidence Interval (2-Sided) 95%
2.52 to 12
Estimation Comments [Not Specified]
Show Statistical Analysis 19 Hide Statistical Analysis 19
Statistical Analysis Overview Comparison Group Selection aTIV (6 to <36 Months), TIV (6 to <36 Months)
Comments No risk subjects.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.
Method of Estimation Estimation Parameter GMT ratio (H1N1 strain)
Estimated Value 3.66
Confidence Interval (2-Sided) 95%
3.05 to 4.39
Estimation Comments [Not Specified]
Show Statistical Analysis 20 Hide Statistical Analysis 20
Statistical Analysis Overview Comparison Group Selection aTIV (6 to <36 Months), TIV (6 to <36 Months)
Comments No risk subjects
Type of Statistical Test Non-Inferiority or Equivalence
Comments Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.
Method of Estimation Estimation Parameter GMT ratio (H3N2 strain)
Estimated Value 2.68
Confidence Interval (2-Sided) 95%
2.4 to 2.99
Estimation Comments [Not Specified]
Show Statistical Analysis 21 Hide Statistical Analysis 21
Statistical Analysis Overview Comparison Group Selection aTIV (6 to <36 Months), TIV (6 to <36 Months)
Comments No risk subjects.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.
Method of Estimation Estimation Parameter GMT ratio (B strain)
Estimated Value 3.97
Confidence Interval (2-Sided) 95%
3.42 to 4.61
Estimation Comments [Not Specified]
Show Statistical Analysis 22 Hide Statistical Analysis 22
Statistical Analysis Overview Comparison Group Selection aTIV (6 to <36 Months), TIV (6 to <36 Months)
Comments At risk subjects.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.
Method of Estimation Estimation Parameter GMT ratio (H1N1 strain)
Estimated Value 2.72
Confidence Interval (2-Sided) 95%
1.02 to 7.31
Estimation Comments [Not Specified]
Show Statistical Analysis 23 Hide Statistical Analysis 23
Statistical Analysis Overview Comparison Group Selection aTIV (6 to <36 Months), TIV (6 to <36 Months)
Comments At risk subjects.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.
Method of Estimation Estimation Parameter GMT ratio (H3N2 strain)
Estimated Value 3.5
Confidence Interval (2-Sided) 95%
1.85 to 6.62
Estimation Comments [Not Specified]
Show Statistical Analysis 24 Hide Statistical Analysis 24
Statistical Analysis Overview Comparison Group Selection aTIV (6 to <36 Months), TIV (6 to <36 Months)
Comments At risk subjects.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.
Method of Estimation Estimation Parameter GMT ratio (B strain)
Estimated Value 5.26
Confidence Interval (2-Sided) 95%
2.32 to 12
Estimation Comments [Not Specified]
Show Statistical Analysis 25 Hide Statistical Analysis 25
Statistical Analysis Overview Comparison Group Selection aTIV (36 to <72 Months), Comparator TIV (36 to <72 Months)
Comments No risk subjects.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.
Method of Estimation Estimation Parameter GMT ratio (H1N1 strain)
Estimated Value 1.55
Confidence Interval (2-Sided) 95%
1.21 to 1.97
Estimation Comments [Not Specified]
Show Statistical Analysis 26 Hide Statistical Analysis 26
Statistical Analysis Overview Comparison Group Selection aTIV (36 to <72 Months), Comparator TIV (36 to <72 Months)
Comments No risk subjects
Type of Statistical Test Non-Inferiority or Equivalence
Comments Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.
Method of Estimation Estimation Parameter GMT ratio (H3N2 strain)
Estimated Value 1.51
Confidence Interval (2-Sided) 95%
1.26 to 1.82
Estimation Comments [Not Specified]
Show Statistical Analysis 27 Hide Statistical Analysis 27
Statistical Analysis Overview Comparison Group Selection aTIV (36 to <72 Months), Comparator TIV (36 to <72 Months)
Comments No risk subjects
Type of Statistical Test Non-Inferiority or Equivalence
Comments Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.
Method of Estimation Estimation Parameter GMT ratio (B strain)
Estimated Value 1.9
Confidence Interval (2-Sided) 95%
1.52 to 2.38
Estimation Comments [Not Specified]
Show Statistical Analysis 28 Hide Statistical Analysis 28
Statistical Analysis Overview Comparison Group Selection aTIV (36 to <72 Months), Comparator TIV (36 to <72 Months)
Comments At risk subjects
Type of Statistical Test Non-Inferiority or Equivalence
Comments Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.
Method of Estimation Estimation Parameter GMT ratio (H1N1 strain)
Estimated Value 1.76
Confidence Interval (2-Sided) 95%
0.57 to 5.4
Estimation Comments [Not Specified]
Show Statistical Analysis 29 Hide Statistical Analysis 29
Statistical Analysis Overview Comparison Group Selection aTIV (36 to <72 Months), Comparator TIV (36 to <72 Months)
Comments At risk subjects
Type of Statistical Test Non-Inferiority or Equivalence
Comments Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.
Method of Estimation Estimation Parameter GMT ratio (H3N2 strain)
Estimated Value 1.78
Confidence Interval (2-Sided) 95%
1.09 to 2.89
Estimation Comments [Not Specified]
Show Statistical Analysis 30 Hide Statistical Analysis 30
Statistical Analysis Overview Comparison Group Selection aTIV (36 to <72 Months), Comparator TIV (36 to <72 Months)
Comments At risk subjects
Type of Statistical Test Non-Inferiority or Equivalence
Comments Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.
Method of Estimation Estimation Parameter GMT ratio (B strain)
Estimated Value 1.82
Confidence Interval (2-Sided) 95%
0.73 to 4.54
Estimation Comments [Not Specified]
Show Statistical Analysis 31 Hide Statistical Analysis 31
Statistical Analysis Overview Comparison Group Selection aTIV (36 to <72 Months), TIV (36 to <72 Months)
Comments No risk subjects
Type of Statistical Test Non-Inferiority or Equivalence
Comments Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.
Method of Estimation Estimation Parameter GMT ratio (H1N1 strain)
Estimated Value 2.4
Confidence Interval (2-Sided) 95%
1.89 to 3.05
Estimation Comments [Not Specified]
Show Statistical Analysis 32 Hide Statistical Analysis 32
Statistical Analysis Overview Comparison Group Selection aTIV (36 to <72 Months), TIV (36 to <72 Months)
Comments No risk subjects.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.
Method of Estimation Estimation Parameter GMT ratio (H3N2 strain)
Estimated Value 1.54
Confidence Interval (2-Sided) 95%
1.29 to 1.85
Estimation Comments [Not Specified]
Show Statistical Analysis 33 Hide Statistical Analysis 33
Statistical Analysis Overview Comparison Group Selection aTIV (36 to <72 Months), TIV (36 to <72 Months)
Comments No risk subjects
Type of Statistical Test Non-Inferiority or Equivalence
Comments Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.
Method of Estimation Estimation Parameter GMT ratio (B strain)
Estimated Value 1.7
Confidence Interval (2-Sided) 95%
1.36 to 2.11
Estimation Comments [Not Specified]
Show Statistical Analysis 34 Hide Statistical Analysis 34
Statistical Analysis Overview Comparison Group Selection aTIV (36 to <72 Months), TIV (36 to <72 Months)
Comments At risk subjects.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.
Method of Estimation Estimation Parameter GMT ratio (H1N1 strain)
Estimated Value 2.12
Confidence Interval (2-Sided) 95%
0.58 to 7.71
Estimation Comments [Not Specified]
Show Statistical Analysis 35 Hide Statistical Analysis 35
Statistical Analysis Overview Comparison Group Selection aTIV (36 to <72 Months), TIV (36 to <72 Months)
Comments At risk subjects
Type of Statistical Test Non-Inferiority or Equivalence
Comments Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.
Method of Estimation Estimation Parameter GMT ratio (H3N2 strain)
Estimated Value 2.81
Confidence Interval (2-Sided) 95%
1.61 to 4.89
Estimation Comments [Not Specified]
Show Statistical Analysis 36 Hide Statistical Analysis 36
Statistical Analysis Overview Comparison Group Selection aTIV (36 to <72 Months), TIV (36 to <72 Months)
Comments At risk subjects
Type of Statistical Test Non-Inferiority or Equivalence
Comments Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.
Method of Estimation Estimation Parameter GMT ratio (B strain)
Estimated Value 1.17
Confidence Interval (2-Sided) 95%
0.37 to 3.67
Estimation Comments [Not Specified]
14.Secondary Outcome
Title Comparison of Antibody Responses of aTIV Versus Comparator TIV and TIV in Terms of Percentage of Subjects Achieving Seroconversion or ≥4-fold Increase in HI Titer Against Homologous Strains in Subjects at Risk/Not at Risk, by Age Subgroup
Hide Description The non-inferiority of HI antibody responses of aTIV to that of the licensed comparator TIV and to investigational TIV was assessed in terms of percentage of subjects achieving seroconversion or ≥4-fold increase in HI titers at three weeks after last vaccination against the three homologous vaccine strains in subjects with a defined set of underlying medical conditions (at risk) and in healthy subjects (not at risk) , by age sub group.
Time Frame Day 50
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the Per Protocol Set.
Arm/Group Title aTIV (6 to <72 Months) Compartor TIV (6 to <72 Months) TIV (6 to <72 Months) aTIV (6 to <36 Months) Compartor TIV (6 to <36 Months) TIV (6 to <36 Months) aTIV (36 to <72 Months) Comparator TIV (36 to <72 Months) TIV (36 to <72 Months)
Hide Arm/Group Description:
Subjects received an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV), subjects aged between 6 to <36 months received two doses (Day 1 & 29) while subjects aged ≥36 months received one dose (at Day 1) of the vaccine
Subjects received a licensed comparator trivalent split influenza vaccine (comparator TIV), subjects aged between 6 to <36 months received two doses (Day 1 & 29) while subjects aged ≥36 months received one dose (at Day 1) of the vaccine
Subjects received an investigational trivalent split influenza vaccine (TIV), subjects aged between 6 to <36 months received two doses (Day 1 & 29) while subjects aged ≥36 months received one dose (Day 1) of the vaccine
Subjects received two doses (Day 1 & 29) of an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV)
Subjects received two doses (Day 1 & 29) of a licensed comparator trivalent split influenza vaccine (comparator TIV)
Subjects received two doses (Day 1 & 29) of an investigational trivalent split influenza vaccine (TIV)
Subjects received one dose (Day 1) of investigational MF59-adjuvanted trivalent influenza vaccine (aTIV)
Subjects received one dose (Day 1) of a licensed comparator trivalent split influenza vaccine (comparator TIV)
Subjects received one dose (Day 1) of an investigational trivalent split influenza vaccine (TIV)
Overall Number of Participants Analyzed 660 722 739 425 612 623 235 110 116
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentages of subjects
H1N1 norisk(N=658,722,739,425,612,623,233,110,116)
93
(91 to 95)
85
(82 to 87)
79
(76 to 82)
95
(92 to 97)
84
(81 to 87)
78
(75 to 82)
91
(86 to 94)
88
(81 to 94)
83
(75 to 89)
H3N2 norisk(N=660,722,739,425,612,623,235,110,116)
97
(95 to 98)
93
(91 to 94)
90
(87 to 92)
98
(96 to 99)
93
(91 to 95)
90
(88 to 93)
94
(91 to 97)
90
(83 to 95)
86
(79 to 92)
B norisk(N=660,722,739,425,612,623,235,110,116)
98
(96 to 99)
86
(83 to 88)
84
(82 to 87)
98
(96 to 99)
85
(82 to 88)
83
(79 to 86)
98
(95 to 99)
90
(83 to 95)
94
(88 to 98)
H1N1 at risk (N=22,35,26,12,23,19,10,12,7)
82
(60 to 95)
83
(66 to 93)
85
(65 to 96)
92
(62 to 100)
87
(66 to 97)
89
(67 to 99)
70
(35 to 93)
75
(43 to 95)
71
(29 to 96)
H3N2 at risk(N=22,35,26,12,23,19,10,12,7)
86
(65 to 97)
86
(70 to 95)
81
(61 to 93)
83
(52 to 98)
78
(56 to 93)
74
(49 to 91)
90
(55 to 100)
100
(74 to 100)
100
(59 to 100)
B at risk(N=22,35,26,12,23,19,10,12,7)
100
(85 to 100)
86
(70 to 98)
88
(70 to 98)
100
(74 to 100)
91
(72 to 99)
84
(60 to 97)
100
(69 to 100)
75
(43 to 95)
100
(59 to 100)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection aTIV (6 to <72 Months), Compartor TIV (6 to <72 Months)
Comments No risk subjects.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was > -10%
Method of Estimation Estimation Parameter Group difference (H1N1 strain)
Estimated Value 9
Confidence Interval (2-Sided) 95%
5.4 to 12
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection aTIV (6 to <72 Months), Compartor TIV (6 to <72 Months)
Comments No risk subjects.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was > -10%.
Method of Estimation Estimation Parameter Group difference (H3N2 strain)
Estimated Value 4
Confidence Interval (2-Sided) 95%
1.8 to 6.6
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection aTIV (6 to <72 Months), Compartor TIV (6 to <72 Months)
Comments No risk subjects.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was > -10%.
Method of Estimation Estimation Parameter Group difference (B strain)
Estimated Value 12
Confidence Interval (2-Sided) 95%
9.2 to 14.8
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection aTIV (6 to <72 Months), Compartor TIV (6 to <72 Months)
Comments At risk subjects.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was > -10%.
Method of Estimation Estimation Parameter Group difference (H1N1 strain)
Estimated Value -1
Confidence Interval (2-Sided) 95%
-24 to 18.7
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection aTIV (6 to <72 Months), Compartor TIV (6 to <72 Months)
Comments At risk subjects.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was > -10%.
Method of Estimation Estimation Parameter Group difference (H3N2 strain)
Estimated Value 1
Confidence Interval (2-Sided) 95%
-21.2 to 18.9
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection aTIV (6 to <72 Months), Compartor TIV (6 to <72 Months)
Comments At risk subjects.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was > -10%.
Method of Estimation Estimation Parameter Group difference (B strain)
Estimated Value 14
Confidence Interval (2-Sided) 95%
-1.6 to 29.5
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection aTIV (6 to <72 Months), TIV (6 to <72 Months)
Comments No risk subjects.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was > -10%.
Method of Estimation Estimation Parameter Group difference (H1N1 strain)
Estimated Value 14
Confidence Interval (2-Sided) 95%
10.7 to 17.7
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection aTIV (6 to <72 Months), TIV (6 to <72 Months)
Comments No risk subjects.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was > -10%.
Method of Estimation Estimation Parameter Group difference (H3N2 strain)
Estimated Value 7
Confidence Interval (2-Sided) 95%
4.6 to 9.8
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection aTIV (6 to <72 Months), TIV (6 to <72 Months)
Comments No risk subjects
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was > -10%.
Method of Estimation Estimation Parameter Group difference (B strain)
Estimated Value 13
Confidence Interval (2-Sided) 95%
10.7 to 16.4
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection aTIV (6 to <72 Months), TIV (6 to <72 Months)
Comments At risk subjects.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was > -10%.
Method of Estimation Estimation Parameter Group difference (H1N1 strain)
Estimated Value -3
Confidence Interval (2-Sided) 95%
-26.1 to 19.2
Estimation Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection aTIV (6 to <72 Months), TIV (6 to <72 Months)
Comments At risk subjects.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was > -10%.
Method of Estimation Estimation Parameter Group difference (H3N2 strain)
Estimated Value 6
Confidence Interval (2-Sided) 95%
-17.5 to 27.3
Estimation Comments [Not Specified]
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection aTIV (6 to <72 Months), TIV (6 to <72 Months)
Comments At risk subjects.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was > -10%.
Method of Estimation Estimation Parameter Group difference (B strain)
Estimated Value 12
Confidence Interval (2-Sided) 95%
-4.4 to 29.2
Estimation Comments [Not Specified]
Show Statistical Analysis 13 Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection aTIV (6 to <36 Months), Compartor TIV (6 to <36 Months)
Comments No risk subjects.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was > -10%.
Method of Estimation Estimation Parameter Group difference (H1N1 strain)
Estimated Value 11
Confidence Interval (2-Sided) 95%
7.2 to 14.5
Estimation Comments [Not Specified]
Show Statistical Analysis 14 Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection aTIV (6 to <36 Months), Compartor TIV (6 to <36 Months)
Comments No risk subjects.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was > -10%.
Method of Estimation Estimation Parameter Group difference (H3N2 strain)
Estimated Value 5
Confidence Interval (2-Sided) 95%
2.6 to 7.5
Estimation Comments [Not Specified]
Show Statistical Analysis 15 Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection aTIV (6 to <36 Months), Compartor TIV (6 to <36 Months)
Comments No risk subjects.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was > -10%.
Method of Estimation Estimation Parameter Group difference (B strain)
Estimated Value 13
Confidence Interval (2-Sided) 95%
9.5 to 15.8
Estimation Comments [Not Specified]
Show Statistical Analysis 16 Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection aTIV (6 to <36 Months), Compartor TIV (6 to <36 Months)
Comments At risk subjects.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was > -10%.
Method of Estimation Estimation Parameter Group difference (H1N1 strain)
Estimated Value 5
Confidence Interval (2-Sided) 95%
-24.7 to 26.3
Estimation Comments [Not Specified]
Show Statistical Analysis 17 Hide Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection aTIV (6 to <36 Months), Compartor TIV (6 to <36 Months)
Comments At risk subjects.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was > -10%.
Method of Estimation Estimation Parameter Group difference (H3N2 strain)
Estimated Value 5
Confidence Interval (2-Sided) 95%
-26.9 to 30.3
Estimation Comments [Not Specified]
Show Statistical Analysis 18 Hide Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection aTIV (6 to <36 Months), Compartor TIV (6 to <36 Months)
Comments At risk subjects.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was > -10%.
Method of Estimation Estimation Parameter Group difference (B strain)
Estimated Value 9
Confidence Interval (2-Sided) 95%
-16.9 to 27.1
Estimation Comments [Not Specified]
Show Statistical Analysis 19 Hide Statistical Analysis 19
Statistical Analysis Overview Comparison Group Selection aTIV (6 to <36 Months), TIV (6 to <36 Months)
Comments No risk subjects.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was > -10%.
Method of Estimation Estimation Parameter Group difference (H1N1 strain)
Estimated Value 16
Confidence Interval (2-Sided) 95%
12.4 to 20.2
Estimation Comments [Not Specified]
Show Statistical Analysis 20 Hide Statistical Analysis 20
Statistical Analysis Overview Comparison Group Selection aTIV (6 to <36 Months), TIV (6 to <36 Months)
Comments No risk subjects
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was > -10%.
Method of Estimation Estimation Parameter Group difference (H3N2 strain)
Estimated Value 8
Confidence Interval (2-Sided) 95%
5.1 to 10.5
Estimation Comments [Not Specified]
Show Statistical Analysis 21 Hide Statistical Analysis 21
Statistical Analysis Overview Comparison Group Selection aTIV (6 to <36 Months), TIV (6 to <36 Months)
Comments No risk subjects
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was > -10%.
Method of Estimation Estimation Parameter Group difference (B strain)
Estimated Value 15
Confidence Interval (2-Sided) 95%
12 to 18.6
Estimation Comments [Not Specified]
Show Statistical Analysis 22 Hide Statistical Analysis 22
Statistical Analysis Overview Comparison Group Selection aTIV (6 to <36 Months), TIV (6 to <36 Months)
Comments At risk subjects
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was > -10%.
Method of Estimation Estimation Parameter Group difference (H1N1 strain)
Estimated Value 2
Confidence Interval (2-Sided) 95%
-27.1 to 25.5
Estimation Comments [Not Specified]
Show Statistical Analysis 23 Hide Statistical Analysis 23
Statistical Analysis Overview Comparison Group Selection aTIV (6 to <36 Months), TIV (6 to <36 Months)
Comments At risk subjects
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was > -10%.
Method of Estimation Estimation Parameter Group difference (H3N2 strain)
Estimated Value 10
Confidence Interval (2-Sided) 95%
-23.5 to 37.2
Estimation Comments [Not Specified]
Show Statistical Analysis 24 Hide Statistical Analysis 24
Statistical Analysis Overview Comparison Group Selection aTIV (6 to <36 Months), TIV (6 to <36 Months)
Comments At risk subjects.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was > -10%.
Method of Estimation Estimation Parameter Group difference (B strain)
Estimated Value 16
Confidence Interval (2-Sided) 95%
-10.7 to 38
Estimation Comments [Not Specified]
Show Statistical Analysis 25 Hide Statistical Analysis 25
Statistical Analysis Overview Comparison Group Selection aTIV (36 to <72 Months), Comparator TIV (36 to <72 Months)
Comments No risk subjects.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was > -10%.
Method of Estimation Estimation Parameter Group difference (H1N1 strain)
Estimated Value 2
Confidence Interval (2-Sided) 95%
-4.2 to 10.4
Estimation Comments [Not Specified]
Show Statistical Analysis 26 Hide Statistical Analysis 26
Statistical Analysis Overview Comparison Group Selection aTIV (36 to <72 Months), Comparator TIV (36 to <72 Months)
Comments No risk subjects.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was > -10%.
Method of Estimation Estimation Parameter Group difference (H3N2 subjects)
Estimated Value 4
Confidence Interval (2-Sided) 95%
-1.2 to 11.9
Estimation Comments [Not Specified]
Show Statistical Analysis 27 Hide Statistical Analysis 27
Statistical Analysis Overview Comparison Group Selection aTIV (36 to <72 Months), Comparator TIV (36 to <72 Months)
Comments No risk subjects.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was > -10%.
Method of Estimation Estimation Parameter Group difference (B strain)
Estimated Value 8
Confidence Interval (2-Sided) 95%
2.9 to 15.1
Estimation Comments [Not Specified]
Show Statistical Analysis 28 Hide Statistical Analysis 28
Statistical Analysis Overview Comparison Group Selection aTIV (36 to <72 Months), Comparator TIV (36 to <72 Months)
Comments At risk subjects.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was > -10%.
Method of Estimation Estimation Parameter Group difference (H1N1 strain)
Estimated Value -5
Confidence Interval (2-Sided) 95%
-42.4 to 32
Estimation Comments [Not Specified]
Show Statistical Analysis 29 Hide Statistical Analysis 29
Statistical Analysis Overview Comparison Group Selection aTIV (36 to <72 Months), Comparator TIV (36 to <72 Months)
Comments At risk subjects.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was > -10%.
Method of Estimation Estimation Parameter Group difference (H3N2 strain)
Estimated Value -10
Confidence Interval (2-Sided) 95%
-41.2 to 16.6
Estimation Comments [Not Specified]
Show Statistical Analysis 30 Hide Statistical Analysis 30
Statistical Analysis Overview Comparison Group Selection aTIV (36 to <72 Months), Comparator TIV (36 to <72 Months)
Comments At risk subjects.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was > -10%.
Method of Estimation Estimation Parameter Group difference (B strain)
Estimated Value 25
Confidence Interval (2-Sided) 95%
-7.1 to 53.9
Estimation Comments [Not Specified]
Show Statistical Analysis 31 Hide Statistical Analysis 31
Statistical Analysis Overview Comparison Group Selection aTIV (36 to <72 Months), TIV (36 to <72 Months)
Comments No risk subjects.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was > -10%.
Method of Estimation Estimation Parameter Group difference (H1N1 strain)
Estimated Value 8
Confidence Interval (2-Sided) 95%
1 to 16.4
Estimation Comments [Not Specified]
Show Statistical Analysis 32 Hide Statistical Analysis 32
Statistical Analysis Overview Comparison Group Selection aTIV (36 to <72 Months), TIV (36 to <72 Months)
Comments No risk subjects.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was > -10%.
Method of Estimation Estimation Parameter Group difference (H3N2 strain)
Estimated Value 8
Confidence Interval (2-Sided) 95%
2 to 16.1
Estimation Comments [Not Specified]
Show Statistical Analysis 33 Hide Statistical Analysis 33
Statistical Analysis Overview Comparison Group Selection aTIV (36 to <72 Months), TIV (36 to <72 Months)
Comments No risk subjects.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was > -10%.
Method of Estimation Estimation Parameter Group difference (B strain)
Estimated Value 4
Confidence Interval (2-Sided) 95%
0 to 10
Estimation Comments [Not Specified]
Show Statistical Analysis 34 Hide Statistical Analysis 34
Statistical Analysis Overview Comparison Group Selection aTIV (36 to <72 Months), TIV (36 to <72 Months)
Comments At risk subjects.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was > -10%.
Method of Estimation Estimation Parameter Group difference (H1N1 strain)
Estimated Value -1
Confidence Interval (2-Sided) 95%
-42.1 to 43
Estimation Comments [Not Specified]
Show Statistical Analysis 35 Hide Statistical Analysis 35
Statistical Analysis Overview Comparison Group Selection aTIV (36 to <72 Months), TIV (36 to <72 Months)
Comments At risk subjects
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was > -10%.
Method of Estimation Estimation Parameter Group difference (H3N2 strain)
Estimated Value -10
Confidence Interval (2-Sided) 95%
-41.5 to 28.7
Estimation Comments [Not Specified]
Show Statistical Analysis 36 Hide Statistical Analysis 36
Statistical Analysis Overview Comparison Group Selection aTIV (36 to <72 Months), TIV (36 to <72 Months)
Comments At risk subjects.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was > -10%.
Method of Estimation Estimation Parameter Group difference (B strain)
Estimated Value 0
Confidence Interval (2-Sided) 95%
-29 to 36.8
Estimation Comments [Not Specified]
15.Secondary Outcome
Title Comparison of Antibody Responses of TIV Versus Comparator TIV in Terms of Percentage of Subjects Achieving Seroconversion or ≥4-fold Increase in HI Titer Against Homologous Strains in Subjects at Risk/Not at Risk, by Age Sub Group-FAS
Hide Description The superiority of HI antibody responses of aTIV compared to TIV and comparator TIV assessed in terms of of percentage of subjects achieving seroconversion or ≥4-fold increase in HI Titer at three weeks after last vaccination against the three homologous vaccine strains in subjects with a defined set of underlying medical conditions (at risk) and healthy subjects (not at risk), by age sub group.
Time Frame Day 50
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the Full Analysis Set.
Arm/Group Title aTIV (6 to <72 Months) Compartor TIV (6 to <72 Months) TIV (6 to <72 Months) aTIV (6 to <36 Months) Compartor TIV (6 to <36 Months) TIV (6 to <36 Months) aTIV (36 to <72 Months) Comparator TIV (36 to <72 Months) TIV (36 to <72 Months)
Hide Arm/Group Description:
Subjects received an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV), subjects aged between 6 to <36 months received two doses (Day 1 & 29) while subjects aged ≥36 months received one dose (at Day 1) of the vaccine
Subjects received a licensed comparator trivalent split influenza vaccine (comparator TIV), subjects aged between 6 to <36 months received two doses (Day 1 & 29) while subjects aged ≥36 months received one dose (at Day 1) of the vaccine
Subjects received an investigational trivalent split influenza vaccine (TIV), subjects aged between 6 to <36 months received two doses (Day 1 & 29) while subjects aged ≥36 months received one dose (Day 1) of the vaccine
Subjects received two doses (Day 1 & 29) of an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV)
Subjects received two doses (Day 1 & 29) of a licensed comparator trivalent split influenza vaccine (comparator TIV)
Subjects received two doses (Day 1 & 29) of an investigational trivalent split influenza vaccine (TIV)
Subjects received one dose (Day 1) of investigational MF59-adjuvanted trivalent influenza vaccine (aTIV)
Subjects received one dose (Day 1) of a licensed comparator trivalent split influenza vaccine (comparator TIV)
Subjects received one dose (Day 1) of an investigational trivalent split influenza vaccine (TIV)
Overall Number of Participants Analyzed 719 799 814 459 673 688 260 126 126
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentages of subjects
H1N1 norisk(N=717,799,814,459,673,688,258,126,126)
93
(91 to 95)
84
(81 to 86)
79
(76 to 81)
95
(92 to 96)
83
(80 to 86)
78
(75 to 81)
91
(87 to 94)
89
(82 to 94)
81
(73 to 87)
H3N2 norisk(N=719,799,814,459,673,688,260,126,126)
97
(95 to 98)
93
(91 to 94)
90
(88 to 92)
98
(96 to 99)
93
(91 to 95)
91
(88 to 93)
95
(91 to 97)
91
(85 to 96)
87
(79 to 92)
B norisk(N=719,799,814,459,673,688,260,126,126)
97
(96 to 99)
86
(84 to 89)
84
(82 to 87)
98
(96 to 99)
85
(83 to 88)
83
(80 to 85)
97
(95 to 99)
91
(85 to 96)
94
(88 to 97)
H1N1 at risk(N=28,40,35,17,26,26,11,14,9)
79
(59 to 92)
83
(67 to 93)
83
(66 to 93)
82
(57 to 96)
85
(65 to 96)
85
(65 to 96)
73
(39 to 94)
79
(49 to 95)
78
(40 to 97)
H3N2 at risk(N=28,40,35,17,26,26,11,14,9)
89
(72 to 98)
85
(70 to 94)
83
(66 to 93)
88
(64 to 99)
77
(56 to 91)
77
(56 to 91)
91
(59 to 100)
100
(77 to 100)
100
(66 to 100)
B at risk(N=28,40,35,17,26,26,11,14,9)
96
(82 to 100)
88
(73 to 96)
89
(73 to 97)
94
(71 to 100)
92
(75 to 99)
85
(65 to 96)
100
(72 to 100)
79
(49 to 95)
100
(66 to 100)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection aTIV (6 to <72 Months), Compartor TIV (6 to <72 Months)
Comments No risk subjects.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was > -10%.
Method of Estimation Estimation Parameter Group difference (H1N1 strain)
Estimated Value 10
Confidence Interval (2-Sided) 95%
6.4 to 12.8
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection aTIV (6 to <72 Months), Compartor TIV (6 to <72 Months)
Comments No risk subjects.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was > -10%.
Method of Estimation Estimation Parameter Group difference (H3N2 strain)
Estimated Value 4
Confidence Interval (2-Sided) 95%
1.8 to 6.4
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection aTIV (6 to <72 Months), Compartor TIV (6 to <72 Months)
Comments No risk subjects.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was > -10%.
Method of Estimation Estimation Parameter Group difference (B strain)
Estimated Value 11
Confidence Interval (2-Sided) 95%
8.6 to 13.9
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection aTIV (6 to <72 Months), Compartor TIV (6 to <72 Months)
Comments At risk subjects.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was > -10%.
Method of Estimation Estimation Parameter Group difference (H1N1 strain)
Estimated Value -4
Confidence Interval (2-Sided) 95%
-24.7 to 14.9
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection aTIV (6 to <72 Months), Compartor TIV (6 to <72 Months)
Comments At risk subjects.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was > -10%.
Method of Estimation Estimation Parameter Group difference (H3N2 strain)
Estimated Value 4
Confidence Interval (2-Sided) 95%
-14.4 to 20.7
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection aTIV (6 to <72 Months), Compartor TIV (6 to <72 Months)
Comments At risk subjects.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was > -10%.
Method of Estimation Estimation Parameter Group difference (B strain)
Estimated Value 9
Confidence Interval (2-Sided) 95%
-6.8 to 23.4
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection aTIV (6 to <72 Months), TIV (6 to <72 Months)
Comments No risk subjects.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was > -10%.
Method of Estimation Estimation Parameter Group difference (H1N1 strain)
Estimated Value 15
Confidence Interval (2-Sided) 95%
11.3 to 18.1
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection aTIV (6 to <72 Months), TIV (6 to <72 Months)
Comments No risk subjects.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was > -10%.
Method of Estimation Estimation Parameter Group difference (H3N2 strain)
Estimated Value 7
Confidence Interval (2-Sided) 95%
4.2 to 9.1
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection aTIV (6 to <72 Months), TIV (6 to <72 Months)
Comments No risk subjects.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was > -10%.
Method of Estimation Estimation Parameter Group difference (B strain)
Estimated Value 13
Confidence Interval (2-Sided) 95%
10.5 to 16.1
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection aTIV (6 to <72 Months), TIV (6 to <72 Months)
Comments At risk subjects
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was > -10%.
Method of Estimation Estimation Parameter Group difference (H1N1 strain)
Estimated Value -4
Confidence Interval (2-Sided) 95%
-25.3 to 15.4
Estimation Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection aTIV (6 to <72 Months), TIV (6 to <72 Months)
Comments At risk subjects.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was > -10%.
Method of Estimation Estimation Parameter Group difference (H3N2 strain)
Estimated Value 6
Confidence Interval (2-Sided) 95%
-12.7 to 24.2
Estimation Comments [Not Specified]
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection aTIV (6 to <72 Months), TIV (6 to <72 Months)
Comments At risk subjects.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was > -10%.
Method of Estimation Estimation Parameter Group differences (B strain)
Estimated Value 8
Confidence Interval (2-Sided) 95%
-7.8 to 23.2
Estimation Comments [Not Specified]
Show Statistical Analysis 13 Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection aTIV (6 to <36 Months), Compartor TIV (6 to <36 Months)
Comments No risk subjects.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was > -10%.
Method of Estimation Estimation Parameter Group difference (H1N1 strain)
Estimated Value 12
Confidence Interval (2-Sided) 95%
8.2 to 15.3
Estimation Comments [Not Specified]
Show Statistical Analysis 14 Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection aTIV (6 to <36 Months), Compartor TIV (6 to <36 Months)
Comments No risk subjects.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was > -10%.
Method of Estimation Estimation Parameter Group difference (H3N2 strain)
Estimated Value 5
Confidence Interval (2-Sided) 95%
2.5 to 7.4
Estimation Comments [Not Specified]
Show Statistical Analysis 15 Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection aTIV (6 to <36 Months), Compartor TIV (6 to <36 Months)
Comments No risk subjects.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was > -10%.
Method of Estimation Estimation Parameter Group difference (B strain)
Estimated Value 12
Confidence Interval (2-Sided) 95%
9.2 to 15.3
Estimation Comments [Not Specified]
Show Statistical Analysis 16 Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection aTIV (6 to <36 Months), Compartor TIV (6 to <36 Months)
Comments At risk subjects.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was > -10%.
Method of Estimation Estimation Parameter Group difference (H1N1 strain)
Estimated Value -2
Confidence Interval (2-Sided) 95%
-28.5 to 20.2
Estimation Comments [Not Specified]
Show Statistical Analysis 17 Hide Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection aTIV (6 to <36 Months), Compartor TIV (6 to <36 Months)
Comments At risk subjects.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was > -10%.
Method of Estimation Estimation Parameter Group difference (H3N2 strain)
Estimated Value 11
Confidence Interval (2-Sided) 95%
-14.9 to 33.5
Estimation Comments [Not Specified]
Show Statistical Analysis 18 Hide Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection aTIV (6 to <36 Months), Compartor TIV (6 to <36 Months)
Comments At risk subjects.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was > -10%.
Method of Estimation Estimation Parameter Group difference (B strain)
Estimated Value 2
Confidence Interval (2-Sided) 95%
-20.7 to 19.7
Estimation Comments [Not Specified]
Show Statistical Analysis 19 Hide Statistical Analysis 19
Statistical Analysis Overview Comparison Group Selection aTIV (6 to <36 Months), TIV (6 to <36 Months)
Comments No risk subjects.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was > -10%.
Method of Estimation Estimation Parameter Group difference (H1N1 strain)
Estimated Value 16
Confidence Interval (2-Sided) 95%
12.6 to 20.1
Estimation Comments [Not Specified]
Show Statistical Analysis 20 Hide Statistical Analysis 20
Statistical Analysis Overview