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Safety and Immunogenicity of A/H1N1-SOIV (Swine Flu) Vaccine With and Without Adjuvant in Children (3 to < 9 Years)

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ClinicalTrials.gov Identifier: NCT00972816
Recruitment Status : Completed
First Posted : September 9, 2009
Results First Posted : January 27, 2011
Last Update Posted : April 14, 2016
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Prevention
Condition Influenza
Intervention Biological: MF59-eH1N1
Enrollment 1357
Recruitment Details 36 centers in the U.S., of which 34 centers enrolled subjects.
Pre-assignment Details  
Arm/Group Title 3.75_(50) MF59 7.5_(0) MF59 7.5_(50)MF59 7.5_(100)MF59 15_(0) MF59 15_(50) MF59 15_(100) MF59 30_(0) MF59
Hide Arm/Group Description 3.75 μg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22 7.5 μg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22 7.5 μg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22 7.5 μg A/H1N1 antigen with 100% MF59 adjuvant administered on study day 1 and day 22 15 μg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22 15 μg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22 15 μg A/H1N1 antigen with 100% MF59 adjuvant administered on study day 1 and day 22 30 μg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22
Period Title: Overall Study
Started 173 169 169 169 169 169 169 170
Completed 156 158 160 161 157 158 159 161
Not Completed 17 11 9 8 12 11 10 9
Reason Not Completed
Adverse Event             0             0             1             0             0             0             0             0
Withdrawal by Subject             4             2             1             3             0             1             1             2
Lost to Follow-up             11             9             7             5             11             10             7             7
Inappropriate enrolment             0             0             0             0             0             0             2             0
Unable to classify             2             0             0             0             1             0             0             0
Arm/Group Title 3.75_(50)MF59 7.5 Without MF59 7.5_(50)MF59 7.5_(100)MF59 15 Without MF59 15_(50)MF59 15_(100)MF59 30 Without MF59 Total
Hide Arm/Group Description 50% of MF59 with 3.75 µg A/H1N1 antigen 1 dose of 7.5 µg A/H1N1 50% of MF59 with 7.5 µg A/H1N1 antigen 100% of MF59 with 7.5 µg A/H1N1 antigen 1 dose of 15 µg A/H1N1 50% of MF59 with 15 µg A/H1N1 antigen 100% of MF59 with 15 µg A/H1N1 antigen 1 dose of 30 µg A/H1N1 Total of all reporting groups
Overall Number of Baseline Participants 173 169 169 169 169 169 169 170 1357
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 173 participants 169 participants 169 participants 169 participants 169 participants 169 participants 169 participants 170 participants 1357 participants
5.6  (1.7) 5.2  (1.7) 5.5  (1.8) 5.9  (1.7) 5.6  (1.7) 5.5  (1.7) 5.5  (1.7) 5.5  (1.7) 5.5  (1.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 173 participants 169 participants 169 participants 169 participants 169 participants 169 participants 169 participants 170 participants 1357 participants
Female
81
  46.8%
88
  52.1%
83
  49.1%
83
  49.1%
79
  46.7%
80
  47.3%
75
  44.4%
83
  48.8%
652
  48.0%
Male
92
  53.2%
81
  47.9%
86
  50.9%
86
  50.9%
90
  53.3%
89
  52.7%
94
  55.6%
87
  51.2%
705
  52.0%
1.Primary Outcome
Title Antibody Responses According to the Hemagglutinin Inhibition (HI) Assay After the First and Second Vaccinations
Hide Description

HI antibody assay (used to assess immune responses in subjects following vaccination) according to the Center for Biologics Evaluation and Research (CBER) guidance for <65 years of age: The lower bound of the two-sided 95% Confidence Interval (CI) for the percentages of subjects achieving seroconversion for HI antibody should be ≥ 40% and the lower bound of the two-sided 95% CI for the percentages of subjects achieving an HI antibody titer ≥ 1:40 should be ≥ 70%. Both criteria (seroconversion and HI antibody titer ≥ 40) had to be fulfilled to establish immunogenicity.

PPS Day 1–29 analysis set: N= 143, 149, 149, 146, 147, 147, 144, and 144 for Groups A, B, C, D, E, F,G,and H respectively.

PPS Day 1–202 analysis set: N= 82, 85, 84, 84, 86, 87, 82, and 79 for Groups A, B, C, D, E, F, G, and H respectively.

PPS Day 1–387 analysis set: N= 55, 63, 61, 58, 61, 65, 59, and 63 for Groups A, B, C, D, E, F, G, and H respectively.

Time Frame Day 22, Day 29, Day 43, Day 202 and Day 387
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on per protocol set (PPS) population
Arm/Group Title 3.75_(50)MF59 7.5 Without MF59 7.5_(50)MF59 7.5_(100)MF59 15 Without MF59 15_(50)MF59 15_(100)MF59 30 Without MF59
Hide Arm/Group Description:
50% of MF59 with 3.75 µg A/H1N1 antigen
1 dose of 7.5 µg A/H1N1
50% of MF59 with 7.5 µg A/H1N1 antigen
100% of MF59 with 7.5 µg A/H1N1 antigen
1 dose of 15 µg A/H1N1
50% of MF59 with 15 µg A/H1N1 antigen
100% of MF59 with 15 µg A/H1N1 antigen
1 dose of 30 µg A/H1N1
Overall Number of Participants Analyzed 152 156 156 156 155 157 156 153
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of subjects
HI titer ≥1:40 (Baseline)
11
(6 to 17)
9
(5 to 15)
13
(8 to 19)
11
(6 to 170)
15
(10 to 22)
9
(5 to 15)
8
(4 to 13)
12
(8 to 19)
HI titer ≥1:40 day 22
84
(77 to 89)
48
(40 to 56)
81
(74 to 87)
91
(85 to 95)
61
(52 to 68)
82
(75 to 88)
94
(89 to 97)
65
(57 to 73)
Seroconversion day 22
82
(74 to 87)
46
(38 to 54)
78
(70 to 84)
88
(82 to 93)
58
(50 to 66)
82
(75 to 87)
92
(86 to 95)
60
(52 to 68)
HI titer ≥1:40 (Day 29)
99
(96 to 100)
79
(71 to 85)
100
(98 to 100)
99
(95 to 100)
88
(82 to 93)
100
(98 to 100)
100
(97 to 100)
97
(92 to 99)
Seroconversion (Day 29)
99
(95 to 100)
78
(70 to 84)
99
(95 to 100)
99
(95 to 100)
87
(81 to 92)
100
(98 to 100)
100
(97 to 100)
94
(88 to 97)
HI titer ≥1:40 day 43
99
(96 to 100)
79
(72 to 85)
100
(98 to 100)
99
(95 to 100)
87
(81 to 92)
99
(97 to 100)
100
(98 to 100)
92
(86 to 95)
Seroconversion day 43
98
(94 to 100)
78
(70 to 84)
97
(93 to 99)
97
(94 to 99)
85
(78 to 90)
99
(95 to 100)
99
(96 to 100)
88
(82 to 93)
HI titer ≥1:40 day 202 (N=82,85,84,84,86,87,82,79)
95
(88 to 99)
65
(54 to 75)
93
(85 to 97)
95
(88 to 99)
74
(64 to 83)
95
(89 to 99)
95
(88 to 99)
81
(71 to 89)
Seroconversion day 202 (N=82,85,84,84,86,87,82,79)
83
(73 to 90)
55
(44 to 66)
83
(74 to 91)
83
(74 to 91)
63
(52 to 73)
90
(81 to 95)
90
(82 to 96)
66
(54 to 76)
HI titer ≥1:40 day 387 (N=55,63,61,58,61,65,59,63)
80
(67 to 90)
56
(42 to 68)
75
(63 to 86)
88
(77 to 95)
49
(36 to 62)
78
(67 to 88)
81
(69 to 90)
65
(52 to 77)
Seroconversion day 387 (N=55,63,61,58,61,65,59,63)
65
(51 to 78)
49
(36 to 62)
69
(56 to 80)
78
(65 to 87)
44
(32 to 58)
75
(63 to 85)
71
(58 to 82)
51
(38 to 64)
2.Secondary Outcome
Title Geometric Mean Titer (GMT) After Each Vaccination by Vaccine Group
Hide Description

Immunogenicity was measured in terms of GMTs After each vaccination by vaccine Group.

PPS Day1–29 analysis set: N=143, 149, 149, 146, 147, 147, 144, and 144 for Groups A, B, C, D, E, F, G, and H respectively.

PPS Day 1–202 analysis set. N= 82, 85, 84, 84, 86, 87, 82, and 79 for Groups A, B, C, D, E, F, G, and H respectively.

Time Frame Day 22, Day 29, Day 43, Day 202 and Day 387
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on per protocol set (PPS) population
Arm/Group Title 3.75_(50)MF59 7.5 Without MF59 7.5_(50)MF59 7.5_(100)MF59 15 Without MF59 15_(50)MF59 15_(100)MF59 30 Without MF59
Hide Arm/Group Description:
50% of MF59 with 3.75 µg A/H1N1 antigen
1 dose of 7.5 µg A/H1N1
50% of MF59 with 7.5 µg A/H1N1 antigen
100% of MF59 with 7.5 µg A/H1N1 antigen
1 dose of 15 µg A/H1N1
50% of MF59 with 15 µg A/H1N1 antigen
100% of MF59 with 15 µg A/H1N1 antigen
1 dose of 30 µg A/H1N1
Overall Number of Participants Analyzed 152 156 156 156 155 157 156 153
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
GMT Baseline
8.5
(7 to 10)
7.3
(6 to 8.8)
8.7
(7.2 to 11)
8.7
(6.7 to 9.9)
9.1
(7.5 to 11)
7.5
(6.2 to 9.1)
7
(5.8 to 8.4)
9.1
(7.5 to 11)
GMTs day 22
107
(78 to 148)
27
(20 to 37)
88
(64 to 121)
163
(118 to 223)
49
(36 to 68)
106
(77 to 145)
160
(116 to 220)
62
(45 to 85)
GMT Day 29
747
(588 to 950)
138
(109 to 174)
685
(542 to 866)
984
(775 to 1249)
214
(169 to 271)
761
(600 to 966)
1070
(841 to 1360)
297
(235 to 377)
GMTs day 43
560
(450 to 699)
113
(91 to 140)
480
(386 to 597)
637
(511 to 793)
174
(140 to 217)
524
(420 to 652)
778
(625 to 969)
223
(179 to 278)
GMTs day 202 (N=143,149,149,146,147,147,144,144)
117
(88 to 157)
45
(34 to 59)
107
(80 to 144)
132
(99 to 177)
55
(41 to 74)
134
(100 to 179)
131
(97 to 176)
81
(60 to 109)
GMTs day 387 (N=55,63,61,58,61,65,59,63)
54
(37 to 78)
28
(20 to 40)
57
(40 to 82)
70
(49 to 102)
30
(21 to 42)
59
(41 to 83)
63
(44 to 90)
45
(31 to 64)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 3.75_(50)MF59, 7.5 Without MF59
Comments A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.
Type of Statistical Test Non-Inferiority or Equivalence
Comments For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
Method of Estimation Estimation Parameter Geometric mean ratio at day 22
Estimated Value 3.998
Confidence Interval (2-Sided) 95%
2.659 to 6.009
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 3.75_(50)MF59, 7.5_(50)MF59
Comments A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.
Type of Statistical Test Non-Inferiority or Equivalence
Comments For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
Method of Estimation Estimation Parameter Geometric mean ratio at day 22
Estimated Value 1.222
Confidence Interval (2-Sided) 95%
0.813 to 1.838
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 3.75_(50)MF59, 7.5_(100)MF59
Comments A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.
Type of Statistical Test Non-Inferiority or Equivalence
Comments For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
Method of Estimation Estimation Parameter Geometric mean ratio at day 22
Estimated Value 0.661
Confidence Interval (2-Sided) 95%
0.440 to 0.994
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection 3.75_(50)MF59, 15 Without MF59
Comments A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.
Type of Statistical Test Non-Inferiority or Equivalence
Comments For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
Method of Estimation Estimation Parameter Geometric mean ratio at day 22
Estimated Value 2.178
Confidence Interval (2-Sided) 95%
1.449 to 3.276
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection 3.75_(50)MF59, 15_(50)MF59
Comments A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.
Type of Statistical Test Non-Inferiority or Equivalence
Comments For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
Method of Estimation Estimation Parameter Geometric mean ratio at day 22
Estimated Value 1.017
Confidence Interval (2-Sided) 95%
0.676 to 1.528
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection 3.75_(50)MF59, 15_(100)MF59
Comments A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.
Type of Statistical Test Non-Inferiority or Equivalence
Comments For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
Method of Estimation Estimation Parameter Geometric mean ratio at day 22
Estimated Value 0.673
Confidence Interval (2-Sided) 95%
0.448 to 1.012
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection 3.75_(50)MF59, 30 Without MF59
Comments A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.
Type of Statistical Test Non-Inferiority or Equivalence
Comments For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
Method of Estimation Estimation Parameter Geometric mean ratio at day 22
Estimated Value 1.742
Confidence Interval (2-Sided) 95%
1.156 to 2.626
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection 7.5 Without MF59, 7.5_(50)MF59
Comments A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.
Type of Statistical Test Non-Inferiority or Equivalence
Comments For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
Method of Estimation Estimation Parameter Geometric mean ratio at day 22
Estimated Value 0.306
Confidence Interval (2-Sided) 95%
0.204 to 0.458
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection 7.5 Without MF59, 7.5_(100)MF59
Comments A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.
Type of Statistical Test Non-Inferiority or Equivalence
Comments For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
Method of Estimation Estimation Parameter Geometric mean ratio at day 22
Estimated Value 0.165
Confidence Interval (2-Sided) 95%
0.110 to 0.248
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection 7.5 Without MF59, 15 Without MF59
Comments A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.
Type of Statistical Test Non-Inferiority or Equivalence
Comments For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
Method of Estimation Estimation Parameter Geometric mean ratio at day 22
Estimated Value 0.545
Confidence Interval (2-Sided) 95%
0.363 to 0.818
Estimation Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection 7.5 Without MF59, 15_(50)MF59
Comments A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.
Type of Statistical Test Non-Inferiority or Equivalence
Comments For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
Method of Estimation Estimation Parameter Geometric mean ratio at day 22
Estimated Value 0.254
Confidence Interval (2-Sided) 95%
0.170 to 0.381
Estimation Comments [Not Specified]
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection 7.5 Without MF59, 15_(100)MF59
Comments A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.
Type of Statistical Test Non-Inferiority or Equivalence
Comments For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
Method of Estimation Estimation Parameter Geometric mean ratio at day 22
Estimated Value 0.168
Confidence Interval (2-Sided) 95%
0.112 to 0.252
Estimation Comments [Not Specified]
Show Statistical Analysis 13 Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection 7.5 Without MF59, 30 Without MF59
Comments A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.
Type of Statistical Test Non-Inferiority or Equivalence
Comments For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
Method of Estimation Estimation Parameter Geometric mean ratio at day 22
Estimated Value 0.436
Confidence Interval (2-Sided) 95%
0.290 to 0.655
Estimation Comments [Not Specified]
Show Statistical Analysis 14 Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection 7.5_(50)MF59, 7.5_(100)MF59
Comments A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.
Type of Statistical Test Non-Inferiority or Equivalence
Comments For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
Method of Estimation Estimation Parameter Geometric mean ratio at day 22
Estimated Value 0.541
Confidence Interval (2-Sided) 95%
0.361 to 0.811
Estimation Comments [Not Specified]
Show Statistical Analysis 15 Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection 7.5_(50)MF59, 15 Without MF59
Comments A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.
Type of Statistical Test Non-Inferiority or Equivalence
Comments For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
Method of Estimation Estimation Parameter Geometric mean ratio at day 22
Estimated Value 1.783
Confidence Interval (2-Sided) 95%
1.188 to 2.676
Estimation Comments [Not Specified]
Show Statistical Analysis 16 Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection 7.5_(50)MF59, 15_(50)MF59
Comments A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.
Type of Statistical Test Non-Inferiority or Equivalence
Comments For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
Method of Estimation Estimation Parameter Geometric mean ratio at day 22
Estimated Value 0.832
Confidence Interval (2-Sided) 95%
0.555 to 1.246
Estimation Comments [Not Specified]
Show Statistical Analysis 17 Hide Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection 7.5_(50)MF59, 15_(100)MF59
Comments A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.
Type of Statistical Test Non-Inferiority or Equivalence
Comments For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
Method of Estimation Estimation Parameter Geometric mean ratio at day 22
Estimated Value 0.551
Confidence Interval (2-Sided) 95%
0.367 to 0.826
Estimation Comments [Not Specified]
Show Statistical Analysis 18 Hide Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection 7.5_(50)MF59, 30 Without MF59
Comments A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.
Type of Statistical Test Non-Inferiority or Equivalence
Comments For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
Method of Estimation Estimation Parameter Geometric mean ratio at day 22
Estimated Value 1.426
Confidence Interval (2-Sided) 95%
0.950 to 2.140
Estimation Comments [Not Specified]
Show Statistical Analysis 19 Hide Statistical Analysis 19
Statistical Analysis Overview Comparison Group Selection 7.5_(100)MF59, 15 Without MF59
Comments A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.
Type of Statistical Test Non-Inferiority or Equivalence
Comments For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
Method of Estimation Estimation Parameter Geometric mean ratio at day 22
Estimated Value 3.295
Confidence Interval (2-Sided) 95%
2.196 to 4.944
Estimation Comments [Not Specified]
Show Statistical Analysis 20 Hide Statistical Analysis 20
Statistical Analysis Overview Comparison Group Selection 7.5_(100)MF59, 15_(50)MF59
Comments A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.
Type of Statistical Test Non-Inferiority or Equivalence
Comments For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
Method of Estimation Estimation Parameter Geometric mean ratio at day 22
Estimated Value 1.538
Confidence Interval (2-Sided) 95%
1.026 to 2.303
Estimation Comments [Not Specified]
Show Statistical Analysis 21 Hide Statistical Analysis 21
Statistical Analysis Overview Comparison Group Selection 7.5_(100)MF59, 15_(100)MF59
Comments A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.
Type of Statistical Test Non-Inferiority or Equivalence
Comments For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
Method of Estimation Estimation Parameter Geometric mean ratio at day 22
Estimated Value 1.018
Confidence Interval (2-Sided) 95%
0.679 to 1.526
Estimation Comments [Not Specified]
Show Statistical Analysis 22 Hide Statistical Analysis 22
Statistical Analysis Overview Comparison Group Selection 7.5_(100)MF59, 30 Without MF59
Comments A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.
Type of Statistical Test Non-Inferiority or Equivalence
Comments For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
Method of Estimation Estimation Parameter Geometric mean ratio at day 22
Estimated Value 2.635
Confidence Interval (2-Sided) 95%
1.754 to 3.959
Estimation Comments [Not Specified]
Show Statistical Analysis 23 Hide Statistical Analysis 23
Statistical Analysis Overview Comparison Group Selection 15 Without MF59, 15_(50)MF59
Comments A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.
Type of Statistical Test Non-Inferiority or Equivalence
Comments For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
Method of Estimation Estimation Parameter Geometric mean ratio at day 22
Estimated Value 0.467
Confidence Interval (2-Sided) 95%
0.311 to 0.7
Estimation Comments [Not Specified]
Show Statistical Analysis 24 Hide Statistical Analysis 24
Statistical Analysis Overview Comparison Group Selection 15 Without MF59, 15_(100)MF59
Comments A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.
Type of Statistical Test Non-Inferiority or Equivalence
Comments For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
Method of Estimation Estimation Parameter Geometric mean ratio at day 22
Estimated Value 0.309
Confidence Interval (2-Sided) 95%
0.206 to 0.463
Estimation Comments [Not Specified]
Show Statistical Analysis 25 Hide Statistical Analysis 25
Statistical Analysis Overview Comparison Group Selection 15 Without MF59, 30 Without MF59
Comments A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other
Type of Statistical Test Non-Inferiority or Equivalence
Comments For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
Method of Estimation Estimation Parameter Geometric mean ratio at day 22
Estimated Value 0.8
Confidence Interval (2-Sided) 95%
0.532 to 1.203
Estimation Comments [Not Specified]
Show Statistical Analysis 26 Hide Statistical Analysis 26
Statistical Analysis Overview Comparison Group Selection 15_(50)MF59, 15_(100)MF59
Comments A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.
Type of Statistical Test Non-Inferiority or Equivalence
Comments For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
Method of Estimation Estimation Parameter Geometric mean ratio at day 22
Estimated Value 0.662
Confidence Interval (2-Sided) 95%
0.442 to 0.992
Estimation Comments [Not Specified]
Show Statistical Analysis 27 Hide Statistical Analysis 27
Statistical Analysis Overview Comparison Group Selection 15_(50)MF59, 30 Without MF59
Comments A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.
Type of Statistical Test Non-Inferiority or Equivalence
Comments For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
Method of Estimation Estimation Parameter Geometric mean ratio at day 22
Estimated Value 1.714
Confidence Interval (2-Sided) 95%
1.142 to 2.572
Estimation Comments [Not Specified]
Show Statistical Analysis 28 Hide Statistical Analysis 28
Statistical Analysis Overview Comparison Group Selection 15_(100)MF59, 30 Without MF59
Comments A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.
Type of Statistical Test Non-Inferiority or Equivalence
Comments A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.
Method of Estimation Estimation Parameter Geometric mean ratio at day 22
Estimated Value 2.589
Confidence Interval (2-Sided) 95%
1.723 to 3.889
Estimation Comments [Not Specified]
Show Statistical Analysis 29 Hide Statistical Analysis 29
Statistical Analysis Overview Comparison Group Selection 3.75_(50)MF59, 7.5 Without MF59
Comments A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.
Type of Statistical Test Non-Inferiority or Equivalence
Comments For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
Method of Estimation Estimation Parameter Geometric mean ratio at day 43
Estimated Value 4.975
Confidence Interval (2-Sided) 95%
3.757 to 6.589
Estimation Comments [Not Specified]
Show Statistical Analysis 30 Hide Statistical Analysis 30
Statistical Analysis Overview Comparison Group Selection 3.75_(50)MF59, 7.5_(50)MF59
Comments A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.
Type of Statistical Test Non-Inferiority or Equivalence
Comments For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
Method of Estimation Estimation Parameter Geometric mean ratio at day 43
Estimated Value 1.168
Confidence Interval (2-Sided) 95%
0.881 to 1.547
Estimation Comments [Not Specified]
Show Statistical Analysis 31 Hide Statistical Analysis 31
Statistical Analysis Overview Comparison Group Selection 3.75_(50)MF59, 7.5_(100)MF59
Comments A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.
Type of Statistical Test Non-Inferiority or Equivalence
Comments For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
Method of Estimation Estimation Parameter Geometric mean ratio at day 43
Estimated Value 0.880
Confidence Interval (2-Sided) 95%
0.665 to 1.166
Estimation Comments [Not Specified]
Show Statistical Analysis 32 Hide Statistical Analysis 32
Statistical Analysis Overview Comparison Group Selection 3.75_(50)MF59, 15 Without MF59
Comments A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.
Type of Statistical Test Non-Inferiority or Equivalence
Comments For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
Method of Estimation Estimation Parameter Geometric mean ratio at day 43
Estimated Value 3.219
Confidence Interval (2-Sided) 95%
2.430 to 4.264
Estimation Comments [Not Specified]
Show Statistical Analysis 33 Hide Statistical Analysis 33
Statistical Analysis Overview Comparison Group Selection 3.75_(50)MF59, 15_(50)MF59
Comments A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.
Type of Statistical Test Non-Inferiority or Equivalence
Comments For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
Method of Estimation Estimation Parameter Geometric mean ratio at day 43
Estimated Value 1.070
Confidence Interval (2-Sided) 95%
0.808 to 1.417
Estimation Comments [Not Specified]
Show Statistical Analysis 34 Hide Statistical Analysis 34
Statistical Analysis Overview Comparison Group Selection 3.75_(50)MF59, 15_(100)MF59
Comments A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.
Type of Statistical Test Non-Inferiority or Equivalence
Comments For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
Method of Estimation Estimation Parameter Geometric mean ratio at day 43
Estimated Value 0.720
Confidence Interval (2-Sided) 95%
0.544 to 0.954
Estimation Comments [Not Specified]
Show Statistical Analysis 35 Hide Statistical Analysis 35
Statistical Analysis Overview Comparison Group Selection 3.75_(50)MF59, 30 Without MF59
Comments A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.
Type of Statistical Test Non-Inferiority or Equivalence
Comments For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
Method of Estimation Estimation Parameter Geometric mean ratio at day 43
Estimated Value 2.509
Confidence Interval (2-Sided) 95%
1.891 to 3.330
Estimation Comments [Not Specified]
Show Statistical Analysis 36 Hide Statistical Analysis 36
Statistical Analysis Overview Comparison Group Selection 7.5 Without MF59, 7.5_(50)MF59
Comments A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.
Type of Statistical Test Non-Inferiority or Equivalence
Comments For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
Method of Estimation Estimation Parameter Geometric mean ratio at day 43
Estimated Value 0.235
Confidence Interval (2-Sided) 95%
0.178 to 0.310
Estimation Comments [Not Specified]
Show Statistical Analysis 37 Hide Statistical Analysis 37
Statistical Analysis Overview Comparison Group Selection 7.5 Without MF59, 7.5_(100)MF59
Comments A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.
Type of Statistical Test Non-Inferiority or Equivalence
Comments For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
Method of Estimation Estimation Parameter Geometric mean ratio at day 43
Estimated Value 0.177
Confidence Interval (2-Sided) 95%
0.134 to 0.234
Estimation Comments [Not Specified]
Show Statistical Analysis 38 Hide Statistical Analysis 38
Statistical Analysis Overview Comparison Group Selection 7.5 Without MF59, 15 Without MF59
Comments A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.
Type of Statistical Test Non-Inferiority or Equivalence
Comments For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
Method of Estimation Estimation Parameter Geometric mean ratio at day 43
Estimated Value 0.647
Confidence Interval (2-Sided) 95%
0.489 to 0.856
Estimation Comments [Not Specified]
Show Statistical Analysis 39 Hide Statistical Analysis 39
Statistical Analysis Overview Comparison Group Selection 7.5 Without MF59, 15_(50)MF59
Comments A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.
Type of Statistical Test Non-Inferiority or Equivalence
Comments For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
Method of Estimation Estimation Parameter Geometric mean ratio at day 43
Estimated Value 0.215
Confidence Interval (2-Sided) 95%
0.163 to 0.284
Estimation Comments [Not Specified]
Show Statistical Analysis 40 Hide Statistical Analysis 40
Statistical Analysis Overview Comparison Group Selection 7.5 Without MF59, 15_(100)MF59
Comments A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.
Type of Statistical Test Non-Inferiority or Equivalence
Comments For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
Method of Estimation Estimation Parameter Geometric mean ratio at day 43
Estimated Value 0.145
Confidence Interval 95%
0.109 to 0.191
Estimation Comments [Not Specified]
Show Statistical Analysis 41 Hide Statistical Analysis 41
Statistical Analysis Overview Comparison Group Selection 7.5 Without MF59, 30 Without MF59
Comments A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.
Type of Statistical Test Non-Inferiority or Equivalence
Comments For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
Method of Estimation Estimation Parameter Geometric mean ratio at day 43
Estimated Value 0.504
Confidence Interval (2-Sided) 95%
0.381 to 0.668
Estimation Comments [Not Specified]
Show Statistical Analysis 42 Hide Statistical Analysis 42
Statistical Analysis Overview Comparison Group Selection 7.5_(50)MF59, 7.5_(100)MF59
Comments A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.
Type of Statistical Test Non-Inferiority or Equivalence
Comments For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
Method of Estimation Estimation Parameter Geometric mean ratio at day 43
Estimated Value 0.754
Confidence Interval (2-Sided) 95%
0.570 to 0.997
Estimation Comments [Not Specified]
Show Statistical Analysis 43 Hide Statistical Analysis 43
Statistical Analysis Overview Comparison Group Selection 7.5_(50)MF59, 15 Without MF59
Comments A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.
Type of Statistical Test Non-Inferiority or Equivalence
Comments For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
Method of Estimation Estimation Parameter Geometric mean ratio at day 43
Estimated Value 2.756
Confidence Interval (2-Sided) 95%
2.083 to 3.647
Estimation Comments [Not Specified]
Show Statistical Analysis 44 Hide Statistical Analysis 44
Statistical Analysis Overview Comparison Group Selection 7.5_(50)MF59, 15_(50)MF59
Comments A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.
Type of Statistical Test Non-Inferiority or Equivalence
Comments For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
Method of Estimation Estimation Parameter Geometric mean ratio at day 43
Estimated Value 0.916
Confidence Interval (2-Sided) 95%
0.694 to 1.211
Estimation Comments [Not Specified]
Show Statistical Analysis 45 Hide Statistical Analysis 45
Statistical Analysis Overview Comparison Group Selection 7.5_(50)MF59, 15_(100)MF59
Comments A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.
Type of Statistical Test Non-Inferiority or Equivalence
Comments For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
Method of Estimation Estimation Parameter Geometric mean ratio at day 43
Estimated Value 0.616
Confidence Interval (2-Sided) 95%
0.466 to 1.815
Estimation Comments [Not Specified]
Show Statistical Analysis 46 Hide Statistical Analysis 46
Statistical Analysis Overview Comparison Group Selection 7.5_(50)MF59, 30 Without MF59
Comments A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.
Type of Statistical Test Non-Inferiority or Equivalence
Comments For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
Method of Estimation Estimation Parameter Geometric mean ratio at day 43
Estimated Value 2.149
Confidence Interval (2-Sided) 95%
1.624 to 2.843
Estimation Comments [Not Specified]
Show Statistical Analysis 47 Hide Statistical Analysis 47
Statistical Analysis Overview Comparison Group Selection 7.5_(100)MF59, 15 Without MF59
Comments A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.
Type of Statistical Test Non-Inferiority or Equivalence
Comments For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
Method of Estimation Estimation Parameter Geometric mean ratio at day 43
Estimated Value 3.656
Confidence Interval (2-Sided) 95%
2.764 to 4.836
Estimation Comments [Not Specified]
Show Statistical Analysis 48 Hide Statistical Analysis 48
Statistical Analysis Overview Comparison Group Selection 7.5_(100)MF59, 15_(50)MF59
Comments A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.
Type of Statistical Test Non-Inferiority or Equivalence
Comments For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
Method of Estimation Estimation Parameter Geometric mean ratio at day 43
Estimated Value 1.216
Confidence Interval (2-Sided) 95%
0.920 to 1.606
Estimation Comments [Not Specified]
Show Statistical Analysis 49 Hide Statistical Analysis 49
Statistical Analysis Overview Comparison Group Selection 7.5_(100)MF59, 15_(100)MF59
Comments A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.
Type of Statistical Test Non-Inferiority or Equivalence
Comments For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
Method of Estimation Estimation Parameter Geometric mean ratio at day 43
Estimated Value 0.818
Confidence Interval (2-Sided) 95%
0.619 to 1.081
Estimation Comments [Not Specified]
Show Statistical Analysis 50 Hide Statistical Analysis 50
Statistical Analysis Overview Comparison Group Selection 7.5_(100)MF59, 30 Without MF59
Comments A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.
Type of Statistical Test Non-Inferiority or Equivalence
Comments For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
Method of Estimation Estimation Parameter Geometric mean ratio at day 43
Estimated Value 2.850
Confidence Interval (2-Sided) 95%
2.152 to 3.773
Estimation Comments [Not Specified]
Show Statistical Analysis 51 Hide Statistical Analysis 51
Statistical Analysis Overview Comparison Group Selection 15 Without MF59, 15_(50)MF59
Comments A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.
Type of Statistical Test Non-Inferiority or Equivalence
Comments For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
Method of Estimation Estimation Parameter Geometric mean ratio at day 43
Estimated Value 0.332
Confidence Interval (2-Sided) 95%
0.251 to 0.440
Estimation Comments [Not Specified]
Show Statistical Analysis 52 Hide Statistical Analysis 52
Statistical Analysis Overview Comparison Group Selection 15 Without MF59, 15_(100)MF59
Comments A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.
Type of Statistical Test Non-Inferiority or Equivalence
Comments For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
Method of Estimation Estimation Parameter Geometric mean ratio at day 43
Estimated Value 0.224
Confidence Interval (2-Sided) 95%
0.169 to 0.296
Estimation Comments [Not Specified]
Show Statistical Analysis 53 Hide Statistical Analysis 53
Statistical Analysis Overview Comparison Group Selection 15 Without MF59, 30 Without MF59
Comments A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.
Type of Statistical Test Non-Inferiority or Equivalence
Comments For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
Method of Estimation Estimation Parameter Geometric mean ratio at day 43
Estimated Value 0.780
Confidence Interval (2-Sided) 95%
0.588 to 1.003
Estimation Comments [Not Specified]
Show Statistical Analysis 54 Hide Statistical Analysis 54
Statistical Analysis Overview Comparison Group Selection 15_(50)MF59, 15_(100)MF59
Comments A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.
Type of Statistical Test Non-Inferiority or Equivalence
Comments For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
Method of Estimation Estimation Parameter Geometric mean ratio at day 43
Estimated Value 0.673
Confidence Interval (2-Sided) 95%
0.509 to 0.889
Estimation Comments [Not Specified]
Show Statistical Analysis 55 Hide Statistical Analysis 55
Statistical Analysis Overview Comparison Group Selection 15_(50)MF59, 30 Without MF59
Comments A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.
Type of Statistical Test Non-Inferiority or Equivalence
Comments For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
Method of Estimation Estimation Parameter Geometric mean ratio at day 43
Estimated Value 2.345
Confidence Interval (2-Sided) 95%
1.772 to 3.102
Estimation Comments [Not Specified]
Show Statistical Analysis 56 Hide Statistical Analysis 56
Statistical Analysis Overview Comparison Group Selection 15_(100)MF59, 30 Without MF59
Comments A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.
Type of Statistical Test Non-Inferiority or Equivalence
Comments For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
Method of Estimation Estimation Parameter Geometric mean ratio at day 43
Estimated Value 3.485
Confidence Interval (2-Sided) 95%
2.633 to 4.614
Estimation Comments [Not Specified]
Show Statistical Analysis 57 Hide Statistical Analysis 57
Statistical Analysis Overview Comparison Group Selection 3.75_(50)MF59, 7.5 Without MF59
Comments A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.
Type of Statistical Test Non-Inferiority or Equivalence
Comments For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
Method of Estimation Estimation Parameter Geometric mean ratio at day 202
Estimated Value 2.624
Confidence Interval (2-Sided) 95%
1.817 to 3.789
Estimation Comments [Not Specified]
Show Statistical Analysis 58 Hide Statistical Analysis 58
Statistical Analysis Overview Comparison Group Selection 3.75_(50)MF59, 7.5_(50)MF59
Comments A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.
Type of Statistical Test Non-Inferiority or Equivalence
Comments For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
Method of Estimation Estimation Parameter Geometric mean ratio at day 202
Estimated Value 1.096
Confidence Interval (2-Sided) 95%
0.760 to 1.580
Estimation Comments [Not Specified]
Show Statistical Analysis 59 Hide Statistical Analysis 59
Statistical Analysis Overview Comparison Group Selection 3.75_(50)MF59, 7.5_(100)MF59
Comments A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.
Type of Statistical Test Non-Inferiority or Equivalence
Comments For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
Method of Estimation Estimation Parameter Geometric mean ratio at day 202
Estimated Value 0.888
Confidence Interval (2-Sided) 95%
0.615 to 1.282
Estimation Comments [Not Specified]
Show Statistical Analysis 60 Hide Statistical Analysis 60
Statistical Analysis Overview Comparison Group Selection 3.75_(50)MF59, 15 Without MF59
Comments A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.
Type of Statistical Test Non-Inferiority or Equivalence
Comments For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
Method of Estimation Estimation Parameter Geometric mean ratio at day 202
Estimated Value 2.120
Confidence Interval (2-Sided) 95%
1.473 to 3.052
Estimation Comments [Not Specified]
Show Statistical Analysis 61 Hide Statistical Analysis 61
Statistical Analysis Overview Comparison Group Selection 3.75_(50)MF59, 15_(50)MF59
Comments A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.
Type of Statistical Test Non-Inferiority or Equivalence
Comments For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
Method of Estimation Estimation Parameter Geometric mean ratio at day 202
Estimated Value 0.876
Confidence Interval (2-Sided) 95%
0.610 to 1.260
Estimation Comments [Not Specified]
Show Statistical Analysis 62 Hide Statistical Analysis 62
Statistical Analysis Overview Comparison Group Selection 3.75_(50)MF59, 15_(100)MF59
Comments A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.
Type of Statistical Test Non-Inferiority or Equivalence
Comments For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67
Method of Estimation Estimation Parameter Geometric mean ratio at day 202
Estimated Value 0.898
Confidence Interval (2-Sided) 95%
0.622 to 1.298
Estimation Comments [Not Specified]
Show Statistical Analysis 63 Hide Statistical Analysis 63
Statistical Analysis Overview Comparison Group Selection 3.75_(50)MF59, 30 Without MF59
Comments A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.
Type of Statistical Test Non-Inferiority or Equivalence
Comments For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
Method of Estimation Estimation Parameter Geometric mean ratio at day 202
Estimated Value 1.451
Confidence Interval (2-Sided) 95%
1.000 to 2.105
Estimation Comments [Not Specified]
Show Statistical Analysis 64 Hide Statistical Analysis 64
Statistical Analysis Overview Comparison Group Selection 7.5 Without MF59, 7.5_(50)MF59
Comments A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.
Type of Statistical Test Non-Inferiority or Equivalence
Comments For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
Method of Estimation Estimation Parameter Geometric mean ratio at day 202
Estimated Value 0.418
Confidence Interval (2-Sided) 95%
0.289 to 0.603
Estimation Comments [Not Specified]
Show Statistical Analysis 65 Hide Statistical Analysis 65
Statistical Analysis Overview Comparison Group Selection 7.5 Without MF59, 7.5_(100)MF59
Comments A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.
Type of Statistical Test Non-Inferiority or Equivalence
Comments For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
Method of Estimation Estimation Parameter Geometric mean ratio at day 202
Estimated Value 0.338
Confidence Interval (2-Sided) 95%
0.235 to 0.487
Estimation Comments [Not Specified]
Show Statistical Analysis 66 Hide Statistical Analysis 66
Statistical Analysis Overview Comparison Group Selection 7.5 Without MF59, 15 Without MF59
Comments A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.
Type of Statistical Test Non-Inferiority or Equivalence
Comments For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
Method of Estimation Estimation Parameter Geometric mean ratio at day 202
Estimated Value 0.808
Confidence Interval (2-Sided) 95%
0.561 to 1.165
Estimation Comments [Not Specified]
Show Statistical Analysis 67 Hide Statistical Analysis 67
Statistical Analysis Overview Comparison Group Selection 7.5 Without MF59, 15 Without MF59
Comments A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.
Type of Statistical Test Non-Inferiority or Equivalence
Comments For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
Method of Estimation Estimation Parameter Geometric mean ratio at day 202
Estimated Value 0.334
Confidence Interval (2-Sided) 95%
0.233 to 0.479
Estimation Comments [Not Specified]
Show Statistical Analysis 68 Hide Statistical Analysis 68
Statistical Analysis Overview Comparison Group Selection 7.5 Without MF59, 15_(100)MF59
Comments A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.
Type of Statistical Test Non-Inferiority or Equivalence
Comments For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
Method of Estimation Estimation Parameter Geometric mean ratio at day 202
Estimated Value 0.342
Confidence Interval (2-Sided) 95%
0.237 to 0.494
Estimation Comments [Not Specified]
Show Statistical Analysis 69 Hide Statistical Analysis 69
Statistical Analysis Overview Comparison Group Selection 7.5 Without MF59, 30 Without MF59
Comments A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.
Type of Statistical Test Non-Inferiority or Equivalence
Comments For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
Method of Estimation Estimation Parameter Geometric mean ratio at day 202
Estimated Value 0.553
Confidence Interval (2-Sided) 95%
0.382 to 0.801
Estimation Comments [Not Specified]
Show Statistical Analysis 70 Hide Statistical Analysis 70
Statistical Analysis Overview Comparison Group Selection 7.5_(50)MF59, 7.5_(100)MF59
Comments A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.
Type of Statistical Test Non-Inferiority or Equivalence
Comments For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
Method of Estimation Estimation Parameter Geometric mean ratio at day 202
Estimated Value 0.811
Confidence Interval (2-Sided) 95%
0.562 to 1.169
Estimation Comments [Not Specified]
Show Statistical Analysis 71 Hide Statistical Analysis 71
Statistical Analysis Overview Comparison Group Selection 7.5_(50)MF59, 15 Without MF59
Comments A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.
Type of Statistical Test Non-Inferiority or Equivalence
Comments For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
Method of Estimation Estimation Parameter Geometric mean ratio at day 202
Estimated Value 1.935
Confidence Interval (2-Sided) 95%
1.347 to 2.780
Estimation Comments [Not Specified]
Show Statistical Analysis 72 Hide Statistical Analysis 72
Statistical Analysis Overview Comparison Group Selection 7.5_(50)MF59, 15_(50)MF59
Comments A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.
Type of Statistical Test Non-Inferiority or Equivalence
Comments For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
Method of Estimation Estimation Parameter Geometric mean ratio at day 202
Estimated Value 0.800
Confidence Interval (2-Sided) 95%
0.558 to 1.147
Estimation Comments [Not Specified]
Show Statistical Analysis 73 Hide Statistical Analysis 73
Statistical Analysis Overview Comparison Group Selection 7.5_(50)MF59, 15_(100)MF59
Comments A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.
Type of Statistical Test Non-Inferiority or Equivalence
Comments For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
Method of Estimation Estimation Parameter Geometric mean ratio at day 202
Estimated Value 0.820
Confidence Interval (2-Sided) 95%
0.568 to 1.184
Estimation Comments [Not Specified]
Show Statistical Analysis 74 Hide Statistical Analysis 74
Statistical Analysis Overview Comparison Group Selection 7.5_(50)MF59, 30 Without MF59
Comments A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.
Type of Statistical Test Non-Inferiority or Equivalence
Comments For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
Method of Estimation Estimation Parameter Geometric mean ratio at day 202
Estimated Value 1.324
Confidence Interval (2-Sided) 95%
0.915 to 1.917
Estimation Comments [Not Specified]
Show Statistical Analysis 75 Hide Statistical Analysis 75
Statistical Analysis Overview Comparison Group Selection 7.5_(100)MF59, 15 Without MF59
Comments A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.
Type of Statistical Test Non-Inferiority or Equivalence
Comments For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
Method of Estimation Estimation Parameter Geometric mean ratio at day 202
Estimated Value 2.388
Confidence Interval (2-Sided) 95%
1.658 to 3.438
Estimation Comments [Not Specified]
Show Statistical Analysis 76 Hide Statistical Analysis 76
Statistical Analysis Overview Comparison Group Selection 7.5_(100)MF59, 15_(50)MF59
Comments A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.
Type of Statistical Test Non-Inferiority or Equivalence
Comments For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
Method of Estimation Estimation Parameter Geometric mean ratio at day 202
Estimated Value 0.987
Confidence Interval (2-Sided) 95%
0.688 to 1.416
Estimation Comments [Not Specified]
Show Statistical Analysis 77 Hide Statistical Analysis 77
Statistical Analysis Overview Comparison Group Selection 7.5_(100)MF59, 15_(100)MF59
Comments A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.
Type of Statistical Test Non-Inferiority or Equivalence
Comments For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
Method of Estimation Estimation Parameter Geometric mean ratio at day 202
Estimated Value 1.012
Confidence Interval (2-Sided) 95%
0.701 to 1.460
Estimation Comments [Not Specified]
Show Statistical Analysis 78 Hide Statistical Analysis 78
Statistical Analysis Overview Comparison Group Selection 7.5_(100)MF59, 30 Without MF59
Comments A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.
Type of Statistical Test Non-Inferiority or Equivalence
Comments For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
Method of Estimation Estimation Parameter Geometric mean ratio at day 202
Estimated Value 1.634
Confidence Interval (2-Sided) 95%
1.128 to 2.366
Estimation Comments [Not Specified]
Show Statistical Analysis 79 Hide Statistical Analysis 79
Statistical Analysis Overview Comparison Group Selection 15 Without MF59, 15_(50)MF59
Comments A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.
Type of Statistical Test Non-Inferiority or Equivalence
Comments For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
Method of Estimation Estimation Parameter Geometric mean ratio at day 202
Estimated Value 0.413
Confidence Interval (2-Sided) 95%
0.288 to 0.592
Estimation Comments [Not Specified]
Show Statistical Analysis 80 Hide Statistical Analysis 80
Statistical Analysis Overview Comparison Group Selection 15 Without MF59, 15_(100)MF59
Comments A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.
Type of Statistical Test Non-Inferiority or Equivalence
Comments For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
Method of Estimation Estimation Parameter Geometric mean ratio at day 202
Estimated Value 0.424
Confidence Interval (2-Sided) 95%
0.294 to 0.610
Estimation Comments [Not Specified]
Show Statistical Analysis 81 Hide Statistical Analysis 81
Statistical Analysis Overview Comparison Group Selection 15 Without MF59, 30 Without MF59
Comments A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.
Type of Statistical Test Non-Inferiority or Equivalence
Comments For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
Method of Estimation Estimation Parameter Geometric mean ratio at day 202
Estimated Value 0.684
Confidence Interval (2-Sided) 95%
0.473 to 0.990
Estimation Comments [Not Specified]
Show Statistical Analysis 82 Hide Statistical Analysis 82
Statistical Analysis Overview Comparison Group Selection 15_(50)MF59, 15_(100)MF59
Comments A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.
Type of Statistical Test Non-Inferiority or Equivalence
Comments For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
Method of Estimation Estimation Parameter Geometric mean ratio at day 202
Estimated Value 1.025
Confidence Interval (2-Sided) 95%
0.714 to 1.473
Estimation Comments [Not Specified]
Show Statistical Analysis 83 Hide Statistical Analysis 83
Statistical Analysis Overview Comparison Group Selection 15_(50)MF59, 30 Without MF59
Comments A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.
Type of Statistical Test Non-Inferiority or Equivalence
Comments For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
Method of Estimation Estimation Parameter Geometric mean ratio at day 202
Estimated Value 1.656
Confidence Interval (2-Sided) 95%
1.150 to 2.385
Estimation Comments [Not Specified]
Show Statistical Analysis 84 Hide Statistical Analysis 84
Statistical Analysis Overview Comparison Group Selection 15_(100)MF59, 30 Without MF59
Comments A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.
Type of Statistical Test Non-Inferiority or Equivalence
Comments For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
Method of Estimation Estimation Parameter Geometric mean ratio at day 202
Estimated Value 1.615
Confidence Interval (2-Sided) 95%
1.115 to 2.339
Estimation Comments [Not Specified]
Show Statistical Analysis 85 Hide Statistical Analysis 85
Statistical Analysis Overview Comparison Group Selection 3.75_(50)MF59, 7.5 Without MF59
Comments A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.
Type of Statistical Test Non-Inferiority or Equivalence
Comments For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
Method of Estimation Estimation Parameter Geometric mean ratio at day 387
Estimated Value 1.906
Confidence Interval (2-Sided) 95%
1.177 to 3.087
Estimation Comments [Not Specified]
Show Statistical Analysis 86 Hide Statistical Analysis 86
Statistical Analysis Overview Comparison Group Selection 3.75_(50)MF59, 7.5_(50)MF59
Comments A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.
Type of Statistical Test Non-Inferiority or Equivalence
Comments For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
Method of Estimation Estimation Parameter Geometric mean ratio at day 387
Estimated Value 0.945
Confidence Interval (2-Sided) 95%
0.583 to 1.533
Estimation Comments [Not Specified]
Show Statistical Analysis 87 Hide Statistical Analysis 87
Statistical Analysis Overview Comparison Group Selection 3.75_(50)MF59, 7.5_(100)MF59
Comments A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.
Type of Statistical Test Non-Inferiority or Equivalence
Comments For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
Method of Estimation Estimation Parameter Geometric mean ratio at day 387
Estimated Value 0.763
Confidence Interval (2-Sided) 95%
0.468 to 1.245
Estimation Comments [Not Specified]
Show Statistical Analysis 88 Hide Statistical Analysis 88
Statistical Analysis Overview Comparison Group Selection 3.75_(50)MF59, 15 Without MF59
Comments A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.
Type of Statistical Test Non-Inferiority or Equivalence
Comments For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
Method of Estimation Estimation Parameter Geometric mean ratio at day 387
Estimated Value 1.818
Confidence Interval (2-Sided) 95%
1.119 to 2.956
Estimation Comments [Not Specified]
Show Statistical Analysis 89 Hide Statistical Analysis 89
Statistical Analysis Overview Comparison Group Selection 3.75_(50)MF59, 15_(50)MF59
Comments A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.
Type of Statistical Test Non-Inferiority or Equivalence
Comments For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
Method of Estimation Estimation Parameter Geometric mean ratio at day 387
Estimated Value 0.917
Confidence Interval (2-Sided) 95%
0.568 to 1.481
Estimation Comments [Not Specified]
Show Statistical Analysis 90 Hide Statistical Analysis 90
Statistical Analysis Overview Comparison Group Selection 3.75_(50)MF59, 15_(100)MF59
Comments A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.
Type of Statistical Test Non-Inferiority or Equivalence
Comments For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
Method of Estimation Estimation Parameter Geometric mean ratio at day 387
Estimated Value 0.855
Confidence Interval (2-Sided) 95%
0.524 to 1.396
Estimation Comments [Not Specified]
Show Statistical Analysis 91 Hide Statistical Analysis 91
Statistical Analysis Overview Comparison Group Selection 3.75_(50)MF59, 30 Without MF59
Comments A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.
Type of Statistical Test Non-Inferiority or Equivalence
Comments For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
Method of Estimation Estimation Parameter Geometric mean ratio at day 387
Estimated Value 1.203
Confidence Interval (2-Sided) 95%
0.745 to 1.943
Estimation Comments [Not Specified]
Show Statistical Analysis 92 Hide Statistical Analysis 92
Statistical Analysis Overview Comparison Group Selection 7.5 Without MF59, 7.5_(50)MF59
Comments A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.
Type of Statistical Test Non-Inferiority or Equivalence
Comments For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
Method of Estimation Estimation Parameter Geometric mean ratio at day 387
Estimated Value 0.496
Confidence Interval (2-Sided) 95%
0.310 to 0.794
Estimation Comments [Not Specified]
Show Statistical Analysis 93 Hide Statistical Analysis 93
Statistical Analysis Overview Comparison Group Selection 7.5 Without MF59, 7.5_(100)MF59
Comments A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.
Type of Statistical Test Non-Inferiority or Equivalence
Comments For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
Method of Estimation Estimation Parameter Geometric mean ratio at day 387
Estimated Value 0.400
Confidence Interval (2-Sided) 95%
0.250 to 0.641
Estimation Comments [Not Specified]
Show Statistical Analysis 94 Hide Statistical Analysis 94
Statistical Analysis Overview Comparison Group Selection 7.5 Without MF59, 15 Without MF59
Comments A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.
Type of Statistical Test Non-Inferiority or Equivalence
Comments For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
Method of Estimation Estimation Parameter Geometric mean ratio at day 387
Estimated Value 0.954
Confidence Interval (2-Sided) 95%
0.596 to 1.528
Estimation Comments [Not Specified]
Show Statistical Analysis 95 Hide Statistical Analysis 95
Statistical Analysis Overview Comparison Group Selection 7.5 Without MF59, 15_(50)MF59
Comments A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.
Type of Statistical Test Non-Inferiority or Equivalence
Comments For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
Method of Estimation Estimation Parameter Geometric mean ratio at day 387
Estimated Value 0.481
Confidence Interval (2-Sided) 95%
0.306 to 0.758
Estimation Comments [Not Specified]
Show Statistical Analysis 96 Hide Statistical Analysis 96
Statistical Analysis Overview Comparison Group Selection 7.5 Without MF59, 15_(100)MF59
Comments A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.
Type of Statistical Test Non-Inferiority or Equivalence
Comments For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
Method of Estimation Estimation Parameter Geometric mean ratio at day 387
Estimated Value 0.449
Confidence Interval (2-Sided) 95%
0.279 to 0.722
Estimation Comments [Not Specified]
Show Statistical Analysis 97 Hide Statistical Analysis 97
Statistical Analysis Overview Comparison Group Selection 7.5 Without MF59, 30 Without MF59
Comments A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.
Type of Statistical Test Non-Inferiority or Equivalence
Comments For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
Method of Estimation Estimation Parameter Geometric mean ratio at day 387
Estimated Value 0.631
Confidence Interval (2-Sided) 95%
0.398 to 1.002
Estimation Comments [Not Specified]
Show Statistical Analysis 98 Hide Statistical Analysis 98
Statistical Analysis Overview Comparison Group Selection 7.5_(50)MF59, 7.5_(100)MF59
Comments A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.
Type of Statistical Test Non-Inferiority or Equivalence
Comments For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
Method of Estimation Estimation Parameter Geometric mean ratio at day 387
Estimated Value 0.807
Confidence Interval (2-Sided) 95%
0.500 to 1.304
Estimation Comments [Not Specified]
Show Statistical Analysis 99 Hide Statistical Analysis 99
Statistical Analysis Overview Comparison Group Selection 7.5_(50)MF59, 15 Without MF59
Comments A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.
Type of Statistical Test Non-Inferiority or Equivalence
Comments For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
Method of Estimation Estimation Parameter Geometric mean ratio at day 387
Estimated Value 1.924
Confidence Interval (2-Sided) 95%
1.193 to 3.102
Estimation Comments [Not Specified]
Show Statistical Analysis 100 Hide Statistical Analysis 100
Statistical Analysis Overview Comparison Group Selection 7.5_(50)MF59, 15_(50)MF59
Comments A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.
Type of Statistical Test Non-Inferiority or Equivalence
Comments For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
Method of Estimation Estimation Parameter Geometric mean ratio at day 387
Estimated Value 0.970
Confidence Interval (2-Sided) 95%
0.611 to 1.541
Estimation Comments [Not Specified]
Show Statistical Analysis 101 Hide Statistical Analysis 101
Statistical Analysis Overview Comparison Group Selection 7.5_(50)MF59, 15_(100)MF59
Comments A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.
Type of Statistical Test Non-Inferiority or Equivalence
Comments For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
Method of Estimation Estimation Parameter Geometric mean ratio at day 387
Estimated Value 0.905
Confidence Interval (2-Sided) 95%
0.561 to 1.460
Estimation Comments [Not Specified]
Show Statistical Analysis 102 Hide Statistical Analysis 102
Statistical Analysis Overview Comparison Group Selection 7.5_(50)MF59, 30 Without MF59
Comments A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.
Type of Statistical Test Non-Inferiority or Equivalence
Comments For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
Method of Estimation Estimation Parameter Geometric mean ratio at day 387
Estimated Value 1.273
Confidence Interval (2-Sided) 95%
0.798 to 2.030
Estimation Comments [Not Specified]
Show Statistical Analysis 103 Hide Statistical Analysis 103
Statistical Analysis Overview Comparison Group Selection 7.5_(100)MF59, 15 Without MF59
Comments A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.
Type of Statistical Test Non-Inferiority or Equivalence
Comments For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
Method of Estimation Estimation Parameter Geometric mean ratio at day 387
Estimated Value 2.383
Confidence Interval (2-Sided) 95%
1.474 to 3.851
Estimation Comments [Not Specified]
Show Statistical Analysis 104 Hide Statistical Analysis 104
Statistical Analysis Overview Comparison Group Selection 7.5_(100)MF59, 15_(50)MF59
Comments A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.
Type of Statistical Test Non-Inferiority or Equivalence
Comments For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
Method of Estimation Estimation Parameter Geometric mean ratio at day 387
Estimated Value 1.202
Confidence Interval (2-Sided) 95%
0.754 to 1.915
Estimation Comments [Not Specified]
Show Statistical Analysis 105 Hide Statistical Analysis 105
Statistical Analysis Overview Comparison Group Selection 7.5_(100)MF59, 15_(100)MF59
Comments A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.
Type of Statistical Test Non-Inferiority or Equivalence
Comments For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
Method of Estimation Estimation Parameter Geometric mean ratio at day 387
Estimated Value 1.120
Confidence Interval (2-Sided) 95%
0.689 to 1.821
Estimation Comments [Not Specified]
Show Statistical Analysis 106 Hide Statistical Analysis 106
Statistical Analysis Overview Comparison Group Selection 7.5_(100)MF59, 30 Without MF59
Comments A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.
Type of Statistical Test Non-Inferiority or Equivalence
Comments For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
Method of Estimation Estimation Parameter Geometric mean ratio at day 387
Estimated Value 1.576
Confidence Interval (2-Sided) 95%
0.987 to 2.516
Estimation Comments [Not Specified]
Show Statistical Analysis 107 Hide Statistical Analysis 107
Statistical Analysis Overview Comparison Group Selection 15 Without MF59, 15_(50)MF59
Comments A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.
Type of Statistical Test Non-Inferiority or Equivalence
Comments For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
Method of Estimation Estimation Parameter Geometric mean ratio at day 387
Estimated Value 0.504
Confidence Interval (2-Sided) 95%
0.316 to 0.805
Estimation Comments [Not Specified]
Show Statistical Analysis 108 Hide Statistical Analysis 108
Statistical Analysis Overview Comparison Group Selection 15 Without MF59, 15_(100)MF59
Comments A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.
Type of Statistical Test Non-Inferiority or Equivalence
Comments For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
Method of Estimation Estimation Parameter Geometric mean ratio at day 387
Estimated Value 0.470
Confidence Interval (2-Sided) 95%
0.293 to 0.754
Estimation Comments [Not Specified]
Show Statistical Analysis 109 Hide Statistical Analysis 109
Statistical Analysis Overview Comparison Group Selection 15 Without MF59, 30 Without MF59
Comments A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.
Type of Statistical Test Non-Inferiority or Equivalence
Comments For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
Method of Estimation Estimation Parameter Geometric mean ratio at day 387
Estimated Value 0.662
Confidence Interval (2-Sided) 95%
0.414 to 1.056
Estimation Comments [Not Specified]
Show Statistical Analysis 110 Hide Statistical Analysis 110
Statistical Analysis Overview Comparison Group Selection 15_(50)MF59, 15_(100)MF59
Comments A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.
Type of Statistical Test Non-Inferiority or Equivalence
Comments For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
Method of Estimation Estimation Parameter Geometric mean ratio at day 387
Estimated Value 0.932
Confidence Interval (2-Sided) 95%
0.583 to 1.492
Estimation Comments [Not Specified]
Show Statistical Analysis 111 Hide Statistical Analysis 111
Statistical Analysis Overview Comparison Group Selection 15_(50)MF59, 30 Without MF59
Comments A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.
Type of Statistical Test Non-Inferiority or Equivalence
Comments For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
Method of Estimation Estimation Parameter Geometric mean ratio at day 387
Estimated Value 1.312
Confidence Interval (2-Sided) 95%
0.831 to 2.071
Estimation Comments [Not Specified]
Show Statistical Analysis 112 Hide Statistical Analysis 112
Statistical Analysis Overview Comparison Group Selection 15_(100)MF59, 30 Without MF59
Comments A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.
Type of Statistical Test Non-Inferiority or Equivalence
Comments For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
Method of Estimation Estimation Parameter Geometric mean ratio at day 387
Estimated Value 1.407
Confidence Interval (2-Sided) 95%
0.880 to 2.249
Estimation Comments [Not Specified]
Show Statistical Analysis 113 Hide Statistical Analysis 113
Statistical Analysis Overview Comparison Group Selection 3.75_(50)MF59, 7.5 Without MF59
Comments A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.
Type of Statistical Test Non-Inferiority or Equivalence
Comments For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
Method of Estimation Estimation Parameter Geometric Mean Ratio at day 29
Estimated Value 5.428
Confidence Interval (2-Sided) 95%
4 to 7.365
Estimation Comments [Not Specified]
Show Statistical Analysis 114 Hide Statistical Analysis 114
Statistical Analysis Overview Comparison Group Selection 3.75_(50)MF59, 7.5_(50)MF59
Comments A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.
Type of Statistical Test Non-Inferiority or Equivalence
Comments For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
Method of Estimation Estimation Parameter Geometric Mean Ratio at day 29
Estimated Value 1.091
Confidence Interval (2-Sided) 95%
0.804 to 1.481
Estimation Comments [Not Specified]
Show Statistical Analysis 115 Hide Statistical Analysis 115
Statistical Analysis Overview Comparison Group Selection 3.75_(50)MF59, 7.5_(100)MF59
Comments A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.
Type of Statistical Test Non-Inferiority or Equivalence
Comments For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
Method of Estimation Estimation Parameter Geometric Mean Ratio at day 29
Estimated Value 0.759
Confidence Interval (2-Sided) 95%
0.559 to 1.031
Estimation Comments [Not Specified]
Show Statistical Analysis 116 Hide Statistical Analysis 116
Statistical Analysis Overview Comparison Group Selection 3.75_(50)MF59, 15 Without MF59
Comments A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other
Type of Statistical Test Non-Inferiority or Equivalence
Comments For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
Method of Estimation Estimation Parameter Geometric Mean Ratio at day 29
Estimated Value 3.499
Confidence Interval (2-Sided) 95%
2.577 to 4.751
Estimation Comments [Not Specified]
Show Statistical Analysis 117 Hide Statistical Analysis 117
Statistical Analysis Overview Comparison Group Selection 3.75_(50)MF59, 15_(50)MF59
Comments A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.
Type of Statistical Test Non-Inferiority or Equivalence
Comments For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
Method of Estimation Estimation Parameter Geometric Mean Ratio at day 29
Estimated Value 0.982
Confidence Interval (2-Sided) 95%
0.722 to 1.334
Estimation Comments [Not Specified]
Show Statistical Analysis 118 Hide Statistical Analysis 118
Statistical Analysis Overview Comparison Group Selection 3.75_(50)MF59, 15_(100)MF59
Comments A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other
Type of Statistical Test Non-Inferiority or Equivalence
Comments For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
Method of Estimation Estimation Parameter Geometric Mean Ratio at day 29
Estimated Value 0.699
Confidence Interval (2-Sided) 95%
0.513 to 0.95
Estimation Comments [Not Specified]
Show Statistical Analysis 119 Hide Statistical Analysis 119
Statistical Analysis Overview Comparison Group Selection 3.75_(50)MF59, 30 Without MF59
Comments A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.
Type of Statistical Test Non-Inferiority or Equivalence
Comments For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
Method of Estimation Estimation Parameter Geometric Mean Ratio at day 29
Estimated Value 2.513
Confidence Interval (2-Sided) 95%
1.846 to 3.421
Estimation Comments [Not Specified]
Show Statistical Analysis 120 Hide Statistical Analysis 120
Statistical Analysis Overview Comparison Group Selection 7.5 Without MF59, 7.5_(50)MF59
Comments A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.
Type of Statistical Test Non-Inferiority or Equivalence
Comments For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
Method of Estimation Estimation Parameter Geometric Mean Ratio at day 29
Estimated Value 0.201
Confidence Interval (2-Sided) 95%
0.149 to 0.272
Estimation Comments [Not Specified]
Show Statistical Analysis 121 Hide Statistical Analysis 121
Statistical Analysis Overview Comparison Group Selection 7.5 Without MF59, 7.5_(100)MF59
Comments A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.
Type of Statistical Test Non-Inferiority or Equivalence
Comments For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
Method of Estimation Estimation Parameter Geometric Mean Ratio at day 29
Estimated Value 0.14
Confidence Interval (2-Sided) 95%
0.103 to 0.189
Estimation Comments [Not Specified]
Show Statistical Analysis 122 Hide Statistical Analysis 122
Statistical Analysis Overview Comparison Group Selection 7.5 Without MF59, 15 Without MF59
Comments A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.
Type of Statistical Test Non-Inferiority or Equivalence
Comments For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
Method of Estimation Estimation Parameter Geometric Mean Ratio at day 29
Estimated Value 0.645
Confidence Interval (2-Sided) 95%
0.476 to 0.873
Estimation Comments [Not Specified]
Show Statistical Analysis 123 Hide Statistical Analysis 123
Statistical Analysis Overview Comparison Group Selection 7.5 Without MF59, 15_(50)MF59
Comments A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other
Type of Statistical Test Non-Inferiority or Equivalence
Comments For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
Method of Estimation Estimation Parameter Geometric Mean Ratio at day 29
Estimated Value 0.181
Confidence Interval (2-Sided) 95%
0.134 to 0.245
Estimation Comments [Not Specified]
Show Statistical Analysis 124 Hide Statistical Analysis 124
Statistical Analysis Overview Comparison Group Selection 7.5 Without MF59, 15_(100)MF59
Comments A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.
Type of Statistical Test Non-Inferiority or Equivalence
Comments For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
Method of Estimation Estimation Parameter Geometric Mean Ratio at day 29
Estimated Value 0.129
Confidence Interval (2-Sided) 95%
0.095 to 0.174
Estimation Comments [Not Specified]
Show Statistical Analysis 125 Hide Statistical Analysis 125
Statistical Analysis Overview Comparison Group Selection 7.5 Without MF59, 30 Without MF59
Comments A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other
Type of Statistical Test Non-Inferiority or Equivalence
Comments For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67
Method of Estimation Estimation Parameter Geometric Mean Ratio at day 29
Estimated Value 0.463
Confidence Interval (2-Sided) 95%
0.341 to 0.628
Estimation Comments [Not Specified]
Show Statistical Analysis 126 Hide Statistical Analysis 126
Statistical Analysis Overview Comparison Group Selection 7.5_(50)MF59, 7.5_(100)MF59
Comments A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other
Type of Statistical Test Non-Inferiority or Equivalence
Comments For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
Method of Estimation Estimation Parameter Geometric Mean Ratio at day 29
Estimated Value 0.696
Confidence Interval (2-Sided) 95%
0.514 to 0.943
Estimation Comments [Not Specified]
Show Statistical Analysis 127 Hide Statistical Analysis 127
Statistical Analysis Overview Comparison Group Selection 7.5_(50)MF59, 15 Without MF59
Comments A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.
Type of Statistical Test Non-Inferiority or Equivalence
Comments For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
Method of Estimation Estimation Parameter Geometric Mean Ratio at day 29
Estimated Value 3.207
Confidence Interval (2-Sided) 95%
2.368 to 4.343
Estimation Comments [Not Specified]
Show Statistical Analysis 128 Hide Statistical Analysis 128
Statistical Analysis Overview Comparison Group Selection 7.5_(50)MF59, 15_(50)MF59
Comments A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.
Type of Statistical Test Non-Inferiority or Equivalence
Comments For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
Method of Estimation Estimation Parameter Geometric Mean Ratio at day 29
Estimated Value 0.9
Confidence Interval (2-Sided) 95%
0.665 to 1.218
Estimation Comments [Not Specified]
Show Statistical Analysis 129 Hide Statistical Analysis 129
Statistical Analysis Overview Comparison Group Selection 7.5_(50)MF59, 15_(100)MF59
Comments A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.
Type of Statistical Test Non-Inferiority or Equivalence
Comments For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
Method of Estimation Estimation Parameter Geometric Mean Ratio at day 29
Estimated Value 0.64
Confidence Interval (2-Sided) 95%
0.472 to 0.868
Estimation Comments [Not Specified]
Show Statistical Analysis 130 Hide Statistical Analysis 130
Statistical Analysis Overview Comparison Group Selection 7.5_(50)MF59, 30 Without MF59
Comments A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.
Type of Statistical Test Non-Inferiority or Equivalence
Comments For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
Method of Estimation Estimation Parameter Geometric Mean Ratio at day 29
Estimated Value 2.303
Confidence Interval (2-Sided) 95%
1.7 to 3.121
Estimation Comments [Not Specified]
Show Statistical Analysis 131 Hide Statistical Analysis 131
Statistical Analysis Overview Comparison Group Selection 7.5_(100)MF59, 15 Without MF59
Comments A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.
Type of Statistical Test Non-Inferiority or Equivalence
Comments For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
Method of Estimation Estimation Parameter Geometric Mean Ratio at day 29
Estimated Value 4.608
Confidence Interval (2-Sided) 95%
3.398 to 6.249
Estimation Comments [Not Specified]
Show Statistical Analysis 132 Hide Statistical Analysis 132
Statistical Analysis Overview Comparison Group Selection 7.5_(100)MF59, 15_(50)MF59
Comments A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.
Type of Statistical Test Non-Inferiority or Equivalence
Comments For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
Method of Estimation Estimation Parameter Geometric Mean Ratio at day 29
Estimated Value 1.293
Confidence Interval (2-Sided) 95%
0.954 to 1.753
Estimation Comments [Not Specified]
Show Statistical Analysis 133 Hide Statistical Analysis 133
Statistical Analysis Overview Comparison Group Selection 7.5_(100)MF59, 15_(100)MF59
Comments A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.
Type of Statistical Test Non-Inferiority or Equivalence
Comments For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
Method of Estimation Estimation Parameter Geometric Mean Ratio at day 29
Estimated Value 0.92
Confidence Interval (2-Sided) 95%
0.677 to 1.249
Estimation Comments [Not Specified]
Show Statistical Analysis 134 Hide Statistical Analysis 134
Statistical Analysis Overview Comparison Group Selection 7.5_(100)MF59, 30 Without MF59
Comments A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other
Type of Statistical Test Non-Inferiority or Equivalence
Comments For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
Method of Estimation Estimation Parameter Geometric Mean Ratio at day 29
Estimated Value 3.31
Confidence Interval (2-Sided) 95%
2.436 to 4.496
Estimation Comments [Not Specified]
Show Statistical Analysis 135 Hide Statistical Analysis 135
Statistical Analysis Overview Comparison Group Selection 15 Without MF59, 15_(50)MF59
Comments A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.
Type of Statistical Test Non-Inferiority or Equivalence
Comments For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
Method of Estimation Estimation Parameter Geometric Mean Ratio at day 29
Estimated Value 0.281
Confidence Interval (2-Sided) 95%
0.207 to 0.38
Estimation Comments [Not Specified]
Show Statistical Analysis 136 Hide Statistical Analysis 136
Statistical Analysis Overview Comparison Group Selection 15 Without MF59, 15_(100)MF59
Comments A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.
Type of Statistical Test Non-Inferiority or Equivalence
Comments For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
Method of Estimation Estimation Parameter Geometric Mean Ratio at day 29
Estimated Value 0.2
Confidence Interval (2-Sided) 95%
0.147 to 0.271
Estimation Comments [Not Specified]
Show Statistical Analysis 137 Hide Statistical Analysis 137
Statistical Analysis Overview Comparison Group Selection 15 Without MF59, 30 Without MF59
Comments A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.
Type of Statistical Test Non-Inferiority or Equivalence
Comments For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
Method of Estimation Estimation Parameter Geometric Mean Ratio at day 29
Estimated Value 0.718
Confidence Interval (2-Sided) 95%
0.529 to 0.975
Estimation Comments [Not Specified]
Show Statistical Analysis 138 Hide Statistical Analysis 138
Statistical Analysis Overview Comparison Group Selection 15_(50)MF59, 15_(100)MF59
Comments A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.
Type of Statistical Test Non-Inferiority or Equivalence
Comments For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
Method of Estimation Estimation Parameter Geometric Mean Ratio at day 29
Estimated Value 0.712
Confidence Interval (2-Sided) 95%
0.524 to 0.966
Estimation Comments [Not Specified]
Show Statistical Analysis 139 Hide Statistical Analysis 139
Statistical Analysis Overview Comparison Group Selection 15_(50)MF59, 30 Without MF59
Comments A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.
Type of Statistical Test Non-Inferiority or Equivalence
Comments For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
Method of Estimation Estimation Parameter Geometric Mean Ratio at day 29
Estimated Value 2.56
Confidence Interval (2-Sided) 95%
1.886 to 3.474
Estimation Comments [Not Specified]
Show Statistical Analysis 140 Hide Statistical Analysis 140
Statistical Analysis Overview Comparison Group Selection 15_(100)MF59, 30 Without MF59
Comments A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other
Type of Statistical Test Non-Inferiority or Equivalence
Comments For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
Method of Estimation Estimation Parameter Geometric Mean Ratio at day 29
Estimated Value 3.597
Confidence Interval (2-Sided) 95%
2.646 to 4.89
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010.
Hide Description HI antibody assay (used to assess immune responses in subjects following vaccination) according to the Committee for Medicinal Products for Human Use (CHMP) guidance: in adults ages 18 to 60 years are:The percentage of subjects with seroconversion or significant increase in HI antibody is > 40%.The percentage of subjects achieving an HI titer ≥ 40 is > 70% and The GMR is > 2.5. All 3 criteria (seroconversion/significant increase, HI antibody titer ≥ 40, and GMR) had to be fulfilled to establish immunogenicity.Subgroup analysis based on receipt of recent seasonal vaccination. Comparison between subjects previously vaccinated versus not vaccinated with seasonal influenza vaccines.Subgroups without recent seasonal flu vaccine:PPS Day1, Day 1–22 and Day1–43 analysis set. N= 141, 147, 150, 148, 146, 146, 150, and 146 for Groups A, B, C, D, E, F, G, and H respectively. PPS Day 1–29 analysis set. N= 132, 140, 143, 139, 138, 136, 139, and 138 for Groups A, B, C, D, E, F, G,and H respectively.
Time Frame Day 22, Day 29, Day 43
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was done on PPS population
Arm/Group Title 3.75_(50)MF59 7.5 Without MF59 7.5_(50)MF59 7.5_(100)MF59 15 Without MF59 15_(50)MF59 15_(100)MF59 30 Without MF59
Hide Arm/Group Description:
50% of MF59 with 3.75 µg A/H1N1 antigen
1 dose of 7.5 µg A/H1N1
50% of MF59 with 7.5 µg A/H1N1 antigen
100% of MF59 with 7.5 µg A/H1N1 antigen
1 dose of 15 µg A/H1N1
50% of MF59 with 15 µg A/H1N1 antigen
100% of MF59 with 15 µg A/H1N1 antigen
1 dose of 30 µg A/H1N1
Overall Number of Participants Analyzed 152 156 156 156 155 157 156 153
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of Subjects
Seroconversion (Day 22/Day 1)with seasonal flu vac
73
(39 to 94)
22
(3 to 60)
83
(36 to 100)
100
(63 to 100)
44
(14 to 79)
73
(39 to 94)
100
(54 to 100)
71
(29 to 96)
Seroconversion (Day 29/Day 1)with seasonal flu vac
100
(72 to 100)
67
(30 to 93)
83
(36 to 100)
100
(59 to 100)
67
(30 to 93)
100
(72 to 100)
100
(48 to 100)
83
(36 to 100)
Seroconversion (Day 43/Day 1)with seasonal flu va
91
(59 to 100)
78
(40 to 97)
67
(22 to 96)
88
(47 to 100)
78
(40 to 97)
100
(72 to 100)
100
(54 to 100)
86
(42 to 100)
HI titer ≥1:40 (Day 1)_ with seasonal flu vac
18
(2 to 52)
22
(3 to 60)
50
(12 to 88)
38
(9 to 76)
0
(0 to 34)
9
(0 to 41)
17
(0 to 64)
0
(0 to 41)
HI titer ≥1:40 (Day 22)_ with seasonal flu vac
73
(39 to 94)
33
(7 to 70)
100
(54 to 100)
100
(63 to 100)
44
(14 to 79)
73
(39 to 94)
100
(54 to 100)
71
(29 to 96)
HI titer ≥1:40 (Day 29)_ with seasonal flu vac
100
(72 to 100)
67
(30 to 93)
100
(54 to 100)
100
(59 to 100)
67
(30 to 93)
100
(72 to 100)
100
(48 to 100)
100
(54 to 100)
HI titer ≥1:40 (Day 43)_ with seasonal flu vac
100
(72 to 100)
78
(40 to 97)
100
(54 to 100)
100
(63 to 100)
78
(40 to 97)
100
(72 to 100)
100
(54 to 100)
86
(42 to 100)
Seroconversion (Day 22/Day 1)without flu vac
82
(75 to 88)
47
(39 to 55)
77
(70 to 84)
88
(81 to 93)
59
(50 to 67)
82
(75 to 88)
91
(86 to 95)
60
(51 to 68)
Seroconversion (Day 29/Day 1)without flu vac
98
(95 to 100)
79
(71 to 85)
99
(96 to 100)
99
(95 to 100)
88
(82 to 93)
100
(97 to 100)
100
(97 to 100)
94
(89 to 97)
Seroconversion (Day 43/Day 1)without flu vac
99
(95 to 100)
78
(70 to 84)
98
(94 to 100)
98
(94 to 100)
85
(78 to 90)
99
(95 to 100)
99
(96 to 100)
88
(82 to 93)
HI titer ≥1:40 (Day 1) without flu vac
10
(6 to 16)
8
(4 to 14)
11
(7 to 18)
9
(5 to 15)
16
(11 to 23)
9
(5 to 15)
7
(4 to 13)
13
(8 to 20)
HI titer ≥1:40 (Day 22)without flu vac
84
(77 to 90)
49
(41 to 57)
80
(73 to 86)
91
(85 to 95)
62
(53 to 70)
83
(76 to 89)
93
(88 to 97)
65
(57 to 73)
HI titer ≥1:40 (Day 29) without flu vac
99
(96 to 100)
79
(72 to 86)
100
(97 to 100)
99
(95 to 100)
90
(84 to 94)
100
(97 to 100)
100
(97 to 100)
96
(92 to 99)
HI titer ≥1:40 (Day 43) without flu vac
99
(96 to 100)
79
(71 to 85)
100
(98 to 100)
99
(95 to 100)
88
(81 to 93)
99
(96 to 100)
100
(98 to 100)
92
(86 to 96)
4.Secondary Outcome
Title Geometric Mean Titers (GMTs) With and Without Seasonal Influenza Vaccination for Year 2009 to 2010
Hide Description

Immunogenicity was measured in terms of GMTs of Subgroups with receipt of recent seasonal vaccination. Comparison between subjects previously vaccinated versus not vaccinated with seasonal influenza vaccines

Subgroups without recent seasonal flu vaccine:

PPS Day 1, Day 1–22 and Day 1–43 analysis set. N= 141, 147, 150, 148, 146, 146, 150, and 146 for Groups A, B, C, D, E, F, G, and H respectively.

PPS Day 1–29 analysis set. N= 132, 140, 143, 139, 138, 136, 139, and 138 for Groups A, B, C, D, E, F,G, and H respectively.

Subgroups with recent seasonal flu vaccine:PPS Day 1–22 and Day 1-43 analysis set. N= 11, 9, 6, 8, 9, 11, 6, and 7 for Groups A, B, C, D, E, F, G,and H respectively.

PPS Day 1–29 analysis set. N= 11, 9, 6, 7, 9, 11, 5, and 6 for Groups A, B, C, D, E, F, G, and H respectively

Time Frame Day 1, Day 22, Day 29, Day 43
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was done on PPS population.
Arm/Group Title 3.75_(50)MF59 7.5 Without MF59 7.5_(50)MF59 7.5_(100)MF59 15 Without MF59 15_(50)MF59 15_(100)MF59 30 Without MF59
Hide Arm/Group Description:
50% of MF59 with 3.75 µg A/H1N1 antigen
1 dose of 7.5 µg A/H1N1
50% of MF59 with 7.5 µg A/H1N1 antigen
100% of MF59 with 7.5 µg A/H1N1 antigen
1 dose of 15 µg A/H1N1
50% of MF59 with 15 µg A/H1N1 antigen
100% of MF59 with 15 µg A/H1N1 antigen
1 dose of 30 µg A/H1N1
Overall Number of Participants Analyzed 152 156 156 156 155 157 156 153
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Day 1_with seasonal flu vaccination
6.22
(2.16 to 18)
12
(3.63 to 42)
22
(5.54 to 90)
15
(4.5 to 47)
5.42
(1.75 to 17)
5.99
(2.16 to 17)
15
(3.94 to 565)
9.36
(2.69 to 33)
Day 22_ with seasonal flu vaccination
36
(9.11 to 146)
44
(8.93 to 217)
196
(32 to 1213)
209
(45 to 976)
48
(11 to 210)
44
(11 to 166)
345
(61 to 1961)
111
(22 to 567)
Day 29_ with seasonal flu vaccination
278
(90 to 856)
171
(47 to 625)
785
(178 to 3450)
1186
(317 to 4440)
137
(41 to 457)
670
(226 to 1988)
771
(164 to 3628)
184
(43 to 791)
Day 43_ with seasonal flu vaccination
260
(102 to 665)
182
(62 to 537)
503
(146 to 1729)
594
(209 to 1687)
81
(30 to 221)
663
(268 to 1639)
1035
(319 to 3363)
228
(75 to 689)
Day 1_without seasonal flu vaccination
8.54
(7.03 to 10)
7.08
(5.84 to 8.59)
8.3
(6.86 to 10)
7.76
(6.41 to 9.41)
9.35
(7.71 to 11)
7.47
(6.15 to 9.08)
6.8
(5.61 to 8.24)
9.1
(7.51 to 11)
Day 22_ without seasonal flu vaccination
115
(83 to 161)
28
(20 to 38)
85
(61 to 117)
159
(115 to 220)
52
(38 to 72)
109
(79 to 152)
158
(114 to 218)
62
(45 to 85)
Day 29_ without seasonal flu vaccination
810
(633 to 1037)
144
(113 to 183)
669
(527 to 849)
968
(760 to 1232)
228
(179 to 291)
756
(591 to 966)
1080
(847 to 1377)
297
(233 to 377)
Day 43_ without seasonal flu vaccination
600
(477 to 753)
115
(92 to 144)
477
(381 to 596)
643
(514 to 805)
182
(145 to 228)
520
(414 to 653)
770
(615 to 963)
224
(179 to 281)
5.Secondary Outcome
Title Antibody Response Based on Baseline Seropositivity
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Subgroup analysis based on Subjects with seropositivity (pre-vaccination HI antibody titer < 1:10 and prevaccination HI antibody titer ≥ 1:10) at baseline.

Subgroups with baseline HI titer < 1:10: PPS Day 1–29 analysis set. N= 104, 116, 111, 107, 109, 113,120, and 103 for Groups A, B, C, D, E, F, G, and H respectively.

Subgroups with baseline HI titer ≥ 1:10: PPS Day 1–29 analysis set. N= 39, 33, 38, 39, 38, 34, 24, and 41 for Groups A, B, C, D, E, F, G, and H respectively.

Time Frame Day 22, Day 29 and Day 43
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 3.75_(50)MF59 7.5 Without MF59 7.5_(50)MF59 7.5_(100)MF59 15 Without MF59 15_(50)MF59 15_(100)MF59 30 Without MF59
Hide Arm/Group Description:
50% of MF59 with 3.75 µg A/H1N1 antigen
1 dose of 7.5 µg A/H1N1
50% of MF59 with 7.5 µg A/H1N1 antigen
100% of MF59 with 7.5 µg A/H1N1 antigen
1 dose of 15 µg A/H1N1
50% of MF59 with 15 µg A/H1N1 antigen
100% of MF59 with 15 µg A/H1N1 antigen
1 dose of 30 µg A/H1N1
Overall Number of Participants Analyzed 152 156 156 156 155 157 156 153
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of Subjects
Seroconversion (Day 22/Day 1)_baseline HI < 1:10
81
(72 to 88)
39
(30 to 48)
79
(71 to 86)
90
(84 to 95)
54
(44 to 63)
78
(69 to 85)
92
(86 to 96)
61
(52 to 70)
Seroconversion (Day 29/Day 1)_baseline HI < 1:10
99
(95 to 100)
75
(66 to 83)
100
(97 to 100)
98
(93 to 100)
85
(77 to 91)
100
(97 to 100)
100
(97 to 100)
97
(92 to 99)
Seroconversion (Day 43/Day 1)_baseline HI < 1:10
99
(95 to 100)
75
(67 to 83)
100
(97 to 100)
98
(94 to 100)
83
(75 to 90)
99
(95 to 100)
100
(97 to 100)
91
(84 to 96)
HI titer ≥1:40 (Day 1)_ baseline HI <1:10
0
(0 to 3)
0
(0 to 3)
0
(0 to 3)
0
(0 to 3)
0
(0 to 3)
0
(0 to 3)
0
(0 to 3)
0
(0 to 3)
HI titer ≥1:40 (Day 22)_ baseline HI <1:10
81
(72 to 88)
39
(30 to 48)
79
(71 to 86)
90
(84 to 95)
54
(44 to 63)
78
(69 to 85)
92
(86 to 96)
61
(52 to 70)
HI titer ≥1:40 (Day 29)_ baseline HI <1:10
99
(95 to 100)
75
(66 to 83)
100
(97 to 100)
98
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