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

Sponsor
Novartis Vaccines (Industry)
Overall Status
Completed
CT.gov ID
NCT00972816
Collaborator
(none)
1,357
Enrollment
35
Locations
8
Arms
13
Duration (Months)
38.8
Patients Per Site
3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study will evaluate the safety and immunogenicity of different combinations of A/H1N1 S-OIV (swine flu) vaccine in healthy young children.

Condition or Disease Intervention/Treatment Phase
  • Biological: MF59-eH1N1
 Phase 2/Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
1357 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Prevention
Official Title:
A Pivotal Randomized, Single-Blind, Dose-Finding Study to Evaluate Immunogenicity, Safety and Tolerability of Different Formulations of an Adjuvanted and Non-Adjuvanted Egg-Derived, Inactivated Novel Swine Origin A/H1N1 Monovalent Subunit Influenza Virus Vaccine in Healthy Pediatric Subjects 3 to < 9 Years of Age
Study Start Date :
Sep 1, 2009
Actual Primary Completion Date :
Nov 1, 2009
Actual Study Completion Date :
Oct 1, 2010

Arms and Interventions

Arm Intervention/Treatment
Experimental: 3.75_(50)MF59

3.75 μg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22

Biological: MF59-eH1N1
MF59 adjuvanted with egg-derived A/H1N1 antigen. MF59-eH1N1 vaccine is the same vaccine as A/H1N1-SOIV (Swine Origin A/H1N1 Influenza Virus).
Experimental: 7.5_(0) MF59

7.5 μg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22

Biological: MF59-eH1N1
MF59 adjuvanted with egg-derived A/H1N1 antigen. MF59-eH1N1 vaccine is the same vaccine as A/H1N1-SOIV (Swine Origin A/H1N1 Influenza Virus).
Experimental: 7.5_(50) MF59

7.5 μg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22

Biological: MF59-eH1N1
MF59 adjuvanted with egg-derived A/H1N1 antigen. MF59-eH1N1 vaccine is the same vaccine as A/H1N1-SOIV (Swine Origin A/H1N1 Influenza Virus).
Experimental: 7.5_(100) MF59

7.5 μg A/H1N1 antigen with 100% MF59 adjuvant administered on study day 1 and day 22

Biological: MF59-eH1N1
MF59 adjuvanted with egg-derived A/H1N1 antigen. MF59-eH1N1 vaccine is the same vaccine as A/H1N1-SOIV (Swine Origin A/H1N1 Influenza Virus).
Experimental: 15_(0) MF59

15 μg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22

Biological: MF59-eH1N1
MF59 adjuvanted with egg-derived A/H1N1 antigen. MF59-eH1N1 vaccine is the same vaccine as A/H1N1-SOIV (Swine Origin A/H1N1 Influenza Virus).
Experimental: 15_(50)MF59

15 μg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22

Biological: MF59-eH1N1
MF59 adjuvanted with egg-derived A/H1N1 antigen. MF59-eH1N1 vaccine is the same vaccine as A/H1N1-SOIV (Swine Origin A/H1N1 Influenza Virus).
Experimental: 15_(100) MF59

15 μg A/H1N1 antigen with 100% MF59 adjuvant administered on study day 1 and day 22

Biological: MF59-eH1N1
MF59 adjuvanted with egg-derived A/H1N1 antigen. MF59-eH1N1 vaccine is the same vaccine as A/H1N1-SOIV (Swine Origin A/H1N1 Influenza Virus).
Experimental: 30_(0) MF59

30 μg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22

Biological: MF59-eH1N1
MF59 adjuvanted with egg-derived A/H1N1 antigen. MF59-eH1N1 vaccine is the same vaccine as A/H1N1-SOIV (Swine Origin A/H1N1 Influenza Virus).

Outcome Measures

Primary Outcome Measures

  1. Antibody Responses According to the Hemagglutinin Inhibition (HI) Assay After the First and Second Vaccinations [Day 22, Day 29, Day 43, Day 202 and Day 387]

    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.

Secondary Outcome Measures

  1. Geometric Mean Titer (GMT) After Each Vaccination by Vaccine Group [Day 22, Day 29, Day 43, Day 202 and Day 387]

    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.

  2. Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010. [Day 22, Day 29, Day 43]

    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.

  3. Geometric Mean Titers (GMTs) With and Without Seasonal Influenza Vaccination for Year 2009 to 2010 [Day 1, Day 22, Day 29, Day 43]

    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

  4. Antibody Response Based on Baseline Seropositivity [Day 22, Day 29 and Day 43]

    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.

  5. Geometric Mean Titers (GMTs) Based on Baseline Seropositivity [Day 1, Day 22, Day 29, Day 43]

    Subgroup analysis based on Subjects with seropositivity (pre-vaccination HI antibody titer < 1:10 and prevaccination HI antibody titer ≥ 1:10) at baseline. Immunogenicity responses in subjects who are seropositive (A/H1N1 2009 HI titer ≥ 1:10) at Baseline [Day 1 (pre-vaccination)] as compared to those who are seronegative (HI titer < 1:10).

  6. Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination [7 days after first vaccination]

    Solicited local and systemic reactions were assessed after the first vaccination by vaccine group. Source Vocabulary Name: MedDRA (13.1).

  7. Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination [7 days after second vaccination]

    Solicited local and systemic reactions were assessed after the second vaccination by vaccine group.Source Vocabulary Name: MedDRA (13.1)

  8. Number of Participants Reporting Unsolicited Adverse Events (AEs) [Safety monitoring periods were the Primary Period: Day 1 (1st vaccination) through ≤21 days post second vaccination, and the Follow-up Period: >21 Days post second vaccination to 12 months after second vaccination]

    Safety was measured in terms of the Number of Participants Reporting Unsolicited AEs. Source Vocabulary Name: MedDRA (13.1)

Eligibility Criteria

Criteria

Ages Eligible for Study:
3 Years to 8 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Children 3 to < 9 years of age in good health as determined by medical history, physical assessment and clinical judgement of the investigator and without influenza within the past 6 months.
Exclusion Criteria:

  • History of serious disease.

  • History of serious reaction following administration of vaccine or hypersensitivity to vaccine components.

  • Known or suspected impairment/alteration of immune function.

  • Receipt or planned receipt of seasonal trivalent influenza vaccine within 1 week before or after each study vaccination.

For additional entry criteria, please refer to protocol.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Premier Health Research Center, LLC Downey California United States 90241-4982
2 Madera Family Medical Group Madera California United States 93637
3 Center for Clincal Trials, LLC Paramount California United States 90723
4 Center for Clinical Trials, LLC Paramount California United States 90723
5 Center for Clinical Trials of San Gabriel West Covina California United States 91790
6 1st International Research Centers Thornton Colorado United States 80233
7 Pediatrics and Adolescent Medicine Marietta Georgia United States 30062
8 Pediatrics and Adolescent Medicine Woodstock Georgia United States 30189
9 Northern Illinois Research Associates Dekalb Illinois United States 60115
10 Bluegrass Clinical Research, Inc. New Albany Indiana United States 47150
11 Heartland Research Associates LLC Arkansas City Kansas United States 67005
12 Heartland Research Associates LLC Newton Kansas United States 67114
13 Bluegrass Clinical Research, Inc (Brownsboro for drug shipment) Louisville Kentucky United States 40291
14 Meridien Clinical Research Omaha Nebraska United States 68134
15 Clinical Research Center of Nevada Henderson Nevada United States 89015
16 Capital Pediatrics and Adolescent Ctr. Raleigh North Carolina United States 27609
17 Dr. Senders and Associates, Pediatrics Cleveland Ohio United States 44121
18 Prestige Clinical Research Franklin Ohio United States 45005
19 IPS Research Oklahoma City Oklahoma United States 73103
20 The Portland Clinic LLP Beaverton Oregon United States 97006
21 Children's Health Care -West Erie Pennsylvania United States 16506
22 UPMC/Community Medicine (pediatrics) Greenville Pennsylvania United States 16125
23 Pediatric Physicians Research, Inc. Jefferson Hills Pennsylvania United States 15025
24 Pediatric Alliance - Greentree Division (pediatrics) Pittsburgh Pennsylvania United States 15220
25 Omega Clinical Research Warwick Rhode Island United States 02886
26 Holston Medical Group Kingsport Tennessee United States 37660
27 Research Across America Dallas Texas United States 75234
28 West Houston Clinical Research Service Houston Texas United States 77055
29 Pediatric Healthcare of NW Houston Tomball Texas United States 77375
30 J.Lewis Research, Inc./Foothill Family Clinic Salt Lake City Utah United States 84109
31 J. Lewis Research, Inc./Foothill Family Clinic South Salt Lake City Utah United States 84121
32 PI-Coor Clinical Research Burke Virginia United States 22015
33 Virginia Commonwealth University Richmond Virginia United States 23219
34 Rockwood Research Center Spokane Washington United States 99202
35 Instituto Nacional de Ciencias Tlalpan Mexico 14000

Sponsors and Collaborators

  • Novartis Vaccines

Investigators

  • Study Director: Novartis Vaccines and Diagnostics, Novartis

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Novartis Vaccines
ClinicalTrials.gov Identifier:
NCT00972816
Other Study ID Numbers:
  • V112_02
First Posted:
Sep 9, 2009
Last Update Posted:
Apr 14, 2016
Last Verified:
Mar 1, 2016
Keywords provided by Novartis Vaccines
Swine Flu
Flu
Vaccine
Children
Adjuvant
Additional relevant MeSH terms:
Influenza, Human

Study Results

Participant Flow

Recruitment Details 36 centers in the U.S., of which 34 centers enrolled subjects.
Pre-assignment Detail
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
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

Baseline Characteristics

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
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 Participants 173 169 169 169 169 169 169 170 1357
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
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 (Count of 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%
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%

Outcome Measures

1. Primary Outcome
Title Antibody Responses According to the Hemagglutinin Inhibition (HI) Assay After the First and Second Vaccinations
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

Outcome Measure Data

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
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
Measure Participants 152 156 156 156 155 157 156 153
HI titer ≥1:40 (Baseline)
11
9
13
11
15
9
8
12
HI titer ≥1:40 day 22
84
48
81
91
61
82
94
65
Seroconversion day 22
82
46
78
88
58
82
92
60
HI titer ≥1:40 (Day 29)
99
79
100
99
88
100
100
97
Seroconversion (Day 29)
99
78
99
99
87
100
100
94
HI titer ≥1:40 day 43
99
79
100
99
87
99
100
92
Seroconversion day 43
98
78
97
97
85
99
99
88
HI titer ≥1:40 day 202 (N=82,85,84,84,86,87,82,79)
95
65
93
95
74
95
95
81
Seroconversion day 202 (N=82,85,84,84,86,87,82,79)
83
55
83
83
63
90
90
66
HI titer ≥1:40 day 387 (N=55,63,61,58,61,65,59,63)
80
56
75
88
49
78
81
65
Seroconversion day 387 (N=55,63,61,58,61,65,59,63)
65
49
69
78
44
75
71
51
2. Secondary Outcome
Title Geometric Mean Titer (GMT) After Each Vaccination by Vaccine Group
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

Outcome Measure Data

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
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
Measure Participants 152 156 156 156 155 157 156 153
GMT Baseline
8.5
7.3
8.7
8.7
9.1
7.5
7
9.1
GMTs day 22
107
27
88
163
49
106
160
62
GMT Day 29
747
138
685
984
214
761
1070
297
GMTs day 43
560
113
480
637
174
524
778
223
GMTs day 202 (N=143,149,149,146,147,147,144,144)
117
45
107
132
55
134
131
81
GMTs day 387 (N=55,63,61,58,61,65,59,63)
54
28
57
70
30
59
63
45
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.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
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
Parameter Dispersion Type:
Value:
Estimation Comments
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.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
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
Parameter Dispersion Type:
Value:
Estimation Comments
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.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
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
Parameter Dispersion Type:
Value:
Estimation Comments
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.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
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
Parameter Dispersion Type:
Value:
Estimation Comments
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.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
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
Parameter Dispersion Type:
Value:
Estimation Comments
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.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
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
Parameter Dispersion Type:
Value:
Estimation Comments
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.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
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
Parameter Dispersion Type:
Value:
Estimation Comments
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.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
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
Parameter Dispersion Type:
Value:
Estimation Comments
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.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
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
Parameter Dispersion Type:
Value:
Estimation Comments
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.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
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
Parameter Dispersion Type:
Value:
Estimation Comments
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.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
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
Parameter Dispersion Type:
Value:
Estimation Comments
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.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
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
Parameter Dispersion Type:
Value:
Estimation Comments
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.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
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
Parameter Dispersion Type:
Value:
Estimation Comments
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.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
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
Parameter Dispersion Type:
Value:
Estimation Comments
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.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
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
Parameter Dispersion Type:
Value:
Estimation Comments
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.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
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
Parameter Dispersion Type:
Value:
Estimation Comments
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.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
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
Parameter Dispersion Type:
Value:
Estimation Comments
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.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
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
Parameter Dispersion Type:
Value:
Estimation Comments
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.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
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
Parameter Dispersion Type:
Value:
Estimation Comments
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.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
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
Parameter Dispersion Type:
Value:
Estimation Comments
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.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
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
Parameter Dispersion Type:
Value:
Estimation Comments
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.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
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
Parameter Dispersion Type:
Value:
Estimation Comments
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.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
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
Parameter Dispersion Type:
Value:
Estimation Comments
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.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
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
Parameter Dispersion Type:
Value:
Estimation Comments
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.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
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
Parameter Dispersion Type:
Value:
Estimation Comments
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.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
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
Parameter Dispersion Type:
Value:
Estimation Comments
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.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
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
Parameter Dispersion Type:
Value:
Estimation Comments
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.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
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
Parameter Dispersion Type:
Value:
Estimation Comments
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.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
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
Parameter Dispersion Type:
Value:
Estimation Comments
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.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
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
Parameter Dispersion Type:
Value:
Estimation Comments
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.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
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
Parameter Dispersion Type:
Value:
Estimation Comments
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.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
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
Parameter Dispersion Type:
Value:
Estimation Comments
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.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
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
Parameter Dispersion Type:
Value:
Estimation Comments
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.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
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
Parameter Dispersion Type:
Value:
Estimation Comments
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.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
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
Parameter Dispersion Type:
Value:
Estimation Comments
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.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
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
Parameter Dispersion Type:
Value:
Estimation Comments
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.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
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
Parameter Dispersion Type:
Value:
Estimation Comments
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.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
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
Parameter Dispersion Type:
Value:
Estimation Comments
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.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
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
Parameter Dispersion Type:
Value:
Estimation Comments
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.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Geometric mean ratio at day 43
Estimated Value 0.145
Confidence Interval () 95%
0.109 to 0.191
Parameter Dispersion Type:
Value:
Estimation Comments
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.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
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
Parameter Dispersion Type:
Value:
Estimation Comments
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.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
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
Parameter Dispersion Type:
Value:
Estimation Comments
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.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
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
Parameter Dispersion Type:
Value:
Estimation Comments
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.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
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
Parameter Dispersion Type:
Value:
Estimation Comments
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.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
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
Parameter Dispersion Type:
Value:
Estimation Comments
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.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
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
Parameter Dispersion Type:
Value:
Estimation Comments
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.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
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
Parameter Dispersion Type:
Value:
Estimation Comments
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.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
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
Parameter Dispersion Type:
Value:
Estimation Comments
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.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
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
Parameter Dispersion Type:
Value:
Estimation Comments
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.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
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
Parameter Dispersion Type:
Value:
Estimation Comments
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.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
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
Parameter Dispersion Type:
Value:
Estimation Comments
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.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
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
Parameter Dispersion Type:
Value:
Estimation Comments
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.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
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
Parameter Dispersion Type:
Value:
Estimation Comments
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.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
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
Parameter Dispersion Type:
Value:
Estimation Comments
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.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
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
Parameter Dispersion Type:
Value:
Estimation Comments
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.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
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
Parameter Dispersion Type:
Value:
Estimation Comments
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.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
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
Parameter Dispersion Type:
Value:
Estimation Comments
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.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
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
Parameter Dispersion Type:
Value:
Estimation Comments
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.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
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
Parameter Dispersion Type:
Value:
Estimation Comments
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.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
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
Parameter Dispersion Type:
Value:
Estimation Comments
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.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
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
Parameter Dispersion Type:
Value:
Estimation Comments
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
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
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
Parameter Dispersion Type:
Value:
Estimation Comments
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.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
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
Parameter Dispersion Type:
Value:
Estimation Comments
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.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
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
Parameter Dispersion Type:
Value:
Estimation Comments
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.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
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
Parameter Dispersion Type:
Value:
Estimation Comments
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.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
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
Parameter Dispersion Type:
Value:
Estimation Comments
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.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
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
Parameter Dispersion Type:
Value:
Estimation Comments
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.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
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
Parameter Dispersion Type:
Value:
Estimation Comments
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.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
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
Parameter Dispersion Type:
Value:
Estimation Comments
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.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
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
Parameter Dispersion Type:
Value:
Estimation Comments
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.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
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
Parameter Dispersion Type:
Value:
Estimation Comments
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.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
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
Parameter Dispersion Type:
Value:
Estimation Comments
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.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
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
Parameter Dispersion Type:
Value:
Estimation Comments
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.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
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
Parameter Dispersion Type:
Value:
Estimation Comments
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.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
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
Parameter Dispersion Type:
Value:
Estimation Comments
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.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
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
Parameter Dispersion Type:
Value:
Estimation Comments
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.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
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
Parameter Dispersion Type:
Value:
Estimation Comments
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.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
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
Parameter Dispersion Type:
Value:
Estimation Comments
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.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
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
Parameter Dispersion Type:
Value:
Estimation Comments
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.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
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
Parameter Dispersion Type:
Value:
Estimation Comments
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.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
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
Parameter Dispersion Type:
Value:
Estimation Comments
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.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
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
Parameter Dispersion Type:
Value:
Estimation Comments
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.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
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
Parameter Dispersion Type:
Value:
Estimation Comments
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.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
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
Parameter Dispersion Type:
Value:
Estimation Comments
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.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
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
Parameter Dispersion Type:
Value:
Estimation Comments
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.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
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
Parameter Dispersion Type:
Value:
Estimation Comments
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.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
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
Parameter Dispersion Type:
Value:
Estimation Comments
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.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
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
Parameter Dispersion Type:
Value:
Estimation Comments
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.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
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
Parameter Dispersion Type:
Value:
Estimation Comments
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.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
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
Parameter Dispersion Type:
Value:
Estimation Comments
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.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
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
Parameter Dispersion Type:
Value:
Estimation Comments
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.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
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
Parameter Dispersion Type:
Value:
Estimation Comments
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.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
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
Parameter Dispersion Type:
Value:
Estimation Comments
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.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
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
Parameter Dispersion Type:
Value:
Estimation Comments
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.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
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
Parameter Dispersion Type:
Value:
Estimation Comments
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.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
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
Parameter Dispersion Type:
Value:
Estimation Comments
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.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
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
Parameter Dispersion Type:
Value:
Estimation Comments
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.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
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
Parameter Dispersion Type:
Value:
Estimation Comments
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.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
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
Parameter Dispersion Type:
Value:
Estimation Comments
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.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
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
Parameter Dispersion Type:
Value:
Estimation Comments
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.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
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
Parameter Dispersion Type:
Value:
Estimation Comments
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.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
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
Parameter Dispersion Type:
Value:
Estimation Comments
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.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
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
Parameter Dispersion Type:
Value:
Estimation Comments
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.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
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
Parameter Dispersion Type:
Value:
Estimation Comments
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.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
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
Parameter Dispersion Type:
Value:
Estimation Comments
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.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
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
Parameter Dispersion Type:
Value:
Estimation Comments
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.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
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
Parameter Dispersion Type:
Value:
Estimation Comments
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.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
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
Parameter Dispersion Type:
Value:
Estimation Comments
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.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
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
Parameter Dispersion Type:
Value:
Estimation Comments
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.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
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
Parameter Dispersion Type:
Value:
Estimation Comments
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.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
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
Parameter Dispersion Type:
Value:
Estimation Comments
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.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
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
Parameter Dispersion Type:
Value:
Estimation Comments
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.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Geometric Mean Ratio at day 29
Estimated Value 5.428
Confidence Interval (2-Sided) 95%
4 to 7.365
Parameter Dispersion Type:
Value:
Estimation Comments
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.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
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
Parameter Dispersion Type:
Value:
Estimation Comments
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.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
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
Parameter Dispersion Type:
Value:
Estimation Comments
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.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
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
Parameter Dispersion Type:
Value:
Estimation Comments
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.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
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
Parameter Dispersion Type:
Value:
Estimation Comments
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.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
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
Parameter Dispersion Type:
Value:
Estimation Comments
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.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
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
Parameter Dispersion Type:
Value:
Estimation Comments
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.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
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
Parameter Dispersion Type:
Value:
Estimation Comments
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.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
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
Parameter Dispersion Type:
Value:
Estimation Comments
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.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
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
Parameter Dispersion Type:
Value:
Estimation Comments
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.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
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
Parameter Dispersion Type:
Value:
Estimation Comments
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.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
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
Parameter Dispersion Type:
Value:
Estimation Comments
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
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
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
Parameter Dispersion Type:
Value:
Estimation Comments
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.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
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
Parameter Dispersion Type:
Value:
Estimation Comments
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.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
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
Parameter Dispersion Type:
Value:
Estimation Comments
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.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
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
Parameter Dispersion Type:
Value:
Estimation Comments
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.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
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
Parameter Dispersion Type:
Value:
Estimation Comments
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.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
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
Parameter Dispersion Type:
Value:
Estimation Comments
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.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
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
Parameter Dispersion Type:
Value:
Estimation Comments
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.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
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
Parameter Dispersion Type:
Value:
Estimation Comments
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.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
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
Parameter Dispersion Type:
Value:
Estimation Comments
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.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
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
Parameter Dispersion Type:
Value:
Estimation Comments
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.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
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
Parameter Dispersion Type:
Value:
Estimation Comments
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.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
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
Parameter Dispersion Type:
Value:
Estimation Comments
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.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
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
Parameter Dispersion Type:
Value:
Estimation Comments
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.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
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
Parameter Dispersion Type:
Value:
Estimation Comments
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.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
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
Parameter Dispersion Type:
Value:
Estimation Comments
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.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
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
Parameter Dispersion Type:
Value:
Estimation Comments
3. Secondary Outcome
Title Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010.
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

Outcome Measure Data

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
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
Measure Participants 152 156 156 156 155 157 156 153
Seroconversion (Day 22/Day 1)with seasonal flu vac
73
22
83
100
44
73
100
71
Seroconversion (Day 29/Day 1)with seasonal flu vac
100
67
83
100
67
100
100
83
Seroconversion (Day 43/Day 1)with seasonal flu va
91
78
67
88
78
100
100
86
HI titer ≥1:40 (Day 1)_ with seasonal flu vac
18
22
50
38
0
9
17
0
HI titer ≥1:40 (Day 22)_ with seasonal flu vac
73
33
100
100
44
73
100
71
HI titer ≥1:40 (Day 29)_ with seasonal flu vac
100
67
100
100
67
100
100
100
HI titer ≥1:40 (Day 43)_ with seasonal flu vac
100
78
100
100
78
100
100
86
Seroconversion (Day 22/Day 1)without flu vac
82
47
77
88
59
82
91
60
Seroconversion (Day 29/Day 1)without flu vac
98
79
99
99
88
100
100
94
Seroconversion (Day 43/Day 1)without flu vac
99
78
98
98
85
99
99
88
HI titer ≥1:40 (Day 1) without flu vac
10
8
11
9
16
9
7
13
HI titer ≥1:40 (Day 22)without flu vac
84
49
80
91
62
83
93
65
HI titer ≥1:40 (Day 29) without flu vac
99
79
100
99
90
100
100
96
HI titer ≥1:40 (Day 43) without flu vac
99
79
100
99
88
99
100
92
4. Secondary Outcome
Title Geometric Mean Titers (GMTs) With and Without Seasonal Influenza Vaccination for Year 2009 to 2010
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

Outcome Measure Data

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
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
Measure Participants 152 156 156 156 155 157 156 153
Day 1_with seasonal flu vaccination
6.22
12
22
15
5.42
5.99
15
9.36
Day 22_ with seasonal flu vaccination
36
44
196
209
48
44
345
111
Day 29_ with seasonal flu vaccination
278
171
785
1186
137
670
771
184
Day 43_ with seasonal flu vaccination
260
182
503
594
81
663
1035
228
Day 1_without seasonal flu vaccination
8.54
7.08
8.3
7.76
9.35
7.47
6.8
9.1
Day 22_ without seasonal flu vaccination
115
28
85
159
52
109
158
62
Day 29_ without seasonal flu vaccination
810
144
669
968
228
756
1080
297
Day 43_ without seasonal flu vaccination
600
115
477
643
182
520
770
224
5. Secondary Outcome
Title Antibody Response Based on Baseline Seropositivity
Description 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

Outcome Measure Data

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
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
Measure Participants 152 156 156 156 155 157 156 153
Seroconversion (Day 22/Day 1)_baseline HI < 1:10
81
39
79
90
54
78
92
61
Seroconversion (Day 29/Day 1)_baseline HI < 1:10
99
75
100
98
85
100
100
97
Seroconversion (Day 43/Day 1)_baseline HI < 1:10
99
75
100
98
83
99
100
91
HI titer ≥1:40 (Day 1)_ baseline HI <1:10
0
0
0
0
0
0
0
0
HI titer ≥1:40 (Day 22)_ baseline HI <1:10
81
39
79
90
54
78
92
61
HI titer ≥1:40 (Day 29)_ baseline HI <1:10
99
75
100
98
85
100
100
97
HI titer ≥1:40 (Day 43)_ baseline HI <1:10
99
75
100
98
83
99
100
91
Seroconversion (Day 22/Day 1)_baseline HI ≥ 1:10
83
69
73
83
71
95
89
57
Seroconversion (Day 29/Day 1)_baseline HI ≥ 1:10
97
88
95
100
92
100
100
85
Seroconversion (Day 43/Day 1)_baseline HI ≥ 1:10
95
86
88
95
88
97
96
81
HI titer ≥1:40 (Day 1)_ baseline HI ≥1:10
38
40
49
41
59
38
43
45
HI titer ≥1:40 (Day 22)_ baseline HI ≥1:10
90
80
85
93
80
97
100
76
HI titer ≥1:40 (Day 29)_ baseline HI ≥1:10
100
91
100
100
97
100
100
95
HI titer ≥1:40 (Day 43)_ baseline HI ≥1:10
100
91
100
100
98
100
100
93
6. Secondary Outcome
Title Geometric Mean Titers (GMTs) Based on Baseline Seropositivity
Description Subgroup analysis based on Subjects with seropositivity (pre-vaccination HI antibody titer < 1:10 and prevaccination HI antibody titer ≥ 1:10) at baseline. Immunogenicity responses in subjects who are seropositive (A/H1N1 2009 HI titer ≥ 1:10) at Baseline [Day 1 (pre-vaccination)] as compared to those who are seronegative (HI titer < 1:10).
Time Frame Day 1, Day 22, Day 29, Day 43

Outcome Measure Data

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
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
Measure Participants 152 156 156 156 155 157 156 153
GMTDay 1 HI <1:10(110,121,115,115,114,120,128,11
5
5
5.1
5.1
5
5
5.1
5.1
GMTDay 22 HI<1:10(110,121,115,115,114,120,128,11
80
18
62
130
26
72
130
39
GMTDay 29HI <1:10(110,121,115,115,114,120,128,11
664
100
638
885
149
685
950
234
GMTDay 43HI <1:10(110,121,115,115,114,120,128,11
490
85
437
568
121
463
717
177
GMT Day 1 HI ≥ 1:10(42,35,41,41,41,37,28,42)
40
32
47
32
52
35
40
48
GMT Day 22_HI ≥1:10(42,35,41,41,41,37,28,42)
343
132
311
320
284
417
460
252
GMT Day 29_HI ≥1:10(42,35,41,41,41,37,28,42)
1178
460
1063
1281
543
1197
2088
641
GMT Day 43_HI ≥1:10(42,35,41,41,41,37,28,42)
876
320
657
881
464
838
1184
428
7. Secondary Outcome
Title Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination
Description Solicited local and systemic reactions were assessed after the first vaccination by vaccine group. Source Vocabulary Name: MedDRA (13.1).
Time Frame 7 days after first vaccination

Outcome Measure Data

Analysis Population Description
The analysis was performed on safety set 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
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
Measure Participants 171 167 167 168 167 168 166 165
Pain
62
35.8%
43
25.4%
52
30.8%
86
50.9%
47
27.8%
65
38.5%
72
42.6%
51
30%
Erythema
3
1.7%
2
1.2%
4
2.4%
3
1.8%
1
0.6%
1
0.6%
6
3.6%
5
2.9%
Swelling
8
4.6%
5
3%
5
3%
7
4.1%
11
6.5%
11
6.5%
10
5.9%
6
3.5%
Induration
14
8.1%
5
3%
10
5.9%
12
7.1%
10
5.9%
11
6.5%
15
8.9%
12
7.1%
Tenderness
72
41.6%
49
29%
59
34.9%
96
56.8%
50
29.6%
78
46.2%
69
40.8%
60
35.3%
Chills
8
4.6%
3
1.8%
9
5.3%
11
6.5%
5
3%
8
4.7%
8
4.7%
8
4.7%
Myalgia
16
9.2%
8
4.7%
13
7.7%
27
16%
8
4.7%
15
8.9%
17
10.1%
12
7.1%
Arthralgia
7
4%
3
1.8%
9
5.3%
7
4.1%
3
1.8%
8
4.7%
7
4.1%
3
1.8%
Headache
24
13.9%
15
8.9%
30
17.8%
37
21.9%
16
9.5%
25
14.8%
27
16%
17
10%
Nausea
10
5.8%
14
8.3%
13
7.7%
14
8.3%
7
4.1%
11
6.5%
12
7.1%
9
5.3%
Vomiting
4
2.3%
5
3%
10
5.9%
4
2.4%
5
3%
8
4.7%
5
3%
5
2.9%
Diarrhoea
12
6.9%
7
4.1%
6
3.6%
2
1.2%
10
5.9%
3
1.8%
4
2.4%
6
3.5%
Fatigue
27
15.6%
17
10.1%
23
13.6%
29
17.2%
17
10.1%
23
13.6%
29
17.2%
16
9.4%
Fever
9
5.2%
10
5.9%
13
7.7%
14
8.3%
9
5.3%
17
10.1%
16
9.5%
7
4.1%
Stayed home
1
0.6%
0
0%
0
0%
0
0%
0
0%
1
0.6%
1
0.6%
0
0%
Analgesic./anti pyretic used
1
0.6%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
8. Secondary Outcome
Title Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination
Description Solicited local and systemic reactions were assessed after the second vaccination by vaccine group.Source Vocabulary Name: MedDRA (13.1)
Time Frame 7 days after second vaccination

Outcome Measure Data

Analysis Population Description
The analysis was performed on safety set 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
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
Measure Participants 165 163 164 163 162 167 162 164
Pain
53
35
46
59
42
57
48
50
Erythema
4
1
4
5
5
4
5
5
Swelling
8
5
10
9
11
10
12
10
Induration
10
2
9
6
9
15
13
10
Tenderness
55
42
50
65
38
67
57
54
Chills
7
5
5
4
7
4
3
3
Myalgia
12
4
9
16
6
8
9
15
Arthralgia
2
0
1
4
2
2
0
2
Headache
12
12
12
19
14
11
13
9
Nausea
11
7
5
6
8
16
4
5
Vomiting
6
3
4
7
3
3
3
3
Diarrhoea
6
6
5
5
7
7
2
4
Fatigue
16
11
15
14
17
10
13
6
Fever
10
6
5
5
10
8
7
4
Stayed home
1
0
0
0
1
0
0
0
Analgesic/anti pyretic used
0
0
0
0
0
0
0
1
9. Secondary Outcome
Title Number of Participants Reporting Unsolicited Adverse Events (AEs)
Description Safety was measured in terms of the Number of Participants Reporting Unsolicited AEs. Source Vocabulary Name: MedDRA (13.1)
Time Frame Safety monitoring periods were the Primary Period: Day 1 (1st vaccination) through ≤21 days post second vaccination, and the Follow-up Period: >21 Days post second vaccination to 12 months after second vaccination

Outcome Measure Data

Analysis Population Description
The analysis was done on unsolicited safety set 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
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
Measure Participants 171 168 169 168 168 168 167 169
AEs: all (Days 1-43)
98
80
80
85
86
93
79
79
SAEs: all (Days 1-43)
0
0
1
0
0
0
0
0
AEs leading to premature withdrawal (Days 1-43)
0
0
1
0
0
0
0
0
AEs leading to new onset of chronic disorder
0
0
0
0
0
1
0
0
AE leading to medically attended visits(Days 1-43)
31
34
25
40
34
35
28
24
AEs: all (Days 44-387)
95
98
102
93
90
101
90
95
SAEs: all (Days 44-387)
0
5
6
4
3
4
1
0
AEs leading to premature withdrawal (Days 44-387)
0
0
1
0
0
0
0
0
AEs leading to new onset of chronic dis.
2
7
4
3
4
3
6
3
AE leading to medically attended visit(Days44-387)
95
97
102
93
90
100
89
95

Adverse Events

Time Frame All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
Adverse Event Reporting Description If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
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
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
All Cause Mortality
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
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN)
Serious Adverse Events
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
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/171 (0%) 5/168 (3%) 7/169 (4.1%) 4/168 (2.4%) 3/168 (1.8%) 4/168 (2.4%) 1/167 (0.6%) 0/169 (0%)
Congenital, familial and genetic disorders
Hydrocele 0/171 (0%) 0/168 (0%) 1/169 (0.6%) 0/168 (0%) 0/168 (0%) 0/168 (0%) 0/167 (0%) 0/169 (0%)
Ear and labyrinth disorders
Cerumen Impaction 0/171 (0%) 1/168 (0.6%) 0/169 (0%) 0/168 (0%) 0/168 (0%) 0/168 (0%) 0/167 (0%) 0/169 (0%)
Infections and infestations
Appendicitis Perforated 0/171 (0%) 0/168 (0%) 1/169 (0.6%) 0/168 (0%) 0/168 (0%) 0/168 (0%) 0/167 (0%) 0/169 (0%)
Chronic Tonsillitis 0/171 (0%) 0/168 (0%) 0/169 (0%) 0/168 (0%) 1/168 (0.6%) 0/168 (0%) 0/167 (0%) 0/169 (0%)
Otitis Media Chronic 0/171 (0%) 0/168 (0%) 0/169 (0%) 0/168 (0%) 1/168 (0.6%) 0/168 (0%) 0/167 (0%) 0/169 (0%)
Peritonsillar Abscess 0/171 (0%) 0/168 (0%) 1/169 (0.6%) 0/168 (0%) 0/168 (0%) 0/168 (0%) 0/167 (0%) 0/169 (0%)
Pharyngitis Streptococcal 0/171 (0%) 0/168 (0%) 0/169 (0%) 1/168 (0.6%) 0/168 (0%) 0/168 (0%) 0/167 (0%) 0/169 (0%)
Pharyngotonsillitis 0/171 (0%) 1/168 (0.6%) 0/169 (0%) 0/168 (0%) 0/168 (0%) 0/168 (0%) 0/167 (0%) 0/169 (0%)
Pneumonia 0/171 (0%) 0/168 (0%) 1/169 (0.6%) 1/168 (0.6%) 0/168 (0%) 0/168 (0%) 0/167 (0%) 0/169 (0%)
Staphylococcal Scalded Skin Syndrome 0/171 (0%) 0/168 (0%) 0/169 (0%) 0/168 (0%) 0/168 (0%) 1/168 (0.6%) 0/167 (0%) 0/169 (0%)
Viral Infection 0/171 (0%) 0/168 (0%) 0/169 (0%) 1/168 (0.6%) 0/168 (0%) 0/168 (0%) 0/167 (0%) 0/169 (0%)
Injury, poisoning and procedural complications
Fall 0/171 (0%) 0/168 (0%) 0/169 (0%) 0/168 (0%) 0/168 (0%) 1/168 (0.6%) 0/167 (0%) 0/169 (0%)
Foreign Body 0/171 (0%) 0/168 (0%) 0/169 (0%) 0/168 (0%) 1/168 (0.6%) 0/168 (0%) 0/167 (0%) 0/169 (0%)
Ulna Fracture 0/171 (0%) 0/168 (0%) 0/169 (0%) 0/168 (0%) 0/168 (0%) 1/168 (0.6%) 0/167 (0%) 0/169 (0%)
Metabolism and nutrition disorders
Dehydration 0/171 (0%) 0/168 (0%) 1/169 (0.6%) 0/168 (0%) 0/168 (0%) 1/168 (0.6%) 0/167 (0%) 0/169 (0%)
Nervous system disorders
Febrile Convulsion 0/171 (0%) 0 0/168 (0%) 0 1/169 (0.6%) 1 0/168 (0%) 0 0/168 (0%) 0 0/168 (0%) 0 0/167 (0%) 0 0/169 (0%) 0
Altered state of consciousness 0/171 (0%) 1/168 (0.6%) 0/169 (0%) 0/168 (0%) 0/168 (0%) 0/168 (0%) 0/167 (0%) 0/169 (0%)
Psychiatric disorders
Aggression 0/171 (0%) 0/168 (0%) 0/169 (0%) 1/168 (0.6%) 0/168 (0%) 0/168 (0%) 0/167 (0%) 0/169 (0%)
Bipolar Disorder 0/171 (0%) 0/168 (0%) 0/169 (0%) 0/168 (0%) 0/168 (0%) 0/168 (0%) 1/167 (0.6%) 0/169 (0%)
Intermittent Explosive Disorder 0/171 (0%) 0/168 (0%) 0/169 (0%) 0/168 (0%) 0/168 (0%) 0/168 (0%) 1/167 (0.6%) 0/169 (0%)
Oppositional Defiant Disorder 0/171 (0%) 1/168 (0.6%) 0/169 (0%) 0/168 (0%) 0/168 (0%) 0/168 (0%) 0/167 (0%) 0/169 (0%)
Post-Traumatic Stress Disorder 0/171 (0%) 0/168 (0%) 1/169 (0.6%) 0/168 (0%) 0/168 (0%) 0/168 (0%) 0/167 (0%) 0/169 (0%)
Reproductive system and breast disorders
Ovarian Mass 0/171 (0%) 0/168 (0%) 0/169 (0%) 0/168 (0%) 1/168 (0.6%) 0/168 (0%) 0/167 (0%) 0/169 (0%)
Respiratory, thoracic and mediastinal disorders
Asthma 0/171 (0%) 0/168 (0%) 0/169 (0%) 0/168 (0%) 0/168 (0%) 1/168 (0.6%) 0/167 (0%) 0/169 (0%)
Pharyngeal Stenosis 0/171 (0%) 0/168 (0%) 0/169 (0%) 0/168 (0%) 0/168 (0%) 1/168 (0.6%) 0/167 (0%) 0/169 (0%)
Pneumomediastinum 0/171 (0%) 0/168 (0%) 0/169 (0%) 1/168 (0.6%) 0/168 (0%) 0/168 (0%) 0/167 (0%) 0/169 (0%)
Wheezing 0/171 (0%) 1/168 (0.6%) 0/169 (0%) 0/168 (0%) 0/168 (0%) 0/168 (0%) 0/167 (0%) 0/169 (0%)
Skin and subcutaneous tissue disorders
Swelling Face 0/171 (0%) 0/168 (0%) 0/169 (0%) 1/168 (0.6%) 0/168 (0%) 0/168 (0%) 0/167 (0%) 0/169 (0%)
Other (Not Including Serious) Adverse Events
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
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 171/171 (100%) 168/168 (100%) 169/169 (100%) 168/168 (100%) 168/168 (100%) 168/168 (100%) 167/167 (100%) 169/169 (100%)
Gastrointestinal disorders
Vomiting 22/171 (12.9%) 14/168 (8.3%) 27/169 (16%) 20/168 (11.9%) 19/168 (11.3%) 18/168 (10.7%) 20/167 (12%) 21/169 (12.4%)
Nausea 21/171 (12.3%) 20/168 (11.9%) 13/169 (7.7%) 19/168 (11.3%) 16/168 (9.5%) 23/168 (13.7%) 16/167 (9.6%) 14/169 (8.3%)
Diarrhea 22/171 (12.9%) 16/168 (9.5%) 17/169 (10.1%) 10/168 (6%) 22/168 (13.1%) 13/168 (7.7%) 12/167 (7.2%) 16/169 (9.5%)
General disorders
Pyrexia 41/171 (24%) 34/168 (20.2%) 38/169 (22.5%) 34/168 (20.2%) 44/168 (26.2%) 34/168 (20.2%) 34/167 (20.4%) 26/169 (15.4%)
Injection site pain 98/171 (57.3%) 70/168 (41.7%) 85/169 (50.3%) 117/168 (69.6%) 85/168 (50.6%) 99/168 (58.9%) 100/167 (59.9%) 89/169 (52.7%)
Injection site erythema 29/171 (17%) 16/168 (9.5%) 26/169 (15.4%) 38/168 (22.6%) 25/168 (14.9%) 26/168 (15.5%) 36/167 (21.6%) 35/169 (20.7%)
Fatigue 33/171 (19.3%) 22/168 (13.1%) 31/169 (18.3%) 32/168 (19%) 30/168 (17.9%) 29/168 (17.3%) 36/167 (21.6%) 20/169 (11.8%)
Injection site induration 23/171 (13.5%) 5/168 (3%) 19/169 (11.2%) 19/168 (11.3%) 18/168 (10.7%) 23/168 (13.7%) 32/167 (19.2%) 24/169 (14.2%)
Injection site swelling 17/171 (9.9%) 8/168 (4.8%) 14/169 (8.3%) 19/168 (11.3%) 19/168 (11.3%) 20/168 (11.9%) 24/167 (14.4%) 18/169 (10.7%)
Chills 17/171 (9.9%) 8/168 (4.8%) 13/169 (7.7%) 14/168 (8.3%) 12/168 (7.1%) 12/168 (7.1%) 11/167 (6.6%) 11/169 (6.5%)
Infections and infestations
Nasopharyngitis 14/171 (8.2%) 4/168 (2.4%) 10/169 (5.9%) 10/168 (6%) 7/168 (4.2%) 10/168 (6%) 9/167 (5.4%) 7/169 (4.1%)
Upper respiratory track infection 29/171 (17%) 36/168 (21.4%) 23/169 (13.6%) 26/168 (15.5%) 25/168 (14.9%) 21/168 (12.5%) 21/167 (12.6%) 22/169 (13%)
Conjunctivitis 3/171 (1.8%) 5/168 (3%) 4/169 (2.4%) 15/168 (8.9%) 6/168 (3.6%) 7/168 (4.2%) 5/167 (3%) 5/169 (3%)
Bronchitis 13/171 (7.6%) 8/168 (4.8%) 5/169 (3%) 10/168 (6%) 7/168 (4.2%) 4/168 (2.4%) 6/167 (3.6%) 3/169 (1.8%)
Pharyngitis 13/171 (7.6%) 9/168 (5.4%) 14/169 (8.3%) 15/168 (8.9%) 12/168 (7.1%) 10/168 (6%) 6/167 (3.6%) 6/169 (3.6%)
Pharyngitis Streptococcal 17/171 (9.9%) 19/168 (11.3%) 18/169 (10.7%) 20/168 (11.9%) 15/168 (8.9%) 20/168 (11.9%) 13/167 (7.8%) 17/169 (10.1%)
Sinusitis 9/171 (5.3%) 7/168 (4.2%) 7/169 (4.1%) 11/168 (6.5%) 9/168 (5.4%) 13/168 (7.7%) 3/167 (1.8%) 9/169 (5.3%)
Viral Infection 13/171 (7.6%) 5/168 (3%) 11/169 (6.5%) 13/168 (7.7%) 10/168 (6%) 17/168 (10.1%) 13/167 (7.8%) 12/169 (7.1%)
Otitis Media 17/171 (9.9%) 14/168 (8.3%) 28/169 (16.6%) 18/168 (10.7%) 21/168 (12.5%) 18/168 (10.7%) 23/167 (13.8%) 23/169 (13.6%)
OTITIS MEDIA ACUTE 9/171 (5.3%) 3/168 (1.8%) 4/169 (2.4%) 4/168 (2.4%) 7/168 (4.2%) 3/168 (1.8%) 5/167 (3%) 9/169 (5.3%)
Musculoskeletal and connective tissue disorders
Myalgia 24/171 (14%) 10/168 (6%) 17/169 (10.1%) 36/168 (21.4%) 13/168 (7.7%) 18/168 (10.7%) 22/167 (13.2%) 22/169 (13%)
Arthralgia 9/171 (5.3%) 2/168 (1.2%) 12/169 (7.1%) 9/168 (5.4%) 6/168 (3.6%) 9/168 (5.4%) 8/167 (4.8%) 4/169 (2.4%)
Nervous system disorders
Headache 37/171 (21.6%) 31/168 (18.5%) 39/169 (23.1%) 44/168 (26.2%) 28/168 (16.7%) 37/168 (22%) 38/167 (22.8%) 28/169 (16.6%)
Respiratory, thoracic and mediastinal disorders
Cough 34/171 (19.9%) 36/168 (21.4%) 30/169 (17.8%) 27/168 (16.1%) 34/168 (20.2%) 35/168 (20.8%) 40/167 (24%) 38/169 (22.5%)
Rhinorrhoea 10/171 (5.8%) 9/168 (5.4%) 7/169 (4.1%) 9/168 (5.4%) 11/168 (6.5%) 17/168 (10.1%) 15/167 (9%) 11/169 (6.5%)
Asthma 14/171 (8.2%) 8/168 (4.8%) 10/169 (5.9%) 10/168 (6%) 6/168 (3.6%) 7/168 (4.2%) 11/167 (6.6%) 6/169 (3.6%)
Nasal congestion 12/171 (7%) 7/168 (4.2%) 6/169 (3.6%) 4/168 (2.4%) 11/168 (6.5%) 6/168 (3.6%) 8/167 (4.8%) 8/169 (4.7%)
Oropharyngeal pain 13/171 (7.6%) 9/168 (5.4%) 5/169 (3%) 11/168 (6.5%) 12/168 (7.1%) 12/168 (7.1%) 14/167 (8.4%) 5/169 (3%)
Rhinitis Allergic 10/171 (5.8%) 9/168 (5.4%) 7/169 (4.1%) 9/168 (5.4%) 11/168 (6.5%) 17/168 (10.1%) 15/167 (9%) 11/169 (6.5%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/Title Posting Director
Organization Novartis Vaccines and Diagnostics
Phone
Email RegContactVacUS.nvdit@Novartis.com
Responsible Party:
Novartis Vaccines
ClinicalTrials.gov Identifier:
NCT00972816
Other Study ID Numbers:
  • V112_02
First Posted:
Sep 9, 2009
Last Update Posted:
Apr 14, 2016
Last Verified:
Mar 1, 2016