Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    V112_04
Previous Study | Return to List | Next Study

Safety and Immunogenicity of A/H1N1-SOIV (Swine Flu) Vaccine With and Without Adjuvant in Children, Adolescents and Adults (3 to 64 Years)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00973700
Recruitment Status : Completed
First Posted : September 9, 2009
Results First Posted : May 23, 2011
Last Update Posted : December 2, 2015
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Novel 2009 Influenza H1N1
Interventions Biological: MF59-eH1N1_f
Biological: eH1N1_f
Enrollment 784
Recruitment Details Participants were enrolled at one center in Costa Rica.
Pre-assignment Details All enrolled subjects were included in the trial.
Arm/Group Title 2x7.5adj 7.5adj_1_8 7.5adj_1_22 15_1_22 2x15_1_22
Hide Arm/Group Description A/H1N1 7.5 mcg with MF59; two doses on day 1 A/H1N1 7.5 mcg with MF59; one dose on days 1 and 8 A/H1N1 7.5 mcg with MF59; one dose on days 1 and 22 A/H1N1 15 mcg no MF59; one dose on days 1 and 22 A/H1N1 15 mcg no MF59; two doses on days 1 and 22
Period Title: Overall Study
Started 56 56 168 336 168
Completed 49 54 158 318 158
Not Completed 7 2 10 18 10
Reason Not Completed
Withdrawal by Subject             2             2             8             4             4
Lost to Follow-up             5             0             1             8             5
Inappropriate enrolment             0             0             0             4             0
Unable to Classify             0             0             1             2             1
Arm/Group Title 2x7.5adj 7.5adj_1_8 7.5adj_1_22 15_1_22 2x15_1_22 Total
Hide Arm/Group Description A/H1N1 7.5 mcg with MF59; two doses on day 1 A/H1N1 7.5 mcg with MF59; one dose on days 1 and 8 A/H1N1 7.5 mcg with MF59; one dose on days 1 and 22 A/H1N1 15 mcg no MF59; one dose on days 1 and 22 A/H1N1 15 mcg no MF59; two doses on days 1 and 22 Total of all reporting groups
Overall Number of Baseline Participants 56 56 168 336 168 784
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized   [1] 
Measure Type: Number
Unit of measure:  Subjects
Number Analyzed 56 participants 56 participants 168 participants 336 participants 168 participants 784 participants
3 to < 9 years 0 0 56 84 56 196
9 to 17 years 0 0 56 84 56 196
18 to 64 years 56 56 56 168 56 392
[1]
Measure Description: The number of participants analyzed for each outcome measure below is not the same with the numbers provided in the participant flow module as this number is based on the age and/or the group analyses.
Sex/Gender, Customized  
Measure Type: Number
Unit of measure:  Subjects
Number Analyzed 56 participants 56 participants 168 participants 336 participants 168 participants 784 participants
Female (3 to <9 years) 0 0 29 46 23 98
Male (3 to < 9 years) 0 0 27 38 33 98
Female (9 to 17 years) 0 0 40 40 30 110
Male (9 to 17 years) 0 0 16 44 26 86
Female (18 to 64 years) 33 40 29 96 29 227
Male (18 to 64 years) 23 16 27 72 27 165
1.Primary Outcome
Title Percentage of Subjects With Seroconversion and HI Titer ≥1:40 in Children 3 to 17 Years of Age
Hide Description

Seroconversion: The percentage of subjects with either a pre-vaccination HI titer < 1:10 and a post-vaccination HI titer >1:40 or a prevaccination HI titer >1:10 and a minimum four-fold rise in post-vaccination HI antibody titer.

The analyses were performed on the Per-Protocol Set (PPS).

Time Frame Day 1 to day 387
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was done on the per-protocol set.
Arm/Group Title 15_1_22
Hide Arm/Group Description:
A/H1N1 15 mcg no MF59; one dose on days 1 and 22
Overall Number of Participants Analyzed 149
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentages of Subjects
HI Titer ≥40 on day 1
26
(19 to 33)
HI Titer ≥40 on day 22
83
(76 to 89)
HI Titer ≥40 on day 29
95
(91 to 98)
HI Titer ≥40 on day 43
92
(86 to 96)
HI Titer ≥40 on day 217 (N=129)
88
(81 to 93)
HI Titer ≥40 on day 387 (N=136)
80
(72 to 86)
Seroconversion on day 22
79
(71 to 85)
Seroconversion on day 29
92
(86 to 96)
Seroconversion on day 43
87
(81 to 92)
Seroconversion on day 217 (N=129)
71
(62 to 78)
Seroconversion on day 387 (N=136)
63
(54 to 71)
2.Primary Outcome
Title Percentage of Subjects With Seroconversion and HI Titer ≥ 1:40 in Adults 18 to 64 Years of Age
Hide Description

Seroconversion: The percentage of subjects with either a pre-vaccination HI titer < 1:10 and a post-vaccination HI titer >1:40 or a prevaccination HI titer >1:10 and a minimum four-fold rise in post-vaccination HI antibody titer.

Analyses were performed on the Per-Protocol set (PPS).

Time Frame Day 1 to day 387
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was done on the per-protocol set.
Arm/Group Title 15_1_22
Hide Arm/Group Description:
A/H1N1 on study days 1 and 22
Overall Number of Participants Analyzed 132
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentages of Subjects
HI Titer ≥40 on day 1
18
(12 to 26)
HI Titer ≥40 on day 8
93
(87 to 97)
HI Titer ≥40 on day 15
99
(96 to 100)
HI Titer ≥40 on day 22
98
(95 to 100)
HI Titer ≥40 on day 29
99
(96 to 100)
HI Titer ≥40 on Day 43
100
(97 to 100)
HI Titer ≥40 on Day 217 (N=111)
91
(84 to 96)
HI Titer ≥40 on Day 387 (N=120)
84
(76 to 90)
Seroconversion on day 8
86
(78 to 91)
Seroconversion on day 15
94
(88 to 97)
Seroconversion on day 22
94
(88 to 97)
Seroconversion on day 29
95
(90 to 98)
Seroconversion on day 43
95
(90 to 98)
Seroconversion on day 217 (N=111)
81
(73 to 88)
Seroconversion on day 387 (N=120)
75
(66 to 82)
3.Secondary Outcome
Title Age Distribution at Baseline
Hide Description [Not Specified]
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
The overall number of baseline participants.
Arm/Group Title 2x7.5adj 7.5adj_1_8 7.5adj_1_22 15_1_22 2x15_1_22
Hide Arm/Group Description:
A/H1N1 7.5 mcg with MF59; two doses on day 1
A/H1N1 7.5 mcg with MF59; two doses on day 1
A/H1N1 7.5 mcg with MF59; two doses on day 1
A/H1N1 7.5 mcg with MF59; two doses on day 1
A/H1N1 7.5 mcg with MF59; two doses on day 1
Overall Number of Participants Analyzed 56 56 168 336 168
Mean (Standard Deviation)
Unit of Measure: years
3 to <9 years (N=0, 0, 56, 84, 56) NA [1]   (NA) NA [1]   (NA) 5.5  (1.7) 5.7  (1.7) 5.4  (1.9)
9 to 17 years (N=0, 0, 56, 84, 56) NA [1]   (NA) NA [1]   (NA) 13.1  (2.5) 12.8  (2.3) 13.1  (2.5)
18 to 64 years (N= 56, 56, 56, 168, 56) 35.1  (10.8) 38.6  (11.1) 37.3  (11.2) 37.0  (11.7) 37.4  (11.0)
[1]
Not Applicable (NA) as 0 subjects were in this category.
4.Secondary Outcome
Title Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in 3 to <9 Years and 9 to 17 Years
Hide Description

Seroconversion: The percentage of subjects with either a pre-vaccination HI titer < 1:10 and a post-vaccination HI titer >1:40 or a prevaccination HI titer >1:10 and a minimum four-fold rise in post-vaccination HI antibody titer.

The analyses were performed on the Per-Protocol Set (PPS).

Time Frame Day 1 to day 387
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis is done on the per-protocol set.
Arm/Group Title 7.5adj_1_22 15_1_22 2x15_1_22
Hide Arm/Group Description:
A/H1N1 7.5 mcg with MF59; one dose on days 1 and 22
A/H1N1 15 mcg no MF59; one dose on days 1 and 22
A/H1N1 15 mcg no MF59; two doses on days 1 and 22
Overall Number of Participants Analyzed 91 149 99
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentages of Subjects
HI Titer ≥40 on day 1 (3 to <9 yrs; N=46,75,47)
24
(13 to 39)
23
(14 to 34)
23
(12 to 38)
HI Titer ≥40 on day 22 (3 to <9 yrs; N=46,75,47)
93
(82 to 99)
71
(59 to 81)
79
(64 to 89)
HI Titer ≥40 on day 29 (3 to < 9 yrs; N=46,75,47)
100
(92 to 100)
92
(83 to 97)
96
(85 to 99)
HI Titer ≥40 on day 43 (3 to < 9 yrs; N=46,75,47)
100
(92 to 100)
85
(75 to 92)
96
(85 to 99)
HI Titer ≥40 on day 217 (3 to < 9 yrs; N=41,66,40)
100
(91 to 100)
80
(69 to 89)
78
(62 to 89)
HI Titer ≥40 on day 387 (3 to < 9 yrs; N=43,70,42)
93
(81 to 99)
73
(61 to 83)
62
(46 to 76)
Seroconversion on day 22 (3 to <9 yrs; N=46,75,47)
91
(79 to 98)
69
(58 to 79)
79
(64 to 89)
Seroconversion on day 29 (3 to <9 yrs; N=46,75,47)
98
(88 to 100)
92
(83 to 97)
96
(85 to 99)
Seroconversion on day 43 (3 to <9 yrs; N=46,75,47)
96
(85 to 99)
84
(74 to 91)
94
(82 to 99)
Seroconversion on day 217 (3 to <9 yrs;N=41,66,40)
88
(74 to 96)
65
(52 to 76)
65
(48 to 79)
Seroconversion on day 387 (3 to <9 yrs;N=43,70,42)
77
(61 to 88)
56
(43 to 68)
50
(34 to 66)
HI Titer ≥40 on day 1 (9 to 17 yrs;N=45,74,52)
42
(28 to 58)
28
(19 to 40)
33
(20 to 47)
HI Titer ≥40 on day 22 (9 to 17 yrs; N=45,74,52)
98
(88 to 100)
96
(89 to 99)
100
(93 to 100)
HI Titer ≥40 on day 29 (9 to 17 yrs; N=45,74,52)
100
(92 to 100)
99
(93 to 100)
100
(93 to 100)
HI Titer ≥40 on day 43 (9 to 17 yrs; N=45,74,52)
100
(92 to 100)
99
(93 to 100)
100
(93 to 100)
HI Titer ≥40 on day 217 (9 to 17 yrs; N=37,63,45)
100
(91 to 100)
95
(87 to 99)
98
(88 to 100)
HI Titer ≥40 on day 387 (9 to 17 yrs; N=37,66,47)
89
(75 to 97)
88
(78 to 95)
89
(77 to 96)
Seroconversion on day 22 (9 to 17 yrs; N=45,74,52)
87
(73 to 95)
88
(78 to 94)
94
(84 to 99)
Seroconversion on day 29 (9 to 17 yrs; N=45,74,52)
89
(76 to 96)
92
(83 to 97)
94
(84 to 99)
Seroconversion on day 43 (9 to 17 yrs; N=45,74,52)
84
(71 to 94)
91
(81 to 96)
92
(81 to 98)
Seroconversion on day 217 (9 to 17 yrs;N=37,63,45)
68
(50 to 82)
76
(64 to 86)
76
(60 to 87)
Seroconversion on day 387 (9 to 17 yrs;N=37,66,47)
59
(42 to 75)
70
(57 to 80)
70
(55 to 83)
5.Secondary Outcome
Title HI GMRs, in 3 to <9 Years and 9 to 17 Years
Hide Description

Geometric Mean Ratios (GMRs) of hemagglutination inhibition (HI) antibody assay (ratio of post-vaccination versus pre-vaccination HI titers).

The analyses were performed on the the per-protocol set (PPS).

Time Frame Day 1 to day 387
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis is done on the per-protocol set.
Arm/Group Title 7.5adj_1_22 15_1_22 2x15_1_22
Hide Arm/Group Description:
A/H1N1 7.5 mcg with MF59; one dose on days 1 and 22
A/H1N1 15 mcg no MF59; one dose on days 1 and 22
A/H1N1 15 mcg no MF59; two doses on days 1 and 22
Overall Number of Participants Analyzed 91 149 99
Geometric Mean (95% Confidence Interval)
Unit of Measure: Ratio
GMR on day 22 (3 to < 9 yrs; N=46,75,47)
31
(19 to 50)
12
(8.51 to 18)
16
(10 to 26)
GMR on day 29 (3 to < 9 yrs; N=46,75,47)
169
(110 to 260)
35
(24 to 49)
53
(35 to 82)
GMR on day 43 (3 to < 9 yrs; N=46,75,47)
120
(75 to 192)
22
(15 to 32)
44
(27 to 69)
GMR on day 217 (3 to <9 yrs; N=41,66,40)
19
(12 to 30)
7.79
(5.46 to 11)
8.07
(5.11 to 13)
GMR on day 387 (3 to <9 yrs; N=43,70,42)
14
(8.27 to 24)
6.9
(4.58 to 10)
5.94
(3.5 to 10)
GMR on day 22 (9 to 17 yrs; N=45,74,52)
42
(24 to 74)
52
(34 to 81)
66
(39 to 111)
GMR on day 29 (9 to 17 yrs; N=45,74,52)
63
(36 to 109)
70
(45 to 108)
79
(47 to 132)
GMR on day 43 (9 to 17 yrs; N=45,74,52)
44
(25 to 77)
48
(31 to 75)
59
(35 to 100)
GMR on day 217 (9 to 17 yrs; N=37,63,45)
10
(5.66 to 18)
17
(11 to 26)
13
(7.92 to 23)
GMR on day 387 (9 to 17 yrs; N=37,66,47)
7.22
(3.77 to 14)
16
(9.53 to 25)
13
(7.53 to 24)
6.Secondary Outcome
Title HI GMR, in Adults 18 to 64 Years
Hide Description

Geometric Mean Ratios (GMRs) of hemagglutination inhibition (HI) antibody assay (ratio of post-vaccination versus pre-vaccination HI titers).

The analyses were performed on the Per-Protocol Set (PPS).

Time Frame Day 1 to day 387
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis is done on the per-protocol set.
Arm/Group Title 2x7.5adj 7.5adj_1_8 7.5adj_1_22 15_1_22 2x15_1_22
Hide Arm/Group Description:
A/H1N1 7.5 mcg with MF59; two doses on day 1
A/H1N1 7.5 mcg with MF59; one dose on days 1 and 8
A/H1N1 7.5 mcg with MF59; one dose on days 1 and 22
A/H1N1 15 mcg no MF59; one dose on days 1 and 22
A/H1N1 15 mcg no MF59; two doses on days 1 and 22
Overall Number of Participants Analyzed 41 45 45 132 47
Geometric Mean (95% Confidence Interval)
Unit of Measure: Ratio
GMR on day 8
48
(28 to 85)
35
(21 to 60)
57
(33 to 97)
43
(32 to 59)
63
(37 to 106)
GMR on day 15
115
(70 to 189)
181
(113 to 292)
200
(124 to 322)
138
(104 to 182)
123
(77 to 197)
GMR on day 22
79
(48 to 130)
100
(63 to 160)
123
(77 to 197)
85
(64 to 111)
72
(45 to 113)
GMR on day 29
56
(35 to 89)
76
(49 to 118)
160
(103 to 248)
83
(64 to 107)
66
(43 to 101)
GMR on day 43
44
(27 to 71)
64
(40 to 101)
101
(63 to 161)
76
(58 to 100)
65
(41 to 102)
GMR on day (N=0,0,35,111,34)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
30
(18 to 48)
16
(12 to 20)
16
(10 to 27)
GMR on day 387 (N=38,40,38,120,42)
6.61
(3.92 to 11)
11
(6.81 to 19)
21
(12 to 36)
12
(8.99 to 16)
9.21
(5.61 to 15)
[1]
Zero subjects were enrolled in this group.
7.Secondary Outcome
Title Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in Adults 18 to 64 Years
Hide Description

Seroconversion: The percentage of subjects with either a pre-vaccination HI titer < 1:10 and a post-vaccination HI titer >1:40 or a prevaccination HI titer >1:10 and a minimum four-fold rise in post-vaccination HI antibody titer.

The analyses were performed on the per-protocol set (PPS).

Time Frame 7 days and 21 days after each vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis is done on the per-protocol set.
Arm/Group Title 2x7.5adj 7.5adj_1_8 7.5adj_1_22 15_1_22 2x15_1_22
Hide Arm/Group Description:
A/H1N1 7.5 mcg with MF59; two doses on day 1
A/H1N1 7.5 mcg with MF59; one dose on days 1 and 8
A/H1N1 7.5 mcg with MF59; one dose on days 1 and 22
A/H1N1 15 mcg no MF59; one dose on days 1 and 22
A/H1N1 15 mcg no MF59; two doses on days 1 and 22
Overall Number of Participants Analyzed 41 45 45 132 47
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentages of Subjects
HI Titer ≥40 on day 8
100
(91 to 100)
91
(79 to 98)
96
(85 to 99)
93
(87 to 97)
96
(85 to 99)
HI Titer ≥40 on day 15
100
(91 to 100)
100
(92 to 100)
98
(88 to 100)
99
(96 to 100)
100
(92 to 100)
HI Titer ≥40 on day 22
100
(91 to 100)
98
(88 to 100)
98
(88 to 100)
98
(95 to 100)
98
(89 to 100)
HI Titer ≥40 on day 29
100
(91 to 100)
98
(88 to 100)
100
(92 to 100)
99
(96 to 100)
100
(92 to 100)
HI Titer ≥40 on day 43
98
(87 to 100)
100
(92 to 100)
98
(88 to 100)
100
(97 to 100)
100
(92 to 100)
HI Titer ≥40 on day 217 (N=0,0,35,111,34)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
97
(85 to 100)
91
(84 to 96)
97
(85 to 100)
HI Titer ≥40 on day 387 (N=38,40,38,120,42)
76
(60 to 89)
90
(76 to 97)
92
(79 to 98)
84
(76 to 90)
83
(69 to 93)
Seroconversion on day 8
95
(83 to 99)
80
(65 to 90)
93
(82 to 99)
86
(78 to 91)
94
(82 to 99)
Seroconversion on day 15
98
(87 to 100)
100
(92 to 100)
98
(88 to 100)
94
(88 to 97)
98
(89 to 100)
Seroconversion on day 22
95
(83 to 99)
91
(79 to 98)
96
(85 to 99)
94
(88 to 97)
96
(85 to 99)
Seroconversion on day 29
95
(83 to 99)
93
(82 to 99)
98
(88 to 100)
95
(90 to 98)
98
(89 to 100)
Seroconversion on day 43
85
(71 to 94)
93
(82 to 99)
96
(85 to 99)
95
(90 to 98)
98
(89 to 100)
Seroconversion on day 217 (N=0,0,35,111,34)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
94
(81 to 99)
81
(73 to 88)
88
(73 to 97)
Seroconversion on day 387 (N=38,40,38,120,42)
66
(49 to 80)
80
(64 to 91)
87
(72 to 96)
75
(66 to 82)
69
(53 to 82)
HI Titer ≥40 on day 1
20
(9 to 35)
22
(11 to 37)
13
(5 to 27)
18
(12 to 26)
21
(11 to 36)
[1]
No subjects were analyzed for this group.
8.Secondary Outcome
Title Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age
Hide Description

Number of subjects with specified solicited local and systemic reactions in adult subjects (3 to <9 years of age).

Postvac: postvaccination; Analges: analgesics; Antipyr: antipyretics. The analyses were performed on the safety set. Note: 1) postvac 1 = after the first vaccination and 2) postvac 2 = after the second vaccination

Time Frame 7 days after each vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis is done on the safety set.
Arm/Group Title 7.5adj_1_22 15_1_22 2x15_1_22
Hide Arm/Group Description:
A/H1N1 7.5 mcg with MF59; one dose on days 1 and 22
A/H1N1 15 mcg no MF59; one dose on days 1 and 22
A/H1N1 15 mcg no MF59; two doses on days 1 and 22
Overall Number of Participants Analyzed 55 84 54
Measure Type: Number
Unit of Measure: Number of subjects
Local Reactions postvac. 1 25 31 20
Erythema postvac. 1 1 0 0
Induration postvac. 1 0 3 1
Swelling postvac. 1 3 4 3
Tenderness postvac. 1 21 23 17
Pain postvac. 1 21 25 17
Systemic Reaction postvac. 1 24 28 17
Headache postvac. 1 7 12 9
Fatigue postvac. 1 6 8 5
Myalgia postvac. 1 4 8 6
Arthralgia postvac. 1 0 2 2
Chills postvac. 1 3 1 2
Nausea postvac. 1 5 7 4
Vomiting postvac. 1 0 1 2
Diarrhea postvac. 1 0 0 1
Other Reactions postvac. 1 10 10 6
Analges/Antipyr Used postvac. 1 (N=55, 83, 54) 9 8 6
Stayed Home postvac.1(N=55,83,54) 1 2 0
Body Temp > 40 C postvac.1 0 0 0
Local Reactions postvac. 2 (N=55, 83, 54) 20 29 21
Erythema postvac. 2 (N=55, 83, 54) 3 1 1
Induration postvac. 2 (N=55, 83, 54) 8 1 2
Swelling postvac. 2 (N=55, 83, 54) 8 0 2
Tenderness postvac. 2 (N=55, 83, 54) 15 27 16
Pain postvac. 2 (N=55, 83, 54) 18 23 19
Systemic Reaction postvac. 2 (N=55, 83, 54) 13 22 18
Headache postvac. 2 (N=55, 83, 54) 5 12 3
Fatigue postvac. 2 (N=55, 83, 54) 1 5 2
Myalgia postvac. 2 (N=55, 83, 54) 3 2 5
Arthralgia postvac. 2 (N=55, 83, 54) 0 2 5
Chills postvac. 2 (N=55, 83, 54) 2 2 1
Nausea postvac. 2 (N=55, 83, 54) 5 5 1
Vomiting postvac. 2 (N=55, 83, 54) 0 1 3
Diarrhea postvac. 2 (N=55, 83, 54) 0 1 2
Other Reactions postvac. 2 (N=55, 82, 54) 5 7 7
Analges/Antipyr Used postvac. 2 (N=55, 83, 54) 4 6 7
Stayed Home postvac. 2 (N=55, 82, 54) 1 2 0
Body Temp > 40 C postvac. 2 (N=55, 83, 54) 0 0 0
9.Secondary Outcome
Title Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age
Hide Description

Number of subjects with specified solicited local and systemic reactions in adult subjects (9 to 17 years of age).

Postvac: postvaccination Analges: analgesics Antipyr: antipyretics The analyses were performed on the safety set.

Note: 1) postvac 1 = after the first vaccination and 2) postvac 2 = after the second vaccination.

Time Frame 7 days after each vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis is done on the safety set.
Arm/Group Title 7.5adj_1_22 15_1_22 2x15_1_22
Hide Arm/Group Description:
A/H1N1 7.5 mcg with MF59; one dose on days 1 and 22
A/H1N1 15 mcg no MF59; one dose on days 1 and 22
A/H1N1 15 mcg no MF59; two doses on days 1 and 22
Overall Number of Participants Analyzed 53 84 57
Measure Type: Number
Unit of Measure: Number of subjects
Local Reactions postvac. 1 37 36 29
Erythema postvac. 1 1 1 0
Induration postvac. 1 1 6 1
Swelling postvac. 1 1 4 3
Tenderness postvac. 1 26 23 21
Pain postvac. 1 32 30 25
Systemic Reaction postvac. 1 24 36 16
Headache postvac. 1 17 20 8
Fatigue postvac. 1 9 13 11
Myalgia postvac. 1 11 15 11
Arthralgia postvac. 1 2 2 0
Chills postvac. 1 1 2 1
Nausea postvac. 1 3 7 5
Vomiting postvac. 1 0 1 0
Diarrhea postvac. 1 2 0 0
Other Reactions postvac. 1 11 10 8
Analgesic/Antipyretic Used postvac. 1 10 10 7
Stayed Home postvac. 1 2 1 2
Body Temp > 40 C postvac. 1 0 0 0
Local Reactions postvac. 2 (N=52, 84, 55) 31 36 27
Erythema postvac. 2 (N=52, 84, 55) 0 3 1
Induration postvac. 2 (N=52, 84, 55) 2 3 4
Swelling postvac. 2 (N=52, 84, 55) 2 5 3
Tenderness postvac. 2 (N=52, 84, 55) 20 25 25
Pain postvac. 2 (N=52, 84, 55) 27 30 26
Systemic Reaction postvac. 2 (N=52, 84, 55) 18 29 14
Headache postvac. 2 (N=52, 84, 55) 12 16 8
Fatigue postvac. 2 (N=52, 84, 55) 3 6 9
Myalgia postvac. 2 (N=52, 84, 55) 8 9 7
Arthralgia postvac. 2 (N=52, 84, 55) 0 4 4
Chills postvac. 2 (N=52, 84, 55) 2 2 3
Nausea postvac. 2 (N=52, 84, 55) 3 7 2
Vomiting postvac. 2 (N=52, 84, 55) 1 0 0
Diarrhea postvac. 2 (N=52, 84, 55) 2 3 0
Other Reactions postvac. 2 (N=52, 84, 55) 1 10 4
Analges/Antipyr Used postvac. 2 (N=52, 84, 55) 1 9 4
Stayed Home postvac. 2 (N=52, 84, 55) 0 1 0
Body Temp > 40 C postvac. 2 (N=52, 84, 55) 0 0 0
10.Secondary Outcome
Title Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age
Hide Description

Number of subjects with specified solicited local and systemic reactions in adult subjects (18 to 64 years of age).

Note: 1) postvac. 1 = after the first vaccination and 2) postvac. 2 = after the second vaccination.

The analyses were performed on the safety set.

Time Frame 7 days after each vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis is done on the safety set.
Arm/Group Title 2x7.5adj 7.5adj_1_8 7.5adj_1_22 15_1_22 2x15_1_22
Hide Arm/Group Description:
A/H1N1 7.5 mcg with MF59; two doses on day 1
A/H1N1 7.5 mcg with MF59; one dose on days 1 and 8
A/H1N1 7.5 mcg with MF59; one dose on days 1 and 22
A/H1N1 15 mcg no MF59; one dose on days 1 and 22
A/H1N1 15 mcg no MF59; two doses on days 1 and 22
Overall Number of Participants Analyzed 54 56 56 159 54
Measure Type: Number
Unit of Measure: Number of subjects
Local Reactions postvac. 1 39 26 38 56 19
Erythema postvac. 1 3 0 2 2 1
Induration postvac. 1 5 4 5 6 3
Swelling postvac. 1 3 3 5 4 2
Tenderness postvac. 1 33 21 26 35 14
Pain postvac. 1 36 23 32 41 16
Systemic Reaction postvac. 1 34 31 31 71 22
Headache postvac. 1 26 18 22 42 12
Fatigue postvac. 1 17 16 16 32 15
Myalgia postvac. 1 21 13 16 28 12
Arthralgia postvac. 1 4 1 6 10 2
Chills postvac. 1 4 3 6 6 4
Nausea postvac. 1 7 9 8 16 13
Vomiting postvac. 1 0 0 0 1 1
Diarrhea postvac. 1 2 1 0 8 3
Other Reactions postvac. 1 14 7 12 13 5
Analgesic/Antipyretic Used postvac. 1 14 6 12 13 4
Stayed Home postvac. 1 (N=53,55,56,157,54) 2 1 2 0 1
Body Temp > 40 C postvac. 1 0 0 0 0 0
Local Reactions postvac. 2 (N=0,55,56,158,53) 0 21 28 56 17
Erythema postvac. 2 (N=0,55,56,158,53) 0 1 2 5 1
Induration postvac. 2 (N=0,55,56,158,53) 0 3 4 4 3
Swelling postvac. 2 (N=0,55,56,158,53) 0 2 5 7 5
Tenderness postvac. 2 (N=0,55,56,157853) 0 16 24 48 16
Pain postvac. 2 (N=0,55,56,158,53) 0 19 24 45 15
Systemic Reaction postvac. 2 (N=0,55,56,158,53) 0 26 28 53 14
Headache postvac. 2 (N=0,55,56,158, 53) 0 18 18 25 11
Fatigue postvac. 2 (N=0,55,56,158, 53) 0 14 13 24 10
Myalgia postvac. 2 (N=0,55,56,158, 53) 0 9 14 26 7
Arthralgia postvac. 2 (N=0,55,56,158, 53) 0 5 7 16 4
Chills postvac. 2 (N=0,55,56,158, 53) 0 8 5 5 8
Nausea postvac. 2 (N=0,55,56,158, 53) 0 8 5 7 3
Vomiting postvac. 2 (N=0,55,56,158, 53) 0 1 0 2 1
Diarrhea postvac. 2 (N=0,55,56,158, 53) 0 1 0 4 1
Other Reactions postvac. 2 (N=0,55,56,158, 53) 0 8 7 11 7
Analgesi/Antipyr Used postvac 2 (N=0,55,56,158,53) 0 7 7 11 6
Stayed Home postvaccination 2 (N=0,53,0,156,53) 0 2 0 1 2
Body Temp > 40 C postvac. 2 (N=0,55,56,158,53) 0 0 0 1 0
Time Frame All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387).
Adverse Event Reporting Description Data provided in Other Adverse Events (>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.
 
Arm/Group Title 2x7.5adj (18 to 64 Yrs) 7.5adj_1_8 (18 to 64 Yrs) 7.5adj_1_22 (18-64 Yrs) 15_1_22 (18 to 64 Yrs) 2x15_1_22 (18 to 64 Yrs) 7.5adj_1_22 (9 to 17 Yrs) 15_1_22 (9 to 17 Yrs) 2x15_1_22 (9 to 17 Yrs) 7.5adj_1_22 (3 to <9 Yrs) 15_1_22 (3 to <9 Yrs) 2x15_1_22 (3 to <9 Yrs)
Hide Arm/Group Description A/H1N1 7.5 mcg with MF59; two doses on day 1 A/H1N1 7.5 mcg with MF59; one dose on days 1 and 8 A/H1N1 7.5 mcg with MF59; one dose on days 1 and 22 A/H1N1 15 mcg no MF59; one dose on days 1 and 22 A/H1N1 15 mcg no MF59; two doses on days 1 and 22 A/H1N1 7.5 mcg with MF59; one dose on days 1 and 22 A/H1N1 15 mcg no MF59; one dose on days 1 and 22 A/H1N1 15 mcg no MF59; two doses on days 1 and 22 A/H1N1 7.5 mcg with MF59; one dose on days 1 and 22 A/H1N1 15 mcg no MF59; one dose on days 1 and 22 A/H1N1 15 mcg no MF59; two doses on days 1 and 22
All-Cause Mortality
2x7.5adj (18 to 64 Yrs) 7.5adj_1_8 (18 to 64 Yrs) 7.5adj_1_22 (18-64 Yrs) 15_1_22 (18 to 64 Yrs) 2x15_1_22 (18 to 64 Yrs) 7.5adj_1_22 (9 to 17 Yrs) 15_1_22 (9 to 17 Yrs) 2x15_1_22 (9 to 17 Yrs) 7.5adj_1_22 (3 to <9 Yrs) 15_1_22 (3 to <9 Yrs) 2x15_1_22 (3 to <9 Yrs)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--      --/--      --/--      --/--      --/--      --/--      --/--    
Hide Serious Adverse Events
2x7.5adj (18 to 64 Yrs) 7.5adj_1_8 (18 to 64 Yrs) 7.5adj_1_22 (18-64 Yrs) 15_1_22 (18 to 64 Yrs) 2x15_1_22 (18 to 64 Yrs) 7.5adj_1_22 (9 to 17 Yrs) 15_1_22 (9 to 17 Yrs) 2x15_1_22 (9 to 17 Yrs) 7.5adj_1_22 (3 to <9 Yrs) 15_1_22 (3 to <9 Yrs) 2x15_1_22 (3 to <9 Yrs)
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 Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/54 (3.70%)      0/56 (0.00%)      1/56 (1.79%)      4/159 (2.52%)      1/54 (1.85%)      1/53 (1.89%)      1/84 (1.19%)      0/57 (0.00%)      2/55 (3.64%)      0/84 (0.00%)      0/54 (0.00%)    
Endocrine disorders                       
Precocious Puberty * 1  0/54 (0.00%)  0 0/56 (0.00%)  0 0/56 (0.00%)  0 0/159 (0.00%)  0 0/54 (0.00%)  0 0/53 (0.00%)  0 0/84 (0.00%)  0 0/57 (0.00%)  0 1/55 (1.82%)  1 0/84 (0.00%)  0 0/54 (0.00%)  0
Gastrointestinal disorders                       
abdominal pain  1  0/54 (0.00%)  0 0/56 (0.00%)  0 0/56 (0.00%)  0 0/159 (0.00%)  0 0/54 (0.00%)  0 1/53 (1.89%)  1 0/84 (0.00%)  0 0/57 (0.00%)  0 0/55 (0.00%)  0 0/84 (0.00%)  0 0/54 (0.00%)  0
Infections and infestations                       
appendicitis * 1  0/54 (0.00%)  0 0/56 (0.00%)  0 0/56 (0.00%)  0 0/159 (0.00%)  0 0/54 (0.00%)  0 0/53 (0.00%)  0 1/84 (1.19%)  1 0/57 (0.00%)  0 0/55 (0.00%)  0 0/84 (0.00%)  0 0/54 (0.00%)  0
urinary tract infection * 1  1/54 (1.85%)  1 0/56 (0.00%)  0 0/56 (0.00%)  0 0/159 (0.00%)  0 0/54 (0.00%)  0 0/53 (0.00%)  0 0/84 (0.00%)  0 0/57 (0.00%)  0 0/55 (0.00%)  0 0/84 (0.00%)  0 0/54 (0.00%)  0
Musculoskeletal and connective tissue disorders                       
intervertebral disc protrusion * 1  0/54 (0.00%)  0 0/56 (0.00%)  0 0/56 (0.00%)  0 1/159 (0.63%)  1 0/54 (0.00%)  0 0/53 (0.00%)  0 0/84 (0.00%)  0 0/57 (0.00%)  0 0/55 (0.00%)  0 0/84 (0.00%)  0 0/54 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)                       
brain neoplasm * 1  0/54 (0.00%)  0 0/56 (0.00%)  0 1/56 (1.79%)  1 0/159 (0.00%)  0 0/54 (0.00%)  0 0/53 (0.00%)  0 0/84 (0.00%)  0 0/57 (0.00%)  0 0/55 (0.00%)  0 0/84 (0.00%)  0 0/54 (0.00%)  0
breast cancer  1  1/54 (1.85%)  1 0/56 (0.00%)  0 0/56 (0.00%)  0 0/159 (0.00%)  0 0/54 (0.00%)  0 0/53 (0.00%)  0 0/84 (0.00%)  0 0/57 (0.00%)  0 0/55 (0.00%)  0 0/84 (0.00%)  0 0/54 (0.00%)  0
Pregnancy, puerperium and perinatal conditions                       
abortion threatened * 1  1/54 (1.85%)  1 0/56 (0.00%)  0 0/56 (0.00%)  0 0/159 (0.00%)  0 0/54 (0.00%)  0 0/53 (0.00%)  0 0/84 (0.00%)  0 0/57 (0.00%)  0 0/55 (0.00%)  0 0/84 (0.00%)  0 0/54 (0.00%)  0
high risk pregnancy * 1  1/54 (1.85%)  1 0/56 (0.00%)  0 0/56 (0.00%)  0 0/159 (0.00%)  0 0/54 (0.00%)  0 0/53 (0.00%)  0 0/84 (0.00%)  0 0/57 (0.00%)  0 0/55 (0.00%)  0 0/84 (0.00%)  0 0/54 (0.00%)  0
Renal and urinary disorders                       
nephrolithiasis * 1  0/54 (0.00%)  0 0/56 (0.00%)  0 0/56 (0.00%)  0 1/159 (0.63%)  1 0/54 (0.00%)  0 0/53 (0.00%)  0 0/84 (0.00%)  0 0/57 (0.00%)  0 0/55 (0.00%)  0 0/84 (0.00%)  0 0/54 (0.00%)  0
Reproductive system and breast disorders                       
uterine haemorrhage * 1  0/54 (0.00%)  0 0/56 (0.00%)  0 0/56 (0.00%)  0 1/159 (0.63%)  1 0/54 (0.00%)  0 0/53 (0.00%)  0 0/84 (0.00%)  0 0/57 (0.00%)  0 0/55 (0.00%)  0 0/84 (0.00%)  0 0/54 (0.00%)  0
Social circumstances                       
sexual abuse * 1  0/54 (0.00%)  0 0/56 (0.00%)  0 0/56 (0.00%)  0 0/159 (0.00%)  0 0/54 (0.00%)  0 0/53 (0.00%)  0 0/84 (0.00%)  0 0/57 (0.00%)  0 1/55 (1.82%)  1 0/84 (0.00%)  0 0/54 (0.00%)  0
Surgical and medical procedures                       
rhinoplasty * 1 [1]  0/54 (0.00%)  0 0/56 (0.00%)  0 0/56 (0.00%)  0 0/159 (0.00%)  0 1/54 (1.85%)  1 0/53 (0.00%)  0 0/84 (0.00%)  0 0/57 (0.00%)  0 0/55 (0.00%)  0 0/84 (0.00%)  0 0/54 (0.00%)  0
hysterectomy * 1  0/54 (0.00%)  0 0/56 (0.00%)  0 0/56 (0.00%)  0 1/159 (0.63%)  1 0/54 (0.00%)  0 0/53 (0.00%)  0 0/84 (0.00%)  0 0/57 (0.00%)  0 0/55 (0.00%)  0 0/84 (0.00%)  0 0/54 (0.00%)  0
inguinal hernia repair * 1  0/54 (0.00%)  0 0/56 (0.00%)  0 0/56 (0.00%)  0 1/159 (0.63%)  1 0/54 (0.00%)  0 0/53 (0.00%)  0 0/84 (0.00%)  0 0/57 (0.00%)  0 0/55 (0.00%)  0 0/84 (0.00%)  0 0/54 (0.00%)  0
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 17.1
[1]
This AE was reported in the Adults (18 to 64 years of age) under group 2x15_1_22.
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
2x7.5adj (18 to 64 Yrs) 7.5adj_1_8 (18 to 64 Yrs) 7.5adj_1_22 (18-64 Yrs) 15_1_22 (18 to 64 Yrs) 2x15_1_22 (18 to 64 Yrs) 7.5adj_1_22 (9 to 17 Yrs) 15_1_22 (9 to 17 Yrs) 2x15_1_22 (9 to 17 Yrs) 7.5adj_1_22 (3 to <9 Yrs) 15_1_22 (3 to <9 Yrs) 2x15_1_22 (3 to <9 Yrs)
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 Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   49/54 (90.74%)      41/56 (73.21%)      48/56 (85.71%)      119/159 (74.84%)      35/54 (64.81%)      46/53 (86.79%)      67/84 (79.76%)      43/57 (75.44%)      40/55 (72.73%)      61/84 (72.62%)      41/54 (75.93%)    
Gastrointestinal disorders                       
nausea  1  7/54 (12.96%)  7 13/56 (23.21%)  23 11/56 (19.64%)  17 21/159 (13.21%)  28 5/54 (9.26%)  8 6/53 (11.32%)  6 12/84 (14.29%)  16 6/57 (10.53%)  11 8/55 (14.55%)  10 10/84 (11.90%)  14 5/54 (9.26%)  5
vomiting  1  0/54 (0.00%)  0 1/56 (1.79%)  1 0/56 (0.00%)  0 3/159 (1.89%)  5 1/54 (1.85%)  2 1/53 (1.89%)  1 3/84 (3.57%)  3 1/57 (1.75%)  1 0/55 (0.00%)  0 2/84 (2.38%)  2 5/54 (9.26%)  5
diarrhea  1  2/54 (3.70%)  2 2/56 (3.57%)  4 1/56 (1.79%)  1 13/159 (8.18%)  13 3/54 (5.56%)  5 4/53 (7.55%)  4 5/84 (5.95%)  5 0/57 (0.00%)  0 1/55 (1.82%)  1 3/84 (3.57%)  3 5/54 (9.26%)  5
General disorders                       
injection site erythema  1  3/54 (5.56%)  5 1/56 (1.79%)  1 3/56 (5.36%)  4 6/159 (3.77%)  7 2/54 (3.70%)  3 1/53 (1.89%)  1 4/84 (4.76%)  4 1/57 (1.75%)  1 3/55 (5.45%)  4 1/84 (1.19%)  1 1/54 (1.85%)  1
injection site pain  1  39/54 (72.22%)  130 31/56 (55.36%)  79 42/56 (75.00%)  113 79/159 (49.69%)  173 23/54 (42.59%)  108 42/53 (79.25%)  116 52/84 (61.90%)  117 37/57 (64.91%)  160 32/55 (58.18%)  75 43/84 (51.19%)  102 29/54 (53.70%)  116
injection site swelling  1  1/54 (1.85%)  2 2/56 (3.57%)  2 2/56 (3.57%)  2 5/159 (3.14%)  5 2/54 (3.70%)  2 1/53 (1.89%)  1 2/84 (2.38%)  2 1/57 (1.75%)  1 3/55 (5.45%)  3 2/84 (2.38%)  2 2/54 (3.70%)  2
pyrexia  1  2/54 (3.70%)  2 4/56 (7.14%)  5 6/56 (10.71%)  8 12/159 (7.55%)  13 2/54 (3.70%)  2 3/53 (5.66%)  4 3/84 (3.57%)  3 6/57 (10.53%)  8 8/55 (14.55%)  8 10/84 (11.90%)  13 10/54 (18.52%)  12
fatigue  1  17/54 (31.48%)  20 20/56 (35.71%)  34 21/56 (37.50%)  36 45/159 (28.30%)  73 18/54 (33.33%)  30 11/53 (20.75%)  13 15/84 (17.86%)  23 14/57 (24.56%)  26 6/55 (10.91%)  7 11/84 (13.10%)  16 6/54 (11.11%)  9
chills  1  4/54 (7.41%)  5 9/56 (16.07%)  11 8/56 (14.29%)  12 10/159 (6.29%)  12 11/54 (20.37%)  14 3/53 (5.66%)  3 4/84 (4.76%)  4 4/57 (7.02%)  5 4/55 (7.27%)  6 2/84 (2.38%)  3 2/54 (3.70%)  3
Infections and infestations                       
nasopharyngitis * 1  10/54 (18.52%)  11 6/56 (10.71%)  7 8/56 (14.29%)  8 24/159 (15.09%)  26 6/54 (11.11%)  7 7/53 (13.21%)  7 12/84 (14.29%)  15 11/57 (19.30%)  12 4/55 (7.27%)  6 17/84 (20.24%)  20 11/54 (20.37%)  15
upper respiratory tract infection * 1  1/54 (1.85%)  1 2/56 (3.57%)  2 5/56 (8.93%)  6 6/159 (3.77%)  7 0/54 (0.00%)  0 1/53 (1.89%)  1 3/84 (3.57%)  3 3/57 (5.26%)  3 4/55 (7.27%)  5 7/84 (8.33%)  9 6/54 (11.11%)  7
tonsillitis * 1  1/54 (1.85%)  1 0/56 (0.00%)  0 0/56 (0.00%)  0 0/159 (0.00%)  0 0/54 (0.00%)  0 0/53 (0.00%)  0 0/84 (0.00%)  0 0/57 (0.00%)  0 3/55 (5.45%)  4 3/84 (3.57%)  3 6/54 (11.11%)  6
varicella * 1  0/54 (0.00%)  0 0/56 (0.00%)  0 0/56 (0.00%)  0 0/159 (0.00%)  0 0/54 (0.00%)  0 0/53 (0.00%)  0 0/84 (0.00%)  0 0/57 (0.00%)  0 1/55 (1.82%)  1 0/84 (0.00%)  0 3/54 (5.56%)  3
Musculoskeletal and connective tissue disorders                       
myalgia  1  21/54 (38.89%)  28 17/56 (30.36%)  25 21/56 (37.50%)  34 42/159 (26.42%)  73 17/54 (31.48%)  22 18/53 (33.96%)  22 20/84 (23.81%)  26 14/57 (24.56%)  22 5/55 (9.09%)  8 10/84 (11.90%)  12 9/54 (16.67%)  13
arthralgia  1  4/54 (7.41%)  4 6/56 (10.71%)  6 10/56 (17.86%)  14 24/159 (15.09%)  32 4/54 (7.41%)  7 2/53 (3.77%)  2 5/84 (5.95%)  7 5/57 (8.77%)  5 0/55 (0.00%)  0 4/84 (4.76%)  4 7/54 (12.96%)  7
pain in extremity * 1  1/54 (1.85%)  1 3/56 (5.36%)  3 2/56 (3.57%)  2 1/159 (0.63%)  1 1/54 (1.85%)  1 0/53 (0.00%)  0 0/84 (0.00%)  0 0/57 (0.00%)  0 0/55 (0.00%)  0 1/84 (1.19%)  1 0/54 (0.00%)  0
backpain * 1  0/54 (0.00%)  0 1/56 (1.79%)  1 3/56 (5.36%)  4 2/159 (1.26%)  3 2/54 (3.70%)  3 0/53 (0.00%)  0 0/84 (0.00%)  0 0/57 (0.00%)  0 0/55 (0.00%)  0 0/84 (0.00%)  0 0/54 (0.00%)  0
Nervous system disorders                       
headache * 1  27/54 (50.00%)  31 21/56 (37.50%)  49 27/56 (48.21%)  57 56/159 (35.22%)  91 17/54 (31.48%)  30 21/53 (39.62%)  39 29/84 (34.52%)  48 11/57 (19.30%)  22 11/55 (20.00%)  12 21/84 (25.00%)  31 11/54 (20.37%)  15
dizziness * 1  1/54 (1.85%)  1 3/56 (5.36%)  3 1/56 (1.79%)  1 1/159 (0.63%)  1 1/54 (1.85%)  1 0/53 (0.00%)  0 0/84 (0.00%)  0 1/57 (1.75%)  1 0/55 (0.00%)  0 0/84 (0.00%)  0 0/54 (0.00%)  0
Respiratory, thoracic and mediastinal disorders                       
cough * 1  2/54 (3.70%)  2 2/56 (3.57%)  2 1/56 (1.79%)  1 8/159 (5.03%)  9 3/54 (5.56%)  3 0/53 (0.00%)  0 4/84 (4.76%)  4 1/57 (1.75%)  1 0/55 (0.00%)  0 6/84 (7.14%)  7 4/54 (7.41%)  5
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 17.1
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
Layout table for Results Point of Contact information
Name/Title: Posting Director
Organization: Novartis Vaccines and Diagnostics
EMail: RegContactVacUS.nvdit@Novartis.com
Layout table for additonal information
Responsible Party: Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier: NCT00973700    
Other Study ID Numbers: V112_04
First Submitted: September 2, 2009
First Posted: September 9, 2009
Results First Submitted: October 20, 2010
Results First Posted: May 23, 2011
Last Update Posted: December 2, 2015