Trial Outcomes & Findings for Immunogenicity, Safety and Tolerability of Prepandemic Influenza and Seasonal Influenza Vaccine in Adult Subjects (NCT NCT00481065)
NCT ID: NCT00481065
Last Updated: 2014-02-03
Results Overview
Seroconversion (serocon.) is defined as negative pre-vaccination serum (titer \<10 for HI \[Haemagglutination Inhibition\], area ≤4 mm\^2 for SRH \[Single Radial Haemolysis\]) / positive post-vaccination titer (titer ≥ 40 for HI, area ≥ 25 mm\^2 for SRH). Significant increase in antibody titer is defined as at least a fourfold increase from non-negative pre-vaccination serum (HI ≥ 10) or at least 50% increase in the SRH area. Seroprotection is defined as a HI titer ≥40 and a SRH area ≥25 mm\^2.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
405 participants
Primary outcome timeframe
21 days after second and third vaccinations (day 43 and day 403)
Results posted on
2014-02-03
Participant Flow
Participants were enrolled at 1 center in Colombia.
All subjects enrolled were included in the trial. A total of 405 subjects was enrolled and randomized into 8 groups in this study. The participant flow data are from the all randomized set.
Participant milestones
| Measure |
Concomitant Alone
1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV\_a into the other arm on day 1 then 1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV\_a into the other arm on day 1 then 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 382
|
Concomitant+Mixed
1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV\_a into the other arm on day 1, 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 382
|
Concomitant+MF59-eH5N1
1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV\_a into the other arm on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 382
|
Mixed
1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 1 and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 382
|
Mixed + Mixed
dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 1, day 22, and day 382
|
Mixed+MF59-eH5N1
1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 382
|
MF59-eH5N1+eTIV_a
1 dose of MF59-eH5N1 on day 1, 1 dose of eTIV\_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 382
|
eTIV_a+MF59-eH5N1
1 dose of eTIV\_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 382
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
51
|
50
|
51
|
52
|
51
|
51
|
50
|
49
|
|
Overall Study
COMPLETED
|
29
|
33
|
32
|
37
|
28
|
27
|
34
|
30
|
|
Overall Study
NOT COMPLETED
|
22
|
17
|
19
|
15
|
23
|
24
|
16
|
19
|
Reasons for withdrawal
| Measure |
Concomitant Alone
1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV\_a into the other arm on day 1 then 1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV\_a into the other arm on day 1 then 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 382
|
Concomitant+Mixed
1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV\_a into the other arm on day 1, 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 382
|
Concomitant+MF59-eH5N1
1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV\_a into the other arm on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 382
|
Mixed
1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 1 and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 382
|
Mixed + Mixed
dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 1, day 22, and day 382
|
Mixed+MF59-eH5N1
1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 382
|
MF59-eH5N1+eTIV_a
1 dose of MF59-eH5N1 on day 1, 1 dose of eTIV\_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 382
|
eTIV_a+MF59-eH5N1
1 dose of eTIV\_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 382
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse event or death
|
1
|
1
|
3
|
0
|
2
|
0
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
11
|
12
|
7
|
11
|
13
|
12
|
9
|
10
|
|
Overall Study
Lost to Follow-up
|
4
|
2
|
4
|
3
|
3
|
3
|
2
|
5
|
|
Overall Study
Inappropriate enrollment
|
4
|
0
|
2
|
0
|
2
|
1
|
0
|
1
|
|
Overall Study
Administrative reason
|
0
|
0
|
0
|
0
|
0
|
2
|
1
|
0
|
|
Overall Study
Protocol Violation
|
2
|
1
|
1
|
1
|
2
|
6
|
3
|
2
|
|
Overall Study
Unable to classify
|
0
|
1
|
2
|
0
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Immunogenicity, Safety and Tolerability of Prepandemic Influenza and Seasonal Influenza Vaccine in Adult Subjects
Baseline characteristics by cohort
| Measure |
Concomitant Alone
n=51 Participants
1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV\_a into the other arm on day 1 then 1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV\_a into the other arm on day 1 then 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 382
|
Concomitant+Mixed
n=50 Participants
1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV\_a into the other arm on day 1, 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 382
|
Concomitant+MF59-eH5N1
n=51 Participants
1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV\_a into the other arm on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 382
|
Mixed
n=52 Participants
1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 1 and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 382
|
Mixed + Mixed
n=51 Participants
dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 1, day 22, and day 382
|
Mixed+MF59-eH5N1
n=51 Participants
1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 382
|
MF59-eH5N1+eTIV_a
n=50 Participants
1 dose of MF59-eH5N1 on day 1, 1 dose of eTIV\_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 382
|
eTIV_a+MF59-eH5N1
n=49 Participants
1 dose of eTIV\_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 382
|
Total
n=405 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
29 years
STANDARD_DEVIATION 6.2 • n=93 Participants
|
29.4 years
STANDARD_DEVIATION 5.8 • n=4 Participants
|
29.5 years
STANDARD_DEVIATION 6.5 • n=27 Participants
|
29.8 years
STANDARD_DEVIATION 6.8 • n=483 Participants
|
29.6 years
STANDARD_DEVIATION 6.1 • n=36 Participants
|
28.8 years
STANDARD_DEVIATION 6.2 • n=10 Participants
|
27.9 years
STANDARD_DEVIATION 6.2 • n=115 Participants
|
30.1 years
STANDARD_DEVIATION 6.2 • n=40 Participants
|
29.3 years
STANDARD_DEVIATION 6.2 • n=8 Participants
|
|
Sex: Female, Male
Female
|
42 Participants
n=93 Participants
|
31 Participants
n=4 Participants
|
36 Participants
n=27 Participants
|
30 Participants
n=483 Participants
|
36 Participants
n=36 Participants
|
39 Participants
n=10 Participants
|
30 Participants
n=115 Participants
|
32 Participants
n=40 Participants
|
276 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=93 Participants
|
19 Participants
n=4 Participants
|
15 Participants
n=27 Participants
|
22 Participants
n=483 Participants
|
15 Participants
n=36 Participants
|
12 Participants
n=10 Participants
|
20 Participants
n=115 Participants
|
17 Participants
n=40 Participants
|
129 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: 21 days after second and third vaccinations (day 43 and day 403)Population: The analysis was done on the full analysis set (FAS).
Seroconversion (serocon.) is defined as negative pre-vaccination serum (titer \<10 for HI \[Haemagglutination Inhibition\], area ≤4 mm\^2 for SRH \[Single Radial Haemolysis\]) / positive post-vaccination titer (titer ≥ 40 for HI, area ≥ 25 mm\^2 for SRH). Significant increase in antibody titer is defined as at least a fourfold increase from non-negative pre-vaccination serum (HI ≥ 10) or at least 50% increase in the SRH area. Seroprotection is defined as a HI titer ≥40 and a SRH area ≥25 mm\^2.
Outcome measures
| Measure |
Concomitant Alone
n=46 Participants
1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV\_a into the other arm on day 1 then 1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV\_a into the other arm on day 1 then 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 382
|
Concomitant+Mixed
n=48 Participants
1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV\_a into the other arm on day 1, 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 382
|
Concomitant+MF59-eH5N1
n=47 Participants
1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV\_a into the other arm on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 382
|
Mixed
n=50 Participants
1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 1 and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 382
|
Mixed + Mixed
n=49 Participants
dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 1, day 22, and day 382
|
Mixed+MF59-eH5N1
n=48 Participants
1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 382
|
MF59-eH5N1+eTIV_a
n=48 Participants
1 dose of MF59-eH5N1 on day 1, 1 dose of eTIV\_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 382
|
eTIV_a+MF59-eH5N1
n=44 Participants
1 dose of eTIV\_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 382
|
|---|---|---|---|---|---|---|---|---|
|
Number Subjects Who Responded to Two or Three Vaccinations of the MF59-H5N1 Influenza Vaccine
SRH serocon. (2nd vacc) N=46,48,46,50,46,48,47,42
|
14 Subjects
Interval 18.0 to 46.0
|
38 Subjects
Interval 65.0 to 90.0
|
43 Subjects
Interval 82.0 to 99.0
|
11 Subjects
Interval 12.0 to 37.0
|
31 Subjects
Interval 52.0 to 80.0
|
38 Subjects
Interval 67.0 to 91.0
|
23 Subjects
Interval 34.0 to 64.0
|
25 Subjects
Interval 43.0 to 74.0
|
|
Number Subjects Who Responded to Two or Three Vaccinations of the MF59-H5N1 Influenza Vaccine
SRH seroprot. (2nd vacc) N=46,48,46,50,48,48,47,43
|
17 Subjects
Interval 23.0 to 52.0
|
40 Subjects
Interval 70.0 to 93.0
|
43 Subjects
Interval 82.0 to 99.0
|
14 Subjects
Interval 16.0 to 42.0
|
35 Subjects
Interval 58.0 to 85.0
|
42 Subjects
Interval 75.0 to 95.0
|
26 Subjects
Interval 40.0 to 70.0
|
29 Subjects
Interval 51.0 to 81.0
|
|
Number Subjects Who Responded to Two or Three Vaccinations of the MF59-H5N1 Influenza Vaccine
SRH serocon. (3rd vacc) N=25,25,28,35,25,20,28,25
|
24 Subjects
Interval 80.0 to 100.0
|
20 Subjects
Interval 59.0 to 93.0
|
27 Subjects
Interval 82.0 to 100.0
|
27 Subjects
Interval 54.0 to 85.0
|
12 Subjects
Interval 28.0 to 69.0
|
12 Subjects
Interval 36.0 to 81.0
|
18 Subjects
Interval 44.0 to 81.0
|
16 Subjects
Interval 43.0 to 82.0
|
|
Number Subjects Who Responded to Two or Three Vaccinations of the MF59-H5N1 Influenza Vaccine
SRH seroprot. (3rd vacc) N=25,25,28,35,25,20,28,25
|
25 Subjects
Interval 86.0 to 100.0
|
21 Subjects
Interval 64.0 to 95.0
|
27 Subjects
Interval 82.0 to 100.0
|
27 Subjects
Interval 60.0 to 90.0
|
11 Subjects
Interval 24.0 to 65.0
|
15 Subjects
Interval 51.0 to 91.0
|
23 Subjects
Interval 63.0 to 94.0
|
19 Subjects
Interval 55.0 to 91.0
|
|
Number Subjects Who Responded to Two or Three Vaccinations of the MF59-H5N1 Influenza Vaccine
MN ≥40 (day 1) N=46,48,47,50,49,48,48,44)
|
11 Subjects
|
11 Subjects
|
10 Subjects
|
11 Subjects
|
10 Subjects
|
10 Subjects
|
11 Subjects
|
11 Subjects
|
|
Number Subjects Who Responded to Two or Three Vaccinations of the MF59-H5N1 Influenza Vaccine
MN ≥40 (2nd vacc) N=46,48,46,50,48,48,47,43
|
14 Subjects
Interval 18.0 to 46.0
|
36 Subjects
Interval 60.0 to 86.0
|
44 Subjects
Interval 85.0 to 99.0
|
16 Subjects
Interval 20.0 to 47.0
|
36 Subjects
Interval 60.0 to 86.0
|
44 Subjects
Interval 80.0 to 98.0
|
24 Subjects
Interval 36.0 to 66.0
|
20 Subjects
Interval 31.0 to 62.0
|
|
Number Subjects Who Responded to Two or Three Vaccinations of the MF59-H5N1 Influenza Vaccine
MN ≥40 (3rd vacc) N=25,25,28,35,25,20,28,25
|
24 Subjects
Interval 80.0 to 100.0
|
24 Subjects
Interval 80.0 to 100.0
|
28 Subjects
Interval 88.0 to 100.0
|
31 Subjects
Interval 73.0 to 97.0
|
22 Subjects
Interval 69.0 to 97.0
|
20 Subjects
Interval 83.0 to 100.0
|
26 Subjects
Interval 76.0 to 99.0
|
23 Subjects
Interval 74.0 to 99.0
|
|
Number Subjects Who Responded to Two or Three Vaccinations of the MF59-H5N1 Influenza Vaccine
SRH seroprot. (day 1) N=46,48,47,50,49,48,48,44)
|
3 Subjects
|
6 Subjects
|
1 Subjects
|
4 Subjects
|
4 Subjects
|
6 Subjects
|
4 Subjects
|
5 Subjects
|
|
Number Subjects Who Responded to Two or Three Vaccinations of the MF59-H5N1 Influenza Vaccine
HI seroprot. (3rd vacc) N=24,25,28,35,25,20,28,25
|
18 Subjects
Interval 53.0 to 90.0
|
15 Subjects
Interval 39.0 to 79.0
|
26 Subjects
Interval 76.0 to 99.0
|
20 Subjects
Interval 39.0 to 74.0
|
16 Subjects
Interval 43.0 to 82.0
|
14 Subjects
Interval 46.0 to 88.0
|
24 Subjects
Interval 67.0 to 96.0
|
16 Subjects
Interval 43.0 to 82.0
|
|
Number Subjects Who Responded to Two or Three Vaccinations of the MF59-H5N1 Influenza Vaccine
HI seroprot. (day1) N=46,48,47,50,49,48,48,44
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
2 Subjects
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number Subjects Who Responded to Two or Three Vaccinations of the MF59-H5N1 Influenza Vaccine
HI serocon. (2nd vacc) N=46,48,46,49,48,48,47,43
|
12 Subjects
Interval 14.0 to 41.0
|
33 Subjects
Interval 54.0 to 81.0
|
37 Subjects
Interval 66.0 to 91.0
|
13 Subjects
Interval 15.0 to 41.0
|
31 Subjects
Interval 49.0 to 78.0
|
34 Subjects
Interval 56.0 to 83.0
|
19 Subjects
Interval 26.0 to 56.0
|
22 Subjects
Interval 35.0 to 67.0
|
|
Number Subjects Who Responded to Two or Three Vaccinations of the MF59-H5N1 Influenza Vaccine
HI seroprot. (2nd vacc) N=46,48,46,49,48,48,47,43
|
12 Subjects
Interval 14.0 to 41.0
|
34 Subjects
Interval 56.0 to 83.0
|
37 Subjects
Interval 66.0 to 91.0
|
14 Subjects
Interval 17.0 to 43.0
|
32 Subjects
Interval 52.0 to 80.0
|
34 Subjects
Interval 56.0 to 83.0
|
19 Subjects
Interval 26.0 to 56.0
|
22 Subjects
Interval 35.0 to 67.0
|
|
Number Subjects Who Responded to Two or Three Vaccinations of the MF59-H5N1 Influenza Vaccine
HI serocon. (3rd vacc) N=23,24,36,39,31,20,32,32
|
17 Subjects
Interval 52.0 to 90.0
|
15 Subjects
Interval 39.0 to 79.0
|
26 Subjects
Interval 76.0 to 99.0
|
19 Subjects
Interval 37.0 to 71.0
|
16 Subjects
Interval 43.0 to 82.0
|
13 Subjects
Interval 41.0 to 85.0
|
24 Subjects
Interval 67.0 to 96.0
|
16 Subjects
Interval 43.0 to 82.0
|
PRIMARY outcome
Timeframe: 21 days after second and third vaccinations (day 22 and day 43)Population: Full analysis set (FAS)
Geometric mean Ratio (GMR) was calculated for the haemagglutination inhibition (HI), microneutralization (MN) and single-radial haemolysis (SRH) result as well as the associated 95% confidence intervals. GMR was calculated as 21 days after second and third vaccinations over day 1.
Outcome measures
| Measure |
Concomitant Alone
n=46 Participants
1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV\_a into the other arm on day 1 then 1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV\_a into the other arm on day 1 then 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 382
|
Concomitant+Mixed
n=48 Participants
1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV\_a into the other arm on day 1, 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 382
|
Concomitant+MF59-eH5N1
n=47 Participants
1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV\_a into the other arm on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 382
|
Mixed
n=50 Participants
1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 1 and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 382
|
Mixed + Mixed
n=49 Participants
dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 1, day 22, and day 382
|
Mixed+MF59-eH5N1
n=48 Participants
1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 382
|
MF59-eH5N1+eTIV_a
n=48 Participants
1 dose of MF59-eH5N1 on day 1, 1 dose of eTIV\_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 382
|
eTIV_a+MF59-eH5N1
n=44 Participants
1 dose of eTIV\_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 382
|
|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Ratio After Two or Three Vaccinations of the MF59-eH5N1 Influenza Vaccine
HI (2nd vacc) N= 46,48,46,49,48,48,47,43
|
2.11 Ratio
Interval 1.29 to 3.46
|
12 Ratio
Interval 7.09 to 19.0
|
23 Ratio
Interval 14.0 to 37.0
|
2.16 Ratio
Interval 1.33 to 3.49
|
9.52 Ratio
Interval 5.86 to 15.0
|
14 Ratio
Interval 8.32 to 22.0
|
2.96 Ratio
Interval 1.81 to 4.86
|
5.34 Ratio
Interval 3.2 to 8.91
|
|
Geometric Mean Ratio After Two or Three Vaccinations of the MF59-eH5N1 Influenza Vaccine
HI (3rd vacc) N= 24,25,28,35,25,20,28,25
|
34 Ratio
Interval 15.0 to 76.0
|
17 Ratio
Interval 7.82 to 37.0
|
93 Ratio
Interval 44.0 to 197.0
|
10 Ratio
Interval 5.36 to 20.0
|
9.89 Ratio
Interval 4.5 to 22.0
|
21 Ratio
Interval 8.56 to 49.0
|
66 Ratio
Interval 31.0 to 139.0
|
12 Ratio
Interval 5.53 to 26.0
|
|
Geometric Mean Ratio After Two or Three Vaccinations of the MF59-eH5N1 Influenza Vaccine
SRH (2nd vacc) N= 46,48,46,49,46,47,47,42
|
1.82 Ratio
Interval 1.35 to 2.44
|
5.32 Ratio
Interval 3.98 to 7.09
|
9.64 Ratio
Interval 7.17 to 13.0
|
1.58 Ratio
Interval 1.19 to 2.11
|
4.25 Ratio
Interval 3.16 to 5.71
|
6.04 Ratio
Interval 4.5 to 8.11
|
2.9 Ratio
Interval 2.16 to 3.88
|
3.26 Ratio
Interval 2.39 to 4.44
|
|
Geometric Mean Ratio After Two or Three Vaccinations of the MF59-eH5N1 Influenza Vaccine
SRH (3rd vacc) N= 25,25,28,35,25,20,28,25
|
9.92 Ratio
Interval 6.73 to 15.0
|
6.22 Ratio
Interval 4.25 to 9.12
|
11 Ratio
Interval 7.47 to 16.0
|
5.13 Ratio
Interval 3.69 to 7.13
|
3.1 Ratio
Interval 2.07 to 4.65
|
6.76 Ratio
Interval 4.33 to 11.0
|
7.17 Ratio
Interval 4.95 to 10.0
|
4.55 Ratio
Interval 3.08 to 6.74
|
|
Geometric Mean Ratio After Two or Three Vaccinations of the MF59-eH5N1 Influenza Vaccine
MN (2nd vacc) N= 46,48,47,50,49,48,48,44
|
2.12 Ratio
Interval 1.54 to 2.91
|
7.64 Ratio
Interval 5.61 to 10.0
|
13 Ratio
Interval 9.45 to 18.0
|
2.15 Ratio
Interval 1.59 to 2.92
|
6.79 Ratio
Interval 4.98 to 9.26
|
11 Ratio
Interval 8.04 to 15.0
|
3.86 Ratio
Interval 2.82 to 5.29
|
3.49 Ratio
Interval 2.52 to 4.84
|
|
Geometric Mean Ratio After Two or Three Vaccinations of the MF59-eH5N1 Influenza Vaccine
MN (3rd vacc) N= 24,25,28,35,25,20,28,25
|
38 Ratio
Interval 23.0 to 64.0
|
39 Ratio
Interval 23.0 to 64.0
|
66 Ratio
Interval 40.0 to 109.0
|
16 Ratio
Interval 10.0 to 25.0
|
13 Ratio
Interval 8.0 to 23.0
|
23 Ratio
Interval 13.0 to 41.0
|
58 Ratio
Interval 36.0 to 95.0
|
21 Ratio
Interval 12.0 to 35.0
|
PRIMARY outcome
Timeframe: 21 days after second vaccination (day 43)Population: The analysis was done on the full analysis set (FAS).
seroconversion: negative pre-vaccination serum (HI titer \<10, SRH area =\<4 mm\^2)/positive post-vaccination titer (HI titer =\>10) or at least 50% increase in the SRH area. Seroprotection is defined as a HI titer ≥40 and a SRH area ≥25 mm\^2.
Outcome measures
| Measure |
Concomitant Alone
n=46 Participants
1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV\_a into the other arm on day 1 then 1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV\_a into the other arm on day 1 then 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 382
|
Concomitant+Mixed
n=48 Participants
1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV\_a into the other arm on day 1, 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 382
|
Concomitant+MF59-eH5N1
n=47 Participants
1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV\_a into the other arm on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 382
|
Mixed
n=50 Participants
1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 1 and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 382
|
Mixed + Mixed
n=49 Participants
dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 1, day 22, and day 382
|
Mixed+MF59-eH5N1
n=48 Participants
1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 382
|
MF59-eH5N1+eTIV_a
n=48 Participants
1 dose of MF59-eH5N1 on day 1, 1 dose of eTIV\_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 382
|
eTIV_a+MF59-eH5N1
n=44 Participants
1 dose of eTIV\_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 382
|
|---|---|---|---|---|---|---|---|---|
|
Number of Subjects Who Responded to Two Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain H1N1)
HI seroprot. (day 1)
|
13 Subjects
|
18 Subjects
|
16 Subjects
|
23 Subjects
|
15 Subjects
|
19 Subjects
|
24 Subjects
|
20 Subjects
|
|
Number of Subjects Who Responded to Two Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain H1N1)
HI seroconversion N=46,48,46,49,48,48,47,43
|
33 Subjects
Interval 57.0 to 84.0
|
35 Subjects
Interval 58.0 to 85.0
|
36 Subjects
Interval 64.0 to 89.0
|
29 Subjects
Interval 43.0 to 72.0
|
37 Subjects
Interval 63.0 to 88.0
|
37 Subjects
Interval 63.0 to 88.0
|
29 Subjects
Interval 46.0 to 75.0
|
31 Subjects
Interval 56.0 to 85.0
|
|
Number of Subjects Who Responded to Two Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain H1N1)
HI seroprotection N=46,48,46,49,48,48,47,43
|
37 Subjects
Interval 66.0 to 91.0
|
45 Subjects
Interval 83.0 to 99.0
|
43 Subjects
Interval 82.0 to 99.0
|
39 Subjects
Interval 64.0 to 88.0
|
44 Subjects
Interval 80.0 to 98.0
|
41 Subjects
Interval 72.0 to 94.0
|
43 Subjects
Interval 80.0 to 98.0
|
40 Subjects
Interval 81.0 to 99.0
|
PRIMARY outcome
Timeframe: 21 days after second and third vaccinations (day 43 and day 403)Population: The analysis was done on the full analysis set (FAS).
seroconversion (serocon.): negative pre-vaccination serum (HI titer \<10, SRH area =\<4 mm\^2)/positive post-vaccination titer (HI titer =\>10) or at least 50% increase in the SRH area. Seroprotection is defined as a HI titer ≥40 and a SRH area ≥25 mm\^2.
Outcome measures
| Measure |
Concomitant Alone
n=46 Participants
1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV\_a into the other arm on day 1 then 1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV\_a into the other arm on day 1 then 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 382
|
Concomitant+Mixed
n=48 Participants
1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV\_a into the other arm on day 1, 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 382
|
Concomitant+MF59-eH5N1
n=47 Participants
1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV\_a into the other arm on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 382
|
Mixed
n=50 Participants
1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 1 and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 382
|
Mixed + Mixed
n=49 Participants
dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 1, day 22, and day 382
|
Mixed+MF59-eH5N1
n=48 Participants
1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 382
|
MF59-eH5N1+eTIV_a
n=48 Participants
1 dose of MF59-eH5N1 on day 1, 1 dose of eTIV\_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 382
|
eTIV_a+MF59-eH5N1
n=44 Participants
1 dose of eTIV\_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 382
|
|---|---|---|---|---|---|---|---|---|
|
Number of Subjects Who Responded to Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain H3N2)
HI serocon. (2nd vacc) N=46,48,46,49,48,48,47,43
|
23 Subjects
Interval 35.0 to 65.0
|
36 Subjects
Interval 60.0 to 86.0
|
35 Subjects
Interval 61.0 to 87.0
|
35 Subjects
Interval 55.0 to 82.0
|
40 Subjects
Interval 70.0 to 93.0
|
40 Subjects
Interval 70.0 to 93.0
|
35 Subjects
Interval 60.0 to 86.0
|
29 Subjects
Interval 51.0 to 81.0
|
|
Number of Subjects Who Responded to Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain H3N2)
HI seroprot. (day 1)
|
20 Subjects
|
22 Subjects
|
14 Subjects
|
23 Subjects
|
26 Subjects
|
22 Subjects
|
12 Subjects
|
22 Subjects
|
|
Number of Subjects Who Responded to Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain H3N2)
HI seroprot. (3rd vacc) N=30,33,36,39,31,29,34,32
|
18 Subjects
Interval 53.0 to 90.0
|
15 Subjects
Interval 39.0 to 79.0
|
26 Subjects
Interval 76.0 to 99.0
|
20 Subjects
Interval 39.0 to 74.0
|
16 Subjects
Interval 43.0 to 82.0
|
14 Subjects
Interval 46.0 to 88.0
|
86 Subjects
Interval 67.0 to 96.0
|
64 Subjects
Interval 43.0 to 82.0
|
|
Number of Subjects Who Responded to Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain H3N2)
HI seroprot. (2nd vacc) N=46,48,46,50,48,48,47,43)
|
39 Subjects
Interval 71.0 to 94.0
|
46 Subjects
Interval 86.0 to 99.0
|
44 Subjects
Interval 85.0 to 99.0
|
49 Subjects
Interval 89.0 to 100.0
|
48 Subjects
Interval 93.0 to 100.0
|
48 Subjects
Interval 93.0 to 100.0
|
47 Subjects
Interval 92.0 to 100.0
|
40 Subjects
Interval 81.0 to 99.0
|
|
Number of Subjects Who Responded to Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain H3N2)
HI serocon. (3rd vacc) N=25,25,28,35,25,20,28,25
|
19 Subjects
Interval 55.0 to 91.0
|
20 Subjects
Interval 59.0 to 93.0
|
26 Subjects
Interval 76.0 to 99.0
|
30 Subjects
Interval 70.0 to 95.0
|
18 Subjects
Interval 51.0 to 88.0
|
17 Subjects
Interval 62.0 to 97.0
|
25 Subjects
Interval 72.0 to 98.0
|
21 Subjects
Interval 64.0 to 95.0
|
PRIMARY outcome
Timeframe: 21 days after second and third vaccinations (day 43 and day 403)Population: The analysis was done on the full analysis set (FAS).
seroconversion (serocon.): negative pre-vaccination serum (HI titer \<10, SRH area =\<4 mm\^2)/positive post-vaccination titer (HI titer =\>10) or at least 50% increase in the SRH area. Seroprotection is defined as a HI titer ≥40 and a SRH area ≥25 mm\^2.
Outcome measures
| Measure |
Concomitant Alone
n=46 Participants
1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV\_a into the other arm on day 1 then 1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV\_a into the other arm on day 1 then 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 382
|
Concomitant+Mixed
n=48 Participants
1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV\_a into the other arm on day 1, 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 382
|
Concomitant+MF59-eH5N1
n=47 Participants
1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV\_a into the other arm on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 382
|
Mixed
n=50 Participants
1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 1 and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 382
|
Mixed + Mixed
n=49 Participants
dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 1, day 22, and day 382
|
Mixed+MF59-eH5N1
n=48 Participants
1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 382
|
MF59-eH5N1+eTIV_a
n=48 Participants
1 dose of MF59-eH5N1 on day 1, 1 dose of eTIV\_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 382
|
eTIV_a+MF59-eH5N1
n=44 Participants
1 dose of eTIV\_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 382
|
|---|---|---|---|---|---|---|---|---|
|
Number of Subjects Who Responded to Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain B)
HI serocon. (2nd vacc) N=46,48,46,50,48,48,47,43
|
37 Subjects
Interval 66.0 to 91.0
|
38 Subjects
Interval 65.0 to 90.0
|
36 Subjects
Interval 64.0 to 89.0
|
41 Subjects
Interval 69.0 to 91.0
|
41 Subjects
Interval 72.0 to 94.0
|
35 Subjects
Interval 58.0 to 85.0
|
36 Subjects
Interval 62.0 to 88.0
|
28 Subjects
Interval 49.0 to 79.0
|
|
Number of Subjects Who Responded to Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain B)
HI serocon. (3rd vacc) N=25,25,28,35,25,20,28,25
|
19 Subjects
Interval 55.0 to 91.0
|
17 Subjects
Interval 46.0 to 85.0
|
19 Subjects
Interval 48.0 to 84.0
|
27 Subjects
Interval 60.0 to 90.0
|
15 Subjects
Interval 39.0 to 79.0
|
13 Subjects
Interval 41.0 to 85.0
|
11 Subjects
Interval 22.0 to 59.0
|
15 Subjects
Interval 39.0 to 79.0
|
|
Number of Subjects Who Responded to Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain B)
HI seroprot. (day 1)
|
5 Subjects
|
4 Subjects
|
6 Subjects
|
10 Subjects
|
2 Subjects
|
9 Subjects
|
12 Subjects
|
5 Subjects
|
|
Number of Subjects Who Responded to Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain B)
HI seroprot. (2nd vacc) N=46,48,46,50,48,48,47,43
|
40 Subjects
Interval 74.0 to 95.0
|
43 Subjects
Interval 77.0 to 97.0
|
42 Subjects
Interval 79.0 to 98.0
|
46 Subjects
Interval 81.0 to 98.0
|
44 Subjects
Interval 80.0 to 98.0
|
45 Subjects
Interval 83.0 to 99.0
|
44 Subjects
Interval 82.0 to 99.0
|
32 Subjects
Interval 59.0 to 86.0
|
|
Number of Subjects Who Responded to Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain B)
HI seroprot. (3rd vacc) N=25,25,28,35,25,20,28,25
|
22 Subjects
Interval 69.0 to 97.0
|
21 Subjects
Interval 64.0 to 95.0
|
22 Subjects
Interval 59.0 to 92.0
|
31 Subjects
Interval 73.0 to 97.0
|
18 Subjects
Interval 51.0 to 88.0
|
18 Subjects
Interval 68.0 to 99.0
|
17 Subjects
Interval 41.0 to 78.0
|
20 Subjects
Interval 59.0 to 93.0
|
PRIMARY outcome
Timeframe: 21 days after second vaccination (day 43)Population: Full analysis set (FAS)
For each vaccine group, the least squares GMRs were calculated for the haemagglutination inhibition (HI) results as well as the associated 95% confidence intervals. GMR was calculated over day 1.
Outcome measures
| Measure |
Concomitant Alone
n=46 Participants
1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV\_a into the other arm on day 1 then 1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV\_a into the other arm on day 1 then 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 382
|
Concomitant+Mixed
n=48 Participants
1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV\_a into the other arm on day 1, 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 382
|
Concomitant+MF59-eH5N1
n=46 Participants
1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV\_a into the other arm on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 382
|
Mixed
n=50 Participants
1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 1 and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 382
|
Mixed + Mixed
n=48 Participants
dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 1, day 22, and day 382
|
Mixed+MF59-eH5N1
n=48 Participants
1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 382
|
MF59-eH5N1+eTIV_a
n=47 Participants
1 dose of MF59-eH5N1 on day 1, 1 dose of eTIV\_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 382
|
eTIV_a+MF59-eH5N1
n=43 Participants
1 dose of eTIV\_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 382
|
|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Ratio After Two Doses of the Seasonal eTIV_a Influenza Vaccine (Strain H1N1)
|
15 Ratio
Interval 9.54 to 23.0
|
13 Ratio
Interval 8.43 to 20.0
|
14 Ratio
Interval 8.82 to 21.0
|
6.77 Ratio
Interval 4.46 to 10.0
|
12 Ratio
Interval 7.81 to 18.0
|
10 Ratio
Interval 6.69 to 16.0
|
6.23 Ratio
Interval 4.03 to 9.61
|
11 Ratio
Interval 6.76 to 17.0
|
PRIMARY outcome
Timeframe: 21 days after second and third vaccinations (day 43 and day 403)Population: Full analysis set (FAS)
For each vaccine group, the least squares GMRs were calculated for the haemagglutination inhibition (HI) results for each time point of the study, as well as the associated 95% confidence intervals. GMR was calculated over day 1.
Outcome measures
| Measure |
Concomitant Alone
n=46 Participants
1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV\_a into the other arm on day 1 then 1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV\_a into the other arm on day 1 then 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 382
|
Concomitant+Mixed
n=48 Participants
1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV\_a into the other arm on day 1, 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 382
|
Concomitant+MF59-eH5N1
n=47 Participants
1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV\_a into the other arm on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 382
|
Mixed
n=50 Participants
1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 1 and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 382
|
Mixed + Mixed
n=49 Participants
dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 1, day 22, and day 382
|
Mixed+MF59-eH5N1
n=48 Participants
1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 382
|
MF59-eH5N1+eTIV_a
n=48 Participants
1 dose of MF59-eH5N1 on day 1, 1 dose of eTIV\_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 382
|
eTIV_a+MF59-eH5N1
n=44 Participants
1 dose of eTIV\_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 382
|
|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Ratio After Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccine (Strain H3N1)
HI GMR (2nd vacc) N= 46,48,46,50,48,48,47,43
|
6.01 Ratio
Interval 4.01 to 9.01
|
9.72 Ratio
Interval 6.54 to 14.0
|
9.34 Ratio
Interval 6.22 to 14.0
|
11 Ratio
Interval 7.54 to 16.0
|
11 Ratio
Interval 7.26 to 16.0
|
10 Ratio
Interval 6.92 to 15.0
|
11 Ratio
Interval 7.25 to 16.0
|
7.54 Ratio
Interval 4.96 to 11.0
|
|
Geometric Mean Ratio After Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccine (Strain H3N1)
HI GMR (3rd vacc) N= 25,25,28,35,25,20,28,25
|
17 Ratio
Interval 9.56 to 29.0
|
10 Ratio
Interval 6.04 to 18.0
|
17 Ratio
Interval 9.86 to 28.0
|
18 Ratio
Interval 11.0 to 29.0
|
8.92 Ratio
Interval 5.12 to 16.0
|
11 Ratio
Interval 5.8 to 20.0
|
17 Ratio
Interval 10.0 to 29.0
|
13 Ratio
Interval 7.64 to 23.0
|
PRIMARY outcome
Timeframe: 21 days after second and third vaccinations (day 43 and day 403)Population: Full analysis set (FAS)
For each vaccine group, the least squares GMRs were calculated for the haemagglutination inhibition (HI) results for each time point of the study, as well as the associated 95% confidence intervals. GMR was calculated over day 1.
Outcome measures
| Measure |
Concomitant Alone
n=46 Participants
1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV\_a into the other arm on day 1 then 1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV\_a into the other arm on day 1 then 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 382
|
Concomitant+Mixed
n=48 Participants
1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV\_a into the other arm on day 1, 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 382
|
Concomitant+MF59-eH5N1
n=47 Participants
1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV\_a into the other arm on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 382
|
Mixed
n=50 Participants
1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 1 and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 382
|
Mixed + Mixed
n=49 Participants
dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 1, day 22, and day 382
|
Mixed+MF59-eH5N1
n=48 Participants
1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 382
|
MF59-eH5N1+eTIV_a
n=48 Participants
1 dose of MF59-eH5N1 on day 1, 1 dose of eTIV\_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 382
|
eTIV_a+MF59-eH5N1
n=44 Participants
1 dose of eTIV\_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 382
|
|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Ratio After Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccine (Strain B)
HI GMR (3rd vacc) N= 25,25,28,35,25,20,28,25
|
8.85 Ratio
Interval 5.86 to 13.0
|
5.47 Ratio
Interval 3.64 to 8.22
|
7.95 Ratio
Interval 5.37 to 12.0
|
7.17 Ratio
Interval 5.05 to 10.0
|
5.29 Ratio
Interval 3.51 to 8.0
|
5.1 Ratio
Interval 3.22 to 8.06
|
4.17 Ratio
Interval 2.82 to 6.18
|
4.26 Ratio
Interval 2.84 to 6.4
|
|
Geometric Mean Ratio After Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccine (Strain B)
HI GMR (2nd vacc) N= 46,48,46,50,48,48,47,43
|
11 Ratio
Interval 7.85 to 17.0
|
13 Ratio
Interval 9.01 to 19.0
|
10 Ratio
Interval 6.94 to 15.0
|
10 Ratio
Interval 7.22 to 15.0
|
17 Ratio
Interval 12.0 to 25.0
|
8.77 Ratio
Interval 6.07 to 13.0
|
10 Ratio
Interval 6.97 to 15.0
|
8.0 Ratio
Interval 5.44 to 12.0
|
SECONDARY outcome
Timeframe: 21 days after second and third vaccinations (day 43 and day 403)The evaluate the safety of the administration of two or three vaccinations of MF59-eH5N1 influenza vaccine, either given sequentially, concomitantly or mixed extemporaneously with seasonal eTIV\_a influenza vaccine.
Outcome measures
| Measure |
Concomitant Alone
n=50 Participants
1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV\_a into the other arm on day 1 then 1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV\_a into the other arm on day 1 then 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 382
|
Concomitant+Mixed
n=50 Participants
1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV\_a into the other arm on day 1, 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 382
|
Concomitant+MF59-eH5N1
n=51 Participants
1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV\_a into the other arm on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 382
|
Mixed
n=51 Participants
1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 1 and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 382
|
Mixed + Mixed
n=51 Participants
dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 1, day 22, and day 382
|
Mixed+MF59-eH5N1
n=50 Participants
1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 382
|
MF59-eH5N1+eTIV_a
n=49 Participants
1 dose of MF59-eH5N1 on day 1, 1 dose of eTIV\_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 382
|
eTIV_a+MF59-eH5N1
n=49 Participants
1 dose of eTIV\_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 382
|
|---|---|---|---|---|---|---|---|---|
|
Number of Subjects Reporting Local and Systemic Reactions by Vaccination
Sweating (N=50,48,47,51,48,47,47,43) 2nd vacc
|
NA Subjects
Vaccine was not administered on this date.
|
0 Subjects
|
1 Subjects
|
NA Subjects
Vaccine was not administered on this date.
|
0 Subjects
|
2 Subjects
|
1 Subjects
|
1 Subjects
|
|
Number of Subjects Reporting Local and Systemic Reactions by Vaccination
Fatigue (N=50,48,47,51,48,47,47,43) 2nd vacc
|
NA Subjects
Vaccine was not administered on this date.
|
1 Subjects
|
0 Subjects
|
NA Subjects
Vaccine was not administered on this date.
|
1 Subjects
|
1 Subjects
|
2 Subjects
|
2 Subjects
|
|
Number of Subjects Reporting Local and Systemic Reactions by Vaccination
Nausea (N=50,48,47,51,48,47,47,43) 2nd vacc
|
NA Subjects
Vaccine was not administered on this date.
|
0 Subjects
|
1 Subjects
|
NA Subjects
Vaccine was not administered on this date.
|
1 Subjects
|
1 Subjects
|
2 Subjects
|
2 Subjects
|
|
Number of Subjects Reporting Local and Systemic Reactions by Vaccination
Erythema (N=50,48,47,51,48,47,47,43) 2nd vacc
|
0 Subjects
|
8 Subjects
|
8 Subjects
|
0 Subjects
|
8 Subjects
|
8 Subjects
|
7 Subjects
|
5 Subjects
|
|
Number of Subjects Reporting Local and Systemic Reactions by Vaccination
Induration (N=50,48,47,51,48,47,47,43) 2nd vacc
|
0 Subjects
|
2 Subjects
|
3 Subjects
|
0 Subjects
|
3 Subjects
|
2 Subjects
|
1 Subjects
|
3 Subjects
|
|
Number of Subjects Reporting Local and Systemic Reactions by Vaccination
Swelling (N=50,48,47,51,48,47,47,43) 2nd vacc
|
0 Subjects
|
2 Subjects
|
5 Subjects
|
0 Subjects
|
4 Subjects
|
1 Subjects
|
1 Subjects
|
1 Subjects
|
|
Number of Subjects Reporting Local and Systemic Reactions by Vaccination
Ecchymosis (N=50,48,47,51,48,47,47,43) 2nd vacc
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
1 Subjects
|
1 Subjects
|
1 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Local and Systemic Reactions by Vaccination
Pain (N=50,48,47,51,48,47,47,43) 2nd vacc
|
0 Subjects
|
21 Subjects
|
16 Subjects
|
0 Subjects
|
20 Subjects
|
18 Subjects
|
12 Subjects
|
16 Subjects
|
|
Number of Subjects Reporting Local and Systemic Reactions by Vaccination
Erythema (N=31,33,36,39,31,29,34,31) 3rd vacc
|
8 Subjects
|
4 Subjects
|
9 Subjects
|
9 Subjects
|
0 Subjects
|
7 Subjects
|
6 Subjects
|
11 Subjects
|
|
Number of Subjects Reporting Local and Systemic Reactions by Vaccination
Induration (N=31,33,36,39,31,29,34,31) 3rd vacc
|
6 Subjects
|
6 Subjects
|
14 Subjects
|
9 Subjects
|
0 Subjects
|
9 Subjects
|
7 Subjects
|
8 Subjects
|
|
Number of Subjects Reporting Local and Systemic Reactions by Vaccination
Swelling (N=31,33,36,39,31,29,34,31) 3rd vacc
|
5 Subjects
|
3 Subjects
|
9 Subjects
|
2 Subjects
|
0 Subjects
|
8 Subjects
|
6 Subjects
|
5 Subjects
|
|
Number of Subjects Reporting Local and Systemic Reactions by Vaccination
Ecchymosis (N=31,33,36,39,31,29,34,31) 3rd vacc
|
2 Subjects
|
1 Subjects
|
1 Subjects
|
1 Subjects
|
1 Subjects
|
1 Subjects
|
2 Subjects
|
3 Subjects
|
|
Number of Subjects Reporting Local and Systemic Reactions by Vaccination
Pain (N=31,33,36,39,31,29,34,31) 3rd vacc
|
20 Subjects
|
16 Subjects
|
21 Subjects
|
23 Subjects
|
20 Subjects
|
0 Subjects
|
17 Subjects
|
15 Subjects
|
|
Number of Subjects Reporting Local and Systemic Reactions by Vaccination
Chills (N=50,48,47,51,48,47,47,43) 2nd vacc
|
NA Subjects
Vaccine was not administered on this date.
|
0 Subjects
|
1 Subjects
|
NA Subjects
Vaccine was not administered on this date.
|
2 Subjects
|
4 Subjects
|
2 Subjects
|
2 Subjects
|
|
Number of Subjects Reporting Local and Systemic Reactions by Vaccination
Malaise (N=50,48,47,51,48,47,47,43) 2nd vacc
|
NA Subjects
Vaccine was not administered on this date.
|
2 Subjects
|
4 Subjects
|
NA Subjects
Vaccine was not administered on this date.
|
7 Subjects
|
6 Subjects
|
2 Subjects
|
6 Subjects
|
|
Number of Subjects Reporting Local and Systemic Reactions by Vaccination
Myalgia (N=50,48,47,51,48,47,47,43) 2nd vacc
|
NA Subjects
Vaccine was not administered on this date.
|
8 Subjects
|
7 Subjects
|
NA Subjects
Vaccine was not administered on this date.
|
9 Subjects
|
6 Subjects
|
3 Subjects
|
5 Subjects
|
|
Number of Subjects Reporting Local and Systemic Reactions by Vaccination
Arthralgia (N=50,48,47,51,48,47,47,43) 2nd vacc
|
NA Subjects
Vaccine was not administered on this date.
|
0 Subjects
|
3 Subjects
|
NA Subjects
Vaccine was not administered on this date.
|
1 Subjects
|
4 Subjects
|
2 Subjects
|
2 Subjects
|
|
Number of Subjects Reporting Local and Systemic Reactions by Vaccination
Headache (N=50,48,47,51,48,47,47,43) 2nd vacc
|
NA Subjects
Vaccine was not administered on this date.
|
2 Subjects
|
5 Subjects
|
NA Subjects
Vaccine was not administered on this date.
|
6 Subjects
|
5 Subjects
|
3 Subjects
|
4 Subjects
|
|
Number of Subjects Reporting Local and Systemic Reactions by Vaccination
Myalgia (N=30,33,36,39,31,29,34,32) 3rd vacc
|
12 Subjects
|
11 Subjects
|
17 Subjects
|
13 Subjects
|
12 Subjects
|
10 Subjects
|
8 Subjects
|
13 Subjects
|
|
Number of Subjects Reporting Local and Systemic Reactions by Vaccination
Arthralgia (N=31,33,36,39,31,29,34,32) 3rd vacc
|
2 Subjects
|
0 Subjects
|
5 Subjects
|
4 Subjects
|
4 Subjects
|
3 Subjects
|
4 Subjects
|
4 Subjects
|
|
Number of Subjects Reporting Local and Systemic Reactions by Vaccination
Fever≥ 38°C (N=50,48,47,51,48,47,47,43) 2nd vacc
|
NA Subjects
Vaccine was not administered on this date.
|
0 Subjects
|
0 Subjects
|
NA Subjects
Vaccine was not administered on this date.
|
1 Subjects
|
3 Subjects
|
0 Subjects
|
2 Subjects
|
|
Number of Subjects Reporting Local and Systemic Reactions by Vaccination
Headache (N=31,32,36,39,31,29,34,32) 3rd vacc
|
8 Subjects
|
7 Subjects
|
11 Subjects
|
7 Subjects
|
10 Subjects
|
8 Subjects
|
5 Subjects
|
7 Subjects
|
|
Number of Subjects Reporting Local and Systemic Reactions by Vaccination
Chills (N=31,49,36,39,31,50,34,49) 3rd vacc
|
3 Subjects
|
0 Subjects
|
6 Subjects
|
3 Subjects
|
4 Subjects
|
0 Subjects
|
3 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Local and Systemic Reactions by Vaccination
Malaise (N=31,33,36,39,31,29,34,32) 3rd vacc
|
6 Subjects
|
5 Subjects
|
9 Subjects
|
10 Subjects
|
8 Subjects
|
7 Subjects
|
9 Subjects
|
7 Subjects
|
|
Number of Subjects Reporting Local and Systemic Reactions by Vaccination
Sweating (N=31,49,36,39,51,29,49,32) 3rd vacc
|
2 Subjects
|
0 Subjects
|
2 Subjects
|
2 Subjects
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
3 Subjects
|
|
Number of Subjects Reporting Local and Systemic Reactions by Vaccination
Fatigue (N=31,33,36,39,31,50,34,32) 3rd vacc
|
2 Subjects
|
1 Subjects
|
3 Subjects
|
1 Subjects
|
2 Subjects
|
2 Subjects
|
1 Subjects
|
1 Subjects
|
|
Number of Subjects Reporting Local and Systemic Reactions by Vaccination
Nausea (N=31,33,36,39,31,50,34,32) 3rd vacc
|
1 Subjects
|
1 Subjects
|
3 Subjects
|
2 Subjects
|
3 Subjects
|
0 Subjects
|
2 Subjects
|
2 Subjects
|
|
Number of Subjects Reporting Local and Systemic Reactions by Vaccination
Fever≥ 38°C (N=31,48,47,51,48,29,34,32) 3rd vacc
|
2 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
1 Subjects
|
1 Subjects
|
2 Subjects
|
SECONDARY outcome
Timeframe: 21 days after booster vaccination (day 403)Population: Full analysis set (FAS)
Booster was given on day 382; seroconversion: negative pre-vaccination serum (HI titer \<10, SRH area ≤ 4 mm\^2)/positive post-vaccination titer (HI titer ≥10) or at least 50% increase in SRH area; Seroprotection is defined as a HI titer ≥40 and a SRH area ≥25 mm\^2. The number of subjects achieving seroconversion or significant increase and seroprotection were calculated at day 382.
Outcome measures
| Measure |
Concomitant Alone
n=39 Participants
1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV\_a into the other arm on day 1 then 1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV\_a into the other arm on day 1 then 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 382
|
Concomitant+Mixed
n=31 Participants
1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV\_a into the other arm on day 1, 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 382
|
Concomitant+MF59-eH5N1
1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV\_a into the other arm on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 382
|
Mixed
1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 1 and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 382
|
Mixed + Mixed
dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 1, day 22, and day 382
|
Mixed+MF59-eH5N1
1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 382
|
MF59-eH5N1+eTIV_a
1 dose of MF59-eH5N1 on day 1, 1 dose of eTIV\_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 382
|
eTIV_a+MF59-eH5N1
1 dose of eTIV\_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 382
|
|---|---|---|---|---|---|---|---|---|
|
Number of Subjects With Immunogenicity Results After the Booster Vaccination Against the MF59-eH5N1 Influenza Vaccine Mixed Extemporaneously With the Seasonal eTIV_a Influenza Vaccine
Seroconversion (HI) - seTIV_a (B) N=35, 25
|
6 Subjects
Interval 7.0 to 34.0
|
4 Subjects
Interval 5.0 to 36.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Immunogenicity Results After the Booster Vaccination Against the MF59-eH5N1 Influenza Vaccine Mixed Extemporaneously With the Seasonal eTIV_a Influenza Vaccine
Seroprotection (HI) _MF59-H5N1 (N=35, 25)
|
26 Subjects
Interval 57.0 to 88.0
|
16 Subjects
Interval 43.0 to 82.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Immunogenicity Results After the Booster Vaccination Against the MF59-eH5N1 Influenza Vaccine Mixed Extemporaneously With the Seasonal eTIV_a Influenza Vaccine
Seroconversion (HI)_MF59-H5N1
|
25 Subjects
Interval 54.0 to 85.0
|
15 Subjects
Interval 39.0 to 79.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Immunogenicity Results After the Booster Vaccination Against the MF59-eH5N1 Influenza Vaccine Mixed Extemporaneously With the Seasonal eTIV_a Influenza Vaccine
Seroprotection (SRH)_MF59-H5N1 (N=35, 25)
|
50 Subjects
Interval 39.0 to 74.0
|
7 Subjects
Interval 12.0 to 49.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Immunogenicity Results After the Booster Vaccination Against the MF59-eH5N1 Influenza Vaccine Mixed Extemporaneously With the Seasonal eTIV_a Influenza Vaccine
Seroconversion (SRH)_MF59-H5N1 (N=35, 25)
|
21 Subjects
Interval 42.0 to 76.0
|
10 Subjects
Interval 21.0 to 61.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Immunogenicity Results After the Booster Vaccination Against the MF59-eH5N1 Influenza Vaccine Mixed Extemporaneously With the Seasonal eTIV_a Influenza Vaccine
Seroprotection (HI) - eTIV_a (H1N1) N=35, 25
|
33 Subjects
Interval 81.0 to 99.0
|
24 Subjects
Interval 80.0 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Immunogenicity Results After the Booster Vaccination Against the MF59-eH5N1 Influenza Vaccine Mixed Extemporaneously With the Seasonal eTIV_a Influenza Vaccine
Seroconversion (HI) - eTIV_a (H1N1) N=39, 25
|
17 Subjects
Interval 31.0 to 66.0
|
10 Subjects
Interval 21.0 to 61.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Immunogenicity Results After the Booster Vaccination Against the MF59-eH5N1 Influenza Vaccine Mixed Extemporaneously With the Seasonal eTIV_a Influenza Vaccine
Seroprotection (HI) - eTIV_a (H3N2) N=35, 25
|
35 Subjects
Interval 90.0 to 100.0
|
25 Subjects
Interval 86.0 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Immunogenicity Results After the Booster Vaccination Against the MF59-eH5N1 Influenza Vaccine Mixed Extemporaneously With the Seasonal eTIV_a Influenza Vaccine
Seroconversion (HI) - eTIV_a (H3N2) N=39, 25
|
12 Subjects
Interval 19.0 to 52.0
|
5 Subjects
Interval 7.0 to 41.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Immunogenicity Results After the Booster Vaccination Against the MF59-eH5N1 Influenza Vaccine Mixed Extemporaneously With the Seasonal eTIV_a Influenza Vaccine
Seroprotection (HI) - eTIV_a (B) N=35, 25
|
31 Subjects
Interval 73.0 to 97.0
|
18 Subjects
Interval 51.0 to 88.0
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 21 days after booster vaccination (day 403)Population: Full analysis set (FAS)
For each vaccine group, the least squares GMRs were calculated for the HI and SRH results for each time point of the study, as well as the associated 95% confidence intervals. GMR was calculated over day 382 for all time points for the booster dose.
Outcome measures
| Measure |
Concomitant Alone
n=39 Participants
1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV\_a into the other arm on day 1 then 1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV\_a into the other arm on day 1 then 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 382
|
Concomitant+Mixed
n=31 Participants
1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV\_a into the other arm on day 1, 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 382
|
Concomitant+MF59-eH5N1
1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV\_a into the other arm on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 382
|
Mixed
1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 1 and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 382
|
Mixed + Mixed
dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 1, day 22, and day 382
|
Mixed+MF59-eH5N1
1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 382
|
MF59-eH5N1+eTIV_a
1 dose of MF59-eH5N1 on day 1, 1 dose of eTIV\_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 382
|
eTIV_a+MF59-eH5N1
1 dose of eTIV\_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 382
|
|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Ratio After the Booster Vaccination Against the MF59-eH5N1 Influenza Vaccine Mixed Extemporaneously With the Seasonal eTIV_a Influenza Vaccine
HI (eTIV_a, H1N1) N=35, 25
|
4.82 Ratio
Interval 3.05 to 7.73
|
2.61 Ratio
Interval 1.51 to 4.51
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Ratio After the Booster Vaccination Against the MF59-eH5N1 Influenza Vaccine Mixed Extemporaneously With the Seasonal eTIV_a Influenza Vaccine
HI (MF59-H5N1) N=35, 25
|
13 Ratio
Interval 6.99 to 25.0
|
7.14 Ratio
Interval 3.4 to 15.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Ratio After the Booster Vaccination Against the MF59-eH5N1 Influenza Vaccine Mixed Extemporaneously With the Seasonal eTIV_a Influenza Vaccine
SRH (MF59-H5N1) N=35, 25
|
4.88 Ratio
Interval 3.59 to 6.63
|
2.77 Ratio
Interval 1.93 to 3.98
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Ratio After the Booster Vaccination Against the MF59-eH5N1 Influenza Vaccine Mixed Extemporaneously With the Seasonal eTIV_a Influenza Vaccine
HI (eTIV_a, H3N2) N=35, 25
|
2.62 Ratio
Interval 1.83 to 3.76
|
2.21 Ratio
Interval 1.44 to 3.39
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Ratio After the Booster Vaccination Against the MF59-eH5N1 Influenza Vaccine Mixed Extemporaneously With the Seasonal eTIV_a Influenza Vaccine
HI (eTIV_a, B) N=35, 25
|
1.96 Ratio
Interval 1.55 to 2.48
|
1.94 Ratio
Interval 1.47 to 2.55
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Concomitant Alone
Serious events: 4 serious events
Other events: 38 other events
Deaths: 0 deaths
Concomitant+Mixed
Serious events: 1 serious events
Other events: 42 other events
Deaths: 0 deaths
Concomitant+MF59-eH5N1
Serious events: 2 serious events
Other events: 41 other events
Deaths: 0 deaths
Mixed
Serious events: 3 serious events
Other events: 39 other events
Deaths: 0 deaths
Mixed + Mixed
Serious events: 3 serious events
Other events: 42 other events
Deaths: 0 deaths
Mixed+MF59-eH5N1
Serious events: 0 serious events
Other events: 43 other events
Deaths: 0 deaths
MF59-eH5N1+eTIV_a
Serious events: 0 serious events
Other events: 37 other events
Deaths: 0 deaths
eTIV_a+MF59-eH5N1
Serious events: 1 serious events
Other events: 38 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Concomitant Alone
n=50 participants at risk
1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV\_a into the other arm on day 1 then 1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV\_a into the other arm on day 1 then 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 382
|
Concomitant+Mixed
n=50 participants at risk
1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV\_a into the other arm on day 1, 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 382
|
Concomitant+MF59-eH5N1
n=51 participants at risk
1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV\_a into the other arm on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 382
|
Mixed
n=51 participants at risk
1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 1 and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 382
|
Mixed + Mixed
n=51 participants at risk
dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 1, day 22, and day 382
|
Mixed+MF59-eH5N1
n=50 participants at risk
1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 382
|
MF59-eH5N1+eTIV_a
n=49 participants at risk
1 dose of MF59-eH5N1 on day 1, 1 dose of eTIV\_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 382
|
eTIV_a+MF59-eH5N1
n=49 participants at risk
1 dose of eTIV\_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 382
|
|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Appendicitis
|
0.00%
0/50 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
2.0%
1/50 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
0.00%
0/51 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
0.00%
0/51 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
0.00%
0/51 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
0.00%
0/50 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
0.00%
0/49 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
0.00%
0/49 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
|
Infections and infestations
Gastrointestinal infection
|
0.00%
0/50 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
0.00%
0/50 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
0.00%
0/51 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
2.0%
1/51 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
0.00%
0/51 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
0.00%
0/50 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
0.00%
0/49 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
0.00%
0/49 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
|
Infections and infestations
Periorbital cellulitis
|
2.0%
1/50 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
0.00%
0/50 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
0.00%
0/51 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
0.00%
0/51 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
0.00%
0/51 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
0.00%
0/50 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
0.00%
0/49 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
0.00%
0/49 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/50 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
0.00%
0/50 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
0.00%
0/51 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
2.0%
1/51 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
0.00%
0/51 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
0.00%
0/50 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
0.00%
0/49 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
0.00%
0/49 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/50 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
0.00%
0/50 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
0.00%
0/51 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
2.0%
1/51 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
0.00%
0/51 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
0.00%
0/50 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
0.00%
0/49 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
0.00%
0/49 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/50 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
0.00%
0/50 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
0.00%
0/51 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
0.00%
0/51 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
2.0%
1/51 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
0.00%
0/50 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
0.00%
0/49 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
0.00%
0/49 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
|
Investigations
Aspiration bronchial
|
0.00%
0/50 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
0.00%
0/50 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
0.00%
0/51 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
0.00%
0/51 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
2.0%
1/51 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
0.00%
0/50 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
0.00%
0/49 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
0.00%
0/49 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-Cell small lymphocytic lymphoma
|
0.00%
0/50 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
0.00%
0/50 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
2.0%
1/51 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
0.00%
0/51 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
0.00%
0/51 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
0.00%
0/50 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
0.00%
0/49 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
0.00%
0/49 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ependymoma
|
0.00%
0/50 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
0.00%
0/50 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
2.0%
1/51 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
0.00%
0/51 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
0.00%
0/51 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
0.00%
0/50 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
0.00%
0/49 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
0.00%
0/49 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
2.0%
1/50 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
0.00%
0/50 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
0.00%
0/51 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
0.00%
0/51 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
0.00%
0/51 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
0.00%
0/50 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
0.00%
0/49 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
2.0%
1/49 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous incomplete
|
2.0%
1/50 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
0.00%
0/50 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
0.00%
0/51 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
0.00%
0/51 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
0.00%
0/51 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
0.00%
0/50 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
0.00%
0/49 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
0.00%
0/49 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/50 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
0.00%
0/50 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
0.00%
0/51 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
0.00%
0/51 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
2.0%
1/51 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
0.00%
0/50 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
0.00%
0/49 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
0.00%
0/49 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
|
Injury, poisoning and procedural complications
Injury
|
2.0%
1/50 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
0.00%
0/50 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
0.00%
0/51 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
0.00%
0/51 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
0.00%
0/51 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
0.00%
0/50 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
0.00%
0/49 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
0.00%
0/49 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
Other adverse events
| Measure |
Concomitant Alone
n=50 participants at risk
1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV\_a into the other arm on day 1 then 1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV\_a into the other arm on day 1 then 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 382
|
Concomitant+Mixed
n=50 participants at risk
1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV\_a into the other arm on day 1, 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 382
|
Concomitant+MF59-eH5N1
n=51 participants at risk
1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV\_a into the other arm on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 382
|
Mixed
n=51 participants at risk
1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 1 and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 382
|
Mixed + Mixed
n=51 participants at risk
dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 1, day 22, and day 382
|
Mixed+MF59-eH5N1
n=50 participants at risk
1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 382
|
MF59-eH5N1+eTIV_a
n=49 participants at risk
1 dose of MF59-eH5N1 on day 1, 1 dose of eTIV\_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 382
|
eTIV_a+MF59-eH5N1
n=49 participants at risk
1 dose of eTIV\_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 382
|
|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Gastritis
|
2.0%
1/50 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
6.0%
3/50 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
0.00%
0/51 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
3.9%
2/51 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
3.9%
2/51 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
2.0%
1/50 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
8.2%
4/49 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
2.0%
1/49 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
|
Gastrointestinal disorders
Nausea
|
8.0%
4/50 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
10.0%
5/50 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
11.8%
6/51 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
3.9%
2/51 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
9.8%
5/51 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
8.0%
4/50 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
8.2%
4/49 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
14.3%
7/49 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
|
General disorders
Chills
|
10.0%
5/50 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
10.0%
5/50 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
19.6%
10/51 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
15.7%
8/51 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
15.7%
8/51 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
16.0%
8/50 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
10.2%
5/49 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
6.1%
3/49 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
|
General disorders
Fatigue
|
6.0%
3/50 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
8.0%
4/50 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
9.8%
5/51 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
5.9%
3/51 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
9.8%
5/51 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
8.0%
4/50 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
8.2%
4/49 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
8.2%
4/49 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
|
General disorders
Injection site erythema
|
24.0%
12/50 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
34.0%
17/50 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
33.3%
17/51 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
31.4%
16/51 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
41.2%
21/51 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
32.0%
16/50 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
32.7%
16/49 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
42.9%
21/49 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
|
General disorders
Injection site haemorrhage
|
6.0%
3/50 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
10.0%
5/50 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
3.9%
2/51 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
9.8%
5/51 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
9.8%
5/51 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
6.0%
3/50 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
6.1%
3/49 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
6.1%
3/49 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
|
General disorders
Injection site induration
|
22.0%
11/50 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
30.0%
15/50 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
39.2%
20/51 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
31.4%
16/51 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
29.4%
15/51 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
30.0%
15/50 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
20.4%
10/49 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
30.6%
15/49 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
|
General disorders
Injection site pain
|
58.0%
29/50 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
68.0%
34/50 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
64.7%
33/51 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
62.7%
32/51 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
66.7%
34/51 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
64.0%
32/50 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
67.3%
33/49 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
59.2%
29/49 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
|
General disorders
Injection site swelling
|
16.0%
8/50 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
18.0%
9/50 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
25.5%
13/51 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
19.6%
10/51 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
19.6%
10/51 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
20.0%
10/50 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
18.4%
9/49 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
22.4%
11/49 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
|
General disorders
Malaise
|
30.0%
15/50 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
34.0%
17/50 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
41.2%
21/51 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
37.3%
19/51 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
39.2%
20/51 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
42.0%
21/50 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
34.7%
17/49 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
26.5%
13/49 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
|
General disorders
Pyrexia
|
10.0%
5/50 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
0.00%
0/50 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
2.0%
1/51 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
7.8%
4/51 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
7.8%
4/51 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
16.0%
8/50 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
4.1%
2/49 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
12.2%
6/49 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
|
Infections and infestations
Influenza
|
6.0%
3/50 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
2.0%
1/50 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
0.00%
0/51 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
2.0%
1/51 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
2.0%
1/51 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
2.0%
1/50 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
2.0%
1/49 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
2.0%
1/49 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
|
Infections and infestations
Sinusitis
|
2.0%
1/50 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
2.0%
1/50 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
0.00%
0/51 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
0.00%
0/51 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
2.0%
1/51 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
0.00%
0/50 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
0.00%
0/49 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
6.1%
3/49 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
|
Infections and infestations
Tonsillitis
|
4.0%
2/50 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
4.0%
2/50 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
0.00%
0/51 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
0.00%
0/51 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
3.9%
2/51 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
6.0%
3/50 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
2.0%
1/49 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
0.00%
0/49 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.0%
3/50 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
8.0%
4/50 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
17.6%
9/51 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
11.8%
6/51 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
11.8%
6/51 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
18.0%
9/50 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
14.3%
7/49 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
12.2%
6/49 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
30.0%
15/50 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
48.0%
24/50 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
47.1%
24/51 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
45.1%
23/51 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
43.1%
22/51 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
34.0%
17/50 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
36.7%
18/49 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
34.7%
17/49 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
|
Nervous system disorders
Headache
|
36.0%
18/50 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
30.0%
15/50 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
43.1%
22/51 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
27.5%
14/51 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
49.0%
25/51 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
38.0%
19/50 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
26.5%
13/49 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
30.6%
15/49 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
|
Nervous system disorders
Migraine
|
6.0%
3/50 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
2.0%
1/50 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
0.00%
0/51 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
2.0%
1/51 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
0.00%
0/51 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
0.00%
0/50 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
0.00%
0/49 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
0.00%
0/49 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/50 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
0.00%
0/50 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
2.0%
1/51 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
3.9%
2/51 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
3.9%
2/51 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
8.0%
4/50 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
2.0%
1/49 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
0.00%
0/49 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/50 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
0.00%
0/50 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
2.0%
1/51 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
5.9%
3/51 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
3.9%
2/51 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
2.0%
1/50 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
0.00%
0/49 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
0.00%
0/49 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
6.0%
3/50 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
4.0%
2/50 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
15.7%
8/51 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
7.8%
4/51 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
5.9%
3/51 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
8.0%
4/50 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
4.1%
2/49 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
8.2%
4/49 • All adverse events and serious adverse events were collected for 20 months (the duration of the study).
the number of subjects included here are from the safety population and not the enrolled population as disclosed in the Demography and Study Termination sections.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60