Trial Outcomes & Findings for Phase 3 Safety and Immunogenicity Study of aQIV in Elderly Adults (NCT NCT03314662)
NCT ID: NCT03314662
Last Updated: 2020-07-22
Results Overview
The GMT of the post-vaccination (Day 22) hemagglutination inhibition (HI) titer. The GMT ratio was defined as the GMT for aTIV-1 (or aTIV-2) over the GMT for aQIV for all of the four strains.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1778 participants
Primary outcome timeframe
Day 22
Results posted on
2020-07-22
Participant Flow
20 study centers in the United States
All enrolled subjects were randomized.
Participant milestones
| Measure |
aQIV
MF59-adjuvanted Quadrivalent Subunit Inactivated Egg-derived Influenza Vaccine (aQIV) contains each of the 2 influenza type A strains and each of the two influenza type B strains in the vaccine.The strain composition is that recommended by the World Health Organization for the 2017-2018 Northern Hemisphere influenza season (WHO, 2017) for quadrivalent vaccines.
|
aTIV-1
Licensed MF59-adjuvanted Trivalent Subunit Inactivated Egg-derived Influenza Vaccine (aTIV-1) contains each of the 2 influenza type A strains and one influenza type B strain in the vaccine.The strain composition is that recommended by the World Health Organization for the 2017-2018 Northern Hemisphere influenza season (WHO, 2017) for trivalent vaccines.
|
aTIV-2
MF59-adjuvanted Trivalent Subunit Inactivated Egg-derived Influenza Vaccine contains each of the 2 influenza type A strains and alternate influenza type B strain in the vaccine.The strain composition is that recommended by the World Health Organization for the 2017-2018 Northern Hemisphere influenza season (WHO, 2017) for trivalent vaccines except the B strain present in this vaccine is the second/alternate B strain recommended for inclusion in quadrivalent vaccines (ie, Alternate B strain).
|
|---|---|---|---|
|
Overall Study
STARTED
|
889
|
445
|
444
|
|
Overall Study
Treated
|
888
|
444
|
444
|
|
Overall Study
COMPLETED
|
881
|
440
|
439
|
|
Overall Study
NOT COMPLETED
|
8
|
5
|
5
|
Reasons for withdrawal
| Measure |
aQIV
MF59-adjuvanted Quadrivalent Subunit Inactivated Egg-derived Influenza Vaccine (aQIV) contains each of the 2 influenza type A strains and each of the two influenza type B strains in the vaccine.The strain composition is that recommended by the World Health Organization for the 2017-2018 Northern Hemisphere influenza season (WHO, 2017) for quadrivalent vaccines.
|
aTIV-1
Licensed MF59-adjuvanted Trivalent Subunit Inactivated Egg-derived Influenza Vaccine (aTIV-1) contains each of the 2 influenza type A strains and one influenza type B strain in the vaccine.The strain composition is that recommended by the World Health Organization for the 2017-2018 Northern Hemisphere influenza season (WHO, 2017) for trivalent vaccines.
|
aTIV-2
MF59-adjuvanted Trivalent Subunit Inactivated Egg-derived Influenza Vaccine contains each of the 2 influenza type A strains and alternate influenza type B strain in the vaccine.The strain composition is that recommended by the World Health Organization for the 2017-2018 Northern Hemisphere influenza season (WHO, 2017) for trivalent vaccines except the B strain present in this vaccine is the second/alternate B strain recommended for inclusion in quadrivalent vaccines (ie, Alternate B strain).
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
5
|
4
|
4
|
|
Overall Study
Death
|
2
|
0
|
0
|
Baseline Characteristics
analysis presented for subjects with available data.
Baseline characteristics by cohort
| Measure |
aQIV
n=889 Participants
MF59-adjuvanted Quadrivalent Subunit Inactivated Egg-derived Influenza Vaccine (aQIV) contains each of the 2 influenza type A strains and each of the two influenza type B strains in the vaccine. The strain composition is that recommended by the World Health Organization for the 2017-2018 Northern Hemisphere influenza season (WHO, 2017) for quadrivalent vaccines.
|
aTIV-1
n=445 Participants
Licensed MF59-adjuvanted Trivalent Subunit Inactivated Egg-derived Influenza Vaccine (aTIV-1) contains each of the 2 influenza type A strains and one influenza type B strain in the vaccine. The strain composition is that recommended by the World Health Organization for the 2017-2018 Northern Hemisphere influenza season (WHO, 2017) for trivalent vaccines.
|
aTIV-2
n=444 Participants
MF59-adjuvanted Trivalent Subunit Inactivated Egg-derived Influenza Vaccine contains each of the 2 influenza type A strains and alternate influenza type B strain in the vaccine.The strain composition is that recommended by the World Health Organization for the 2017-2018 Northern Hemisphere influenza season (WHO, 2017) for trivalent vaccines except the B strain present in this vaccine is the second/alternate B strain recommended for inclusion in quadrivalent vaccines (ie, Alternate B strain).
|
Total
n=1778 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
72.4 years
STANDARD_DEVIATION 5.54 • n=889 Participants
|
72.4 years
STANDARD_DEVIATION 5.60 • n=445 Participants
|
72.6 years
STANDARD_DEVIATION 5.46 • n=444 Participants
|
72.5 years
STANDARD_DEVIATION 5.53 • n=1778 Participants
|
|
Sex: Female, Male
Female
|
517 Participants
n=889 Participants
|
249 Participants
n=445 Participants
|
241 Participants
n=444 Participants
|
1007 Participants
n=1778 Participants
|
|
Sex: Female, Male
Male
|
372 Participants
n=889 Participants
|
196 Participants
n=445 Participants
|
203 Participants
n=444 Participants
|
771 Participants
n=1778 Participants
|
|
Race/Ethnicity, Customized
White
|
814 Participants
n=889 Participants
|
403 Participants
n=445 Participants
|
411 Participants
n=444 Participants
|
1628 Participants
n=1778 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
59 Participants
n=889 Participants
|
37 Participants
n=445 Participants
|
29 Participants
n=444 Participants
|
125 Participants
n=1778 Participants
|
|
Race/Ethnicity, Customized
Asian
|
9 Participants
n=889 Participants
|
2 Participants
n=445 Participants
|
1 Participants
n=444 Participants
|
12 Participants
n=1778 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Pacific Islander
|
1 Participants
n=889 Participants
|
1 Participants
n=445 Participants
|
0 Participants
n=444 Participants
|
2 Participants
n=1778 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
5 Participants
n=889 Participants
|
0 Participants
n=445 Participants
|
2 Participants
n=444 Participants
|
7 Participants
n=1778 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=889 Participants
|
2 Participants
n=445 Participants
|
1 Participants
n=444 Participants
|
4 Participants
n=1778 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
59 Participants
n=889 Participants
|
37 Participants
n=445 Participants
|
31 Participants
n=444 Participants
|
127 Participants
n=1778 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
827 Participants
n=889 Participants
|
408 Participants
n=445 Participants
|
410 Participants
n=444 Participants
|
1645 Participants
n=1778 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
2 Participants
n=889 Participants
|
0 Participants
n=445 Participants
|
2 Participants
n=444 Participants
|
4 Participants
n=1778 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
1 Participants
n=889 Participants
|
0 Participants
n=445 Participants
|
1 Participants
n=444 Participants
|
2 Participants
n=1778 Participants
|
|
Region of Enrollment
United States
|
889 participants
n=889 Participants
|
445 participants
n=445 Participants
|
444 participants
n=444 Participants
|
1778 participants
n=1778 Participants
|
|
Height
|
167.54 cm
STANDARD_DEVIATION 9.350 • n=885 Participants • analysis presented for subjects with available data.
|
167.92 cm
STANDARD_DEVIATION 10.535 • n=442 Participants • analysis presented for subjects with available data.
|
168.38 cm
STANDARD_DEVIATION 10.646 • n=444 Participants • analysis presented for subjects with available data.
|
167.84 cm
STANDARD_DEVIATION 9.990 • n=1771 Participants • analysis presented for subjects with available data.
|
|
Weight
|
83.24 kg
STANDARD_DEVIATION 19.064 • n=885 Participants • analysis presented for subjects with available data.
|
84.18 kg
STANDARD_DEVIATION 8.963 • n=442 Participants • analysis presented for subjects with available data.
|
84.24 kg
STANDARD_DEVIATION 17.825 • n=444 Participants • analysis presented for subjects with available data.
|
83.73 kg
STANDARD_DEVIATION 18.731 • n=1771 Participants • analysis presented for subjects with available data.
|
|
BMI
|
29.60 kg/m^2
STANDARD_DEVIATION 6.157 • n=885 Participants • analysis presented for subjects with available data.
|
29.79 kg/m^2
STANDARD_DEVIATION 5.858 • n=442 Participants • analysis presented for subjects with available data.
|
29.69 kg/m^2
STANDARD_DEVIATION 5.647 • n=444 Participants • analysis presented for subjects with available data.
|
29.67 kg/m^2
STANDARD_DEVIATION 5.956 • n=1771 Participants • analysis presented for subjects with available data.
|
|
Influenza Vaccination History
No
|
129 Participants
n=889 Participants
|
65 Participants
n=445 Participants
|
43 Participants
n=444 Participants
|
237 Participants
n=1778 Participants
|
|
Influenza Vaccination History
Yes
|
760 Participants
n=889 Participants
|
380 Participants
n=445 Participants
|
401 Participants
n=444 Participants
|
1541 Participants
n=1778 Participants
|
|
Total Risk Score (Comorbidity)
|
46.0 units on a scale
STANDARD_DEVIATION 33.50 • n=889 Participants
|
44.6 units on a scale
STANDARD_DEVIATION 30.25 • n=445 Participants
|
46.5 units on a scale
STANDARD_DEVIATION 34.15 • n=444 Participants
|
45.8 units on a scale
STANDARD_DEVIATION 32.88 • n=1778 Participants
|
PRIMARY outcome
Timeframe: Day 22Population: The per protocol set (PPS) Immunogenicity comprised all subjects who were randomized, received at least 1 study vaccination, and provided immunogenicity data at Day 1 and Day 22, and who did not have any major protocol deviations that were assessed as potentially impacting on immunogenicity results
The GMT of the post-vaccination (Day 22) hemagglutination inhibition (HI) titer. The GMT ratio was defined as the GMT for aTIV-1 (or aTIV-2) over the GMT for aQIV for all of the four strains.
Outcome measures
| Measure |
aQIV
n=872 Participants
MF59-adjuvanted Quadrivalent Subunit Inactivated Egg-derived Influenza Vaccine (aQIV) contains each of the 2 influenza type A strains and each of the 2 influenza type B strains in the vaccine. The strain composition is that recommended by the World Health Organization for the 2017-2018 Northern Hemisphere influenza season (WHO, 2017) for quadrivalent vaccines.
|
aTIV-1
n=436 Participants
Licensed MF59-adjuvanted Trivalent Subunit Inactivated Egg-derived Influenza Vaccine (aTIV-1) contains each of the 2 influenza type A strains and one influenza type B strain in the vaccine. The strain composition is that recommended by the World Health Organization for the 2017-2018 Northern Hemisphere influenza season (WHO, 2017) for trivalent vaccines.
|
aTIV-2
n=433 Participants
MF59-adjuvanted Trivalent Subunit Inactivated Egg-derived Influenza Vaccine (aTIV-2) contains each of the 2 influenza type A strains and alternate influenza type B strain in the vaccine. The strain composition is that recommended by the World Health Organization for the 2017-2018 Northern Hemisphere influenza season (WHO, 2017) for trivalent vaccines except the B strain present in this vaccine is the second/alternate B strain recommended for inclusion in quadrivalent vaccines (ie, Alternate B strain).
|
aTIV-1/aTIV-2
n=869 Participants
Pooled Subjects Treated with aTIV-1 and aTIV-2
|
|---|---|---|---|---|
|
Immunogenicity Endpoint: The Geometric Mean Titer (GMT) and GMT Ratio for the Four Strains Included in the Vaccine, Non-inferiority Analysis.
A/H1N1
|
65.01 Geometric mean titer
Interval 57.79 to 73.13
|
NA Geometric mean titer
Analysis not specified for individual strain.
|
NA Geometric mean titer
Analysis not specified for individual strain.
|
75.16 Geometric mean titer
Interval 66.68 to 84.72
|
|
Immunogenicity Endpoint: The Geometric Mean Titer (GMT) and GMT Ratio for the Four Strains Included in the Vaccine, Non-inferiority Analysis.
A/H3N2
|
294.91 Geometric mean titer
Interval 261.88 to 332.09
|
NA Geometric mean titer
Analysis not specified for individual strain.
|
NA Geometric mean titer
Analysis not specified for individual strain.
|
293.31 Geometric mean titer
Interval 259.91 to 330.99
|
|
Immunogenicity Endpoint: The Geometric Mean Titer (GMT) and GMT Ratio for the Four Strains Included in the Vaccine, Non-inferiority Analysis.
B/Yamagata
|
24.67 Geometric mean titer
Interval 22.67 to 26.84
|
15.96 Geometric mean titer
Interval 14.48 to 17.59
|
24.30 Geometric mean titer
Interval 22.0 to 26.84
|
NA Geometric mean titer
Analysis was not performed
|
|
Immunogenicity Endpoint: The Geometric Mean Titer (GMT) and GMT Ratio for the Four Strains Included in the Vaccine, Non-inferiority Analysis.
B/Victoria
|
30.78 Geometric mean titer
Interval 28.27 to 33.51
|
30.13 Geometric mean titer
Interval 27.31 to 33.24
|
21.80 Geometric mean titer
Interval 19.73 to 24.09
|
NA Geometric mean titer
Analysis was not performed
|
PRIMARY outcome
Timeframe: Day 22Population: The per protocol set (PPS) Immunogenicity comprised all subjects who were randomized, received at least 1 study vaccination, and provided immunogenicity data at Day 1 and Day 22, and who did not have any major protocol deviations that were assessed as potentially impacting on immunogenicity results.
The SCR is defined as the percentage of subjects with either a pre-vaccination HI titer \< 1:10 and a post-vaccination HI titer \>= 1:40 or a pre-vaccination HI titer \>= 1:10 and a \>= 4-fold increase in post-vaccination HI titer. The SCR Difference is defined as the difference between the SCR of post- vaccination (Day 22) HI titer for aTIV-1 (or aTIV-2) and the SCR of post-vaccination (Day 22) HI titer for aQIV. aTIV-1 and aTIV-2 vaccine groups are pooled for the analysis of A-H1N1 and A-H3N2 strains. For B/Victoria TIV=TIV-1. For B/Yamagata TIV=TIV-2.
Outcome measures
| Measure |
aQIV
n=872 Participants
MF59-adjuvanted Quadrivalent Subunit Inactivated Egg-derived Influenza Vaccine (aQIV) contains each of the 2 influenza type A strains and each of the 2 influenza type B strains in the vaccine. The strain composition is that recommended by the World Health Organization for the 2017-2018 Northern Hemisphere influenza season (WHO, 2017) for quadrivalent vaccines.
|
aTIV-1
n=436 Participants
Licensed MF59-adjuvanted Trivalent Subunit Inactivated Egg-derived Influenza Vaccine (aTIV-1) contains each of the 2 influenza type A strains and one influenza type B strain in the vaccine. The strain composition is that recommended by the World Health Organization for the 2017-2018 Northern Hemisphere influenza season (WHO, 2017) for trivalent vaccines.
|
aTIV-2
n=433 Participants
MF59-adjuvanted Trivalent Subunit Inactivated Egg-derived Influenza Vaccine (aTIV-2) contains each of the 2 influenza type A strains and alternate influenza type B strain in the vaccine. The strain composition is that recommended by the World Health Organization for the 2017-2018 Northern Hemisphere influenza season (WHO, 2017) for trivalent vaccines except the B strain present in this vaccine is the second/alternate B strain recommended for inclusion in quadrivalent vaccines (ie, Alternate B strain).
|
aTIV-1/aTIV-2
Pooled Subjects Treated with aTIV-1 and aTIV-2
|
|---|---|---|---|---|
|
Immunogenicity Endpoint: The Difference Between the Seroconversion Rate (SCR) for the Four Strains Included in the Vaccine, Non-inferiority Analysis
A/H1N1
|
35.21 percentage of subjects
Interval 32.0 to 38.5
|
39.45 percentage of subjects
Interval 34.8 to 44.2
|
37.41 percentage of subjects
Interval 32.8 to 44.2
|
—
|
|
Immunogenicity Endpoint: The Difference Between the Seroconversion Rate (SCR) for the Four Strains Included in the Vaccine, Non-inferiority Analysis
A/H3N2
|
39.33 percentage of subjects
Interval 36.1 to 42.7
|
39.70 percentage of subjects
Interval 36.4 to 43.0
|
37.18 percentage of subjects
Interval 32.6 to 41.9
|
—
|
|
Immunogenicity Endpoint: The Difference Between the Seroconversion Rate (SCR) for the Four Strains Included in the Vaccine, Non-inferiority Analysis
B/Yamagata
|
16.4 percentage of subjects
Interval 14.0 to 19.0
|
NA percentage of subjects
Not applicable as the strain is not present in aTIV vaccine
|
15.47 percentage of subjects
Interval 12.2 to 19.2
|
—
|
|
Immunogenicity Endpoint: The Difference Between the Seroconversion Rate (SCR) for the Four Strains Included in the Vaccine, Non-inferiority Analysis
B/Victoria
|
13.42 percentage of subjects
Interval 11.2 to 15.9
|
12.16 percentage of subjects
Interval 9.24 to 15.6
|
NA percentage of subjects
Not applicable as the strain is not present in aTIV vaccine
|
—
|
PRIMARY outcome
Timeframe: Day 22Population: The PPS Immunogenicity comprised all subjects who were randomized, received at least 1 study vaccination, and provided immunogenicity data at Day 1 and Day 22, and who did not have any major protocol deviations that were assessed as potentially impacting on immunogenicity results.
The percentage of subjects vaccinated with aQIV achieving SCR at Day 22 was assessed for each of the 4 strains. SCR was defined as the percentage of subjects with either a pre-vaccination HI titer \<1:10 and a post-vaccination HI titer ≥1:40 or a pre-vaccination HI titer ≥1:10 and a ≥4-fold increase in post-vaccination HI titer. Assessment criteria was considered fulfilled if the lower bound of the two-sided 95% confidence interval for the percentage of subjects achieving SCR for HI antibody should meet or exceed 30%.
Outcome measures
| Measure |
aQIV
n=872 Participants
MF59-adjuvanted Quadrivalent Subunit Inactivated Egg-derived Influenza Vaccine (aQIV) contains each of the 2 influenza type A strains and each of the 2 influenza type B strains in the vaccine. The strain composition is that recommended by the World Health Organization for the 2017-2018 Northern Hemisphere influenza season (WHO, 2017) for quadrivalent vaccines.
|
aTIV-1
n=436 Participants
Licensed MF59-adjuvanted Trivalent Subunit Inactivated Egg-derived Influenza Vaccine (aTIV-1) contains each of the 2 influenza type A strains and one influenza type B strain in the vaccine. The strain composition is that recommended by the World Health Organization for the 2017-2018 Northern Hemisphere influenza season (WHO, 2017) for trivalent vaccines.
|
aTIV-2
n=433 Participants
MF59-adjuvanted Trivalent Subunit Inactivated Egg-derived Influenza Vaccine (aTIV-2) contains each of the 2 influenza type A strains and alternate influenza type B strain in the vaccine. The strain composition is that recommended by the World Health Organization for the 2017-2018 Northern Hemisphere influenza season (WHO, 2017) for trivalent vaccines except the B strain present in this vaccine is the second/alternate B strain recommended for inclusion in quadrivalent vaccines (ie, Alternate B strain).
|
aTIV-1/aTIV-2
Pooled Subjects Treated with aTIV-1 and aTIV-2
|
|---|---|---|---|---|
|
Immunogenicity Endpoint: The Percentage of Subjects Achieving SCR for Hemagglutination Inhibition (HI) Antibody for the Four Strains Included in the Vaccine.
A/H1N1
|
35.21 Percentage of subjects
Interval 32.03 to 38.48
|
39.45 Percentage of subjects
Interval 34.8 to 44.2
|
37.41 Percentage of subjects
Interval 32.8 to 40.2
|
—
|
|
Immunogenicity Endpoint: The Percentage of Subjects Achieving SCR for Hemagglutination Inhibition (HI) Antibody for the Four Strains Included in the Vaccine.
A/H3N2
|
39.33 Percentage of subjects
Interval 36.08 to 42.67
|
39.70 Percentage of subjects
Interval 36.43 to 43.04
|
37.18 Percentage of subjects
Interval 32.6 to 41.9
|
—
|
|
Immunogenicity Endpoint: The Percentage of Subjects Achieving SCR for Hemagglutination Inhibition (HI) Antibody for the Four Strains Included in the Vaccine.
B/Yamagata
|
16.40 Percentage of subjects
Interval 14.0 to 19.03
|
NA Percentage of subjects
Not applicable as the strain is not present in an aTIV vaccine
|
15.47 Percentage of subjects
Interval 12.2 to 19.2
|
—
|
|
Immunogenicity Endpoint: The Percentage of Subjects Achieving SCR for Hemagglutination Inhibition (HI) Antibody for the Four Strains Included in the Vaccine.
B/Victoria
|
13.42 Percentage of subjects
Interval 11.22 to 15.86
|
12.16 Percentage of subjects
Interval 9.24 to 15.6
|
NA Percentage of subjects
Not applicable as the strain is not present in an aTIV vaccine
|
—
|
PRIMARY outcome
Timeframe: Day 22Population: The PPS Immunogenicity comprised all subjects who were randomized, received at least 1 study vaccination, and provided immunogenicity data at Day 1 and Day 22, and who did not have any major protocol deviations that were assessed as potentially impacting on immunogenicity results.
The percentage of subjects vaccinated with aQIV achieving HI antibody titers ≥ 1:40 at Day 22 was assessed for each of the 4 strains. Assessment criteria was considered fulfilled if the lower bound of the two-sided 95% confidence interval for the percentage of subjects achieving a post-vaccination HI antibody titer ≥ 1:40 should meet or exceed 60%.
Outcome measures
| Measure |
aQIV
n=872 Participants
MF59-adjuvanted Quadrivalent Subunit Inactivated Egg-derived Influenza Vaccine (aQIV) contains each of the 2 influenza type A strains and each of the 2 influenza type B strains in the vaccine. The strain composition is that recommended by the World Health Organization for the 2017-2018 Northern Hemisphere influenza season (WHO, 2017) for quadrivalent vaccines.
|
aTIV-1
n=436 Participants
Licensed MF59-adjuvanted Trivalent Subunit Inactivated Egg-derived Influenza Vaccine (aTIV-1) contains each of the 2 influenza type A strains and one influenza type B strain in the vaccine. The strain composition is that recommended by the World Health Organization for the 2017-2018 Northern Hemisphere influenza season (WHO, 2017) for trivalent vaccines.
|
aTIV-2
n=433 Participants
MF59-adjuvanted Trivalent Subunit Inactivated Egg-derived Influenza Vaccine (aTIV-2) contains each of the 2 influenza type A strains and alternate influenza type B strain in the vaccine. The strain composition is that recommended by the World Health Organization for the 2017-2018 Northern Hemisphere influenza season (WHO, 2017) for trivalent vaccines except the B strain present in this vaccine is the second/alternate B strain recommended for inclusion in quadrivalent vaccines (ie, Alternate B strain).
|
aTIV-1/aTIV-2
Pooled Subjects Treated with aTIV-1 and aTIV-2
|
|---|---|---|---|---|
|
Immunogenicity Endpoint: The Percent of Subjects Achieving an HI Antibody Titer ≥ 1:40 for the Four Strains Included in the Vaccines.
A/H1N1
|
69.38 Percentage of subjects
Interval 66.2 to 72.43
|
71.79 Percentage of subjects
Interval 67.31 to 75.97
|
68.82 Percentage of subjects
Interval 64.23 to 73.16
|
—
|
|
Immunogenicity Endpoint: The Percent of Subjects Achieving an HI Antibody Titer ≥ 1:40 for the Four Strains Included in the Vaccines.
A/H3N2
|
93.92 Percentage of subjects
Interval 92.12 to 95.41
|
94.72 Percentage of subjects
Interval 92.19 to 96.63
|
94.92 Percentage of subjects
Interval 92.41 to 96.79
|
—
|
|
Immunogenicity Endpoint: The Percent of Subjects Achieving an HI Antibody Titer ≥ 1:40 for the Four Strains Included in the Vaccines.
B/Yamagata
|
32.80 Percentage of subjects
Interval 29.69 to 36.03
|
21.79 Percentage of subjects
Interval 18.0 to 25.96
|
36.95 Percentage of subjects
Interval 32.39 to 41.69
|
—
|
|
Immunogenicity Endpoint: The Percent of Subjects Achieving an HI Antibody Titer ≥ 1:40 for the Four Strains Included in the Vaccines.
B/Victoria
|
38.19 Percentage of subjects
Interval 34.95 to 41.51
|
36.93 Percentage of subjects
Interval 32.38 to 41.65
|
24.48 Percentage of subjects
Interval 20.5 to 28.81
|
—
|
SECONDARY outcome
Timeframe: Day 1 and Day 22Population: The PPS Immunogenicity comprised all subjects who were randomized, received at least 1 study vaccination, and provided immunogenicity data at Day 1 and Day 22, and who did not have any major protocol deviations that were assessed as potentially impacting on immunogenicity results.
For the assessment of GMTs using HI assay, aTIV-1 and aTIV-2 vaccine groups were pooled for the analysis of A-H1N1 and A-H3N2 strains. aTIV-1 and aTIV-2 vaccine groups are pooled for the analysis of A-H1N1 and A-H3N2 strains. For B-Victoria TIV=aTIV-1. For B-Yamagata TIV=aTIV-2. The immunologic superiority in HI antibody responses for the alternate B strain (eg, the influenza B strain included in the aQIV but not in the aTIV formulation) were assessed for each aTIV separately, using the GMT ratio (aTIV/aQIV) at Day 22.
Outcome measures
| Measure |
aQIV
n=872 Participants
MF59-adjuvanted Quadrivalent Subunit Inactivated Egg-derived Influenza Vaccine (aQIV) contains each of the 2 influenza type A strains and each of the 2 influenza type B strains in the vaccine. The strain composition is that recommended by the World Health Organization for the 2017-2018 Northern Hemisphere influenza season (WHO, 2017) for quadrivalent vaccines.
|
aTIV-1
n=436 Participants
Licensed MF59-adjuvanted Trivalent Subunit Inactivated Egg-derived Influenza Vaccine (aTIV-1) contains each of the 2 influenza type A strains and one influenza type B strain in the vaccine. The strain composition is that recommended by the World Health Organization for the 2017-2018 Northern Hemisphere influenza season (WHO, 2017) for trivalent vaccines.
|
aTIV-2
n=433 Participants
MF59-adjuvanted Trivalent Subunit Inactivated Egg-derived Influenza Vaccine (aTIV-2) contains each of the 2 influenza type A strains and alternate influenza type B strain in the vaccine. The strain composition is that recommended by the World Health Organization for the 2017-2018 Northern Hemisphere influenza season (WHO, 2017) for trivalent vaccines except the B strain present in this vaccine is the second/alternate B strain recommended for inclusion in quadrivalent vaccines (ie, Alternate B strain).
|
aTIV-1/aTIV-2
n=869 Participants
Pooled Subjects Treated with aTIV-1 and aTIV-2
|
|---|---|---|---|---|
|
Immunogenicity Endpoint: Geometric Mean Titers (GMT) Against Homologous Strains
A/H1N1 Day 1
|
19.07 geometric mean titer
Interval 17.66 to 20.6
|
NA geometric mean titer
Analysis not specified for individual strain.
|
NA geometric mean titer
Analysis not specified for individual strain.
|
18.77 geometric mean titer
Interval 17.47 to 20.17
|
|
Immunogenicity Endpoint: Geometric Mean Titers (GMT) Against Homologous Strains
A/H1N1 Day 22
|
57.07 geometric mean titer
Interval 52.67 to 61.84
|
NA geometric mean titer
Analysis not specified for individual strain.
|
NA geometric mean titer
Analysis not specified for individual strain.
|
63.73 geometric mean titer
Interval 58.6 to 69.32
|
|
Immunogenicity Endpoint: Geometric Mean Titers (GMT) Against Homologous Strains
A/H3N2 Day 1
|
73.27 geometric mean titer
Interval 66.36 to 80.9
|
NA geometric mean titer
Analysis not specified for individual strain.
|
NA geometric mean titer
Analysis not specified for individual strain.
|
71.83 geometric mean titer
Interval 65.39 to 78.9
|
|
Immunogenicity Endpoint: Geometric Mean Titers (GMT) Against Homologous Strains
A/H3N2 Day 22
|
245.85 geometric mean titer
Interval 225.57 to 267.95
|
NA geometric mean titer
Analysis not specified for individual strain.
|
NA geometric mean titer
Analysis not specified for individual strain.
|
236.27 geometric mean titer
Interval 217.53 to 256.63
|
|
Immunogenicity Endpoint: Geometric Mean Titers (GMT) Against Homologous Strains
B/Yamagata Day 1
|
10.41 geometric mean titer
Interval 9.86 to 10.98
|
NA geometric mean titer
Analysis not specified for alternate strain.
|
10.76 geometric mean titer
Interval 9.97 to 11.61
|
NA geometric mean titer
Analysis was not performed.
|
|
Immunogenicity Endpoint: Geometric Mean Titers (GMT) Against Homologous Strains
B/Yamagata Day 22
|
21.15 geometric mean titer
Interval 19.75 to 22.66
|
NA geometric mean titer
Analysis not specified for alternate strain.
|
20.74 geometric mean titer
Interval 18.86 to 22.8
|
NA geometric mean titer
Analysis was not performed.
|
|
Immunogenicity Endpoint: Geometric Mean Titers (GMT) Against Homologous Strains
B/Victoria Day 1
|
14.15 geometric mean titer
Interval 13.3 to 15.05
|
15.18 geometric mean titer
Interval 13.85 to 16.64
|
NA geometric mean titer
Analysis not specified for alternate strain.
|
NA geometric mean titer
Analysis was not performed.
|
|
Immunogenicity Endpoint: Geometric Mean Titers (GMT) Against Homologous Strains
B/Victoria Day 22
|
24.91 geometric mean titer
Interval 23.21 to 26.74
|
25.54 geometric mean titer
Interval 23.03 to 28.33
|
NA geometric mean titer
Analysis not specified for alternate strain.
|
NA geometric mean titer
Analysis was not performed.
|
SECONDARY outcome
Timeframe: Day 22/Day 1Population: The PPS Immunogenicity comprised all subjects who were randomized, received at least 1 study vaccination, and provided immunogenicity data at Day 1 and Day 22, and who did not have any major protocol deviations that were assessed as potentially impacting on immunogenicity results.
The GMR was assessed as the postvaccination HI titer divided by the prevaccination HI titer (Day 22/Day 1). aTIV-1 and aTIV-2 vaccine groups were pooled for the analysis of A-H1N1 and A-H3N2 strains. For B-Victoria TIV=aTIV-1. For B-Yamagata TIV=aTIV-2.
Outcome measures
| Measure |
aQIV
n=872 Participants
MF59-adjuvanted Quadrivalent Subunit Inactivated Egg-derived Influenza Vaccine (aQIV) contains each of the 2 influenza type A strains and each of the 2 influenza type B strains in the vaccine. The strain composition is that recommended by the World Health Organization for the 2017-2018 Northern Hemisphere influenza season (WHO, 2017) for quadrivalent vaccines.
|
aTIV-1
n=436 Participants
Licensed MF59-adjuvanted Trivalent Subunit Inactivated Egg-derived Influenza Vaccine (aTIV-1) contains each of the 2 influenza type A strains and one influenza type B strain in the vaccine. The strain composition is that recommended by the World Health Organization for the 2017-2018 Northern Hemisphere influenza season (WHO, 2017) for trivalent vaccines.
|
aTIV-2
n=433 Participants
MF59-adjuvanted Trivalent Subunit Inactivated Egg-derived Influenza Vaccine (aTIV-2) contains each of the 2 influenza type A strains and alternate influenza type B strain in the vaccine. The strain composition is that recommended by the World Health Organization for the 2017-2018 Northern Hemisphere influenza season (WHO, 2017) for trivalent vaccines except the B strain present in this vaccine is the second/alternate B strain recommended for inclusion in quadrivalent vaccines (ie, Alternate B strain).
|
aTIV-1/aTIV-2
n=869 Participants
Pooled Subjects Treated with aTIV-1 and aTIV-2
|
|---|---|---|---|---|
|
Immunogenicity Endpoint: Geometric Mean Ratio (GMR) of Post Vaccination HI Titer Over the Pre-vaccination HI Titer Against Homologous Strains
B/Yamagata
|
2.03 geometric mean ratio
Interval 1.92 to 2.15
|
NA geometric mean ratio
Analysis not specified for alternate strain.
|
1.93 geometric mean ratio
Interval 1.79 to 2.08
|
NA geometric mean ratio
Analysis was not performed.
|
|
Immunogenicity Endpoint: Geometric Mean Ratio (GMR) of Post Vaccination HI Titer Over the Pre-vaccination HI Titer Against Homologous Strains
A/H1N1
|
2.99 geometric mean ratio
Interval 2.78 to 3.22
|
NA geometric mean ratio
Analysis not specified for individual strain.
|
NA geometric mean ratio
Analysis not specified for individual strain.
|
3.40 geometric mean ratio
Interval 3.14 to 3.67
|
|
Immunogenicity Endpoint: Geometric Mean Ratio (GMR) of Post Vaccination HI Titer Over the Pre-vaccination HI Titer Against Homologous Strains
A/H3N2
|
3.36 geometric mean ratio
Interval 3.07 to 3.66
|
NA geometric mean ratio
Analysis not specified for individual strain.
|
NA geometric mean ratio
Analysis not specified for individual strain.
|
3.29 geometric mean ratio
Interval 3.02 to 3.59
|
|
Immunogenicity Endpoint: Geometric Mean Ratio (GMR) of Post Vaccination HI Titer Over the Pre-vaccination HI Titer Against Homologous Strains
B/Victoria
|
1.76 geometric mean ratio
Interval 1.66 to 1.86
|
1.68 geometric mean ratio
Interval 1.55 to 1.82
|
NA geometric mean ratio
Analysis not specified for alternate strain.
|
NA geometric mean ratio
Analysis was not performed.
|
SECONDARY outcome
Timeframe: Day 1 and Day 22Population: The PPS Immunogenicity comprised all subjects who were randomized, received at least 1 study vaccination, and provided immunogenicity data at Day 1 and Day 22, and who did not have any major protocol deviations that were assessed as potentially impacting on immunogenicity results.
The percentage of subjects with HI titer of ≥1:40 at Day 1 (prevaccination) and Day 22 (postvaccination) was assessed for homologous strains. aTIV-1 and aTIV-2 vaccine groups are pooled for the analysis of A-H1N1 and A-H3N2 strains. For B/Victoria TIV=TIV-1. For B/Yamagata TIV=TIV-2.
Outcome measures
| Measure |
aQIV
n=872 Participants
MF59-adjuvanted Quadrivalent Subunit Inactivated Egg-derived Influenza Vaccine (aQIV) contains each of the 2 influenza type A strains and each of the 2 influenza type B strains in the vaccine. The strain composition is that recommended by the World Health Organization for the 2017-2018 Northern Hemisphere influenza season (WHO, 2017) for quadrivalent vaccines.
|
aTIV-1
n=436 Participants
Licensed MF59-adjuvanted Trivalent Subunit Inactivated Egg-derived Influenza Vaccine (aTIV-1) contains each of the 2 influenza type A strains and one influenza type B strain in the vaccine. The strain composition is that recommended by the World Health Organization for the 2017-2018 Northern Hemisphere influenza season (WHO, 2017) for trivalent vaccines.
|
aTIV-2
n=433 Participants
MF59-adjuvanted Trivalent Subunit Inactivated Egg-derived Influenza Vaccine (aTIV-2) contains each of the 2 influenza type A strains and alternate influenza type B strain in the vaccine. The strain composition is that recommended by the World Health Organization for the 2017-2018 Northern Hemisphere influenza season (WHO, 2017) for trivalent vaccines except the B strain present in this vaccine is the second/alternate B strain recommended for inclusion in quadrivalent vaccines (ie, Alternate B strain).
|
aTIV-1/aTIV-2
n=869 Participants
Pooled Subjects Treated with aTIV-1 and aTIV-2
|
|---|---|---|---|---|
|
Immunogenicity Endpoint: The Percentage of Subjects With a Titer ≥1:40 Against Homologous Strains
A/H3N2 Day 1
|
70.64 percentage of subjects
Interval 67.5 to 73.65
|
NA percentage of subjects
Analysis not specified for individual strain.
|
NA percentage of subjects
Analysis not specified for individual strain.
|
70.66 percentage of subjects
Interval 67.5 to 73.67
|
|
Immunogenicity Endpoint: The Percentage of Subjects With a Titer ≥1:40 Against Homologous Strains
B/Yamagata Day 22
|
32.80 percentage of subjects
Interval 26.69 to 36.03
|
NA percentage of subjects
Analysis not specified for alternate strain.
|
36.95 percentage of subjects
Interval 32.39 to 41.69
|
NA percentage of subjects
Analysis was not performed.
|
|
Immunogenicity Endpoint: The Percentage of Subjects With a Titer ≥1:40 Against Homologous Strains
B/Victoria Day 22
|
38.19 percentage of subjects
Interval 34.95 to 41.51
|
36.93 percentage of subjects
Interval 32.38 to 41.65
|
NA percentage of subjects
Analysis not specified for alternate strain.
|
NA percentage of subjects
Analysis was not performed.
|
|
Immunogenicity Endpoint: The Percentage of Subjects With a Titer ≥1:40 Against Homologous Strains
A/H1N1 Day 1
|
33.26 percentage of subjects
Interval 30.13 to 36.49
|
NA percentage of subjects
Analysis not specified for individual strain.
|
NA percentage of subjects
Analysis not specified for individual strain.
|
31.07 percentage of subjects
Interval 28.0 to 34.27
|
|
Immunogenicity Endpoint: The Percentage of Subjects With a Titer ≥1:40 Against Homologous Strains
A/H1N1 Day 22
|
69.38 percentage of subjects
Interval 66.2 to 72.43
|
NA percentage of subjects
Analysis not specified for individual strain.
|
NA percentage of subjects
Analysis not specified for individual strain.
|
70.31 percentage of subjects
Interval 67.15 to 73.33
|
|
Immunogenicity Endpoint: The Percentage of Subjects With a Titer ≥1:40 Against Homologous Strains
A/H3N2 Day 22
|
93.92 percentage of subjects
Interval 92.12 to 95.41
|
NA percentage of subjects
Analysis not specified for individual strain.
|
NA percentage of subjects
Analysis not specified for individual strain.
|
94.82 percentage of subjects
Interval 93.13 to 96.2
|
|
Immunogenicity Endpoint: The Percentage of Subjects With a Titer ≥1:40 Against Homologous Strains
B/Yamagata Day 1
|
11.12 percentage of subjects
Interval 9.11 to 13.4
|
NA percentage of subjects
Analysis not specified for alternate strain.
|
11.55 percentage of subjects
Interval 8.69 to 14.94
|
NA percentage of subjects
Analysis was not performed.
|
|
Immunogenicity Endpoint: The Percentage of Subjects With a Titer ≥1:40 Against Homologous Strains
B/Victoria Day 1
|
19.72 percentage of subjects
Interval 17.13 to 22.52
|
22.71 percentage of subjects
Interval 18.86 to 26.93
|
NA percentage of subjects
Analysis not specified for alternate strain.
|
NA percentage of subjects
Analysis was not performed.
|
SECONDARY outcome
Timeframe: Day 22Population: The PPS Immunogenicity comprised all subjects who were randomized, received at least 1 study vaccination, and provided immunogenicity data at Day 1 and Day 22, and who did not have any major protocol deviations that were assessed as potentially impacting on immunogenicity results.
The SCR was defined as the percentage of subjects with either a prevaccination HI titer \<1:10 and a postvaccination HI titer ≥1:40 or a prevaccination HI titer ≥1:10 and a ≥4-fold increase in postvaccination HI titer. For assessment if SCR using HI assay, aTIV-1 and aTIV-2 vaccine groups were pooled for the analysis of A-H1N1 and A-H3N2 strains. For B-Victoria TIV=aTIV-1. For B-Yamagata TIV=aTIV-2. The immunologic superiority in HI antibody responses for the alternate B strain (eg, the influenza B strain included in the aQIV but not in the aTIV formulation) were assessed for each aTIV separately, using the difference in SCR (aTIV-aQIV) at Day 22.
Outcome measures
| Measure |
aQIV
n=872 Participants
MF59-adjuvanted Quadrivalent Subunit Inactivated Egg-derived Influenza Vaccine (aQIV) contains each of the 2 influenza type A strains and each of the 2 influenza type B strains in the vaccine. The strain composition is that recommended by the World Health Organization for the 2017-2018 Northern Hemisphere influenza season (WHO, 2017) for quadrivalent vaccines.
|
aTIV-1
n=436 Participants
Licensed MF59-adjuvanted Trivalent Subunit Inactivated Egg-derived Influenza Vaccine (aTIV-1) contains each of the 2 influenza type A strains and one influenza type B strain in the vaccine. The strain composition is that recommended by the World Health Organization for the 2017-2018 Northern Hemisphere influenza season (WHO, 2017) for trivalent vaccines.
|
aTIV-2
n=433 Participants
MF59-adjuvanted Trivalent Subunit Inactivated Egg-derived Influenza Vaccine (aTIV-2) contains each of the 2 influenza type A strains and alternate influenza type B strain in the vaccine. The strain composition is that recommended by the World Health Organization for the 2017-2018 Northern Hemisphere influenza season (WHO, 2017) for trivalent vaccines except the B strain present in this vaccine is the second/alternate B strain recommended for inclusion in quadrivalent vaccines (ie, Alternate B strain).
|
aTIV-1/aTIV-2
n=869 Participants
Pooled Subjects Treated with aTIV-1 and aTIV-2
|
|---|---|---|---|---|
|
Immunogenicity Endpoint: The Percentage of Subjects With SCR Against Homologous Strains
A/H1N1
|
35.21 Percentage of subjects
Interval 32.03 to 38.48
|
NA Percentage of subjects
Analysis not specified for individual strain.
|
NA Percentage of subjects
Analysis not specified for individual strain.
|
38.43 Percentage of subjects
Interval 35.19 to 41.76
|
|
Immunogenicity Endpoint: The Percentage of Subjects With SCR Against Homologous Strains
A/H3N2
|
39.33 Percentage of subjects
Interval 36.08 to 42.67
|
NA Percentage of subjects
Analysis not specified for individual strain.
|
NA Percentage of subjects
Analysis not specified for individual strain.
|
39.70 Percentage of subjects
Interval 36.43 to 43.04
|
|
Immunogenicity Endpoint: The Percentage of Subjects With SCR Against Homologous Strains
B/Yamagata
|
16.40 Percentage of subjects
Interval 14.0 to 19.03
|
NA Percentage of subjects
Analysis not specified for alternate strain.
|
15.47 Percentage of subjects
Interval 12.2 to 19.23
|
NA Percentage of subjects
Analysis was not performed.
|
|
Immunogenicity Endpoint: The Percentage of Subjects With SCR Against Homologous Strains
B/Victoria
|
13.42 Percentage of subjects
Interval 11.22 to 15.86
|
12.16 Percentage of subjects
Interval 9.24 to 15.6
|
NA Percentage of subjects
Analysis not specified for alternate strain.
|
NA Percentage of subjects
Analysis was not performed.
|
SECONDARY outcome
Timeframe: Day 1 through Day 7Population: The Solicited Safety Set consists of all subjects in the FAS who received at least one dose or partial dose of study vaccine and have provided any evaluable follow-up safety data (solicited AE data).
Safety of vaccination was assessed in terms of percentage of subjects reporting solicited AEs up to 7 days after vaccination.
Outcome measures
| Measure |
aQIV
n=883 Participants
MF59-adjuvanted Quadrivalent Subunit Inactivated Egg-derived Influenza Vaccine (aQIV) contains each of the 2 influenza type A strains and each of the 2 influenza type B strains in the vaccine. The strain composition is that recommended by the World Health Organization for the 2017-2018 Northern Hemisphere influenza season (WHO, 2017) for quadrivalent vaccines.
|
aTIV-1
n=439 Participants
Licensed MF59-adjuvanted Trivalent Subunit Inactivated Egg-derived Influenza Vaccine (aTIV-1) contains each of the 2 influenza type A strains and one influenza type B strain in the vaccine. The strain composition is that recommended by the World Health Organization for the 2017-2018 Northern Hemisphere influenza season (WHO, 2017) for trivalent vaccines.
|
aTIV-2
n=438 Participants
MF59-adjuvanted Trivalent Subunit Inactivated Egg-derived Influenza Vaccine (aTIV-2) contains each of the 2 influenza type A strains and alternate influenza type B strain in the vaccine. The strain composition is that recommended by the World Health Organization for the 2017-2018 Northern Hemisphere influenza season (WHO, 2017) for trivalent vaccines except the B strain present in this vaccine is the second/alternate B strain recommended for inclusion in quadrivalent vaccines (ie, Alternate B strain).
|
aTIV-1/aTIV-2
Pooled Subjects Treated with aTIV-1 and aTIV-2
|
|---|---|---|---|---|
|
Safety Endpoint: Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) Following Vaccination
Any local solicited AE
|
385 Participants
|
170 Participants
|
167 Participants
|
—
|
|
Safety Endpoint: Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) Following Vaccination
Any systemic solicited AE
|
231 Participants
|
107 Participants
|
110 Participants
|
—
|
SECONDARY outcome
Timeframe: Day 1 through Day 22Population: The Overall Safety Set consists of all subjects in the FAS who received at least one dose or partial dose of study vaccine and have provided any evaluable follow-up safety data.
Safety of vaccination was assessed in terms of percentage of subjects reporting unsolicited AEs up to 21 days after vaccination.
Outcome measures
| Measure |
aQIV
n=888 Participants
MF59-adjuvanted Quadrivalent Subunit Inactivated Egg-derived Influenza Vaccine (aQIV) contains each of the 2 influenza type A strains and each of the 2 influenza type B strains in the vaccine. The strain composition is that recommended by the World Health Organization for the 2017-2018 Northern Hemisphere influenza season (WHO, 2017) for quadrivalent vaccines.
|
aTIV-1
n=444 Participants
Licensed MF59-adjuvanted Trivalent Subunit Inactivated Egg-derived Influenza Vaccine (aTIV-1) contains each of the 2 influenza type A strains and one influenza type B strain in the vaccine. The strain composition is that recommended by the World Health Organization for the 2017-2018 Northern Hemisphere influenza season (WHO, 2017) for trivalent vaccines.
|
aTIV-2
n=444 Participants
MF59-adjuvanted Trivalent Subunit Inactivated Egg-derived Influenza Vaccine (aTIV-2) contains each of the 2 influenza type A strains and alternate influenza type B strain in the vaccine. The strain composition is that recommended by the World Health Organization for the 2017-2018 Northern Hemisphere influenza season (WHO, 2017) for trivalent vaccines except the B strain present in this vaccine is the second/alternate B strain recommended for inclusion in quadrivalent vaccines (ie, Alternate B strain).
|
aTIV-1/aTIV-2
Pooled Subjects Treated with aTIV-1 and aTIV-2
|
|---|---|---|---|---|
|
Safety Endpoint: Number of Subjects With Unsolicited AEs
|
136 Participants
|
50 Participants
|
68 Participants
|
—
|
SECONDARY outcome
Timeframe: Day 1 through Day 181Population: The Overall Safety Set consists of all subjects in the FAS who received at least one dose or partial dose of study vaccine and have provided any evaluable follow-up safety data.
Safety of vaccination was assessed in terms of percentage of subjects reporting SAEs, AEs leading to withdrawal, NOCDs, and AESIs and medically attended AE up to 180 days after vaccination.
Outcome measures
| Measure |
aQIV
n=888 Participants
MF59-adjuvanted Quadrivalent Subunit Inactivated Egg-derived Influenza Vaccine (aQIV) contains each of the 2 influenza type A strains and each of the 2 influenza type B strains in the vaccine. The strain composition is that recommended by the World Health Organization for the 2017-2018 Northern Hemisphere influenza season (WHO, 2017) for quadrivalent vaccines.
|
aTIV-1
n=444 Participants
Licensed MF59-adjuvanted Trivalent Subunit Inactivated Egg-derived Influenza Vaccine (aTIV-1) contains each of the 2 influenza type A strains and one influenza type B strain in the vaccine. The strain composition is that recommended by the World Health Organization for the 2017-2018 Northern Hemisphere influenza season (WHO, 2017) for trivalent vaccines.
|
aTIV-2
n=444 Participants
MF59-adjuvanted Trivalent Subunit Inactivated Egg-derived Influenza Vaccine (aTIV-2) contains each of the 2 influenza type A strains and alternate influenza type B strain in the vaccine. The strain composition is that recommended by the World Health Organization for the 2017-2018 Northern Hemisphere influenza season (WHO, 2017) for trivalent vaccines except the B strain present in this vaccine is the second/alternate B strain recommended for inclusion in quadrivalent vaccines (ie, Alternate B strain).
|
aTIV-1/aTIV-2
Pooled Subjects Treated with aTIV-1 and aTIV-2
|
|---|---|---|---|---|
|
Safety Endpoint: Number of Subjects With Serious AEs (SAEs), AEs Leading to Withdrawal From the Study, New Onset of Chronic Diseases (NOCDs) and AEs of Special Interest (AESIs)
SAEs
|
37 Participants
|
28 Participants
|
18 Participants
|
—
|
|
Safety Endpoint: Number of Subjects With Serious AEs (SAEs), AEs Leading to Withdrawal From the Study, New Onset of Chronic Diseases (NOCDs) and AEs of Special Interest (AESIs)
AEs leading to withdrawal
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Safety Endpoint: Number of Subjects With Serious AEs (SAEs), AEs Leading to Withdrawal From the Study, New Onset of Chronic Diseases (NOCDs) and AEs of Special Interest (AESIs)
NOCDs
|
23 Participants
|
16 Participants
|
14 Participants
|
—
|
|
Safety Endpoint: Number of Subjects With Serious AEs (SAEs), AEs Leading to Withdrawal From the Study, New Onset of Chronic Diseases (NOCDs) and AEs of Special Interest (AESIs)
AESIs
|
1 Participants
|
1 Participants
|
0 Participants
|
—
|
Adverse Events
aQIV
Serious events: 37 serious events
Other events: 461 other events
Deaths: 2 deaths
aTIV-1
Serious events: 28 serious events
Other events: 217 other events
Deaths: 0 deaths
aTIV-2
Serious events: 18 serious events
Other events: 215 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
aQIV
n=888 participants at risk
MF59-adjuvanted Quadrivalent Subunit Inactivated Egg-derived Influenza Vaccine (aQIV) contains each of the 2 influenza type A strains and each of the two influenza type B strains in the vaccine.
MF59-adjuvanted Quadrivalent Subunit Inactivated Egg-derived Influenza Vaccine (aQIV): The strain composition is that recommended by the World Health Organization for the 2017-2018 Northern Hemisphere influenza season (WHO, 2017) for quadrivalent vaccines.
|
aTIV-1
n=444 participants at risk
Licensed MF59-adjuvanted Trivalent Subunit Inactivated Egg-derived Influenza Vaccine (aTIV-1) contains each of the 2 influenza type A strains and one influenza type B strain in the vaccine.
Licensed MF59-adjuvanted Trivalent Subunit Inactivated Egg-derived Influenza Vaccine (aTIV-1): The strain composition is that recommended by the World Health Organization for the 2017-2018 Northern Hemisphere influenza season (WHO, 2017) for trivalent vaccines.
|
aTIV-2
n=444 participants at risk
MF59-adjuvanted Trivalent Subunit Inactivated Egg-derived Influenza Vaccine contains each of the 2 influenza type A strains and alternate influenza type B strain in the vaccine.
MF59-adjuvanted Trivalent Subunit Inactivated Egg-derived Influenza Vaccine Containing the Alternate B Strain (aTIV-2): The strain composition is that recommended by the World Health Organization for the 2017-2018 Northern Hemisphere influenza season (WHO, 2017) for trivalent vaccines except the B strain present in this vaccine is the second/alternate B strain recommended for inclusion in quadrivalent vaccines (ie, Alternate B strain).
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.11%
1/888 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
0.00%
0/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
0.00%
0/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/888 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
0.23%
1/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
0.00%
0/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
|
Cardiac disorders
Coronary artery disease
|
0.11%
1/888 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
0.23%
1/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
0.45%
2/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
|
Cardiac disorders
Atrial fibrillation
|
0.11%
1/888 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
0.00%
0/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
0.23%
1/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/888 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
0.00%
0/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
0.23%
1/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
|
Cardiac disorders
Angina unstable
|
0.11%
1/888 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
0.00%
0/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
0.00%
0/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.11%
1/888 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
0.00%
0/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
0.00%
0/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/888 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
0.23%
1/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
0.00%
0/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
|
Cardiac disorders
Sinus node dysfunction
|
0.00%
0/888 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
0.23%
1/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
0.00%
0/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/888 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
0.23%
1/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
0.00%
0/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
|
Gastrointestinal disorders
Abdominal pain
|
0.11%
1/888 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
0.00%
0/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
0.00%
0/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
|
Gastrointestinal disorders
Diverticular perforation
|
0.11%
1/888 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
0.00%
0/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
0.00%
0/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/888 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
0.00%
0/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
0.23%
1/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
|
Gastrointestinal disorders
Gastrointestinal perforation
|
0.00%
0/888 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
0.00%
0/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
0.23%
1/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
|
Gastrointestinal disorders
Ileus paralytic
|
0.00%
0/888 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
0.00%
0/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
0.23%
1/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.11%
1/888 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
0.00%
0/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
0.00%
0/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
0.00%
0/888 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
0.23%
1/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
0.00%
0/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.11%
1/888 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
0.00%
0/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
0.00%
0/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/888 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
0.00%
0/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
0.23%
1/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
|
General disorders
Death
|
0.23%
2/888 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
0.00%
0/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
0.00%
0/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
|
General disorders
Asthenia
|
0.00%
0/888 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
0.00%
0/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
0.23%
1/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
|
General disorders
Chest pain
|
0.11%
1/888 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
0.00%
0/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
0.00%
0/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/888 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
0.23%
1/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
0.00%
0/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/888 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
0.23%
1/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
0.00%
0/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/888 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
0.00%
0/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
0.23%
1/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/888 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
0.23%
1/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
0.23%
1/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
|
Hepatobiliary disorders
Cholangitis acute
|
0.00%
0/888 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
0.23%
1/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
0.00%
0/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/888 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
0.23%
1/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
0.00%
0/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
|
Infections and infestations
Pneumonia
|
0.79%
7/888 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
0.90%
4/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
0.23%
1/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
|
Infections and infestations
Influenza
|
0.11%
1/888 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
0.00%
0/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
0.45%
2/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
|
Infections and infestations
Sepsis
|
0.11%
1/888 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
0.23%
1/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
0.00%
0/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
|
Infections and infestations
Abscess intestinal
|
0.00%
0/888 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
0.00%
0/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
0.23%
1/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
|
Infections and infestations
Cellulitis
|
0.11%
1/888 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
0.00%
0/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
0.00%
0/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
|
Infections and infestations
Pneumonia bacterial
|
0.11%
1/888 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
0.00%
0/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
0.00%
0/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
|
Infections and infestations
Pyelonephritis
|
0.11%
1/888 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
0.00%
0/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
0.00%
0/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.00%
0/888 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
0.23%
1/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
0.00%
0/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
|
Infections and infestations
Urinary tract infection
|
0.11%
1/888 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
0.00%
0/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
0.00%
0/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
|
Infections and infestations
Viral pericarditis
|
0.00%
0/888 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
0.23%
1/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
0.00%
0/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.11%
1/888 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
0.00%
0/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
0.00%
0/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/888 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
0.23%
1/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
0.00%
0/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.11%
1/888 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
0.00%
0/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
0.00%
0/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/888 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
0.23%
1/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
0.00%
0/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
|
Injury, poisoning and procedural complications
Procedural dizziness
|
0.00%
0/888 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
0.23%
1/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
0.00%
0/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/888 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
0.23%
1/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
0.00%
0/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
|
Injury, poisoning and procedural complications
Scapula fracture
|
0.11%
1/888 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
0.00%
0/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
0.00%
0/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.11%
1/888 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
0.00%
0/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
0.00%
0/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.11%
1/888 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
0.00%
0/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
0.00%
0/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.11%
1/888 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
0.00%
0/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
0.00%
0/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.11%
1/888 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
0.23%
1/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
0.00%
0/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
|
Metabolism and nutrition disorders
Dehydration
|
0.11%
1/888 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
0.00%
0/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
0.00%
0/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.34%
3/888 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
0.68%
3/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
0.00%
0/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.00%
0/888 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
0.23%
1/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
0.00%
0/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.00%
0/888 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
0.00%
0/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
0.23%
1/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.00%
0/888 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
0.00%
0/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
0.23%
1/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/888 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
0.23%
1/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
0.00%
0/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer in situ
|
0.00%
0/888 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
0.23%
1/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
0.00%
0/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
0.00%
0/888 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
0.00%
0/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
0.23%
1/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer stage IV
|
0.11%
1/888 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
0.00%
0/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
0.00%
0/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pituitary tumour benign
|
0.00%
0/888 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
0.23%
1/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
0.00%
0/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin cancer
|
0.11%
1/888 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
0.00%
0/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
0.00%
0/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
|
Nervous system disorders
Carotid artery stenosis
|
0.11%
1/888 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
0.45%
2/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
0.00%
0/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
|
Nervous system disorders
Amyotrophic lateral sclerosis
|
0.00%
0/888 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
0.23%
1/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
0.00%
0/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/888 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
0.00%
0/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
0.23%
1/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
|
Nervous system disorders
Ischaemic cerebral infarction
|
0.00%
0/888 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
0.23%
1/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
0.00%
0/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/888 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
0.23%
1/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
0.00%
0/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
|
Nervous system disorders
Presyncope
|
0.11%
1/888 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
0.00%
0/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
0.00%
0/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
|
Nervous system disorders
Seizure
|
0.11%
1/888 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
0.00%
0/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
0.00%
0/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
|
Nervous system disorders
Syncope
|
0.00%
0/888 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
0.23%
1/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
0.00%
0/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
|
Psychiatric disorders
Confusional state
|
0.11%
1/888 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
0.00%
0/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
0.00%
0/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
|
Renal and urinary disorders
Acute kidney injury
|
0.11%
1/888 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
0.23%
1/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
0.00%
0/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
|
Renal and urinary disorders
Renal mass
|
0.11%
1/888 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
0.00%
0/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
0.00%
0/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/888 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
0.23%
1/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
0.23%
1/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/888 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
0.00%
0/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
0.23%
1/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
|
Vascular disorders
Thrombosis
|
0.00%
0/888 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
0.23%
1/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
0.23%
1/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
|
Vascular disorders
Accelerated hypertension
|
0.00%
0/888 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
0.23%
1/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
0.00%
0/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
|
Vascular disorders
Aortic aneurysm
|
0.00%
0/888 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
0.00%
0/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
0.23%
1/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
|
Vascular disorders
Aortic dissection
|
0.11%
1/888 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
0.00%
0/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
0.00%
0/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
|
Vascular disorders
Hypotension
|
0.00%
0/888 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
0.00%
0/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
0.23%
1/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
Other adverse events
| Measure |
aQIV
n=888 participants at risk
MF59-adjuvanted Quadrivalent Subunit Inactivated Egg-derived Influenza Vaccine (aQIV) contains each of the 2 influenza type A strains and each of the two influenza type B strains in the vaccine.
MF59-adjuvanted Quadrivalent Subunit Inactivated Egg-derived Influenza Vaccine (aQIV): The strain composition is that recommended by the World Health Organization for the 2017-2018 Northern Hemisphere influenza season (WHO, 2017) for quadrivalent vaccines.
|
aTIV-1
n=444 participants at risk
Licensed MF59-adjuvanted Trivalent Subunit Inactivated Egg-derived Influenza Vaccine (aTIV-1) contains each of the 2 influenza type A strains and one influenza type B strain in the vaccine.
Licensed MF59-adjuvanted Trivalent Subunit Inactivated Egg-derived Influenza Vaccine (aTIV-1): The strain composition is that recommended by the World Health Organization for the 2017-2018 Northern Hemisphere influenza season (WHO, 2017) for trivalent vaccines.
|
aTIV-2
n=444 participants at risk
MF59-adjuvanted Trivalent Subunit Inactivated Egg-derived Influenza Vaccine contains each of the 2 influenza type A strains and alternate influenza type B strain in the vaccine.
MF59-adjuvanted Trivalent Subunit Inactivated Egg-derived Influenza Vaccine Containing the Alternate B Strain (aTIV-2): The strain composition is that recommended by the World Health Organization for the 2017-2018 Northern Hemisphere influenza season (WHO, 2017) for trivalent vaccines except the B strain present in this vaccine is the second/alternate B strain recommended for inclusion in quadrivalent vaccines (ie, Alternate B strain).
|
|---|---|---|---|
|
General disorders
Redness
|
21.2%
188/888 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
17.3%
77/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
18.2%
81/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
|
General disorders
Swelling
|
15.1%
134/888 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
15.5%
69/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
14.4%
64/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
|
General disorders
Pain
|
31.0%
275/888 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
28.2%
125/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
24.5%
109/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
|
General disorders
Fatigue
|
16.2%
144/888 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
15.1%
67/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
11.7%
52/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
8.0%
71/888 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
7.7%
34/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
7.0%
31/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.0%
80/888 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
8.3%
37/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
7.0%
31/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
|
Nervous system disorders
Headache
|
11.8%
105/888 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
10.4%
46/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
11.0%
49/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
|
Gastrointestinal disorders
Diarrhea
|
5.4%
48/888 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
5.4%
24/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
6.8%
30/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
|
General disorders
Ecchymosis
|
7.8%
69/888 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
6.3%
28/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
5.2%
23/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
|
General disorders
Other
|
5.4%
48/888 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
2.7%
12/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
3.8%
17/444 • SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7
|
Additional Information
Seqirus Clinical Trial Disclosure Manager
Seqirus
Phone: Phone: 1-855-358-8966
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60