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Safety and Immunogenicity of MF59C.1 Adjuvanted Trivalent Subunit Influenza Vaccine in Elderly Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01162122
Recruitment Status : Completed
First Posted : July 14, 2010
Results First Posted : June 12, 2014
Last Update Posted : June 26, 2014
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Prevention
Condition Influenza
Interventions Biological: MF59 adjuvanted trivalent subunit influenza vaccine (aTIV)
Biological: Non-adjuvanted trivalent subunit influenza vaccine (TIV)
Enrollment 7109
Recruitment Details Subjects were enrolled from 4 sites in Columbia, 2 sites in Panama, 11 sites in Philippines, 21 sites in USA.
Pre-assignment Details Five enrolled subjects were not randomized and did not receive study vaccination, hence were discontinued.
Arm/Group Title aTIV (Pooled) Licensed TIV
Hide Arm/Group Description Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3). Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).
Period Title: Overall Study
Started 3552 3552
Vaccinated 3541 3541
Completed 3361 3356
Not Completed 191 196
Reason Not Completed
Withdrawal by Subject             52             43
Lost to Follow-up             73             91
Adverse Event             3             2
Death             51             46
Protocol Violation             2             2
Inappropriate enrollment             5             4
Administrative reason             1             1
Unable to classify             3             7
Missing primary reason             1             0
Arm/Group Title aTIV (Pooled) Licensed TIV Total
Hide Arm/Group Description Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3). Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV). Total of all reporting groups
Overall Number of Baseline Participants 3545 3537 7082
Hide Baseline Analysis Population Description
Baseline demography is described for safety set population. A vaccine different from the vaccine assigned at randomization was administered to 7 subjects in each vaccine group. For the safety analysis, these subjects were reassigned to the vaccine group for the vaccine they actually received.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 3545 participants 3537 participants 7082 participants
72.0  (5.3) 71.8  (5.3) 71.9  (5.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3545 participants 3537 participants 7082 participants
Female
2272
  64.1%
2342
  66.2%
4614
  65.2%
Male
1273
  35.9%
1195
  33.8%
2468
  34.8%
1.Primary Outcome
Title Geometric Mean Titers in Subjects After Receiving One Dose of Lot 1 or Lot 2 or Lot 3 of aTIV
Hide Description Immunologic equivalence of 3 consecutive production lots of aTIV (Lot 1, Lot 2 and Lot 3), was assessed in terms of Hemagglutination Inhibition (HI) Geometric Mean Titers (GMTs) in subjects, at three weeks after vaccination, against each vaccine strain.
Time Frame Day 22 post vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the per protocol set population (PPS) i.e all randomised subjects who received the correct vaccine, provided evaluable serum samples, and had no major protocol deviation prior to unblinding.
Arm/Group Title aTIV_Lot 1 aTIV_Lot 2 aTIV_Lot 3
Hide Arm/Group Description:
Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from Lot 1
Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from Lot 2
Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from Lot 3
Overall Number of Participants Analyzed 1073 1078 1076
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
H1N1 strain (N=1072,1078,1075)
209
(189 to 231)
187
(170 to 207)
199
(180 to 220)
H3N2 strain (N=1072,1078,1075)
548
(502 to 598)
542
(498 to 591)
556
(510 to 606)
B strain
56
(51 to 61)
56
(51 to 61)
58
(53 to 64)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection aTIV_Lot 1, aTIV_Lot 2
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments The 95% CIs of GMT ratios for the pairwise lot-to-lot group comparisons should fall within the equivalence range of 0.67 to 1.5.
Method of Estimation Estimation Parameter GMT ratio (H1N1 strain)
Estimated Value 1.12
Confidence Interval (2-Sided) 95%
1 to 1.24
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection aTIV_Lot 1, aTIV_Lot 3
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments The 95% CIs of GMT ratios for the pairwise lot-to-lot group comparisons should fall within the equivalence range of 0.67 to 1.5.
Method of Estimation Estimation Parameter GMT ratio (H1N1 strain)
Estimated Value 1.05
Confidence Interval (2-Sided) 95%
0.95 to 1.17
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection aTIV_Lot 2, aTIV_Lot 3
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments The 95% CIs of GMT ratios for the pairwise lot-to-lot group comparisons should fall within the equivalence range of 0.67 to 1.5.
Method of Estimation Estimation Parameter GMT ratio (H1N1 strain)
Estimated Value 0.94
Confidence Interval (2-Sided) 95%
0.85 to 1.05
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection aTIV_Lot 1, aTIV_Lot 2
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments The 95% CIs of GMT ratios for the pairwise lot-to-lot group comparisons should fall within the equivalence range of 0.67 to 1.5.
Method of Estimation Estimation Parameter GMT ratio (H3N2 strain)
Estimated Value 1.01
Confidence Interval (2-Sided) 95%
0.92 to 1.11
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection aTIV_Lot 1, aTIV_Lot 3
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments The 95% CIs of GMT ratios for the pairwise lot-to-lot group comparisons should fall within the equivalence range of 0.67 to 1.5.
Method of Estimation Estimation Parameter GMT ratio (H3N2 strain)
Estimated Value 0.99
Confidence Interval (2-Sided) 95%
0.9 to 1.08
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection aTIV_Lot 2, aTIV_Lot 3
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments The 95% CIs of GMT ratios for the pairwise lot-to-lot group comparisons should fall within the equivalence range of 0.67 to 1.5.
Method of Estimation Estimation Parameter GMT ratio (H3N2 strain)
Estimated Value 0.98
Confidence Interval (2-Sided) 95%
0.89 to 1.07
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection aTIV_Lot 1, aTIV_Lot 2
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments The 95% CIs of GMT ratios for the pairwise lot-to-lot group comparisons should fall within the equivalence range of 0.67 to 1.5.
Method of Estimation Estimation Parameter GMT ratio (B strain)
Estimated Value 1
Confidence Interval (2-Sided) 95%
0.91 to 1.1
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection aTIV_Lot 1, aTIV_Lot 3
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments The 95% CIs of GMT ratios for the pairwise lot-to-lot group comparisons should fall within the equivalence range of 0.67 to 1.5.
Method of Estimation Estimation Parameter GMT ratio (B strain)
Estimated Value 0.96
Confidence Interval (2-Sided) 95%
0.87 to 1.05
Estimation Comments [Not Specified]
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection aTIV_Lot 2, aTIV_Lot 3
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments The 95% CIs of GMT ratios for the pairwise lot-to-lot group comparisons should fall within the equivalence range of 0.67 to 1.5.
Method of Estimation Estimation Parameter GMT ratio (B strain)
Estimated Value 0.96
Confidence Interval (2-Sided) 95%
0.87 to 1.05
Estimation Comments [Not Specified]
2.Primary Outcome
Title Comparison of aTIV Versus TIV in Terms of Geometric Mean Titers (GMTs) Against Homologous Strains - PPS
Hide Description The non-inferiority of HI antibody responses of aTIV compared to TIV assessed in terms of post vaccination GMTs at three weeks after vaccination against the three homologous vaccine strains.
Time Frame Day 22 post vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on PPS.
Arm/Group Title aTIV (Pooled) Licensed TIV
Hide Arm/Group Description:
Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).
Overall Number of Participants Analyzed 3227 3259
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
H1N1 strain (N=3225,3257)
198
(185 to 211)
141
(132 to 150)
H3N2 strain (N=3225,3256)
544
(513 to 575)
337
(319 to 357)
B strain
55
(52 to 58)
48
(46 to 51)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection aTIV (Pooled), Licensed TIV
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for all 3 homologous strains was >0.67.
Method of Estimation Estimation Parameter GMT ratio (H1N1 strain)
Estimated Value 1.4
Confidence Interval (2-Sided) 95%
1.32 to 1.49
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection aTIV (Pooled), Licensed TIV
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for all 3 homologous strains was >0.67.
Method of Estimation Estimation Parameter GMT ratio (H3N2 strain)
Estimated Value 1.61
Confidence Interval (2-Sided) 95%
1.52 to 1.7
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection aTIV (Pooled), Licensed TIV
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for all 3 homologous strains was >0.67.
Method of Estimation Estimation Parameter GMT ratio (B strain)
Estimated Value 1.15
Confidence Interval (2-Sided) 95%
1.08 to 1.21
Estimation Comments [Not Specified]
3.Primary Outcome
Title Comparison of aTIV Versus TIV in Terms of Percentage of Subjects Achieving Seroconversion Against Homologous Strains-PPS
Hide Description

The non-inferiority of HI antibody responses of aTIV compared to TIV assessed in terms of percentage of subjects achieving seroconversion at three weeks after vaccination against the three homologous vaccine strains.

Seroconversion defined as prevaccination HI titer <10 and postvaccination HI titer ≥40 or at least a 4-fold increase in HI titers from prevaccination HI titer ≥10.

Time Frame Day 22 post vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on PPS.
Arm/Group Title aTIV (Pooled) Licensed TIV
Hide Arm/Group Description:
Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).
Overall Number of Participants Analyzed 3227 3259
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of subjects
H1N1 strain (N=3225,3257)
77.4
(75.9 to 78.9)
67.6
(65.9 to 69.2)
H3N2 strain (N=3225,3256)
74.0
(72.4 to 75.5)
60.7
(59.0 to 62.3)
B strain
47.0
(45.2 to 48.7)
41.2
(39.5 to 43.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection aTIV (Pooled), Licensed TIV
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for all 3 homologous strains was ≥-10%.
Method of Estimation Estimation Parameter Group difference (H1N1 strain)
Estimated Value 9.2
Confidence Interval (2-Sided) 95%
7.1 to 11.3
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection aTIV (Pooled), Licensed TIV
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for all 3 homologous strains was ≥-10%.
Method of Estimation Estimation Parameter Group difference (H3N2 strain)
Estimated Value 12.7
Confidence Interval (2-Sided) 95%
10.5 to 14.9
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection aTIV (Pooled), Licensed TIV
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for all 3 homologous strains was ≥-10%.
Method of Estimation Estimation Parameter Group difference (B strain)
Estimated Value 5.2
Confidence Interval (2-Sided) 95%
3.0 to 7.4
Estimation Comments [Not Specified]
4.Primary Outcome
Title Comparison of aTIV Versus TIV in Terms of GMTs Against Homologous Strains-Full Analysis Set (FAS)
Hide Description The superiority of HI antibody responses of aTIV compared to TIV assessed in terms of post vaccination GMTs at three weeks after vaccination against the three homologous vaccine strains.
Time Frame Day 22 post vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on FAS i.e all randomized subjects who received a study vaccination and provided evaluable serum samples both at day 1 and at day 22
Arm/Group Title aTIV (Pooled) Licensed TIV
Hide Arm/Group Description:
Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).
Overall Number of Participants Analyzed 3479 3482
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
H1N1 strain (N=3477,3480)
196
(184 to 208)
142
(134 to 151)
H3N2 strain (N=3477,3479)
534
(506 to 563)
334
(317 to 353)
B strain
54
(51 to 57)
48
(45 to 50)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection aTIV (Pooled), Licensed TIV
Comments Superiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for at least 2 homologous strains was >1.5.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter GMT ratio (H1N1 strain)
Estimated Value 1.37
Confidence Interval (2-Sided) 95%
1.29 to 1.46
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection aTIV (Pooled), Licensed TIV
Comments Superiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for at least 2 homologous strains was >1.5.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter GMT ratio (H3N2 strain)
Estimated Value 1.60
Confidence Interval (2-Sided) 95%
1.51 to 1.68
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection aTIV (Pooled), Licensed TIV
Comments Superiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for at least 2 homologous strains was >1.5.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter GMT ratio (B strain)
Estimated Value 1.14
Confidence Interval (2-Sided) 95%
1.08 to 1.2
Estimation Comments [Not Specified]
5.Primary Outcome
Title Comparison of aTIV Versus TIV in Terms of Percentage of Subjects Achieving Seroconversion Against Homologous Strains-FAS
Hide Description

The superiority of HI antibody responses of aTIV compared to TIV assessed in terms of percentage of subjects achieving seroconversion at three weeks after vaccination against the three homologous vaccine strains.

Seroconversion defined as prevaccination HI titer <10 and postvaccination HI titer ≥40 or at least a 4-fold increase in HI titers from prevaccination HI titer ≥10.

Time Frame Day 22 post vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on FAS.
Arm/Group Title aTIV (Pooled) Licensed TIV
Hide Arm/Group Description:
Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).
Overall Number of Participants Analyzed 3479 3482
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of subjects
H1N1 strain (N=3477, 3480)
77.3
(75.8 to 78.6)
67.8
(66.2 to 69.3)
H3N2 strain (N=3477,3479)
73.7
(72.2 to 75.1)
60.6
(59.0 to 62.2)
B strain
46.9
(45.3 to 48.6)
41.5
(39.8 to 43.1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection aTIV (Pooled), Licensed TIV
Comments Superiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for at least 2 homologous strains was >10%.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Group difference (H1N1 strain)
Estimated Value 8.9
Confidence Interval (2-Sided) 95%
6.9 to 10.9
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection aTIV (Pooled), Licensed TIV
Comments Superiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for at least 2 homologous strains was >10%.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Group difference (H3N2 strain)
Estimated Value 12.7
Confidence Interval (2-Sided) 95%
10.6 to 14.8
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection aTIV (Pooled), Licensed TIV
Comments Superiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for at least 2 homologous strains was >10%.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Group difference (B strain)
Estimated Value 5.1
Confidence Interval (2-Sided) 95%
2.9 to 7.2
Estimation Comments [Not Specified]
6.Primary Outcome
Title Percentage of Subjects With HI Titers ≥40 Against Homologous Strains
Hide Description The percentage of subjects demonstrating HI titers ≥40, in overall group and in subjects with pre-defined co-morbidities (high risk group), against homologous strains, three weeks after vaccination with aTIV or TIV.
Time Frame Day 22 post vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the FAS.
Arm/Group Title aTIV (Pooled) Licensed TIV
Hide Arm/Group Description:
Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).
Overall Number of Participants Analyzed 3479 3482
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of subjects
H1N1 strain (N=3477,3480) overall
91.1
(90.1 to 92.0)
84.5
(83.3 to 85.7)
H3N2 strain (N=3477,3479) overall
99.0
(98.6 to 99.3)
97.0
(96.4 to 97.6)
B strain, overall
64.6
(62.9 to 66.2)
58.9
(57.3 to 60.6)
H1N1 strain (N=1299,1273), high risk group
91.9
(90.3 to 93.3)
85.8
(83.7 to 87.7)
H3N2 strain (N=1299,1273), high risk group
98.7
(97.9 to 99.2)
96.7
(95.6 to 97.6)
B strain (N=1300,1273), high risk group
66.3
(63.7 to 68.9)
61.4
(58.7 to 64.1)
7.Primary Outcome
Title Percentage of Subjects Achieving Seroconversion in HI Titers, Against Homologous Strains
Hide Description

The percentage of subjects achieving seroconversion in HI titers from baseline, in overall group and in subjects with pre-defined co-morbidities (high risk group), against homologous strains, three weeks after vaccination with aTIV or TIV.

Seroconversion is defined as prevaccination HI titer <10 and postvaccination HI titer ≥40 or at least a 4-fold increase in HI titers from prevaccination HI titer ≥10.

Time Frame Day 22 post vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the FAS.
Arm/Group Title aTIV (Pooled) Licensed TIV
Hide Arm/Group Description:
Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).
Overall Number of Participants Analyzed 3479 3482
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of subjects
H1N1 strain ( N= 3477,3480), overall
77.3
(75.8 to 78.6)
67.8
(66.2 to 69.3)
H3N2 strain ( N= 3477,3479), overall
73.7
(72.2 to 75.1)
60.6
(59.0 to 62.2)
B strain, overall
46.9
(45.3 to 48.6)
41.5
(39.8 to 43.1)
H1N1 strain ( N= 1299,1273), high risk group
72.6
(70.1 to 75.0)
62.0
(59.3 to 64.7)
H3N2 strain ( N= 1299,1273), high risk group
68.9
(66.3 to 71.4)
55.2
(52.4 to 58.0)
B strain (N= 1299,1273), high risk group
40.0
(37.3 to 42.7)
34.3
(31.6 to 36.9)
8.Primary Outcome
Title Geometric Mean Ratio (GMR) of Post- Versus Pre-vaccination HI Titers Against Homologous Strains
Hide Description The GMR of post-vaccination versus pre-vaccination HI titers (day 22/day 1) in overall group and in subjects with pre-defined co-morbidities (high risk group), against homologous strains, three weeks after vaccination with aTIV or TIV.
Time Frame Day 22 post vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the FAS
Arm/Group Title aTIV (Pooled) Licensed TIV
Hide Arm/Group Description:
Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).
Overall Number of Participants Analyzed 3479 3482
Geometric Mean (95% Confidence Interval)
Unit of Measure: Ratio
H1N1 strain (N=3477, 3480), overall
13
(13 to 14)
9.77
(9.14 to 10)
H3N2 strain (N=3477, 3479), overall
10
(9.48 to 11)
6.54
(6.06 to 7.06)
B strain , overall
4.85
(4.59 to 5.13)
4.27
(4.04 to 4.52)
H1N1 strain (N=1299, 1273), high risk group
12
(11 to 14)
9.17
(8.28 to 10)
H3N2 strain (N=1299, 1273), high risk group
9.26
(8.31 to 10)
6.24
(5.59 to 6.96)
B strain (N=1300, 1273), high risk group
4.48
(4.14 to 4.84)
3.99
(3.68 to 4.31)
9.Primary Outcome
Title Percentage of Subjects With HI Titers ≥40 Against Heterologous Strains
Hide Description The percentage of subjects demonstrating HI titers ≥40, in overall group and in subjects with pre-defined co-morbidities (high risk group), against heterologous strains, three weeks after vaccination with aTIV or TIV.
Time Frame Day 22 post vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the FAS.
Arm/Group Title aTIV (Pooled) Licensed TIV
Hide Arm/Group Description:
Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).
Overall Number of Participants Analyzed 887 881
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of subjects
H3N2/Brisbane strain(N=887,880), overall
95.8
(94.3 to 97.1)
94.0
(92.2 to 95.5)
H3N2/Wisconsin strain, overall
99.6
(98.9 to 99.9)
98.4
(97.4 to 99.1)
B strain (N=887,880), overall
76.2
(73.3 to 79.0)
72.4
(69.3 to 75.3)
H3N2/Brisbane (N=330, 333), high risk group
94.9
(91.9 to 97.0)
94.0
(90.9 to 96.3)
H3N2/Wisconsin (N=330, 333), high risk group
99.7
(98.3 to 100)
98.5
(96.5 to 99.5)
B strain (N=330, 333), high risk group
83.3
(78.9 to 87.2)
78.4
(73.6 to 82.7)
10.Primary Outcome
Title Geometric Mean Ratio (GMR) of Post- Versus Pre-vaccination HI Titers, Against Heterologous Strains
Hide Description The GMR of post-vaccination versus pre-vaccination HI titers (day 22/day 1) in overall group and in subjects with pre-defined co-morbidities (high risk group), against heterologous strains, three weeks after vaccination with aTIV or TIV.
Time Frame Day 22 post vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the FAS.
Arm/Group Title aTIV (Pooled) Licensed TIV
Hide Arm/Group Description:
Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).
Overall Number of Participants Analyzed 887 881
Geometric Mean (95% Confidence Interval)
Unit of Measure: Ratio
H3N2/Brisbane strain (N=887,880), overall
5.76
(5.02 to 6.6)
3.87
(3.37 to 4.44)
H3N2/Wisconsin strain, overall
4.95
(4.36 to 5.62)
3.54
(3.12 to 4.03)
B strain (N=887,880), overall
5.76
(5.2 to 6.38)
5.28
(4.76 to 5.85)
H3N2/Brisbane strain (N=330,333), high risk group
5.42
(4.47 to 6.57)
4.15
(3.43 to 5.03)
H3N2/Wisconsin strain (N=330,333), high risk group
4.67
(3.87 to 5.62)
3.73
(3.1 to 4.49)
B strain (N=330,333), high risk group
5.41
(4.66 to 6.28)
4.77
(4.11 to 5.53)
11.Primary Outcome
Title Percentage of Subjects Achieving Seroconversion in HI Titers, Against Heterologous Strains
Hide Description

The percentage of subjects achieving seroconversion in HI titers from baseline, in overall group and in subjects with pre-defined co-morbidities (high risk group), against heterologous strains, three weeks after vaccination with aTIV or TIV.

Seroconversion is defined as prevaccination HI titer <10 and postvaccination HI titer ≥40 or at least a 4-fold increase in HI titers from prevaccination HI titer ≥10.

Time Frame Day 22 post vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the FAS.
Arm/Group Title aTIV (Pooled) Licensed TIV
Hide Arm/Group Description:
Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).
Overall Number of Participants Analyzed 887 881
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of subjects
H3N2/Brisbane, overall (N=887, 880)
60.4
(57.1 to 63.7)
48.4
(45.1 to 51.8)
H3N2/Wisconsin, overall
57.5
(54.2 to 60.8)
45.5
(42.2 to 48.9)
B strain, overall (N=887, 880)
53.3
(50.0 to 56.7)
49.8
(46.4 to 53.1)
H3N2/Brisbane (N= 330,333), high risk group
54.2
(48.7 to 59.7)
41.4
(36.1 to 46.9)
H3N2/Wisconsin ( N= 330,333), high risk group
52.1
(46.6 to 57.6)
38.7
(33.5 to 44.2)
B strain (N= 330, 333), high risk group
46.4
(40.9 to 51.9)
41.7
(36.4 to 47.2)
12.Secondary Outcome
Title Comparison of aTIV Versus TIV in High Risk Group in Terms of GMTs Against Homologous Strains-PPS
Hide Description The non-inferiority of HI antibody responses of ATIV compared to TIV, in subjects with pre-defined co-morbidities (high risk subjects), was assessed in terms of post vaccination GMTs at three weeks after vaccination against the three homologous vaccine strains.
Time Frame Day 22 post vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on PPS.
Arm/Group Title aTIV (Pooled) Licensed TIV
Hide Arm/Group Description:
Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).
Overall Number of Participants Analyzed 1195 1190
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
H1N1 strain (1194, 1190)
221
(201 to 243)
161
(146 to 177)
H3N2 strain (1194, 1190)
519
(477 to 565)
331
(304 to 360)
B strain
61
(56 to 66)
54
(50 to 59)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection aTIV (Pooled), Licensed TIV
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for all 3 homologous strains was >0.67.
Method of Estimation Estimation Parameter GMT ratio (H1N1 strain)
Estimated Value 1.38
Confidence Interval (2-Sided) 95%
1.25 to 1.52
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection aTIV (Pooled), Licensed TIV
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for all 3 homologous strains was >0.67.
Method of Estimation Estimation Parameter GMT ratio (H3N2 strain)
Estimated Value 1.57
Confidence Interval (2-Sided) 95%
1.44 to 1.72
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection aTIV (Pooled), Licensed TIV
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for all 3 homologous strains was >0.67.
Method of Estimation Estimation Parameter GMT ratio (B strain)
Estimated Value 1.12
Confidence Interval (2-Sided) 95%
1.03 to 1.21
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Comparison of HI Antibody Responses of aTIV Versus TIV, in High Risk Group in Terms of Percentage of Subjects Achieving Seroconversion Against Homologous Strains-PPS
Hide Description

The non-inferiority of HI antibody responses of ATIV compared to TIV, in subjects with pre-defined co-morbidities (high risk group), assessed in terms of percentage of subjects achieving seroconversion at three weeks after vaccination against the homologous vaccine strains.

Seroconversion is defined as prevaccination HI titer <10 and postvaccination HI titer ≥40 or at least a 4-fold increase in HI titers from prevaccination HI titer ≥10.

Time Frame Day 22 post vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on PPS.
Arm/Group Title aTIV (Pooled) Licensed TIV
Hide Arm/Group Description:
Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).
Overall Number of Participants Analyzed 1195 1190
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of subjects
H1N1 strain (N=1194, 1190)
73.6
(71.0 to 76.1)
61.7
(58.9 to 64.5)
H3N2 strain (N=1194, 1190)
69.1
(66.4 to 71.7)
54.8
(51.9 to 57.6)
B strain
40.0
(37.2 to 42.8)
34.0
(31.3 to 36.7)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection aTIV (Pooled), Licensed TIV
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for all 3 homologous strains was ≥-10%
Method of Estimation Estimation Parameter Group difference (H1N1 strain)
Estimated Value 11.1
Confidence Interval (2-Sided) 95%
7.5 to 14.6
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection aTIV (Pooled), Licensed TIV
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for all 3 homologous strains was ≥-10%
Method of Estimation Estimation Parameter Group difference (H3N2 strain)
Estimated Value 13.5
Confidence Interval (2-Sided) 95%
9.8 to 17.2
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection aTIV (Pooled), Licensed TIV
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for all 3 homologous strains was ≥-10%
Method of Estimation Estimation Parameter Group difference (B strain)
Estimated Value 5.0
Confidence Interval (2-Sided) 95%
1.4 to 8.5
Estimation Comments [Not Specified]
14.Secondary Outcome
Title Comparison of aTIV Versus TIV in High Risk Group in Terms of GMTs Against Homologous Strains-FAS
Hide Description The superiority of HI antibody responses of aTIV compared to TIV, in subjects with predefined co-morbidities (high risk group) assessed in terms of post vaccination GMTs at three weeks after vaccination against the three homologous vaccine strains.
Time Frame Day 22 post vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on FAS population.
Arm/Group Title aTIV (Pooled) Licensed TIV
Hide Arm/Group Description:
Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).
Overall Number of Participants Analyzed 1300 1273
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
H1N1 strain (N=1299,1273)
212
(194 to 232)
160
(147 to 176)
H3N2 strain (N=1299,1273)
499
(460 to 540)
324
(299 to 351)
B strain
60
(55 to 64)
54
(50 to 58)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection aTIV (Pooled), Licensed TIV
Comments Superiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for at least 2 homologous strains was >1.5.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter GMT ratio (H1N1 strain)
Estimated Value 1.32
Confidence Interval (2-Sided) 95%
1.2 to 1.45
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection aTIV (Pooled), Licensed TIV
Comments Superiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for at least 2 homologous strains was >1.5.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter GMT ratio (H3N2 strain)
Estimated Value 1.54
Confidence Interval (2-Sided) 95%
1.42 to 1.68
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection aTIV (Pooled), Licensed TIV
Comments Superiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for at least 2 homologous strains was >1.5.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter GMT ratio (B strain)
Estimated Value 1.11
Confidence Interval (2-Sided) 95%
1.03 to 1.21
Estimation Comments [Not Specified]
15.Secondary Outcome
Title Comparison of HI Antibody Responses of aTIV Versus TIV, in High Risk Group in Terms of Percentage of Subjects Achieving Seroconversion Against Homologous Strains-FAS
Hide Description

The superiority of HI antibody responses of aTIV compared to TIV, in subjects with pre-defined co-morbidities (high risk group), assessed in terms of percentage of subjects achieving seroconversion at three weeks after vaccination against the homologous vaccine strains.

Seroconversion is defined as prevaccination HI titer <10 and postvaccination HI titer ≥40 or at least a 4-fold increase in HI titers from prevaccination HI titer ≥10.

Time Frame Day 22 postvaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on FAS.
Arm/Group Title aTIV (Pooled) Licensed TIV
Hide Arm/Group Description:
Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).
Overall Number of Participants Analyzed 1300 1273
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of subjects
H1N1 strain (N=1299,1273)
72.6
(70.1 to 75.0)
62.0
(59.3 to 64.7)
H3N2 strain (N=1299,1273)
68.9
(66.3 to 71.4)
55.2
(52.4 to 58.0)
B strain
40.0
(37.3 to 42.7)
34.3
(31.6 to 36.9)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection aTIV (Pooled), Licensed TIV
Comments Superiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for at least 2 homologous strains was >10%.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Group difference (H1N1 strain)
Estimated Value 9.9
Confidence Interval (2-Sided) 95%
6.4 to 13.3
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection aTIV (Pooled), Licensed TIV
Comments Superiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for at least 2 homologous strains was >10%.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Group difference (H3N2 strain)
Estimated Value 13.0
Confidence Interval (2-Sided) 95%
9.5 to 16.6
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection aTIV (Pooled), Licensed TIV
Comments Superiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for at least 2 homologous strains was >10%.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Group difference (B strain)
Estimated Value 4.9
Confidence Interval (2-Sided) 95%
1.5 to 8.3
Estimation Comments [Not Specified]
16.Secondary Outcome
Title Comparison of aTIV Versus TIV in Terms of GMTs Against Heterologous Strains-PPS
Hide Description The non-inferiority of HI antibody responses of aTIV compared to TIV against the heterologous vaccine strains, in overall group and in subjects with pre-defined co-morbidities (high risk subjects), was assessed in terms of post vaccination GMTs at three weeks after vaccination .
Time Frame Day 22 post vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on PPS.
Arm/Group Title aTIV (Pooled) Licensed TIV
Hide Arm/Group Description:
Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).
Overall Number of Participants Analyzed 834 815
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
H3N2/Brisbane (overall) (N=834,814)
369
(329 to 414)
255
(227 to 287)
H3N2/Wisconsin (overall)
1037
(940 to 1144)
764
(691 to 846)
B strain (overall) (N=834,814)
89
(80 to 99)
82
(73 to 91)
H3N2/Brisbane (high risk) (N=302,307)
377
(319 to 445)
279
(236 to 330)
H3N2/Wisconsin (high risk) (N=302,307)
965
(831 to 1121)
751
(646 to 873)
B strain (high risk) (N=302,307)
117
(100 to 136)
105
(90 to 123)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection aTIV (Pooled), Licensed TIV
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for all 3 heterologous strains was >0.67.
Method of Estimation Estimation Parameter GMT Ratio (H3N2/Brisbane-overall)
Estimated Value 1.45
Confidence Interval (2-Sided) 95%
1.29 to 1.63
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection aTIV (Pooled), Licensed TIV
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for all 3 heterologous strains was >0.67.
Method of Estimation Estimation Parameter GMT Ratio (H3N2/Wisconsin-overall)
Estimated Value 1.36
Confidence Interval (2-Sided) 95%
1.23 to 1.5
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection aTIV (Pooled), Licensed TIV
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for all 3 heterologous strains was ≥0.67.
Method of Estimation Estimation Parameter GMT Ratio (B strain-overall)
Estimated Value 1.09
Confidence Interval (2-Sided) 95%
0.98 to 1.21
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection aTIV (Pooled), Licensed TIV
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for all 3 heterologous strains was >0.67.
Method of Estimation Estimation Parameter GMT Ratio(H3N2/Brisbane-high risk group)
Estimated Value 1.35
Confidence Interval 95%
1.13 to 1.61
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection aTIV (Pooled), Licensed TIV
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for all 3 heterologous strains was >0.67.
Method of Estimation Estimation Parameter GMT Ratio(H3N2/Wisconsin-high risk group
Estimated Value 1.29
Confidence Interval (2-Sided) 95%
1.1 to 1.5
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection aTIV (Pooled), Licensed TIV
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for all 3 heterologous strains was >0.67.
Method of Estimation Estimation Parameter GMT Ratio (B strain-high risk group)
Estimated Value 1.11
Confidence Interval (2-Sided) 95%
0.95 to 1.3
Estimation Comments [Not Specified]
17.Secondary Outcome
Title Comparison of aTIV Versus TIV in Terms of GMTs Against Heterologous Strains-FAS
Hide Description The superiority of HI antibody responses of aTIV compared to TIV against the heterologous vaccine strains, in overall group and in subjects with pre-defined co-morbidities (high risk subjects), was assessed in terms of post vaccination GMTs at three weeks after vaccination.
Time Frame Day 22 post vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on FAS.
Arm/Group Title aTIV (Pooled) Licensed TIV
Hide Arm/Group Description:
Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).
Overall Number of Participants Analyzed 887 881
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
H3N2/Brisbane (overall) (N=887,880)
362
(325 to 404)
243
(218 to 271)
H3N2/Wisconsin (overall)
1016
(926 to 1115)
738
(672 to 811)
B strain (overall) (N=887,880)
87
(79 to 97)
80
(72 to 88)
H3N2/Brisbane (high risk) (N=302,307)
364
(312 to 425)
267
(229 to 312)
H3N2/Wisconsin (high risk) (N=302,307)
927
(807 to 1065)
724
(631 to 831)
B strain (high risk) (N=302,307)
112
(97 to 129)
99
(87 to 114)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection aTIV (Pooled), Licensed TIV
Comments Superiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for at least 2 heterologous strains was >1.5.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter GMT ratio (H3N2/Brisbane-overall)
Estimated Value 1.49
Confidence Interval (2-Sided) 95%
1.33 to 1.67
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection aTIV (Pooled), Licensed TIV
Comments Superiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for at least 2 heterologous strains was >1.5.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter GMT ratio(H3N2/Wisconsin-overall)
Estimated Value 1.38
Confidence Interval (2-Sided) 95%
1.25 to 1.52
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection aTIV (Pooled), Licensed TIV
Comments Superiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for at least 2 heterologous strains was >1.5.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter GMT ratio (B strain-overall)
Estimated Value 1.09
Confidence Interval (2-Sided) 95%
0.99 to 1.21
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection aTIV (Pooled), Licensed TIV
Comments Superiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for at least 2 heterologous strains was >1.5.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter GMT ratio (H3N2/Brisbane-high risk)
Estimated Value 1.36
Confidence Interval (2-Sided) 95%
1.15 to 1.61
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection aTIV (Pooled), Licensed TIV
Comments Superiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for at least 2 heterologous strains was >1.5.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter GMT ratio(H3N2/Wisconsin-high risk)
Estimated Value 1.28
Confidence Interval (2-Sided) 95%
1.1 to 1.48
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection aTIV (Pooled), Licensed TIV
Comments Superiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for at least 2 heterologous strains was >1.5.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter GMT ratio (B strain-high risk)
Estimated Value 1.13
Confidence Interval (2-Sided) 95%
0.97 to 1.31
Estimation Comments [Not Specified]
18.Secondary Outcome
Title Comparison of HI Antibody Responses of aTIV Versus TIV, in Terms of Percentage of Subjects Achieving Seroconversion Against Heterologous Strains-PPS
Hide Description

The non-inferiority of HI antibody responses of aTIV compared to TIV against the heterologous strains, in overall group and in subjects with pre-defined co-morbidities (high risk group), assessed in terms of percentage of subjects achieving seroconversion at three weeks after vaccination.

Seroconversion is defined as prevaccination HI titer <10 and postvaccination HI titer ≥40 or at least a 4-fold increase in HI titers from prevaccination HI titer ≥10.

Time Frame Day 22 postvaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on PPS.
Arm/Group Title aTIV (Pooled) Licensed TIV
Hide Arm/Group Description:
Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).
Overall Number of Participants Analyzed 834 815
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of subjects
H3N2/Brisbane (overall) (N=834,814)
60.0
(56.5 to 63.3)
49.1
(45.7 to 52.6)
H3N2/Wisconsin (overall)
57.0
(53.5 to 60.4)
45.9
(42.4 to 49.4)
B strain (overall) (N=834,814)
52.8
(49.3 to 56.2)
49.3
(45.8 to 52.8)
H3N2/Brisbane (high risk) (N=302,307)
54.3
(48.5 to 60.0)
41.7
(36.1 to 47.4)
H3N2/Wisconsin (high risk) (N=302,307)
51.7
(45.9 to 57.4)
38.8
(33.3 to 44.5)
B strain (high risk) (N=302,307)
45.7
(40.0 to 51.5)
41.4
(35.8 to 47.1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection aTIV (Pooled), Licensed TIV
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for all 3 heterologous strains was ≥-10%.
Method of Estimation Estimation Parameter Group difference (H3N2/Brisbane-overall)
Estimated Value 11.3
Confidence Interval (2-Sided) 95%
6.7 to 15.9
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection aTIV (Pooled), Licensed TIV
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for all 3 heterologous strains was ≥-10%.
Method of Estimation Estimation Parameter Group difference(H3N2/Wisconsin-overall)
Estimated Value 11.9
Confidence Interval (2-Sided) 95%
7.3 to 16.6
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection aTIV (Pooled), Licensed TIV
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for all 3 homologous strains was ≥-10%.
Method of Estimation Estimation Parameter Slope
Estimated Value 4.0
Confidence Interval (2-Sided) 95%
-0.4 to 8.4
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection aTIV (Pooled), Licensed TIV
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for all 3 heterologous strains was ≥-10%.
Method of Estimation Estimation Parameter Group difference(H3N2/Brisbane-high risk
Estimated Value 12.3
Confidence Interval (2-Sided) 95%
4.8 to 19.9
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection aTIV (Pooled), Licensed TIV
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for all 3 homologous strains was ≥-10%.
Method of Estimation Estimation Parameter Group difference(H3N2Wisconsin-high risk
Estimated Value 12.6
Confidence Interval (2-Sided) 95%
5.0 to 20.2
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection aTIV (Pooled), Licensed TIV
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for all 3 heterologous strains was ≥-10%.
Method of Estimation Estimation Parameter Group difference (B strain-high risk)
Estimated Value 4.8
Confidence Interval (2-Sided) 95%
-2.1 to 11.8
Estimation Comments [Not Specified]
19.Secondary Outcome
Title Comparison of aTIV Versus TIV in Terms of Percentage of Subjects Achieving Seroconversion Against Heterologous Strains-FAS
Hide Description

The superiority of HI antibody responses of aTIV compared to TIV against the heterologous vaccine strains, in overall group and in subjects with pre-defined co-morbidities (high risk subjects), was assessed in terms of percentage of subjects achieving seroconversion, at three weeks after vaccination.

Seroconversion is defined as prevaccination HI titer <10 and postvaccination HI titer ≥40 or at least a 4-fold increase in HI titers from prevaccination HI titer ≥10.

Time Frame Day 22 post vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on FAS
Arm/Group Title aTIV (Pooled) Licensed TIV
Hide Arm/Group Description:
Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).
Overall Number of Participants Analyzed 887 881
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of subjects
H3N2/Brisbane (overall) (N=887,880)
60.4
(57.1 to 63.7)
48.4
(45.1 to 51.8)
H3N2/Wisconsin (overall)
57.5
(54.2 to 60.8)
45.5
(42.2 to 48.9)
B strain (overall) (N=887,880)
53.3
(50.0 to 56.7)
49.8
(46.4 to 53.1)
H3N2/Brisbane (high risk) (N=330, 333)
54.2
(48.7 to 59.7)
41.4
(36.1 to 46.9)
H3N2/Wisconsin (high risk) (N=330,333)
52.1
(46.6 to 57.6)
38.7
(33.5 to 44.2)
B strain (high risk) (N=330, 333)
46.4
(40.9 to 51.9)
41.7
(36.4 to 47.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection aTIV (Pooled), Licensed TIV
Comments Superiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for at least 2 heterologous strains was >10%.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Group difference (H3N2/Brisbane-overall)
Estimated Value 12.5
Confidence Interval (2-Sided) 95%
8.1 to 16.9
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection aTIV (Pooled), Licensed TIV
Comments Superiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for at least 2 heterologous strains was >10%.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Group difference(H3N2/Wisconsin-overall)
Estimated Value 12.6
Confidence Interval (2-Sided) 95%
8.1 to 17.1
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection aTIV (Pooled), Licensed TIV
Comments Superiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for at least 2 heterologous strains was >10%.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Group difference (B strain-overall)
Estimated Value 4.6
Confidence Interval (2-Sided) 95%
0.4 to 8.8
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection aTIV (Pooled), Licensed TIV
Comments Superiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for at least 2 heterologous strains was >10%.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Group difference(H3N2/Brisbane-high risk
Estimated Value 12.4
Confidence Interval (2-Sided) 95%
5.2 to 19.6
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection aTIV (Pooled), Licensed TIV
Comments Superiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for at least 2 heterologous strains was >10%.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Group difference(H3N2/Wisconsin-highrisk
Estimated Value 13.0
Confidence Interval (2-Sided) 95%
5.8 to 20.3
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection aTIV (Pooled), Licensed TIV
Comments Superiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for at least 2 heterologous strains was >10%.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Group difference (B strain-high risk)
Estimated Value 5.1
Confidence Interval (2-Sided) 95%
-1.6 to 11.8
Estimation Comments [Not Specified]
20.Secondary Outcome
Title Persistence of GMTs Against Homologous and Heterologous Strains
Hide Description The GMTs against homologous and heterologous strains, persisting in subjects at six months (day 181) and one year (day 366) after vaccination with either aTIV or TIV.
Time Frame Day 181, Day 366 post vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was done on the FAS (persistence) subset population i.e all randomized population only from US sites who received a study vaccination, provided evaluable blood samples at day 1, day 22, day 181, and day 366.
Arm/Group Title aTIV (Pooled) Licensed TIV
Hide Arm/Group Description:
Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).
Overall Number of Participants Analyzed 189 191
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
H1N1 (homologous) Day 181
71
(60 to 84)
68
(57 to 80)
H1N1 (homologous) Day 366
49
(41 to 59)
52
(44 to 63)
H3N2 (homologous) Day 181
123
(104 to 146)
91
(77 to 108)
H3N2 (homologous) Day 366
70
(59 to 84)
54
(45 to 64)
B (homologous) Day 181
25
(21 to 29)
22
(19 to 26)
B (homologous) Day 366
21
(18 to 24)
20
(17 to 23)
B (heterologous) Day 181
39
(33 to 45)
38
(33 to 44)
B (heterologous) Day 366
38
(33 to 44)
40
(35 to 46)
H3N2/Brisbane (heterologous) Day 181
100
(84 to 120)
81
(68 to 97)
H3N2/Brisbane(heterologous) Day 366
75
(63 to 90)
72
(60 to 86)
H3N2/Wisconsin (heterologous) Day 181
228
(189 to 275)
194
(161 to 233)
H3N2/Wisconsin (heterologous) Day 366
190
(157 to 231)
182
(150 to 221)
21.Secondary Outcome
Title Percentage of Subjects With Seroconversion Upto One Year After Vaccination, Against Homologous and Heterologous Strains
Hide Description

The percentage of subjects demonstrating seroconversion in HI titers against homologous and heterologous strains, at six months (day 181) and one year (day 366) after vaccination with either aTIV or TIV.

Seroconversion is defined as prevaccination HI titer <10 and postvaccination HI titer ≥40 or at least a 4-fold increase in HI titers from prevaccination HI titer ≥10.

Time Frame Day 181, Day 366 post vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was done on the FAS (persistence) subset.
Arm/Group Title aTIV (Pooled) Licensed TIV
Hide Arm/Group Description:
Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).
Overall Number of Participants Analyzed 189 191
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of subjects
H1N1 (homologous) Day 181
28.6
(22.3 to 35.6)
26.2
(20.1 to 33)
H1N1 (homologous) Day 366
18.5
(13.3 to 24.8)
19.4
(14.0 to 25.7)
H3N2 (homologous) Day 181
36.0
(29.1 to 43.3)
24.6
(18.7 to 31.4)
H3N2 (homologous) Day 366
16.9
(11.9 to 23.1)
12.6
(8.2 to 18.1)
B (homologous) Day 181
3.7
(1.5 to 7.5)
2.6
(0.9 to 6.0)
B (homologous) Day 366
2.1
(0.6 to 5.3)
3.1
(1.2 to 6.7)
B (heterologous) Day 181
2.65
(0.86 to 6.07)
3.14
(1.16 to 6.71)
B (heterologous) Day 366
4.23
(1.84 to 8.17)
3.14
(1.16 to 6.71)
H3N2/Brisbane (heterologous) Day 181
15.34
(10.52 to 21.29)
8.38
(4.86 to 13.25)
H3N2/Brisbane(heterologous) Day 366
7.94
(4.51 to 12.75)
5.24
(2.54 to 9.42)
H3N2/Wisconsin (heterologous) Day 181
12.17
(7.87 to 17.70)
8.90
(5.27 to 13.87)
H3N2/Wisconsin (heterologous) Day 366
8.99
(5.33 to 14.01)
6.28
(3.29 to 10.72)
22.Secondary Outcome
Title Number of Subjects Reporting Influenza Like Illness (ILI) Across Vaccine Groups
Hide Description The number of subjects reporting ILI from three weeks after vaccination to up to one year in aTIV group compared to TIV group, by country.
Time Frame Day 22 through Day 366 post vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the modified full analysis set (mFAS; effectiveness) population i.e all subjects in the randomized population who received a study vaccination but excluding those who received a non-study vaccine during the follow-up phase.
Arm/Group Title aTIV (Pooled) Licensed TIV
Hide Arm/Group Description:
Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).
Overall Number of Participants Analyzed 3497 3498
Measure Type: Number
Unit of Measure: participants
Columbia (N=516, 506) 119 97
Panama (N=108, 102) 20 21
Philippines (N=1836,1835) 102 113
United states (N=1037,1055) 72 76
23.Secondary Outcome
Title Number of High Risk Subjects With Exacerbation of Preexisting Chronic Disease, Across Vaccine Groups
Hide Description The number of high risk subjects reporting exacerbation of preexisting chronic conditions (i.e.congestive heart failure, Chronic Obstructive Pulmonary disease (COPD), asthma, hepatic disease, renal insufficiency, and neurological/neuromuscular or metabolic disorders including diabetes mellitus) in aTIV group compared to TIV group.
Time Frame Day 1 through Day 366 post vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the mFAS (effectiveness) population.
Arm/Group Title aTIV (Pooled) Licensed TIV
Hide Arm/Group Description:
Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).
Overall Number of Participants Analyzed 1307 1281
Measure Type: Number
Unit of Measure: participants
55 48
24.Secondary Outcome
Title Number of Subjects Reporting Healthcare Utilization Across Vaccine Groups
Hide Description The number of subjects with emergency room visits, unscheduled physician visits, and hospitalizations due to community acquired influenza or pneumonia, cardiopulmonary disease, cardiac disease, respiratory or pulmonary disease,in aTIV group compared to TIV group.
Time Frame Day 1 through Day 366 post vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the mFAS (effectiveness).
Arm/Group Title aTIV (Pooled) Licensed TIV
Hide Arm/Group Description:
Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).
Overall Number of Participants Analyzed 3499 3502
Measure Type: Number
Unit of Measure: participants
275 289
25.Secondary Outcome
Title All Cause Mortality Rate, Across Vaccine Groups
Hide Description The all-cause mortality rate (excluding injury)reported in aTIV group compared to TIV group, by country.
Time Frame Day 1 through Day 366 post vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the mFAS (effectiveness).
Arm/Group Title aTIV (Pooled) Licensed TIV
Hide Arm/Group Description:
Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).
Overall Number of Participants Analyzed 3540 3541
Measure Type: Number
Unit of Measure: participants
Columbia (N=519, 509) 7 7
Panama (N=109, 105) 0 0
Philippines (N=1873,1867) 39 34
United states (N=1039,1060) 6 5
26.Secondary Outcome
Title Number of Subjects Reporting Solicited Adverse Events Following Vaccination
Hide Description The number of subjects reporting solicited local and systemic adverse events and other adverse events in aTIV group compared to TIV group.
Time Frame Day 1 through Day 7 post vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the safety set i.e all randomized subjects who received a study vaccination and provided postvaccination safety data.
Arm/Group Title aTIV (Pooled) Licensed TIV
Hide Arm/Group Description:
Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).
Overall Number of Participants Analyzed 3505 3495
Measure Type: Number
Unit of Measure: participants
Any Local 1137 593
Injection site erythema (N=3492, 3485) 43 18
Injection site induration (N=3494, 3488) 45 17
Injection site tenderness (N=3495,3483) 739 391
Injection site swelling (N=3495,3488) 43 15
Injection site pain (N=3495,3485) 875 425
Any sytemic 1120 902
Chills (N=3495,3485) 235 163
Myalgia (N=3496,3487) 515 339
Arthralgia (N=3492,3486) 296 272
Headache (N= 3495,3486) 463 391
Fatigue (N= 3494, 3484) 466 361
Nausea (N=3492,3482) 101 98
Vomiting (N=3494,3483) 48 59
Diarrhea (N=3494,3485) 168 158
Fever (≥ 38°C) 122 116
Any other 210 165
Oral Temperature (≥ 40°C) 3 0
Analgesic/Antipyretic used 158 122
Time Frame Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title aTIV (Pooled) Licensed TIV
Hide Arm/Group Description Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3). Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).
All-Cause Mortality
aTIV (Pooled) Licensed TIV
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
aTIV (Pooled) Licensed TIV
Affected / at Risk (%) Affected / at Risk (%)
Total   264/3545 (7.45%)   243/3537 (6.87%) 
Blood and lymphatic system disorders     
Anemia * 1  2/3545 (0.06%)  5/3537 (0.14%) 
Disseminated intravascular coagulation * 1  1/3545 (0.03%)  0/3537 (0.00%) 
Idiopathic Thrombocytopenic coagulation * 1  1/3545 (0.03%)  0/3537 (0.00%) 
Leukocytosis * 1  0/3545 (0.00%)  1/3537 (0.03%) 
Sideroblastic anaemia * 1  1/3545 (0.03%)  0/3537 (0.00%) 
Cardiac disorders     
Acute coronary syndrome * 1  2/3545 (0.06%)  0/3537 (0.00%) 
Acute myocardial infarction * 1  11/3545 (0.31%)  7/3537 (0.20%) 
Angina pectoris * 1  1/3545 (0.03%)  2/3537 (0.06%) 
Angina unstable * 1  3/3545 (0.08%)  1/3537 (0.03%) 
Arrhythmia * 1  0/3545 (0.00%)  2/3537 (0.06%) 
Arteriosclerosis coronary artery * 1  2/3545 (0.06%)  0/3537 (0.00%) 
Atrial Fibrillation * 1  4/3545 (0.11%)  8/3537 (0.23%) 
Atrial tachycardia * 1  1/3545 (0.03%)  0/3537 (0.00%) 
Bradycardia * 1  2/3545 (0.06%)  0/3537 (0.00%) 
Cardiac arrest * 1  0/3545 (0.00%)  2/3537 (0.06%) 
Cardiac disorder * 1  2/3545 (0.06%)  0/3537 (0.00%) 
Cardiac failure * 1  3/3545 (0.08%)  4/3537 (0.11%) 
Cardiac failure congestive * 1  8/3545 (0.23%)  16/3537 (0.45%) 
Cardio-respiratory arrest * 1  3/3545 (0.08%)  1/3537 (0.03%) 
Cardiogenic shock * 1  0/3545 (0.00%)  1/3537 (0.03%) 
Coronary artery disease * 1  7/3545 (0.20%)  6/3537 (0.17%) 
Dressler's syndrome * 1  1/3545 (0.03%)  0/3537 (0.00%) 
Hypertensive heart disease * 1  2/3545 (0.06%)  1/3537 (0.03%) 
Hypertrophic cardiomyopathy * 1  0/3545 (0.00%)  1/3537 (0.03%) 
Myocardial infarction * 1  10/3545 (0.28%)  9/3537 (0.25%) 
Myocardial Ischemia * 1  3/3545 (0.08%)  2/3537 (0.06%) 
Nodal arrythmia * 1  1/3545 (0.03%)  0/3537 (0.00%) 
Pericarditis * 1  1/3545 (0.03%)  0/3537 (0.00%) 
Sinus Tachycardia * 1  1/3545 (0.03%)  0/3537 (0.00%) 
Ventricular extrasystoles * 1  2/3545 (0.06%)  0/3537 (0.00%) 
Ventricular tachycardia * 1  1/3545 (0.03%)  1/3537 (0.03%) 
Congenital, familial and genetic disorders     
Hydrocele * 1  1/3545 (0.03%)  1/3537 (0.03%) 
Ear and labyrinth disorders     
Vertigo * 1  1/3545 (0.03%)  1/3537 (0.03%) 
Vertigo positional * 1  2/3545 (0.06%)  1/3537 (0.03%) 
Eye disorders     
Blindness unilateral * 1  0/3545 (0.00%)  1/3537 (0.03%) 
Corneal degeneration * 1  0/3545 (0.00%)  1/3537 (0.03%) 
Retinal neovascularisation * 1  0/3545 (0.00%)  1/3537 (0.03%) 
Viterous hemorrhage * 1  0/3545 (0.00%)  1/3537 (0.03%) 
Gastrointestinal disorders     
Abdominal hernia * 1  1/3545 (0.03%)  0/3537 (0.00%) 
Abdominal pain * 1  0/3545 (0.00%)  1/3537 (0.03%) 
Abdominal pain upper * 1  0/3545 (0.00%)  1/3537 (0.03%) 
Abdominal wall hematoma * 1  0/3545 (0.00%)  1/3537 (0.03%) 
Ascites * 1  1/3545 (0.03%)  0/3537 (0.00%) 
Colitis * 1  0/3545 (0.00%)  1/3537 (0.03%) 
Diverticular perforation * 1  0/3545 (0.00%)  1/3537 (0.03%) 
Diverticulum * 1  1/3545 (0.03%)  2/3537 (0.06%) 
Duodenal ulcer perforation * 1  0/3545 (0.00%)  1/3537 (0.03%) 
Dyspepsia * 1  0/3545 (0.00%)  1/3537 (0.03%) 
Erosive oesophagitis * 1  1/3545 (0.03%)  0/3537 (0.00%) 
Femoral hernia,obstructive * 1  1/3545 (0.03%)  0/3537 (0.00%) 
Gastric ulcer perforation * 1  0/3545 (0.00%)  1/3537 (0.03%) 
Gastritis * 1  1/3545 (0.03%)  1/3537 (0.03%) 
Gastrointestinal haemorrhage * 1  2/3545 (0.06%)  1/3537 (0.03%) 
Hiatus hernia * 1  1/3545 (0.03%)  1/3537 (0.03%) 
Ileus * 1  0/3545 (0.00%)  1/3537 (0.03%) 
Ileus paralytic * 1  0/3545 (0.00%)  1/3537 (0.03%) 
Inguinal hernia, obstructive * 1  0/3545 (0.00%)  1/3537 (0.03%) 
Intestinal perforation * 1  1/3545 (0.03%)  0/3537 (0.00%) 
Irritable bowel syndrome * 1  1/3545 (0.03%)  0/3537 (0.00%) 
Large intestine perforation * 1  1/3545 (0.03%)  0/3537 (0.00%) 
Lower gastrointestinal haemorrhage * 1  1/3545 (0.03%)  1/3537 (0.03%) 
Oesophagitis * 1  1/3545 (0.03%)  0/3537 (0.00%) 
Pancreatic mass * 1  1/3545 (0.03%)  0/3537 (0.00%) 
Pancreatitis * 1  4/3545 (0.11%)  0/3537 (0.00%) 
Pancreatitis acute * 1  1/3545 (0.03%)  1/3537 (0.03%) 
Peptic ulcer * 1  0/3545 (0.00%)  4/3537 (0.11%) 
Peptic ulcer perforation * 1  1/3545 (0.03%)  0/3537 (0.00%) 
Pneumoperitonium * 1  0/3545 (0.00%)  1/3537 (0.03%) 
Rectal haemorrhage * 1  1/3545 (0.03%)  1/3537 (0.03%) 
Small intestinal obstruction * 1  0/3545 (0.00%)  4/3537 (0.11%) 
Upper gastrointestinal haemorrhage * 1  4/3545 (0.11%)  7/3537 (0.20%) 
Volvulus * 1  1/3545 (0.03%)  0/3537 (0.00%) 
General disorders     
Chest pain * 1  7/3545 (0.20%)  3/3537 (0.08%) 
Hernia obstructive * 1  0/3545 (0.00%)  1/3537 (0.03%) 
Multi-organ failure * 1  3/3545 (0.08%)  1/3537 (0.03%) 
Non-cardiac chest pain * 1  1/3545 (0.03%)  1/3537 (0.03%) 
Pyrexia * 1  1/3545 (0.03%)  2/3537 (0.06%) 
Hepatobiliary disorders     
Bile duct stone * 1  1/3545 (0.03%)  0/3537 (0.00%) 
Cholecystitis * 1  7/3545 (0.20%)  2/3537 (0.06%) 
Cholecystitis chronic * 1  1/3545 (0.03%)  0/3537 (0.00%) 
Cholelithiasis * 1  4/3545 (0.11%)  4/3537 (0.11%) 
Chronic hepatic failure * 1  1/3545 (0.03%)  0/3537 (0.00%) 
Hepatic cirrhosis * 1  1/3545 (0.03%)  0/3537 (0.00%) 
Jaundice * 1  0/3545 (0.00%)  1/3537 (0.03%) 
Immune system disorders     
Drug hypersensitivity * 1  1/3545 (0.03%)  0/3537 (0.00%) 
Infections and infestations     
Appendicitis * 1  1/3545 (0.03%)  2/3537 (0.06%) 
Arthritis bacterial * 1  0/3545 (0.00%)  1/3537 (0.03%) 
Arthritis infective * 1  0/3545 (0.00%)  1/3537 (0.03%) 
Bronchitis * 1  5/3545 (0.14%)  1/3537 (0.03%) 
Cellulitis * 1  2/3545 (0.06%)  3/3537 (0.08%) 
Cellulitis staphylococcal * 1  1/3545 (0.03%)  0/3537 (0.00%) 
Cystitis * 1  0/3545 (0.00%)  1/3537 (0.03%) 
Diverticulitis * 1  1/3545 (0.03%)  2/3537 (0.06%) 
Escherichia sepsis * 1  1/3545 (0.03%)  0/3537 (0.00%) 
Gastroenteritis * 1  5/3545 (0.14%)  6/3537 (0.17%) 
Gastroenteritis viral * 1  0/3545 (0.00%)  1/3537 (0.03%) 
Herpes zoster * 1  0/3545 (0.00%)  1/3537 (0.03%) 
Incision site infection * 1  0/3545 (0.00%)  1/3537 (0.03%) 
Infected skin ulcer * 1  1/3545 (0.03%)  0/3537 (0.00%) 
Infectious peritonitis * 1  1/3545 (0.03%)  1/3537 (0.03%) 
Laryngitis * 1  1/3545 (0.03%)  0/3537 (0.00%) 
Leptospirosis * 1  1/3545 (0.03%)  0/3537 (0.00%) 
Lobar pneumonia * 1  2/3545 (0.06%)  1/3537 (0.03%) 
Lower respiratory tract infection * 1  0/3545 (0.00%)  1/3537 (0.03%) 
Meningitis aseptic * 1  0/3545 (0.00%)  1/3537 (0.03%) 
Peritonsillar abscess * 1  0/3545 (0.00%)  1/3537 (0.03%) 
Pneumonia * 1  32/3545 (0.90%)  35/3537 (0.99%) 
Pneumonia viral * 1  1/3545 (0.03%)  0/3537 (0.00%) 
Pulmonary Tuberculosis * 1  2/3545 (0.06%)  2/3537 (0.06%) 
Pyelonephritis acute * 1  0/3545 (0.00%)  1/3537 (0.03%) 
Sepsis * 1  3/3545 (0.08%)  2/3537 (0.06%) 
Septic shock * 1  3/3545 (0.08%)  3/3537 (0.08%) 
Staphylococcal infection * 1  0/3545 (0.00%)  1/3537 (0.03%) 
Streptococcal sepsis * 1  1/3545 (0.03%)  1/3537 (0.03%) 
Tetanus * 1  0/3545 (0.00%)  1/3537 (0.03%) 
Tracheobronchitis * 1  1/3545 (0.03%)  0/3537 (0.00%) 
Tuberculosis * 1  1/3545 (0.03%)  0/3537 (0.00%) 
Upper respiratory tract infection * 1  1/3545 (0.03%)  0/3537 (0.00%) 
Urinary tract infection * 1  8/3545 (0.23%)  6/3537 (0.17%) 
Urosepsis * 1  0/3545 (0.00%)  1/3537 (0.03%) 
Wound abscess * 1  0/3545 (0.00%)  1/3537 (0.03%) 
Injury, poisoning and procedural complications     
Back injury * 1  1/3545 (0.03%)  0/3537 (0.00%) 
Brain herniation * 1  0/3545 (0.00%)  1/3537 (0.03%) 
Clavicle fracture * 1  0/3545 (0.00%)  1/3537 (0.03%) 
Concussion * 1  1/3545 (0.03%)  0/3537 (0.00%) 
Craniocerebral injury * 1  0/3545 (0.00%)  1/3537 (0.03%) 
Facial bones fracture * 1  0/3545 (0.00%)  1/3537 (0.03%) 
Fall * 1  1/3545 (0.03%)  0/3537 (0.00%) 
Femoral neck fracture * 1  2/3545 (0.06%)  1/3537 (0.03%) 
Femur fracture * 1  3/3545 (0.08%)  4/3537 (0.11%) 
Foot fracture * 1  0/3545 (0.00%)  1/3537 (0.03%) 
Forearm Fracture * 1  0/3545 (0.00%)  1/3537 (0.03%) 
Hip fracture * 1  1/3545 (0.03%)  3/3537 (0.08%) 
Humerus Fracture * 1  0/3545 (0.00%)  1/3537 (0.03%) 
Incisional hernia * 1  0/3545 (0.00%)  1/3537 (0.03%) 
Jaw fracture * 1  0/3545 (0.00%)  1/3537 (0.03%) 
Laceration * 1  0/3545 (0.00%)  1/3537 (0.03%) 
Lower limb fracture * 1  1/3545 (0.03%)  0/3537 (0.00%) 
Multiple injuries * 1  1/3545 (0.03%)  0/3537 (0.00%) 
Nerve injury * 1  1/3545 (0.03%)  0/3537 (0.00%) 
Pelvic fracture * 1  0/3545 (0.00%)  1/3537 (0.03%) 
Perirenal haematoma * 1  0/3545 (0.00%)  1/3537 (0.03%) 
Post procedural haemorrhage * 1  1/3545 (0.03%)  0/3537 (0.00%) 
Postoperative adhesion * 1  0/3545 (0.00%)  1/3537 (0.03%) 
Radius fracture * 1  0/3545 (0.00%)  1/3537 (0.03%) 
Seroma * 1  0/3545 (0.00%)  1/3537 (0.03%) 
Spinal compression fracture * 1  1/3545 (0.03%)  0/3537 (0.00%) 
Spinal cord injury * 1  0/3545 (0.00%)  1/3537 (0.03%) 
Subdural haematoma * 1  1/3545 (0.03%)  0/3537 (0.00%) 
Thoracic vertebral fracture * 1  0/3545 (0.00%)  1/3537 (0.03%) 
Tibia fracture * 1  1/3545 (0.03%)  0/3537 (0.00%) 
Traumatic liver injury * 1  0/3545 (0.00%)  1/3537 (0.03%) 
Wound dehiscence * 1  0/3545 (0.00%)  1/3537 (0.03%) 
Wrist fracture * 1  2/3545 (0.06%)  0/3537 (0.00%) 
Metabolism and nutrition disorders     
Dehydration * 1  1/3545 (0.03%)  1/3537 (0.03%) 
Diabetes Mellitus * 1  5/3545 (0.14%)  2/3537 (0.06%) 
Diabetes mellitus inadequate control * 1  2/3545 (0.06%)  2/3537 (0.06%) 
Diabetic foot * 1  2/3545 (0.06%)  1/3537 (0.03%) 
Diabetic ketoacidosis * 1  0/3545 (0.00%)  1/3537 (0.03%) 
Electrolyte imbalance * 1  1/3545 (0.03%)  0/3537 (0.00%) 
Hyperglycaemia * 1  2/3545 (0.06%)  1/3537 (0.03%) 
Hypocalcaemia * 1  0/3545 (0.00%)  1/3537 (0.03%) 
Hypoglycaemia * 1  2/3545 (0.06%)  0/3537 (0.00%) 
Hypokalaemia * 1  0/3545 (0.00%)  1/3537 (0.03%) 
Hypomagnesaemia * 1  0/3545 (0.00%)  1/3537 (0.03%) 
Hyponatraemia * 1  0/3545 (0.00%)  1/3537 (0.03%) 
Malnutrition * 1  0/3545 (0.00%)  1/3537 (0.03%) 
Type 2 diabetes mellitus * 1  3/3545 (0.08%)  0/3537 (0.00%) 
Arthropathy * 1  1/3545 (0.03%)  0/3537 (0.00%) 
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  3/3545 (0.08%)  3/3537 (0.08%) 
Arthritis * 1  3/3545 (0.08%)  0/3537 (0.00%) 
Costochondritis * 1  1/3545 (0.03%)  0/3537 (0.00%) 
Gouty arthritis * 1  1/3545 (0.03%)  0/3537 (0.00%) 
Intervertebral disc degeneration * 1  0/3545 (0.00%)  1/3537 (0.03%) 
Intervertebral disc protrusion * 1  0/3545 (0.00%)  3/3537 (0.08%) 
Lumbar spinal stenosis * 1  1/3545 (0.03%)  1/3537 (0.03%) 
Osteoarthritis * 1  7/3545 (0.20%)  12/3537 (0.34%) 
Rhabdomyolysis * 1  0/3545 (0.00%)  1/3537 (0.03%) 
Spinal column stenosis * 1  1/3545 (0.03%)  0/3537 (0.00%) 
Spondylolisthesis * 1  1/3545 (0.03%)  0/3537 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Acute leukaemia * 1  1/3545 (0.03%)  0/3537 (0.00%) 
Acute myeloid leukaemia * 1  1/3545 (0.03%)  1/3537 (0.03%) 
Adenocarcinoma * 1  0/3545 (0.00%)  1/3537 (0.03%) 
B-cell lymphoma * 1  0/3545 (0.00%)  1/3537 (0.03%) 
Basal cell carcinoma * 1  1/3545 (0.03%)  0/3537 (0.00%) 
Bladder adenocarcinoma stage unspecified * 1  0/3545 (0.00%)  1/3537 (0.03%) 
Bladder cancer * 1  1/3545 (0.03%)  0/3537 (0.00%) 
Bladder transitional cell carcinoma * 1  2/3545 (0.06%)  0/3537 (0.00%) 
Brain neoplasm malignant * 1  1/3545 (0.03%)  0/3537 (0.00%) 
Breast cancer * 1  1/3545 (0.03%)  3/3537 (0.08%) 
Breast cancer stage II * 1  1/3545 (0.03%)  0/3537 (0.00%) 
Chronic myeloid leukaemia * 1  1/3545 (0.03%)  0/3537 (0.00%) 
Colon adenoma * 1  0/3545 (0.00%)  1/3537 (0.03%) 
Colon cancer * 1  2/3545 (0.06%)  1/3537 (0.03%) 
Gastric cancer * 1  0/3545 (0.00%)  1/3537 (0.03%) 
Gastrointestinal stromal tumor * 1  0/3545 (0.00%)  1/3537 (0.03%) 
Lung adenocarcinoma * 1  1/3545 (0.03%)  1/3537 (0.03%) 
Lung cancer metastatic * 1  1/3545 (0.03%)  0/3537 (0.00%) 
Lung carcinoma cell type unspecified stage IV * 1  1/3545 (0.03%)  0/3537 (0.00%) 
Lung neoplasm malignant * 1  0/3545 (0.00%)  1/3537 (0.03%) 
Lung squamous cell carcinoma stage unspecified * 1  0/3545 (0.00%)  1/3537 (0.03%) 
Malignant melanoma * 1  1/3545 (0.03%)  0/3537 (0.00%) 
Meningioma * 1  1/3545 (0.03%)  0/3537 (0.00%) 
Metastases to lung * 1  0/3545 (0.00%)  1/3537 (0.03%) 
Metastatic neoplasm * 1  1/3545 (0.03%)  0/3537 (0.00%) 
Neoplasm malignant * 1  0/3545 (0.00%)  1/3537 (0.03%) 
Non-small cell lung cancer * 1  1/3545 (0.03%)  0/3537 (0.00%) 
Oesophageal carcinoma * 1  0/3545 (0.00%)  1/3537 (0.03%) 
Ovarian adenoma * 1  0/3545 (0.00%)  1/3537 (0.03%) 
Pancreatic neoplasm * 1  0/3545 (0.00%)  2/3537 (0.06%) 
Prolymphocytic leukaemia * 1  0/3545 (0.00%)  1/3537 (0.03%) 
Prostrate cancer * 1  2/3545 (0.06%)  4/3537 (0.11%) 
Rectal cancer * 1  1/3545 (0.03%)  0/3537 (0.00%) 
Sarcoma * 1  1/3545 (0.03%)  0/3537 (0.00%) 
Squamous cell carcinoma of the cervix * 1  0/3545 (0.00%)  1/3537 (0.03%) 
Transitional cell carcinoma * 1  2/3545 (0.06%)  0/3537 (0.00%) 
Nervous system disorders     
Ovarian cancer * 1  0/3545 (0.00%)  1/3537 (0.03%) 
Pancreatic carcinoma * 1  0/3545 (0.00%)  1/3537 (0.03%) 
Carotid artery disease * 1  0/3545 (0.00%)  1/3537 (0.03%) 
Carotid artery stenosis * 1  1/3545 (0.03%)  1/3537 (0.03%) 
Cerebellar infraction * 1  1/3545 (0.03%)  1/3537 (0.03%) 
Cerebral haemorrhage * 1  3/3545 (0.08%)  2/3537 (0.06%) 
Cerebral infraction * 1  3/3545 (0.08%)  2/3537 (0.06%) 
Cerebral ischaemia * 1  0/3545 (0.00%)  1/3537 (0.03%) 
Cerebrovascular accident * 1  4/3545 (0.11%)  10/3537 (0.28%) 
Cerebrovascular disorder * 1  8/3545 (0.23%)  3/3537 (0.08%) 
Cervical myelopathy * 1  0/3545 (0.00%)  1/3537 (0.03%) 
Cervicobrachial syndrome * 1  0/3545 (0.00%)  1/3537 (0.03%) 
Convulsion * 1  2/3545 (0.06%)  0/3537 (0.00%) 
Dementia alzheimer's type * 1  1/3545 (0.03%)  1/3537 (0.03%) 
Dementia with lewy bodies * 1  1/3545 (0.03%)  0/3537 (0.00%) 
Embolic stroke * 1  0/3545 (0.00%)  1/3537 (0.03%) 
Guillain-barre syndrome * 1  0/3545 (0.00%)  1/3537 (0.03%) 
Haemorrhage intracranial * 1  1/3545 (0.03%)  1/3537 (0.03%) 
Headcahe * 1  0/3545 (0.00%)  1/3537 (0.03%) 
Hemiplegia * 1  1/3545 (0.03%)  0/3537 (0.00%) 
Ishaemic stroke * 1  0/3545 (0.00%)  3/3537 (0.08%) 
Metabolic encephalopathy * 1  0/3545 (0.00%)  1/3537 (0.03%) 
Radiculopathy * 1  1/3545 (0.03%)  0/3537 (0.00%) 
Ruptured cerebral aneurysm * 1  1/3545 (0.03%)  0/3537 (0.00%) 
Stroke in evolution * 1  0/3545 (0.00%)  1/3537 (0.03%) 
Subarachnoid hemorrhage * 1  1/3545 (0.03%)  1/3537 (0.03%) 
Syncope * 1  4/3545 (0.11%)  4/3537 (0.11%) 
Transient ischemic attack * 1  3/3545 (0.08%)  2/3537 (0.06%) 
Vertebrobasilar insufficiency * 1  0/3545 (0.00%)  1/3537 (0.03%) 
VIIth nerve paralysis * 1  1/3545 (0.03%)  0/3537 (0.00%) 
Confusional state * 1  0/3545 (0.00%)  1/3537 (0.03%) 
Psychiatric disorders     
Mental status change * 1  1/3545 (0.03%)  0/3537 (0.00%) 
Renal and urinary disorders     
Azotemia * 1  1/3545 (0.03%)  0/3537 (0.00%) 
Calculus ureteric * 1  1/3545 (0.03%)  0/3537 (0.00%) 
Nephropathy * 1  1/3545 (0.03%)  0/3537 (0.00%) 
Obstructive uropathy * 1  1/3545 (0.03%)  0/3537 (0.00%) 
Renal Failure * 1  2/3545 (0.06%)  0/3537 (0.00%) 
Renal Failure acute * 1  3/3545 (0.08%)  2/3537 (0.06%) 
Renal failure chronic * 1  2/3545 (0.06%)  2/3537 (0.06%) 
Reproductive system and breast disorders     
Benign prostatic hyperplasia * 1  0/3545 (0.00%)  1/3537 (0.03%) 
Endometriosis * 1  1/3545 (0.03%)  0/3537 (0.00%) 
Prostatomegaly * 1  0/3545 (0.00%)  1/3537 (0.03%) 
Uterovaginal prolapse * 1  0/3545 (0.00%)  1/3537 (0.03%) 
Respiratory, thoracic and mediastinal disorders     
Acute respiratory failure * 1  0/3545 (0.00%)  1/3537 (0.03%) 
Asthma * 1  1/3545 (0.03%)  0/3537 (0.00%) 
Asthmatic crisis * 1  0/3545 (0.00%)  1/3537 (0.03%) 
Chronic obstructive pulmonary disease * 1  10/3545 (0.28%)  14/3537 (0.40%) 
Dyspnea * 1  2/3545 (0.06%)  2/3537 (0.06%) 
Hypoxia * 1  1/3545 (0.03%)  0/3537 (0.00%) 
Interstitial lung disease * 1  1/3545 (0.03%)  0/3537 (0.00%) 
Pleural effusion * 1  1/3545 (0.03%)  2/3537 (0.06%) 
Pneumonia aspiration * 1  2/3545 (0.06%)  0/3537 (0.00%) 
Pulmonary embolism * 1  3/3545 (0.08%)  0/3537 (0.00%) 
Pulmonary hypertension * 1  1/3545 (0.03%)  0/3537 (0.00%) 
Pulmonary mass * 1  1/3545 (0.03%)  0/3537 (0.00%) 
Pulmonary edema * 1  1/3545 (0.03%)  1/3537 (0.03%) 
Respiratory arrest * 1  1/3545 (0.03%)  0/3537 (0.00%) 
Respiratory failure * 1  2/3545 (0.06%)  3/3537 (0.08%) 
Upper airway obstruction * 1  1/3545 (0.03%)  0/3537 (0.00%) 
Angioedema * 1  1/3545 (0.03%)  0/3537 (0.00%) 
Vascular disorders     
Aneurysm ruptured * 1  0/3545 (0.00%)  1/3537 (0.03%) 
Aortic aneurysm * 1  3/3545 (0.08%)  1/3537 (0.03%) 
Aortic dissection * 1  0/3545 (0.00%)  1/3537 (0.03%) 
Aortic stenosis * 1  0/3545 (0.00%)  1/3537 (0.03%) 
Arteriosclerosis * 1  1/3545 (0.03%)  1/3537 (0.03%) 
Hypertension * 1  8/3545 (0.23%)  8/3537 (0.23%) 
Hypertensive crisis * 1  4/3545 (0.11%)  2/3537 (0.06%) 
Hypotension * 1  2/3545 (0.06%)  1/3537 (0.03%) 
Peripheral artery aneurysm * 1  1/3545 (0.03%)  1/3537 (0.03%) 
Varicose ulceration * 1  1/3545 (0.03%)  0/3537 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
aTIV (Pooled) Licensed TIV
Affected / at Risk (%) Affected / at Risk (%)
Total   1678/3545 (47.33%)   1257/3537 (35.54%) 
Gastrointestinal disorders     
Diarrhoea  1  186/3545 (5.25%)  172/3537 (4.86%) 
General disorders     
Chills  1  258/3545 (7.28%)  176/3537 (4.98%) 
Fatigue  1  480/3545 (13.54%)  379/3537 (10.72%) 
Injection site erythema  1  292/3545 (8.24%)  255/3537 (7.21%) 
Injection site pain  1  1172/3545 (33.06%)  643/3537 (18.18%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  315/3545 (8.89%)  293/3537 (8.28%) 
Myalgia  1  536/3545 (15.12%)  360/3537 (10.18%) 
Nervous system disorders     
Headache  1  492/3545 (13.88%)  426/3537 (12.04%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Posting Director
Organization: Novartis Vaccines and Diagnostics
EMail: RegistryContactVaccinesUS@novartis.com
Layout table for additonal information
Responsible Party: Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier: NCT01162122    
Other Study ID Numbers: V70_27
First Submitted: July 13, 2010
First Posted: July 14, 2010
Results First Submitted: January 28, 2014
Results First Posted: June 12, 2014
Last Update Posted: June 26, 2014