Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 97 of 112 for:    mf59

Clinical Study to Evaluate Safety, Immunogenicity of Investigational Flu Vaccine Compared to an Approved Flu Vaccine in Children Previously Vaccinated in Trial V118_05 (NCT01964989)

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: NCT02583256
Recruitment Status : Completed
First Posted : October 22, 2015
Results First Posted : April 24, 2019
Last Update Posted : April 24, 2019
Sponsor:
Information provided by (Responsible Party):
Seqirus

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition Influenza
Interventions Biological: Adjuvanted QIV (aQIV)
Biological: Non-adjuvanted QIV
Enrollment 1601
Recruitment Details This study was conducted at 17 sites in total; 9 sites in Finland, 4 sites in the Philippines and 4 sites in Thailand.
Pre-assignment Details All enrolled subjects were included in the study.
Arm/Group Title aQIV/aQIV aQIV/QIV QIV/aQIV QIV/QIV
Hide Arm/Group Description

Subjects previously vaccinated with aQIV followed one year later by aQIV

Adjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)

Subjects previously vaccinated with aQIV followed one year later by QIV

Non-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)

Subjects previously vaccinated with QIV followed one year later by aQIV

Adjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)

Subjects previously vaccinated with QIV followed one year later by QIV

Non-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)

Period Title: Overall Study
Started 403 403 402 393
Exposed 403 403 402 393
Completed 400 401 400 390
Not Completed 3 2 2 3
Reason Not Completed
Withdrawal by Subject             0             1             1             0
Lost to Follow-up             1             1             0             1
Administrative/Other             2             0             1             2
Arm/Group Title aQIV/aQIV aQIV/QIV QIV/aQIV QIV/QIV Total
Hide Arm/Group Description

Subjects previously vaccinated with aQIV followed one year later by aQIV

Adjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)

Subjects previously vaccinated with aQIV followed one year later by QIV

Non-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)

Subjects previously vaccinated with QIV followed one year later by aQIV

Adjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)

Subjects previously vaccinated with QIV followed one year later by QIV

Non-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)

Total of all reporting groups
Overall Number of Baseline Participants 403 403 402 393 1601
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 403 participants 403 participants 402 participants 393 participants 1601 participants
54.4  (17.12) 52.3  (17.02) 53.4  (17.32) 53.3  (17.30) 53.0  (16.91)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 403 participants 403 participants 402 participants 393 participants 1601 participants
Female
197
  48.9%
189
  46.9%
206
  51.2%
178
  45.3%
770
  48.1%
Male
206
  51.1%
214
  53.1%
196
  48.8%
215
  54.7%
831
  51.9%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 403 participants 403 participants 402 participants 393 participants 1601 participants
Hispanic or Latino
1
   0.2%
0
   0.0%
0
   0.0%
0
   0.0%
1
   0.1%
Not Hispanic or Latino
402
  99.8%
403
 100.0%
402
 100.0%
392
  99.7%
1599
  99.9%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
1
   0.3%
1
   0.1%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 403 participants 403 participants 402 participants 393 participants 1601 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
364
  90.3%
364
  90.3%
362
  90.0%
355
  90.3%
1445
  90.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
White
38
   9.4%
36
   8.9%
37
   9.2%
35
   8.9%
146
   9.1%
Other
1
   0.2%
3
   0.7%
3
   0.7%
3
   0.8%
10
   0.6%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 403 participants 403 participants 402 participants 393 participants 1601 participants
Philippines
210
  52.1%
211
  52.4%
213
  53.0%
212
  53.9%
846
  52.8%
Finland
39
   9.7%
39
   9.7%
39
   9.7%
38
   9.7%
155
   9.7%
Thailand
154
  38.2%
153
  38.0%
150
  37.3%
143
  36.4%
600
  37.5%
Risk Status   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 403 participants 403 participants 402 participants 393 participants 1601 participants
At risk
10
   2.5%
20
   5.0%
18
   4.5%
13
   3.3%
61
   3.8%
Not at risk
393
  97.5%
383
  95.0%
384
  95.5%
380
  96.7%
1540
  96.2%
[1]
Measure Description: Subjects with underlying conditions that posed high risk of influenza complications (at risk/not at risk)
1.Primary Outcome
Title Immunogenicity Endpoint: Geometric Mean Titer (GMT) and GMT Ratio as Determined by Hemagglutination Inhibition (HI) Assay on Day 22 Against Homologous Strains (aQIV-primed Comparison), Noninferiority Analysis
Hide Description

GMT and 95% confidence interval (CI) were analyzed for Day 22 against homologous strains using ANCOVA with study specific covariates.

Strains tested: A/H1N1 California/07/2009; A/H3N2 Switzerland/9715293/2013; B/Victoria Brisbane/60/2008; B/Yamagata Phuket/3073/2013.

Time Frame Day 22
Hide Outcome Measure Data
Hide Analysis Population Description
Immunogenicity per protocol set (PPS) consisting of all subjects who received a study vaccination and provided immunogenicity data, and who correctly received the study vaccine, had no major protocol deviations, and did not develop reverse transcription polymerase chain reaction(RT-PCR) confirmed influenza infection between baseline and Visit 2.
Arm/Group Title aQIV/aQIV aQIV/QIV
Hide Arm/Group Description:

Subjects previously vaccinated with aQIV followed one year later by aQIV

Adjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)

Subjects previously vaccinated with aQIV followed one year later by QIV

Non-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)

Overall Number of Participants Analyzed 403 398
Geometric Mean (95% Confidence Interval)
Unit of Measure: titer
A/H1N1
1219.00
(1137.35 to 1306.52)
1020.89
(953.22 to 1093.36)
A/H3N2
2355.52
(2226.19 to 2492.35)
2529.83
(2392.90 to 2674.59)
B/Yamagata
276.23
(252.73 to 301.92)
232.82
(213.25 to 254.19)
B/Victoria
388.35
(355.33 to 424.44)
328.42
(300.76 to 358.63)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection aQIV/aQIV, aQIV/QIV
Comments Comparison performed for strain A/H1N1.
Type of Statistical Test Non-Inferiority
Comments Lower bound of two-sided 95% CI on the ratio of aQIV-aQIV/aQIV-QIV HI GMT should not fall below 0.667.
Method of Estimation Estimation Parameter GMT ratio
Estimated Value 1.19
Confidence Interval (2-Sided) 95%
1.1 to 1.3
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection aQIV/aQIV, aQIV/QIV
Comments Comparison performed for strain A/H3N2.
Type of Statistical Test Non-Inferiority
Comments Lower bound of two-sided 95% CI on the ratio of aQIV-aQIV/aQIV-QIV HI GMT should not fall below 0.667.
Method of Estimation Estimation Parameter GMT ratio
Estimated Value 0.93
Confidence Interval (2-Sided) 95%
0.9 to 1.0
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection aQIV/aQIV, aQIV/QIV
Comments Comparison performed for strain B/Yamagata.
Type of Statistical Test Non-Inferiority
Comments Lower bound of two-sided 95% CI on the ratio of aQIV-aQIV/aQIV-QIV HI GMT should not fall below 0.667.
Method of Estimation Estimation Parameter GMT ratio
Estimated Value 1.19
Confidence Interval (2-Sided) 95%
1.1 to 1.3
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection aQIV/aQIV, aQIV/QIV
Comments Comparison performed for strain B/Victoria.
Type of Statistical Test Non-Inferiority
Comments Lower bound of two-sided 95% CI on the ratio of aQIV-aQIV/aQIV-QIV HI GMT should not fall below 0.667.
Method of Estimation Estimation Parameter GMT ratio
Estimated Value 1.18
Confidence Interval (2-Sided) 95%
1.1 to 1.3
Estimation Comments [Not Specified]
2.Primary Outcome
Title Immunogenicity Endpoint: GMT and GMT Ratio as Determined by HI Assay on Day 22 Against Homologous Strains (aQIV-primed Comparison), Superiority Analysis
Hide Description

GMT and 95% CI were analyzed for Day 22 against homologous strains using ANCOVA with study specific covariates.

Strains tested: A/H1N1 California/07/2009; A/H3N2 Switzerland/9715293/2013; B/Victoria Brisbane/60/2008; B/Yamagata Phuket/3073/2013.

Time Frame Day 22
Hide Outcome Measure Data
Hide Analysis Population Description
The immunogenicity full analysis set (FAS) consisting of all subjects who received a study vaccination and provided immunogenicity data at both Visit 1 (baseline) and at least one post-vaccination visit.
Arm/Group Title aQIV/aQIV aQIV/QIV
Hide Arm/Group Description:

Subjects previously vaccinated with aQIV followed one year later by aQIV

Adjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)

Subjects previously vaccinated with aQIV followed one year later by QIV

Non-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)

Overall Number of Participants Analyzed 403 403
Geometric Mean (95% Confidence Interval)
Unit of Measure: titer
A/H1N1
1218.91
(1137.02 to 1306.70)
1023.37
(955.72 to 1095.81)
A/H3N2
2345.71
(2216.84 to 2482.07)
2521.60
(2385.43 to 2665.56)
B/Yamagata
274.75
(251.09 to 300.65)
230.51
(210.97 to 251.86)
B/Victoria
387.35
(354.15 to 423.66)
326.68
(299.10 to 356.81)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection aQIV/aQIV, aQIV/QIV
Comments Comparison performed for strain A/H1N1.
Type of Statistical Test Superiority
Comments Superiority criterion for the GMT ratio: Lower bound of two-sided 95% CI on the ratio of aQIV-aQIV/aQIV-QIV HI GMT should exceed 1.
Method of Estimation Estimation Parameter GMT ratio
Estimated Value 1.19
Confidence Interval (2-Sided) 95%
1.1 to 1.3
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection aQIV/aQIV, aQIV/QIV
Comments Comparison performed for strain A/H3N2.
Type of Statistical Test Superiority
Comments Lower bound of two-sided 95% CI on the ratio of aQIV-aQIV/aQIV-QIV HI GMT should exceed 1.
Method of Estimation Estimation Parameter GMT ratio
Estimated Value 0.93
Confidence Interval (2-Sided) 95%
0.9 to 1.0
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection aQIV/aQIV, aQIV/QIV
Comments Comparison performed for strain B/Yamagata.
Type of Statistical Test Superiority
Comments Lower bound of two-sided 95% CI on the ratio of aQIV-aQIV/aQIV-QIV HI GMT should exceed 1.
Method of Estimation Estimation Parameter GMT ratio
Estimated Value 1.19
Confidence Interval (2-Sided) 95%
1.1 to 1.3
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection aQIV/aQIV, aQIV/QIV
Comments Comparison performed for strain B/Victoria.
Type of Statistical Test Superiority
Comments Lower bound of two-sided 95% CI on the ratio of aQIV-aQIV/aQIV-QIV HI GMT should exceed 1.
Method of Estimation Estimation Parameter GMT ratio
Estimated Value 1.19
Confidence Interval (2-Sided) 95%
1.1 to 1.3
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Immunogenicity Endpoint: GMT and GMT Ratio as Determined by HI Assay on Day 22 Against Homologous Strains (QIV-primed Comparison)
Hide Description

GMT and 95% CI were analyzed for Day 22 against homologous strains using ANCOVA with study specific covariates.

Strains tested: A/H1N1 California/07/2009; A/H3N2 Switzerland/9715293/2013; B/Victoria Brisbane/60/2008; B/Yamagata Phuket/3073/2013.

Time Frame Day 22
Hide Outcome Measure Data
Hide Analysis Population Description
The immunogenicity PPS consisting of all subjects who received a study vaccination and provided immunogenicity data, and who correctly received the study vaccine, had no major protocol deviations, and did not develop RT-PCR-confirmed influenza infection between baseline and Visit 2.
Arm/Group Title QIV/aQIV QIV/QIV
Hide Arm/Group Description:

Subjects previously vaccinated with QIV followed one year later by aQIV

Adjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)

Subjects previously vaccinated with QIV followed one year later by QIV

Non-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)

Overall Number of Participants Analyzed 397 389
Geometric Mean (95% Confidence Interval)
Unit of Measure: titer
A/H1N1
1206.20
(1123.80 to 1294.65)
866.51
(807.30 to 930.06)
A/H3N2
2369.95
(2236.39 to 2511.48)
2229.48
(2103.42 to 2363.10)
B/Yamagata
221.54
(202.12 to 242.82)
156.01
(142.32 to 171.02)
B/Victoria
330.94
(302.38 to 362.21)
244.03
(222.84 to 267.24)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection QIV/aQIV, QIV/QIV
Comments Comparison performed for strain A/H1N1.
Type of Statistical Test Non-Inferiority
Comments Lower bound of two-sided 95% CI on the ratio of QIV-aQIV/QIV-QIV HI GMT should not fall below 0.667.
Method of Estimation Estimation Parameter GMT ratio
Estimated Value 1.39
Confidence Interval (2-Sided) 95%
1.28 to 1.51
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection QIV/aQIV, QIV/QIV
Comments Comparison performed for strain A/H3N2
Type of Statistical Test Non-Inferiority
Comments Lower bound of two-sided 95% CI on the ratio of QIV-aQIV/QIV-QIV HI GMT should not fall below 0.667.
Method of Estimation Estimation Parameter GMT ratio
Estimated Value 1.06
Confidence Interval (2-Sided) 95%
0.99 to 1.14
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection QIV/aQIV, QIV/QIV
Comments Comparison performed for strain B/Yamagata.
Type of Statistical Test Non-Inferiority
Comments Lower bound of two-sided 95% CI on the ratio of QIV-aQIV/QIV-QIV HI GMT should not fall below 0.667.
Method of Estimation Estimation Parameter GMT ratio
Estimated Value 1.42
Confidence Interval (2-Sided) 95%
1.27 to 1.58
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection QIV/aQIV, QIV/QIV
Comments Comparison performed for strain B/Victoria.
Type of Statistical Test Non-Inferiority
Comments Lower bound of two-sided 95% CI on the ratio of QIV-aQIV/QIV-QIV HI GMT should not fall below 0.667.
Method of Estimation Estimation Parameter GMT ratio
Estimated Value 1.36
Confidence Interval (2-Sided) 95%
1.22 to 1.51
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Immunogenicity Endpoint: GMT and GMT Ratio as Determined by HI Assay on Day 181 Against Homologous Strains (aQIV-primed and QIV-primed Comparison)
Hide Description

GMT and 95% CI were analyzed for Day 181 against homologous strains using ANCOVA with study specific covariates.

Strains tested: A/H1N1 California/07/2009; A/H3N2 Switzerland/9715293/2013; B/Victoria Brisbane/60/2008; B/Yamagata Phuket/3073/2013.

Time Frame Day 181
Hide Outcome Measure Data
Hide Analysis Population Description
The Immunogenicity PPS consisting of all subjects who received a study vaccination and provided immunogenicity data, and who correctly received the study vaccine, had no major protocol deviations, and did not develop RT-PCR-confirmed influenza infection between baseline and Visit 2.
Arm/Group Title aQIV/aQIV aQIV/QIV QIV/aQIV QIV/QIV
Hide Arm/Group Description:

Subjects previously vaccinated with aQIV followed one year later by aQIV

Adjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)

Subjects previously vaccinated with aQIV followed one year later by QIV

Non-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)

Subjects previously vaccinated with QIV followed one year later by aQIV

Adjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)

Subjects previously vaccinated with QIV followed one year later by QIV

Non-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)

Overall Number of Participants Analyzed 403 398 397 389
Geometric Mean (95% Confidence Interval)
Unit of Measure: titer
A/H1N1
489.45
(449.93 to 532.45)
411.72
(378.83 to 447.46)
429.06
(393.73 to 467.57)
307.36
(282.02 to 334.98)
A/H3N2
1423.38
(1310.04 to 1546.52)
1438.40
(1325.53 to 1560.89)
1233.84
(1133.08 to 1343.56)
1222.21
(1121.92 to 1331.46)
B/Yamagata
97.01
(88.67 to 106.13)
86.43
(79.09 to 94.45)
73.37
(66.88 to 80.49)
56.57
(51.56 to 62.08)
B/Victoria
128.32
(115.17 to 142.97)
115.26
(103.57 to 128.26)
104.93
(94.02 to 117.10)
79.76
(71.41 to 89.09)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection aQIV/aQIV, aQIV/QIV
Comments Comparison performed for strain A/H1N1.
Type of Statistical Test Non-Inferiority
Comments Lower bound of two-sided 95% CI on the ratio of aQIV-aQIV/aQIV-QIV HI GMT should not fall below 0.667.
Method of Estimation Estimation Parameter GMT ratio
Estimated Value 1.19
Confidence Interval (2-Sided) 95%
1.07 to 1.32
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection aQIV/aQIV, aQIV/QIV
Comments Comparison performed for strain A/H3N2.
Type of Statistical Test Non-Inferiority
Comments Lower bound of two-sided 95% CI on the ratio of aQIV-aQIV/aQIV-QIV HI GMT should not fall below 0.667.
Method of Estimation Estimation Parameter GMT ratio
Estimated Value 0.99
Confidence Interval (2-Sided) 95%
0.90 to 1.09
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection aQIV/aQIV, aQIV/QIV
Comments Comparison performed for strain B/Yamagata.
Type of Statistical Test Non-Inferiority
Comments Lower bound of two-sided 95% CI on the ratio of aQIV-aQIV/aQIV-QIV HI GMT should not fall below 0.667.
Method of Estimation Estimation Parameter GMT ratio
Estimated Value 1.12
Confidence Interval (2-Sided) 95%
1.01 to 1.25
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection aQIV/aQIV, aQIV/QIV
Comments Comparison performed for strain B/Victoria.
Type of Statistical Test Non-Inferiority
Comments Lower bound of two-sided 95% CI on the ratio of aQIV-aQIV/aQIV-QIV HI GMT should not fall below 0.667.
Method of Estimation Estimation Parameter GMT ratio
Estimated Value 1.11
Confidence Interval (2-Sided) 95%
0.98 to 1.27
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection QIV/aQIV, QIV/QIV
Comments Comparison performed for strain A/H1N1.
Type of Statistical Test Non-Inferiority
Comments Lower bound of two-sided 95% CI on the ratio of QIV-aQIV/QIV-QIV HI GMT should not fall below 0.667.
Method of Estimation Estimation Parameter GMT ratio
Estimated Value 1.4
Confidence Interval (2-Sided) 95%
1.3 to 1.5
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection QIV/aQIV, QIV/QIV
Comments Comparison performed for strain A/H3N2.
Type of Statistical Test Non-Inferiority
Comments Lower bound of two-sided 95% CI on the ratio of QIV-aQIV/QIV-QIV HI GMT should not fall below 0.667.
Method of Estimation Estimation Parameter GMT ratio
Estimated Value 1.01
Confidence Interval (2-Sided) 95%
0.9 to 1.1
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection QIV/aQIV, QIV/QIV
Comments Comparison performed for strain B/Yamagata.
Type of Statistical Test Non-Inferiority
Comments Lower bound of two-sided 95% CI on the ratio of QIV-aQIV/QIV-QIV HI GMT should not fall below 0.667.
Method of Estimation Estimation Parameter GMT ratio
Estimated Value 1.30
Confidence Interval (2-Sided) 95%
1.2 to 1.4
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection QIV/aQIV, QIV/QIV
Comments Comparison performed for strain B/Victoria.
Type of Statistical Test Non-Inferiority
Comments Lower bound of two-sided 95% CI on the ratio of QIV-aQIV/QIV-QIV HI GMT should not fall below 0.667.
Method of Estimation Estimation Parameter GMT ratio
Estimated Value 1.32
Confidence Interval (2-Sided) 95%
1.2 to 1.5
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Immunogenicity Endpoint: Seroconversion Rate (SCR) on Day 22 Against Homologous Strains (aQIV-primed and QIV-primed Comparison)
Hide Description

The percentage of subjects achieving seroconversion at Day 22 after vaccination is reported against homologous strains. Seroconversion was defined in subjects seronegative at baseline (i.e. HI titer <1:10 on Day 1) as postvaccination HI titer ≥1:40 and defined in subjects seropositive at baseline (i.e. HI titer ≥1:10 on Day 1) as a minimum of a 4-fold increase in post-vaccination HI titer.

Strains tested: A/H1N1 California/07/2009; A/H3N2 Switzerland/9715293/2013; B/Victoria Brisbane/60/2008; B/Yamagata Phuket/3073/2013.

Time Frame Day 1, Day 22
Hide Outcome Measure Data
Hide Analysis Population Description
The Immunogenicity PPS consisting of all subjects who received a study vaccination and provided immunogenicity data, and who correctly received the study vaccine, had no major protocol deviations, and did not develop RT-PCR-confirmed influenza infection between baseline and Visit 2.
Arm/Group Title aQIV/aQIV aQIV/QIV QIV/aQIV QIV/QIV
Hide Arm/Group Description:

Subjects previously vaccinated with aQIV followed one year later by aQIV

Adjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)

Subjects previously vaccinated with aQIV followed one year later by QIV

Non-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)

Subjects previously vaccinated with QIV followed one year later by aQIV

Adjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)

Subjects previously vaccinated with QIV followed one year later by QIV

Non-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)

Overall Number of Participants Analyzed 403 398 397 389
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of subjects
A/H1N1
62.7
(57.8 to 67.4)
60.9
(55.9 to 65.7)
72.04
(67.35 to 76.40)
62.37
(57.34 to 67.21)
A/H3N2
68.9
(64.1 to 73.4)
68.0
(63.2 to 72.6)
72.80
(68.13 to 77.12)
76.74
(72.21 to 80.86)
B/Yamagata
76.4
(71.9 to 80.4)
72.0
(67.4 to 76.4)
79.44
(75.11 to 83.32)
66.49
(61.51 to 71.21)
B/Victoria
77.4
(73.0 to 81.4)
74.8
(70.2 to 79.0)
77.92
(73.49 to 81.92)
69.55
(64.66 to 74.14)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection aQIV/aQIV, aQIV/QIV
Comments Comparison performed for strain A/H1N1.
Type of Statistical Test Non-Inferiority
Comments The lower bound of two-sided 95% CI on the difference between SCR should not be below -10%.
Method of Estimation Estimation Parameter SCR difference
Estimated Value 1.8
Confidence Interval (2-Sided) 95%
-4.9 to 8.6
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection aQIV/aQIV, aQIV/QIV
Comments Comparison performed for strain A/H3N2.
Type of Statistical Test Non-Inferiority
Comments The lower bound of two-sided 95% CI on the difference between SCR should not be below -10%.
Method of Estimation Estimation Parameter SCR difference
Estimated Value 0.9
Confidence Interval (2-Sided) 95%
-5.6 to 7.3
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection aQIV/aQIV, aQIV/QIV
Comments Comparison performed for strain B/Yamagata.
Type of Statistical Test Non-Inferiority
Comments The lower bound of two-sided 95% CI on the difference between SCR should not be below -10%.
Method of Estimation Estimation Parameter SCR difference
Estimated Value 4.3
Confidence Interval (2-Sided) 95%
-1.8 to 10.4
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection aQIV/aQIV, aQIV/QIV
Comments Comparison performed for strain B/Victoria.
Type of Statistical Test Non-Inferiority
Comments The lower bound of two-sided 95% CI on the difference between SCR should not be below -10%.
Method of Estimation Estimation Parameter SCR difference
Estimated Value 2.6
Confidence Interval (2-Sided) 95%
-3.3 to 8.5
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection QIV/aQIV, QIV/QIV
Comments Comparison performed for strain A/H1N1.
Type of Statistical Test Non-Inferiority
Comments The lower bound of two-sided 95% CI on the difference between SCR should not be below -10%.
Method of Estimation Estimation Parameter SCR difference
Estimated Value 9.67
Confidence Interval (2-Sided) 95%
3.11 to 16.17
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection QIV/aQIV, QIV/QIV
Comments Comparison performed for strain A/H3N2.
Type of Statistical Test Non-Inferiority
Comments The lower bound of two-sided 95% CI on the difference between SCR should not be below -10%.
Method of Estimation Estimation Parameter SCR difference
Estimated Value -3.95
Confidence Interval (2-Sided) 95%
-10.02 to 2.15
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection QIV/aQIV, QIV/QIV
Comments Comparison performed for strain B/Yamagata.
Type of Statistical Test Non-Inferiority
Comments The lower bound of two-sided 95% CI on the difference between SCR should not be below -10%.
Method of Estimation Estimation Parameter SCR difference
Estimated Value 12.95
Confidence Interval (2-Sided) 95%
6.73 to 19.12
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection QIV/aQIV, QIV/QIV
Comments Comparison performed for strain B/Victoria.
Type of Statistical Test Non-Inferiority
Comments The lower bound of two-sided 95% CI on the difference between SCR should not be below -10%.
Method of Estimation Estimation Parameter SCR difference
Estimated Value 8.36
Confidence Interval (2-Sided) 95%
2.17 to 14.54
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Immunogenicity Endpoint: Geometric Mean Ratio (GMR) as Determined by HI Assay for Day 22/Day 1 and Day 181/Day 1 for Against Homologous Strains
Hide Description

The GMR is the geometric mean of the fold increase in HI titer from Day 1 to Day 22 or Day 181. GMR and 95% CI were analyzed against homologous strains using ANCOVA with study specific covariates.

Strains tested: A/H1N1 California/07/2009; A/H3N2 Switzerland/9715293/2013; B/Victoria Brisbane/60/2008; B/Yamagata Phuket/3073/2013.

Time Frame Day 22, Day 181
Hide Outcome Measure Data
Hide Analysis Population Description
The immunogenicity PPS consisting of all subjects who received a study vaccination and provided immunogenicity data, and who correctly received the study vaccine, had no major protocol deviations, and did not develop RT-PCR-confirmed influenza infection between baseline and Visit 2.
Arm/Group Title aQIV/aQIV aQIV/QIV QIV/aQIV QIV/QIV
Hide Arm/Group Description:

Subjects previously vaccinated with aQIV followed one year later by aQIV

Adjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)

Subjects previously vaccinated with aQIV followed one year later by QIV

Non-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)

Subjects previously vaccinated with QIV followed one year later by aQIV

Adjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)

Subjects previously vaccinated with QIV followed one year later by QIV

Non-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)

Overall Number of Participants Analyzed 403 398 397 389
Geometric Mean (95% Confidence Interval)
Unit of Measure: ratio
A/H1N1 (Day 22/Day 1)
7.69
(7.17 to 8.24)
6.44
(6.01 to 6.90)
7.61
(7.09 to 8.17)
5.47
(5.09 to 5.87)
A/H1N1 (Day 181/Day 1)
3.11
(2.86 to 3.38)
2.61
(2.40 to 2.84)
2.72
(2.50 to 2.97)
1.95
(1.79 to 2.13)
A/H3N2 (Day 22/Day 1)
9.02
(8.53 to 9.55)
9.69
(9.17 to 10.25)
9.08
(8.57 to 9.62)
8.54
(8.06 to 9.05)
A/H3N2 (Day 181/Day 1)
5.44
(5.01 to 5.91)
5.50
(5.07 to 5.97)
4.72
(4.33 to 5.14)
4.67
(4.29 to 5.09)
B/Yamagata (Day 22/Day 1)
7.81
(7.14 to 8.54)
6.58
(6.03 to 7.19)
6.26
(5.71 to 6.86)
4.41
(4.02 to 4.83)
B/Yamagata (Day 181/Day 1)
2.74
(2.50 to 3.00)
2.44
(2.23 to 2.67)
2.07
(1.89 to 2.27)
1.60
(1.46 to 1.75)
B/Victoria (Day 22/Day 1)
7.86
(7.19 to 8.59)
6.64
(6.09 to 7.26)
6.70
(6.12 to 7.33)
4.94
(4.51 to 5.41)
B/Victoria (Day 181/Day 1)
2.59
(2.33 to 2.89)
2.33
(2.09 to 2.59)
2.12
(1.90 to 2.36)
1.61
(1.44 to 1.80)
7.Secondary Outcome
Title Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 on Day 22 and Day 181 Against Homologous Strains
Hide Description

The percentage of subjects achieving HI titer ≥1:40 at Day 22 and Day 181 after vaccination is reported against homologous strains.

Strains tested: A/H1N1 California/07/2009; A/H3N2 Switzerland/9715293/2013; B/Victoria Brisbane/60/2008; B/Yamagata Phuket/3073/2013.

Time Frame Day 22, Day 181
Hide Outcome Measure Data
Hide Analysis Population Description
The Immunogenicity PPS consisting of all subjects who received a study vaccination and provided immunogenicity data, and who correctly received the study vaccine, had no major protocol deviations, and did not develop RT-PCR-confirmed influenza infection between baseline and Visit 2.
Arm/Group Title aQIV/aQIV aQIV/QIV QIV/aQIV QIV/QIV
Hide Arm/Group Description:

Subjects previously vaccinated with aQIV followed one year later by aQIV

Adjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)

Subjects previously vaccinated with aQIV followed one year later by QIV

Non-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)

Subjects previously vaccinated with QIV followed one year later by aQIV

Adjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)

Subjects previously vaccinated with QIV followed one year later by QIV

Non-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)

Overall Number of Participants Analyzed 403 398 397 389
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of subjects
A/H1N1 (Day 22)
100
(99.1 to 100)
100
(99.1 to 100)
100
(99.1 to 100)
99.7
(98.6 to 100)
A/H1N1 (Day 181)
100
(99.1 to 100)
99.2
(97.8 to 99.8)
99.2
(97.8 to 99.8)
95.9
(93.4 to 97.6)
A/H3N2 (Day 22)
100
(99.1 to 100)
100
(99.1 to 100)
100
(99.1 to 100)
100
(99.1 to 100)
A/H3N2 (Day 181)
99.8
(98.6 to 100)
100
(99.1 to 100)
100
(99.1 to 100)
98.7
(97.0 to 99.6)
B/Yamagata (Day 22)
98.5
(96.8 to 99.5)
98.7
(97.1 to 99.6)
98.5
(96.7 to 99.4)
96.6
(94.3 to 98.2)
B/Yamagata (Day 181)
94.3
(91.5 to 96.3)
93.9
(91.1 to 96.1)
83.9
(79.9 to 87.4)
76.1
(71.5 to 80.3)
B/Victoria (Day 22)
99.9
(98.6 to 100)
100
(99.1 to 100)
99.5
(98.2 to 99.9)
97.9
(95.9 to 99.1)
B/Victoria (Day 181)
95.3
(92.7 to 97.1)
93.9
(91.1 to 96.1)
86.7
(83.0 to 89.9)
76.9
(72.2 to 80.9)
8.Secondary Outcome
Title Immunogenicity Endpoints: Percentage of Subjects With HI Titer ≥1:110, ≥1:151, ≥1:215, ≥1:330 and ≥1:629 on Day 22 Against Homologous Strains
Hide Description

The percentage of subjects achieving HI Titers ≥1:110, ≥1:151, ≥1:215, ≥1:330 and ≥1:629 at Day 22 after vaccination is reported against homologous strains.

Strains tested: A/H1N1 California/07/2009; A/H3N2 Switzerland/9715293/2013; B/Victoria Brisbane/60/2008; B/Yamagata Phuket/3073/2013.

Time Frame Day 22
Hide Outcome Measure Data
Hide Analysis Population Description
The Immunogenicity PPS consisting of all subjects who received a study vaccination and provided immunogenicity data, and who correctly received the study vaccine, had no major protocol deviations, and did not develop RT-PCR-confirmed influenza infection between baseline and Visit 2.
Arm/Group Title aQIV/aQIV aQIV/QIV QIV/aQIV QIV/QIV
Hide Arm/Group Description:

Subjects previously vaccinated with aQIV followed one year later by aQIV

Adjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)

Subjects previously vaccinated with aQIV followed one year later by QIV

Non-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)

Subjects previously vaccinated with QIV followed one year later by aQIV

Adjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)

Subjects previously vaccinated with QIV followed one year later by QIV

Non-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)

Overall Number of Participants Analyzed 403 398 397 389
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of subjects
A/H1N1, HI ≥1:110
100.0
(99.1 to 100.0)
100.0
(99.1 to 100.0)
99.7
(98.6 to 100.0)
97.7
(95.6 to 98.9)
A/H1N1, HI ≥1:151
100.0
(99.1 to 100.0)
100.0
(99.1 to 100.0)
99.5
(98.2 to 99.9)
97.4
(95.3 to 98.8)
A/H1N1, HI ≥1:215
99.8
(98.6 to 100.0)
99.2
(97.8 to 99.8)
97.5
(95.4 to 98.8)
93.8
(90.9 to 96.0)
A/H1N1, HI ≥1:330
97.3
(95.2 to 98.6)
93.7
(90.8 to 95.9)
93.2
(90.3 to 95.5)
82.5
(78.3 to 86.1)
A/ H1N1 ≥1:629
94.8
(92.1 to 96.7)
87.6
(84.0 to 90.7)
87.9
(84.3 to 91.0)
74.2
(69.6 to 78.5)
A/H3N2, HI ≥1:110
99.8
(98.6 to 100.0)
100.0
(99.1 to 100.0)
100.0
(99.1 to 100.0)
99.5
(98.1 to 99.9)
A/H3N2, HI ≥1:151
99.8
(98.6 to 100.0)
100.0
(99.1 to 100.0)
100.0
(99.1 to 100.0)
99.5
(98.1 to 99.9)
A/H3N2, HI ≥1:215
99.5
(98.2 to 99.9)
100.0
(99.1 to 100.0)
100.0
(99.1 to 100.0)
97.7
(95.6 to 98.9)
A/H3N2, HI ≥1:330
99.3
(97.8 to 99.8)
99.7
(98.6 to 100.0)
99.5
(98.2 to 99.9)
95.9
(93.4 to 97.6)
A/H3N2, HI ≥1:629
99.0
(97.5 to 99.7)
99.7
(98.6 to 100.0)
99.2
(97.8 to 99.8)
95.1
(92.4 to 97.0)
B/Yamagata, HI ≥1:110
90.8
(87.5 to 93.4)
88.4
(84.8 to 91.4)
82.7
(78.6 to 86.3)
68.3
(63.4 to 73.0)
B/Yamagata, HI ≥1:151
87.6
(83.9 to 90.6)
81.6
(77.4 to 85.3)
75.9
(71.4 to 80.0)
59.9
(54.8 to 64.9)
B/Yamagata, HI ≥1:215
69.9
(65.2 to 74.3)
64.2
(59.3 to 69.0)
53.3
(48.2 to 58.3)
38.5
(33.6 to 43.6)
B/Yamagata, HI ≥1:330
44.0
(39.1 to 49.0)
34.3
(29.6 to 39.2)
25.1
(20.9 to 29.7)
14.9
(11.5 to 18.9)
B/Yamagata, HI ≥1:629
27.9
(23.5 to 32.5)
20.9
(17.0 to 25.2)
14.2
(10.9 to 18.1)
7.3
(4.9 to 10.4)
B/Victoria, HI ≥1:110
93.0
(90.1 to 95.3)
89.9
(86.5 to 92.7)
86.0
(82.8 to 89.8)
76.1
(71.5 to 80.3)
B/Victoria, HI ≥1:151
91.3
(88.1 to 93.9)
87.9
(84.3 to 90.9)
83.0
(78.9 to 86.6)
70.6
(65.8 to 75.1)
B/Victoria, HI ≥1:215
79.6
(75.3 to 83.4)
73.4
(69.1 to 78.0)
67.5
(62.6 to 72.1)
53.0
(47.9 to 58.1)
B/Victoria, HI ≥1:330
58.7
(53.7 to 63.6)
48.7
(43.8 to 53.8)
41.9
(37.0 to 46.9)
32.0
(27.4 to 37.0)
B/Victoria, HI ≥1:629
45.3
(40.3 to 50.3)
37.6
(32.8 to 42.6)
34.3
(29.6 to 39.2)
24.1
(19.9 to 28.8)
9.Secondary Outcome
Title Immunogenicity Endpoint: GMT as Determined by HI Assay on Day 1, Day 22, and Day 181 Against Heterologous Strains
Hide Description

GMT and 95% CI were analyzed for Day 22 for the heterologous strains using ANCOVA with study specific covariates.

The two heterologous strains selected for HI testing in this study were the H3N2 strain, A/Hong Kong/4801/2014 (X-263B), and the B/ Victoria lineage strain, B/Malaysia/2506/2004.

Time Frame Day 1, Day 22, Day 181
Hide Outcome Measure Data
Hide Analysis Population Description
The Immunogenicity PPS consisting of all subjects who received a study vaccination and provided immunogenicity data, and who correctly received the study vaccine, had no major protocol deviations, and did not develop RT-PCR-confirmed influenza infection between baseline and Visit 2.
Arm/Group Title aQIV/aQIV aQIV/QIV QIV/aQIV QIV/QIV
Hide Arm/Group Description:

Subjects previously vaccinated with aQIV followed one year later by aQIV

Adjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)

Subjects previously vaccinated with aQIV followed one year later by QIV

Non-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)

Subjects previously vaccinated with QIV followed one year later by aQIV

Adjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)

Subjects previously vaccinated with QIV followed one year later by QIV

Non-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)

Overall Number of Participants Analyzed 60 57 59 58
Geometric Mean (95% Confidence Interval)
Unit of Measure: titer
A/H3N2 (Day 1)
97.7
(59.4 to 160.6)
156.6
(96.1 to 255.1)
40.9
(25.3 to 66.0)
91.6
(55.6 to 150.8)
A/H3N2 (Day 22)
2436.1
(2058.0 to 2883.6)
2415.2
(2049.9 to 2845.5)
2225.1
(1872.6 to 2643.8)
2097.2
(1769.7 to 2485.2)
A/H3N2 (Day 181)
898.1
(707.5 to 1139.9)
917.6
(728.2 to 1156.3)
953.2
(746.7 to 1216.6)
791.7
(621.5 to 1008.3)
B/Victoria (Day 1)
33.4
(24.6 to 45.3)
23.8
(17.6 to 32.2)
15.8
(11.8 to 21.2)
15.9
(11.7 to 21.6)
B/Victoria (Day 22)
327.1
(255.7 to 418.4)
248.4
(195.3 to 316.0)
283.2
(222.8 to 359.8)
204.8
(159.6 to 262.8)
B/Victoria (Day 181)
107.1
(79.3 to 144.6)
85.6
(63.9 to 114.7)
77.5
(57.9 to 103.9)
56.0
(41.2 to 76.0)
10.Secondary Outcome
Title Immunogenicity Endpoint: GMR as Determined by HI Assay for Day 22/Day 1 and Day 181/Day 1 Against Heterologous Strains
Hide Description

The GMR is the geometric mean of the fold increase in HI titer from Day 1 to Day 22 or Day 181. GMR and 95% CI were analyzed for the heterologous strains using ANCOVA with study specific covariates.

The two heterologous strains selected for HI testing in this study were the H3N2 strain, A/Hong Kong/4801/2014 (X-263B), and the B Victoria lineage strain, B/Malaysia/2506/2004.

Time Frame Day 22/Day 1 and Day 181/Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
The Immunogenicity PPS consisting of all subjects who received a study vaccination and provided immunogenicity data, and who correctly received the study vaccine, had no major protocol deviations, and did not develop RT-PCR-confirmed influenza infection between baseline and Visit 2.
Arm/Group Title aQIV/aQIV aQIV/QIV QIV/aQIV QIV/QIV
Hide Arm/Group Description:

Subjects previously vaccinated with aQIV followed one year later by aQIV

Adjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)

Subjects previously vaccinated with aQIV followed one year later by QIV

Non-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)

Subjects previously vaccinated with QIV followed one year later by aQIV

Adjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)

Subjects previously vaccinated with QIV followed one year later by QIV

Non-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)

Overall Number of Participants Analyzed 60 57 59 58
Geometric Mean (95% Confidence Interval)
Unit of Measure: ratio
A/H3N2 (Day 22/Day 1)
14.67
(12.4 to 17.4)
14.55
(12.3 to 17.1)
13.40
(11.3 to 15.9)
12.63
(10.7 to 15.0)
A/H3N2 (Day 181/Day 1)
5.31
(4.2 to 6.7)
5.42
(4.3 to 6.8)
5.63
(4.4 to 7.2)
4.68
(3.7 to 6.0)
B/Victoria (Day 22/Day 1)
13.40
(10.5 to 17.1)
10.18
(8.0 to 13.0)
11.60
(9.1 to 14.7)
8.39
(6.5 to 10.8)
B/Victoria (Day 181/Day 1)
4.38
(3.2 to 5.9)
3.50
(2.6 to 4.7)
3.17
(2.4 to 4.3)
2.29
(1.7 to 3.1)
11.Secondary Outcome
Title Immunogenicity Endpoint: Percentage of Subjects Achieving SCR and HI Titer ≥1:40 on Day 22 and Day 181 Against Heterologous Strains
Hide Description

The percentage of subjects achieving HI titer ≥1:40 at Day 22 and Day 181 after vaccination and the percentage of subject who experienced seroconversion is reported for homologous strains. Seroconversion was defined in subjects seronegative at baseline (i.e. HI titer <1:10 on Day 1) as post-vaccination HI titer ≥1:40 and defined in subjects seropositive at baseline (i.e. HI titer ≥1:10 on Day 1) as a minimum of a 4-fold increase in post-vaccination HI titer.

The two heterologous strains selected for HI testing in this study were the H3N2 strain, A/Hong Kong/4801/2014 (X-263B), and the B/Victoria lineage strain, B/Malaysia/2506/2004.

Time Frame Day 22, Day 181
Hide Outcome Measure Data
Hide Analysis Population Description
The Immunogenicity PPS consisting of all subjects who received a study vaccination and provided immunogenicity data, and who correctly received the study vaccine, had no major protocol deviations, and did not develop RT-PCR-confirmed influenza infection between baseline and Visit 2.
Arm/Group Title aQIV/aQIV aQIV/QIV QIV/aQIV QIV/QIV
Hide Arm/Group Description:

Subjects previously vaccinated with aQIV followed one year later by aQIV

Adjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)

Subjects previously vaccinated with aQIV followed one year later by QIV

Non-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)

Subjects previously vaccinated with QIV followed one year later by aQIV

Adjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)

Subjects previously vaccinated with QIV followed one year later by QIV

Non-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)

Overall Number of Participants Analyzed 60 57 59 58
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of subjects
A/H3N2, SCR (Day 22)
78.3
(65.8 to 87.9)
73.7
(60.3 to 84.5)
83.1
(71.0 to 91.6)
69.0
(55.5 to 80.5)
A/ H3N2, HI titer ≥1:40 (Day 22)
100
(94.0 to 100)
100
(93.7 to 100)
100
(93.9 to 100)
100
(93.8 to 100)
A/ H3N2, HI titer ≥1:40 (Day 181)
100
(93.8 to 100)
100
(93.68 to 100)
100
(93.8 to 100)
98.2
(90.4 to 100)
B/Victoria, SCR (Day 22)
75.0
(62.1 to 85.3)
82.1
(69.6 to 91.1)
81.4
(69.1 to 90.3)
77.6
(64.7 to 87.5)
B/Victoria, HI titer ≥1:40 (Day 22)
98.3
(91.1 to 100)
100
(93.6 to 100)
96.6
(88.3 to 99.6)
98.3
(90.8 to 100)
B/ Victoria, HI titer ≥1:40 (Day 181)
91.4
(81.0 to 97.1)
83.6
(71.2 to 92.2)
74.1
(61.0 to 84.7)
64.3
(50.4 to 76.6)
12.Secondary Outcome
Title Immunogenicity Endpoint: GMT as Determined by Microneutralization (MN) Assay on Day 1, Day 22, and Day 181 Against Homologous Strains
Hide Description

To further characterize immune response, MN GMT and 95% CI were analyzed for Day 1, Day 22, and Day 181 against homologous strains.

Strains tested: A/H1N1 California/07/2009; A/H3N2 Switzerland/9715293/2013; B/Victoria Brisbane/60/2008; B/Yamagata Phuket/3073/2013.

Time Frame Day 1, Day 22, Day 181
Hide Outcome Measure Data
Hide Analysis Population Description
The Immunogenicity PPS consisting of all subjects who received a study vaccination and provided immunogenicity data, and who correctly received the study vaccine, had no major protocol deviations, and did not develop RT-PCR-confirmed influenza infection between baseline and Visit 2.
Arm/Group Title aQIV/aQIV aQIV/QIV QIV/aQIV QIV/QIV
Hide Arm/Group Description:

Subjects previously vaccinated with aQIV followed one year later by aQIV

Adjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)

Subjects previously vaccinated with aQIV followed one year later by QIV

Non-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)

Subjects previously vaccinated with QIV followed one year later by aQIV

Adjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)

Subjects previously vaccinated with QIV followed one year later by QIV

Non-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)

Overall Number of Participants Analyzed 60 60 60 60
Geometric Mean (95% Confidence Interval)
Unit of Measure: titer
A/H1N1 (Day 1)
264.36
(173.8 to 402.1)
198.13
(127.8 to 307.0)
104.28
(67.0 to 162.3)
140.38
(90.0 to 219.1)
A/H1N1 (Day 22)
2253.81
(1713.5 to 2964.5)
2295.46
(1729.5 to 3046.7)
2992.29
(2238.5 to 3999.9)
1543.54
(1156.5 to 20660.1)
A/H1N1 (Day 181)
727.04
(568.6 to 929.6)
725.35
(560.7 to 938.4)
686.98
(527.2 to 895.2)
412.34
(317.2 to 536.0)
A/H3N2 (Day 1)
160.88
(103.6 to 249.7)
113.74
(71.9 to 180.0)
133.25
(83.8 to 211.8)
97.47
(61.1 to 155.6)
A/H3N2 (Day 22)
5532.06
(4441.7 to 6890.0)
6649.94
(5275.3 to 8382.7)
5019.51
(3978.6 to 6332.8)
4696.37
(3699.4 to 5962.1)
A/H3N2 (Day 181)
2069.22
(1488.8 to 2875.9)
2127.88
(1500.4 to 3017.8)
2138.80
(1505.0 to 3039.5)
1696.57
(1178.4 to 2442.5)
B/Yamagata (Day 1)
29.82
(22.2 to 40.1)
37.99
(27.9 to 51.7)
21.57
(15.8 to 29.5)
21.07
(15.4 to 28.9)
B/Yamagata (Day 22)
388.29
(299.1 to 504.0)
301.39
(229.0 to 396.7)
247.31
(187.6 to 326.0)
197.51
(149.3 to 261.4)
B/Yamagata (Day 181)
107.05
(81.4 to 140.8)
103.59
(77.5 to 138.5)
82.90
(61.9 to 111.0)
56.03
(41.5 to 75.6)
B/Victoria (Day 1)
43.66
(33.1 to 57.6)
43.13
(32.3 to 57.6)
27.96
(20.9 to 37.4)
33.14
(24.7 to 44.4)
B/Victoria (Day 22)
355.63
(271.8 to 465.4)
346.99
(262.6 to 458.5)
338.49
(255.0 to 449.4)
193.09
(145.5 to 256.3)
B/Victoria (Day 181)
124.31
(95.3 to 162.1)
106.08
(80.2 to 140.3)
95.87
(72.1 to 127.5)
60.54
(45.4 to 80.7)
13.Secondary Outcome
Title Immunogenicity Endpoint: GMR as Determined by MN Assay for Day 22/Day 1 and Day 181/Day 1 Against Homologous Strains
Hide Description

The GMR is the geometric mean of the fold increase in MN titer from Day 1 to Day 22 or Day 181. GMR and 95% CI were analyzed for the homologous strains using ANCOVA with study specific covariates.

Strains tested: A/H1N1 California/07/2009; A/H3N2 Switzerland/9715293/2013; B/Victoria Brisbane/60/2008; B/Yamagata Phuket/3073/2013.

Time Frame Day 22/Day 1 and Day 181/Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
The Immunogenicity PPS consisting of all subjects who received a study vaccination and provided immunogenicity data, and who correctly received the study vaccine, had no major protocol deviations, and did not develop RT-PCR-confirmed influenza infection between baseline and Visit 2.
Arm/Group Title aQIV/aQIV aQIV/QIV QIV/aQIV QIV/QIV
Hide Arm/Group Description:

Subjects previously vaccinated with aQIV followed one year later by aQIV

Adjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)

Subjects previously vaccinated with aQIV followed one year later by QIV

Non-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)

Subjects previously vaccinated with QIV followed one year later by aQIV

Adjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)

Subjects previously vaccinated with QIV followed one year later by QIV

Non-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)

Overall Number of Participants Analyzed 60 60 60 60
Geometric Mean (95% Confidence Interval)
Unit of Measure: ratio
A/H1N1 (Day 22/Day 1)
11.85
(9.0 to 15.6)
12.07
(9.1 to 16.0)
15.73
(11.8 to 21.0)
8.11
(6.1 to 10.8)
A/H1N1 (Day 181/Day 1)
3.67
(2.9 to 4.7)
3.66
(2.8 to 4.7)
3.47
(2.7 to 4.5)
2.08
(1.6 to 2.7)
A/H3N2 (Day 22/Day 1)
28.19
(22.6 to 35.1)
33.88
(26.9 to 42.7)
25.57
(20.3 to 32.3)
23.93
(18.8 to 30.4)
A/H3N2 (Day 181/Day 1)
10.63
(7.6 to 14.8)
10.93
(7.7 to 15.5)
10.99
(7.7 to 15.6)
8.72
(6.1 to 12.5)
B/Yamagata (Day 22/Day 1)
14.11
(10.9 to 18.3)
10.95
(8.3 to 14.4)
8.99
(6.8 to 11.8)
7.18
(5.4 to 9.5)
B/Yamagata (Day 181/Day 1)
3.97
(3.0 to 5.2)
3.84
(2.9 to 5.1)
3.07
(2.3 to 4.1)
2.08
(1.5 to 2.8)
B/Victoria (Day 22/Day 1)
9.43
(7.2 to 12.3)
9.20
(7.0 to 12.2)
8.97
(6.8 to 11.9)
5.12
(3.9 to 6.8)
B/Victoria (Day 181/Day 1)
3.25
(2.5 to 4.2)
2.77
(2.1 to 3.7)
2.51
(1.9 to 3.3)
1.58
(1.2 to 2.1)
14.Secondary Outcome
Title Immunogenicity Endpoint: Anti-neuraminidase (NA) GMTs on Day 1, Day 22, and Day 181 Against Homologous Strains
Hide Description

To further characterize immune response, adjusted anti-NA GMT and 95% CI were analyzed for Day 1, Day 22, and Day 181 against homologous strains.

Strains tested: N1 (PR8 H6N1 California/07/2009), N2 (PR8 H6N2 Switzerl/9715293/2013); B/Victoria Brisbane/60/2008; B/Yamagata Phuket/3073/2013.

Time Frame Day 1, Day 22, Day 181
Hide Outcome Measure Data
Hide Analysis Population Description
The Immunogenicity PPS consisting of all subjects who received a study vaccination and provided immunogenicity data, and who correctly received the study vaccine, had no major protocol deviations, and did not develop RT-PCR-confirmed influenza infection between baseline and Visit 2.
Arm/Group Title aQIV/aQIV aQIV/QIV QIV/aQIV QIV/QIV
Hide Arm/Group Description:

Subjects previously vaccinated with aQIV followed one year later by aQIV

Adjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)

Subjects previously vaccinated with aQIV followed one year later by QIV

Non-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)

Subjects previously vaccinated with QIV followed one year later by aQIV

Adjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)

Subjects previously vaccinated with QIV followed one year later by QIV

Non-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)

Overall Number of Participants Analyzed 56 62 59 60
Geometric Mean (95% Confidence Interval)
Unit of Measure: titer
N1 (Day 1)
1174.69
(767.8 to 1797.3)
1209.21
(815.7 to 1792.6)
230.09
(154.7 to 342.2)
182.80
(122.7 to 272.2)
N1 (Day 22)
3403.72
(2821.4 to 4106.2)
3161.01
(2654.7 to 3763.9)
3588.43
(2994.0 to 4300.9)
2410.65
(2001.2 to 2903.9)
N1 (Day 181)
2477.65
(1958.9 to 3133.7)
1649.89
(1324.9 to 2054.5)
2018.32
(1610.4 to 2529.5)
870.73
(691.0 to 1097.2)
N2 (Day 1)
204.59
(121.3 to 345.2)
289.86
(178.6 to 470.4)
86.08
(52.8 to 140.3)
86.34
(52.9 to 140.9)
N2 (Day 22)
915.19
(753.5 to 1111.6)
1050.44
(876.7 to 1258.7)
1242.36
(1031.4 to 1496.5)
980.87
(813.8 to 1182.2)
N2 (Day 181)
505.91
(375.2 to 682.2)
565.69
(426.7 to 749.9)
516.51
(388.6 to 686.4)
369.04
(277.5 to 490.8)
B/Victoria (Day 1)
497.11
(344.3 to 717.7)
548.92
(390.7 to 771.2)
306.48
(217.6 to 431.7)
237.96
(168.7 to 335.6)
B/Victoria (Day 22)
3175.99
(2736.5 to 3686.0)
3336.65
(2906.2 to 3830.8)
3331.87
(2894.6 to 3835.2)
2418.50
(2094.6 to 2792.74)
B/Victoria (Day 181)
1424.38
(1108.1 to 1831.0)
1587.86
(1256.5 to 2006.6)
1443.37
(1140.1 to 1827.3)
1030.77
(810.3 to 1311.3)
B/Yamagata (Day 1)
290.06
(202.3 to 415.8)
282.17
(201.7 to 394.8)
148.35
(106.0 to 207.6)
126.07
(90.0 to 176.6)
B/Yamagata (Day 22)
1288.67
(1094.6 to 1517.2)
1250.88
(1074.3 to 1456.5)
1275.06
(1093.5 to 1486.7)
883.66
(756.1 to 1032.7)
B/Yamagata (Day 181)
727.17
(560.2 to 943.9)
596.62
(467.2 to 762.0)
511.73
(400.7 to 653.5)
391.23
(305.3 to 501.3)
15.Secondary Outcome
Title Immunogenicity Endpoint: Anti-NA GMR for Day 22/Day 1 and Day 181/Day 1 Against Homologous Strains
Hide Description

The GMR is the geometric mean of the fold increase in anti-NA titer from Day 1 to Day 22 or Day 181. GMR and 95% CI were analyzed against homologous strains using ANCOVA with study specific covariates.

Strains tested: N1 (PR8 H6N1 California/07/2009), N2 (PR8 H6N2 Switzerl/9715293/2013); B/Victoria Brisbane/60/2008; B/Yamagata Phuket/3073/2013.

Time Frame Day 22/Day 1 and Day 181/Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
The Immunogenicity PPS consisting of all subjects who received a study vaccination and provided immunogenicity data, and who correctly received the study vaccine, had no major protocol deviations, and did not develop RT-PCR-confirmed influenza infection between baseline and Visit 2.
Arm/Group Title aQIV/aQIV aQIV/QIV QIV/aQIV QIV/QIV
Hide Arm/Group Description:

Subjects previously vaccinated with aQIV followed one year later by aQIV

Adjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)

Subjects previously vaccinated with aQIV followed one year later by QIV

Non-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)

Subjects previously vaccinated with QIV followed one year later by aQIV

Adjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)

Subjects previously vaccinated with QIV followed one year later by QIV

Non-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)

Overall Number of Participants Analyzed 56 62 59 60
Geometric Mean (95% Confidence Interval)
Unit of Measure: ratio
N1 (Day 22/Day 1)
5.40
(4.5 to 6.5)
5.02
(4.2 to 6.0)
5.70
(4.8 to 6.8)
3.83
(3.2 to 4.6)
N1 (Day 181/Day 1)
3.95
(3.1 to 5.0)
2.63
(2.1 to 3.3)
3.22
(2.6 to 4.0)
1.39
(1.1 to 1.8)
N2 (Day 22/Day 1)
4.51
(3.7 to 5.5)
5.18
(4.3 to 6.2)
6.13
(5.1 to 7.4)
4.84
(4.0 to 5.8)
N2 (Day 181/Day 1)
2.45
(1.8 to 3.3)
2.74
(2.1 to 3.6)
2.50
(1.9 to 3.3)
1.79
(1.3 to 2.4)
B/Yamagata (Day 22/Day 1)
5.75
(4.9 to 6.8)
5.59
(4.8 to 6.5)
5.69
(4.9 to 6.6)
3.95
(3.4 to 4.6)
B/Yamagata (Day 181/Day 1)
3.29
(2.5 to 4.3)
2.70
(2.1 to 3.4)
2.32
(1.81 to 3.0)
1.77
(1.4 to 2.3)
B/Victoria (Day 22/Day 1)
6.81
(5.9 to 7.9)
7.15
(6.2 to 8.2)
7.14
(6.2 to 8.2)
5.18
(4.5 to 6.0)
B/Victoria (Day 181/Day 1)
3.05
(2.4 to 3.9)
3.40
(2.7 to 4.3)
3.09
(2.4 to 3.9)
2.21
(1.7 to 2.8)
16.Secondary Outcome
Title Safety Endpoint: Percentage of Subjects With Solicited AEs
Hide Description Safety of revaccination was assessed in terms of percentage of subjects reporting solicited AEs up to 7 days after vaccination.
Time Frame Day 1 to Day 7 after vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The solicited safety set consisting of all subjects who received a study vaccination with evaluable solicited AE data recorded on a diary card.
Arm/Group Title aQIV/aQIV aQIV/QIV QIV/aQIV QIV/QIV
Hide Arm/Group Description:

Subjects previously vaccinated with aQIV followed one year later by aQIV

Adjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)

Subjects previously vaccinated with aQIV followed one year later by QIV

Non-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)

Subjects previously vaccinated with QIV followed one year later by aQIV

Adjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)

Subjects previously vaccinated with QIV followed one year later by QIV

Non-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)

Overall Number of Participants Analyzed 403 403 402 393
Measure Type: Number
Unit of Measure: percentage of subjects
Any Solicited AE 64.76 50.12 53.48 40.71
Solicited Local AE 44.67 37.97 36.82 29.52
Solicited Systemic AE 39.21 24.81 30.85 18.83
Other (analgesic/antipyretic use) 27.54 10.17 16.92 10.43
17.Secondary Outcome
Title Safety Endpoint: Percentage of Subjects With Unsolicited AEs
Hide Description Safety of revaccination was assessed in terms of percentage of subjects reporting unsolicited AEs during the overall study period (Day 1 to Day 366).
Time Frame Day 1 to Day 366
Hide Outcome Measure Data
Hide Analysis Population Description
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred).
Arm/Group Title aQIV/aQIV aQIV/QIV QIV/aQIV QIV/QIV
Hide Arm/Group Description:

Subjects previously vaccinated with aQIV followed one year later by aQIV

Adjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)

Subjects previously vaccinated with aQIV followed one year later by QIV

Non-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)

Subjects previously vaccinated with QIV followed one year later by aQIV

Adjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)

Subjects previously vaccinated with QIV followed one year later by QIV

Non-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)

Overall Number of Participants Analyzed 403 403 402 393
Measure Type: Number
Unit of Measure: percentage of subjects
Any Unsolicited AE 54.09 55.33 55.97 52.16
Related Unsolicited AE 6.20 3.97 5.72 3.82
18.Secondary Outcome
Title Safety Endpoint: Percentage of Subjects With Serious Adverse Events (SAE), AEs Leading to Withdrawal, New Onset of Chronic Disease (NOCD), AE of Special Interest (AESI), and Medically Attended AE.
Hide Description

Safety of revaccination was assessed in terms of percentage of subjects reporting SAEs, AEs leading to withdrawal, NOCD, AESI and medically attended AE. Each subject was followed for a period of 12 months after receipt of the study vaccine.

NOCDs include AEs that represents a new diagnosis of a chronic medical condition that was not present or suspected in a subject prior to study enrollment. AESIs include potentially immune-mediated disorders which were reported by the investigators.

Time Frame Day 1 to Day 366
Hide Outcome Measure Data
Hide Analysis Population Description
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited adverse event (AE) data (including those where it was reported/confirmed that no events had occurred).
Arm/Group Title aQIV/aQIV aQIV/QIV QIV/aQIV QIV/QIV
Hide Arm/Group Description:

Subjects previously vaccinated with aQIV followed one year later by aQIV

Adjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)

Subjects previously vaccinated with aQIV followed one year later by QIV

Non-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)

Subjects previously vaccinated with QIV followed one year later by aQIV

Adjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)

Subjects previously vaccinated with QIV followed one year later by QIV

Non-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)

Overall Number of Participants Analyzed 403 403 402 393
Measure Type: Number
Unit of Measure: percentage of subjects
SAE 2.48 2.73 1.74 2.04
AE leading to withdrawal 0 0 0 0
NOCD 0.50 0 0 0
AESI 0 0 0 0.25
Medically attended AE 51.61 54.34 53.98 48.60
19.Secondary Outcome
Title Safety Endpoint: Percentage of Subjects With Diagnosis of Failure to Thrive or Short Stature
Hide Description Safety of revaccination was assessed in terms of percentage of subjects reporting diagnosis of failure to thrive or short stature up to 12 months after last vaccination.
Time Frame Day 1 to Day 366
Hide Outcome Measure Data
Hide Analysis Population Description
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred).
Arm/Group Title aQIV/aQIV aQIV/QIV QIV/aQIV QIV/QIV
Hide Arm/Group Description:

Subjects previously vaccinated with aQIV followed one year later by aQIV

Adjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)

Subjects previously vaccinated with aQIV followed one year later by QIV

Non-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)

Subjects previously vaccinated with QIV followed one year later by aQIV

Adjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)

Subjects previously vaccinated with QIV followed one year later by QIV

Non-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)

Overall Number of Participants Analyzed 403 403 402 393
Measure Type: Number
Unit of Measure: percentage of subjects
0.25 0.74 0.25 0.76
20.Secondary Outcome
Title Safety Endpoint: Percentage of Subjects With Otitis Media, or Pneumonia, or Influenza-like Illness
Hide Description Safety of revaccination was assessed in terms of percentage of subjects reporting otitis media, or pneumonia, or influenza-like illness up to 12 months after last vaccination.
Time Frame Day 1 to Day 366
Hide Outcome Measure Data
Hide Analysis Population Description
The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred).
Arm/Group Title aQIV/aQIV aQIV/QIV QIV/aQIV QIV/QIV
Hide Arm/Group Description:

Subjects previously vaccinated with aQIV followed one year later by aQIV

Adjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)

Subjects previously vaccinated with aQIV followed one year later by QIV

Non-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)

Subjects previously vaccinated with QIV followed one year later by aQIV

Adjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)

Subjects previously vaccinated with QIV followed one year later by QIV

Non-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)

Overall Number of Participants Analyzed 403 403 402 393
Measure Type: Number
Unit of Measure: percentage of subjects
otitis media, any event 3.23 3.47 3.73 2.80
pneumonia, any event 1.49 1.49 0.75 1.78
influenza-like illness 7.94 10.17 9.20 7.89
21.Secondary Outcome
Title Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains
Hide Description

The percentage of subjects achieving MN titer ≥1:20, ≥1:40, ≥1:80 ≥1:160, ≥1:320 and ≥1:640 at Day 22 and Day 181 after vaccination is reported against homologous strains.

Strains tested: A/H1N1 California/07/2009; A/H3N2 Switzerland/9715293/2013; B/Victoria Brisbane/60/2008; B/Yamagata Phuket/3073/2013.

Time Frame Day 22, Day 181
Hide Outcome Measure Data
Hide Analysis Population Description
The Immunogenicity PPS consisting of all subjects who received a study vaccination and provided immunogenicity data (MN titer ≥1:20, ≥1:40, ≥1:80, >four-fold rise), and who correctly received the study vaccine, had no major protocol deviations, and did not develop RT-PCR-confirmed influenza infection between baseline and Visit 2.
Arm/Group Title aQIV/aQIV aQIV/QIV QIV/aQIV QIV/QIV
Hide Arm/Group Description:

Subjects previously vaccinated with aQIV followed one year later by aQIV

Adjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)

Subjects previously vaccinated with aQIV followed one year later by QIV

Non-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)

Subjects previously vaccinated with QIV followed one year later by aQIV

Adjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)

Subjects previously vaccinated with QIV followed one year later by QIV

Non-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)

Overall Number of Participants Analyzed 60 59 60 59
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of subjects
A/ H1N1, ≥1:20 (Day 22)
100.00
(93.94 to 100.00)
100.00
(93.94 to 100.00)
100.00
(94.04 to 100.00)
100.00
(93.94 to 100.00)
A/ H1N1, ≥1:40 (Day 22)
98.31
(90.91 to 99.96)
100.00
(93.94 to 100.00)
100.00
(94.04 to 100.00)
100.00
(93.94 to 100.00)
A/H1N1, ≥1:80 (Day 22)
98.31
(90.91 to 99.96)
100.00
(93.94 to 100.00)
100.00
(94.04 to 100.00)
98.31
(90.91 to 99.96)
A/H1N1, ≥1:160 (Day 22)
98.31
(90.91 to 99.96)
100.00
(93.94 to 100.00)
100.00
(94.04 to 100.00)
94.92
(85.85 to 98.94)
A/H1N1, ≥1:320 (Day 22)
96.61
(88.29 to 99.59)
100.00
(93.94 to 100.00)
100.00
(94.04 to 100.00)
94.92
(85.85 to 98.94)
A/H1N1, ≥1:640 (Day 22)
96.61
(88.29 to 99.59)
98.31
(90.91 to 99.96)
91.67
(81.61 to 97.24)
81.36
(69.09 to 90.31)
A/H1N1, ≥1:20 (Day 181)
100.00
(94.04 to 100.00)
100.00
(93.84 to 100.00)
100.00
(93.84 to 100.00)
98.28
(90.76 to 99.96)
A/H1N1, ≥1:40 (Day 181)
100.00
(94.04 to 100.00)
100.00
(93.84 to 100.00)
100.00
(93.84 to 100.00)
96.55
(88.09 to 99.58)
A/H1N1, ≥1:80 (Day 181)
100.00
(94.04 to 100.00)
100.00
(93.84 to 100.00)
100.00
(93.84 to 100.00)
93.10
(83.27 to 98.09)
A/H1N1, ≥1:160 (Day 181)
96.67
(88.47 to 99.59)
98.28
(90.76 to 99.96)
94.83
(85.62 to 98.92)
81.03
(68.59 to 90.13)
A/H1N1, ≥1:320 (Day 181)
91.67
(81.61 to 97.24)
91.38
(81.02 to 97.14)
84.48
(72.58 to 92.65)
63.79
(50.12 to 76.01)
A/H1N1, ≥1:640 (Day 181)
80.00
(67.67 to 89.22)
63.79
(50.12 to 76.01)
55.17
(41.54 to 68.26)
48.28
(34.95 to 61.78)
A/H3N2, ≥1:20 (Day 22)
100.00
(94.04 to 100.00)
100.00
(93.94 to 100.00)
100.00
(94.04 to 100.00)
98.28
(90.76 to 99.96)
A/H3N2, ≥1:40 (Day 22)
100.00
(94.04 to 100.00)
100.00
(93.94 to 100.00)
100.00
(94.04 to 100.00)
98.28
(90.76 to 99.96)
A/H3N2, ≥1:80 (Day 22)
100.00
(94.04 to 100.00)
100.00
(93.94 to 100.00)
100.00
(94.04 to 100.00)
98.28
(90.76 to 99.96)
A/H3N2, ≥1:160 (Day 22)
100.00
(94.04 to 100.00)
100.00
(93.94 to 100.00)
100.00
(94.04 to 100.00)
98.28
(90.76 to 99.96)
A/H3N2, ≥1:320 (Day 22)
100.00
(94.04 to 100.00)
100.00
(93.94 to 100.00)
100.00
(94.04 to 100.00)
98.28
(90.76 to 99.96)
A/H3N2, ≥1:640 (Day 22)
100.00
(94.04 to 100.00)
100.00
(93.94 to 100.00)
100.00
(94.04 to 100.00)
98.28
(90.76 to 99.96)
A/H3N2, ≥1:20 (Day 181)
100.00
(94.04 to 100.00)
98.28
(90.76 to 99.96)
100.00
(93.84 to 100.00)
98.21
(90.45 to 99.95)
A/H3N2, ≥1:40 (Day 181)
100.00
(94.04 to 100.00)
98.28
(90.76 to 99.96)
100.00
(93.84 to 100.00)
96.43
(87.69 to 99.56)
A/H3N2, ≥1:80 (Day 181)
100.00
(94.04 to 100.00)
98.28
(90.76 to 99.96)
100.00
(93.84 to 100.00)
91.07
(80.38 to 97.04)
A/H3N2, ≥1:160 (Day 181)
96.67
(88.47 to 99.59)
98.28
(90.76 to 99.96)
96.55
(88.09 to 99.58)
89.29
(78.12 to 95.97)
A/H3N2, ≥1:320 (Day 181)
91.67
(81.61 to 97.24)
94.83
(85.62 to 98.92)
93.10
(83.27 to 98.09)
85.71
(73.78 to 93.62)
A/H3N2, ≥1:640 (Day 181)
86.67
(75.41 to 94.06)
86.21
(74.62 to 93.85)
84.48
(72.58 to 92.65)
83.93
(71.67 to 92.38)
B/Yamagata, ≥1:20 (Day 22)
100.00
(94.04 to 100.00)
100.00
(93.94 to 100.00)
96.67
(88.47 to 99.59)
96.55
(88.09 to 99.58)
B/Yamagata, ≥1:40 (Day 22)
98.33
(91.06 to 99.96)
98.31
(90.91 to 99.96)
96.67
(88.47 to 99.59)
93.10
(83.27 to 98.09)
B/Yamagata, ≥1:80 (Day 22)
95.00
(86.08 to 98.96)
96.61
(88.29 to 99.59)
95.00
(86.08 to 98.96)
89.66
(78.83 to 96.11)
B/Yamagata, ≥1:160 (Day 22)
91.67
(81.61 to 97.24)
86.44
(75.02 to 93.96)
78.33
(65.80 to 87.93)
70.69
(57.27 to 81.91)
B/Yamagata, ≥1:320 (Day 22)
75.00
(62.14 to 85.28)
72.88
(59.73 to 83.64)
65.00
(51.60 to 76.87)
50.00
(36.58 to 63.42)
B/Yamagata, ≥1:640 (Day 22)
58.33
(44.88 to 70.93)
47.46
(34.30 to 60.88)
31.67
(20.26 to 44.96)
24.14
(13.87 to 37.17)
B/Yamagata, ≥1:20 (Day 181)
98.33
(91.06 to 99.96)
96.55
(88.09 to 99.58)
93.10
(83.27 to 98.09)
80.36
(67.57 to 89.77)
B/Yamagata, ≥1:40 (Day 181)
93.33
(83.80 to 98.15)
93.10
(83.27 to 98.09)
79.31
(66.65 to 88.83)
71.43
(57.79 to 82.70)
B/Yamagata, ≥1:80 (Day 181)
71.67
(58.56 to 82.55)
72.41
(59.10 to 83.34)
56.90
(42.23 to 69.84)
46.43
(32.99 to 60.26)
B/Yamagata, ≥1:160 (Day 181)
45.00
(32.12 to 58.39)
48.28
(34.95 to 61.78)
32.76
(21.01 to 46.34)
17.86
(8.91 to 30.40)
B/Yamagata, ≥1:320 (Day 181)
25.00
(14.72 to 37.86)
24.14
(13.87 to 37.17)
15.52
(7.35 to 27.42)
7.14
(1.98 to 17.29)
B/Yamagata, ≥1:640 (Day 181)
3.33
(0.41 to 11.53)
8.62
(2.86 to 18.98)
5.17
(1.08 to 14.38)
3.57
(0.44 to 12.31)
B/Victoria, ≥1:20 (Day 22)
98.31
(90.91 to 99.96)
100.00
(93.94 to 100.00)
100.00
(94.04 to 100.00)
98.31
(90.91 to 99.96)
B/Victoria, ≥1:40 (Day 22)
94.92
(85.85 to 98.94)
100.00
(93.94 to 100.00)
96.67
(88.47 to 99.59)
93.22
(83.54 to 98.12)
B/Victoria, ≥1:80 (Day 22)
91.53
(81.32 to 97.19)
96.61
(88.29 to 99.59)
90.00
(79.49 to 96.24)
84.75
(73.01 to 92.78)
B/Victoria, ≥1:160 (Day 22)
86.44
(75.02 to 93.96)
86.44
(75.02 to 93.96)
81.67
(69.56 to 90.48)
69.49
(56.13 to 80.81)
B/Victoria, ≥1:320 (Day 22)
74.58
(61.56 to 85.02)
67.80
(54.36 to 79.38)
58.33
(44.88 to 70.93)
35.59
(23.55 to 49.13)
B/Victoria, ≥1:640 (Day 22)
49.15
(35.89 to 62.50)
42.37
(29.61 to 55.93)
33.33
(21.69 to 46.69)
22.03
(12.29 to 34.73)
B/Victoria, ≥1:20 (Day 181)
100.00
(94.04 to 100.00)
100.00
(93.84 to 100.00)
98.28
(90.76 to 99.96)
96.43
(87.69 to 99.56)
B/Victoria, ≥1:40 (Day 181)
86.67
(75.41 to 94.06)
87.93
(76.70 to 95.01)
74.14
(60.96 to 84.74)
60.71
(46.75 to 73.50)
B/Victoria, ≥1:80 (Day 181)
78.33
(65.80 to 87.93)
63.79
(50.12 to 76.01)
44.83
(31.74 to 58.46)
41.07
(28.10 to 55.02)
B/Victoria, ≥1:160 (Day 181)
58.33
(44.88 to 70.93)
43.10
(30.16 to 56.77)
27.59
(16.66 to 40.90)
23.21
(12.98 to 36.42)
B/Victoria, ≥1:320 (Day 181)
31.67
(20.26 to 44.96)
20.69
(11.17 to 33.35)
18.97
(9.87 to 31.41)
8.93
(2.96 to 19.62)
B/Victoria, ≥1:640 (Day 181)
8.33
(2.76 to 18.39)
15.52
(7.35 to 27.42)
12.07
(4.99 to 23.30)
5.36
(1.12 to 14.87)
22.Secondary Outcome
Title Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains
Hide Description

The percentage of subjects achieving anti-NA titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 after vaccination is reported against homologous strains

Strains tested: N1 (PR8 H6N1 California/07/2009), N2 (PR8 H6N2 Switzerl/9715293/2013); B/Victoria Brisbane/60/2008; B/Yamagata Phuket/3073/2013.

Time Frame Day 22, Day 181
Hide Outcome Measure Data
Hide Analysis Population Description
The Immunogenicity PPS consisting of all subjects who received a study vaccination and provided immunogenicity data, and who correctly received the study vaccine, had no major protocol deviations, and did not develop RT-PCR-confirmed influenza infection between baseline and Visit 2.
Arm/Group Title aQIV/aQIV aQIV/QIV QIV/aQIV QIV/QIV
Hide Arm/Group Description:

Subjects previously vaccinated with aQIV followed one year later by aQIV

Adjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)

Subjects previously vaccinated with aQIV followed one year later by QIV

Non-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)

Subjects previously vaccinated with QIV followed one year later by aQIV

Adjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)

Subjects previously vaccinated with QIV followed one year later by QIV

Non-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)

Overall Number of Participants Analyzed 56 62 59 60
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of subjects
N1, ≥1:20 (Day 22)
100.00
(93.62 to 100.00)
100.00
(94.22 to 100.00)
100.00
(93.94 to 100.00)
100.00
(94.04 to 100.00)
N1, ≥1:40 (Day 22)
100.00
(93.62 to 100.00)
100.00
(94.22 to 100.00)
100.00
(93.94 to 100.00)
98.33
(91.06 to 99.96)
N1, ≥1:80 (Day 22)
100.00
(93.62 to 100.00)
100.00
(94.22 to 100.00)
100.00
(93.94 to 100.00)
98.33
(91.06 to 99.96)
N1, ≥1:160 (Day 22)
100.00
(93.62 to 100.00)
100.00
(94.22 to 100.00)
100.00
(93.94 to 100.00)
93.33
(83.80 to 98.15)
N1, ≥1:320 (Day 22)
100.00
(93.62 to 100.00)
100.00
(94.22 to 100.00)
100.00
(93.94 to 100.00)
88.33
(77.43 to 95.18)
N1,≥1:640 (Day 22)
100.00
(93.62 to 100.00)
100.00
(94.22 to 100.00)
98.31
(90.91 to 99.96)
85.00
(73.43 to 92.90)
N1, ≥1:20 (Day 181)
100.00
(93.51 to 100.00)
100.00
(94.13 to 100.00)
100.00
(93.84 to 100.00)
93.33
(83.80 to 98.15)
N1, ≥1:40 (Day 181)
100.00
(93.51 to 100.00)
100.00
(94.13 to 100.00)
100.00
(93.84 to 100.00)
91.67
(81.61 to 97.24)
N1, ≥1:80 (Day 181)
100.00
(93.51 to 100.00)
100.00
(94.13 to 100.00)
100.00
(93.84 to 100.00)
86.67
(75.41 to 94.06)
N1, ≥1:160 (Day 181)
100.00
(93.51 to 100.00)
100.00
(94.13 to 100.00)
96.55
(88.09 to 99.58)
81.67
(69.56 to 90.48)
N1, ≥1:320 (Day 181)
100.00
(93.51 to 100.00)
96.72
(88.65 to 99.60)
93.10
(83.27 to 98.09)
70.00
(56.79 to 81.15)
N1, ≥1:640 (Day 181)
100.00
(93.51 to 100.00)
93.44
(84.05 to 98.18)
72.41
(59.10 to 83.34)
51.67
(38.39 to 64.77)
N2, ≥1:20 (Day 22)
100.00
(93.62 to 100.00)
100.00
(94.22 to 100.00)
100.00
(93.94 to 100.00)
100.00
(94.04 to 100.00)
N2, ≥1:40 (Day 22)
100.00
(93.62 to 100.00)
100.00
(94.22 to 100.00)
100.00
(93.94 to 100.00)
100.00
(94.04 to 100.00)
N2, ≥1:80 (Day 22)
98.21
(90.45 to 99.95)
100.00
(94.22 to 100.00)
98.31
(90.91 to 99.96)
96.67
(88.47 to 99.59)
N2, ≥1:160 (Day 22)
98.21
(90.45 to 99.95)
100.00
(94.22 to 100.00)
98.31
(90.91 to 99.96)
90.00
(79.49 to 96.24)
N2, ≥1:320 (Day 22)
94.64
(85.13 to 98.88)
96.77
(88.83 to 99.61)
94.92
(85.85 to 98.94)
85.00
(73.43 to 92.90)
N2, ≥1:640 (Day 22)
85.71
(73.78 to 93.62)
88.71
(78.11 to 95.34)
79.66
(67.17 to 89.02)
68.33
(55.04 to 79.74)
N2, ≥1:20 (Day 181)
100.00
(93.51 to 100.00)
100.00
(94.04 to 100.00)
100.00
(93.84 to 100.00)
90.00
(79.49 to 96.24)
N2, ≥1:40 (Day 181)
98.18
(90.28 to 99.95)
98.33
(91.06 to 99.96)
89.66
(78.83 to 96.11)
88.33
(77.43 to 95.18)
N2, ≥1:80 (Day 181)
94.55
(84.88 to 98.86)
98.33
(91.06 to 99.96)
86.21
(74.62 to 93.85)
80.00
(67.67 to 89.22)
N2, ≥1:160 (Day 181)
85.45
(73.34 to 93.50)
95.00
(86.08 to 98.96)
81.03
(68.59 to 90.13)
70.00
(56.79 to 81.15)
N2, ≥1:320 (Day 181)
80.00
(67.03 to 89.57)
85.00
(73.43 to 92.90)
67.24
(53.66 to 78.99)
61.67
(48.21 to 73.93)
N2, ≥1:640 (Day 181)
70.91
(57.10 to 82.37)
81.67
(69.56 to 90.48)
55.17
(41.54 to 68.26)
50.00
(36.81 to 63.19)
B/Yamagata, ≥1:20 (Day 22)
100.00
(93.62 to 100.00)
100.00
(94.13 to 100.00)
100.00
(93.04 to 100.00)
100.00
(94.04 to 100.00)
B/Yamagata, ≥1:40 (Day 22)
100.00
(93.62 to 100.00)
100.00
(94.13 to 100.00)
100.00
(93.94 to 100.00)
100.00
(94.04 to 100.00)
B/Yamagata, ≥1:80 (Day 22)
98.21
(90.45 to 99.95)
100.00
(94.13 to 100.00)
100.00
(93.94 to 100.00)
100.00
(94.04 to 100.00)
B/Yamagata, ≥1:160 (Day 22)
98.21
(90.45 to 99.95)
100.00
(94.13 to 100.00)
100.00
(93.94 to 100.00)
98.33
(91.06 to 99.96)
B/Yamagata, ≥1:320 (Day 22)
98.21
(90.45 to 99.95)
100.00
(94.13 to 100.00)
96.61
(88.29 to 99.59)
88.33
(77.43 to 95.18)
B/Yamagata, ≥1:640 (Day 22)
91.07
(80.38 to 97.04)
91.80
(81.90 to 97.28)
89.83
(79.17 to 96.18)
66.67
(53.31 to 78.31)
B/Yamagata, ≥1:20 (Day 181)
100.00
(93.51 to 100.00)
98.33
(91.06 to 99.96)
100.00
(93.84 to 100.00)
100.00
(94.04 to 100.00)
B/Yamagata, ≥1:40 (Day 181)
100.00
(93.51 to 100.00)
98.33
(91.06 to 99.96)
98.28
(90.76 to 99.96)
96.67
(88.47 to 99.59)
B/Yamagata, ≥1:80 (Day 181)
100.00
(93.51 to 100.00)
98.33
(91.06 to 99.96)
96.55
(88.09 to 99.58)
90.00
(79.49 to 96.24)
B/Yamagata, ≥1:160 (Day 181)
98.18
(90.28 to 99.95)
96.67
(88.47 to 99.59)
91.38
(81.02 to 97.14)
81.67
(69.56 to 90.48)
B/Yamagata, ≥1:320 (Day 181)
92.73
(82.41 to 97.98)
86.67
(75.41 to 94.06)
84.48
(72.58 to 92.65)
65.00
(51.60 to 76.87)
B/Yamagata, ≥1:640 (Day 181)
72.73
(59.04 to 83.86)
61.67
(48.21 to 73.93)
51.72
(38.22 to 65.05)
40.00
(27.56 to 53.46)
B/Victoria, ≥1:20 (Day 22)
100.00
(93.62 to 100.00)
100.00
(94.22 to 100.00)
100.00
(93.94 to 100.00)
100.00
(94.04 to 100.00)
B/Victoria, ≥1:40 (Day 22)
100.00
(93.62 to 100.00)
100.00
(94.22 to 100.00)
100.00
(93.94 to 100.00)
100.00
(94.04 to 100.00)
B/Victoria, ≥1:80 (Day 22)
100.00
(93.62 to 100.00)
100.00
(94.22 to 100.00)
100.00
(93.94 to 100.00)
100.00
(94.04 to 100.00)
B/Victoria, ≥1:160 (Day 22)
100.00
(93.62 to 100.00)
100.00
(94.22 to 100.00)
100.00
(93.94 to 100.00)
100.00
(94.04 to 100.00)
B/Victoria, ≥1:320 (Day 22)
100.00
(93.62 to 100.00)
100.00
(94.22 to 100.00)
100.00
(93.94 to 100.00)
98.33
(91.06 to 99.96)
B/Victoria, ≥1:640 (Day 22)
100.00
(93.62 to 100.00)
100.00
(94.22 to 100.00)
100.00
(93.94 to 100.00)
91.67
(81.61 to 97.24)
B/Victoria, ≥1:20 (Day 181)
100.00
(93.51 to 100.00)
100.00
(94.13 to 100.00)
100.00
(93.84 to 100.00)
100.00
(94.04 to 100.00)
B/Victoria, ≥1:40 (Day 181)
100.00
(93.51 to 100.00)
100.00
(94.13 to 100.00)
100.00
(93.84 to 100.00)
100.00
(94.04 to 100.00)
B/Victoria, ≥1:80 (Day 181)
100.00
(93.51 to 100.00)
100.00
(94.13 to 100.00)
100.00
(93.84 to 100.00)
100.00
(94.04 to 100.00)
B/Victoria, ≥1:160 (Day 181)
100.00
(93.51 to 100.00)
100.00
(94.13 to 100.00)
96.55
(88.09 to 99.58)
96.67
(88.47 to 99.59)
B/Victoria, ≥1:320 (Day 181)
94.55
(84.88 to 98.86)
100.00
(94.13 to 100.00)
95.55
(88.09 to 99.58)
83.33
(71.48 to 91.71)
B/Victoria, ≥1:640 (Day 181)
89.09
(77.75 to 95.89)
95.08
(86.29 to 98.97)
81.03
(68.59 to 90.13)
70.00
(56.79 to 81.15)
Time Frame Day 1 - Day 366
Adverse Event Reporting Description

The overall safety set included all subjects who were in the solicited safety set and/or in the unsolicited safety set.

Assessment of revaccination safety included:

SAEs collected between Day 1 to Day 366 Non-serious AEs included solicited AEs collected between Day 1 to Day 7 after last vaccination, and unsolicited AEs collected between Day 1 to Day 366 after last vaccination

 
Arm/Group Title aQIV-aQIV aQIV-QIV QIV-aQIV QIV-QIV
Hide Arm/Group Description

Subjects previously vaccinated with aQIV followed one year later by aQIV

Adjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)

Subjects previously vaccinated with aQIV followed one year later by QIV

Non-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)

Subjects previously vaccinated with QIV followed one year later by aQIV

Adjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)

Subjects previously vaccinated with QIV followed one year later by QIV

Non-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)

All-Cause Mortality
aQIV-aQIV aQIV-QIV QIV-aQIV QIV-QIV
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/403 (0.00%)   0/403 (0.00%)   0/402 (0.00%)   0/393 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
aQIV-aQIV aQIV-QIV QIV-aQIV QIV-QIV
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   10/403 (2.48%)   11/403 (2.73%)   7/402 (1.74%)   8/393 (2.04%) 
Blood and lymphatic system disorders         
Iron Deficiency Anaemia  1  0/403 (0.00%)  0/403 (0.00%)  0/402 (0.00%)  1/393 (0.25%) 
Lymphadenitis  1  0/403 (0.00%)  0/403 (0.00%)  0/402 (0.00%)  1/393 (0.25%) 
Congenital, familial and genetic disorders         
Spina Bifida Occulta  1  0/403 (0.00%)  0/403 (0.00%)  0/402 (0.00%)  1/393 (0.25%) 
Ear and labyrinth disorders         
Vertigo  1  1/403 (0.25%)  0/403 (0.00%)  0/402 (0.00%)  0/393 (0.00%) 
Gastrointestinal disorders         
Aphthous Ulcer  1  0/403 (0.00%)  0/403 (0.00%)  0/402 (0.00%)  1/393 (0.25%) 
Dyspepsia  1  1/403 (0.25%)  0/403 (0.00%)  0/402 (0.00%)  0/393 (0.00%) 
Gastritis  1  2/403 (0.50%)  0/403 (0.00%)  0/402 (0.00%)  0/393 (0.00%) 
Immune system disorders         
Anaphylactic Reaction  1  0/403 (0.00%)  0/403 (0.00%)  0/402 (0.00%)  1/393 (0.25%) 
Infections and infestations         
Amoebic Dysentery  1  1/403 (0.25%)  0/403 (0.00%)  0/402 (0.00%)  0/393 (0.00%) 
Appendiceal Abscess  1  0/403 (0.00%)  1/403 (0.25%)  0/402 (0.00%)  0/393 (0.00%) 
Bronchitis  1  0/403 (0.00%)  1/403 (0.25%)  1/402 (0.25%)  0/393 (0.00%) 
Dengue Fever  1  1/403 (0.25%)  0/403 (0.00%)  0/402 (0.00%)  0/393 (0.00%) 
External Ear Cellulitis  1  0/403 (0.00%)  1/403 (0.25%)  0/402 (0.00%)  0/393 (0.00%) 
Gastroenteritis  1  0/403 (0.00%)  4/403 (0.99%)  4/402 (1.00%)  1/393 (0.25%) 
Herpangina  1  0/403 (0.00%)  0/403 (0.00%)  1/402 (0.25%)  0/393 (0.00%) 
Pneumonia  1  1/403 (0.25%)  1/403 (0.25%)  0/402 (0.00%)  1/393 (0.25%) 
Respiratory Tract Infection  1  0/403 (0.00%)  1/403 (0.25%)  0/402 (0.00%)  0/393 (0.00%) 
Tonsillitis  1  0/403 (0.00%)  0/403 (0.00%)  1/402 (0.25%)  1/393 (0.25%) 
Urinary Tract Infection  1  1/403 (0.25%)  0/403 (0.00%)  0/402 (0.00%)  1/393 (0.25%) 
Injury, poisoning and procedural complications         
Animal Bite  1  1/403 (0.25%)  1/403 (0.25%)  0/402 (0.00%)  1/393 (0.25%) 
Fall  1  0/403 (0.00%)  1/403 (0.25%)  0/402 (0.00%)  0/393 (0.00%) 
Jaw Fracture  1  1/403 (0.25%)  0/403 (0.00%)  0/402 (0.00%)  0/393 (0.00%) 
Wound Secretion  1  0/403 (0.00%)  1/403 (0.25%)  0/402 (0.00%)  0/393 (0.00%) 
Nervous system disorders         
Febrile Convulsion  1  1/403 (0.25%)  0/403 (0.00%)  0/402 (0.00%)  0/393 (0.00%) 
Vascular disorders         
Kawasaki's Disease  1  0/403 (0.00%)  0/403 (0.00%)  0/402 (0.00%)  1/393 (0.25%) 
1
Term from vocabulary, MedDRA version 19.1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
aQIV-aQIV aQIV-QIV QIV-aQIV QIV-QIV
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   289/403 (71.71%)   269/403 (66.75%)   274/402 (68.16%)   229/393 (58.27%) 
Gastrointestinal disorders         
Diarrhoea  1  22/403 (5.46%)  8/403 (1.99%)  14/402 (3.48%)  16/393 (4.07%) 
Vomiting  1  29/403 (7.20%)  15/403 (3.72%)  19/402 (4.73%)  13/393 (3.31%) 
General disorders         
Influenza Like Illness  1  32/403 (7.94%)  41/403 (10.17%)  37/402 (9.20%)  31/393 (7.89%) 
Injection Site Erythema  1  81/403 (20.10%)  57/403 (14.14%)  51/402 (12.69%)  39/393 (9.92%) 
Injection Site Induration  1  62/403 (15.38%)  55/403 (13.65%)  38/402 (9.45%)  24/393 (6.11%) 
Injection Site Pain  1  163/403 (40.45%)  137/403 (34.00%)  134/402 (33.33%)  120/393 (30.53%) 
Pyrexia  1  96/403 (23.82%)  46/403 (11.41%)  72/402 (17.91%)  51/393 (12.98%) 
Infections and infestations         
Nasopharyngitis  1  21/403 (5.21%)  19/403 (4.71%)  26/402 (6.47%)  16/393 (4.07%) 
Upper Respiratory Tract Infection  1  78/403 (19.35%)  100/403 (24.81%)  99/402 (24.63%)  73/393 (18.58%) 
Nervous system disorders         
Somnolence  1  79/403 (19.60%)  45/403 (11.17%)  55/402 (13.68%)  25/393 (6.36%) 
Psychiatric disorders         
Eating Disorder  1  66/403 (16.38%)  28/403 (6.95%)  52/402 (12.94%)  24/393 (6.11%) 
Irritability  1  60/403 (14.89%)  44/403 (10.92%)  50/402 (12.44%)  36/393 (9.16%) 
1
Term from vocabulary, MedDRA version 19.1
Indicates events were collected by systematic assessment
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
Name/Title: Seqirus Clinical Trial Disclosure Manager
Organization: Seqirus
Phone: Phone: 1-855-358-8966
Responsible Party: Seqirus
ClinicalTrials.gov Identifier: NCT02583256     History of Changes
Other Study ID Numbers: V118_05E3
2015-002973-39 ( EudraCT Number )
First Submitted: October 16, 2015
First Posted: October 22, 2015
Results First Submitted: February 25, 2019
Results First Posted: April 24, 2019
Last Update Posted: April 24, 2019