Trial Outcomes & Findings for 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) (NCT NCT02583256)
NCT ID: NCT02583256
Last Updated: 2019-04-24
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1601 participants
Primary outcome timeframe
Day 22
Results posted on
2019-04-24
Participant Flow
This study was conducted at 17 sites in total; 9 sites in Finland, 4 sites in the Philippines and 4 sites in Thailand.
All enrolled subjects were included in the study.
Participant milestones
| Measure |
aQIV/aQIV
Subjects previously vaccinated with aQIV followed one year later by aQIV
Adjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)
|
aQIV/QIV
Subjects previously vaccinated with aQIV followed one year later by QIV
Non-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)
|
QIV/aQIV
Subjects previously vaccinated with QIV followed one year later by aQIV
Adjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)
|
QIV/QIV
Subjects previously vaccinated with QIV followed one year later by QIV
Non-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
403
|
403
|
402
|
393
|
|
Overall Study
Exposed
|
403
|
403
|
402
|
393
|
|
Overall Study
COMPLETED
|
400
|
401
|
400
|
390
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
2
|
3
|
Reasons for withdrawal
| Measure |
aQIV/aQIV
Subjects previously vaccinated with aQIV followed one year later by aQIV
Adjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)
|
aQIV/QIV
Subjects previously vaccinated with aQIV followed one year later by QIV
Non-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)
|
QIV/aQIV
Subjects previously vaccinated with QIV followed one year later by aQIV
Adjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)
|
QIV/QIV
Subjects previously vaccinated with QIV followed one year later by QIV
Non-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
0
|
1
|
|
Overall Study
Administrative/Other
|
2
|
0
|
1
|
2
|
Baseline Characteristics
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)
Baseline characteristics by cohort
| Measure |
aQIV/aQIV
n=403 Participants
Subjects previously vaccinated with aQIV followed one year later by aQIV
Adjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)
|
aQIV/QIV
n=403 Participants
Subjects previously vaccinated with aQIV followed one year later by QIV
Non-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)
|
QIV/aQIV
n=402 Participants
Subjects previously vaccinated with QIV followed one year later by aQIV
Adjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)
|
QIV/QIV
n=393 Participants
Subjects previously vaccinated with QIV followed one year later by QIV
Non-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)
|
Total
n=1601 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
54.4 months
STANDARD_DEVIATION 17.12 • n=99 Participants
|
52.3 months
STANDARD_DEVIATION 17.02 • n=107 Participants
|
53.4 months
STANDARD_DEVIATION 17.32 • n=206 Participants
|
53.3 months
STANDARD_DEVIATION 17.30 • n=7 Participants
|
53.0 months
STANDARD_DEVIATION 16.91 • n=31 Participants
|
|
Sex: Female, Male
Female
|
197 Participants
n=99 Participants
|
189 Participants
n=107 Participants
|
206 Participants
n=206 Participants
|
178 Participants
n=7 Participants
|
770 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
206 Participants
n=99 Participants
|
214 Participants
n=107 Participants
|
196 Participants
n=206 Participants
|
215 Participants
n=7 Participants
|
831 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
402 Participants
n=99 Participants
|
403 Participants
n=107 Participants
|
402 Participants
n=206 Participants
|
392 Participants
n=7 Participants
|
1599 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Asian
|
364 Participants
n=99 Participants
|
364 Participants
n=107 Participants
|
362 Participants
n=206 Participants
|
355 Participants
n=7 Participants
|
1445 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
White
|
38 Participants
n=99 Participants
|
36 Participants
n=107 Participants
|
37 Participants
n=206 Participants
|
35 Participants
n=7 Participants
|
146 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
10 Participants
n=31 Participants
|
|
Region of Enrollment
Philippines
|
210 Participants
n=99 Participants
|
211 Participants
n=107 Participants
|
213 Participants
n=206 Participants
|
212 Participants
n=7 Participants
|
846 Participants
n=31 Participants
|
|
Region of Enrollment
Finland
|
39 Participants
n=99 Participants
|
39 Participants
n=107 Participants
|
39 Participants
n=206 Participants
|
38 Participants
n=7 Participants
|
155 Participants
n=31 Participants
|
|
Region of Enrollment
Thailand
|
154 Participants
n=99 Participants
|
153 Participants
n=107 Participants
|
150 Participants
n=206 Participants
|
143 Participants
n=7 Participants
|
600 Participants
n=31 Participants
|
|
Risk Status
At risk
|
10 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
13 Participants
n=7 Participants
|
61 Participants
n=31 Participants
|
|
Risk Status
Not at risk
|
393 Participants
n=99 Participants
|
383 Participants
n=107 Participants
|
384 Participants
n=206 Participants
|
380 Participants
n=7 Participants
|
1540 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: Day 22Population: 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.
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.
Outcome measures
| Measure |
aQIV/aQIV
n=403 Participants
Subjects previously vaccinated with aQIV followed one year later by aQIV
Adjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)
|
aQIV/QIV
n=398 Participants
Subjects previously vaccinated with aQIV followed one year later by QIV
Non-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)
|
QIV/aQIV
Subjects previously vaccinated with QIV followed one year later by aQIV
Adjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)
|
QIV/QIV
Subjects previously vaccinated with QIV followed one year later by QIV
Non-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)
|
|---|---|---|---|---|
|
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
A/H1N1
|
1219.00 titer
Interval 1137.35 to 1306.52
|
1020.89 titer
Interval 953.22 to 1093.36
|
—
|
—
|
|
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
A/H3N2
|
2355.52 titer
Interval 2226.19 to 2492.35
|
2529.83 titer
Interval 2392.9 to 2674.59
|
—
|
—
|
|
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
B/Yamagata
|
276.23 titer
Interval 252.73 to 301.92
|
232.82 titer
Interval 213.25 to 254.19
|
—
|
—
|
|
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
B/Victoria
|
388.35 titer
Interval 355.33 to 424.44
|
328.42 titer
Interval 300.76 to 358.63
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 22Population: 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.
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.
Outcome measures
| Measure |
aQIV/aQIV
n=403 Participants
Subjects previously vaccinated with aQIV followed one year later by aQIV
Adjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)
|
aQIV/QIV
n=403 Participants
Subjects previously vaccinated with aQIV followed one year later by QIV
Non-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)
|
QIV/aQIV
Subjects previously vaccinated with QIV followed one year later by aQIV
Adjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)
|
QIV/QIV
Subjects previously vaccinated with QIV followed one year later by QIV
Non-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)
|
|---|---|---|---|---|
|
Immunogenicity Endpoint: GMT and GMT Ratio as Determined by HI Assay on Day 22 Against Homologous Strains (aQIV-primed Comparison), Superiority Analysis
A/H1N1
|
1218.91 titer
Interval 1137.02 to 1306.7
|
1023.37 titer
Interval 955.72 to 1095.81
|
—
|
—
|
|
Immunogenicity Endpoint: GMT and GMT Ratio as Determined by HI Assay on Day 22 Against Homologous Strains (aQIV-primed Comparison), Superiority Analysis
A/H3N2
|
2345.71 titer
Interval 2216.84 to 2482.07
|
2521.60 titer
Interval 2385.43 to 2665.56
|
—
|
—
|
|
Immunogenicity Endpoint: GMT and GMT Ratio as Determined by HI Assay on Day 22 Against Homologous Strains (aQIV-primed Comparison), Superiority Analysis
B/Yamagata
|
274.75 titer
Interval 251.09 to 300.65
|
230.51 titer
Interval 210.97 to 251.86
|
—
|
—
|
|
Immunogenicity Endpoint: GMT and GMT Ratio as Determined by HI Assay on Day 22 Against Homologous Strains (aQIV-primed Comparison), Superiority Analysis
B/Victoria
|
387.35 titer
Interval 354.15 to 423.66
|
326.68 titer
Interval 299.1 to 356.81
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 22Population: 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.
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.
Outcome measures
| Measure |
aQIV/aQIV
n=397 Participants
Subjects previously vaccinated with aQIV followed one year later by aQIV
Adjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)
|
aQIV/QIV
n=389 Participants
Subjects previously vaccinated with aQIV followed one year later by QIV
Non-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)
|
QIV/aQIV
Subjects previously vaccinated with QIV followed one year later by aQIV
Adjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)
|
QIV/QIV
Subjects previously vaccinated with QIV followed one year later by QIV
Non-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)
|
|---|---|---|---|---|
|
Immunogenicity Endpoint: GMT and GMT Ratio as Determined by HI Assay on Day 22 Against Homologous Strains (QIV-primed Comparison)
A/H1N1
|
1206.20 titer
Interval 1123.8 to 1294.65
|
866.51 titer
Interval 807.3 to 930.06
|
—
|
—
|
|
Immunogenicity Endpoint: GMT and GMT Ratio as Determined by HI Assay on Day 22 Against Homologous Strains (QIV-primed Comparison)
A/H3N2
|
2369.95 titer
Interval 2236.39 to 2511.48
|
2229.48 titer
Interval 2103.42 to 2363.1
|
—
|
—
|
|
Immunogenicity Endpoint: GMT and GMT Ratio as Determined by HI Assay on Day 22 Against Homologous Strains (QIV-primed Comparison)
B/Yamagata
|
221.54 titer
Interval 202.12 to 242.82
|
156.01 titer
Interval 142.32 to 171.02
|
—
|
—
|
|
Immunogenicity Endpoint: GMT and GMT Ratio as Determined by HI Assay on Day 22 Against Homologous Strains (QIV-primed Comparison)
B/Victoria
|
330.94 titer
Interval 302.38 to 362.21
|
244.03 titer
Interval 222.84 to 267.24
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 181Population: 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.
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.
Outcome measures
| Measure |
aQIV/aQIV
n=403 Participants
Subjects previously vaccinated with aQIV followed one year later by aQIV
Adjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)
|
aQIV/QIV
n=398 Participants
Subjects previously vaccinated with aQIV followed one year later by QIV
Non-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)
|
QIV/aQIV
n=397 Participants
Subjects previously vaccinated with QIV followed one year later by aQIV
Adjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)
|
QIV/QIV
n=389 Participants
Subjects previously vaccinated with QIV followed one year later by QIV
Non-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)
|
|---|---|---|---|---|
|
Immunogenicity Endpoint: GMT and GMT Ratio as Determined by HI Assay on Day 181 Against Homologous Strains (aQIV-primed and QIV-primed Comparison)
A/H1N1
|
489.45 titer
Interval 449.93 to 532.45
|
411.72 titer
Interval 378.83 to 447.46
|
429.06 titer
Interval 393.73 to 467.57
|
307.36 titer
Interval 282.02 to 334.98
|
|
Immunogenicity Endpoint: GMT and GMT Ratio as Determined by HI Assay on Day 181 Against Homologous Strains (aQIV-primed and QIV-primed Comparison)
A/H3N2
|
1423.38 titer
Interval 1310.04 to 1546.52
|
1438.40 titer
Interval 1325.53 to 1560.89
|
1233.84 titer
Interval 1133.08 to 1343.56
|
1222.21 titer
Interval 1121.92 to 1331.46
|
|
Immunogenicity Endpoint: GMT and GMT Ratio as Determined by HI Assay on Day 181 Against Homologous Strains (aQIV-primed and QIV-primed Comparison)
B/Yamagata
|
97.01 titer
Interval 88.67 to 106.13
|
86.43 titer
Interval 79.09 to 94.45
|
73.37 titer
Interval 66.88 to 80.49
|
56.57 titer
Interval 51.56 to 62.08
|
|
Immunogenicity Endpoint: GMT and GMT Ratio as Determined by HI Assay on Day 181 Against Homologous Strains (aQIV-primed and QIV-primed Comparison)
B/Victoria
|
128.32 titer
Interval 115.17 to 142.97
|
115.26 titer
Interval 103.57 to 128.26
|
104.93 titer
Interval 94.02 to 117.1
|
79.76 titer
Interval 71.41 to 89.09
|
SECONDARY outcome
Timeframe: Day 1, Day 22Population: 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.
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.
Outcome measures
| Measure |
aQIV/aQIV
n=403 Participants
Subjects previously vaccinated with aQIV followed one year later by aQIV
Adjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)
|
aQIV/QIV
n=398 Participants
Subjects previously vaccinated with aQIV followed one year later by QIV
Non-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)
|
QIV/aQIV
n=397 Participants
Subjects previously vaccinated with QIV followed one year later by aQIV
Adjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)
|
QIV/QIV
n=389 Participants
Subjects previously vaccinated with QIV followed one year later by QIV
Non-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)
|
|---|---|---|---|---|
|
Immunogenicity Endpoint: Seroconversion Rate (SCR) on Day 22 Against Homologous Strains (aQIV-primed and QIV-primed Comparison)
A/H1N1
|
62.7 percentage of subjects
Interval 57.8 to 67.4
|
60.9 percentage of subjects
Interval 55.9 to 65.7
|
72.04 percentage of subjects
Interval 67.35 to 76.4
|
62.37 percentage of subjects
Interval 57.34 to 67.21
|
|
Immunogenicity Endpoint: Seroconversion Rate (SCR) on Day 22 Against Homologous Strains (aQIV-primed and QIV-primed Comparison)
A/H3N2
|
68.9 percentage of subjects
Interval 64.1 to 73.4
|
68.0 percentage of subjects
Interval 63.2 to 72.6
|
72.80 percentage of subjects
Interval 68.13 to 77.12
|
76.74 percentage of subjects
Interval 72.21 to 80.86
|
|
Immunogenicity Endpoint: Seroconversion Rate (SCR) on Day 22 Against Homologous Strains (aQIV-primed and QIV-primed Comparison)
B/Yamagata
|
76.4 percentage of subjects
Interval 71.9 to 80.4
|
72.0 percentage of subjects
Interval 67.4 to 76.4
|
79.44 percentage of subjects
Interval 75.11 to 83.32
|
66.49 percentage of subjects
Interval 61.51 to 71.21
|
|
Immunogenicity Endpoint: Seroconversion Rate (SCR) on Day 22 Against Homologous Strains (aQIV-primed and QIV-primed Comparison)
B/Victoria
|
77.4 percentage of subjects
Interval 73.0 to 81.4
|
74.8 percentage of subjects
Interval 70.2 to 79.0
|
77.92 percentage of subjects
Interval 73.49 to 81.92
|
69.55 percentage of subjects
Interval 64.66 to 74.14
|
SECONDARY outcome
Timeframe: Day 22, Day 181Population: 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.
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.
Outcome measures
| Measure |
aQIV/aQIV
n=403 Participants
Subjects previously vaccinated with aQIV followed one year later by aQIV
Adjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)
|
aQIV/QIV
n=398 Participants
Subjects previously vaccinated with aQIV followed one year later by QIV
Non-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)
|
QIV/aQIV
n=397 Participants
Subjects previously vaccinated with QIV followed one year later by aQIV
Adjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)
|
QIV/QIV
n=389 Participants
Subjects previously vaccinated with QIV followed one year later by QIV
Non-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)
|
|---|---|---|---|---|
|
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
B/Yamagata (Day 22/Day 1)
|
7.81 ratio
Interval 7.14 to 8.54
|
6.58 ratio
Interval 6.03 to 7.19
|
6.26 ratio
Interval 5.71 to 6.86
|
4.41 ratio
Interval 4.02 to 4.83
|
|
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
B/Yamagata (Day 181/Day 1)
|
2.74 ratio
Interval 2.5 to 3.0
|
2.44 ratio
Interval 2.23 to 2.67
|
2.07 ratio
Interval 1.89 to 2.27
|
1.60 ratio
Interval 1.46 to 1.75
|
|
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
B/Victoria (Day 22/Day 1)
|
7.86 ratio
Interval 7.19 to 8.59
|
6.64 ratio
Interval 6.09 to 7.26
|
6.70 ratio
Interval 6.12 to 7.33
|
4.94 ratio
Interval 4.51 to 5.41
|
|
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
B/Victoria (Day 181/Day 1)
|
2.59 ratio
Interval 2.33 to 2.89
|
2.33 ratio
Interval 2.09 to 2.59
|
2.12 ratio
Interval 1.9 to 2.36
|
1.61 ratio
Interval 1.44 to 1.8
|
|
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
A/H1N1 (Day 22/Day 1)
|
7.69 ratio
Interval 7.17 to 8.24
|
6.44 ratio
Interval 6.01 to 6.9
|
7.61 ratio
Interval 7.09 to 8.17
|
5.47 ratio
Interval 5.09 to 5.87
|
|
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
A/H1N1 (Day 181/Day 1)
|
3.11 ratio
Interval 2.86 to 3.38
|
2.61 ratio
Interval 2.4 to 2.84
|
2.72 ratio
Interval 2.5 to 2.97
|
1.95 ratio
Interval 1.79 to 2.13
|
|
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
A/H3N2 (Day 22/Day 1)
|
9.02 ratio
Interval 8.53 to 9.55
|
9.69 ratio
Interval 9.17 to 10.25
|
9.08 ratio
Interval 8.57 to 9.62
|
8.54 ratio
Interval 8.06 to 9.05
|
|
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
A/H3N2 (Day 181/Day 1)
|
5.44 ratio
Interval 5.01 to 5.91
|
5.50 ratio
Interval 5.07 to 5.97
|
4.72 ratio
Interval 4.33 to 5.14
|
4.67 ratio
Interval 4.29 to 5.09
|
SECONDARY outcome
Timeframe: Day 22, Day 181Population: 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.
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.
Outcome measures
| Measure |
aQIV/aQIV
n=403 Participants
Subjects previously vaccinated with aQIV followed one year later by aQIV
Adjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)
|
aQIV/QIV
n=398 Participants
Subjects previously vaccinated with aQIV followed one year later by QIV
Non-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)
|
QIV/aQIV
n=397 Participants
Subjects previously vaccinated with QIV followed one year later by aQIV
Adjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)
|
QIV/QIV
n=389 Participants
Subjects previously vaccinated with QIV followed one year later by QIV
Non-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)
|
|---|---|---|---|---|
|
Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 on Day 22 and Day 181 Against Homologous Strains
A/H1N1 (Day 22)
|
100 percentage of subjects
Interval 99.1 to 100.0
|
100 percentage of subjects
Interval 99.1 to 100.0
|
100 percentage of subjects
Interval 99.1 to 100.0
|
99.7 percentage of subjects
Interval 98.6 to 100.0
|
|
Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 on Day 22 and Day 181 Against Homologous Strains
A/H1N1 (Day 181)
|
100 percentage of subjects
Interval 99.1 to 100.0
|
99.2 percentage of subjects
Interval 97.8 to 99.8
|
99.2 percentage of subjects
Interval 97.8 to 99.8
|
95.9 percentage of subjects
Interval 93.4 to 97.6
|
|
Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 on Day 22 and Day 181 Against Homologous Strains
A/H3N2 (Day 22)
|
100 percentage of subjects
Interval 99.1 to 100.0
|
100 percentage of subjects
Interval 99.1 to 100.0
|
100 percentage of subjects
Interval 99.1 to 100.0
|
100 percentage of subjects
Interval 99.1 to 100.0
|
|
Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 on Day 22 and Day 181 Against Homologous Strains
A/H3N2 (Day 181)
|
99.8 percentage of subjects
Interval 98.6 to 100.0
|
100 percentage of subjects
Interval 99.1 to 100.0
|
100 percentage of subjects
Interval 99.1 to 100.0
|
98.7 percentage of subjects
Interval 97.0 to 99.6
|
|
Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 on Day 22 and Day 181 Against Homologous Strains
B/Yamagata (Day 22)
|
98.5 percentage of subjects
Interval 96.8 to 99.5
|
98.7 percentage of subjects
Interval 97.1 to 99.6
|
98.5 percentage of subjects
Interval 96.7 to 99.4
|
96.6 percentage of subjects
Interval 94.3 to 98.2
|
|
Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 on Day 22 and Day 181 Against Homologous Strains
B/Yamagata (Day 181)
|
94.3 percentage of subjects
Interval 91.5 to 96.3
|
93.9 percentage of subjects
Interval 91.1 to 96.1
|
83.9 percentage of subjects
Interval 79.9 to 87.4
|
76.1 percentage of subjects
Interval 71.5 to 80.3
|
|
Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 on Day 22 and Day 181 Against Homologous Strains
B/Victoria (Day 22)
|
99.9 percentage of subjects
Interval 98.6 to 100.0
|
100 percentage of subjects
Interval 99.1 to 100.0
|
99.5 percentage of subjects
Interval 98.2 to 99.9
|
97.9 percentage of subjects
Interval 95.9 to 99.1
|
|
Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 on Day 22 and Day 181 Against Homologous Strains
B/Victoria (Day 181)
|
95.3 percentage of subjects
Interval 92.7 to 97.1
|
93.9 percentage of subjects
Interval 91.1 to 96.1
|
86.7 percentage of subjects
Interval 83.0 to 89.9
|
76.9 percentage of subjects
Interval 72.2 to 80.9
|
SECONDARY outcome
Timeframe: Day 22Population: 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.
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.
Outcome measures
| Measure |
aQIV/aQIV
n=403 Participants
Subjects previously vaccinated with aQIV followed one year later by aQIV
Adjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)
|
aQIV/QIV
n=398 Participants
Subjects previously vaccinated with aQIV followed one year later by QIV
Non-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)
|
QIV/aQIV
n=397 Participants
Subjects previously vaccinated with QIV followed one year later by aQIV
Adjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)
|
QIV/QIV
n=389 Participants
Subjects previously vaccinated with QIV followed one year later by QIV
Non-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)
|
|---|---|---|---|---|
|
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
A/H1N1, HI ≥1:110
|
100.0 percentage of subjects
Interval 99.1 to 100.0
|
100.0 percentage of subjects
Interval 99.1 to 100.0
|
99.7 percentage of subjects
Interval 98.6 to 100.0
|
97.7 percentage of subjects
Interval 95.6 to 98.9
|
|
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
A/H1N1, HI ≥1:151
|
100.0 percentage of subjects
Interval 99.1 to 100.0
|
100.0 percentage of subjects
Interval 99.1 to 100.0
|
99.5 percentage of subjects
Interval 98.2 to 99.9
|
97.4 percentage of subjects
Interval 95.3 to 98.8
|
|
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
A/H1N1, HI ≥1:215
|
99.8 percentage of subjects
Interval 98.6 to 100.0
|
99.2 percentage of subjects
Interval 97.8 to 99.8
|
97.5 percentage of subjects
Interval 95.4 to 98.8
|
93.8 percentage of subjects
Interval 90.9 to 96.0
|
|
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
A/H1N1, HI ≥1:330
|
97.3 percentage of subjects
Interval 95.2 to 98.6
|
93.7 percentage of subjects
Interval 90.8 to 95.9
|
93.2 percentage of subjects
Interval 90.3 to 95.5
|
82.5 percentage of subjects
Interval 78.3 to 86.1
|
|
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
A/ H1N1 ≥1:629
|
94.8 percentage of subjects
Interval 92.1 to 96.7
|
87.6 percentage of subjects
Interval 84.0 to 90.7
|
87.9 percentage of subjects
Interval 84.3 to 91.0
|
74.2 percentage of subjects
Interval 69.6 to 78.5
|
|
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
A/H3N2, HI ≥1:110
|
99.8 percentage of subjects
Interval 98.6 to 100.0
|
100.0 percentage of subjects
Interval 99.1 to 100.0
|
100.0 percentage of subjects
Interval 99.1 to 100.0
|
99.5 percentage of subjects
Interval 98.1 to 99.9
|
|
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
A/H3N2, HI ≥1:151
|
99.8 percentage of subjects
Interval 98.6 to 100.0
|
100.0 percentage of subjects
Interval 99.1 to 100.0
|
100.0 percentage of subjects
Interval 99.1 to 100.0
|
99.5 percentage of subjects
Interval 98.1 to 99.9
|
|
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
A/H3N2, HI ≥1:215
|
99.5 percentage of subjects
Interval 98.2 to 99.9
|
100.0 percentage of subjects
Interval 99.1 to 100.0
|
100.0 percentage of subjects
Interval 99.1 to 100.0
|
97.7 percentage of subjects
Interval 95.6 to 98.9
|
|
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
A/H3N2, HI ≥1:330
|
99.3 percentage of subjects
Interval 97.8 to 99.8
|
99.7 percentage of subjects
Interval 98.6 to 100.0
|
99.5 percentage of subjects
Interval 98.2 to 99.9
|
95.9 percentage of subjects
Interval 93.4 to 97.6
|
|
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
A/H3N2, HI ≥1:629
|
99.0 percentage of subjects
Interval 97.5 to 99.7
|
99.7 percentage of subjects
Interval 98.6 to 100.0
|
99.2 percentage of subjects
Interval 97.8 to 99.8
|
95.1 percentage of subjects
Interval 92.4 to 97.0
|
|
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
B/Yamagata, HI ≥1:110
|
90.8 percentage of subjects
Interval 87.5 to 93.4
|
88.4 percentage of subjects
Interval 84.8 to 91.4
|
82.7 percentage of subjects
Interval 78.6 to 86.3
|
68.3 percentage of subjects
Interval 63.4 to 73.0
|
|
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
B/Yamagata, HI ≥1:151
|
87.6 percentage of subjects
Interval 83.9 to 90.6
|
81.6 percentage of subjects
Interval 77.4 to 85.3
|
75.9 percentage of subjects
Interval 71.4 to 80.0
|
59.9 percentage of subjects
Interval 54.8 to 64.9
|
|
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
B/Yamagata, HI ≥1:215
|
69.9 percentage of subjects
Interval 65.2 to 74.3
|
64.2 percentage of subjects
Interval 59.3 to 69.0
|
53.3 percentage of subjects
Interval 48.2 to 58.3
|
38.5 percentage of subjects
Interval 33.6 to 43.6
|
|
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
B/Yamagata, HI ≥1:330
|
44.0 percentage of subjects
Interval 39.1 to 49.0
|
34.3 percentage of subjects
Interval 29.6 to 39.2
|
25.1 percentage of subjects
Interval 20.9 to 29.7
|
14.9 percentage of subjects
Interval 11.5 to 18.9
|
|
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
B/Yamagata, HI ≥1:629
|
27.9 percentage of subjects
Interval 23.5 to 32.5
|
20.9 percentage of subjects
Interval 17.0 to 25.2
|
14.2 percentage of subjects
Interval 10.9 to 18.1
|
7.3 percentage of subjects
Interval 4.9 to 10.4
|
|
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
B/Victoria, HI ≥1:110
|
93.0 percentage of subjects
Interval 90.1 to 95.3
|
89.9 percentage of subjects
Interval 86.5 to 92.7
|
86.0 percentage of subjects
Interval 82.8 to 89.8
|
76.1 percentage of subjects
Interval 71.5 to 80.3
|
|
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
B/Victoria, HI ≥1:151
|
91.3 percentage of subjects
Interval 88.1 to 93.9
|
87.9 percentage of subjects
Interval 84.3 to 90.9
|
83.0 percentage of subjects
Interval 78.9 to 86.6
|
70.6 percentage of subjects
Interval 65.8 to 75.1
|
|
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
B/Victoria, HI ≥1:215
|
79.6 percentage of subjects
Interval 75.3 to 83.4
|
73.4 percentage of subjects
Interval 69.1 to 78.0
|
67.5 percentage of subjects
Interval 62.6 to 72.1
|
53.0 percentage of subjects
Interval 47.9 to 58.1
|
|
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
B/Victoria, HI ≥1:330
|
58.7 percentage of subjects
Interval 53.7 to 63.6
|
48.7 percentage of subjects
Interval 43.8 to 53.8
|
41.9 percentage of subjects
Interval 37.0 to 46.9
|
32.0 percentage of subjects
Interval 27.4 to 37.0
|
|
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
B/Victoria, HI ≥1:629
|
45.3 percentage of subjects
Interval 40.3 to 50.3
|
37.6 percentage of subjects
Interval 32.8 to 42.6
|
34.3 percentage of subjects
Interval 29.6 to 39.2
|
24.1 percentage of subjects
Interval 19.9 to 28.8
|
SECONDARY outcome
Timeframe: Day 1, Day 22, Day 181Population: 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.
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.
Outcome measures
| Measure |
aQIV/aQIV
n=60 Participants
Subjects previously vaccinated with aQIV followed one year later by aQIV
Adjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)
|
aQIV/QIV
n=57 Participants
Subjects previously vaccinated with aQIV followed one year later by QIV
Non-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)
|
QIV/aQIV
n=59 Participants
Subjects previously vaccinated with QIV followed one year later by aQIV
Adjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)
|
QIV/QIV
n=58 Participants
Subjects previously vaccinated with QIV followed one year later by QIV
Non-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)
|
|---|---|---|---|---|
|
Immunogenicity Endpoint: GMT as Determined by HI Assay on Day 1, Day 22, and Day 181 Against Heterologous Strains
A/H3N2 (Day 1)
|
97.7 titer
Interval 59.4 to 160.6
|
156.6 titer
Interval 96.1 to 255.1
|
40.9 titer
Interval 25.3 to 66.0
|
91.6 titer
Interval 55.6 to 150.8
|
|
Immunogenicity Endpoint: GMT as Determined by HI Assay on Day 1, Day 22, and Day 181 Against Heterologous Strains
A/H3N2 (Day 22)
|
2436.1 titer
Interval 2058.0 to 2883.6
|
2415.2 titer
Interval 2049.9 to 2845.5
|
2225.1 titer
Interval 1872.6 to 2643.8
|
2097.2 titer
Interval 1769.7 to 2485.2
|
|
Immunogenicity Endpoint: GMT as Determined by HI Assay on Day 1, Day 22, and Day 181 Against Heterologous Strains
A/H3N2 (Day 181)
|
898.1 titer
Interval 707.5 to 1139.9
|
917.6 titer
Interval 728.2 to 1156.3
|
953.2 titer
Interval 746.7 to 1216.6
|
791.7 titer
Interval 621.5 to 1008.3
|
|
Immunogenicity Endpoint: GMT as Determined by HI Assay on Day 1, Day 22, and Day 181 Against Heterologous Strains
B/Victoria (Day 1)
|
33.4 titer
Interval 24.6 to 45.3
|
23.8 titer
Interval 17.6 to 32.2
|
15.8 titer
Interval 11.8 to 21.2
|
15.9 titer
Interval 11.7 to 21.6
|
|
Immunogenicity Endpoint: GMT as Determined by HI Assay on Day 1, Day 22, and Day 181 Against Heterologous Strains
B/Victoria (Day 22)
|
327.1 titer
Interval 255.7 to 418.4
|
248.4 titer
Interval 195.3 to 316.0
|
283.2 titer
Interval 222.8 to 359.8
|
204.8 titer
Interval 159.6 to 262.8
|
|
Immunogenicity Endpoint: GMT as Determined by HI Assay on Day 1, Day 22, and Day 181 Against Heterologous Strains
B/Victoria (Day 181)
|
107.1 titer
Interval 79.3 to 144.6
|
85.6 titer
Interval 63.9 to 114.7
|
77.5 titer
Interval 57.9 to 103.9
|
56.0 titer
Interval 41.2 to 76.0
|
SECONDARY outcome
Timeframe: Day 22/Day 1 and Day 181/Day 1Population: 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.
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.
Outcome measures
| Measure |
aQIV/aQIV
n=60 Participants
Subjects previously vaccinated with aQIV followed one year later by aQIV
Adjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)
|
aQIV/QIV
n=57 Participants
Subjects previously vaccinated with aQIV followed one year later by QIV
Non-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)
|
QIV/aQIV
n=59 Participants
Subjects previously vaccinated with QIV followed one year later by aQIV
Adjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)
|
QIV/QIV
n=58 Participants
Subjects previously vaccinated with QIV followed one year later by QIV
Non-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)
|
|---|---|---|---|---|
|
Immunogenicity Endpoint: GMR as Determined by HI Assay for Day 22/Day 1 and Day 181/Day 1 Against Heterologous Strains
A/H3N2 (Day 22/Day 1)
|
14.67 ratio
Interval 12.4 to 17.4
|
14.55 ratio
Interval 12.3 to 17.1
|
13.40 ratio
Interval 11.3 to 15.9
|
12.63 ratio
Interval 10.7 to 15.0
|
|
Immunogenicity Endpoint: GMR as Determined by HI Assay for Day 22/Day 1 and Day 181/Day 1 Against Heterologous Strains
A/H3N2 (Day 181/Day 1)
|
5.31 ratio
Interval 4.2 to 6.7
|
5.42 ratio
Interval 4.3 to 6.8
|
5.63 ratio
Interval 4.4 to 7.2
|
4.68 ratio
Interval 3.7 to 6.0
|
|
Immunogenicity Endpoint: GMR as Determined by HI Assay for Day 22/Day 1 and Day 181/Day 1 Against Heterologous Strains
B/Victoria (Day 22/Day 1)
|
13.40 ratio
Interval 10.5 to 17.1
|
10.18 ratio
Interval 8.0 to 13.0
|
11.60 ratio
Interval 9.1 to 14.7
|
8.39 ratio
Interval 6.5 to 10.8
|
|
Immunogenicity Endpoint: GMR as Determined by HI Assay for Day 22/Day 1 and Day 181/Day 1 Against Heterologous Strains
B/Victoria (Day 181/Day 1)
|
4.38 ratio
Interval 3.2 to 5.9
|
3.50 ratio
Interval 2.6 to 4.7
|
3.17 ratio
Interval 2.4 to 4.3
|
2.29 ratio
Interval 1.7 to 3.1
|
SECONDARY outcome
Timeframe: Day 22, Day 181Population: 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.
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.
Outcome measures
| Measure |
aQIV/aQIV
n=60 Participants
Subjects previously vaccinated with aQIV followed one year later by aQIV
Adjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)
|
aQIV/QIV
n=57 Participants
Subjects previously vaccinated with aQIV followed one year later by QIV
Non-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)
|
QIV/aQIV
n=59 Participants
Subjects previously vaccinated with QIV followed one year later by aQIV
Adjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)
|
QIV/QIV
n=58 Participants
Subjects previously vaccinated with QIV followed one year later by QIV
Non-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)
|
|---|---|---|---|---|
|
Immunogenicity Endpoint: Percentage of Subjects Achieving SCR and HI Titer ≥1:40 on Day 22 and Day 181 Against Heterologous Strains
A/H3N2, SCR (Day 22)
|
78.3 percentage of subjects
Interval 65.8 to 87.9
|
73.7 percentage of subjects
Interval 60.3 to 84.5
|
83.1 percentage of subjects
Interval 71.0 to 91.6
|
69.0 percentage of subjects
Interval 55.5 to 80.5
|
|
Immunogenicity Endpoint: Percentage of Subjects Achieving SCR and HI Titer ≥1:40 on Day 22 and Day 181 Against Heterologous Strains
A/ H3N2, HI titer ≥1:40 (Day 22)
|
100 percentage of subjects
Interval 94.0 to 100.0
|
100 percentage of subjects
Interval 93.7 to 100.0
|
100 percentage of subjects
Interval 93.9 to 100.0
|
100 percentage of subjects
Interval 93.8 to 100.0
|
|
Immunogenicity Endpoint: Percentage of Subjects Achieving SCR and HI Titer ≥1:40 on Day 22 and Day 181 Against Heterologous Strains
A/ H3N2, HI titer ≥1:40 (Day 181)
|
100 percentage of subjects
Interval 93.8 to 100.0
|
100 percentage of subjects
Interval 93.68 to 100.0
|
100 percentage of subjects
Interval 93.8 to 100.0
|
98.2 percentage of subjects
Interval 90.4 to 100.0
|
|
Immunogenicity Endpoint: Percentage of Subjects Achieving SCR and HI Titer ≥1:40 on Day 22 and Day 181 Against Heterologous Strains
B/Victoria, SCR (Day 22)
|
75.0 percentage of subjects
Interval 62.1 to 85.3
|
82.1 percentage of subjects
Interval 69.6 to 91.1
|
81.4 percentage of subjects
Interval 69.1 to 90.3
|
77.6 percentage of subjects
Interval 64.7 to 87.5
|
|
Immunogenicity Endpoint: Percentage of Subjects Achieving SCR and HI Titer ≥1:40 on Day 22 and Day 181 Against Heterologous Strains
B/Victoria, HI titer ≥1:40 (Day 22)
|
98.3 percentage of subjects
Interval 91.1 to 100.0
|
100 percentage of subjects
Interval 93.6 to 100.0
|
96.6 percentage of subjects
Interval 88.3 to 99.6
|
98.3 percentage of subjects
Interval 90.8 to 100.0
|
|
Immunogenicity Endpoint: Percentage of Subjects Achieving SCR and HI Titer ≥1:40 on Day 22 and Day 181 Against Heterologous Strains
B/ Victoria, HI titer ≥1:40 (Day 181)
|
91.4 percentage of subjects
Interval 81.0 to 97.1
|
83.6 percentage of subjects
Interval 71.2 to 92.2
|
74.1 percentage of subjects
Interval 61.0 to 84.7
|
64.3 percentage of subjects
Interval 50.4 to 76.6
|
SECONDARY outcome
Timeframe: Day 1, Day 22, Day 181Population: 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.
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.
Outcome measures
| Measure |
aQIV/aQIV
n=60 Participants
Subjects previously vaccinated with aQIV followed one year later by aQIV
Adjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)
|
aQIV/QIV
n=60 Participants
Subjects previously vaccinated with aQIV followed one year later by QIV
Non-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)
|
QIV/aQIV
n=60 Participants
Subjects previously vaccinated with QIV followed one year later by aQIV
Adjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)
|
QIV/QIV
n=60 Participants
Subjects previously vaccinated with QIV followed one year later by QIV
Non-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)
|
|---|---|---|---|---|
|
Immunogenicity Endpoint: GMT as Determined by Microneutralization (MN) Assay on Day 1, Day 22, and Day 181 Against Homologous Strains
A/H1N1 (Day 1)
|
264.36 titer
Interval 173.8 to 402.1
|
198.13 titer
Interval 127.8 to 307.0
|
104.28 titer
Interval 67.0 to 162.3
|
140.38 titer
Interval 90.0 to 219.1
|
|
Immunogenicity Endpoint: GMT as Determined by Microneutralization (MN) Assay on Day 1, Day 22, and Day 181 Against Homologous Strains
A/H1N1 (Day 22)
|
2253.81 titer
Interval 1713.5 to 2964.5
|
2295.46 titer
Interval 1729.5 to 3046.7
|
2992.29 titer
Interval 2238.5 to 3999.9
|
1543.54 titer
Interval 1156.5 to 20660.1
|
|
Immunogenicity Endpoint: GMT as Determined by Microneutralization (MN) Assay on Day 1, Day 22, and Day 181 Against Homologous Strains
A/H1N1 (Day 181)
|
727.04 titer
Interval 568.6 to 929.6
|
725.35 titer
Interval 560.7 to 938.4
|
686.98 titer
Interval 527.2 to 895.2
|
412.34 titer
Interval 317.2 to 536.0
|
|
Immunogenicity Endpoint: GMT as Determined by Microneutralization (MN) Assay on Day 1, Day 22, and Day 181 Against Homologous Strains
A/H3N2 (Day 1)
|
160.88 titer
Interval 103.6 to 249.7
|
113.74 titer
Interval 71.9 to 180.0
|
133.25 titer
Interval 83.8 to 211.8
|
97.47 titer
Interval 61.1 to 155.6
|
|
Immunogenicity Endpoint: GMT as Determined by Microneutralization (MN) Assay on Day 1, Day 22, and Day 181 Against Homologous Strains
A/H3N2 (Day 22)
|
5532.06 titer
Interval 4441.7 to 6890.0
|
6649.94 titer
Interval 5275.3 to 8382.7
|
5019.51 titer
Interval 3978.6 to 6332.8
|
4696.37 titer
Interval 3699.4 to 5962.1
|
|
Immunogenicity Endpoint: GMT as Determined by Microneutralization (MN) Assay on Day 1, Day 22, and Day 181 Against Homologous Strains
A/H3N2 (Day 181)
|
2069.22 titer
Interval 1488.8 to 2875.9
|
2127.88 titer
Interval 1500.4 to 3017.8
|
2138.80 titer
Interval 1505.0 to 3039.5
|
1696.57 titer
Interval 1178.4 to 2442.5
|
|
Immunogenicity Endpoint: GMT as Determined by Microneutralization (MN) Assay on Day 1, Day 22, and Day 181 Against Homologous Strains
B/Yamagata (Day 1)
|
29.82 titer
Interval 22.2 to 40.1
|
37.99 titer
Interval 27.9 to 51.7
|
21.57 titer
Interval 15.8 to 29.5
|
21.07 titer
Interval 15.4 to 28.9
|
|
Immunogenicity Endpoint: GMT as Determined by Microneutralization (MN) Assay on Day 1, Day 22, and Day 181 Against Homologous Strains
B/Yamagata (Day 22)
|
388.29 titer
Interval 299.1 to 504.0
|
301.39 titer
Interval 229.0 to 396.7
|
247.31 titer
Interval 187.6 to 326.0
|
197.51 titer
Interval 149.3 to 261.4
|
|
Immunogenicity Endpoint: GMT as Determined by Microneutralization (MN) Assay on Day 1, Day 22, and Day 181 Against Homologous Strains
B/Yamagata (Day 181)
|
107.05 titer
Interval 81.4 to 140.8
|
103.59 titer
Interval 77.5 to 138.5
|
82.90 titer
Interval 61.9 to 111.0
|
56.03 titer
Interval 41.5 to 75.6
|
|
Immunogenicity Endpoint: GMT as Determined by Microneutralization (MN) Assay on Day 1, Day 22, and Day 181 Against Homologous Strains
B/Victoria (Day 1)
|
43.66 titer
Interval 33.1 to 57.6
|
43.13 titer
Interval 32.3 to 57.6
|
27.96 titer
Interval 20.9 to 37.4
|
33.14 titer
Interval 24.7 to 44.4
|
|
Immunogenicity Endpoint: GMT as Determined by Microneutralization (MN) Assay on Day 1, Day 22, and Day 181 Against Homologous Strains
B/Victoria (Day 22)
|
355.63 titer
Interval 271.8 to 465.4
|
346.99 titer
Interval 262.6 to 458.5
|
338.49 titer
Interval 255.0 to 449.4
|
193.09 titer
Interval 145.5 to 256.3
|
|
Immunogenicity Endpoint: GMT as Determined by Microneutralization (MN) Assay on Day 1, Day 22, and Day 181 Against Homologous Strains
B/Victoria (Day 181)
|
124.31 titer
Interval 95.3 to 162.1
|
106.08 titer
Interval 80.2 to 140.3
|
95.87 titer
Interval 72.1 to 127.5
|
60.54 titer
Interval 45.4 to 80.7
|
SECONDARY outcome
Timeframe: Day 22/Day 1 and Day 181/Day 1Population: 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.
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.
Outcome measures
| Measure |
aQIV/aQIV
n=60 Participants
Subjects previously vaccinated with aQIV followed one year later by aQIV
Adjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)
|
aQIV/QIV
n=60 Participants
Subjects previously vaccinated with aQIV followed one year later by QIV
Non-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)
|
QIV/aQIV
n=60 Participants
Subjects previously vaccinated with QIV followed one year later by aQIV
Adjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)
|
QIV/QIV
n=60 Participants
Subjects previously vaccinated with QIV followed one year later by QIV
Non-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)
|
|---|---|---|---|---|
|
Immunogenicity Endpoint: GMR as Determined by MN Assay for Day 22/Day 1 and Day 181/Day 1 Against Homologous Strains
A/H1N1 (Day 22/Day 1)
|
11.85 ratio
Interval 9.0 to 15.6
|
12.07 ratio
Interval 9.1 to 16.0
|
15.73 ratio
Interval 11.8 to 21.0
|
8.11 ratio
Interval 6.1 to 10.8
|
|
Immunogenicity Endpoint: GMR as Determined by MN Assay for Day 22/Day 1 and Day 181/Day 1 Against Homologous Strains
A/H1N1 (Day 181/Day 1)
|
3.67 ratio
Interval 2.9 to 4.7
|
3.66 ratio
Interval 2.8 to 4.7
|
3.47 ratio
Interval 2.7 to 4.5
|
2.08 ratio
Interval 1.6 to 2.7
|
|
Immunogenicity Endpoint: GMR as Determined by MN Assay for Day 22/Day 1 and Day 181/Day 1 Against Homologous Strains
A/H3N2 (Day 22/Day 1)
|
28.19 ratio
Interval 22.6 to 35.1
|
33.88 ratio
Interval 26.9 to 42.7
|
25.57 ratio
Interval 20.3 to 32.3
|
23.93 ratio
Interval 18.8 to 30.4
|
|
Immunogenicity Endpoint: GMR as Determined by MN Assay for Day 22/Day 1 and Day 181/Day 1 Against Homologous Strains
A/H3N2 (Day 181/Day 1)
|
10.63 ratio
Interval 7.6 to 14.8
|
10.93 ratio
Interval 7.7 to 15.5
|
10.99 ratio
Interval 7.7 to 15.6
|
8.72 ratio
Interval 6.1 to 12.5
|
|
Immunogenicity Endpoint: GMR as Determined by MN Assay for Day 22/Day 1 and Day 181/Day 1 Against Homologous Strains
B/Yamagata (Day 22/Day 1)
|
14.11 ratio
Interval 10.9 to 18.3
|
10.95 ratio
Interval 8.3 to 14.4
|
8.99 ratio
Interval 6.8 to 11.8
|
7.18 ratio
Interval 5.4 to 9.5
|
|
Immunogenicity Endpoint: GMR as Determined by MN Assay for Day 22/Day 1 and Day 181/Day 1 Against Homologous Strains
B/Yamagata (Day 181/Day 1)
|
3.97 ratio
Interval 3.0 to 5.2
|
3.84 ratio
Interval 2.9 to 5.1
|
3.07 ratio
Interval 2.3 to 4.1
|
2.08 ratio
Interval 1.5 to 2.8
|
|
Immunogenicity Endpoint: GMR as Determined by MN Assay for Day 22/Day 1 and Day 181/Day 1 Against Homologous Strains
B/Victoria (Day 22/Day 1)
|
9.43 ratio
Interval 7.2 to 12.3
|
9.20 ratio
Interval 7.0 to 12.2
|
8.97 ratio
Interval 6.8 to 11.9
|
5.12 ratio
Interval 3.9 to 6.8
|
|
Immunogenicity Endpoint: GMR as Determined by MN Assay for Day 22/Day 1 and Day 181/Day 1 Against Homologous Strains
B/Victoria (Day 181/Day 1)
|
3.25 ratio
Interval 2.5 to 4.2
|
2.77 ratio
Interval 2.1 to 3.7
|
2.51 ratio
Interval 1.9 to 3.3
|
1.58 ratio
Interval 1.2 to 2.1
|
SECONDARY outcome
Timeframe: Day 1, Day 22, Day 181Population: 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.
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.
Outcome measures
| Measure |
aQIV/aQIV
n=56 Participants
Subjects previously vaccinated with aQIV followed one year later by aQIV
Adjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)
|
aQIV/QIV
n=62 Participants
Subjects previously vaccinated with aQIV followed one year later by QIV
Non-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)
|
QIV/aQIV
n=59 Participants
Subjects previously vaccinated with QIV followed one year later by aQIV
Adjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)
|
QIV/QIV
n=60 Participants
Subjects previously vaccinated with QIV followed one year later by QIV
Non-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)
|
|---|---|---|---|---|
|
Immunogenicity Endpoint: Anti-neuraminidase (NA) GMTs on Day 1, Day 22, and Day 181 Against Homologous Strains
N1 (Day 1)
|
1174.69 titer
Interval 767.8 to 1797.3
|
1209.21 titer
Interval 815.7 to 1792.6
|
230.09 titer
Interval 154.7 to 342.2
|
182.80 titer
Interval 122.7 to 272.2
|
|
Immunogenicity Endpoint: Anti-neuraminidase (NA) GMTs on Day 1, Day 22, and Day 181 Against Homologous Strains
N1 (Day 22)
|
3403.72 titer
Interval 2821.4 to 4106.2
|
3161.01 titer
Interval 2654.7 to 3763.9
|
3588.43 titer
Interval 2994.0 to 4300.9
|
2410.65 titer
Interval 2001.2 to 2903.9
|
|
Immunogenicity Endpoint: Anti-neuraminidase (NA) GMTs on Day 1, Day 22, and Day 181 Against Homologous Strains
N1 (Day 181)
|
2477.65 titer
Interval 1958.9 to 3133.7
|
1649.89 titer
Interval 1324.9 to 2054.5
|
2018.32 titer
Interval 1610.4 to 2529.5
|
870.73 titer
Interval 691.0 to 1097.2
|
|
Immunogenicity Endpoint: Anti-neuraminidase (NA) GMTs on Day 1, Day 22, and Day 181 Against Homologous Strains
N2 (Day 1)
|
204.59 titer
Interval 121.3 to 345.2
|
289.86 titer
Interval 178.6 to 470.4
|
86.08 titer
Interval 52.8 to 140.3
|
86.34 titer
Interval 52.9 to 140.9
|
|
Immunogenicity Endpoint: Anti-neuraminidase (NA) GMTs on Day 1, Day 22, and Day 181 Against Homologous Strains
N2 (Day 22)
|
915.19 titer
Interval 753.5 to 1111.6
|
1050.44 titer
Interval 876.7 to 1258.7
|
1242.36 titer
Interval 1031.4 to 1496.5
|
980.87 titer
Interval 813.8 to 1182.2
|
|
Immunogenicity Endpoint: Anti-neuraminidase (NA) GMTs on Day 1, Day 22, and Day 181 Against Homologous Strains
N2 (Day 181)
|
505.91 titer
Interval 375.2 to 682.2
|
565.69 titer
Interval 426.7 to 749.9
|
516.51 titer
Interval 388.6 to 686.4
|
369.04 titer
Interval 277.5 to 490.8
|
|
Immunogenicity Endpoint: Anti-neuraminidase (NA) GMTs on Day 1, Day 22, and Day 181 Against Homologous Strains
B/Victoria (Day 1)
|
497.11 titer
Interval 344.3 to 717.7
|
548.92 titer
Interval 390.7 to 771.2
|
306.48 titer
Interval 217.6 to 431.7
|
237.96 titer
Interval 168.7 to 335.6
|
|
Immunogenicity Endpoint: Anti-neuraminidase (NA) GMTs on Day 1, Day 22, and Day 181 Against Homologous Strains
B/Victoria (Day 22)
|
3175.99 titer
Interval 2736.5 to 3686.0
|
3336.65 titer
Interval 2906.2 to 3830.8
|
3331.87 titer
Interval 2894.6 to 3835.2
|
2418.50 titer
Interval 2094.6 to 2792.74
|
|
Immunogenicity Endpoint: Anti-neuraminidase (NA) GMTs on Day 1, Day 22, and Day 181 Against Homologous Strains
B/Victoria (Day 181)
|
1424.38 titer
Interval 1108.1 to 1831.0
|
1587.86 titer
Interval 1256.5 to 2006.6
|
1443.37 titer
Interval 1140.1 to 1827.3
|
1030.77 titer
Interval 810.3 to 1311.3
|
|
Immunogenicity Endpoint: Anti-neuraminidase (NA) GMTs on Day 1, Day 22, and Day 181 Against Homologous Strains
B/Yamagata (Day 1)
|
290.06 titer
Interval 202.3 to 415.8
|
282.17 titer
Interval 201.7 to 394.8
|
148.35 titer
Interval 106.0 to 207.6
|
126.07 titer
Interval 90.0 to 176.6
|
|
Immunogenicity Endpoint: Anti-neuraminidase (NA) GMTs on Day 1, Day 22, and Day 181 Against Homologous Strains
B/Yamagata (Day 22)
|
1288.67 titer
Interval 1094.6 to 1517.2
|
1250.88 titer
Interval 1074.3 to 1456.5
|
1275.06 titer
Interval 1093.5 to 1486.7
|
883.66 titer
Interval 756.1 to 1032.7
|
|
Immunogenicity Endpoint: Anti-neuraminidase (NA) GMTs on Day 1, Day 22, and Day 181 Against Homologous Strains
B/Yamagata (Day 181)
|
727.17 titer
Interval 560.2 to 943.9
|
596.62 titer
Interval 467.2 to 762.0
|
511.73 titer
Interval 400.7 to 653.5
|
391.23 titer
Interval 305.3 to 501.3
|
SECONDARY outcome
Timeframe: Day 22/Day 1 and Day 181/Day 1Population: 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.
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.
Outcome measures
| Measure |
aQIV/aQIV
n=56 Participants
Subjects previously vaccinated with aQIV followed one year later by aQIV
Adjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)
|
aQIV/QIV
n=62 Participants
Subjects previously vaccinated with aQIV followed one year later by QIV
Non-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)
|
QIV/aQIV
n=59 Participants
Subjects previously vaccinated with QIV followed one year later by aQIV
Adjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)
|
QIV/QIV
n=60 Participants
Subjects previously vaccinated with QIV followed one year later by QIV
Non-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)
|
|---|---|---|---|---|
|
Immunogenicity Endpoint: Anti-NA GMR for Day 22/Day 1 and Day 181/Day 1 Against Homologous Strains
N1 (Day 22/Day 1)
|
5.40 ratio
Interval 4.5 to 6.5
|
5.02 ratio
Interval 4.2 to 6.0
|
5.70 ratio
Interval 4.8 to 6.8
|
3.83 ratio
Interval 3.2 to 4.6
|
|
Immunogenicity Endpoint: Anti-NA GMR for Day 22/Day 1 and Day 181/Day 1 Against Homologous Strains
N1 (Day 181/Day 1)
|
3.95 ratio
Interval 3.1 to 5.0
|
2.63 ratio
Interval 2.1 to 3.3
|
3.22 ratio
Interval 2.6 to 4.0
|
1.39 ratio
Interval 1.1 to 1.8
|
|
Immunogenicity Endpoint: Anti-NA GMR for Day 22/Day 1 and Day 181/Day 1 Against Homologous Strains
N2 (Day 22/Day 1)
|
4.51 ratio
Interval 3.7 to 5.5
|
5.18 ratio
Interval 4.3 to 6.2
|
6.13 ratio
Interval 5.1 to 7.4
|
4.84 ratio
Interval 4.0 to 5.8
|
|
Immunogenicity Endpoint: Anti-NA GMR for Day 22/Day 1 and Day 181/Day 1 Against Homologous Strains
N2 (Day 181/Day 1)
|
2.45 ratio
Interval 1.8 to 3.3
|
2.74 ratio
Interval 2.1 to 3.6
|
2.50 ratio
Interval 1.9 to 3.3
|
1.79 ratio
Interval 1.3 to 2.4
|
|
Immunogenicity Endpoint: Anti-NA GMR for Day 22/Day 1 and Day 181/Day 1 Against Homologous Strains
B/Yamagata (Day 22/Day 1)
|
5.75 ratio
Interval 4.9 to 6.8
|
5.59 ratio
Interval 4.8 to 6.5
|
5.69 ratio
Interval 4.9 to 6.6
|
3.95 ratio
Interval 3.4 to 4.6
|
|
Immunogenicity Endpoint: Anti-NA GMR for Day 22/Day 1 and Day 181/Day 1 Against Homologous Strains
B/Yamagata (Day 181/Day 1)
|
3.29 ratio
Interval 2.5 to 4.3
|
2.70 ratio
Interval 2.1 to 3.4
|
2.32 ratio
Interval 1.81 to 3.0
|
1.77 ratio
Interval 1.4 to 2.3
|
|
Immunogenicity Endpoint: Anti-NA GMR for Day 22/Day 1 and Day 181/Day 1 Against Homologous Strains
B/Victoria (Day 22/Day 1)
|
6.81 ratio
Interval 5.9 to 7.9
|
7.15 ratio
Interval 6.2 to 8.2
|
7.14 ratio
Interval 6.2 to 8.2
|
5.18 ratio
Interval 4.5 to 6.0
|
|
Immunogenicity Endpoint: Anti-NA GMR for Day 22/Day 1 and Day 181/Day 1 Against Homologous Strains
B/Victoria (Day 181/Day 1)
|
3.05 ratio
Interval 2.4 to 3.9
|
3.40 ratio
Interval 2.7 to 4.3
|
3.09 ratio
Interval 2.4 to 3.9
|
2.21 ratio
Interval 1.7 to 2.8
|
SECONDARY outcome
Timeframe: Day 1 to Day 7 after vaccinationPopulation: The solicited safety set consisting of all subjects who received a study vaccination with evaluable solicited AE data recorded on a diary card.
Safety of revaccination was assessed in terms of percentage of subjects reporting solicited AEs up to 7 days after vaccination.
Outcome measures
| Measure |
aQIV/aQIV
n=403 Participants
Subjects previously vaccinated with aQIV followed one year later by aQIV
Adjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)
|
aQIV/QIV
n=403 Participants
Subjects previously vaccinated with aQIV followed one year later by QIV
Non-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)
|
QIV/aQIV
n=402 Participants
Subjects previously vaccinated with QIV followed one year later by aQIV
Adjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)
|
QIV/QIV
n=393 Participants
Subjects previously vaccinated with QIV followed one year later by QIV
Non-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)
|
|---|---|---|---|---|
|
Safety Endpoint: Percentage of Subjects With Solicited AEs
Solicited Local AE
|
44.67 percentage of subjects
|
37.97 percentage of subjects
|
36.82 percentage of subjects
|
29.52 percentage of subjects
|
|
Safety Endpoint: Percentage of Subjects With Solicited AEs
Any Solicited AE
|
64.76 percentage of subjects
|
50.12 percentage of subjects
|
53.48 percentage of subjects
|
40.71 percentage of subjects
|
|
Safety Endpoint: Percentage of Subjects With Solicited AEs
Solicited Systemic AE
|
39.21 percentage of subjects
|
24.81 percentage of subjects
|
30.85 percentage of subjects
|
18.83 percentage of subjects
|
|
Safety Endpoint: Percentage of Subjects With Solicited AEs
Other (analgesic/antipyretic use)
|
27.54 percentage of subjects
|
10.17 percentage of subjects
|
16.92 percentage of subjects
|
10.43 percentage of subjects
|
SECONDARY outcome
Timeframe: Day 1 to Day 366Population: 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).
Safety of revaccination was assessed in terms of percentage of subjects reporting unsolicited AEs during the overall study period (Day 1 to Day 366).
Outcome measures
| Measure |
aQIV/aQIV
n=403 Participants
Subjects previously vaccinated with aQIV followed one year later by aQIV
Adjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)
|
aQIV/QIV
n=403 Participants
Subjects previously vaccinated with aQIV followed one year later by QIV
Non-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)
|
QIV/aQIV
n=402 Participants
Subjects previously vaccinated with QIV followed one year later by aQIV
Adjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)
|
QIV/QIV
n=393 Participants
Subjects previously vaccinated with QIV followed one year later by QIV
Non-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)
|
|---|---|---|---|---|
|
Safety Endpoint: Percentage of Subjects With Unsolicited AEs
Any Unsolicited AE
|
54.09 percentage of subjects
|
55.33 percentage of subjects
|
55.97 percentage of subjects
|
52.16 percentage of subjects
|
|
Safety Endpoint: Percentage of Subjects With Unsolicited AEs
Related Unsolicited AE
|
6.20 percentage of subjects
|
3.97 percentage of subjects
|
5.72 percentage of subjects
|
3.82 percentage of subjects
|
SECONDARY outcome
Timeframe: Day 1 to Day 366Population: 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).
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.
Outcome measures
| Measure |
aQIV/aQIV
n=403 Participants
Subjects previously vaccinated with aQIV followed one year later by aQIV
Adjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)
|
aQIV/QIV
n=403 Participants
Subjects previously vaccinated with aQIV followed one year later by QIV
Non-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)
|
QIV/aQIV
n=402 Participants
Subjects previously vaccinated with QIV followed one year later by aQIV
Adjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)
|
QIV/QIV
n=393 Participants
Subjects previously vaccinated with QIV followed one year later by QIV
Non-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)
|
|---|---|---|---|---|
|
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.
SAE
|
2.48 percentage of subjects
|
2.73 percentage of subjects
|
1.74 percentage of subjects
|
2.04 percentage of subjects
|
|
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.
AE leading to withdrawal
|
0 percentage of subjects
|
0 percentage of subjects
|
0 percentage of subjects
|
0 percentage of subjects
|
|
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.
NOCD
|
0.50 percentage of subjects
|
0 percentage of subjects
|
0 percentage of subjects
|
0 percentage of subjects
|
|
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.
AESI
|
0 percentage of subjects
|
0 percentage of subjects
|
0 percentage of subjects
|
0.25 percentage of subjects
|
|
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.
Medically attended AE
|
51.61 percentage of subjects
|
54.34 percentage of subjects
|
53.98 percentage of subjects
|
48.60 percentage of subjects
|
SECONDARY outcome
Timeframe: Day 1 to Day 366Population: 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).
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.
Outcome measures
| Measure |
aQIV/aQIV
n=403 Participants
Subjects previously vaccinated with aQIV followed one year later by aQIV
Adjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)
|
aQIV/QIV
n=403 Participants
Subjects previously vaccinated with aQIV followed one year later by QIV
Non-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)
|
QIV/aQIV
n=402 Participants
Subjects previously vaccinated with QIV followed one year later by aQIV
Adjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)
|
QIV/QIV
n=393 Participants
Subjects previously vaccinated with QIV followed one year later by QIV
Non-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)
|
|---|---|---|---|---|
|
Safety Endpoint: Percentage of Subjects With Diagnosis of Failure to Thrive or Short Stature
|
0.25 percentage of subjects
|
0.74 percentage of subjects
|
0.25 percentage of subjects
|
0.76 percentage of subjects
|
SECONDARY outcome
Timeframe: Day 1 to Day 366Population: 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).
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.
Outcome measures
| Measure |
aQIV/aQIV
n=403 Participants
Subjects previously vaccinated with aQIV followed one year later by aQIV
Adjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)
|
aQIV/QIV
n=403 Participants
Subjects previously vaccinated with aQIV followed one year later by QIV
Non-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)
|
QIV/aQIV
n=402 Participants
Subjects previously vaccinated with QIV followed one year later by aQIV
Adjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)
|
QIV/QIV
n=393 Participants
Subjects previously vaccinated with QIV followed one year later by QIV
Non-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)
|
|---|---|---|---|---|
|
Safety Endpoint: Percentage of Subjects With Otitis Media, or Pneumonia, or Influenza-like Illness
pneumonia, any event
|
1.49 percentage of subjects
|
1.49 percentage of subjects
|
0.75 percentage of subjects
|
1.78 percentage of subjects
|
|
Safety Endpoint: Percentage of Subjects With Otitis Media, or Pneumonia, or Influenza-like Illness
otitis media, any event
|
3.23 percentage of subjects
|
3.47 percentage of subjects
|
3.73 percentage of subjects
|
2.80 percentage of subjects
|
|
Safety Endpoint: Percentage of Subjects With Otitis Media, or Pneumonia, or Influenza-like Illness
influenza-like illness
|
7.94 percentage of subjects
|
10.17 percentage of subjects
|
9.20 percentage of subjects
|
7.89 percentage of subjects
|
SECONDARY outcome
Timeframe: Day 22, Day 181Population: 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.
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.
Outcome measures
| Measure |
aQIV/aQIV
n=60 Participants
Subjects previously vaccinated with aQIV followed one year later by aQIV
Adjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)
|
aQIV/QIV
n=59 Participants
Subjects previously vaccinated with aQIV followed one year later by QIV
Non-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)
|
QIV/aQIV
n=60 Participants
Subjects previously vaccinated with QIV followed one year later by aQIV
Adjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)
|
QIV/QIV
n=59 Participants
Subjects previously vaccinated with QIV followed one year later by QIV
Non-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)
|
|---|---|---|---|---|
|
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
A/ H1N1, ≥1:20 (Day 22)
|
100.00 percentage of subjects
Interval 93.94 to 100.0
|
100.00 percentage of subjects
Interval 93.94 to 100.0
|
100.00 percentage of subjects
Interval 94.04 to 100.0
|
100.00 percentage of subjects
Interval 93.94 to 100.0
|
|
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
A/ H1N1, ≥1:40 (Day 22)
|
98.31 percentage of subjects
Interval 90.91 to 99.96
|
100.00 percentage of subjects
Interval 93.94 to 100.0
|
100.00 percentage of subjects
Interval 94.04 to 100.0
|
100.00 percentage of subjects
Interval 93.94 to 100.0
|
|
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
A/H1N1, ≥1:80 (Day 22)
|
98.31 percentage of subjects
Interval 90.91 to 99.96
|
100.00 percentage of subjects
Interval 93.94 to 100.0
|
100.00 percentage of subjects
Interval 94.04 to 100.0
|
98.31 percentage of subjects
Interval 90.91 to 99.96
|
|
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
A/H1N1, ≥1:160 (Day 22)
|
98.31 percentage of subjects
Interval 90.91 to 99.96
|
100.00 percentage of subjects
Interval 93.94 to 100.0
|
100.00 percentage of subjects
Interval 94.04 to 100.0
|
94.92 percentage of subjects
Interval 85.85 to 98.94
|
|
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
A/H1N1, ≥1:320 (Day 22)
|
96.61 percentage of subjects
Interval 88.29 to 99.59
|
100.00 percentage of subjects
Interval 93.94 to 100.0
|
100.00 percentage of subjects
Interval 94.04 to 100.0
|
94.92 percentage of subjects
Interval 85.85 to 98.94
|
|
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
A/H1N1, ≥1:640 (Day 22)
|
96.61 percentage of subjects
Interval 88.29 to 99.59
|
98.31 percentage of subjects
Interval 90.91 to 99.96
|
91.67 percentage of subjects
Interval 81.61 to 97.24
|
81.36 percentage of subjects
Interval 69.09 to 90.31
|
|
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
A/H1N1, ≥1:20 (Day 181)
|
100.00 percentage of subjects
Interval 94.04 to 100.0
|
100.00 percentage of subjects
Interval 93.84 to 100.0
|
100.00 percentage of subjects
Interval 93.84 to 100.0
|
98.28 percentage of subjects
Interval 90.76 to 99.96
|
|
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
A/H1N1, ≥1:40 (Day 181)
|
100.00 percentage of subjects
Interval 94.04 to 100.0
|
100.00 percentage of subjects
Interval 93.84 to 100.0
|
100.00 percentage of subjects
Interval 93.84 to 100.0
|
96.55 percentage of subjects
Interval 88.09 to 99.58
|
|
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
A/H1N1, ≥1:80 (Day 181)
|
100.00 percentage of subjects
Interval 94.04 to 100.0
|
100.00 percentage of subjects
Interval 93.84 to 100.0
|
100.00 percentage of subjects
Interval 93.84 to 100.0
|
93.10 percentage of subjects
Interval 83.27 to 98.09
|
|
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
A/H1N1, ≥1:160 (Day 181)
|
96.67 percentage of subjects
Interval 88.47 to 99.59
|
98.28 percentage of subjects
Interval 90.76 to 99.96
|
94.83 percentage of subjects
Interval 85.62 to 98.92
|
81.03 percentage of subjects
Interval 68.59 to 90.13
|
|
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
A/H1N1, ≥1:320 (Day 181)
|
91.67 percentage of subjects
Interval 81.61 to 97.24
|
91.38 percentage of subjects
Interval 81.02 to 97.14
|
84.48 percentage of subjects
Interval 72.58 to 92.65
|
63.79 percentage of subjects
Interval 50.12 to 76.01
|
|
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
A/H1N1, ≥1:640 (Day 181)
|
80.00 percentage of subjects
Interval 67.67 to 89.22
|
63.79 percentage of subjects
Interval 50.12 to 76.01
|
55.17 percentage of subjects
Interval 41.54 to 68.26
|
48.28 percentage of subjects
Interval 34.95 to 61.78
|
|
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
A/H3N2, ≥1:20 (Day 22)
|
100.00 percentage of subjects
Interval 94.04 to 100.0
|
100.00 percentage of subjects
Interval 93.94 to 100.0
|
100.00 percentage of subjects
Interval 94.04 to 100.0
|
98.28 percentage of subjects
Interval 90.76 to 99.96
|
|
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
A/H3N2, ≥1:40 (Day 22)
|
100.00 percentage of subjects
Interval 94.04 to 100.0
|
100.00 percentage of subjects
Interval 93.94 to 100.0
|
100.00 percentage of subjects
Interval 94.04 to 100.0
|
98.28 percentage of subjects
Interval 90.76 to 99.96
|
|
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
A/H3N2, ≥1:80 (Day 22)
|
100.00 percentage of subjects
Interval 94.04 to 100.0
|
100.00 percentage of subjects
Interval 93.94 to 100.0
|
100.00 percentage of subjects
Interval 94.04 to 100.0
|
98.28 percentage of subjects
Interval 90.76 to 99.96
|
|
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
A/H3N2, ≥1:160 (Day 22)
|
100.00 percentage of subjects
Interval 94.04 to 100.0
|
100.00 percentage of subjects
Interval 93.94 to 100.0
|
100.00 percentage of subjects
Interval 94.04 to 100.0
|
98.28 percentage of subjects
Interval 90.76 to 99.96
|
|
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
A/H3N2, ≥1:320 (Day 22)
|
100.00 percentage of subjects
Interval 94.04 to 100.0
|
100.00 percentage of subjects
Interval 93.94 to 100.0
|
100.00 percentage of subjects
Interval 94.04 to 100.0
|
98.28 percentage of subjects
Interval 90.76 to 99.96
|
|
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
A/H3N2, ≥1:640 (Day 22)
|
100.00 percentage of subjects
Interval 94.04 to 100.0
|
100.00 percentage of subjects
Interval 93.94 to 100.0
|
100.00 percentage of subjects
Interval 94.04 to 100.0
|
98.28 percentage of subjects
Interval 90.76 to 99.96
|
|
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
A/H3N2, ≥1:20 (Day 181)
|
100.00 percentage of subjects
Interval 94.04 to 100.0
|
98.28 percentage of subjects
Interval 90.76 to 99.96
|
100.00 percentage of subjects
Interval 93.84 to 100.0
|
98.21 percentage of subjects
Interval 90.45 to 99.95
|
|
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
A/H3N2, ≥1:40 (Day 181)
|
100.00 percentage of subjects
Interval 94.04 to 100.0
|
98.28 percentage of subjects
Interval 90.76 to 99.96
|
100.00 percentage of subjects
Interval 93.84 to 100.0
|
96.43 percentage of subjects
Interval 87.69 to 99.56
|
|
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
A/H3N2, ≥1:80 (Day 181)
|
100.00 percentage of subjects
Interval 94.04 to 100.0
|
98.28 percentage of subjects
Interval 90.76 to 99.96
|
100.00 percentage of subjects
Interval 93.84 to 100.0
|
91.07 percentage of subjects
Interval 80.38 to 97.04
|
|
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
A/H3N2, ≥1:160 (Day 181)
|
96.67 percentage of subjects
Interval 88.47 to 99.59
|
98.28 percentage of subjects
Interval 90.76 to 99.96
|
96.55 percentage of subjects
Interval 88.09 to 99.58
|
89.29 percentage of subjects
Interval 78.12 to 95.97
|
|
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
A/H3N2, ≥1:320 (Day 181)
|
91.67 percentage of subjects
Interval 81.61 to 97.24
|
94.83 percentage of subjects
Interval 85.62 to 98.92
|
93.10 percentage of subjects
Interval 83.27 to 98.09
|
85.71 percentage of subjects
Interval 73.78 to 93.62
|
|
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
A/H3N2, ≥1:640 (Day 181)
|
86.67 percentage of subjects
Interval 75.41 to 94.06
|
86.21 percentage of subjects
Interval 74.62 to 93.85
|
84.48 percentage of subjects
Interval 72.58 to 92.65
|
83.93 percentage of subjects
Interval 71.67 to 92.38
|
|
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
B/Yamagata, ≥1:20 (Day 22)
|
100.00 percentage of subjects
Interval 94.04 to 100.0
|
100.00 percentage of subjects
Interval 93.94 to 100.0
|
96.67 percentage of subjects
Interval 88.47 to 99.59
|
96.55 percentage of subjects
Interval 88.09 to 99.58
|
|
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
B/Yamagata, ≥1:40 (Day 22)
|
98.33 percentage of subjects
Interval 91.06 to 99.96
|
98.31 percentage of subjects
Interval 90.91 to 99.96
|
96.67 percentage of subjects
Interval 88.47 to 99.59
|
93.10 percentage of subjects
Interval 83.27 to 98.09
|
|
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
B/Yamagata, ≥1:80 (Day 22)
|
95.00 percentage of subjects
Interval 86.08 to 98.96
|
96.61 percentage of subjects
Interval 88.29 to 99.59
|
95.00 percentage of subjects
Interval 86.08 to 98.96
|
89.66 percentage of subjects
Interval 78.83 to 96.11
|
|
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
B/Yamagata, ≥1:160 (Day 22)
|
91.67 percentage of subjects
Interval 81.61 to 97.24
|
86.44 percentage of subjects
Interval 75.02 to 93.96
|
78.33 percentage of subjects
Interval 65.8 to 87.93
|
70.69 percentage of subjects
Interval 57.27 to 81.91
|
|
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
B/Yamagata, ≥1:320 (Day 22)
|
75.00 percentage of subjects
Interval 62.14 to 85.28
|
72.88 percentage of subjects
Interval 59.73 to 83.64
|
65.00 percentage of subjects
Interval 51.6 to 76.87
|
50.00 percentage of subjects
Interval 36.58 to 63.42
|
|
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
B/Yamagata, ≥1:640 (Day 22)
|
58.33 percentage of subjects
Interval 44.88 to 70.93
|
47.46 percentage of subjects
Interval 34.3 to 60.88
|
31.67 percentage of subjects
Interval 20.26 to 44.96
|
24.14 percentage of subjects
Interval 13.87 to 37.17
|
|
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
B/Yamagata, ≥1:20 (Day 181)
|
98.33 percentage of subjects
Interval 91.06 to 99.96
|
96.55 percentage of subjects
Interval 88.09 to 99.58
|
93.10 percentage of subjects
Interval 83.27 to 98.09
|
80.36 percentage of subjects
Interval 67.57 to 89.77
|
|
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
B/Yamagata, ≥1:40 (Day 181)
|
93.33 percentage of subjects
Interval 83.8 to 98.15
|
93.10 percentage of subjects
Interval 83.27 to 98.09
|
79.31 percentage of subjects
Interval 66.65 to 88.83
|
71.43 percentage of subjects
Interval 57.79 to 82.7
|
|
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
B/Yamagata, ≥1:80 (Day 181)
|
71.67 percentage of subjects
Interval 58.56 to 82.55
|
72.41 percentage of subjects
Interval 59.1 to 83.34
|
56.90 percentage of subjects
Interval 42.23 to 69.84
|
46.43 percentage of subjects
Interval 32.99 to 60.26
|
|
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
B/Yamagata, ≥1:160 (Day 181)
|
45.00 percentage of subjects
Interval 32.12 to 58.39
|
48.28 percentage of subjects
Interval 34.95 to 61.78
|
32.76 percentage of subjects
Interval 21.01 to 46.34
|
17.86 percentage of subjects
Interval 8.91 to 30.4
|
|
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
B/Yamagata, ≥1:320 (Day 181)
|
25.00 percentage of subjects
Interval 14.72 to 37.86
|
24.14 percentage of subjects
Interval 13.87 to 37.17
|
15.52 percentage of subjects
Interval 7.35 to 27.42
|
7.14 percentage of subjects
Interval 1.98 to 17.29
|
|
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
B/Yamagata, ≥1:640 (Day 181)
|
3.33 percentage of subjects
Interval 0.41 to 11.53
|
8.62 percentage of subjects
Interval 2.86 to 18.98
|
5.17 percentage of subjects
Interval 1.08 to 14.38
|
3.57 percentage of subjects
Interval 0.44 to 12.31
|
|
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
B/Victoria, ≥1:20 (Day 22)
|
98.31 percentage of subjects
Interval 90.91 to 99.96
|
100.00 percentage of subjects
Interval 93.94 to 100.0
|
100.00 percentage of subjects
Interval 94.04 to 100.0
|
98.31 percentage of subjects
Interval 90.91 to 99.96
|
|
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
B/Victoria, ≥1:40 (Day 22)
|
94.92 percentage of subjects
Interval 85.85 to 98.94
|
100.00 percentage of subjects
Interval 93.94 to 100.0
|
96.67 percentage of subjects
Interval 88.47 to 99.59
|
93.22 percentage of subjects
Interval 83.54 to 98.12
|
|
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
B/Victoria, ≥1:80 (Day 22)
|
91.53 percentage of subjects
Interval 81.32 to 97.19
|
96.61 percentage of subjects
Interval 88.29 to 99.59
|
90.00 percentage of subjects
Interval 79.49 to 96.24
|
84.75 percentage of subjects
Interval 73.01 to 92.78
|
|
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
B/Victoria, ≥1:160 (Day 22)
|
86.44 percentage of subjects
Interval 75.02 to 93.96
|
86.44 percentage of subjects
Interval 75.02 to 93.96
|
81.67 percentage of subjects
Interval 69.56 to 90.48
|
69.49 percentage of subjects
Interval 56.13 to 80.81
|
|
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
B/Victoria, ≥1:320 (Day 22)
|
74.58 percentage of subjects
Interval 61.56 to 85.02
|
67.80 percentage of subjects
Interval 54.36 to 79.38
|
58.33 percentage of subjects
Interval 44.88 to 70.93
|
35.59 percentage of subjects
Interval 23.55 to 49.13
|
|
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
B/Victoria, ≥1:640 (Day 22)
|
49.15 percentage of subjects
Interval 35.89 to 62.5
|
42.37 percentage of subjects
Interval 29.61 to 55.93
|
33.33 percentage of subjects
Interval 21.69 to 46.69
|
22.03 percentage of subjects
Interval 12.29 to 34.73
|
|
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
B/Victoria, ≥1:20 (Day 181)
|
100.00 percentage of subjects
Interval 94.04 to 100.0
|
100.00 percentage of subjects
Interval 93.84 to 100.0
|
98.28 percentage of subjects
Interval 90.76 to 99.96
|
96.43 percentage of subjects
Interval 87.69 to 99.56
|
|
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
B/Victoria, ≥1:40 (Day 181)
|
86.67 percentage of subjects
Interval 75.41 to 94.06
|
87.93 percentage of subjects
Interval 76.7 to 95.01
|
74.14 percentage of subjects
Interval 60.96 to 84.74
|
60.71 percentage of subjects
Interval 46.75 to 73.5
|
|
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
B/Victoria, ≥1:80 (Day 181)
|
78.33 percentage of subjects
Interval 65.8 to 87.93
|
63.79 percentage of subjects
Interval 50.12 to 76.01
|
44.83 percentage of subjects
Interval 31.74 to 58.46
|
41.07 percentage of subjects
Interval 28.1 to 55.02
|
|
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
B/Victoria, ≥1:160 (Day 181)
|
58.33 percentage of subjects
Interval 44.88 to 70.93
|
43.10 percentage of subjects
Interval 30.16 to 56.77
|
27.59 percentage of subjects
Interval 16.66 to 40.9
|
23.21 percentage of subjects
Interval 12.98 to 36.42
|
|
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
B/Victoria, ≥1:320 (Day 181)
|
31.67 percentage of subjects
Interval 20.26 to 44.96
|
20.69 percentage of subjects
Interval 11.17 to 33.35
|
18.97 percentage of subjects
Interval 9.87 to 31.41
|
8.93 percentage of subjects
Interval 2.96 to 19.62
|
|
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
B/Victoria, ≥1:640 (Day 181)
|
8.33 percentage of subjects
Interval 2.76 to 18.39
|
15.52 percentage of subjects
Interval 7.35 to 27.42
|
12.07 percentage of subjects
Interval 4.99 to 23.3
|
5.36 percentage of subjects
Interval 1.12 to 14.87
|
SECONDARY outcome
Timeframe: Day 22, Day 181Population: 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.
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.
Outcome measures
| Measure |
aQIV/aQIV
n=56 Participants
Subjects previously vaccinated with aQIV followed one year later by aQIV
Adjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)
|
aQIV/QIV
n=62 Participants
Subjects previously vaccinated with aQIV followed one year later by QIV
Non-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)
|
QIV/aQIV
n=59 Participants
Subjects previously vaccinated with QIV followed one year later by aQIV
Adjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)
|
QIV/QIV
n=60 Participants
Subjects previously vaccinated with QIV followed one year later by QIV
Non-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)
|
|---|---|---|---|---|
|
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
B/Yamagata, ≥1:80 (Day 22)
|
98.21 percentage of subjects
Interval 90.45 to 99.95
|
100.00 percentage of subjects
Interval 94.13 to 100.0
|
100.00 percentage of subjects
Interval 93.94 to 100.0
|
100.00 percentage of subjects
Interval 94.04 to 100.0
|
|
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
B/Yamagata, ≥1:160 (Day 22)
|
98.21 percentage of subjects
Interval 90.45 to 99.95
|
100.00 percentage of subjects
Interval 94.13 to 100.0
|
100.00 percentage of subjects
Interval 93.94 to 100.0
|
98.33 percentage of subjects
Interval 91.06 to 99.96
|
|
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
B/Yamagata, ≥1:320 (Day 22)
|
98.21 percentage of subjects
Interval 90.45 to 99.95
|
100.00 percentage of subjects
Interval 94.13 to 100.0
|
96.61 percentage of subjects
Interval 88.29 to 99.59
|
88.33 percentage of subjects
Interval 77.43 to 95.18
|
|
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
N1, ≥1:20 (Day 22)
|
100.00 percentage of subjects
Interval 93.62 to 100.0
|
100.00 percentage of subjects
Interval 94.22 to 100.0
|
100.00 percentage of subjects
Interval 93.94 to 100.0
|
100.00 percentage of subjects
Interval 94.04 to 100.0
|
|
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
N1, ≥1:40 (Day 22)
|
100.00 percentage of subjects
Interval 93.62 to 100.0
|
100.00 percentage of subjects
Interval 94.22 to 100.0
|
100.00 percentage of subjects
Interval 93.94 to 100.0
|
98.33 percentage of subjects
Interval 91.06 to 99.96
|
|
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
N1, ≥1:80 (Day 22)
|
100.00 percentage of subjects
Interval 93.62 to 100.0
|
100.00 percentage of subjects
Interval 94.22 to 100.0
|
100.00 percentage of subjects
Interval 93.94 to 100.0
|
98.33 percentage of subjects
Interval 91.06 to 99.96
|
|
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
N1, ≥1:160 (Day 22)
|
100.00 percentage of subjects
Interval 93.62 to 100.0
|
100.00 percentage of subjects
Interval 94.22 to 100.0
|
100.00 percentage of subjects
Interval 93.94 to 100.0
|
93.33 percentage of subjects
Interval 83.8 to 98.15
|
|
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
N1, ≥1:320 (Day 22)
|
100.00 percentage of subjects
Interval 93.62 to 100.0
|
100.00 percentage of subjects
Interval 94.22 to 100.0
|
100.00 percentage of subjects
Interval 93.94 to 100.0
|
88.33 percentage of subjects
Interval 77.43 to 95.18
|
|
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
N1,≥1:640 (Day 22)
|
100.00 percentage of subjects
Interval 93.62 to 100.0
|
100.00 percentage of subjects
Interval 94.22 to 100.0
|
98.31 percentage of subjects
Interval 90.91 to 99.96
|
85.00 percentage of subjects
Interval 73.43 to 92.9
|
|
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
N1, ≥1:20 (Day 181)
|
100.00 percentage of subjects
Interval 93.51 to 100.0
|
100.00 percentage of subjects
Interval 94.13 to 100.0
|
100.00 percentage of subjects
Interval 93.84 to 100.0
|
93.33 percentage of subjects
Interval 83.8 to 98.15
|
|
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
N1, ≥1:40 (Day 181)
|
100.00 percentage of subjects
Interval 93.51 to 100.0
|
100.00 percentage of subjects
Interval 94.13 to 100.0
|
100.00 percentage of subjects
Interval 93.84 to 100.0
|
91.67 percentage of subjects
Interval 81.61 to 97.24
|
|
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
N1, ≥1:80 (Day 181)
|
100.00 percentage of subjects
Interval 93.51 to 100.0
|
100.00 percentage of subjects
Interval 94.13 to 100.0
|
100.00 percentage of subjects
Interval 93.84 to 100.0
|
86.67 percentage of subjects
Interval 75.41 to 94.06
|
|
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
N1, ≥1:160 (Day 181)
|
100.00 percentage of subjects
Interval 93.51 to 100.0
|
100.00 percentage of subjects
Interval 94.13 to 100.0
|
96.55 percentage of subjects
Interval 88.09 to 99.58
|
81.67 percentage of subjects
Interval 69.56 to 90.48
|
|
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
N1, ≥1:320 (Day 181)
|
100.00 percentage of subjects
Interval 93.51 to 100.0
|
96.72 percentage of subjects
Interval 88.65 to 99.6
|
93.10 percentage of subjects
Interval 83.27 to 98.09
|
70.00 percentage of subjects
Interval 56.79 to 81.15
|
|
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
N1, ≥1:640 (Day 181)
|
100.00 percentage of subjects
Interval 93.51 to 100.0
|
93.44 percentage of subjects
Interval 84.05 to 98.18
|
72.41 percentage of subjects
Interval 59.1 to 83.34
|
51.67 percentage of subjects
Interval 38.39 to 64.77
|
|
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
N2, ≥1:20 (Day 22)
|
100.00 percentage of subjects
Interval 93.62 to 100.0
|
100.00 percentage of subjects
Interval 94.22 to 100.0
|
100.00 percentage of subjects
Interval 93.94 to 100.0
|
100.00 percentage of subjects
Interval 94.04 to 100.0
|
|
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
N2, ≥1:40 (Day 22)
|
100.00 percentage of subjects
Interval 93.62 to 100.0
|
100.00 percentage of subjects
Interval 94.22 to 100.0
|
100.00 percentage of subjects
Interval 93.94 to 100.0
|
100.00 percentage of subjects
Interval 94.04 to 100.0
|
|
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
N2, ≥1:80 (Day 22)
|
98.21 percentage of subjects
Interval 90.45 to 99.95
|
100.00 percentage of subjects
Interval 94.22 to 100.0
|
98.31 percentage of subjects
Interval 90.91 to 99.96
|
96.67 percentage of subjects
Interval 88.47 to 99.59
|
|
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
N2, ≥1:160 (Day 22)
|
98.21 percentage of subjects
Interval 90.45 to 99.95
|
100.00 percentage of subjects
Interval 94.22 to 100.0
|
98.31 percentage of subjects
Interval 90.91 to 99.96
|
90.00 percentage of subjects
Interval 79.49 to 96.24
|
|
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
N2, ≥1:320 (Day 22)
|
94.64 percentage of subjects
Interval 85.13 to 98.88
|
96.77 percentage of subjects
Interval 88.83 to 99.61
|
94.92 percentage of subjects
Interval 85.85 to 98.94
|
85.00 percentage of subjects
Interval 73.43 to 92.9
|
|
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
N2, ≥1:640 (Day 22)
|
85.71 percentage of subjects
Interval 73.78 to 93.62
|
88.71 percentage of subjects
Interval 78.11 to 95.34
|
79.66 percentage of subjects
Interval 67.17 to 89.02
|
68.33 percentage of subjects
Interval 55.04 to 79.74
|
|
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
N2, ≥1:20 (Day 181)
|
100.00 percentage of subjects
Interval 93.51 to 100.0
|
100.00 percentage of subjects
Interval 94.04 to 100.0
|
100.00 percentage of subjects
Interval 93.84 to 100.0
|
90.00 percentage of subjects
Interval 79.49 to 96.24
|
|
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
N2, ≥1:40 (Day 181)
|
98.18 percentage of subjects
Interval 90.28 to 99.95
|
98.33 percentage of subjects
Interval 91.06 to 99.96
|
89.66 percentage of subjects
Interval 78.83 to 96.11
|
88.33 percentage of subjects
Interval 77.43 to 95.18
|
|
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
N2, ≥1:80 (Day 181)
|
94.55 percentage of subjects
Interval 84.88 to 98.86
|
98.33 percentage of subjects
Interval 91.06 to 99.96
|
86.21 percentage of subjects
Interval 74.62 to 93.85
|
80.00 percentage of subjects
Interval 67.67 to 89.22
|
|
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
N2, ≥1:160 (Day 181)
|
85.45 percentage of subjects
Interval 73.34 to 93.5
|
95.00 percentage of subjects
Interval 86.08 to 98.96
|
81.03 percentage of subjects
Interval 68.59 to 90.13
|
70.00 percentage of subjects
Interval 56.79 to 81.15
|
|
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
N2, ≥1:320 (Day 181)
|
80.00 percentage of subjects
Interval 67.03 to 89.57
|
85.00 percentage of subjects
Interval 73.43 to 92.9
|
67.24 percentage of subjects
Interval 53.66 to 78.99
|
61.67 percentage of subjects
Interval 48.21 to 73.93
|
|
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
N2, ≥1:640 (Day 181)
|
70.91 percentage of subjects
Interval 57.1 to 82.37
|
81.67 percentage of subjects
Interval 69.56 to 90.48
|
55.17 percentage of subjects
Interval 41.54 to 68.26
|
50.00 percentage of subjects
Interval 36.81 to 63.19
|
|
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
B/Yamagata, ≥1:20 (Day 22)
|
100.00 percentage of subjects
Interval 93.62 to 100.0
|
100.00 percentage of subjects
Interval 94.13 to 100.0
|
100.00 percentage of subjects
Interval 93.04 to 100.0
|
100.00 percentage of subjects
Interval 94.04 to 100.0
|
|
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
B/Yamagata, ≥1:40 (Day 22)
|
100.00 percentage of subjects
Interval 93.62 to 100.0
|
100.00 percentage of subjects
Interval 94.13 to 100.0
|
100.00 percentage of subjects
Interval 93.94 to 100.0
|
100.00 percentage of subjects
Interval 94.04 to 100.0
|
|
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
B/Yamagata, ≥1:640 (Day 22)
|
91.07 percentage of subjects
Interval 80.38 to 97.04
|
91.80 percentage of subjects
Interval 81.9 to 97.28
|
89.83 percentage of subjects
Interval 79.17 to 96.18
|
66.67 percentage of subjects
Interval 53.31 to 78.31
|
|
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
B/Yamagata, ≥1:20 (Day 181)
|
100.00 percentage of subjects
Interval 93.51 to 100.0
|
98.33 percentage of subjects
Interval 91.06 to 99.96
|
100.00 percentage of subjects
Interval 93.84 to 100.0
|
100.00 percentage of subjects
Interval 94.04 to 100.0
|
|
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
B/Yamagata, ≥1:40 (Day 181)
|
100.00 percentage of subjects
Interval 93.51 to 100.0
|
98.33 percentage of subjects
Interval 91.06 to 99.96
|
98.28 percentage of subjects
Interval 90.76 to 99.96
|
96.67 percentage of subjects
Interval 88.47 to 99.59
|
|
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
B/Yamagata, ≥1:80 (Day 181)
|
100.00 percentage of subjects
Interval 93.51 to 100.0
|
98.33 percentage of subjects
Interval 91.06 to 99.96
|
96.55 percentage of subjects
Interval 88.09 to 99.58
|
90.00 percentage of subjects
Interval 79.49 to 96.24
|
|
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
B/Yamagata, ≥1:160 (Day 181)
|
98.18 percentage of subjects
Interval 90.28 to 99.95
|
96.67 percentage of subjects
Interval 88.47 to 99.59
|
91.38 percentage of subjects
Interval 81.02 to 97.14
|
81.67 percentage of subjects
Interval 69.56 to 90.48
|
|
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
B/Yamagata, ≥1:320 (Day 181)
|
92.73 percentage of subjects
Interval 82.41 to 97.98
|
86.67 percentage of subjects
Interval 75.41 to 94.06
|
84.48 percentage of subjects
Interval 72.58 to 92.65
|
65.00 percentage of subjects
Interval 51.6 to 76.87
|
|
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
B/Yamagata, ≥1:640 (Day 181)
|
72.73 percentage of subjects
Interval 59.04 to 83.86
|
61.67 percentage of subjects
Interval 48.21 to 73.93
|
51.72 percentage of subjects
Interval 38.22 to 65.05
|
40.00 percentage of subjects
Interval 27.56 to 53.46
|
|
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
B/Victoria, ≥1:20 (Day 22)
|
100.00 percentage of subjects
Interval 93.62 to 100.0
|
100.00 percentage of subjects
Interval 94.22 to 100.0
|
100.00 percentage of subjects
Interval 93.94 to 100.0
|
100.00 percentage of subjects
Interval 94.04 to 100.0
|
|
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
B/Victoria, ≥1:40 (Day 22)
|
100.00 percentage of subjects
Interval 93.62 to 100.0
|
100.00 percentage of subjects
Interval 94.22 to 100.0
|
100.00 percentage of subjects
Interval 93.94 to 100.0
|
100.00 percentage of subjects
Interval 94.04 to 100.0
|
|
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
B/Victoria, ≥1:80 (Day 22)
|
100.00 percentage of subjects
Interval 93.62 to 100.0
|
100.00 percentage of subjects
Interval 94.22 to 100.0
|
100.00 percentage of subjects
Interval 93.94 to 100.0
|
100.00 percentage of subjects
Interval 94.04 to 100.0
|
|
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
B/Victoria, ≥1:160 (Day 22)
|
100.00 percentage of subjects
Interval 93.62 to 100.0
|
100.00 percentage of subjects
Interval 94.22 to 100.0
|
100.00 percentage of subjects
Interval 93.94 to 100.0
|
100.00 percentage of subjects
Interval 94.04 to 100.0
|
|
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
B/Victoria, ≥1:320 (Day 22)
|
100.00 percentage of subjects
Interval 93.62 to 100.0
|
100.00 percentage of subjects
Interval 94.22 to 100.0
|
100.00 percentage of subjects
Interval 93.94 to 100.0
|
98.33 percentage of subjects
Interval 91.06 to 99.96
|
|
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
B/Victoria, ≥1:640 (Day 22)
|
100.00 percentage of subjects
Interval 93.62 to 100.0
|
100.00 percentage of subjects
Interval 94.22 to 100.0
|
100.00 percentage of subjects
Interval 93.94 to 100.0
|
91.67 percentage of subjects
Interval 81.61 to 97.24
|
|
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
B/Victoria, ≥1:20 (Day 181)
|
100.00 percentage of subjects
Interval 93.51 to 100.0
|
100.00 percentage of subjects
Interval 94.13 to 100.0
|
100.00 percentage of subjects
Interval 93.84 to 100.0
|
100.00 percentage of subjects
Interval 94.04 to 100.0
|
|
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
B/Victoria, ≥1:40 (Day 181)
|
100.00 percentage of subjects
Interval 93.51 to 100.0
|
100.00 percentage of subjects
Interval 94.13 to 100.0
|
100.00 percentage of subjects
Interval 93.84 to 100.0
|
100.00 percentage of subjects
Interval 94.04 to 100.0
|
|
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
B/Victoria, ≥1:80 (Day 181)
|
100.00 percentage of subjects
Interval 93.51 to 100.0
|
100.00 percentage of subjects
Interval 94.13 to 100.0
|
100.00 percentage of subjects
Interval 93.84 to 100.0
|
100.00 percentage of subjects
Interval 94.04 to 100.0
|
|
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
B/Victoria, ≥1:160 (Day 181)
|
100.00 percentage of subjects
Interval 93.51 to 100.0
|
100.00 percentage of subjects
Interval 94.13 to 100.0
|
96.55 percentage of subjects
Interval 88.09 to 99.58
|
96.67 percentage of subjects
Interval 88.47 to 99.59
|
|
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
B/Victoria, ≥1:320 (Day 181)
|
94.55 percentage of subjects
Interval 84.88 to 98.86
|
100.00 percentage of subjects
Interval 94.13 to 100.0
|
95.55 percentage of subjects
Interval 88.09 to 99.58
|
83.33 percentage of subjects
Interval 71.48 to 91.71
|
|
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
B/Victoria, ≥1:640 (Day 181)
|
89.09 percentage of subjects
Interval 77.75 to 95.89
|
95.08 percentage of subjects
Interval 86.29 to 98.97
|
81.03 percentage of subjects
Interval 68.59 to 90.13
|
70.00 percentage of subjects
Interval 56.79 to 81.15
|
Adverse Events
aQIV-aQIV
Serious events: 10 serious events
Other events: 289 other events
Deaths: 0 deaths
aQIV-QIV
Serious events: 11 serious events
Other events: 269 other events
Deaths: 0 deaths
QIV-aQIV
Serious events: 7 serious events
Other events: 274 other events
Deaths: 0 deaths
QIV-QIV
Serious events: 8 serious events
Other events: 229 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
aQIV-aQIV
n=403 participants at risk
Subjects previously vaccinated with aQIV followed one year later by aQIV
Adjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)
|
aQIV-QIV
n=403 participants at risk
Subjects previously vaccinated with aQIV followed one year later by QIV
Non-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)
|
QIV-aQIV
n=402 participants at risk
Subjects previously vaccinated with QIV followed one year later by aQIV
Adjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)
|
QIV-QIV
n=393 participants at risk
Subjects previously vaccinated with QIV followed one year later by QIV
Non-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Iron Deficiency Anaemia
|
0.00%
0/403 • Day 1 - Day 366
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
|
0.00%
0/403 • Day 1 - Day 366
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
|
0.00%
0/402 • Day 1 - Day 366
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
|
0.25%
1/393 • Day 1 - Day 366
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
|
|
Blood and lymphatic system disorders
Lymphadenitis
|
0.00%
0/403 • Day 1 - Day 366
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
|
0.00%
0/403 • Day 1 - Day 366
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
|
0.00%
0/402 • Day 1 - Day 366
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
|
0.25%
1/393 • Day 1 - Day 366
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
|
|
Congenital, familial and genetic disorders
Spina Bifida Occulta
|
0.00%
0/403 • Day 1 - Day 366
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
|
0.00%
0/403 • Day 1 - Day 366
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
|
0.00%
0/402 • Day 1 - Day 366
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
|
0.25%
1/393 • Day 1 - Day 366
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
|
|
Ear and labyrinth disorders
Vertigo
|
0.25%
1/403 • Day 1 - Day 366
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
|
0.00%
0/403 • Day 1 - Day 366
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
|
0.00%
0/402 • Day 1 - Day 366
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
|
0.00%
0/393 • Day 1 - Day 366
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
|
|
Gastrointestinal disorders
Aphthous Ulcer
|
0.00%
0/403 • Day 1 - Day 366
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
|
0.00%
0/403 • Day 1 - Day 366
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
|
0.00%
0/402 • Day 1 - Day 366
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
|
0.25%
1/393 • Day 1 - Day 366
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
|
|
Gastrointestinal disorders
Dyspepsia
|
0.25%
1/403 • Day 1 - Day 366
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
|
0.00%
0/403 • Day 1 - Day 366
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
|
0.00%
0/402 • Day 1 - Day 366
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
|
0.00%
0/393 • Day 1 - Day 366
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
|
|
Gastrointestinal disorders
Gastritis
|
0.50%
2/403 • Day 1 - Day 366
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
|
0.00%
0/403 • Day 1 - Day 366
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
|
0.00%
0/402 • Day 1 - Day 366
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
|
0.00%
0/393 • Day 1 - Day 366
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
|
|
Immune system disorders
Anaphylactic Reaction
|
0.00%
0/403 • Day 1 - Day 366
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
|
0.00%
0/403 • Day 1 - Day 366
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
|
0.00%
0/402 • Day 1 - Day 366
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
|
0.25%
1/393 • Day 1 - Day 366
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
|
|
Infections and infestations
Amoebic Dysentery
|
0.25%
1/403 • Day 1 - Day 366
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
|
0.00%
0/403 • Day 1 - Day 366
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
|
0.00%
0/402 • Day 1 - Day 366
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
|
0.00%
0/393 • Day 1 - Day 366
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
|
|
Infections and infestations
Appendiceal Abscess
|
0.00%
0/403 • Day 1 - Day 366
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
|
0.25%
1/403 • Day 1 - Day 366
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
|
0.00%
0/402 • Day 1 - Day 366
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
|
0.00%
0/393 • Day 1 - Day 366
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
|
|
Infections and infestations
Bronchitis
|
0.00%
0/403 • Day 1 - Day 366
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
|
0.25%
1/403 • Day 1 - Day 366
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
|
0.25%
1/402 • Day 1 - Day 366
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
|
0.00%
0/393 • Day 1 - Day 366
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
|
|
Infections and infestations
Dengue Fever
|
0.25%
1/403 • Day 1 - Day 366
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
|
0.00%
0/403 • Day 1 - Day 366
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
|
0.00%
0/402 • Day 1 - Day 366
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
|
0.00%
0/393 • Day 1 - Day 366
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
|
|
Infections and infestations
External Ear Cellulitis
|
0.00%
0/403 • Day 1 - Day 366
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
|
0.25%
1/403 • Day 1 - Day 366
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
|
0.00%
0/402 • Day 1 - Day 366
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
|
0.00%
0/393 • Day 1 - Day 366
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
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/403 • Day 1 - Day 366
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
|
0.99%
4/403 • Day 1 - Day 366
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
|
1.00%
4/402 • Day 1 - Day 366
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
|
0.25%
1/393 • Day 1 - Day 366
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
|
|
Infections and infestations
Herpangina
|
0.00%
0/403 • Day 1 - Day 366
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
|
0.00%
0/403 • Day 1 - Day 366
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
|
0.25%
1/402 • Day 1 - Day 366
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
|
0.00%
0/393 • Day 1 - Day 366
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
|
|
Infections and infestations
Pneumonia
|
0.25%
1/403 • Day 1 - Day 366
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
|
0.25%
1/403 • Day 1 - Day 366
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
|
0.00%
0/402 • Day 1 - Day 366
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
|
0.25%
1/393 • Day 1 - Day 366
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
|
|
Infections and infestations
Respiratory Tract Infection
|
0.00%
0/403 • Day 1 - Day 366
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
|
0.25%
1/403 • Day 1 - Day 366
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
|
0.00%
0/402 • Day 1 - Day 366
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
|
0.00%
0/393 • Day 1 - Day 366
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
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/403 • Day 1 - Day 366
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
|
0.00%
0/403 • Day 1 - Day 366
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
|
0.25%
1/402 • Day 1 - Day 366
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
|
0.25%
1/393 • Day 1 - Day 366
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
|
|
Infections and infestations
Urinary Tract Infection
|
0.25%
1/403 • Day 1 - Day 366
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
|
0.00%
0/403 • Day 1 - Day 366
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
|
0.00%
0/402 • Day 1 - Day 366
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
|
0.25%
1/393 • Day 1 - Day 366
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
|
|
Injury, poisoning and procedural complications
Animal Bite
|
0.25%
1/403 • Day 1 - Day 366
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
|
0.25%
1/403 • Day 1 - Day 366
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
|
0.00%
0/402 • Day 1 - Day 366
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
|
0.25%
1/393 • Day 1 - Day 366
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
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/403 • Day 1 - Day 366
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
|
0.25%
1/403 • Day 1 - Day 366
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
|
0.00%
0/402 • Day 1 - Day 366
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
|
0.00%
0/393 • Day 1 - Day 366
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
|
|
Injury, poisoning and procedural complications
Jaw Fracture
|
0.25%
1/403 • Day 1 - Day 366
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
|
0.00%
0/403 • Day 1 - Day 366
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
|
0.00%
0/402 • Day 1 - Day 366
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
|
0.00%
0/393 • Day 1 - Day 366
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
|
|
Injury, poisoning and procedural complications
Wound Secretion
|
0.00%
0/403 • Day 1 - Day 366
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
|
0.25%
1/403 • Day 1 - Day 366
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
|
0.00%
0/402 • Day 1 - Day 366
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
|
0.00%
0/393 • Day 1 - Day 366
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
|
|
Nervous system disorders
Febrile Convulsion
|
0.25%
1/403 • Day 1 - Day 366
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
|
0.00%
0/403 • Day 1 - Day 366
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
|
0.00%
0/402 • Day 1 - Day 366
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
|
0.00%
0/393 • Day 1 - Day 366
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
|
|
Vascular disorders
Kawasaki's Disease
|
0.00%
0/403 • Day 1 - Day 366
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
|
0.00%
0/403 • Day 1 - Day 366
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
|
0.00%
0/402 • Day 1 - Day 366
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
|
0.25%
1/393 • Day 1 - Day 366
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
|
Other adverse events
| Measure |
aQIV-aQIV
n=403 participants at risk
Subjects previously vaccinated with aQIV followed one year later by aQIV
Adjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)
|
aQIV-QIV
n=403 participants at risk
Subjects previously vaccinated with aQIV followed one year later by QIV
Non-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)
|
QIV-aQIV
n=402 participants at risk
Subjects previously vaccinated with QIV followed one year later by aQIV
Adjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)
|
QIV-QIV
n=393 participants at risk
Subjects previously vaccinated with QIV followed one year later by QIV
Non-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
5.5%
22/403 • Day 1 - Day 366
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
|
2.0%
8/403 • Day 1 - Day 366
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
|
3.5%
14/402 • Day 1 - Day 366
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
|
4.1%
16/393 • Day 1 - Day 366
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
|
|
Gastrointestinal disorders
Vomiting
|
7.2%
29/403 • Day 1 - Day 366
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
|
3.7%
15/403 • Day 1 - Day 366
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
|
4.7%
19/402 • Day 1 - Day 366
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
|
3.3%
13/393 • Day 1 - Day 366
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
|
|
General disorders
Influenza Like Illness
|
7.9%
32/403 • Day 1 - Day 366
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
|
10.2%
41/403 • Day 1 - Day 366
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
|
9.2%
37/402 • Day 1 - Day 366
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
|
7.9%
31/393 • Day 1 - Day 366
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
|
|
General disorders
Injection Site Erythema
|
20.1%
81/403 • Day 1 - Day 366
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
|
14.1%
57/403 • Day 1 - Day 366
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
|
12.7%
51/402 • Day 1 - Day 366
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
|
9.9%
39/393 • Day 1 - Day 366
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
|
|
General disorders
Injection Site Induration
|
15.4%
62/403 • Day 1 - Day 366
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
|
13.6%
55/403 • Day 1 - Day 366
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
|
9.5%
38/402 • Day 1 - Day 366
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
|
6.1%
24/393 • Day 1 - Day 366
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
|
|
General disorders
Injection Site Pain
|
40.4%
163/403 • Day 1 - Day 366
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
|
34.0%
137/403 • Day 1 - Day 366
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
|
33.3%
134/402 • Day 1 - Day 366
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
|
30.5%
120/393 • Day 1 - Day 366
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
|
|
General disorders
Pyrexia
|
23.8%
96/403 • Day 1 - Day 366
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
|
11.4%
46/403 • Day 1 - Day 366
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
|
17.9%
72/402 • Day 1 - Day 366
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
|
13.0%
51/393 • Day 1 - Day 366
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
|
|
Infections and infestations
Nasopharyngitis
|
5.2%
21/403 • Day 1 - Day 366
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
|
4.7%
19/403 • Day 1 - Day 366
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
|
6.5%
26/402 • Day 1 - Day 366
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
|
4.1%
16/393 • Day 1 - Day 366
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
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
19.4%
78/403 • Day 1 - Day 366
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
|
24.8%
100/403 • Day 1 - Day 366
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
|
24.6%
99/402 • Day 1 - Day 366
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
|
18.6%
73/393 • Day 1 - Day 366
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
|
|
Nervous system disorders
Somnolence
|
19.6%
79/403 • Day 1 - Day 366
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
|
11.2%
45/403 • Day 1 - Day 366
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
|
13.7%
55/402 • Day 1 - Day 366
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
|
6.4%
25/393 • Day 1 - Day 366
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
|
|
Psychiatric disorders
Eating Disorder
|
16.4%
66/403 • Day 1 - Day 366
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
|
6.9%
28/403 • Day 1 - Day 366
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
|
12.9%
52/402 • Day 1 - Day 366
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
|
6.1%
24/393 • Day 1 - Day 366
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
|
|
Psychiatric disorders
Irritability
|
14.9%
60/403 • Day 1 - Day 366
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
|
10.9%
44/403 • Day 1 - Day 366
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
|
12.4%
50/402 • Day 1 - Day 366
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
|
9.2%
36/393 • Day 1 - Day 366
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
|
Additional Information
Seqirus Clinical Trial Disclosure Manager
Seqirus
Phone: Phone: 1-855-358-8966
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60