Trial Outcomes & Findings for Clinical Study to Evaluate Safety, Immunogenicity of Investigational Flu Vaccine Compared to an Approved Flu Vaccine (QIV) in Children Previously Vaccinated in Trial V118_05 (NCT NCT02255409)
NCT ID: NCT02255409
Last Updated: 2023-03-15
Results Overview
Safety was assessed in terms of number of subjects between 12 months and 7 years of age reporting unsolicited events up to 12 months after last vaccination with either aQIV or QIV (comparator): serious adverse events (SAEs), AEs leading to study withdrawal, new onset chronic disease (NOCDs), adverse events of special interest (AESIs) and medically attended AEs after vaccination.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
607 participants
Primary outcome timeframe
Day 1 through Day 356
Results posted on
2023-03-15
Participant Flow
Subjects were enrolled from 30 sites in 2 countries (Finland and United States)
All enrolled subjects were included in the trial
Participant milestones
| Measure |
Adjuvanted Quadrivalent Influenza Vaccine (aQIV)
Subjects approximately ≥12 months to 7 years of age who had received aQIV in the parent study V118\_05 received aQIV in study V118\_05E1.
|
Comparator Quadrivalent Influenza Vaccine (QIV)
Subjects approximately ≥12 months to 7 years of age who had received TIV in the parent study V118\_05 received QIV in study V118\_05E1.
|
|---|---|---|
|
Overall Study
STARTED
|
318
|
289
|
|
Overall Study
COMPLETED
|
304
|
258
|
|
Overall Study
NOT COMPLETED
|
14
|
31
|
Reasons for withdrawal
| Measure |
Adjuvanted Quadrivalent Influenza Vaccine (aQIV)
Subjects approximately ≥12 months to 7 years of age who had received aQIV in the parent study V118\_05 received aQIV in study V118\_05E1.
|
Comparator Quadrivalent Influenza Vaccine (QIV)
Subjects approximately ≥12 months to 7 years of age who had received TIV in the parent study V118\_05 received QIV in study V118\_05E1.
|
|---|---|---|
|
Overall Study
Administrative Reason
|
3
|
7
|
|
Overall Study
Withdrawal by Subject
|
1
|
5
|
|
Overall Study
Lost to Follow-up
|
10
|
19
|
Baseline Characteristics
Clinical Study to Evaluate Safety, Immunogenicity of Investigational Flu Vaccine Compared to an Approved Flu Vaccine (QIV) in Children Previously Vaccinated in Trial V118_05
Baseline characteristics by cohort
| Measure |
Adjuvanted Quadrivalent Influenza Vaccine (aQIV)
n=318 Participants
Subjects approximately ≥12 months to 7 years of age who had received aQIV in the parent study V118\_05 received aQIV in the study V118\_05E1.
|
Comparator Quadrivalent Influenza Vaccine (QIV)
n=289 Participants
Subjects approximately ≥12 months to 7 years of age who had received TIV in the parent study V118\_05 received QIV in study V118\_05E1.
|
Total
n=607 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
44.7 months
STANDARD_DEVIATION 19.04 • n=93 Participants
|
42.0 months
STANDARD_DEVIATION 17.47 • n=4 Participants
|
43.4 months
STANDARD_DEVIATION 18.35 • n=27 Participants
|
|
Sex: Female, Male
Female
|
171 Participants
n=93 Participants
|
155 Participants
n=4 Participants
|
326 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
147 Participants
n=93 Participants
|
134 Participants
n=4 Participants
|
281 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
64 Participants
n=93 Participants
|
48 Participants
n=4 Participants
|
112 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
253 Participants
n=93 Participants
|
241 Participants
n=4 Participants
|
494 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
75 Participants
n=93 Participants
|
65 Participants
n=4 Participants
|
140 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
231 Participants
n=93 Participants
|
209 Participants
n=4 Participants
|
440 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
10 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
22 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
269 participants
n=93 Participants
|
238 participants
n=4 Participants
|
507 participants
n=27 Participants
|
|
Region of Enrollment
Finland
|
49 participants
n=93 Participants
|
51 participants
n=4 Participants
|
100 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Day 1 through Day 356Population: The Unsolicited Safety Set consisting of subjects who received a study vaccination and who had any AE assessments (ie, a subject did not have to have an AE to be included in this population) was used for analysis.
Safety was assessed in terms of number of subjects between 12 months and 7 years of age reporting unsolicited events up to 12 months after last vaccination with either aQIV or QIV (comparator): serious adverse events (SAEs), AEs leading to study withdrawal, new onset chronic disease (NOCDs), adverse events of special interest (AESIs) and medically attended AEs after vaccination.
Outcome measures
| Measure |
aQIV
n=317 Participants
Subjects approximately ≥12 months to 7 years of age who had received aQIV in the parent study V118\_05 received aQIV in study V118\_05E1.
|
Comparator QIV
n=288 Participants
Subjects approximately ≥12 months to 7 years of age who had received TIV in the parent study V118\_05 received QIV in study V118\_05E1.
|
|---|---|---|
|
Safety Endpoint: Number of Subjects With SAEs, AEs Leading to Withdrawal From the Study, NOCDs, AESIs and Medically Attended AEs.
SAEs
|
7 Participants
|
4 Participants
|
|
Safety Endpoint: Number of Subjects With SAEs, AEs Leading to Withdrawal From the Study, NOCDs, AESIs and Medically Attended AEs.
At least possibly related SAEs
|
0 Participants
|
0 Participants
|
|
Safety Endpoint: Number of Subjects With SAEs, AEs Leading to Withdrawal From the Study, NOCDs, AESIs and Medically Attended AEs.
NOCDs
|
13 Participants
|
7 Participants
|
|
Safety Endpoint: Number of Subjects With SAEs, AEs Leading to Withdrawal From the Study, NOCDs, AESIs and Medically Attended AEs.
AESIs
|
1 Participants
|
1 Participants
|
|
Safety Endpoint: Number of Subjects With SAEs, AEs Leading to Withdrawal From the Study, NOCDs, AESIs and Medically Attended AEs.
Medically attended AEs
|
161 Participants
|
141 Participants
|
|
Safety Endpoint: Number of Subjects With SAEs, AEs Leading to Withdrawal From the Study, NOCDs, AESIs and Medically Attended AEs.
AEs leading to withdrawal
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 1, Day 22Population: The Full Analysis Set for Immunogenicity consisting of all enrolled subjects who received a study vaccination and provided evaluable serum samples (homologous strains) for both before (baseline) and after vaccination (ie, Day 22 and/or Day 181). Day 22 analyses are reported for the 302 and 257 (256 for the A/H3N2 strain) participants in the aQIV and Comparator QIV groups, respectively, who had immunogenicity data at both Day 1 and Day 22.
The percentage of subjects achieving seroconversion at Day 22 after vaccination is reported for homologous strains; Seroconversion is defined as hemagglutination inhibition (HI) ≥1:40 for subjects negative at baseline \[\<1:10\]; or a minimum 4-fold increase in HI titer for subjects positive at baseline \[HI ≥1:10\]; Strains tested: A/H1N1 is Influenza A H1N1 California/7/2009 Egg Ab; A/H3N2 is Influenza A H3N2 Texas/50/2012 Ab; B/Yamagata is Influenza B Massachusetts/2/2012 Ab; B/Victoria is Influenza B Brisbane/60/2008 Egg Ab
Outcome measures
| Measure |
aQIV
n=302 Participants
Subjects approximately ≥12 months to 7 years of age who had received aQIV in the parent study V118\_05 received aQIV in study V118\_05E1.
|
Comparator QIV
n=257 Participants
Subjects approximately ≥12 months to 7 years of age who had received TIV in the parent study V118\_05 received QIV in study V118\_05E1.
|
|---|---|---|
|
Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion and Differences in Percentage of Subjects Achieving Seroconversion for Homologous Influenza Strains (Day 22)
A/H1N1
|
57.9 Percentage of subjects
Interval 52.2 to 63.6
|
56.4 Percentage of subjects
Interval 50.1 to 62.6
|
|
Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion and Differences in Percentage of Subjects Achieving Seroconversion for Homologous Influenza Strains (Day 22)
A/H3N2
|
50.7 Percentage of subjects
Interval 44.9 to 56.4
|
56.6 Percentage of subjects
Interval 50.3 to 62.8
|
|
Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion and Differences in Percentage of Subjects Achieving Seroconversion for Homologous Influenza Strains (Day 22)
B/Yamagata
|
73.5 Percentage of subjects
Interval 68.2 to 78.4
|
57.2 Percentage of subjects
Interval 50.9 to 63.3
|
|
Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion and Differences in Percentage of Subjects Achieving Seroconversion for Homologous Influenza Strains (Day 22)
B/Victoria
|
72.2 Percentage of subjects
Interval 66.8 to 77.2
|
58.0 Percentage of subjects
Interval 51.7 to 64.1
|
PRIMARY outcome
Timeframe: Day 1, Day 22Population: The Full Analysis Set for Immunogenicity consisting of all enrolled subjects who received a study vaccination and provided evaluable serum samples (homologous strains) for both before (baseline) and after vaccination (ie, Day 22 and/or Day 181). Day 22 analyses are reported for the 302 and 257 (256 for the A/H3N2 strain) participants in the aQIV and Comparator QIV groups, respectively, who had immunogenicity data at both Day 1 and Day 22.
The percentage of subjects achieving HI titer ≥1:40 at Day 22 after vaccination is reported for homologous strains. Strains tested: A/H1N1 is Influenza A H1N1 California/7/2009 Egg Ab; A/H3N2 is Influenza A H3N2 Texas/50/2012 Ab; B/Yamagata is Influenza B Massachusetts/2/2012 Ab; B/Victoria is Influenza B Brisbane/60/2008 Egg Ab
Outcome measures
| Measure |
aQIV
n=302 Participants
Subjects approximately ≥12 months to 7 years of age who had received aQIV in the parent study V118\_05 received aQIV in study V118\_05E1.
|
Comparator QIV
n=257 Participants
Subjects approximately ≥12 months to 7 years of age who had received TIV in the parent study V118\_05 received QIV in study V118\_05E1.
|
|---|---|---|
|
Immunogenicity Endpoint: Percentage of Subjects Achieving HI Titer ≥ 1:40 and and Differences in Percentage of Subjects Achieving HI Titer ≥ 1:40 for Homologous Influenza Strains (Day 22).
A/H1N1, Homologous
|
100.0 Percentage of subjects
Interval 98.8 to 100.0
|
99.6 Percentage of subjects
Interval 97.9 to 100.0
|
|
Immunogenicity Endpoint: Percentage of Subjects Achieving HI Titer ≥ 1:40 and and Differences in Percentage of Subjects Achieving HI Titer ≥ 1:40 for Homologous Influenza Strains (Day 22).
A/H3N2, Homologous
|
99.7 Percentage of subjects
Interval 98.2 to 100.0
|
100.0 Percentage of subjects
Interval 98.6 to 100.0
|
|
Immunogenicity Endpoint: Percentage of Subjects Achieving HI Titer ≥ 1:40 and and Differences in Percentage of Subjects Achieving HI Titer ≥ 1:40 for Homologous Influenza Strains (Day 22).
B/Yamagata, Homologous
|
95.7 Percentage of subjects
Interval 92.8 to 97.7
|
81.3 Percentage of subjects
Interval 76.0 to 85.9
|
|
Immunogenicity Endpoint: Percentage of Subjects Achieving HI Titer ≥ 1:40 and and Differences in Percentage of Subjects Achieving HI Titer ≥ 1:40 for Homologous Influenza Strains (Day 22).
B/Victoria, Homologous
|
98.0 Percentage of subjects
Interval 95.7 to 99.3
|
72.0 Percentage of subjects
Interval 66.1 to 77.4
|
SECONDARY outcome
Timeframe: Day 1 through Day 366 (Day 1, Day 22, Day 181, Day 366)Population: The Unsolicited Safety Set consisting of subjects who received a study vaccination and who had any AE assessments (ie, a subject did not have to have an AE to be included in this population) was used for analysis.
Short stature was defined as a height/length that was 2 or more standard deviations below the mean for age and gender within a population and was assessed as being below the 2nd z-score (worse outcome) on the length/height-for-age scale. Failure-to-thrive was defined by inadequate weight gain and physical growth and assessed through 2 or more of the following criteria: height/length-for-age, weight-for-age or weight-for-height/length below the 2nd z-score, a child's growth line crossing a z-score line, a sharp change in growth curve or a curve that remains flat. The observations were made for 2 or more time points each divided by at least 2 months.
Outcome measures
| Measure |
aQIV
n=317 Participants
Subjects approximately ≥12 months to 7 years of age who had received aQIV in the parent study V118\_05 received aQIV in study V118\_05E1.
|
Comparator QIV
n=290 Participants
Subjects approximately ≥12 months to 7 years of age who had received TIV in the parent study V118\_05 received QIV in study V118\_05E1.
|
|---|---|---|
|
Safety Endpoint: Number of Subjects With a Diagnosis of Failure to Thrive or Short Stature
Subjects with diagnosis of failure to thrive
|
0 participants
|
0 participants
|
|
Safety Endpoint: Number of Subjects With a Diagnosis of Failure to Thrive or Short Stature
Subjects with diagnosis of short stature
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Day 1 through Day 22Population: The Unsolicited Safety Set consisting of subjects who received a study vaccination and who had any AE assessments (ie, a subject did not have to have an AE to be included in this population) was used for analysis.
Safety was assessed in terms of number of subjects between 12 months and 7 years of age reporting unsolicited events up to 12 months after last vaccination with either aQIV or QIV (comparator).
Outcome measures
| Measure |
aQIV
n=317 Participants
Subjects approximately ≥12 months to 7 years of age who had received aQIV in the parent study V118\_05 received aQIV in study V118\_05E1.
|
Comparator QIV
n=288 Participants
Subjects approximately ≥12 months to 7 years of age who had received TIV in the parent study V118\_05 received QIV in study V118\_05E1.
|
|---|---|---|
|
Safety Endpoint: Number of Subjects With Any Unsolicited AEs
|
85 Participants
|
60 Participants
|
SECONDARY outcome
Timeframe: Up to 7 days following vaccinationPopulation: The Solicited Safety Set consisting of subjects who received a study vaccination and had any assessment of local and systemic reactions and/or assessment of any use of analgesics/antipyretics was used for analysis.
Safety was assessed in terms of number of subjects between 12 months and 7 years of age reporting solicited local and systemic AEs, day 1 to day 7 after vaccination with either aQIV or QIV (comparator).
Outcome measures
| Measure |
aQIV
n=317 Participants
Subjects approximately ≥12 months to 7 years of age who had received aQIV in the parent study V118\_05 received aQIV in study V118\_05E1.
|
Comparator QIV
n=288 Participants
Subjects approximately ≥12 months to 7 years of age who had received TIV in the parent study V118\_05 received QIV in study V118\_05E1.
|
|---|---|---|
|
Safety Endpoint: Number of Subjects With Solicited Local and Systemic Adverse Events (AEs)
Other
|
66 Participants
|
26 Participants
|
|
Safety Endpoint: Number of Subjects With Solicited Local and Systemic Adverse Events (AEs)
Solicited AEs, Any
|
202 Participants
|
148 Participants
|
|
Safety Endpoint: Number of Subjects With Solicited Local and Systemic Adverse Events (AEs)
Solicited Local AEs
|
173 Participants
|
112 Participants
|
|
Safety Endpoint: Number of Subjects With Solicited Local and Systemic Adverse Events (AEs)
Solicited Systemic AEs
|
127 Participants
|
80 Participants
|
SECONDARY outcome
Timeframe: Day 1, Day 181Population: The Full Analysis Set for Immunogenicity consisting of all enrolled subjects who received a study vaccination and provided evaluable serum samples (homologous strains) for both before (baseline) and after vaccination (ie, Day 22 and/or Day 181). Day 181 analyses are reported for the 289 and 251 participants in the aQIV and Comparator QIV groups, respectively, who had immunogenicity data at both Day 1 and Day 181.
The percentage of subjects achieving seroconversion at Day 181 after vaccination is reported for homologous strains. Seroconversion is defined as HI ≥1:40 for subjects negative at baseline \[\<1:10\]; or a minimum 4-fold increase in HI titer for subjects positive at baseline \[HI ≥1:10\]; Strains tested: A/H1N1 is Influenza A H1N1 California/7/2009 Egg Ab; A/H3N2 is Influenza A H3N2 Texas/50/2012 Ab; B/Yamagata is Influenza B Massachusetts/2/2012 Ab; B/Victoria is Influenza B Brisbane/60/2008 Egg Ab.
Outcome measures
| Measure |
aQIV
n=289 Participants
Subjects approximately ≥12 months to 7 years of age who had received aQIV in the parent study V118\_05 received aQIV in study V118\_05E1.
|
Comparator QIV
n=251 Participants
Subjects approximately ≥12 months to 7 years of age who had received TIV in the parent study V118\_05 received QIV in study V118\_05E1.
|
|---|---|---|
|
Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion and Differences in Percentage of Subjects Achieving Seroconversion for Homologous Influenza Strains (Day 181)
A/H1N1, Homologous
|
27.7 Percentage of subjects
Interval 22.6 to 33.2
|
21.9 Percentage of subjects
Interval 17.0 to 27.5
|
|
Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion and Differences in Percentage of Subjects Achieving Seroconversion for Homologous Influenza Strains (Day 181)
A/H3N2, Homologous
|
30.1 Percentage of subjects
Interval 24.9 to 35.8
|
27.9 Percentage of subjects
Interval 22.4 to 33.9
|
|
Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion and Differences in Percentage of Subjects Achieving Seroconversion for Homologous Influenza Strains (Day 181)
B/Yamagata, Homologous
|
24.6 Percentage of subjects
Interval 19.7 to 29.9
|
12.7 Percentage of subjects
Interval 8.9 to 17.5
|
|
Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion and Differences in Percentage of Subjects Achieving Seroconversion for Homologous Influenza Strains (Day 181)
B/Victoria, Homologous
|
21.5 Percentage of subjects
Interval 16.9 to 26.6
|
22.7 Percentage of subjects
Interval 17.7 to 28.4
|
SECONDARY outcome
Timeframe: Day 1, Day 181Population: The Full Analysis Set for Immunogenicity consisting of all enrolled subjects who received a study vaccination and provided evaluable serum samples (homologous strains) for both before (baseline) and after vaccination (ie, Day 22 and/or Day 181). Day 181 analyses are reported for the 289 and 251 participants in the aQIV and Comparator QIV groups, respectively, who had immunogenicity data at both Day 1 and Day 181.
The percentage of subjects achieving HI titer ≥1:40 at Day 181 after vaccination is reported for homologous strains; Strains tested: A/H1N1 is Influenza A H1N1 California/7/2009 Egg Ab; A/H3N2 is Influenza A H3N2 Texas/50/2012 Ab; B/Yamagata is Influenza B Massachusetts/2/2012 Ab; B/Victoria is Influenza B Brisbane/60/2008 Egg Ab
Outcome measures
| Measure |
aQIV
n=289 Participants
Subjects approximately ≥12 months to 7 years of age who had received aQIV in the parent study V118\_05 received aQIV in study V118\_05E1.
|
Comparator QIV
n=251 Participants
Subjects approximately ≥12 months to 7 years of age who had received TIV in the parent study V118\_05 received QIV in study V118\_05E1.
|
|---|---|---|
|
Immunogenicity Endpoint: Percentage of Subjects Achieving HI Titer ≥ 1:40 and Difference in Percentage of Subjects Achieving HI Titer ≥ 1:40 for Homologous Influenza Strains (Day 181)
A/H1N1, Homologous
|
99.7 Percentage of subjects
Interval 98.1 to 100.0
|
94.8 Percentage of subjects
Interval 91.3 to 97.2
|
|
Immunogenicity Endpoint: Percentage of Subjects Achieving HI Titer ≥ 1:40 and Difference in Percentage of Subjects Achieving HI Titer ≥ 1:40 for Homologous Influenza Strains (Day 181)
A/H3N2, Homologous
|
99.7 Percentage of subjects
Interval 98.1 to 100.0
|
94.0 Percentage of subjects
Interval 90.3 to 96.6
|
|
Immunogenicity Endpoint: Percentage of Subjects Achieving HI Titer ≥ 1:40 and Difference in Percentage of Subjects Achieving HI Titer ≥ 1:40 for Homologous Influenza Strains (Day 181)
B/Yamagata, Homologous
|
73.0 Percentage of subjects
Interval 67.5 to 78.0
|
39.8 Percentage of subjects
Interval 33.7 to 46.2
|
|
Immunogenicity Endpoint: Percentage of Subjects Achieving HI Titer ≥ 1:40 and Difference in Percentage of Subjects Achieving HI Titer ≥ 1:40 for Homologous Influenza Strains (Day 181)
B/Victoria, Homologous
|
82.4 Percentage of subjects
Interval 77.5 to 86.6
|
45.0 Percentage of subjects
Interval 38.8 to 51.4
|
SECONDARY outcome
Timeframe: Day 1, Day 22, Day 181Population: The Full Analysis Set for Immunogenicity consisting of all enrolled subjects who received a study vaccination and provided evaluable serum samples (homologous strains) for both before (baseline) and after vaccination (ie, Day 22 and/or Day 181). Day 22 analyses are reported for 302 and 257 (256 for the A/H3N2 strain) participants in the aQIV and Comparator QIV groups, respectively. Day 181 analyses are reported for 289 and 251 participants in the aQIV and Comparator QIV groups, respectively.
Adjusted GMT, GMR and 95% confidence interval (CI) were analyzed using ANCOVA with study specific covariates. Strains tested: A/H1N1 is Influenza A H1N1 California/7/2009 Egg Ab; A/H3N2 is Influenza A H3N2 Texas/50/2012 Ab; B/Yamagata is Influenza B Massachusetts/2/2012 Ab; B/Victoria is Influenza B Brisbane/60/2008 Egg Ab
Outcome measures
| Measure |
aQIV
n=309 Participants
Subjects approximately ≥12 months to 7 years of age who had received aQIV in the parent study V118\_05 received aQIV in study V118\_05E1.
|
Comparator QIV
n=273 Participants
Subjects approximately ≥12 months to 7 years of age who had received TIV in the parent study V118\_05 received QIV in study V118\_05E1.
|
|---|---|---|
|
Immunogenicity Endpoint: Geometric Mean HI Titers (GMTs) and GMT Ratios for Homologous Influenza Strains (Day 1, Day 22, Day 181)
Day 1: A/H1N1, Homologous
|
320.27 titer
Interval 261.9 to 391.6
|
165.23 titer
Interval 134.0 to 203.8
|
|
Immunogenicity Endpoint: Geometric Mean HI Titers (GMTs) and GMT Ratios for Homologous Influenza Strains (Day 1, Day 22, Day 181)
Day 22: A/H1N1, Homologous
|
1036.27 titer
Interval 923.2 to 1163.2
|
700.78 titer
Interval 623.7 to 787.3
|
|
Immunogenicity Endpoint: Geometric Mean HI Titers (GMTs) and GMT Ratios for Homologous Influenza Strains (Day 1, Day 22, Day 181)
Day 181: A/H1N1, Homologous
|
424.00 titer
Interval 374.2 to 480.5
|
282.31 titer
Interval 248.8 to 320.4
|
|
Immunogenicity Endpoint: Geometric Mean HI Titers (GMTs) and GMT Ratios for Homologous Influenza Strains (Day 1, Day 22, Day 181)
Day 1: A/H3N2, Homologous
|
336.88 titer
Interval 268.5 to 422.7
|
155.97 titer
Interval 123.1 to 197.6
|
|
Immunogenicity Endpoint: Geometric Mean HI Titers (GMTs) and GMT Ratios for Homologous Influenza Strains (Day 1, Day 22, Day 181)
Day 22: A/H3N2, Homologous
|
1221.47 titer
Interval 1093.1 to 1364.9
|
908.63 titer
Interval 810.0 to 1019.3
|
|
Immunogenicity Endpoint: Geometric Mean HI Titers (GMTs) and GMT Ratios for Homologous Influenza Strains (Day 1, Day 22, Day 181)
Day 181: A/H3N2, Homologous
|
611.09 titer
Interval 529.0 to 705.9
|
454.46 titer
Interval 391.5 to 527.6
|
|
Immunogenicity Endpoint: Geometric Mean HI Titers (GMTs) and GMT Ratios for Homologous Influenza Strains (Day 1, Day 22, Day 181)
Day 1: B/Yamagata, Homologous
|
32.36 titer
Interval 26.9 to 38.9
|
17.78 titer
Interval 14.7 to 21.5
|
|
Immunogenicity Endpoint: Geometric Mean HI Titers (GMTs) and GMT Ratios for Homologous Influenza Strains (Day 1, Day 22, Day 181)
Day 22: B/Yamagata, Homologous
|
176.04 titer
Interval 150.8 to 205.5
|
100.80 titer
Interval 86.1 to 181.1
|
|
Immunogenicity Endpoint: Geometric Mean HI Titers (GMTs) and GMT Ratios for Homologous Influenza Strains (Day 1, Day 22, Day 181)
Day 181: B/Yamagata, Homologous
|
54.08 titer
Interval 46.6 to 62.8
|
29.26 titer
Interval 25.1 to 34.1
|
|
Immunogenicity Endpoint: Geometric Mean HI Titers (GMTs) and GMT Ratios for Homologous Influenza Strains (Day 1, Day 22, Day 181)
Day 1: B/Victoria, Homologous
|
46.41 titer
Interval 38.0 to 56.6
|
14.33 titer
Interval 11.6 to 17.6
|
|
Immunogenicity Endpoint: Geometric Mean HI Titers (GMTs) and GMT Ratios for Homologous Influenza Strains (Day 1, Day 22, Day 181)
Day 22: B/Victoria, Homologous
|
244.52 titer
Interval 203.6 to 293.7
|
163.95 titer
Interval 135.6 to 198.2
|
|
Immunogenicity Endpoint: Geometric Mean HI Titers (GMTs) and GMT Ratios for Homologous Influenza Strains (Day 1, Day 22, Day 181)
Day 181: B/Victoria, Homologous
|
65.85 titer
Interval 55.9 to 77.6
|
50.88 titer
Interval 42.9 to 60.3
|
SECONDARY outcome
Timeframe: Day 1, Day 22, and Day 181Population: The Full Analysis Set for Immunogenicity consisting of all enrolled subjects who received a study vaccination and provided evaluable serum samples (homologous strains) for both before (baseline) and after vaccination (ie, Day 22 and/or Day 181). Note: Subjects may be included in the Day 181 analyses but not the Day 22 analyses (and vice versa).
The GMR is the geometric mean of the fold increase in HI titer from Day 1 to Day 22 or Day 181. Adjusted GMT, GMR and 95% CI were analyzed using ANCOVA with study specific covariates. Strains tested: A/H1N1 is Influenza A H1N1 California/7/2009 Egg Ab; A/H3N2 is Influenza A H3N2 Texas/50/2012 Ab; B/Yamagata is Influenza B Massachusetts/2/2012 Ab; B/Victoria is Influenza B Brisbane/60/2008 Egg Ab
Outcome measures
| Measure |
aQIV
n=309 Participants
Subjects approximately ≥12 months to 7 years of age who had received aQIV in the parent study V118\_05 received aQIV in study V118\_05E1.
|
Comparator QIV
n=273 Participants
Subjects approximately ≥12 months to 7 years of age who had received TIV in the parent study V118\_05 received QIV in study V118\_05E1.
|
|---|---|---|
|
Immunogenicity Endpoint: Geometric Mean Ratios (GMR) for Homologous Influenza Strains
Day 22/Day 1: A/H1N1, Homologous
|
5.82 ratio
Interval 5.2 to 6.5
|
3.93 ratio
Interval 3.5 to 4.4
|
|
Immunogenicity Endpoint: Geometric Mean Ratios (GMR) for Homologous Influenza Strains
Day 181/Day 1: A/H1N1, Homologous
|
2.40 ratio
Interval 2.1 to 2.7
|
1.60 ratio
Interval 1.4 to 1.8
|
|
Immunogenicity Endpoint: Geometric Mean Ratios (GMR) for Homologous Influenza Strains
Day 22/Day 1: A/H3N2, Homologous
|
5.41 ratio
Interval 4.8 to 6.0
|
4.03 ratio
Interval 3.6 to 4.5
|
|
Immunogenicity Endpoint: Geometric Mean Ratios (GMR) for Homologous Influenza Strains
Day 181/Day 1: A/H3N2, Homologous
|
2.73 ratio
Interval 2.4 to 3.2
|
2.03 ratio
Interval 1.8 to 2.4
|
|
Immunogenicity Endpoint: Geometric Mean Ratios (GMR) for Homologous Influenza Strains
Day 22/Day 1: B/Yamagata, Homologous
|
8.33 ratio
Interval 7.1 to 9.7
|
4.77 ratio
Interval 4.1 to 5.6
|
|
Immunogenicity Endpoint: Geometric Mean Ratios (GMR) for Homologous Influenza Strains
Day 181/Day 1: B/Yamagata, Homologous
|
2.57 ratio
Interval 2.2 to 3.0
|
1.39 ratio
Interval 1.2 to 1.6
|
|
Immunogenicity Endpoint: Geometric Mean Ratios (GMR) for Homologous Influenza Strains
Day 22/Day 1: B/Victoria, Homologous
|
9.26 ratio
Interval 7.7 to 11.1
|
6.21 ratio
Interval 5.1 to 7.5
|
|
Immunogenicity Endpoint: Geometric Mean Ratios (GMR) for Homologous Influenza Strains
Day 181/Day 1: B/Victoria, Homologous
|
2.55 ratio
Interval 2.2 to 3.0
|
1.97 ratio
Interval 1.7 to 2.3
|
SECONDARY outcome
Timeframe: Day 1, Day 181Population: The Full Analysis Set for Immunogenicity consisting of all enrolled subjects who received a study vaccination and provided evaluable serum samples (heterologous strains) for both before (baseline) and after vaccination.
The percentage of subjects achieving seroconversion at Day 181 after vaccination is reported for homologous strains. Seroconversion is defined as HI ≥1:40 for subjects negative at baseline \[\<1:10\]; or a minimum 4-fold increase in HI titer for subjects positive at baseline \[HI ≥1:10\]; Strains tested: A/H3N2 is Influenza A H3N2 Hong Kong/2014 Ab; B/Yamagata is Influenza B Phuket/2013 Ab
Outcome measures
| Measure |
aQIV
n=155 Participants
Subjects approximately ≥12 months to 7 years of age who had received aQIV in the parent study V118\_05 received aQIV in study V118\_05E1.
|
Comparator QIV
n=138 Participants
Subjects approximately ≥12 months to 7 years of age who had received TIV in the parent study V118\_05 received QIV in study V118\_05E1.
|
|---|---|---|
|
Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion and Difference in Percentage of Subjects Achieving Seroconversion for Heterologous Influenza Strains (Day 181)
A/H3N2, Heterologous
|
36.1 Percentage of subjects
Interval 28.6 to 44.2
|
30.4 Percentage of subjects
Interval 22.9 to 38.8
|
|
Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion and Difference in Percentage of Subjects Achieving Seroconversion for Heterologous Influenza Strains (Day 181)
B/Yamagata, Heterologous
|
27.7 Percentage of subjects
Interval 20.9 to 35.5
|
13.2 Percentage of subjects
Interval 8.0 to 20.1
|
SECONDARY outcome
Timeframe: Day 1, Day 181Population: The Full Analysis Set for Immunogenicity consisting of all enrolled subjects who received a study vaccination and provided evaluable serum samples (heterologous strains) for both before (baseline) and after vaccination.
The percentage of subjects achieving HI titer ≥1:40 at Day 181 after vaccination is reported for homologous strains; Strains tested: A/H3N2 is Influenza A H3N2 Hong Kong/2014 Ab; B/Yamagata is Influenza B Phuket/2013 Ab
Outcome measures
| Measure |
aQIV
n=155 Participants
Subjects approximately ≥12 months to 7 years of age who had received aQIV in the parent study V118\_05 received aQIV in study V118\_05E1.
|
Comparator QIV
n=138 Participants
Subjects approximately ≥12 months to 7 years of age who had received TIV in the parent study V118\_05 received QIV in study V118\_05E1.
|
|---|---|---|
|
Immunogenicity Endpoint: Percentage of Subjects Achieving HI Titer ≥ 1:40 and Difference in Percentage of Subjects Achieving HI Titer ≥ 1:40 for Heterologous Influenza Strains (Day 181)
A/H3N2, Heterologous
|
96.8 Percentage of subjects
Interval 92.6 to 98.9
|
80.4 Percentage of subjects
Interval 72.8 to 86.7
|
|
Immunogenicity Endpoint: Percentage of Subjects Achieving HI Titer ≥ 1:40 and Difference in Percentage of Subjects Achieving HI Titer ≥ 1:40 for Heterologous Influenza Strains (Day 181)
B/Yamagata, Heterologous
|
83.9 Percentage of subjects
Interval 77.1 to 89.3
|
37.5 Percentage of subjects
Interval 29.4 to 46.2
|
SECONDARY outcome
Timeframe: Day 1, Day 22, Day 181Population: The Full Analysis Set for Immunogenicity consisting of all enrolled subjects who received a study vaccination and provided evaluable serum samples (heterologous strains) for both before (baseline) and after vaccination.
Adjusted GMT, GMR and 95% CI were analyzed using ANCOVA with study specific covariates. Strains tested: A/H3N2 is Influenza A H3N2 Hong Kong/2014 Ab; B/Yamagata is Influenza B Phuket/2013 Ab
Outcome measures
| Measure |
aQIV
n=155 Participants
Subjects approximately ≥12 months to 7 years of age who had received aQIV in the parent study V118\_05 received aQIV in study V118\_05E1.
|
Comparator QIV
n=138 Participants
Subjects approximately ≥12 months to 7 years of age who had received TIV in the parent study V118\_05 received QIV in study V118\_05E1.
|
|---|---|---|
|
Immunogenicity Endpoint: Geometric Mean HI Titers (GMTs) for Heterologous Influenza Strains (Day 1, Day 22, Day 181)
Day 181: B/Yamagata, Heterologous
|
69.60 titer
Interval 55.7 to 87.0
|
27.27 titer
Interval 21.8 to 34.1
|
|
Immunogenicity Endpoint: Geometric Mean HI Titers (GMTs) for Heterologous Influenza Strains (Day 1, Day 22, Day 181)
Day 1: A/H3N2, Heterologous
|
126.35 titer
Interval 83.7 to 190.8
|
48.02 titer
Interval 31.7 to 72.8
|
|
Immunogenicity Endpoint: Geometric Mean HI Titers (GMTs) for Heterologous Influenza Strains (Day 1, Day 22, Day 181)
Day 22: A/H3N2, Heterologous
|
630.62 titer
Interval 515.0 to 772.2
|
402.54 titer
Interval 328.0 to 494.1
|
|
Immunogenicity Endpoint: Geometric Mean HI Titers (GMTs) for Heterologous Influenza Strains (Day 1, Day 22, Day 181)
Day 181: A/H3N2, Heterologous
|
304.10 titer
Interval 229.9 to 402.3
|
179.12 titer
Interval 134.9 to 237.7
|
|
Immunogenicity Endpoint: Geometric Mean HI Titers (GMTs) for Heterologous Influenza Strains (Day 1, Day 22, Day 181)
Day 1: B/Yamagata, Heterologous
|
30.29 titer
Interval 22.8 to 40.2
|
15.25 titer
Interval 11.5 to 20.3
|
|
Immunogenicity Endpoint: Geometric Mean HI Titers (GMTs) for Heterologous Influenza Strains (Day 1, Day 22, Day 181)
Day 22: B/Yamagata, Heterologous
|
196.27 titer
Interval 156.0 to 246.9
|
88.92 titer
Interval 70.6 to 112.0
|
SECONDARY outcome
Timeframe: Day 1, Day 22, and Day 181Population: The Full Analysis Set for Immunogenicity consisting of all enrolled subjects who received a study vaccination and provided evaluable serum samples (heterologous strains) for both before (baseline) and after vaccination.
The GMR is the geometric mean of the fold increase in HI titer from Day 1 to Day 22 or Day 181. Adjusted GMT, GMR and 95% CI were analyzed using ANCOVA with study specific covariates. Strains tested: A/H3N2 is Influenza A H3N2 Hong Kong/2014 Ab; B/Yamagata is Influenza B Phuket/2013 Ab
Outcome measures
| Measure |
aQIV
n=155 Participants
Subjects approximately ≥12 months to 7 years of age who had received aQIV in the parent study V118\_05 received aQIV in study V118\_05E1.
|
Comparator QIV
n=138 Participants
Subjects approximately ≥12 months to 7 years of age who had received TIV in the parent study V118\_05 received QIV in study V118\_05E1.
|
|---|---|---|
|
Immunogenicity Endpoint: Geometric Mean Ratios (GMR) for Heterologous Influenza Strains
Day 22/Day 1: A/H3N2, Heterologous
|
7.80 ratio
Interval 6.4 to 9.6
|
4.98 ratio
Interval 4.1 to 6.1
|
|
Immunogenicity Endpoint: Geometric Mean Ratios (GMR) for Heterologous Influenza Strains
Day 181/Day 1: A/H3N2, Heterologous
|
3.72 ratio
Interval 2.8 to 4.9
|
2.19 ratio
Interval 1.7 to 2.9
|
|
Immunogenicity Endpoint: Geometric Mean Ratios (GMR) for Heterologous Influenza Strains
Day 22/Day 1: B/Yamagata, Heterologous
|
9.29 ratio
Interval 7.4 to 11.7
|
4.21 ratio
Interval 3.3 to 5.3
|
|
Immunogenicity Endpoint: Geometric Mean Ratios (GMR) for Heterologous Influenza Strains
Day 181/Day 1: B/Yamagata, Heterologous
|
3.31 ratio
Interval 2.7 to 4.1
|
1.30 ratio
Interval 1.0 to 1.6
|
Adverse Events
aQIV
Serious events: 7 serious events
Other events: 253 other events
Deaths: 0 deaths
Comparator QIV
Serious events: 4 serious events
Other events: 210 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
aQIV
n=317 participants at risk
Subjects approximately ≥12 months to 7 years of age who had received aQIV in the parent study V118\_05 received aQIV in study V118\_05E1.
|
Comparator QIV
n=290 participants at risk；n=288 participants at risk
Subjects approximately ≥12 months to 7 years of age who had received TIV in the parent study V118\_05 received QIV in study V118\_05E1.
|
|---|---|---|
|
Congenital, familial and genetic disorders
Right ventricle outflow tract obstruction
|
0.32%
1/317 • Serious AEs: SAEs were captured from day 1 through day 366. Non Serious AEs: Solicited local and systemic AEs were reported from day 1 through day 7 after vaccination. All unsolicited AEs were captured through day 366.
All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set. Note: A total of 318 subjects were assigned to the aQIV arm; however, 1 subject in the aQIV arm incorrectly received QIV instead of aQIV and is included in the Comparator QIV arm for the safety analyses.
|
0.00%
0/288 • Serious AEs: SAEs were captured from day 1 through day 366. Non Serious AEs: Solicited local and systemic AEs were reported from day 1 through day 7 after vaccination. All unsolicited AEs were captured through day 366.
All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set. Note: A total of 318 subjects were assigned to the aQIV arm; however, 1 subject in the aQIV arm incorrectly received QIV instead of aQIV and is included in the Comparator QIV arm for the safety analyses.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/317 • Serious AEs: SAEs were captured from day 1 through day 366. Non Serious AEs: Solicited local and systemic AEs were reported from day 1 through day 7 after vaccination. All unsolicited AEs were captured through day 366.
All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set. Note: A total of 318 subjects were assigned to the aQIV arm; however, 1 subject in the aQIV arm incorrectly received QIV instead of aQIV and is included in the Comparator QIV arm for the safety analyses.
|
0.35%
1/288 • Serious AEs: SAEs were captured from day 1 through day 366. Non Serious AEs: Solicited local and systemic AEs were reported from day 1 through day 7 after vaccination. All unsolicited AEs were captured through day 366.
All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set. Note: A total of 318 subjects were assigned to the aQIV arm; however, 1 subject in the aQIV arm incorrectly received QIV instead of aQIV and is included in the Comparator QIV arm for the safety analyses.
|
|
Blood and lymphatic system disorders
Immune thrombocytopenic purpura
|
0.32%
1/317 • Serious AEs: SAEs were captured from day 1 through day 366. Non Serious AEs: Solicited local and systemic AEs were reported from day 1 through day 7 after vaccination. All unsolicited AEs were captured through day 366.
All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set. Note: A total of 318 subjects were assigned to the aQIV arm; however, 1 subject in the aQIV arm incorrectly received QIV instead of aQIV and is included in the Comparator QIV arm for the safety analyses.
|
0.00%
0/288 • Serious AEs: SAEs were captured from day 1 through day 366. Non Serious AEs: Solicited local and systemic AEs were reported from day 1 through day 7 after vaccination. All unsolicited AEs were captured through day 366.
All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set. Note: A total of 318 subjects were assigned to the aQIV arm; however, 1 subject in the aQIV arm incorrectly received QIV instead of aQIV and is included in the Comparator QIV arm for the safety analyses.
|
|
Metabolism and nutrition disorders
Type 1 diabetes mellitus
|
0.00%
0/317 • Serious AEs: SAEs were captured from day 1 through day 366. Non Serious AEs: Solicited local and systemic AEs were reported from day 1 through day 7 after vaccination. All unsolicited AEs were captured through day 366.
All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set. Note: A total of 318 subjects were assigned to the aQIV arm; however, 1 subject in the aQIV arm incorrectly received QIV instead of aQIV and is included in the Comparator QIV arm for the safety analyses.
|
0.35%
1/288 • Serious AEs: SAEs were captured from day 1 through day 366. Non Serious AEs: Solicited local and systemic AEs were reported from day 1 through day 7 after vaccination. All unsolicited AEs were captured through day 366.
All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set. Note: A total of 318 subjects were assigned to the aQIV arm; however, 1 subject in the aQIV arm incorrectly received QIV instead of aQIV and is included in the Comparator QIV arm for the safety analyses.
|
|
Infections and infestations
Appendicitis
|
0.32%
1/317 • Serious AEs: SAEs were captured from day 1 through day 366. Non Serious AEs: Solicited local and systemic AEs were reported from day 1 through day 7 after vaccination. All unsolicited AEs were captured through day 366.
All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set. Note: A total of 318 subjects were assigned to the aQIV arm; however, 1 subject in the aQIV arm incorrectly received QIV instead of aQIV and is included in the Comparator QIV arm for the safety analyses.
|
0.00%
0/288 • Serious AEs: SAEs were captured from day 1 through day 366. Non Serious AEs: Solicited local and systemic AEs were reported from day 1 through day 7 after vaccination. All unsolicited AEs were captured through day 366.
All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set. Note: A total of 318 subjects were assigned to the aQIV arm; however, 1 subject in the aQIV arm incorrectly received QIV instead of aQIV and is included in the Comparator QIV arm for the safety analyses.
|
|
Infections and infestations
Bronchiolitis
|
0.32%
1/317 • Serious AEs: SAEs were captured from day 1 through day 366. Non Serious AEs: Solicited local and systemic AEs were reported from day 1 through day 7 after vaccination. All unsolicited AEs were captured through day 366.
All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set. Note: A total of 318 subjects were assigned to the aQIV arm; however, 1 subject in the aQIV arm incorrectly received QIV instead of aQIV and is included in the Comparator QIV arm for the safety analyses.
|
0.35%
1/288 • Serious AEs: SAEs were captured from day 1 through day 366. Non Serious AEs: Solicited local and systemic AEs were reported from day 1 through day 7 after vaccination. All unsolicited AEs were captured through day 366.
All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set. Note: A total of 318 subjects were assigned to the aQIV arm; however, 1 subject in the aQIV arm incorrectly received QIV instead of aQIV and is included in the Comparator QIV arm for the safety analyses.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.32%
1/317 • Serious AEs: SAEs were captured from day 1 through day 366. Non Serious AEs: Solicited local and systemic AEs were reported from day 1 through day 7 after vaccination. All unsolicited AEs were captured through day 366.
All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set. Note: A total of 318 subjects were assigned to the aQIV arm; however, 1 subject in the aQIV arm incorrectly received QIV instead of aQIV and is included in the Comparator QIV arm for the safety analyses.
|
0.00%
0/288 • Serious AEs: SAEs were captured from day 1 through day 366. Non Serious AEs: Solicited local and systemic AEs were reported from day 1 through day 7 after vaccination. All unsolicited AEs were captured through day 366.
All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set. Note: A total of 318 subjects were assigned to the aQIV arm; however, 1 subject in the aQIV arm incorrectly received QIV instead of aQIV and is included in the Comparator QIV arm for the safety analyses.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/317 • Serious AEs: SAEs were captured from day 1 through day 366. Non Serious AEs: Solicited local and systemic AEs were reported from day 1 through day 7 after vaccination. All unsolicited AEs were captured through day 366.
All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set. Note: A total of 318 subjects were assigned to the aQIV arm; however, 1 subject in the aQIV arm incorrectly received QIV instead of aQIV and is included in the Comparator QIV arm for the safety analyses.
|
0.35%
1/288 • Serious AEs: SAEs were captured from day 1 through day 366. Non Serious AEs: Solicited local and systemic AEs were reported from day 1 through day 7 after vaccination. All unsolicited AEs were captured through day 366.
All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set. Note: A total of 318 subjects were assigned to the aQIV arm; however, 1 subject in the aQIV arm incorrectly received QIV instead of aQIV and is included in the Comparator QIV arm for the safety analyses.
|
|
Infections and infestations
Tonsillitis
|
0.32%
1/317 • Serious AEs: SAEs were captured from day 1 through day 366. Non Serious AEs: Solicited local and systemic AEs were reported from day 1 through day 7 after vaccination. All unsolicited AEs were captured through day 366.
All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set. Note: A total of 318 subjects were assigned to the aQIV arm; however, 1 subject in the aQIV arm incorrectly received QIV instead of aQIV and is included in the Comparator QIV arm for the safety analyses.
|
0.00%
0/288 • Serious AEs: SAEs were captured from day 1 through day 366. Non Serious AEs: Solicited local and systemic AEs were reported from day 1 through day 7 after vaccination. All unsolicited AEs were captured through day 366.
All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set. Note: A total of 318 subjects were assigned to the aQIV arm; however, 1 subject in the aQIV arm incorrectly received QIV instead of aQIV and is included in the Comparator QIV arm for the safety analyses.
|
|
Infections and infestations
Urinary tract infection
|
0.32%
1/317 • Serious AEs: SAEs were captured from day 1 through day 366. Non Serious AEs: Solicited local and systemic AEs were reported from day 1 through day 7 after vaccination. All unsolicited AEs were captured through day 366.
All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set. Note: A total of 318 subjects were assigned to the aQIV arm; however, 1 subject in the aQIV arm incorrectly received QIV instead of aQIV and is included in the Comparator QIV arm for the safety analyses.
|
0.00%
0/288 • Serious AEs: SAEs were captured from day 1 through day 366. Non Serious AEs: Solicited local and systemic AEs were reported from day 1 through day 7 after vaccination. All unsolicited AEs were captured through day 366.
All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set. Note: A total of 318 subjects were assigned to the aQIV arm; however, 1 subject in the aQIV arm incorrectly received QIV instead of aQIV and is included in the Comparator QIV arm for the safety analyses.
|
Other adverse events
| Measure |
aQIV
n=317 participants at risk
Subjects approximately ≥12 months to 7 years of age who had received aQIV in the parent study V118\_05 received aQIV in study V118\_05E1.
|
Comparator QIV
n=290 participants at risk；n=288 participants at risk
Subjects approximately ≥12 months to 7 years of age who had received TIV in the parent study V118\_05 received QIV in study V118\_05E1.
|
|---|---|---|
|
Nervous system disorders
Somnolence
|
23.3%
74/317 • Serious AEs: SAEs were captured from day 1 through day 366. Non Serious AEs: Solicited local and systemic AEs were reported from day 1 through day 7 after vaccination. All unsolicited AEs were captured through day 366.
All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set. Note: A total of 318 subjects were assigned to the aQIV arm; however, 1 subject in the aQIV arm incorrectly received QIV instead of aQIV and is included in the Comparator QIV arm for the safety analyses.
|
18.3%
53/290 • Serious AEs: SAEs were captured from day 1 through day 366. Non Serious AEs: Solicited local and systemic AEs were reported from day 1 through day 7 after vaccination. All unsolicited AEs were captured through day 366.
All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set. Note: A total of 318 subjects were assigned to the aQIV arm; however, 1 subject in the aQIV arm incorrectly received QIV instead of aQIV and is included in the Comparator QIV arm for the safety analyses.
|
|
General disorders
Influenza like illness
|
7.6%
24/317 • Serious AEs: SAEs were captured from day 1 through day 366. Non Serious AEs: Solicited local and systemic AEs were reported from day 1 through day 7 after vaccination. All unsolicited AEs were captured through day 366.
All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set. Note: A total of 318 subjects were assigned to the aQIV arm; however, 1 subject in the aQIV arm incorrectly received QIV instead of aQIV and is included in the Comparator QIV arm for the safety analyses.
|
10.3%
30/290 • Serious AEs: SAEs were captured from day 1 through day 366. Non Serious AEs: Solicited local and systemic AEs were reported from day 1 through day 7 after vaccination. All unsolicited AEs were captured through day 366.
All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set. Note: A total of 318 subjects were assigned to the aQIV arm; however, 1 subject in the aQIV arm incorrectly received QIV instead of aQIV and is included in the Comparator QIV arm for the safety analyses.
|
|
General disorders
Injection site erythema
|
27.8%
88/317 • Serious AEs: SAEs were captured from day 1 through day 366. Non Serious AEs: Solicited local and systemic AEs were reported from day 1 through day 7 after vaccination. All unsolicited AEs were captured through day 366.
All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set. Note: A total of 318 subjects were assigned to the aQIV arm; however, 1 subject in the aQIV arm incorrectly received QIV instead of aQIV and is included in the Comparator QIV arm for the safety analyses.
|
20.0%
58/290 • Serious AEs: SAEs were captured from day 1 through day 366. Non Serious AEs: Solicited local and systemic AEs were reported from day 1 through day 7 after vaccination. All unsolicited AEs were captured through day 366.
All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set. Note: A total of 318 subjects were assigned to the aQIV arm; however, 1 subject in the aQIV arm incorrectly received QIV instead of aQIV and is included in the Comparator QIV arm for the safety analyses.
|
|
General disorders
Injection site haemorrhage
|
9.5%
30/317 • Serious AEs: SAEs were captured from day 1 through day 366. Non Serious AEs: Solicited local and systemic AEs were reported from day 1 through day 7 after vaccination. All unsolicited AEs were captured through day 366.
All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set. Note: A total of 318 subjects were assigned to the aQIV arm; however, 1 subject in the aQIV arm incorrectly received QIV instead of aQIV and is included in the Comparator QIV arm for the safety analyses.
|
8.6%
25/290 • Serious AEs: SAEs were captured from day 1 through day 366. Non Serious AEs: Solicited local and systemic AEs were reported from day 1 through day 7 after vaccination. All unsolicited AEs were captured through day 366.
All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set. Note: A total of 318 subjects were assigned to the aQIV arm; however, 1 subject in the aQIV arm incorrectly received QIV instead of aQIV and is included in the Comparator QIV arm for the safety analyses.
|
|
General disorders
Injection site induration
|
18.3%
58/317 • Serious AEs: SAEs were captured from day 1 through day 366. Non Serious AEs: Solicited local and systemic AEs were reported from day 1 through day 7 after vaccination. All unsolicited AEs were captured through day 366.
All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set. Note: A total of 318 subjects were assigned to the aQIV arm; however, 1 subject in the aQIV arm incorrectly received QIV instead of aQIV and is included in the Comparator QIV arm for the safety analyses.
|
11.0%
32/290 • Serious AEs: SAEs were captured from day 1 through day 366. Non Serious AEs: Solicited local and systemic AEs were reported from day 1 through day 7 after vaccination. All unsolicited AEs were captured through day 366.
All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set. Note: A total of 318 subjects were assigned to the aQIV arm; however, 1 subject in the aQIV arm incorrectly received QIV instead of aQIV and is included in the Comparator QIV arm for the safety analyses.
|
|
General disorders
Injection site pain
|
46.4%
147/317 • Serious AEs: SAEs were captured from day 1 through day 366. Non Serious AEs: Solicited local and systemic AEs were reported from day 1 through day 7 after vaccination. All unsolicited AEs were captured through day 366.
All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set. Note: A total of 318 subjects were assigned to the aQIV arm; however, 1 subject in the aQIV arm incorrectly received QIV instead of aQIV and is included in the Comparator QIV arm for the safety analyses.
|
28.3%
82/290 • Serious AEs: SAEs were captured from day 1 through day 366. Non Serious AEs: Solicited local and systemic AEs were reported from day 1 through day 7 after vaccination. All unsolicited AEs were captured through day 366.
All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set. Note: A total of 318 subjects were assigned to the aQIV arm; however, 1 subject in the aQIV arm incorrectly received QIV instead of aQIV and is included in the Comparator QIV arm for the safety analyses.
|
|
General disorders
Pyrexia
|
17.4%
55/317 • Serious AEs: SAEs were captured from day 1 through day 366. Non Serious AEs: Solicited local and systemic AEs were reported from day 1 through day 7 after vaccination. All unsolicited AEs were captured through day 366.
All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set. Note: A total of 318 subjects were assigned to the aQIV arm; however, 1 subject in the aQIV arm incorrectly received QIV instead of aQIV and is included in the Comparator QIV arm for the safety analyses.
|
12.8%
37/290 • Serious AEs: SAEs were captured from day 1 through day 366. Non Serious AEs: Solicited local and systemic AEs were reported from day 1 through day 7 after vaccination. All unsolicited AEs were captured through day 366.
All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set. Note: A total of 318 subjects were assigned to the aQIV arm; however, 1 subject in the aQIV arm incorrectly received QIV instead of aQIV and is included in the Comparator QIV arm for the safety analyses.
|
|
Psychiatric disorders
Eating disorder
|
17.4%
55/317 • Serious AEs: SAEs were captured from day 1 through day 366. Non Serious AEs: Solicited local and systemic AEs were reported from day 1 through day 7 after vaccination. All unsolicited AEs were captured through day 366.
All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set. Note: A total of 318 subjects were assigned to the aQIV arm; however, 1 subject in the aQIV arm incorrectly received QIV instead of aQIV and is included in the Comparator QIV arm for the safety analyses.
|
10.3%
30/290 • Serious AEs: SAEs were captured from day 1 through day 366. Non Serious AEs: Solicited local and systemic AEs were reported from day 1 through day 7 after vaccination. All unsolicited AEs were captured through day 366.
All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set. Note: A total of 318 subjects were assigned to the aQIV arm; however, 1 subject in the aQIV arm incorrectly received QIV instead of aQIV and is included in the Comparator QIV arm for the safety analyses.
|
|
Psychiatric disorders
Irritability
|
26.2%
83/317 • Serious AEs: SAEs were captured from day 1 through day 366. Non Serious AEs: Solicited local and systemic AEs were reported from day 1 through day 7 after vaccination. All unsolicited AEs were captured through day 366.
All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set. Note: A total of 318 subjects were assigned to the aQIV arm; however, 1 subject in the aQIV arm incorrectly received QIV instead of aQIV and is included in the Comparator QIV arm for the safety analyses.
|
16.9%
49/290 • Serious AEs: SAEs were captured from day 1 through day 366. Non Serious AEs: Solicited local and systemic AEs were reported from day 1 through day 7 after vaccination. All unsolicited AEs were captured through day 366.
All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set. Note: A total of 318 subjects were assigned to the aQIV arm; however, 1 subject in the aQIV arm incorrectly received QIV instead of aQIV and is included in the Comparator QIV arm for the safety analyses.
|
|
Gastrointestinal disorders
Diarrhoea
|
10.4%
33/317 • Serious AEs: SAEs were captured from day 1 through day 366. Non Serious AEs: Solicited local and systemic AEs were reported from day 1 through day 7 after vaccination. All unsolicited AEs were captured through day 366.
All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set. Note: A total of 318 subjects were assigned to the aQIV arm; however, 1 subject in the aQIV arm incorrectly received QIV instead of aQIV and is included in the Comparator QIV arm for the safety analyses.
|
6.9%
20/290 • Serious AEs: SAEs were captured from day 1 through day 366. Non Serious AEs: Solicited local and systemic AEs were reported from day 1 through day 7 after vaccination. All unsolicited AEs were captured through day 366.
All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set. Note: A total of 318 subjects were assigned to the aQIV arm; however, 1 subject in the aQIV arm incorrectly received QIV instead of aQIV and is included in the Comparator QIV arm for the safety analyses.
|
|
Gastrointestinal disorders
Vomiting
|
6.0%
19/317 • Serious AEs: SAEs were captured from day 1 through day 366. Non Serious AEs: Solicited local and systemic AEs were reported from day 1 through day 7 after vaccination. All unsolicited AEs were captured through day 366.
All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set. Note: A total of 318 subjects were assigned to the aQIV arm; however, 1 subject in the aQIV arm incorrectly received QIV instead of aQIV and is included in the Comparator QIV arm for the safety analyses.
|
3.8%
11/290 • Serious AEs: SAEs were captured from day 1 through day 366. Non Serious AEs: Solicited local and systemic AEs were reported from day 1 through day 7 after vaccination. All unsolicited AEs were captured through day 366.
All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set. Note: A total of 318 subjects were assigned to the aQIV arm; however, 1 subject in the aQIV arm incorrectly received QIV instead of aQIV and is included in the Comparator QIV arm for the safety analyses.
|
|
Infections and infestations
Otitis media
|
11.7%
37/317 • Serious AEs: SAEs were captured from day 1 through day 366. Non Serious AEs: Solicited local and systemic AEs were reported from day 1 through day 7 after vaccination. All unsolicited AEs were captured through day 366.
All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set. Note: A total of 318 subjects were assigned to the aQIV arm; however, 1 subject in the aQIV arm incorrectly received QIV instead of aQIV and is included in the Comparator QIV arm for the safety analyses.
|
11.7%
34/290 • Serious AEs: SAEs were captured from day 1 through day 366. Non Serious AEs: Solicited local and systemic AEs were reported from day 1 through day 7 after vaccination. All unsolicited AEs were captured through day 366.
All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set. Note: A total of 318 subjects were assigned to the aQIV arm; however, 1 subject in the aQIV arm incorrectly received QIV instead of aQIV and is included in the Comparator QIV arm for the safety analyses.
|
|
Infections and infestations
Pharyngitis streptococcal
|
5.0%
16/317 • Serious AEs: SAEs were captured from day 1 through day 366. Non Serious AEs: Solicited local and systemic AEs were reported from day 1 through day 7 after vaccination. All unsolicited AEs were captured through day 366.
All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set. Note: A total of 318 subjects were assigned to the aQIV arm; however, 1 subject in the aQIV arm incorrectly received QIV instead of aQIV and is included in the Comparator QIV arm for the safety analyses.
|
2.1%
6/290 • Serious AEs: SAEs were captured from day 1 through day 366. Non Serious AEs: Solicited local and systemic AEs were reported from day 1 through day 7 after vaccination. All unsolicited AEs were captured through day 366.
All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set. Note: A total of 318 subjects were assigned to the aQIV arm; however, 1 subject in the aQIV arm incorrectly received QIV instead of aQIV and is included in the Comparator QIV arm for the safety analyses.
|
|
Infections and infestations
Upper respiratory tract infection
|
10.1%
32/317 • Serious AEs: SAEs were captured from day 1 through day 366. Non Serious AEs: Solicited local and systemic AEs were reported from day 1 through day 7 after vaccination. All unsolicited AEs were captured through day 366.
All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set. Note: A total of 318 subjects were assigned to the aQIV arm; however, 1 subject in the aQIV arm incorrectly received QIV instead of aQIV and is included in the Comparator QIV arm for the safety analyses.
|
13.1%
38/290 • Serious AEs: SAEs were captured from day 1 through day 366. Non Serious AEs: Solicited local and systemic AEs were reported from day 1 through day 7 after vaccination. All unsolicited AEs were captured through day 366.
All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set. Note: A total of 318 subjects were assigned to the aQIV arm; however, 1 subject in the aQIV arm incorrectly received QIV instead of aQIV and is included in the Comparator QIV arm for the safety analyses.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60