Influenza
Conditions
Brief summary
Safety, Immunogenicity of an Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine Compared to Non-Adjuvanted Comparator Influenza Vaccine in Children Previously Vaccinated in Trial V118\_05
Interventions
1 dose 0.25 ml: ≥6 months to \<36 months, 0.5 ml: ≥36 months to \<72 months
BIOLOGICALnon-adjuvanted Quadrivalent Influenza Vaccine (QIV)
1 dose 0.25 ml: ≥6 months to \<36 months, 0.5 ml: ≥36 months to \<72 months
Sponsors
Seqirus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
12 Months to 84 Months
Healthy volunteers
Yes
Inclusion criteria
1. Male or female subject who has completed their Day 181 clinic visit for non-naïve subjects or their Day 209 clinic visit for naïve subjects in parent study. 2. Individuals who give written informed consent, who can comply with study procedures, and who are available for follow-up
Exclusion criteria
1. Individuals recently vaccinated against influenza. 2. Subjects with contraindications to receive influenza vaccine. 3. Please contact the site for additional eligibility criteria.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety Endpoint: Number of Subjects With SAEs, AEs Leading to Withdrawal From the Study, NOCDs, AESIs and Medically Attended AEs. | Day 1 through Day 356 | 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. |
| Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion and Differences in Percentage of Subjects Achieving Seroconversion for Homologous Influenza Strains (Day 22) | Day 1, 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 |
| 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). | Day 1, 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion and Differences in Percentage of Subjects Achieving Seroconversion for Homologous Influenza Strains (Day 181) | Day 1, 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. |
| 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) | Day 1, 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 |
| Immunogenicity Endpoint: Geometric Mean HI Titers (GMTs) and GMT Ratios for Homologous Influenza Strains (Day 1, Day 22, Day 181) | Day 1, Day 22, Day 181 | 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 |
| Immunogenicity Endpoint: Geometric Mean Ratios (GMR) for Homologous Influenza Strains | Day 1, Day 22, and Day 181 | 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 |
| Safety Endpoint: Number of Subjects With a Diagnosis of Failure to Thrive or Short Stature | Day 1 through Day 366 (Day 1, Day 22, Day 181, Day 366) | 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. |
| 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) | Day 1, Day 181 | 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 |
| Immunogenicity Endpoint: Geometric Mean HI Titers (GMTs) for Heterologous Influenza Strains (Day 1, Day 22, Day 181) | Day 1, Day 22, 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 |
| Immunogenicity Endpoint: Geometric Mean Ratios (GMR) for Heterologous Influenza Strains | Day 1, Day 22, and Day 181 | 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 |
| Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion and Difference in Percentage of Subjects Achieving Seroconversion for Heterologous Influenza Strains (Day 181) | Day 1, 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/H3N2 is Influenza A H3N2 Hong Kong/2014 Ab; B/Yamagata is Influenza B Phuket/2013 Ab |
| Safety Endpoint: Number of Subjects With Any Unsolicited AEs | Day 1 through Day 22 | 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). |
| Safety Endpoint: Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Up to 7 days following vaccination | 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). |
Countries
Finland, United States
Participant flow
Recruitment details
Subjects were enrolled from 30 sites in 2 countries (Finland and United States)
Pre-assignment details
All enrolled subjects were included in the trial
Participants by arm
| Arm | Count |
|---|---|
| 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 the study V118\_05E1. | 318 |
| 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. | 289 |
| Total | 607 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Administrative Reason | 3 | 7 |
| Overall Study | Lost to Follow-up | 10 | 19 |
| Overall Study | Withdrawal by Subject | 1 | 5 |
Baseline characteristics
| Characteristic | Adjuvanted Quadrivalent Influenza Vaccine (aQIV) | Total | Comparator Quadrivalent Influenza Vaccine (QIV) |
|---|---|---|---|
| Age, Continuous | 44.7 months STANDARD_DEVIATION 19.04 | 43.4 months STANDARD_DEVIATION 18.35 | 42.0 months STANDARD_DEVIATION 17.47 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 64 Participants | 112 Participants | 48 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 253 Participants | 494 Participants | 241 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 75 Participants | 140 Participants | 65 Participants |
| Race (NIH/OMB) More than one race | 10 Participants | 22 Participants | 12 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants | 5 Participants | 3 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 231 Participants | 440 Participants | 209 Participants |
| Region of Enrollment Finland | 49 participants | 100 participants | 51 participants |
| Region of Enrollment United States | 269 participants | 507 participants | 238 participants |
| Sex: Female, Male Female | 171 Participants | 326 Participants | 155 Participants |
| Sex: Female, Male Male | 147 Participants | 281 Participants | 134 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 317 | 0 / 290 |
| other Total, other adverse events | 253 / 317 | 210 / 290 |
| serious Total, serious adverse events | 7 / 317 | 4 / 288 |
Outcome results
Primary
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).
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
Time frame: Day 1, Day 22
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| aQIV | 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 |
| aQIV | 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 |
| aQIV | 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 |
| aQIV | 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 |
| Comparator QIV | 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 | 72.0 Percentage of subjects |
| Comparator QIV | 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 | 99.6 Percentage of subjects |
| Comparator QIV | 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 | 81.3 Percentage of subjects |
| Comparator QIV | 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 | 100.0 Percentage of subjects |
Comparison: Vaccine Group Difference (aQIV - QIV) for A/H1N1 at Day 2295% CI: [-0.9, 2.2]
Comparison: Vaccine Group Difference (aQIV - QIV) for A/H3N2 at Day 2295% CI: [-1.9, 1.2]
Comparison: Vaccine Group Difference (aQIV - QIV) for B/Yamagata at Day 2295% CI: [9.3, 20]
Comparison: Vaccine Group Difference (aQIV - QIV) for B/Victoria at Day 2295% CI: [20.6, 32]
Primary
Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion and Differences in Percentage of Subjects Achieving Seroconversion for Homologous Influenza Strains (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
Time frame: Day 1, Day 22
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| aQIV | 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 |
| aQIV | 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 |
| aQIV | 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 |
| aQIV | 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 |
| Comparator QIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion and Differences in Percentage of Subjects Achieving Seroconversion for Homologous Influenza Strains (Day 22) | B/Victoria | 58.0 Percentage of subjects |
| Comparator QIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion and Differences in Percentage of Subjects Achieving Seroconversion for Homologous Influenza Strains (Day 22) | A/H1N1 | 56.4 Percentage of subjects |
| Comparator QIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion and Differences in Percentage of Subjects Achieving Seroconversion for Homologous Influenza Strains (Day 22) | B/Yamagata | 57.2 Percentage of subjects |
| Comparator QIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion and Differences in Percentage of Subjects Achieving Seroconversion for Homologous Influenza Strains (Day 22) | A/H3N2 | 56.6 Percentage of subjects |
Comparison: Vaccine Group Difference (aQIV - QIV) for A/H1N1 at Day 2295% CI: [-6.7, 9.7]
Comparison: Vaccine Group Difference (aQIV - QIV) for A/H3N2 at Day 2295% CI: [-14.2, 2.3]
Comparison: Vaccine Group Difference (aQIV - QIV) for B/Yamagata at Day 2295% CI: [8.4, 24.1]
Comparison: Vaccine Group Difference (aQIV - QIV) for B/Victoria at Day 2295% CI: [6.3, 22]
Primary
Safety Endpoint: Number of Subjects With SAEs, AEs Leading to Withdrawal From the Study, NOCDs, AESIs and Medically Attended AEs.
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.
Time frame: Day 1 through Day 356
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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| aQIV | Safety Endpoint: Number of Subjects With SAEs, AEs Leading to Withdrawal From the Study, NOCDs, AESIs and Medically Attended AEs. | SAEs | 7 Participants |
| aQIV | 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 |
| aQIV | Safety Endpoint: Number of Subjects With SAEs, AEs Leading to Withdrawal From the Study, NOCDs, AESIs and Medically Attended AEs. | NOCDs | 13 Participants |
| aQIV | Safety Endpoint: Number of Subjects With SAEs, AEs Leading to Withdrawal From the Study, NOCDs, AESIs and Medically Attended AEs. | AESIs | 1 Participants |
| aQIV | 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 |
| aQIV | 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 |
| Comparator QIV | Safety Endpoint: Number of Subjects With SAEs, AEs Leading to Withdrawal From the Study, NOCDs, AESIs and Medically Attended AEs. | Medically attended AEs | 141 Participants |
| Comparator QIV | Safety Endpoint: Number of Subjects With SAEs, AEs Leading to Withdrawal From the Study, NOCDs, AESIs and Medically Attended AEs. | SAEs | 4 Participants |
| Comparator QIV | Safety Endpoint: Number of Subjects With SAEs, AEs Leading to Withdrawal From the Study, NOCDs, AESIs and Medically Attended AEs. | AESIs | 1 Participants |
| Comparator QIV | 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 |
| Comparator QIV | 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 |
| Comparator QIV | Safety Endpoint: Number of Subjects With SAEs, AEs Leading to Withdrawal From the Study, NOCDs, AESIs and Medically Attended AEs. | NOCDs | 7 Participants |
Secondary
Immunogenicity Endpoint: Geometric Mean HI Titers (GMTs) and GMT Ratios for Homologous Influenza Strains (Day 1, Day 22, Day 181)
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
Time frame: Day 1, Day 22, Day 181
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| aQIV | 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 |
| aQIV | 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 |
| aQIV | 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 |
| aQIV | 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 |
| aQIV | 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 |
| aQIV | 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 |
| aQIV | 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 |
| aQIV | 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 |
| aQIV | 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 |
| aQIV | 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 |
| aQIV | 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 |
| aQIV | 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 |
| Comparator QIV | 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 | 50.88 titer |
| Comparator QIV | 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 | 165.23 titer |
| Comparator QIV | 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 | 700.78 titer |
| Comparator QIV | 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 | 282.31 titer |
| Comparator QIV | 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 | 155.97 titer |
| Comparator QIV | 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 | 908.63 titer |
| Comparator QIV | 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 | 454.46 titer |
| Comparator QIV | 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 | 17.78 titer |
| Comparator QIV | 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 | 100.80 titer |
| Comparator QIV | 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 | 29.26 titer |
| Comparator QIV | 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 | 14.33 titer |
| Comparator QIV | 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 | 163.95 titer |
Comparison: The ratio of GMT (GMTr) values between aQIV vs. QIV (ie, GMT\[aQIV\]:GMT\[QIV\]) for A/H1N1 at Day 1.95% CI: [1.6, 2.4]
Comparison: GMTr values between aQIV vs. QIV (ie, GMT\[aQIV\]:GMT\[QIV\]) for A/H1N1 at Day 22.95% CI: [1.3, 1.7]
Comparison: GMTr values between aQIV vs. QIV (ie, GMT\[aQIV\]:GMT\[QIV\]) for A/H1N1 at Day 181.95% CI: [1.3, 1.7]
Comparison: GMTr values between aQIV vs. QIV (ie, GMT\[aQIV\]:GMT\[QIV\]) for A/H3N2 at Day 1.95% CI: [1.7, 2.7]
Comparison: GMTr values between aQIV vs. QIV (ie, GMT\[aQIV\]:GMT\[QIV\]) for A/H3N2 at Day 22.95% CI: [1.2, 1.5]
Comparison: GMTr values between aQIV vs. QIV (ie, GMT\[aQIV\]:GMT\[QIV\]) for A/H3N2 at Day 181.95% CI: [1.2, 1.6]
Comparison: GMTr values between aQIV vs. QIV (ie, GMT\[aQIV\]:GMT\[QIV\]) for B/Yamagata at Day 1.95% CI: [1.5, 2.2]
Comparison: GMTr values between aQIV vs. QIV (ie, GMT\[aQIV\]:GMT\[QIV\]) for B/Yamagata at Day 22.95% CI: [1.5, 2]
Comparison: GMTr values between aQIV vs. QIV (ie, GMT\[aQIV\]:GMT\[QIV\]) for B/Yamagata at Day 181.95% CI: [1.6, 2.2]
Comparison: GMTr values between aQIV vs. QIV (ie, GMT\[aQIV\]:GMT\[QIV\]) for B/Victoria at Day 1.95% CI: [2.7, 4]
Comparison: GMTr values between aQIV vs. QIV (ie, GMT\[aQIV\]:GMT\[QIV\]) for B/Victoria at Day 22.95% CI: [1.2, 1.8]
Comparison: GMTr values between aQIV vs. QIV (ie, GMT\[aQIV\]:GMT\[QIV\]) for B/Victoria at Day 181.95% CI: [1.1, 1.5]
Secondary
Immunogenicity Endpoint: Geometric Mean HI Titers (GMTs) for Heterologous Influenza Strains (Day 1, Day 22, 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
Time frame: Day 1, Day 22, Day 181
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| aQIV | 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 |
| aQIV | 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 |
| aQIV | 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 |
| aQIV | 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 |
| aQIV | 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 |
| aQIV | 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 |
| Comparator QIV | Immunogenicity Endpoint: Geometric Mean HI Titers (GMTs) for Heterologous Influenza Strains (Day 1, Day 22, Day 181) | Day 181: B/Yamagata, Heterologous | 27.27 titer |
| Comparator QIV | Immunogenicity Endpoint: Geometric Mean HI Titers (GMTs) for Heterologous Influenza Strains (Day 1, Day 22, Day 181) | Day 22: A/H3N2, Heterologous | 402.54 titer |
| Comparator QIV | Immunogenicity Endpoint: Geometric Mean HI Titers (GMTs) for Heterologous Influenza Strains (Day 1, Day 22, Day 181) | Day 181: A/H3N2, Heterologous | 179.12 titer |
| Comparator QIV | Immunogenicity Endpoint: Geometric Mean HI Titers (GMTs) for Heterologous Influenza Strains (Day 1, Day 22, Day 181) | Day 1: B/Yamagata, Heterologous | 15.25 titer |
| Comparator QIV | Immunogenicity Endpoint: Geometric Mean HI Titers (GMTs) for Heterologous Influenza Strains (Day 1, Day 22, Day 181) | Day 22: B/Yamagata, Heterologous | 88.92 titer |
| Comparator QIV | Immunogenicity Endpoint: Geometric Mean HI Titers (GMTs) for Heterologous Influenza Strains (Day 1, Day 22, Day 181) | Day 1: A/H3N2, Heterologous | 48.02 titer |
Comparison: GMTr values between aQIV vs. QIV (ie, GMT\[aQIV\]:GMT\[QIV\]) for A/H3N2 at Day 1.95% CI: [1.8, 3.8]
Comparison: GMTr values between aQIV vs. QIV (ie, GMT\[aQIV\]:GMT\[QIV\]) for A/H3N2 at Day 22.95% CI: [1.3, 2.9]
Comparison: GMTr values between aQIV vs. QIV (ie, GMT\[aQIV\]:GMT\[QIV\]) for A/H3N2 at Day 181.95% CI: [1.3, 2.2]
Comparison: GMTr values between aQIV vs. QIV (ie, GMT\[aQIV\]:GMT\[QIV\]) for B/Yamagata at Day 1.95% CI: [1.5, 2.6]
Comparison: GMTr values between aQIV vs. QIV (ie, GMT\[aQIV\]:GMT\[QIV\]) for A/H3N2 at Day 22.95% CI: [1.8, 2.7]
Comparison: GMTr values between aQIV vs. QIV (ie, GMT\[aQIV\]:GMT\[QIV\]) for A/H3N2 at Day 181.95% CI: [2.1, 3.2]
Secondary
Immunogenicity Endpoint: Geometric Mean Ratios (GMR) for Heterologous Influenza Strains
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
Time frame: Day 1, Day 22, and Day 181
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| aQIV | Immunogenicity Endpoint: Geometric Mean Ratios (GMR) for Heterologous Influenza Strains | Day 181/Day 1: A/H3N2, Heterologous | 3.72 ratio |
| aQIV | Immunogenicity Endpoint: Geometric Mean Ratios (GMR) for Heterologous Influenza Strains | Day 22/Day 1: B/Yamagata, Heterologous | 9.29 ratio |
| aQIV | Immunogenicity Endpoint: Geometric Mean Ratios (GMR) for Heterologous Influenza Strains | Day 181/Day 1: B/Yamagata, Heterologous | 3.31 ratio |
| aQIV | Immunogenicity Endpoint: Geometric Mean Ratios (GMR) for Heterologous Influenza Strains | Day 22/Day 1: A/H3N2, Heterologous | 7.80 ratio |
| Comparator QIV | Immunogenicity Endpoint: Geometric Mean Ratios (GMR) for Heterologous Influenza Strains | Day 22/Day 1: A/H3N2, Heterologous | 4.98 ratio |
| Comparator QIV | Immunogenicity Endpoint: Geometric Mean Ratios (GMR) for Heterologous Influenza Strains | Day 181/Day 1: A/H3N2, Heterologous | 2.19 ratio |
| Comparator QIV | Immunogenicity Endpoint: Geometric Mean Ratios (GMR) for Heterologous Influenza Strains | Day 181/Day 1: B/Yamagata, Heterologous | 1.30 ratio |
| Comparator QIV | Immunogenicity Endpoint: Geometric Mean Ratios (GMR) for Heterologous Influenza Strains | Day 22/Day 1: B/Yamagata, Heterologous | 4.21 ratio |
Secondary
Immunogenicity Endpoint: Geometric Mean Ratios (GMR) for Homologous Influenza Strains
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
Time frame: Day 1, Day 22, and Day 181
Population: 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).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| aQIV | Immunogenicity Endpoint: Geometric Mean Ratios (GMR) for Homologous Influenza Strains | Day 22/Day 1: A/H1N1, Homologous | 5.82 ratio |
| aQIV | Immunogenicity Endpoint: Geometric Mean Ratios (GMR) for Homologous Influenza Strains | Day 22/Day 1: B/Yamagata, Homologous | 8.33 ratio |
| aQIV | Immunogenicity Endpoint: Geometric Mean Ratios (GMR) for Homologous Influenza Strains | Day 22/Day 1: A/H3N2, Homologous | 5.41 ratio |
| aQIV | Immunogenicity Endpoint: Geometric Mean Ratios (GMR) for Homologous Influenza Strains | Day 181/Day 1: B/Yamagata, Homologous | 2.57 ratio |
| aQIV | Immunogenicity Endpoint: Geometric Mean Ratios (GMR) for Homologous Influenza Strains | Day 181/Day 1: A/H1N1, Homologous | 2.40 ratio |
| aQIV | Immunogenicity Endpoint: Geometric Mean Ratios (GMR) for Homologous Influenza Strains | Day 22/Day 1: B/Victoria, Homologous | 9.26 ratio |
| aQIV | Immunogenicity Endpoint: Geometric Mean Ratios (GMR) for Homologous Influenza Strains | Day 181/Day 1: A/H3N2, Homologous | 2.73 ratio |
| aQIV | Immunogenicity Endpoint: Geometric Mean Ratios (GMR) for Homologous Influenza Strains | Day 181/Day 1: B/Victoria, Homologous | 2.55 ratio |
| Comparator QIV | Immunogenicity Endpoint: Geometric Mean Ratios (GMR) for Homologous Influenza Strains | Day 181/Day 1: A/H3N2, Homologous | 2.03 ratio |
| Comparator QIV | Immunogenicity Endpoint: Geometric Mean Ratios (GMR) for Homologous Influenza Strains | Day 22/Day 1: A/H1N1, Homologous | 3.93 ratio |
| Comparator QIV | Immunogenicity Endpoint: Geometric Mean Ratios (GMR) for Homologous Influenza Strains | Day 181/Day 1: A/H1N1, Homologous | 1.60 ratio |
| Comparator QIV | Immunogenicity Endpoint: Geometric Mean Ratios (GMR) for Homologous Influenza Strains | Day 22/Day 1: A/H3N2, Homologous | 4.03 ratio |
| Comparator QIV | Immunogenicity Endpoint: Geometric Mean Ratios (GMR) for Homologous Influenza Strains | Day 181/Day 1: B/Victoria, Homologous | 1.97 ratio |
| Comparator QIV | Immunogenicity Endpoint: Geometric Mean Ratios (GMR) for Homologous Influenza Strains | Day 22/Day 1: B/Yamagata, Homologous | 4.77 ratio |
| Comparator QIV | Immunogenicity Endpoint: Geometric Mean Ratios (GMR) for Homologous Influenza Strains | Day 181/Day 1: B/Yamagata, Homologous | 1.39 ratio |
| Comparator QIV | Immunogenicity Endpoint: Geometric Mean Ratios (GMR) for Homologous Influenza Strains | Day 22/Day 1: B/Victoria, Homologous | 6.21 ratio |
Secondary
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)
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
Time frame: Day 1, Day 181
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| aQIV | 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 |
| aQIV | 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 |
| Comparator QIV | 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 | 80.4 Percentage of subjects |
| Comparator QIV | 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 | 37.5 Percentage of subjects |
Comparison: Vaccine Group Difference (aQIV - QIV) for A/H3N2 at Day 18195% CI: [9.5, 24.1]
Comparison: Vaccine Group Difference (aQIV - QIV) for B/Yamagata at Day 18195% CI: [35.9, 55.8]
Secondary
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)
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
Time frame: Day 1, Day 181
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| aQIV | 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 |
| aQIV | 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 |
| aQIV | 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 |
| aQIV | 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 |
| Comparator QIV | 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 | 45.0 Percentage of subjects |
| Comparator QIV | 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 | 94.8 Percentage of subjects |
| Comparator QIV | 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 | 39.8 Percentage of subjects |
| Comparator QIV | 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 | 94.0 Percentage of subjects |
Comparison: Vaccine Group Difference (aQIV - QIV) for A/H1N1 at Day 18195% CI: [2.4, 8.4]
Comparison: Vaccine Group Difference (aQIV - QIV) for A/H3N2 at Day 18195% CI: [3.1, 9.3]
Comparison: Vaccine Group Difference (aQIV - QIV) for B/Yamagata at Day 18195% CI: [25, 40.9]
Comparison: Vaccine Group Difference (aQIV - QIV) for B/Victoria at Day 18195% CI: [29.6, 44.7]
Secondary
Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion and Difference in Percentage of Subjects Achieving Seroconversion for Heterologous Influenza Strains (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/H3N2 is Influenza A H3N2 Hong Kong/2014 Ab; B/Yamagata is Influenza B Phuket/2013 Ab
Time frame: Day 1, Day 181
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| aQIV | 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 |
| aQIV | 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 |
| Comparator QIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion and Difference in Percentage of Subjects Achieving Seroconversion for Heterologous Influenza Strains (Day 181) | A/H3N2, Heterologous | 30.4 Percentage of subjects |
| Comparator QIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion and Difference in Percentage of Subjects Achieving Seroconversion for Heterologous Influenza Strains (Day 181) | B/Yamagata, Heterologous | 13.2 Percentage of subjects |
Comparison: Vaccine Group Difference (aQIV - QIV) for A/H3N2 at Day 18195% CI: [-5.2, 16.3]
Comparison: Vaccine Group Difference (aQIV - QIV) for B/Yamagata at Day 18195% CI: [5.3, 23.6]
Secondary
Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion and Differences in Percentage of Subjects Achieving Seroconversion for Homologous Influenza Strains (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.
Time frame: Day 1, Day 181
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| aQIV | 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 |
| aQIV | 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 |
| aQIV | 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 |
| aQIV | 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 |
| Comparator QIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion and Differences in Percentage of Subjects Achieving Seroconversion for Homologous Influenza Strains (Day 181) | B/Victoria, Homologous | 22.7 Percentage of subjects |
| Comparator QIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion and Differences in Percentage of Subjects Achieving Seroconversion for Homologous Influenza Strains (Day 181) | A/H1N1, Homologous | 21.9 Percentage of subjects |
| Comparator QIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion and Differences in Percentage of Subjects Achieving Seroconversion for Homologous Influenza Strains (Day 181) | B/Yamagata, Homologous | 12.7 Percentage of subjects |
| Comparator QIV | Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion and Differences in Percentage of Subjects Achieving Seroconversion for Homologous Influenza Strains (Day 181) | A/H3N2, Homologous | 27.9 Percentage of subjects |
Comparison: Vaccine Group Difference (aQIV - QIV) for A/H1N1 at Day 18195% CI: [-1.6, 13]
Comparison: Vaccine Group Difference (aQIV - QIV) for A/H3N2 at Day 18195% CI: [-5.5, 9.8]
Comparison: Vaccine Group Difference (aQIV - QIV) for B/Yamagata at Day 18195% CI: [5.3, 18.3]
Comparison: Vaccine Group Difference (aQIV - QIV) for B/Victoria at Day 18195% CI: [-8.4, 5.7]
Secondary
Safety Endpoint: Number of Subjects With a Diagnosis of Failure to Thrive or Short Stature
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.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| aQIV | Safety Endpoint: Number of Subjects With a Diagnosis of Failure to Thrive or Short Stature | Subjects with diagnosis of failure to thrive | 0 participants |
| aQIV | Safety Endpoint: Number of Subjects With a Diagnosis of Failure to Thrive or Short Stature | Subjects with diagnosis of short stature | 0 participants |
| Comparator QIV | Safety Endpoint: Number of Subjects With a Diagnosis of Failure to Thrive or Short Stature | Subjects with diagnosis of failure to thrive | 0 participants |
| Comparator QIV | Safety Endpoint: Number of Subjects With a Diagnosis of Failure to Thrive or Short Stature | Subjects with diagnosis of short stature | 0 participants |
Secondary
Safety Endpoint: Number of Subjects With Any Unsolicited AEs
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).
Time frame: Day 1 through Day 22
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| aQIV | Safety Endpoint: Number of Subjects With Any Unsolicited AEs | 85 Participants |
| Comparator QIV | Safety Endpoint: Number of Subjects With Any Unsolicited AEs | 60 Participants |
Secondary
Safety Endpoint: Number of Subjects With Solicited Local and Systemic Adverse Events (AEs)
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).
Time frame: Up to 7 days following vaccination
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| aQIV | Safety Endpoint: Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Solicited AEs, Any | 202 Participants |
| aQIV | Safety Endpoint: Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Solicited Local AEs | 173 Participants |
| aQIV | Safety Endpoint: Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Solicited Systemic AEs | 127 Participants |
| aQIV | Safety Endpoint: Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Other | 66 Participants |
| Comparator QIV | Safety Endpoint: Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Other | 26 Participants |
| Comparator QIV | Safety Endpoint: Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Solicited AEs, Any | 148 Participants |
| Comparator QIV | Safety Endpoint: Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Solicited Systemic AEs | 80 Participants |
| Comparator QIV | Safety Endpoint: Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Solicited Local AEs | 112 Participants |